www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`
`16/075,828
`
`08/06/2018
`
`Daiki MURASE
`
`2537.1600002/MAC
`
`1355
`
`STERNE, KESSLER, GOLDSTEIN & FOX P.L.L.C.
`1100 NEW YORK AVENUE, N.W.
`WASHINGTON, DC 20005
`
`KOSTURKO. GEORGE W
`
`ART UNIT
`
`1628
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`06/25/2019
`
`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):
`e-offiee @ sternekessler. com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`0,7709 A0170” Summary
`
`Application No.
`16/075,828
`Examiner
`GEORGE w KOSTURKO
`
`Applicant(s)
`MU RASE et al.
`Art Unit
`AIA (FITF) Status
`1628
`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 05/29/2019.
`[: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) fl is/are pending in the application.
`
`5a) Of the above claim(s) 1—11,13—15,17—19 and 21 is/are withdrawn from consideration.
`
`E] Claim(s) _ is/are allowed.
`
`Claim(s) 12,16 and 20 is/are rejected.
`
`C] Claim(s) _
`
`is/are objected to.
`
`) ) ) )
`
`6 7
`
`8
`
`
`
`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
`
`participating intellectual property office for the corresponding application. For more information, please see
`
`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 08/06/2018 is/are: a). accepted or b)C] 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). All
`
`b)|:] Some**
`
`c)C] None of the:
`
`1.. Certified copies of the priority documents have been received.
`
`21:] Certified copies of the priority documents have been received in Application No.
`
`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)
`
`1)
`
`Notice of References Cited (PTO-892)
`
`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-
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20190617
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 2
`
`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`1.
`
`The present application, filed on or after March 16, 2013, is being examined
`
`under the first inventor to file provisions of the AIA. Claims 1-21 are currently pending.
`
`Election/Restrictions
`
`2.
`
`Applicant's election with traverse of Group (VIII), claims 12, 16 and 20 in the
`
`reply filed on 05/29/2019 is acknowledged. The traversal is on the ground(s) that there
`
`still is unity of invention between groups Vl-IX, drawn to the darkening of hair or skin in
`
`a subject comprising administering to a subject in need at least one selected from
`
`proguanil or a salt thereof, berberine or a salt thereof or phenformin or a salt thereof as
`
`an active ingredient.
`
`3.
`
`This is not found persuasive because, as demonstrated in the rejection below,
`
`the darkening of hair or skin in a subject comprising administering an effective amount
`
`of proguanil has been taught in the prior art of Reactions, Vol. 1499 page 8 published
`
`May 2014, wherein administration of an effective amount of 100 mg proguanil darkened
`
`(tanned) the skin in a subject in need thereof (paragraphs 1-3). Accordingiy, there is no
`
`singie inventive concept and the groups Vi~i>< aieo tack unity oi invention
`
`4.
`
`Further, as discussed in the restriction requirement tire inventions oi Groups i~iX
`
`do not rotate to a singie generai inventive concept tinder PCT Ruie 13.1, because under
`
`PCT Rnie 13.2, they tank the same or corresponding speciai tecnnioai feature for the
`
`ioiiovving reasons: the teciinioei teatore of Group V, speciiieaiiy a topicai composition
`
`comprising prognonii has been taught in the prior art oi Godowski et ei (Etta/02009137100
`
`pubiisned tti’12/f2009}. Godowski otaims a topicai oomposition comprising a
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 3
`
`therapeutically effective articunt comprising proguanil and a pharmaceutically
`
`acceptable carrier, which reads on the limitation of Group (V). Accordingly, there is no
`
`single inventive concept and the claims/groups lack unity of invention.
`
`5.
`
`6.
`
`The requirement is still deemed proper and is therefore made FINAL.
`
`Claims 1-11, 13-15, 17-19 and 21 were withdrawn from further consideration
`
`pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no
`
`allowable generic or linking claim. Applicant timely traversed the restriction (election)
`
`requirement in the reply filed on 05/29/2019.
`
`7.
