Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 1 of 19 PageID #: 239
`Case 1:17-cv—00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 1 of 19 PageID #: 239
`
`
`
`
`
`EXHIBIT 4
`
`EXHIBIT 4
`
`

`

`
`
`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 2 of 19 PageID #: 240
`:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 2 of 19 PageID #: 240
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
`
`
`
`
`
` F ING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`
`
`
`
` CONF {MATION NO.
`
`10/701,495
`
`11/06/2003
`
`Jean—Baptiste Galey
`
`232979Us0
`
`7627
`
`OBLON, SPIVAK, MCCLELLAND MAIER & NEUSTADT, PC.
`1940 DUKE STREET
`ALEXANDRIA, VA 22314
`
`HENRY, MICHAEL c
`
`ART UNIT
`
`1623
`
`PAPER NUMBER
`
`
`
`
`
`NOT *ICATION DATE
`
`DELIVERY MODE
`
`10/ 1 7/2008
`
`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):
`
`patentdocket @ oblon.com
`oblonpat @ oblon.com
`jgardner @ oblon.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 3 of 19 PageID #: 241
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 3 of 19 PageID #: 241
`Application No.
`Applicant(s)
`
`10/701,495
`
`GALEY, JEAN-BAPTISTE
`
`Office Action Summary
`
`Examiner
`
`MICHAEL c. HENRY
`
`Art Unit
`
`1623 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, 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.
`If 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)IXI Responsive to communication(s) filed on 03 July 2008.
`
`2a)IZI This action is FINAL.
`
`2b)I:I This action is non-final.
`
`3)I:I 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 EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4)IZI Claim(s) 1-6 8-15 and 17-23 is/are pending in the application.
`
`4a) Of the above Claim(s)
`
`is/are withdrawn from consideration.
`
`5)I:I Claim(s) _ is/are allowed.
`
`6)IXI Claim(s) 1-6 8-15 17-23 is/are rejected.
`
`7)I:I Claim(s) _ is/are objected to.
`
`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:I The specification is objected to by the Examiner.
`
`
`
`10)I:I The drawing(s) filed on
`
`is/are: a)I:I accepted or b)I:I 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).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
`
`a)I:I All
`
`b)I:I Some * c)I:I None of:
`
`1.I:I Certified copies of the priority documents have been received.
`
`2.I:I Certified copies of the priority documents have been received in Application No.
`
`3.I:I 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.
`
`Attach ment(s)
`
`1) D Notice of References Cited (PTO-892)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3) |:| Information Disclosure Statement(s) (PTO/SB/08)
`Paper No(s)/Mai| Date
`.
`U.S. Patent and Trademark Office
`
`4) D Interview Summary (PTO-413)
`Paper No(s)/Mai| Date. _
`5) I:I Notice of Informal Patent Application
`6) D Other:
`
`PTOL-326 (Rev. 08—06)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20081010
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 4 of 19 PageID #: 242
`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 4 of 19 PageID #: 242
`
`Application/Control Number: 10/701,495
`
`Page 2
`
`Art Unit: 1623
`
`DETAILED ACTION
`
`The following office action is a responsive to the amendment filed, 07/03/08.
`
`The amendment filed 07/03/08 affects the application, 10/701,495 as follows:
`
`1. Claims 1, 4-6, 13-15, 23 have been amended. Applicants’ amendments have overcome
`
`the rejections made under 35 USC. 102(b) with Dobson et al. Consequently, the said
`
`rejections are withdrawn. However, the rejections made under 35 USC. 103(a) with
`
`Dobson et al. and under 35 USC. 102(b) with Lapinet et al. the are maintained
`
`2. The responsive to applicants’ arguments is contained herein below.
`
`Claims 1-6, 8-15, 17-23 are pending in application
`
`Claim Rejections - 35 USC § 1 02
`
`The following is a quotation of the appropriate paragraphs of 35 USC. 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) the invention was known or used by others in this country, or patented or described in a printed publication in this
`or a foreign country, before the invention thereof by the applicant for a patent.
