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
`
`15/808,632
`
`11/09/2017
`
`Gregory D. Jay
`
`LUB-030
`
`8457
`
`GOODWIN PROCTER LLP
`
`PATENT ADMINISTRATOR
`100 Northern Avenue
`BOSTON MA 02210
`
`KOMATSU U N
`
`ART UNIT
`1658
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`04/08/2019
`
`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.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`
`following e—mail address(es):
`GLENN.WILLIAMS @ GOODWINPROCTERCOM
`PATENTBOS @ GOODWINPROCTERCOM
`PSOUSA-ATWOOD @GOODWINPROCTER.COM
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0/7709 A0170” Summary
`
`Application No.
`15/808,632
`Examiner
`LI N KOMATSU
`
`Applicant(s)
`Jay et al.
`Art Unit
`1658
`
`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 1/17/2019.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2a)D This action is FINAL.
`
`2b)
`
`This action is non-final.
`
`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.
`
`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.
`
`Disposition of Claims*
`5)
`Claim(s)
`
`1—2,4—2O and 28 is/are pending in the application.
`
`5a) Of the above claim(s) 8 and 10 is/are withdrawn from consideration.
`
`
`
`E] Claim(s)
`
`is/are allowed.
`
`Claim(s) 1—2,4—7,9,1 1—20 and 28 is/are rejected.
`
`Claim(s) 1—2,9 and 19—20 is/are objected to.
`
`) ) ) )
`
`are subject to restriction and/or election requirement
`E] Claim(s)
`* If any claims have been determined aflowabie. you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`http://www.jjgptggQV/patents/init_event§/pph/index.'sp or send an inquiry to PPeredhack@g§ptg.ggv.
`
`Application Papers
`
`10). The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 2/28/2018 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):] Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`
`a)D All
`
`b)l:] Some**
`
`c)l:I None of the:
`
`1.8 Certified copies of the priority documents have been received.
`
`2.8 Certified copies of the priority documents have been received in Application No.
`
`31:] 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)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`2) D Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
`
`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20190327
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 2
`
`DETAILED ACTION
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AIA.
`
`2.
`
`In the event the determination of the status of the application as subject to AIA 35
`
`U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
`
`correction of the statutory basis for the cited rejections will not be considered a new
`
`ground of rejection if the prior art relied upon, and the rationale supporting the rejection,
`
`would be the same under either status.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Response to Election/Restriction filed on 1/17/2019 is acknowledged.
`
`Claims 3 and 21 -27 have been cancelled.
`
`New claim 28 has been added.
`
`Claims 1, 2, 4-20 and 28 are pending in this application.
`
`Claims 8 and 10 are withdrawn from consideration as being drawn to non-elected
`
`species.
`
`8.
`
`Claims 1, 2, 4-7, 9, 11-20 and 28 are under examination.
`
`Election/Restrictions
`
`9.
`
`Applicant’s election without traverse of Group 1 (claims 1, 2 and 4-20) and
`
`election without traverse of the PRG4 sequence of residues 25-1404 of SEQ ID NO: 1
`
`as species of PRG4 or a biologically active fragment thereof; administration by injection
`
`as species of route of administering the PRG4 or a biologically active fragment thereof
`
`from claims 6-10; toe joint as species of joint for injection; heel as species of area of
`
`patient’s foot for injection from claim 10; administration of an amount of PRG4 sufficient
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 3
`
`to achieve a concentration of PRG4 in a synovial fluid of a joint of the subject of at least
`
`200 ug/ml as species of amount of PRG4 or a biologically active fragment thereof;
`
`human as species of subject; and weekly administration as species of administering
`
`scheme in the reply filed on 1/17/2019 is acknowledged. Because injection as the
`
`elected route of administering the PRG4 or a biologically active fragment thereof from
`
`claims 6-10 is not a species, the Examiner telephoned Applicant’s representative,
`
`Crystal A. Komm, on 2/6/2019 for clarification and further species election. Applicant’s
`
`representative elected on the phone intra-articular injection into a toe joint as species of
`
`route of administering the PRG4 or a biologically active fragment thereof on 2/7/2019
`
`(see PTO-413B dated 2/12/2018). Since Applicant elected toe joint as the area for
`
`injection, heel as the elected species of area of injection from claim 10 would not be
`
`searched and examined in current office action. The requirement is made FINAL in this
`
`office action.