`
`Secondly, Applicant’s election with traverse of the species proguanil in the reply
`
`filed on 05/29/2019 is acknowledged. The traversal is on the ground(s) that there is no
`
`search burden in searching all the species of the instant claims. These arguments have
`
`been considered but are not found persuasive as such arguments do not apply when
`
`restriction is required under 35 USC 121 and 372, as in the instantly filed application.
`
`Thus, when the Office considers international applications as an International Searching
`
`Authority, as an International Preliminary Examining Authority, and during the national
`
`stage as a Designated or Elected Office under 35 U.S.C. 371, only PCT Rule 13.1 and
`
`13.2 will be followed when considering unity of invention of claims of different categories
`
`without regard to the practice in national applications filed under 35 U.S.C. 111. Thus, it
`
`is maintained that the species do not constitute a special technical feature as defined by
`
`PCT Rule 13.2 and does not define a contribution over the prior art for the reasons of
`
`record. Claims 12, 16 and 20 are the subject of this Office Action.
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 4
`
`Priority
`
`8.
`
`Acknowledgement is made national stage entry of PCT/JP2017/004987 ,
`
`International Filing Date: 02/10/2017. PCT/JP2017/004987 Claims Priority from
`
`Provisional Application 62294667, filed 02/12/2016 and foreign priority to 2016-217082 ,
`
`filed 11/07/2016.
`
`Information Disclosure Statement
`
`9.
`
`The information disclosure statement (IDS) submitted on 08/29/2018 is in
`
`compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure
`
`statement is being considered by the examiner.
`
`10.
`
`11.
`
`Claim Rejections - 35 USC § 1 12-Paragraph B
`
`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION—The specification shall conclude with one or more claims particularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
`
`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter which the applicant regards as his invention.
`
`12.
`
`Claims 12, 16 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112
`
`(pre-AIA), second paragraph, as being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AlA
`
`the applicant regards as the invention.
`
`13.
`
`Claim 12 is directed to a metned tor darkening skin er hair enter, comprising
`
`administrating to or ingesting in a subject in need thereet, at ieast ene seiected item the
`
`greup ennsisting et a betbenne er a sait thereet, ercguanii (it a satt thereoi and
`
`pheniermin er a sait thereef in an etteetive ameunt.
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 5
`
`14.
`
`The term "a subject in need thereof" in claims 12, 16 and 20 is a relative term
`
`which renders the claim indefinite. The phrase “a subject in need thereof” is not defined
`
`in the instant specification (disclosed 4 times in the instant specification).
`
`15.
`
`Additionally, the specification does not provide a standard for ascertaining the
`
`requisite degree on how to discern who is a subject in need of darkening skin or hair
`
`color and who is not, and one of ordinary skill in the art would not be reasonably
`
`apprised of the scope of the invention.
`
`16.
`
`Given the broadest reasonable interpretation of the phrase “a subject in need
`
`thereof”, the examiner has interpreted that any person, male or female qualifies as a
`
`subject in need thereof, and subsequent examination is based on this interpretation.
`
`17.
`
`18.
`
`19.
`
`Claim 12, 16 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-
`
`AlA), second paragraph, as being indefinite for failing to particularly point out and
`
`distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AlA
`
`the applicant regards as the invention.
`
`20.
`
`A broad range or limitation together with a narrow range or limitation that falls
`
`within the broad range or limitation (in the same claim) is considered indefinite, since
`
`the resulting claim does not clearly set forth the metes and bounds of the patent
`
`protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board
`
`of Patent Appeals and lnterferences in EX parte Wu, 10 USPQ2d 2031, 2033 (Ed. Pat.
`
`App. & Inter. 1989), as to where broad language is followed by "such as" and then
`
`narrow language. The Board stated that this can render a claim indefinite by raising a
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 6
`
`question or doubt as to whether the feature introduced by such language is (a) merely
`
`exemplary of the remainder of the claim, and therefore not required, or (b) a required
`
`feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131
`
`USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and EX parte
`
`Hasche, 86 USPQ 481 (Bd. App. 1949).
`
`In the present instance, claim 12 recites the
`
`following methodology of darkening skin or hair color comprising administering to or
`
`ingesting in a subject in need thereof, at least one of selected from the group consisting
`
`of berberine or a salt thereof, proguanil or a salt thereof, and phenformin or a salt
`
`thereof in an effective amount.