`
`Claims 1-2, 4, 5 are rejected under 35 USC. 102(b) as being anticipated by Lapinet et al.
`
`(US 3,978,213).
`
`In claim 1, applicant claims “A method for softening expression lines on a face and/or
`
`forehead in need thereof, comprising topically applying a composition to one or more zones of
`
`the face or forehead marked with expression lines a composition comprising at least one
`
`compound selected from the group consisting of adenosine and adenosine analogues and a
`
`physiologically acceptable medium, wherein the composition comprises 0.1% to 10% by weight
`
`of adenosine and/or adenosine analogue with respect to the total composition weight.” Lapinet
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 5 of 19 PageID #: 243
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 5 of 19 PageID #: 243
`
`Application/Control Number: 10/701 ,495
`
`Page 3
`
`Art Unit: 1623
`
`et al. disclose applicant’s method of softening and enhancing the natural elasticity of the skin
`
`comprising applying topically to human skin a composition comprising an adenosine analogue,
`
`cyclic 3’,5’-adenosine monophosphate (see claims 1-2 and col. 2, line 48- col. 4, line 7). It
`
`should be noted that the application of the composition to skin also encompasses the skin on the
`
`face and forehead and especially since that is where wrinkles (including expression lines)
`
`generally occur. Furthermore, it should be noted that the examiner considers that the softening
`
`of skin also includes a softening of lines especially since Lapinet also disclose that wrinkles
`
`(expression lines) are decreased (softened) by said treatment (see col. 4, lines 3-7) and that said
`
`treatment is applied to soften and soothe human skin that is wrinkled and dry (see col. 1, lines
`
`47—52).
`
`it must also be noted that Lapinet et al. apply the same composition to the skin of the
`
`same subject as applicant and consequently it should have the same inherent effect of softening
`
`of expression lines. Claim 2, which is drawn to the method according to claim 1 wherein said
`
`composition comprises an adenosine analogue, is also encompassed by this rejection, since
`
`Lapinet et al.’s composition also comprises the adenosine analogue, cyclic 3’,5’-adenosine
`
`monophosphate (see claims l-2 and col. 2, line 48- col. 4, line 7). It should be noted that the
`
`application of the composition to skin also encompasses the skin on the face and forehead and
`
`especially since that is where wrinkles (including expression lines) generally occur.
`
`Furthermore, it should be noted that the examiner considers that the softening of skin also
`
`includes a softening of lines especially since Lapinet also disclose that wrinkles (expression
`
`lines) are decreased (softened) by said treatment (see col. 4, lines 3-7) and that said treatment is
`
`applied to soften and soothe human skin that is wrinkled and dry (see col. 1, lines 47—52). It
`
`must also be noted that Lapinet et al. apply the same composition to the skin of the same subject
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 6 of 19 PageID #: 244
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 6 of 19 PageID #: 244
`
`Application/Control Number: 10/701,495
`
`Page 4
`
`Art Unit: 1623
`
`as applicant and consequently it should have the same inherent effect of softening of expression
`
`lines. Claims 4 and 5 which are drawn to said method wherein the composition comprises
`
`specific % by weight of adenosine and/or adenosine analogue, are also anticipated by Lapinet et
`
`al, (see claims 1-2 and col. 2, line 48- col. 4, line 7).
`
`Claim Rejections - 35 USC § 1 03
`
`The following is a quotation of 35 USC. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the
`differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been
`obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability
`shall not be negatived by the manner in which the invention was made.
`
`Claims 1-6, 8-15, 17-23 are rejected under 35 USC. 103(a) as being unpatentable over
`
`Dobson et al. (US 6,423,327 B1).
`
`In claim 1, applicant claims “A method for softening expression lines on a face and/0r
`
`forehead in need thereof, comprising topically applying a composition to one or more zones of
`
`the face or forehead marked with expression lines a composition comprising at least one
`
`compound selected from the group consisting of adenosine and adenosine analogues and a
`
`physiologically acceptable medium, wherein the composition comprises 0.1% to 10% by
`
`weight of adenosine and/0r adenosine analogue with respect to the total composition weight.”