`
`Group 1
`
`is drawn to a method of reducing joint pain in a subject with gout or
`
`pseudogout, and/or a method of treating gout or pseudogout in a subject, the method
`
`comprising administering to the subject a composition comprising PRG4 or a
`
`biologically active fragment thereof. A search was conducted on the elected species;
`
`and the PRG4 sequence of residues 25-1404 of SEQ ID NO: 1 as the elected species
`
`of PRG4 or a biologically active fragment thereof appears to be free of prior art.
`
`However, prior art was found for intra-articular injection into a toe joint as the elected
`
`species of route of administering the PRG4 or a biologically active fragment thereof; toe
`
`joint as the elected species of joint for injection; administration of an amount of PRG4
`
`sufficient to achieve a concentration of PRG4 in a synovial fluid of a joint of the subject
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 4
`
`of at least 200 ug/ml as the elected species of amount of PRG4 or a biologically active
`
`fragment thereof; human as the elected species of subject; and weekly administration
`
`as the elected species of administering scheme. A search was extended to the genus
`
`in claims 1 and 2; and prior art was found. Claim 8 and 10 are withdrawn from
`
`consideration as being drawn to non-elected species. Claims 1, 2, 4-7, 9, 11-20 and 28
`
`are examined on the merits in this office action.
`
`Please note: the PRG4 sequence of residues 25-1404 of SEQ ID NO: 1 as the
`
`elected species of PRG4 or a biologically active fragment thereof is not recited in instant
`
`claims 1, 2, 4-20 and 28.
`
`Objections
`
`10.
`
`The specification is objected to for the following minor informality: The amended
`
`specification filed on 2/28/2018 recites “3) Please delete paragraph [0041] and replace it
`
`with the following paragraph: [0030] As used herein, the term...”. There appears to be
`
`a typo in this recitation. The recitation should be “3) Please delete paragraph [0041]
`
`and replace it with the following paragraph: [0041] As used herein, the term...”.
`
`Applicant is required to correct this error.
`
`Please note, the specification has not been checked to the extent
`
`necessary to determine the presence of all possible error. Applicant's
`
`cooperation is required in correcting any errors of which applicant may become
`
`aware in the specification. MPEP § 608.01.
`
`11.
`
`Claim 1
`
`is objected to for the following minor informality: Claim 1 contains the
`
`acronym “PRG4”. An acronym in the first instance of claims should be expanded
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 5
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`upon/spelled out with the acronym indicated in parentheses, i.e., proteoglycan-4
`
`(PRG4). The abbreviation can be used thereafter.
`
`12.
`
`Claim 2 is objected to for the following minor informality: Applicant is suggested
`
`to amend claim 2 as “A method of treating gout or pseudogout in a subject in need
`
`thereof, the method comprising administering to the subject a composition comprising
`
`PRG4 or a biologically active fragment thereof”.
`
`13.
`
`Claim 9 is objected to for the following minor informality: Claim 9 recites
`
`“...wherein the PRG4 is administered to the subject by injection into area of the patient's
`
`body affected by gout”. Applicant is suggested to amend this recitation as “...wherein
`
`the PRG4 is administered to the subject by injection into area of the subject's body
`
`affected by gout”.
`
`14.
`
`Claim 19 is objected to for the following minor informality: Claim 19 recites “The
`
`method of claim 18, wherein the subject is a human, horse...”. Applicant is suggested
`
`to amend this recitation as “The method of claim 18, wherein the subject is human,
`
`horse...”.
`
`15.
