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www.uspto.gov
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`17/440,875
`
`09/20/2021
`
`Sujin YANG
`
`Q61021YG02
`
`8376
`
`The
`
`our a
`
`The PL Law Group, PLLC
`13800 Coppermine Road
`FL 1-3
`Herndon, VA 20171
`
`BAKER, ADAM D
`
`3786
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`02/29/2024
`
`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):
`
`mail@ thepllaw.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`
`
`Disposition of Claims*
`1-7 is/are pending in the application.
`)
`Claim(s)
`5a) Of the above claim(s) _ is/are withdrawn from consideration.
`C] Claim(s)
`is/are allowed.
`Claim(s) 1-7 is/are rejected.
`(] Claim(s)__ is/are objectedto.
`C] Claim(s
`are subjectto restriction and/or election requirement
`)
`* If any claims have been determined allowable, you maybeeligible 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.jsp or send an inquiry to PPHfeedback@uspto.gov.
`
`) ) ) )
`
`Application Papers
`10)() The specification is objected to by the Examiner.
`11) The drawing(s)filed on 9/20/21 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:
`_—_c)L) None ofthe:
`b)L) Some**
`a)Y) All
`1.) Certified copies of the priority documents have been received.
`2.1.) Certified copies of the priority documents have been received in Application No. |
`3.2.) Copies of the certified copies of the priority documents have been receivedin 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 Date 9/20/21,
`U.S. Patent and Trademark Office
`
`3)
`
`4)
`
`(LJ Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`(Qj Other:
`
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20240215
`
`Application No.
`Applicant(s)
`17/440,875
`YANG, Sujin
`
`Office Action Summary Art Unit|AIA (FITF)StatusExaminer
`ADAM D BAKER
`3786
`Yes
`
`
`
`-- The MAILING DATEof this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORYPERIOD FOR REPLYIS SET TO EXPIRE 3 MONTHS FROM THE MAILING
`DATE OF THIS COMMUNICATION.
`Extensionsof time may be available underthe provisions of 37 CFR 1.136(a). In no event, however, may a reply betimely filed after SIX (6) MONTHSfrom 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) MONTHSfrom 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, evenif timely filed, may reduce any earned patent term
`adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1) Responsive to communication(s) filed on 9/20/21.
`C} A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/werefiled on
`
`2a)() This action is FINAL. 2b)¥)This action is non-final.
`3) An election was madeby the applicant in responseto a restriction requirement set forth during the interview
`on
`; the restriction requirement and election have been incorporated into this action.
`4)(2) 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 Exparte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`

`

`Application/Control Number: 17/440,875
`Art Unit: 3786
`
`Page2
`
`DETAILED ACTION
`
`Notice of Pre-AlA or AIA Status
`
`The present application, filed on or after March 16, 2013, is being examined underthefirst
`
`inventor to file provisions of the AIA.
`
`Priority
`
`Applicant's claim for the benefit of a prior-filed application KR10-2019-0031 746 under 35 U.S.C.
`
`119 is acknowledged.
`
`Applicant's claim for the benefit of a prior-filed application PCT/KR2020/002639 under 35 U.S.C.
`
`371 is acknowledged.
`
`Claim Rejections - 35 USC § 103
`
`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 fora claimed invention may notbe obtained, notwithstanding thatthe claimed
`invention is not identically disclosed as setforth in section 102, if the differences betweenthe
`claimed invention and the prior artare such that the claimed invention as a whole would have
`been obvious beforethe effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall notbe
`negated by the manner in whichthe invention was made.
`
`Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Staab (US
`
`2007/0175484)in view of Alieva (DE102008062426A1) and in view of Kumosani et al (US
`
`10,154,958) and in view of Hajhashemiet al (Hajhashemiet al, Analgesic and Anti-inflammatory
`
`Effects of Rosa damascene Hydroalcoholic Extract and its Essential Oil in Animal Models,|ranian
`
`Journal of Pharmaceutical Research, 9 (2): 163-168 (2010)) and in view of Santo et al (US
`
`2005/0255076).
`
`With respect to claim 1, Staab discloses A condom comprising: a condom body ([0016],
`
`condom body 10); and a lubricant layer formed on an outer surface of the condom body by applying a
`
`lubricant solution comprising a mixture of a lubricant and a composition for antibacterial and anti-
`
`inflammatory activities to the outer surface ([0009], [0029], composition which improved lubricity- so is a
`
`lubricant- with an antibacterial and an anti-inflammatory).
`
`