`
`Claim 8 is drawn to a method of claim 1, wherein said composition comprises adenosine.
`
`Claims 21 and 22 are drawn to a method of claims 1 and 8 respectively, comprising the topical
`
`application to the skin an effective amount of said composition to reduce laugh lines and/0r
`
`reduce frown lines.
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 7 of 19 PageID #: 245
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 7 of 19 PageID #: 245
`
`Application/Control Number: 10/701 ,495
`
`Page 5
`
`Art Unit: 1623
`
`Dobson et al. disclose a method for enhancing the condition of skin in a mammal by
`
`reducing (softening) wrinkles, roughness, dryness, or laxity of the skin, comprising topically
`
`applying to the skin a composition comprising adenosine (see claim 1 and claims 2-10). It
`
`should be noted that the application of the composition to skin also encompasses the skin on the
`
`face and forehead and especially since that is where wrinkles (including expression lines)
`
`generally occur. Furthermore, “expression lines” are referred to as types of wrinkles. That is,
`
`expression lines are wrinkles. Applicant’s attention is drawn to Exhibit A and B which disclose
`
`that expression lines are forms of wrinkles. Exhibit A states that “The wrinkles that seem to
`
`bother us most are “character” or “expression” lines” (see page 1,
`
`lSt line of 211d paragraph). In
`
`addition, Exhibit B sates that “Natural expressions that use specific facial muscles may cause
`
`some wrinkles called "expression lines" to reappear" (see page 4, 2nd paragraph, lines 2—3). Thus,
`
`these exhibits disclose that expression lines are wrinkles. It must also be noted that Dobson et al.
`
`apply the same composition to the skin of the same subject as applicant and consequently it
`
`should have the same inherent effect of softening of expression lines. Dobson et al.’s
`
`composition also reduces wrinkles (which includes frown lines and laugh lines-types of
`
`wrinkles) and contains adenosine (see claim 1 and claims 2-10). It should be noted that the
`
`application of the composition to skin also encompasses the skin on the face and forehead and
`
`especially since that is where wrinkles (including expression lines) generally occur. Furthermore,
`
`Applicant’s attention is drawn to Exhibit C which discloses that expression lines and frown lines
`
`are different forms of wrinkles (i.e., dynamic wrinkles). For example, Exhibit C states that
`
`“Dynamic wrinkles typically form across the forehead, between the eyebrows (frown lines), and
`
`on the sides of the eyes (“crow’s feet”) (see page 1, 2Ild paragraph and entire article).
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 8 of 19 PageID #: 246
`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 8 of 19 PageID #: 246
`
`Application/Control Number: 10/701 ,495
`
`Page 6
`
`Art Unit: 1623
`
`The difference between applicant’s claimed method and the method of Dobson et al. is
`
`that Dobson et al. do not disclose the specific % by weight of adenosine and/or adenosine
`
`analogue. However, the use of specific % by weight of adenosine and/or adenosine analogue,
`
`depends on factors like the severity of the skin or facial condition (such as wrinkles), the location
`
`of the condition and the kind of subject or mammal being treated.
`
`It would have been obvious to one having ordinary skill in the art, at the time the claimed
`
`invention was made to have used the method of Dobson et al. to treat wrinkles or enhance skin or
`
`relax facial features which includes softening expression lines on said face and/or forehead with
`
`a composition comprising adenosine or adenosine analogue, and to use different % by weight of
`
`adenosine or adenosine analogue at the required location, based on factors like the severity of the
`
`skin or facial condition (such as wrinkles), and the kind of subject or mammal being treated.
`
`One having ordinary skill in the art would have been motivated to use the method of
`
`Dobson et al. to treat wrinkles or enhance skin or relax facial features which includes softening
`
`expression lines on said face and/or forehead with a composition comprising adenosine or
`
`adenosine analogue, and to use different % by weight of adenosine or adenosine analogue at the
`
`required location, based on factors like the severity of the skin or facial condition (such as
`
`wrinkles), and the kind of subject or mammal being treated.
