UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
`
`15/655,078
`
`07/20/2017
`
`Alexandru DEAC
`
`36850430001
`
`2919
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE, NW.
`WASHINGTON, DC 20005
`
`TRAN MY CHAU T
`
`ART UNIT
`
`1629
`
`PAPER NUMBER
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`NOTIFICATION DATE
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`DELIVERY MODE
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`10/22/2019
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`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
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`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
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`following e—mail address(es):
`e-offiee @ sternekessler. com
`robin. weatherhead @ abeie.Com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0/7709 A0170” Summary
`
`Application No.
`15/655,078
`Examiner
`MY-CHAU T TRAN
`
`Applicant(s)
`DEAC et al.
`Art Unit
`1629
`
`AIA (FITF) Status
`Yes
`
`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed after SIX (6) MONTHS from the mailing
`date of this communication.
`|f NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1). Responsive to communication(s) filed on 25 July 2019.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) C] This action is non-final.
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`3)[:] An election was made by the applicant in response to a restriction requirement set forth during the interview on
`; the restriction requirement and election have been incorporated into this action.
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`4)[:] Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`5)
`Claim(s)
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`1 and 3—21 is/are pending in the application.
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`5a) Of the above claim(s) 5—7,12 and 18—19 is/are withdrawn from consideration.
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`E] Claim(s) _ is/are allowed.
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`Claim(s) 1,3—4,8—11,13—17 and 20—21 is/are rejected.
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`C] Claim(s) _
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`is/are objected to.
`
`) ) ) )
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`6 7
`
`8
`
`
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`are subject to restriction and/or election requirement
`[:1 Claim(s)
`9
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http://www.uspto.gov/patents/init events/pph/index.'sp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
`10):] The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 25 July 2019 is/are: a)- accepted or b)[:] objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)C] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)I:] All
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`b)|:] Some**
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`c)C] None of the:
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`1.|:] Certified copies of the priority documents have been received.
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`21:] Certified copies of the priority documents have been received in Application No.
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`3D Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
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`1) C] Notice of References Cited (PTO-892)
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`Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`2)
`Paper No(s)/Mail Datew.
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
`
`Part of Paper No./Mai| Date 20191015
`
`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 2
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`DETAILED ACTION
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`Notice ofPre-AIA 0r AIA Status
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`1.
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`The present application, filed on or after March 16, 2013, is being examined under the
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`first inventor to file provisions of the AIA.
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`Application and Claims Status
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`2.
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`Applicant’s amendment and response filed on 07/25/2019 are acknowledged and entered.
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`3.
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`Claims 1—20 were pending. In the amendment as filed, applicants have amended claims
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`1, 3, 9, and 17; cancelled claim 2; and added claim 21. Therefore, claims 1 and 3—21 are
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`currently pending. Additionally, it is relevant to note that the status identifier for instant claim
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`17 is improper since there are markings to indicate the changes that have been made relative to
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`the immediate prior version of the claims, i.e. the claims filed on 07/20/2017. Appropriate
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`correction is require and to further prosecution the status identifier for instant claim 17 is
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`interpreted to be ‘Currently amended’.
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`4.
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`Claims 5—7, 12, 18, and 19 are drawn to non—elected species and/or inventions, wherein
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`the election was made with traverse in the reply filed on 10/12/2018 in respond to the restriction
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`and/or species election requirement(s) mailed on 08/13/2018, and thus these claims remain
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`withdrawn from further consideration by the examiner, 37 CFR 1.142(b), there being no
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`allowable generic claim.
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`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 3
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`5.
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`Accordingly, claims 1, 3, 4, 8—11, 13—17, 20, and 21 are under consideration in this Office
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`Action.
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`Information Disclosure Statement
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`6.
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`The information disclosure statement (IDS) that was filed on 10/08/2019 has been
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`reviewed, and the references that have been considered are initialed as recorded in PTO—1449
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`forms.
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`Drawings
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`7.
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`The replacement drawings were received on 07/25/2019, which has overcome the
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`rejection regarding the color drawings of figures 2—4 and 6—9 and the color photograph of figure
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`5. These drawings are acceptable.
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`Status of Claim(s) 0bjection(s) and /or Rejection(s)
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`8.