`
`Claim 20 is objected to for the following minor informality: Claim 20 recites
`
`“...wherein the PRG4 is a administered weekly...”. There appears to be an extra word
`
`in this recitation. Applicant is suggested to amend this recitation as “...wherein the
`
`PRG4 is administered weekly...”.
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 6
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`Rejections
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`Claim Rejections - 35 USC § 102(a)(1)
`
`16.
`
`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that
`
`form the basis for the rejections under this section made in this Office action:
`
`A person shall be entitled to a patent unless —
`
`(a)(1) the claimed invention was patented, described in a printed
`
`publication, or in public use, on sale or otherwise available to the public
`
`before the effective filing date of the claimed invention.
`
`17.
`
`Claims 1, 2, 4-7, 9, 11-19 and 28 are rejected under 35 U.S.C. 102(a)(1) as
`
`being anticipated by Jay (US 2013/0116186 A1), and as evidenced by Fryar et al
`
`(National Health Statistics Reports, 2018, 122, pages 1-16).
`
`The instant claims 1, 2, 4-7, 9, 11-19 and 28 are drawn to a method of reducing
`
`joint pain in a subject with gout or pseudogout, and/or a method of treating gout or
`
`pseudogout in a subject, the method comprising administering to the subject a
`
`composition comprising PRG4 or a biologically active fragment thereof.
`
`Jay teaches a method of treating subject with an episodic case of gout or
`
`pseudo-gout (one type of joint trauma), the method comprises intra-articularly injecting
`
`lubricin (synonym of PRG4) into the joints such as keen, toe and others (see page 4,
`
`paragraph [0029]).
`
`It meets the limitation of patient population, active method step and
`
`active component (a composition comprising PRG4 or a biologically active fragment
`
`thereof) recited in instant claim 1; and the limitation of instant claim 2. With regards to
`
`the preamble “a method of reducing joint pain” recited in instant claim 1, this is a result-
`
`oriented limitation.
`
`In the instant case, Jay teaches the same active method step, i.e.,
`
`the same patient population and the same compound, therefore, administering the
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 7
`
`same compound to the same patient population would lead to the same effect, i.e.,
`
`reducing joint pain in a subject with gout or pseudogout. Therefore, the method in Jay
`
`meets the limitation of instant claim 1.
`
`lntra-articularly injecting lubricin (synonym of
`
`PRG4) into toe joint in Jay reads on intra-articular injection into a toe joint as the elected
`
`species of route of administering the PRG4 or a biologically active fragment thereof.
`
`With regards to the limitations recited in instant claims 6, 7 and 9, although Jay does not
`
`explicitly state the toe joint for intra-articular injection of lubricin is the area affected by
`
`gout, since Jay teaches intra-articular injection of lubricin into toe joint for treating joint
`
`trauma such as gout or pseudo-gout and re-establishing joint homeostasis (see page 4,
`
`paragraph [0029]), one of skill in the art would understand intra-articularly injecting
`
`lubricin into toe joint in Jay is injecting lubricin into a joint having gout or an area of the
`
`patient’s body affected by gout.
`
`It meets the limitations of instant claims 6, 7 and 9.
`
`With regards to the limitation “wherein treating the gout or pseudogout is
`
`achieved by reducing inflammation associated with gout” recited in instant claim 4, this
`
`is a result-oriented limitation.
`
`In the instant case, the method in Jay is a method
`
`comprising the same active method step and the same active component as the method
`
`recited in instant claim 2. And in the instant case, instant claim 2 does not define the
`
`patient population as a subject in need thereof. Furthermore, the lubricin (synonym of
`
`PRG4) administered in the method in Jay is identical to PRG4 disclosed on page 3,
`
`paragraph [0011]; and Figures 2A-2D and 3A-3D of instant specification. The instant
`
`specification discloses PRG4 inherently reduces inflammation (see page 3, paragraph
`
`[0011]; and Figures 2A-2D and 3A-3D of instant specification). Therefore, the lubricin
`
`(synonym of PRG4) administered in the method in Jay inherently reduces inflammation;
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 8
`
`and the method in Jay is a method wherein treating the gout or pseudogout is achieved
`
`by reducing inflammation associated with gout.