`
`In claim 1, applicant claims “A method for softening expression lines on a face and/or
`
`forehead in need thereof, comprising topically applying a composition to one or more zones of
`
`the face or forehead marked with expression lines a composition comprising at least one
`
`compound selected from the group consisting of adenosine and adenosine analogues and a
`
`physiologically acceptable medium.” Claim 2 is drawn to said method wherein said composition
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 9 of 19 PageID #: 247
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 9 of 19 PageID #: 247
`
`Application/Control Number: 10/701 ,495
`
`Page 7
`
`Art Unit: 1623
`
`comprises a specific adenosine analogue. Claim 3 is drawn to the method according to claim 1,
`
`wherein said composition comprises at least one adenosine analogue including 2’-
`
`deoxyadenosine 2’, 3’-isoproplidene adenosine; toyocamycin, l-methyladenosine ......
`
`Dependent claims 4-6 and 9 are drawn to a method wherein the composition comprises specific
`
`% by weight of adenosine and/or adenosine analogue. Dependent claims 10-15, 17-20 are drawn
`
`to a method wherein the composition has a specific relaxing effect, the use of specific adenosine
`
`analogues, specific % by weight of adenosine and/or adenosine analogue and the application of
`
`the composition on specific locations on the face. Claim 23 is drawn to a method for softening
`
`expression lines on a face and/or forehead in need thereof, comprising topically applying a
`
`composition to one or more zones of the face or forehead marked with expression lines a
`
`composition comprising adenosine in an amount of from 0.1% to 1% by weight with respect to
`
`the total composition and a physiologically acceptable medium.
`
`Dobson et al. disclose a method for enhancing the condition of skin in a mammal by
`
`reducing (softening) wrinkles, roughness, dryness, or laxity of the skin, comprising topically
`
`applying to the skin a composition comprising adenosine (see claim 1 and claims 2-10). Dobson
`
`et al. disclose that adenosine and suitable adenosine analogues are suitable for use in enhancing
`
`skin condition (see col. 3, lines 35-64). Furthermore, Dobson et al. disclose that adenosine
`
`analogues such as adenosine agonists, adenosine receptor agonists, and compounds that increase
`
`intracellular or extracellular adenosine levels are suitable for use in the invention (see col. 3,
`
`lines 35-64). Examples of some adenosine analogues disclosed by Dobson et al. as useful in the
`
`method include 2’-deoxyadenosine 2’, 3’-isoproplidene adenosine; toyocamycin, l-
`
`methyladenosine (see col. 3, lines 40-64). It should be noted that the application of the
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 10 of 19 PageID #: 248
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 10 of 19 PageID #: 248
`
`Application/Control Number: 10/701 ,495
`
`Page 8
`
`Art Unit: 1623
`
`composition to skin also encompasses the skin on the face and forehead and especially since that
`
`is where wrinkles (including expression lines) generally occur. Furthermore, “expression lines”
`
`are referred to as types of wrinkles. That is, expression lines are wrinkles. Applicant’s attention
`
`is drawn to Exhibit A and B which disclose that expression lines are forms of wrinkles. Exhibit
`
`A states that “The wrinkles that seem to bother us most are “character” or “expression” lines”
`
`(see page 1,
`
`lSt line of 211d paragraph). In addition, Exhibit B sates that “Natural expressions that
`
`use specific facial muscles may cause some wrinkles called "expression lines" to reappear” (_see
`
`page 4, 2nd paragraph, lines 2—3). Thus, these exhibits disclose that expression lines are wrinkles.
`
`It must also be noted that Dobson et al. apply the same composition to the skin of the same
`
`subject as applicant and consequently it should have the same inherent effect of softening of
`
`expression lines. Furthermore, the examiner considers the relaxing effect on contractile
`
`f1broblast (as recites in claim 10), an effect or means by which said wrinkles or roughness are
`
`being reduced.