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`The rejection of claims 3, 9, and 17 under 35 U.S.C. 112(b) or 35 USC 112 (pre—AIA),
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`second paragraph, as being indefinite has been withdrawn in light of applicant’s amendments of
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`claims 3, 9, and 17 thereto.
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`9.
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`The rejection of claims 1, 2, 4, 8, 10, 11, 13, and 20 under 35 U.S.C. 102(a)(1) as being
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`anticipated by Nystrom et al. (US Patent 5,635,213) has been withdrawn in View of applicant’s
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`arguments (see pages 10—11 in the respond filed 07/25/2019) and/or amendments of claims 1, 3,
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`9, and 17.
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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 4
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`10.
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`The rejection under the judicially created doctrine of obviousness—type double patenting
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`of claims 16 and 17 over claims 1 and 2 of US. Patent No. 10,117,843 B2 (hereinafter refers to
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`as Conjeevaram et al.) has been withdrawn in light of applicant’s arguments, see page 12 in the
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`respond filed 07/25/2019.
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`Maintained Rejecti0n(s)
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`Claim Rejections - 35 US C § 103
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`11.
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`In the event the determination of the status of the application as subject to AIA 35 USC.
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`102 and 103 (or as subject to pre—AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the
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`statutory basis for the rejection will not be considered a new ground of rejection if the prior art
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`relied upon, and the rationale supporting the rejection, would be the same under either status.
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`12.
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`The following is a quotation of 35 USC. 103 which forms the basis for all obviousness
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`rejections set forth in this Office action:
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`A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not
`identically disclosed as set forth in section 102, if the differences between the claimed invention and the
`prior art are such that the claimed invention as a whole would have been obvious before the effective
`filing date of the claimed invention to a person having ordinary skill in the art to which the claimed
`invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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`13.
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`This application currently names joint inventors. In considering patentability of the
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`claims the examiner presumes that the subject matter of the various claims was commonly
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`owned as of the effective filing date of the claimed invention(s) absent any evidence to the
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`contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and
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`effective filing dates of each claim that was not commonly owned as of the effective filing date
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`of the later invention in order for the examiner to consider the applicability of 35 USC.
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`102(b)(2)(C) for any potential 35 USC. 102(a)(2) prior art against the later invention.
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`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 5
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`14.
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`Claims 1, 3, 4, 8—11, 13—15, 20, and 21 are rejected under 35 U.S.C. 103 as being
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`unpatentable over Nystrom et al. (US Patent 5,635,213).
`
`For claims 1, 3, 4, 8-11, 13, and 15, Nystrom et al. claimed a method for treating
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`Parkinson’s disease by administering intraduodenally a pharmaceutical formulation (Claims 1
`
`and 9). The pharmaceutical formulation comprises L—DOPA (refers to instant claimed levodopa
`
`active agent), carbidopa (refers to instant claimed carbidopa active agent), and an aqueous carrier
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`(refers to instant claimed polymer—based suspending agent and a liquid vehicle) (Claims 1, 3, 5 —
`
`7, and 9). The type of carrier include a solution of methyl cellulose, sodium carboxymethyl
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`cellulose, carboxymethyl cellulose or carboxypolymethylene, or a mixture of any of these
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`materials (Claim 7). Nystrom et al. also claimed that active agent has a particle size in the range
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`of 0.1 to 20 um and preferably then 0.1 to 5 um (Claim 2) (refers to instant claims 10 and 11);
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`and the active agent in an amount from 0.01 up to 20 weight percent and preferably then 0.1 to 5
`
`weight percent (Claim 4). Nystrom et al. also exemplified a pharmaceutical formulation
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`comprising L—DOPA at 2.0 weight percent; carbidopa at 0.5 weight percent; and a 1.8 weight
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`percent water solution of methylcellulose (Example 1) (refers to instant claim 8); and a
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`pharmaceutical formulation comprising 0.3% w/w % Carbopol® 934P (Example 2 and Table 1).
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`These teachings anticipate the instant claimed concentration limitations of levodopa, carbidopa,
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`and the polymer—based suspending agent as recited by claims 1, 4, and 9.