`
`21.
`
`Given the broadest reasonable interpretation of the phrase “ingesting” in light of
`
`the specification, said route of administration encompasses oral administration of at
`
`least one of selected from the group consisting of berberine or a salt thereof, proguanil
`
`or a salt thereof, and phenformin or a salt thereof in an effective amount. Said
`
`“ingesting” is a narrower statement of the range/limitation of “administration”, which
`
`encompasses alternative routes of administration to oral administration including
`
`intravenous administration, topical administration and subcutaneous administration.
`
`22.
`
`Accordingly, one of ordinary skill in the art at the time of the instant invention
`
`would not have been reasonably apprised of the metes and bounds of the subject
`
`matter for which Applicant is presently seeking protection.
`
`23.
`
`For the purposes of examination, the examiner has interpreted that any route of
`
`administering one of selected from the group consisting of berberine, proguanil or
`
`phenformin to a subject in need reads on the claimed limitation, and subsequent
`
`examination is based on this interpretation.
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`24.
`
`Page 7
`
`25.
`
`Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second
`
`paragraph, as being indefinite for failing to particularly point out and distinctly claim the
`
`subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards
`
`as the invention.
`
`26.
`
`Claim 12 is directed to a method fer darkening stain er hair peter, comprising
`
`administrating to er ingesting iit a subject in need titei'eei, at ieaet ene seteeted train the
`
`group consisting et a berberine or a sait thereet, preguanit er a sait titerth and
`
`phetttgrmtrt er a sait thereof tr: an effective amount.
`
`27.
`
`Claim 20 recites the limitation " when applied as an external preparation is in
`
`terms of phenformin, berberine or proguanil from 0.01 to 10 mg". There is insufficient
`
`antecedent basis for this limitation in the claim because the preceding text of the claim,
`
`or the claim from which it depends (claim 12) does not recite that phenformin, berberine
`
`or proguanil is administered topically as an external preparation, but rather an
`
`alternative route of administration, specifically ingesting said compound in a
`
`therapeutically effective amount.
`
`28.
`
`Accordingly, one of ordinary skill in the art at the time of the instant invention
`
`would not have been reasonably apprised of the metes and bounds of the subject
`
`matter for which Applicant is presently seeking protection.
`
`29.
`
`Claim Rejections - 35 USC § 102
`
`30.
`
`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
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 8
`
`correction of the statutory basis for the rejection 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.
`
`31.
`
`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 othenNise available to the public before the effective filing date of the claimed
`invention.
`
`32.
`
`Claim(s)12 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated
`
`by (Reactions Vol. 1499, page 8 published May 2014).
`
`33.
`
`The phrase “a subject in need thereof” is not defined in the instant specification
`
`(disclosed 4 times in the instant specification). Given the broadest reasonable
`
`interpretation of the phrase “a subject in need thereof”, the examiner has interpreted
`
`that any person, male or female of any age qualifies as a subject in need thereof, and
`
`subsequent examination is based on this interpretation.
`
`34.
`
`Reactions teaches the administration of a therapeutic combination comprising
`
`100 mg proguanil in combination with atovaquone to a subject to a male subject in
`
`need. Following administration of proguanil, the subject’s skin became darker (tinted
`
`and tanned) (paragraphs 1-2). Applicant is reminded of MPEP 2111.03 wherein the
`
`transitional term “comprising", which is synonymous with “inciudtng,” "containing,“ or
`
`"characterized by," is inctusive or open~ended and does not exciude additional,
`
`unrecited eiei‘nents or method steps. See, eg Mars inc. 12. Ht]. Heinz (30., 37’? F.3d
`
`1389, 13756, Y1 USPQ2d 1837, 1843 (Fed. Cir. 2004}. in the instant case, the pending
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 9
`
`cieiins do not exciude additioiiai or uhrecited eieittehis such as the ai‘itimaiariai
`
`atovaquohe.
`
`35.
`
`36.
`
`Claim(s) 12 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Browne
`
`et al (British Medical Journal Vol. 5225 pages 550-551. Published 1961).
`
`37.