`
`The difference between applicant’s claimed method and the method of Dobson et al. is
`
`that Dobson et al. do not disclose the specific % by weight of adenosine and/or adenosine
`
`analogue nor the application of the composition on specific locations on the face or skin.
`
`However, the use of specific % by weight of adenosine and/or adenosine analogue or the
`
`application of the composition on specific locations on the face or skin, depends on factors like
`
`the severity of the skin or facial condition (such as wrinkles), the location of the condition and
`
`the kind of subject or mammal being treated.
`
`It would have been obVious to one having ordinary skill in the art, at the time the claimed
`
`invention was made to have used the method of Dobson et al. to treat wrinkles or enhance skin or
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 11 of 19 PageID #: 249
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 11 of 19 PageID #: 249
`
`Application/Control Number: 10/701 ,495
`
`Page 9
`
`Art Unit: 1623
`
`relax facial features with a composition comprising adenosine or adenosine analogue, and to use
`
`different % by weight of adenosine or adenosine analogue at the required location, based on
`
`factors like the severity of the skin or facial condition (such as wrinkles), and the kind of subject
`
`or mammal being treated.
`
`One having ordinary skill in the art would have been motivated to use the method of
`
`Dobson et al. to treat wrinkles or enhance skin or relax facial features with a composition
`
`comprising adenosine or adenosine analogue, and to use different % by weight of adenosine or
`
`adenosine analogue at the required location, based on factors like the severity of the skin or
`
`facial condition (such as wrinkles), and the kind of subject or mammal being treated.
`
`Response to Arguments
`
`Applicant's arguments with respect to claims l-6, 8-15 and 17-23 have been considered
`
`but are not found convincing.
`
`The applicant argues that Dobson teaches applying minimal, millimolar amounts of
`
`adenosine such that dermal cell proliferation is avoided. Thus, the express teaching of Dobson is
`
`to strictly limit the amount of adenosine used to achieve a desired effect while, importantly,
`
`avoiding an undesired effect resulting from the use of too much adenosine. In other words,
`
`Dobson expressly teaches away from using "significant" (that is, greater than 10'3 M) amounts of
`
`adenosine. This is in sharp contrast to the claimed invention which requires the presence of a
`
`significant amount of adenosine compound to achieve the required dermo-relaxation effect. One
`
`skilled in the art, following Dobson, would be led to use extremely minimal amounts of
`
`adenosine and, thus, would be led away from the presently claimed invention which requires
`
`application of significant amounts of adenosine compound to effect dermo-relaxation. Given
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 12 of 19 PageID #: 250
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 12 of 19 PageID #: 250
`
`Application/Control Number: 10/701 ,495
`
`Page 10
`
`Art Unit: 1623
`
`this filndamental teaching away by Dobson, Dobson cannot teach or suggest the claimed
`
`invention.
`
`However, One having ordinary skill in the art would have been motivated to use the
`
`method of Dobson et al. to treat wrinkles (which includes expression lines) or enhance skin or
`
`relax facial features with a composition comprising adenosine or adenosine analogue, and to use
`
`different % by weight of adenosine or adenosine analogue at the required location, based on
`
`factors like the severity of the skin or facial condition (such as wrinkles), and the kind of subject
`
`or mammal being treated. Also, it should be noted that Dobson et al. do not disclose the volume
`
`and density of the molar (M) solutions and thus the moles, concentration or percent by weight of
`
`the adenosine used by Dobson et al. may well be the same as applicant’s.