`
`It meets the limitation of instant claim 4.
`
`Furthermore, since USPTO lacks an experimental facility to make a further
`
`determination, the burden is on Applicant to prove otherwise.
`
`Jay further teaches the lubricin can be a recombinant form of a human lubricin
`
`polypeptide (see page 2, paragraph [0013]).
`
`It meets the limitation of instant claim 5.
`
`Although Jay does not explicitly state a pharmaceutical composition comprising lubricin
`
`and a pharmaceutically acceptable carrier, Jay teach lubricin is injected as a fluid (see
`
`page 4, paragraph [0035]). Therefore, one of skill in the art would understand a
`
`pharmaceutical composition comprising lubricin and a pharmaceutically acceptable
`
`carrier is used for injecting lubricin.
`
`It meets the limitation of instant claim 11.
`
`Jay also teaches injecting an amount of lubricin sufficient to establish a
`
`bioavailable lubricin concentration in the synovial fluid (as opposed to lubricin bound to
`
`cartilage) within the capsule preferably of between 100 ug/mL and 500 ug/mL,
`
`preferably at least greater than 250 ug/mL, and most preferably between 250 ug/mL
`
`and 450 ug/mL (see page 4, paragraph [0033]). A bioavailable lubricin concentration in
`
`the synovial fluid of at least greater than 250 ug/mL and/or between 250 ug/mL and 450
`
`ug/mL in Jay reads on administration of an amount of PRG4 sufficient to achieve a
`
`concentration of PRG4 in a synovial fluid of a joint of the subject of at least 200 ug/ml as
`
`the elected species of amount of PRG4 or a biologically active fragment thereof.
`
`It
`
`meets the limitation of instant claim 15. With regards to the limitation recited in instant
`
`claim 12, first, based on “(as opposed to lubricin bound to cartilage)” taught in Jay, one
`
`of skill in the art would understand the lubricin concentration disclosed on page 4,
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 9
`
`paragraph [0033] in Jay is an amount insufficient to provide boundary lubrication.
`
`Second, since the lubricin concentration in the synovial fluid of at least greater than 250
`
`ug/mL and/or between 250 ug/mL and 450 ug/mL in Jay meets the limitation of instant
`
`claim 15, the lubricin concentration in the synovial fluid of at least greater than 250
`
`ug/mL and/or between 250 ug/mL and 450 ug/mL in Jay is an amount sufficient to treat
`
`joint pain. Therefore, the lubricin concentration in the synovial fluid of at least greater
`
`than 250 ug/mL and/or between 250 ug/mL and 450 ug/mL in Jay meets the limitation
`
`of instant claim 12. Furthermore, in the instant case, as stated above, Jay teaches
`
`various amounts of lubricin for treating gout or pseudo-gout. Since the USPTO is not
`
`equipped to conduct experimentation in order to determine whether the amount recited
`
`in instant claim 12 differs and, if so, to what extent, from the amount discussed in Jay;
`
`with the showing of Jay, the burden of establishing non-anticipation by objective
`
`evidence is shifted to the Applicants. With regards to the limitation recited in instant
`
`claim 28, the instant specification discloses that PRG4 at a concentration of 200 ug/ml
`
`is sufficient to decrease phagocytosis of monosodium urate monohydrate crystals by a
`
`macrophage in a joint (see Figures 1 and 4 of instant specification). Therefore, the
`
`lubricin concentration in the synovial fluid of at least greater than 250 ug/mL and/or
`
`between 250 ug/mL and 450 ug/mL in Jay meets the limitation of instant claim 28. And
`
`as stated above, since the USPTO is not equipped to conduct experimentation in order
`
`to determine whether the amount recited in instant claim 28 differs and, if so, to what
`
`extent, from the amount discussed in Jay; with the showing of Jay, the burden of
`
`establishing non-anticipation by objective evidence is shifted to the Applicants.