`
`The phrase “a subject in need thereof” is not defined in the instant specification
`
`(disclosed 4 times in the instant specification). Given the broadest reasonable
`
`interpretation of the phrase “a subject in need thereof”, the examiner has interpreted
`
`that any person, male or female qualifies as a subject in need thereof, and subsequent
`
`examination is based on this interpretation.
`
`38.
`
`Browne teaches wherein a female patient administered a therapeutically effective
`
`amount of proguanil in combination with aspirin and mepacrine (page 551, left col.
`
`paragraph 4). Browne teaches that following ingestion of proguanil, the skin overlying
`
`the hypermelanotic macules on the face and trunk desquamated with the underlying
`
`macules becoming darker (page 551, left col. paragraphs 3-4).
`
`39.
`
`Applicant is also reminded of MPEP 2111.03 wherein the trahsitiOhai term
`
`“cer’riprisihg”, which is syiioiiyr’nous with ”iiiciudirig," “eertiairtirig,” er "characterized by,"
`
`is inciusive or opewended and does not exciude additiohai, unrecited eiemehts or
`
`methed steps. See, eg, Maize inc. v. HJ. Heinz Ca, 37? F.3d 1369, 1376, “.71 USPQ2d
`
`1837, 1843 (Fed, Cir. 2604). iii the ihstarit case, the pending ciaiihs de het exciude
`
`edditiehai or unrecited eiements such as aspirin or mepacrine in the therapeutic
`
`combination.
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 10
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`Claim Rejections - 35 USC § 103
`
`40.
`
`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 rejection 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.
`
`41.
`
`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, 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.
`
`42.
`
`Claims 12, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable
`
`over the combination of Van Neste et al (Micron Vol. 35, pages 193-200. Published
`
`2004), Hue et al (FR2901133A1 published 11/23/2007; machine translation provided)
`
`and Chulay (US 6,413,993 published 07/02/2002).
`
`43.
`
`Van Neste teaches that the loss of skin color occurs gradually with age (page
`
`195 right col. paragraph 2). Van Neste also teaches that the hair graying trait correlates
`
`closely with chronological aging and occurs to varying degrees in individuals (page 196,
`
`right col. paragraph 2). The average age for graying in whites is mid 30’s, late 30’s for
`
`Asians and mid 40’s for Africans. As such, people who are chronologically aging
`
`represent subjects in need of darkening skin and hair.
`
`44.
`
`Hue teaches the treatment of chronobiologically aging skin and hair, dry skin
`
`and the promotion of keratinocyte proliferation and promoting the level of hair follicles in
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 11
`
`an aging patient comprising administering to a subject in need a glycolysis inducer,
`
`wherein said glycolysis inducer controls differentiation of epidermal cells and increases
`
`proliferation of young cells and improves the appearance of the individual (page 2
`
`paragraph 4 through page 6, page 9 paragraphs 3-5, page 10, paragraphs 1-5, page 11
`
`paragraphs 1-4).
`
`45.
`
`Hue teaches that the elected proguanil is one of eight suitable glycolysis
`
`inhibitors that are effective to treat aging of the skin and hair (page 6 paragraph 4 claims
`
`6, 9-12).
`
`46.
`
`Hue teaches that said glycolysis inhibitor (proguanil) is present in 0.0001 -10%
`
`wt. of a therapeutic composition, and can be ingested as a tabled via oral
`
`administration, or alternatively, be administered topically (page 11, paragraphs 3-6).
`
`47.
`
`Therefore, one of ordinary skill in the art at the time prior to the invention would
`
`have found it prima facie obvious to administer proguanil to subjects aging patients who
`
`are in need of treating aging skin and hair in view of Van Neste and Hue et al in order to
`
`arrive at the instantly claimed methodology. Motivation to administer proguanil to said
`
`subject flows logically from the fact that proguanil was recognized in the art to effectively
`
`treat chronobiologically aging skin and hair, dry skin and the promotion of keratinocyte
`
`proliferation and promoting the level of hair follicles in the administered patient.
`
`48.