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`Furthermore, Nystrom et al. disclose that (i) the pharmaceutical formulation uses a very
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`fine particulate quality of the drug in combination with the viscous aqueous medium to increase
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`the physical stability of the formulation (col. 2, lines 32—38); (ii) it was also unexpected that the
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`chemical stability of L—DOPA was acceptable in this aqueous medium and that good chemical
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`stability was achieved by the exclusion of atmospheric oxygen and the use of an aqueous
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`

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`Art Unit: 1629
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`Page 6
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`medium of high viscosity (col. 38—42). Thus, the pharmaceutical formulation is filled and stored
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`under exclusion of oxygen (col. 2, lines 9—11; col. 3, line 66 thru col. 4, line 13) (refers to instant
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`claims 13 and 15); (iii) the aqueous carrier having a viscosity of at least 300 mPas, measured at a
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`moderate shear rate, and preferably being of a plastic or pseudoplastic nature for the plastic or
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`pseudoplastic properties means that the vehicle or carrier will lower its viscosity during agitation,
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`i.e. so—called shear thinning wherein such a reduction in viscosity makes the liquid aqueous
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`carrier more easy to pump through tubes with a small inner diameter of the type used in this
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`invention (col. 2, lines 50—67); (iv) suitable viscosity may be obtained by adjusting the molecular
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`weight of the colloid used into a suitable range wherein the molecular weight in its turn may be
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`adjusted by selecting a suitable degree of polymerization and/or by selecting a suitable
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`concentration of the colloid in the aqueous system (col. 3, lines 26—39); and (v) the preferred type
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`of aqueous carrier include methyl cellulose, sodium carboxymethyl cellulose, carboxy—methyl
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`cellulose and carbomers (carboxypolymethylenes, trade name Carbopol®) (col. 3, lines 40—43).
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`For claim 20, Nystrom et a1. claimed a method for treating Parkinson’s disease by
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`administering intraduodenally a pharmaceutical formulation (Claims 1 and 9). The
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`pharmaceutical formulation comprises L—DOPA (refers to instant claimed levodopa active
`
`agent), carbidopa (refers to instant claimed carbidopa active agent), and an aqueous carrier
`
`(refers to instant claimed polymer—based suspending agent and a liquid vehicle) (Claims 1, 3, 5 —
`
`7, and 9). The type of carrier include a solution of methyl cellulose, sodium carboxymethyl
`
`cellulose, carboxymethyl cellulose or carboxypolymethylene, or a mixture of any of these
`
`materials (Claim 7). Nystrom et al. also claimed that active agent has a particle size in the range
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`of 0.1 to 20 um and preferably then 0.1 to 5 um (Claim 2); and the active agent in an amount
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`from 0.01 up to 20 weight percent and preferably then 0.1 to 5 weight percent (Claim 4).
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`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 7
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`Nystrom et al. also exemplified a pharmaceutical formulation comprising L—DOPA at 2.0 weight
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`percent; carbidopa at 0.5 weight percent; and a 1.8 weight percent water solution of
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`methylcellulose (Example 1); and a pharmaceutical formulation comprising 0.3% w/w %
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`Carbopol® 934P (Example 2 and Table 1). These teachings anticipate the instant claimed
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`concentration limitations of levodopa, carbidopa, and the polymer—based suspending agent as
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`recited by claims 1, 4, and 9.
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`The teachings of Nystrom et al. differ from the presently claimed invention as follows:
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`(i) While Nystrom et al. do not explicitly teach the limitations recited by claim 1 (i.e. “(ii)
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`the acceptance value of the pharmaceutical composition is less than or equal to 15
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`with respect to the levodopa active agent and less than or equal to 15 with respect to
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`the carbidopa active agent; and (iii) the yield value of the pharmaceutical composition
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`is at least about 0.3 Pa, wherein.“ the acceptance value and yield value are measured
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`after exposing the pharmaceutical composition to a temperature of about 25 OC and
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`relative humidity of about 60% for a period of at least about 8 weeks”), these
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`limitations are functional limitations that characterize intrinsic properties of the
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`claimed pharmaceutical composition, which is taught by Nystrom et al. As recognized
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`by MPEP § 2ll2.01(ll), “Products of identical chemical composition can not have
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`mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655,
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`1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
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`Therefore, if the prior art teaches the identical chemical structure, the properties
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`applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the
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`claimed composition was a pressure sensitive adhesive containing a tacky polymer
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`while the product of the reference was hard and abrasion resistant. “The Board
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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 8
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`correctly found that the virtual identity of monomers and procedures sufficed to
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`support a prima facie case of unpatentability of Spada’s polymer latexes for lack of
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`novelty”).