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 10
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`Furthermore, Jay teaches lubricin is delivered to the synovial cavity at a
`
`concentration in the range of 20-500 ug/mL in a volume of approximately 0.1 -2 mL per
`
`injection, more preferably 1-2 mL; or at a concentration from as low as 20 ug/mL to as
`
`high as 8 mg/mL or even as high as 10 mg/mL in, for example, 2 mL of fluid; or in the
`
`amount of 4 mg/mL-5 mg/mL in, for example, 2 mL of fluid (see page 4, paragraphs
`
`[0034] and [0035]).
`
`It meets the limitation of instant claim 14. Furthermore, lubricin at a
`
`concentration of 20 ug/mL in 2 mL fluid is 40 ug, at a concentration of 4 mg/mL-5
`
`mg/mL in 2 mL fluid is 8-10 mg, at a concentration of 8 mg/mL in 2 mL fluid is 16 mg,
`
`and at a concentration of 10mg/mL in 2 mL fluid is 20 mg. These various amounts of
`
`lubricin taught in Jay meet the limitations of instant claims 16 and 17. With regards to
`
`the limitation recited in instant claim 13, as evidenced by Fryar et al, mean age-adjusted
`
`body weight for men is 89.8 kg (197.9 lb) in 2015—2016, and mean age-adjusted body
`
`weight for women is 77.4 kg (170.6 lb) in 2015—2016 (see page 2, left column, the 2nOI
`
`paragraph in Section “Weight”).
`
`In the instant case, for example, if taking 80 kg as a
`
`mean age-adjusted body weight for human, the amount of PRG4 administered in the
`
`range of 0.1 ug/kg to 4000 ug/kg recited in instant claim 13 equals to 8 ug to 320 mg.
`
`Therefore, the various amounts of lubricin taught in Jay meet the limitation of instant
`
`claim 13.
`
`In addition, Jay teaches the subject is a human (see page 1, paragraph [0010]).
`
`It reads on human as the elected species of subject; and meets the limitation of instant
`
`claims 18 and 19.
`
`And, the MPEP states the following: A genus does not always anticipate a claim
`
`to a species within the genus. However, when the species is clearly named, the species
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 11
`
`claim is anticipated no matter how many other species are additionally named. See EX
`
`parte A, 17 USPQ2d 1716 (Ed. Pat. App. & Inter. 1990) (See MPEP § 2131.02).
`
`Since the reference teaches all the limitations of instant claims 1, 2, 4-7, 9, 11-19
`
`and 28, the reference anticipates instant claims 1, 2, 4-7, 9, 11-19 and 28.
`
`Claim Rejections - 35 USC § 103
`
`18.
`
`The following is a quotation of 35 U.S.C. 103 which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`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
`
`of this title, 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.
`
`19.
`
`The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148
`
`USPQ 459 (1966), that are applied for establishing a background for determining
`
`obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating
`
`obviousness or nonobviousness.
`
`

`

`Application/Control Number: 15/808,632
`Art Unit: 1658
`
`Page 12
`
`20.
`
`Claims 1, 2, 4-7, 9, 11-20 and 28 are rejected under 35 U.S.C. 103 as being
`
`unpatentable over Jay (US 2013/0116186 A1), and as evidenced by Fryar et al
`
`(National Health Statistics Reports, 2018, 122, pages 1-16), and further in view of Jay
`
`(US 2013/0116186 A1).
`
`The instant claims 1, 2, 4-7, 9, 11-20 and 28 are drawn to a method of reducing
`
`joint pain in a subject with gout or pseudogout, and/or a method of treating gout or
`
`pseudogout in a subject, the method comprising administering to the subject a
`
`composition comprising PRG4 or a biologically active fragment thereof.
`
`The rejection to claims 1, 2, 4-7, 9, 11-19 and 28 under 35 U.S.C. 102(a)(1) as
`
`being anticipated by Jay (US 2013/0116186 A1), and as evidenced by Fryar et al
`
`(National Health Statistics Reports, 2018, 122, pages 1-16) has been set forth in
`
`Section 17 above.