`

`Application/Control Number: 17/440,875
`Art Unit: 3786
`
`Page3
`
`Staabis silent on the composition comprising, as an active ingredient, a combination comprising
`
`a fisetin compound, a Rose damasceneextract, a Paeonia suffruticosa Andr. extract, and a Scutellaria
`
`baicalensis extract.
`
`Alieva teaches an analogous active ingredient in which the combined flavonoid (fisetin is a type of
`
`flavonoid) essential oil have an anti-inflammatory effect (p 2 Il 16-17, Examiner notes that “phlovonoid”is
`
`the untranslated term “flavonoid’).
`
`It would have beenobviousto oneof ordinary skill in the art before the effectivefiling date of the
`
`claimed invention to modify the anti-inflammatory active ingredients of Staab to be an essential oil and a
`
`flavonoid as taught by Alieva to be effective in reducing inflammation (Alieva p 2 Il 16-17).
`
`Staab/Alieva is silent on the flavonoid being a fisetin compound and the essential oil being a
`
`Rose damascene extract, and a Paeonia suffruticosa Andr. extract, and a Scutellaria baicalensis extract.
`
`Kumosani et al teaches an analogousanti-inlammatory flavonoid for vaginal use whichis fisetin
`
`(col 16 Il 30-35, col 1 Il 10-15, col 6 Il 10-20).
`
`It would have been obviousto oneofordinary skill in the art before the effective filing date of the
`
`claimed invention to modify the flavonoid of Staab/Alieva to be fisetin as taught by Kumosani et al in order
`
`to have a flavonoid that is effective as an anti-inflammatory and is knownto be safe in the vagina
`
`(Kumosani et al col 16 II 30-35, col 1 Il 10-15, col 6 Il 10-20)
`
`Staab/Alieva/Kumosaniet al is silenton the essential oil being a Rose damascene extract, and a
`
`Paeonia suffruticosa Andr. extract, and a Scutellaria baicalensis extract.
`
`Hajhashemi et al teaches an analogousessential oil for anti-inflammation in which the essential
`
`oilis Rose damasceneextract (p 164 col 1).
`
`It would have beenobviousto oneof ordinary skill in the art before the effectivefiling date of the
`
`claimed invention to modify the essential oil of Staab/Alieva/Kumosani et al to be Rose damascene
`
`extract in order to have an ingredient with well-known anti-inflammatory effects (p 167 col 2).
`
`Staab/Alieva/Kumosaniet al/Hajhashemiet al is silent on and a Paeonia suffruticosa Andr.
`
`extract, and a Scutellaria baicalensis extract.
`
`Santo et al teaches an analogous therapeutic compoundwith anti-bacterial and anti-inflammatory
`
`activities wherein the compound comprises Paeonia suffruticosa Andr. Extract ([0029], extract added to
`
`