`
`The applicant argues that In accordance with the Federal Circuit's decision in Jansen,
`
`these claims must be interpreted to require the specific intent to effect softening of expression
`
`lines. However, as set forth in the above rejections, Dobson et al. disclose a method for
`
`enhancing the condition of skin in a mammal by reducing (softening) wrinkles, roughness,
`
`dryness, or laxity of the skin, comprising topically applying to the skin a composition comprising
`
`adenosine (see claim 1 and claims 2-10). Dobson et al. disclose a method for enhancing the
`
`condition of skin in a mammal by reducing (softening) wrinkles, roughness, dryness, or laxity of
`
`the skin, comprising topically applying to the skin a composition comprising adenosine (see
`
`claim 1 and claims 2-10). It should be noted that the application of the composition to skin also
`
`encompasses the skin on the face and forehead and especially since that is where wrinkles
`
`(including expression lines) generally occur. Furthermore, “expression lines” are referred to as
`
`types of wrinkles. That is, expression lines are wrinkles. Applicant’s attention is drawn to
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 13 of 19 PageID #: 251
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 13 of 19 PageID #: 251
`
`Application/Control Number: 10/701,495
`
`Page 1 1
`
`Art Unit: 1623
`
`Exhibit A and B which disclose that expression lines are forms of wrinkles. Exhibit A states that
`
`“The wrinkles that seem to bother us most are “character” or “expression” lines” (see page 1, ISI
`
`line of 2Ild paragraph). In addition, Exhibit B sates that “Natural expressions that use specific
`
`facial muscles may cause some wrinkles called "expression lines” to reappear” (see page 4, 2‘1d
`
`paragraph, lines 2-3). Thus, these exhibits disclose that expression lines are wrinkles. It must
`
`also be noted that Dobson et al. apply the same composition to the skin of the same subject as
`
`applicant and consequently it should have the same inherent effect of softening of expression
`
`lines (for similar arguments by made by applicant with respect to Lapinet et al., see also the
`
`rejections set forth above).
`
`The applicant argues that neither Dobson nor Lapinet teaches or suggests anything
`
`concerning treatment of the condition (expression lines), let alone the specific amounts of
`
`adenosine required in claim 23. However, One having ordinary skill in the art would have been
`
`motivated to use the method of Dobson et al. to treat wrinkles (which includes expression lines)
`
`or enhance skin or relax facial features with a composition comprising adenosine or adenosine
`
`analogue, and to use different % by weight of adenosine or adenosine analogue at the required
`
`location, based on factors like the severity of the skin or facial condition (such as wrinkles), and
`
`the kind of subject or mammal being treated.
`
`The applicant argues that as demonstrated by Exhibits A-C cited by the Office Action,
`
`expression lines differ from other wrinkles such as those caused by sun damage, and expression
`
`lines are “difficult to treat.” Thus, merely because a reference might disclose methods of treating
`
`other types of less difficult-to-treat wrinkles, it does not mean that such a reference (directed to a
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 14 of 19 PageID #: 252
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 14 of 19 PageID #: 252
`
`Application/Control Number: 10/701,495
`
`Page 12
`
`Art Unit: 1623
`
`different type of wrinkle) teaches or suggests anything about how to treat expression lines. In
`
`other words, for example, a disclosure related to treating wrinkles caused by sun damage cannot
`
`teach or suggest how to treat expression lines, which are recognized as being different, more
`
`difficult-to-treat types of wrinkles. However, Dobson et al. disclose a method for enhancing the
`
`condition of skin in a mammal by reducing (softening) wrinkles, roughness, dryness, or laxity of
`
`the skin, comprising topically applying to the skin a composition comprising adenosine (see
`
`claim 1 and claims 2-10). That is, Dobson et al.’s method includes the treatment of wrinkles in
`
`general (i.e., all types of wrinkles including expression lines) and is not limited to any particular
`
`type of wrinkle such as wrinkles caused by sun damage. Furthermore, Dobson et al. do not
`
`disclose that any particular type of wrinkle is more difficult or easier to treat than others.