`
`The difference between the rejection set forth in Section 17 above and instant
`
`claims 1, 2, 4-7, 9, 11-20 and 28 is that the reference cited in the rejection does not
`
`explicitly teach weekly administration as the elected species of administering scheme;
`
`and the limitation of instant claim 20.
`
`However, Jay teaches that depend on the conditions to be treated, lubricin is
`
`administrated at various schemes ranging from hours to months, even to annually (see
`
`page 4, paragraphs [0036] and [0037]). Therefore, one of ordinary skilled in the art
`
`would have been motivated to optimize the administrating scheme for effectively
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`reducing joint pain in a subject with gout or pseudogout, including weekly
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`administration.
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`It reads on weekly administration as the elected species of
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`administering scheme; and meets the limitation of instant claim 20. The MPEP states
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`Art Unit: 1658
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`the following: Generally, differences in concentration or temperature will not support the
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`patentability of subject matter encompassed by the prior art unless there is evidence
`
`indicating such concentration or temperature is critical. “[W]here the general conditions
`
`of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
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`workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ
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`233, 235 (CCPA 1955) (Claimed process which was performed at a temperature
`
`between 40°C and 80°C and an acid concentration between 25% and 70% was held to
`
`be prima facie obvious over a reference process which differed from the claims only in
`
`that the reference process was performed at a temperature of 100°C and an acid
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`concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The
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`normal desire of scientists or artisans to improve upon what is already generally known
`
`provides the motivation to determine where in a disclosed set of percentage ranges is
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`the optimum combination of percentages”); In re Hoeschele, 406 F.2d 1403, 160 USPQ
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`809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope
`
`of the references were held to be unpatentable thereover because, among other
`
`reasons, there was no evidence of the criticality of the claimed ranges of molecular
`
`weight or molar proportions.). For more recent cases applying this principle, see Merck
`
`& Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert.
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`denied, 493 U.S. 975 (1989);
`
`In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir.
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`1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). (see MPEP
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`§ 2144.05 II A).
`
`Therefore, in view of the teachings of Jay as a whole, it would have been obvious
`
`to one of ordinary skilled in the art to develop a method of reducing joint pain in human
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`Application/Control Number: 15/808,632
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`with gout or pseudogout, and/or a method of treating gout or pseudogout in human, the
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`method comprising administering to the human with gout or pseudogout a composition
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`comprising recombinant human PRG4 (synonym of lubricin in Jay) and a
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`pharmaceutically acceptable carrier, wherein the PRG4 is intra-articularly injected into a
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`toe join weekly, and wherein the amount of PRG4 administered is sufficient to achieve a
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`concentration of PRG4 in a synovial fluid of a joint of the subject of at least 200 ug/ml.
`
`In view of the teachings of Jay as a whole, one of ordinary skilled in the art would have
`
`been motivated to develop a method of reducing joint pain in human with gout or
`
`pseudogout, and/or a method of treating gout or pseudogout in human, the method
`
`comprising administering to the human with gout or pseudogout a composition
`
`comprising recombinant human PRG4 (synonym of lubricin in Jay) and a
`
`pharmaceutically acceptable carrier, wherein the PRG4 is intra-articularly injected into a
`
`toe join weekly, and wherein the amount of PRG4 administered is sufficient to achieve a
`
`concentration of PRG4 in a synovial fluid of a joint of the subject of at least 200 ug/ml,
`
`because as stated above, Jay teaches that depend on the conditions to be treated,
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`lubricin is administrated at various schemes ranging from hours to months, even to
`
`annually. Therefore, one of ordinary skilled in the art would have been motivated to
`
`optimize the administrating scheme for effectively reducing joint pain in a subject with
`
`gout or pseudogout, including weekly administration.