`

`Application/Control Number: 17/440,875
`Art Unit: 3786
`
`Page 4
`
`other compounds with similar purposes,anti-inflammatory), and a Scutellaria baicalensis extract ([0051],
`
`[0054], antibacterial).
`
`It would have beenobviousto oneof ordinary skill in the art before the effectivefiling date of the
`
`claimed invention to modify the compound of Staab/Alieva/Kumosani et al/Hajhashemi et al with the
`
`addition of the extracts as taught by Santo et al in order to further the medical use of the compoundwith
`
`materials known to work onthe outer user (Santo et al [0001]).
`
`With respect to claim 2, Staab/Alieva/Kumosani et al/Hajhashemiet al/Santo et al discloses The
`
`condom ofclaim 1, wherein the fisetin compoundis a kind of flavonoid and is a compound represented by
`
`a molecular formula of CisHi006(Kumosani et al, col 16 Il 30-35, col 1 Il 10-15, col 6 Il 10-20, fisetin, this
`
`claimed formula is the formula forfisetin).
`
`It would have been obviousto oneofordinary skill in the art before the effective filing date of the
`
`claimed invention to modify the flavonoid of Staab/Alieva to be fisetin as taught by Kumosani et al in order
`
`to have a flavonoid that is effective as an anti-inflammatory and is knownto be safe in the vagina
`
`(Kumosani et al col 16 II 30-35, col 1 Il 10-15, col 6 Il 10-20)
`
`With respect to claim 3, Staab/Alieva/Kumosani et al/Hajhashemiet al/Santo et al discloses The
`
`condom of claim 2, wherein the fisetin compound is a compound represented by the following formula
`
`(Kumosani et al, col 16 Il 30-35, col 1 Il 10-15, col6Il 10-20, fisetin, this claimed formula is the formula for
`
`fisetin).
`
`It would have been obviousto oneofordinary skill in the art before the effective filing date of the
`
`claimed invention to modify the flavonoid of Staab/Alieva to be fisetin as taught by Kumosani et al in order
`
`to have a flavonoid that is effective as an anti-inflammatory and is knownto be safe in the vagina
`
`(Kumosani et al col 16 II 30-35, col 1 Il 10-15, col 6 Il 10-20)
`
`With respect to claim 4, Staab/Alileva/Kumosani et al/Hajhashemiet al/Santo et al discloses The
`
`condom ofclaim 2, wherein the Rose damasceneextract is a substance obtained by extraction from
`
`Rose damascenewhich is a small shrub belonging to the family Rosaceae of the order Rosales of
`
`Dicotyledoneae (Hajhashemi p 164 col 1, Rose damascene extract, a rose damascene extract obviously
`
`comesfromtheclaimedtree); the Paeonia suffruticosa Andr. extract is a substance obtained by
`
`extraction from Paeonia suffruticosa Andr. which is a plant belonging to the family Ranunculaceaeof
`
`

`

`Application/Control Number: 17/440,875
`Art Unit: 3786
`
`Page 5
`
`Dicotyledoneae(Santo et al [0029], Paeonia suffruticosa Andr. Extract comes from the claimed plant);
`
`and the Scutellaria baicalensis extract is a substance obtained by extraction from Scutellaria baicalensis
`
`which is a perennial plant belonging to the family Labiatae of the order Tubiflorae of Dicotyledoneae
`
`(Santo et al ([(0051], [0054], a Scutellaria baicalensis extract).
`
`It would have beenobviousto oneof ordinary skill in the art before the effectivefiling date of the
`
`claimed invention to modify the essential oil of Staab/Alieva/Kumosani et al to be Rose damascene
`
`extract in order to have an ingredient with well knownanti-inflammatory effects (p 167 col 2).
`
`It would have been obviousto oneofordinary skill in the art before the effective filing date of the
`
`claimed invention to modify the compound of Staab/Alieva/Kumosani et al/Hajhashemi with the addition of
`
`the extracts as taught by Santoet al in order to further the medical use of the compound with materials
`
`knownto work on the outer user (Santo et al [0001)).
`
`With respect to claim 5, Staab/Alileva/Kumosani et al/Hajhashemiet al/Santo et al discloses The
`
`condom ofclaim 4, wherein the composition is produced by mixing the fisetin compound, the Rose
`
`damasceneextract, the Paeonia suffruticosa Andr. extract and the Scutellaria baicalensis extract together
`
`at a weight ratio of 1: 0.5 to 1.5: 8 to 12: 8 to 12 (Examinerfurther notes,in light of cited prior art that the
`
`claimed weight ratios are design choices considered as result effective variables, which can be optimized
`
`within prior art conditions or through routine experimentation to bestfit each individual human anatomy.
`
`The claimed weight ratio which fell within the broad scope of the references are held to be unpatentable
`
`there over because, among other reasons, there was no evidenceof thecriticality of the claimed weight
`
`ratio within the specification. And where the general conditions of a claim are disclosed in thepriorart, it
`
`is not inventive to discover the optimum or workable ranges by routine experimentation. /n re Hoeschele,
`
`406 F.2d 1403, 160 USPQ 809 (CCPA 1969); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA
`
`1955). Here, it would be obvious to experiment with the claimed ingredients to find the ration which allows
`
`for the desired antibacterial and anti-inflammatory effects- see Santo et al [0102] with a range of ratios in
`
`orderto havethe desired compoundeffect.)
`
`With respect to claim 6, Staab/Alileva/Kumosani et al/Hajhashemiet al/Santo et al discloses The
`
`condom ofclaim 5, wherein the composition is produced by mixing the fisetin compound, the Rose
`
`damasceneextract, the Paeonia suffruticosa Andr. extract and the Scutellaria baicalensis extract together
`
`