`
`Regarding the limitation directed to wherein the administered proguanil darkens
`
`the skin or hair in the administered aging patient, the method of administering an
`
`overlapping therapeutically effective amount of proguanil to the same subject in need
`
`(patient in need of preventing aging skin and hair loss) has been rendered obvious by
`
`the teaching of Hue above. Properties, such as darkening the hair or skin in the
`
`

`

`Application/Control Number: 16/075,828
`Art Unit: 1628
`
`Page 12
`
`administered patient are considered characteristic features of the claimed process of
`
`administering proguanil.
`
`49.
`
`It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594)
`
`discuss the support of rejections wherein the prior art discloses subject matter which
`
`there is reason to believe inherently includes functions that are newly cited or is
`
`identical to a product instantly claimed.
`
`In such a situation the burden is shifted to the
`
`applicants to "prove that subject matter shown to be in the prior art does not possess
`
`characteristic relied on" (205 USPQ 594, second column, first full paragraph). In the
`
`present case the burden is shifted to Applicant to prove that the administration of
`
`proguanil will not darken the skin and hair of the patient in need treating aging skin and
`
`preventing hair loss when applied in in the overlapping therapeutically effective amount.
`
`50.
`
`Secondly, regarding the limitation wherein proguanil is administered in a dose of
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`0.1 to 5000 mg (claim 16) or topically applied in a dose of 0.1-10 mg per area of 100
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`cm2 (claim 20), while the combination of Van Neste and Hue do not specifically teach
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`administration of a dose of 0.1 to 5000 mg or topical administration of 0.1-10 mg per
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`100 cm2, the optimum amount of proguanil administered to the aging patient would have
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`been a matter well within the insight of one of ordinary skill in the art. Such a
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`determination would have been made in accordance with a variety of factors, such as
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`the route of administration, pharmacological considerations, such as activity, efficacy,
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`pharmacokinetics and toxicology profiles of the combined regimen, as well as the age,
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`weight, sex, diet and severity of the medical condition of the patient.
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`51.
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`Furthermore, Chulay (US 6,413,993 published 07/02/2002) teach that provides a
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`range of workable doses of proguanil to that are safe and effective to a 60 kg human
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`

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`Application/Control Number: 16/075,828
`Art Unit: 1628
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`Page 13
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`patient via oral or topical routes including 30 mg-1200 mg/day (0.5 mg/kg/day-20
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`mg/kg/day), which overlaps with the therapeutically effective amounts of the instant
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`claims (col. 2 lines 55-68, col. 3 lines 45-65).
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`52.
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`Thus, the therapeutically effective amount of proguanil administered to said
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`subject would have varied widely and, in the absence of evidence to the contrary, the
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`current claimed specific administration regimen is not seen to be inconsistent with one
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`that would have been determined by the skilled artisan. Furthermore, absent and
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`evidence demonstrating a patentable difference between the compositions administered
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`and the criticality of the therapeutically effective amount, the determination of the
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`optimum or workable amount of proguanil given the guidance of the prior art would have
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`been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-
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`2](ll)(A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)(”[W]here
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`the general conditions of the claim are disclosed in the prior art, it is not inventive to
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`discover the workable ranges by routine experimentation”)
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`53.
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`54.
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`Conclusion
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`55.
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`In view of the rejections set forth above, no claim is allowed.
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`56.
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`Any inquiry concerning this communication or earlier communications from the
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`examiner should be directed to GEORGE W KOSTURKO whose telephone number is
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`(571)270-5903. The examiner can normally be reached on M-F 9:00-5:30.
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`Examiner interviews are available via telephone, in-person, and video
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`conferencing using a USPTO supplied web-based collaboration tool. To schedule an
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`

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`Application/Control Number: 16/075,828
`Art Unit: 1628
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`Page 14
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`interview, applicant is encouraged to use the USPTO Automated Interview Request
`
`(AIR) at http://www.uspto.gov/interviewpractice.
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
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`supervisor, Winston Shen can be reached on 571-272—3157. The fax phone number for
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`the 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
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`Patent Application Information Retrieval (PAIR) system. Status information for
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`published applications may be obtained from either Private PAIR or Public PAIR.
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`GEORGE W. KOSTURKO
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`Examiner
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`Art Unit 1628
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`/THEODORE R. WEST/
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`Primary Examiner, Art Unit 1628
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`