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`(ii) First, the newly amended claims 1, 3, 9, and new claim 21 recites the limitations of
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`“Carbomer H0m0p0lymer Type A” and/or “Carbomer H0m0p0lymer Type B”. These
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`limitations are interpreted to be the compounds Carbopol® 971P and Carbopol®
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`974P, respectively, and this interpretation is fully supported by the present
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`specification in para. [0055] on pg. 12. Even though Nystrom et al. do not explicitly
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`teach the limitations recited by claims 1, 3, 9, and 21 regarding the specific type of
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`‘polymer-based suspending agent’ (i.e. “Carbopol® 971P 0r Carbopol® 974P”),
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`these specific type of ‘polymer-based suspending agent’ are commercially available
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`from Lubrizol (see Product information of Carbopol® 974P, which is also the elected
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`species). Additionally, Nystrom et al. specifically teach using carbomers
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`(carboxypolymethylenes, trade name Carbopol®) as a type of carrier (col. 3, lines 40—
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`43). It would have been obvious for a person of ordinary skill in the art, as of the
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`effective filing date of the claimed invention, to substitute the carbomer of Nystrom et
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`al. with the Carbopol® 974P as taught by Lubrizol. As recognized by MPEP §
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`2144.07, the selection of a known material based on its suitability for its intended use
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`supported a primafacie obviousness determination in Sinclair & Carroll Co. v.
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`Interchemical Corp., 325 US. 327,65 USPQ 297 (1945) (Claims to a printing ink
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`comprising a solvent having the vapor pressure characteristics of butyl carbitol so that
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`the ink would not dry at room temperature but would dry quickly upon heating were
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`held invalid over a reference teaching a printing ink made with a different solvent that
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`Art Unit: 1629
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`Page 9
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`was nonvolatile at room temperature but highly volatile when heated in view of an
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`article which taught the desired boiling point and vapor pressure characteristics of a
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`solvent for printing inks and a catalog teaching the boiling point and vapor pressure
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`characteristics of butyl carbitol. “Reading a list and selecting a known compound to
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`meet known requirements is no more ingenious than selecting the last piece to put in
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`the last opening in ajig—saw puzzle.” 325 US. at 335, 65 USPQ at 301.). See also In
`
`re Leshin, 277 F.2d 197, 125 USPQ 416(CCPA 1960) (selection of a known plastic to
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`make a container of a type made of plastics prior to the invention was held to be
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`obvious).
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`(iii) Though Nystrom et al. do not explicitly teach the concentration for the specific type
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`of ‘polymer-based suspending agent’ recited by claim 9 (i.e. “Carbomer
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`Homopolymer Type A or Carbomer Homopolymer Type B in an amount of about 0.]
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`w/w % to about 0.2 w/w % of the total composition”), Nystrom et a1. specifically teach
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`using 0.3% w/w % Carbopol® 934P (Example 2 and Table 1). As recognized by
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`MPEP § 2144.05, a prima facie case of obviousness exists where the claimed ranges
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`or amounts do not overlap with the prior art but are merely close. Titanium Metals
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`Corp. ofAmerica v. Banner, 778 F.2d 775,783, 227 USPQ 773, 779 (Fed. Cir. 1985)
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`(Court held as proper a rejection of a claim directed to an alloy of “having 0.8%
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`nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a
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`reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and
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`0.94% nickel, 0.31% molybdenum, balance titanium. “The proportions are so close
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`that prima facie one skilled in the art would have expected them to have the same
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`properties”). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520
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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 10
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`U.S. 17, 41USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification
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`process using a pH of 5.0 could infringe a patented purification process requiring a pH
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`of 6.0—9.0, explaining “[t]hat which infringes if later anticipates if earlier”); In re Aller,
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`220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA1955) (Claimed process which was
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`performed at a temperature between 40°C and 80°C and an acid concentration
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`between 25% and 70% was held to be prima facie obvious over a reference process
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`which differed from the claims only in that the reference process was performed at a
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`temperature of 100°C and an acid concentration of 10%).