`

`Application/Control Number: 17/440,875
`Art Unit: 3786
`
`Page6
`
`at a weight ratio of 1: 1: 10: 10 (Examiner further notes,in light of cited prior art that the claimed weight
`
`ratios are design choices considered as result effective variables, which can be optimized within prior art
`
`conditions or through routine experimentation to best fit each individual human anatomy. The claimed
`
`weightratio whichfell within the broad scopeof the references are held to be unpatentable there over
`
`because, among other reasons,there was no evidenceof thecriticality of the claimed weightratio within
`
`the specification. And where the general conditions of a claim are disclosedin the prior art, it is not
`
`inventive to discover the optimum or workable ranges by routine experimentation. In re Hoeschele, 406
`
`F.2d 1403, 160 USPQ 809 (CCPA 1969); /nre Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA
`
`1955). Here, it would be obvious to experiment with the claimed ingredients to find the ration which allows
`
`for the desired antibacterial and anti-inflammatory effects- see Santo et al [0102] with a range ofratios in
`
`order to havethe desired compoundeffect.).
`
`With respect to claim 7, Staab/Alieva/Kumosani et al/Hajhashemiet al/Santo et al discloses The
`
`condom ofclaim 1, wherein the lubricant solution is prepared by mixing the lubricant with 0.001 to 10 wi%
`
`of the composition (Staab [0029], prior art range includes the claimed range and thus meets the
`
`limitation).
`
`Conclusion
`
`Anyinquiry concerning this communication or earlier communications from the examiner should
`
`be directed to ADAM D BAKER whosetelephone numberis (571)270-3333. The examiner can normally
`
`be reached Monday-Friday 9:30-5:30.
`
`Examinerinterviews are available via telephone, in-person, and video conferencing using a
`
`USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use
`
`the USPTO Automated Interview Request(AIR) at http://www.uspto.gov/interviewpractice.
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor,
`
`Rachael E Bredefeld can be reached on (571)270-5237. The fax phone number for the organization
`
`wherethis application or proceeding is assigned is 571-273-8300.
`
`Information regarding the status of published or unpublished applications may be obtained from
`
`Patent Center. Unpublished application information in Patent Centeris available to registered users. To
`
`file and manage patent submissions in Patent Center, visit: httos://patentcenter.uspto.gov. Visit
`
`

`

`Application/Control Number: 17/440,875
`Art Unit: 3786
`
`Page 7
`
`https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and
`
`https://www.uspto.gov/patents/docx for information aboutfiling in DOCX format. For additional questions,
`
`contactthe Electronic Business Center (EBC) at 866-217-9197(toll-free). If you would like assistance
`
`from a USPTO CustomerService Representative, call 800-786-9199 (INUSA OR CANADA)or 571 -272-
`
`1000.
`
`/ADAM BAKER/
`Examiner, Art Unit 3786
`
`

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