`
`In view of the teachings of Jay as set forth above, a person of ordinary skilled in
`
`the art would have reasonable expectation of success in developing a method of
`
`reducing joint pain in human with gout or pseudogout, and/or a method of treating gout
`
`or pseudogout in human, the method comprising administering to the human with gout
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`

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`Application/Control Number: 15/808,632
`Art Unit: 1658
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`or pseudogout a composition comprising recombinant human PRG4 (synonym of
`
`lubricin in Jay) and a pharmaceutically acceptable carrier, wherein the PRG4 is intra-
`
`articularly injected into a toe join weekly, and wherein the amount of PRG4 administered
`
`is sufficient to achieve a concentration of PRG4 in a synovial fluid of a joint of the
`
`subject of at least 200 ug/ml.
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`Obviousness Double Parenting
`
`21.
`
`The nonstatutory double patenting rejection is based on a judicially created
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`doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the
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`unjustified or improper timewise extension of the “right to exclude” granted by a patent
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`and to prevent possible harassment by multiple assignees. A nonstatutory double
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`patenting rejection is appropriate where the claims at issue are not identical, but at least
`
`one examined application claim is not patentably distinct from the reference claim(s)
`
`because the examined application claim is either anticipated by, or would have been
`
`obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d
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`1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.
`
`1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum,
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`686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619
`
`(CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CFR 1.321 (c) or 1.321 (d)
`
`may be used to overcome an actual or provisional rejection based on a nonstatutory
`
`double patenting ground provided the reference application or patent either is shown to
`
`be commonly owned with this application, or claims an invention made as a result of
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`Application/Control Number: 15/808,632
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`activities undertaken within the scope of a joint research agreement. A terminal
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`disclaimer must be signed in compliance with 37 CFR 1.321 (b).
`
`The USPTO internet Web site contains terminal disclaimer forms which may be
`
`used. Please visit http://www.uspto.gov/forms/. The filing date of the application will
`
`determine what form should be used. A web-based eTerminal Disclaimer may be filled
`
`out completely online using web-screens. An eTerminal Disclaimer that meets all
`
`requirements is auto-processed and approved immediately upon submission. For more
`
`information about eTerminal Disclaimers, refer to
`
`
`
`22.
`
`Claims 1, 2, 4, 5, 9 and 11-13 are provisionally rejected on the ground of
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`nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2,
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`4, 6, 8, 11, 12, 14, 15, 21, 33 and 43 of co-pending Application No. 15/546192.
`
`Although the conflicting claims are not identical, they are not patentably distinct
`
`from each other because if one of ordinary skill in the art practiced the claimed invention
`
`of instant claims 1, 2, 4, 5, 9 and 11-13, one would necessarily achieve the claimed
`
`invention of claims 1, 2, 4, 6, 8, 11, 12, 14, 15, 21, 33 and 43 of co-pending Application
`
`No. 15/546192, and vice versa.
`
`23.
`
`Instant claim 1
`
`is drawn to a method of reducing joint pain in a subject with gout
`
`or pseudogout, the method comprising administering to the subject a composition
`
`comprising PRG4 or a biologically active fragment thereof. Dependent claims 5, 9 and
`
`11-13 recite further limitations to the method in instant claim 1.
`
`Instant claim 2 is drawn
`
`to a method of treating gout or pseudogout in a subject, the method comprising
`
`administering to a subject a composition comprising PRG4 or a biologically active
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`Application/Control Number: 15/808,632
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`fragment thereof. Dependent claim 4 recites a result-oriented limitation to the method in
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`instant claim 2.
`
`24.
`
`Claims 1, 2, 4, 6, 8, 11, 12, 14, 15, 21, 33 and 43 of co-pending Application No.
`
`15/546192 recite various methods of treating subjects with various conditions, including
`
`subject with gout or pseudogout, comprising administering PRG4 to the subject in need
`
`thereof. And in view of the combined teachings of claims 1, 2, 4, 6, 8, 11, 12, 14, 15,
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`21, 33 and 43 of co-pending Appl