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`(iv) While Nystrom et al. do not explicitly teach the concentration recited by claim 14
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`(ie. “about 40 mg/mL or the levodopa active agent and about IO mg/mL 0fthe
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`carbidopa active agent”), Nystrom et a1. exemplified a pharmaceutical formulation
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`comprising L—DOPA at 2.0 weight percent and carbidopa at 0.5 weight percent
`
`(Example 1). Thus, Nystrom et al. teach a concentration ratio of L—DOPA to
`
`carbidopa is 4:1. As recognized by MPEP § 2144.05, in the case where the claimed
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`ranges “overlap or lie inside ranges disclosed by the prior art” a primafacie case of
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`obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re
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`Woodrufi, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught
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`carbon monoxide concentrations of “about 1—5%” while the claim was limited to
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`“more than 5%.” The court held that “about 1—5%” allowed for concentrations slightly
`
`above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469—71, 43
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`USPQ2d 1362, 1365—66 (Fed. Cir. 1997) (Claim reciting thickness of a protective
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`layer as falling within a range of “50 to 100 Angstroms” considered primafacie
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`obvious in view of prior art reference teaching that “for suitable protection, the
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`Page 11
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`thickness of the protective layer should be not less than about 10 nm [i.e., 100
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`Angstroms].” The court stated that “by stating that ‘suitable protection’ is provided if
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`the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly
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`teaches the use of a thickness within [applicant’s] claimed range”).
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`Therefore, the combine teachings of Nystrom et al. do render the inventions of the instant
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`claims primafacie obvious.
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`Response to Arguments
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`15.
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`Applicant’s arguments directed to the above rejection under 35 U.S.C. 103 were
`
`considered but they are not persuasive for the following reasons. Please note that the above
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`rejection has been modified from its original version to more clearly address applicant’s newly
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`amended and/or added claims and/or arguments.
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`[1] Applicant alleges that “Nystrom et al. thus fails to establish that the acceptance
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`values and yield values are result-efi‘ective variables in terms of the long-term stability of
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`compositions comprising Carbomer Homopolymer Type A, and Carbomer Homopolymer Type
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`B. See MPEP 2]44.05(II)(B) (stating ”a particular parameter mustfirst be recognized as a
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`result-efi‘ective variable, i.e., a variable which achieves a recognized result, before the
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`determination of the optimum or workable ranges of said variable might be characterized as
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`routine experimentation, because 'obvious to try' is not a valid rationale for an obviousness
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`finding. ”). Accordingly, this rejection must be reconsidered and withdrawn”.
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`This is not found persuasive for the following reasons:
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`[1] The examiner respectfully disagrees. It is the examiner’s position that the teachings
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`of Nystrom et al. do render the invention of the instant claims prima facie obvious. First, as
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`clearly stated in the rejection above the limitations recited by claim 1 (i.e “(ii) the acceptance
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`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 12
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`value of the pharmaceutical composition is less than or equal to 15 with respect to the levodopa
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`active agent and less than or equal to 15 with respect to the carbidopa active agent; and (iii) the
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`yield value of the pharmaceutical composition is at least about 0.3 Pa, wherein: the acceptance
`
`value and yield value are measured after exposing the pharmaceutical composition to a
`
`temperature ofabout 25°C and relative humidity ofabout 60% for a period ofat least about 8
`
`weeks”) are functional limitations that characterize intrinsic properties of the claimed
`
`pharmaceutical composition. Here, the teachings of Nystrom et al. meets the claimed structural
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`features of the claimed pharmaceutical composition as clearly discussed in the rejection above.
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`Further, Nystrom et al. disclose that the pharmaceutical formulation uses a very fine particulate
`
`quality of the drug in combination with the viscous aqueous medium to increase the physical
`
`stability of the formulation (col. 2, lines 32—38). Thus, the pharmaceutical formulation of
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`Nystrom et al. would also perform the claimed functional limitations of the claimed
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`pharmaceutical composition. See MPEP § 2112.01(II). Second, in response to applicant’s
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`argument, applicant is directed to MPEP § 2144.05(lll)(A) that states: Applicants can rebut a
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`prima facie case of obviousness by showing the criticality 0f the range. “The law is replete with
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`cases in which the difference between the claimed invention and the prior art is some range or
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`other variable within the claims. .