`
`The applicant argues that by way of analogy, baldness can be caused by different
`
`mechanisms such as, for example, alopecia or testosterone-related baldness. However, whereas
`
`testosterone-related baldness might be treatable using compounds which inhibit testosterone
`
`production or inhibit conversion of testosterone to active forms, alopecia cannot be treated using
`
`such compounds. Thus, although the effect (baldness) is the same, treatment methods are not
`
`interchangeable for the different types of baldness. However, Dobson et al. disclose a method
`
`for enhancing the condition of skin in a mammal by reducing (softening) wrinkles, roughness,
`
`dryness, or laxity of the skin, comprising topically applying to the skin a composition comprising
`
`adenosine (see claim 1 and claims 2-10). That is, Dobson et al.’s method includes the treatment
`
`of wrinkles in general (i.e., all types of wrinkles including expression lines) and is not limited to
`
`any particular type of wrinkle such as wrinkles caused by sun damage. Furthermore, Dobson et
`
`al. do not disclose that any particular type of wrinkle is more difficult or easier to treat than
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 15 of 19 PageID #: 253
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 15 of 19 PageID #: 253
`
`Application/Control Number: 10/701,495
`
`Page 13
`
`Art Unit: 1623
`
`others. Consequently, a skilled artisan would expect to use Dobson et al.’s compound to treat all
`
`types of wrinkles (including expression lines). In fact, Dobson et al.’s compound may be more
`
`effective on wrinkles that are expression lines. Also, it should also be noted that applicant uses
`
`the same compound as Dobson et al.’s to treat wrinkles (expression lines). This indicates that a
`
`particular compound (such as Dobson et al. ’s compound) can be used to treat different types of
`
`wrinkles (including expression lines). Thus, a comparison of baldness to wrinkles (two distinctly
`
`different conditions) is irrelevant especially.
`
`The applicant argues that treatment methods for treating one type of wrinkle are not
`
`interchangeable with methods for treating expression lines. However, expression lines are a type
`
`of wrinkle and Dobson et al.’s treat wrinkles in general (i.e., all types of wrinkles including
`
`expression lines) not just one kind of wrinkle.
`
`The applicant argues that Neither Dobson nor Lapinet teaches or suggests softening
`
`
`expression lines by applying an adenosine compound thereto. Both Dobson and Lapinet teach
`
`treating wrinkles or damaged skin caused by sun, age and/or environmental factors such as wind.
`
`
`(See, Dobson at col. 1, lines 28-34 and Lap_inet at col. 1, lines 49-56). However, Dobson et al.
`
`disclose a method for enhancing the condition of skin in a mammal by reducing (softening)
`
`wrinkles, roughness, dryness, or laxity of the skin, comprising topically applying to the skin a
`
`composition comprising adenosine (see claim 1 and claims 2-10). That is, Dobson et al.’s
`
`method includes the treatment of wrinkles in general (i.e., all types of wrinkles including
`
`expression lines) and is not limited to any particular type of wrinkle such as wrinkles caused by
`
`sun damage. Furthermore, Dobson et al. does not disclose that any particular type of wrinkle is
`
`more difficult or easier to treat than others. In addition, Lapinet et al. disclose applicant’s method
`
`

`

`Case 1:17-cv-00868-JFB-SRF Document 13-4 Filed 08/18/17 Page 16 of 19 PageID #: 254
`Case 1:17-cv-00868—JFB-SRF Document 13-4 Filed 08/18/17 Page 16 of 19 PageID #: 254
`
`Application/Control Number: 10/701,495
`
`Page 14
`
`Art Unit: 1623
`
`of softening and enhancing the natural elasticity of the skin comprising applying topically to
`
`human skin a composition comprising an adenosine analogue, cyclic 3’,5 ’-adenosine
`
`monophosphate (see claims l-2 and col. 2, line 48- col. 4, line 7). It should be noted that the
`
`application of the composition to skin also encompasses the skin on the face and forehead and
`
`especially since that is where wrinkles (including expression lines) generally occur.
`
`Furthermore, it should be noted that the examiner considers that the softening of skin also
`
`includes a softening of lines especially since Lapinet also disclose that wrinkles (expression
`
`lines) are decreased (softened) by said treatment (see col. 4, lines 3—7) and that said treatment is
`
`applied to soften and soothe human skin that is wrinkled and dry (see col. 1, lines 47-52). It
`
`must also be noted that Lapinet et al. apply the same composition to the skin of the same subject
`
`as applicant and consequently it should, have the s