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`.
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`. In such a situation, the applicant must show that the
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`particular range is critical, generally by showing that the claimed range achieves unexpected
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`results relative to the prior art range.” In re Woodrufi‘, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.
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`Cir. 1990). See also Minerals Separation, Ltd. v. Hyde, 242 US. 261, 271 (1916) (a patent based
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`on a change in the proportions of a prior product or process (changing from 4—10% oil to 1% oil)
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`must be confined to the proportions that were shown to be critical (1%)); In re Scherl, 156 F.2d
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`72, 74—75, 70 USPQ 204, 205 (CCPA 1946) (“Where the issue ofcriticality is involved, the
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`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 13
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`applicant has the burden of establishing his position by a proper showing of the facts upon
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`which he relies.”), In re Becket, 88 F.2d 684 (CCPA 1937) (“Where the component elements of
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`alloys are the same, and where they approach so closely the same range of quantities as is here
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`the case, it seems that there ought to be some noticeable difference in the qualities of the
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`respective alloys”); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933) (“It is well established that,
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`while a change in the proportions of a combination shown to be old, such as is here involved,
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`may be inventive, such changes must be critical as compared with the proportions used in the
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`prior processes, producing a difference in kind rather than degree”), In re Wells, 56 F.2d 674,
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`675 (CCPA 1932) (“Changes in proportions of agents used in combinations .
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`.
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`. in order to be
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`patentable, must be critical as compared with the proportions of the prior processes”). Here,
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`applicants have not provide any type of evidences that the claimed values are ‘critical’ and/or
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`that such values are unexpected.
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`Therefore, the teachings of Nystrom et al. do render the invention of the instant claims prima
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`facie obvious, and the rejection is maintained.
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`16.
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`Claims 16 and 17 are allowable.
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`Allowable Subject Matter
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`17.
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`The following is a statement of reasons for the indication of allowable subject matter:
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`Claims 16 and 17 are allowable for the reason that the cited prior arts do not teach or
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`fairly suggest the presently claimed method of making a pharmaceutical composition with the
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`method step of ‘adding a neutralizing agent to the dispersion to bring the pH to about 6.5 to
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`form a medium’ wherein the claimed pharmaceutical composition comprises the structural
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`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 14
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`features of ‘levodopa active agent’, ‘carbidopa active agent’, and an ‘acrylic acid-based polymer
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`suspending agent’ that is either “Carbomer Homopolymer Type A or Carbomer Homopolymer
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`Type B”.
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`Conclusion
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`18.
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`THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time
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`policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE
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`MONTHS from the mailing date of this action. In the event a first reply is filed within TWO
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`MONTHS of the mailing date of this final action and the advisory action is not mailed until after
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`the end of the THREE—MONTH shortened statutory period, then the shortened statutory period
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`will expire on the date the advisory action is mailed, and any extension fee pursuant to 37
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`CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event,
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`however, will the statutory period for reply expire later than SIX MONTHS from the mailing
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`date of this final action.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to My—Chau T. Tran whose telephone number is 571—272—0810.
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`The examiner can normally be reached on Monday — Friday: 8 am — 4:30 pm (EST).
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`Examiner interviews are available via telephone, in—person, and video conferencing using
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`a USPTO supplied web—based collaboration tool. To schedule an interview, applicant is
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`encouraged to use the USPTO Automated Interview Request (AIR) at
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`
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`

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`Application/Control Number: 15/655,078
`Art Unit: 1629
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`Page 15
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Jeffrey S. Lundgren, can be reached on 571—272—5541. The fax phone number for the
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`organization Where this application or proceeding is assigned is 571—273—8300.
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`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
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`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
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`applications is available through Private PAIR only. For more information about the PAIR
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`system, see . If you have questions on access to the Private PAIR
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`system, contact the Electronic Business Center (EBC) at 866—217—9197 (toll—free). If you would
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`like assistance from a USPTO Customer Service Representative or access to the automated
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`information system, call 800—786—9199 (IN USA OR CANADA) or 571—272—1000.
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`/MY—CHAU T. TRAN/
`Primary Examiner, Art Unit 1629
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`October 17’ 2019
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`