Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Detailed Action
This office action is a response to applicant’s communication submitted June 4, 2026, wherein claims 1, 3-5, 9-11, 17-19, 22, and 23 are amended and claims 2, 6-8, 16, 20, and 21 are canceled. This application is a national stage application of PCT/DK2022/050071, filed April 7, 2022, which claims priority to foreign application PA202170167, filed April 12, 2021.
Claims 1, 3-5, 9-12, 17-19, 22, and 23 are pending in this application.
Claims 1, 3-5, 9-12, 17-19, 22, and 23 as amended are examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, submitted June 4, 2026, with respect to the rejection of claims 3-5, 9, 11, 17-19, and 23 under 35 USC 112(b) for containing the indefinite phrase, “such as,” has been fully considered and found to be persuasive to remove the rejection as the claims have been amended to no longer include this phrase. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted June 4, 2026, with respect to the rejection of claim 7 under 35 USC 112(d) for failing to further limit the base claim, has been fully considered and found to be persuasive to remove the rejection as claim 7 has been canceled. Therefore the rejection is withdrawn.
The following rejections of record in the previous action are maintained:
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-5, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palmeira De Oliveira et al. US pre-grant publication 2017/0224749, cited in PTO-1449, herein referred to as Oliveira)
Independent claim 1 is directed to a vaginal contraceptive formulation comprising an active agent which is a mucoadhesive polymer containing amino groups, having C6 sugar or amino acid monomers with at least 50% of the monomers containing amino groups and the polymer having a molecular weight of 90000-300000 Da. The formulation further contains at least one of a gelling agent and a carrier. Claim 2 requires that the composition contains both a gelling agent and a carrier.
Oliveira discloses topical compositions for treating urogenital diseases. (p. 2 paragraph 19) The composition further includes bioadhesive polymers such as chitosan that form gels and increase vaginal retention. (p. 2 paragraph 20) In particular, the composition comprises a plasticizer, a mucoadhesive polymer, a probiotic or prebiotic, and a pharmacological active substance. (p. 3 paragraphs 36-40) An exemplary formulation (p. 7 paragraph 124) contains 1% medium molecular weight chitosan, 2.5% hydroxypropyl methyl cellulose, 2.5% glycerin, and the remainder as 2% lactic acid. Note that p. 8 paragraph 140 defines “medium molecular weight chitosan” as being chitosan having a molecular weight of 150-310 kDa. Therefore this chitosan falls within the description of an active agent in claim 1. Additionally, p. 18 lines 22-25 of the present specification indicate that HPMC is regarded as a compound falling within the scope of “physiologically acceptable gelling agent” according to the present claims. The glycerin and 2% lactic acid reasonably fall within the scope of a physiologically acceptable carrier according to the present claims. While Oliveira does not specifically describe the composition as a contraceptive, this composition contains the same components recited in the present claims. Chitosan is specifically described in the present specification (p. 23 lines 91-21) as a mucoadhesive polymer suitable as an active agent in the present compositions. Furthermore regarding the requirement that the composition contain a buffer, p. 6 paragraphs 111 and 113 of Oliviera indicate that the lactic acid acts as a buffer. Finally, these compositions can be prepared as films or sponges, which are not foams. (see p. 2 paragraph 19) Therefore Oliveira anticipates claim 1.
Regarding claim 3, defining the water in Oliveira’s composition as the carrier, it would come to about 92% of the composition, falling within the broadest recitation in claim 3. Regarding claim 4, the gelling agent (HPMC) is 2.5%, falling within the broadest recitation in claim 4. Regarding claim 5, p. 7 table 4 teaches that the osmolality can be about 327 mosm/kg. Regarding claim 9, according to the Chemicalbook entry for lactic acid, (Reference included with PTO-892) the mw of lactic acid is about 90 and the density is about 1.2. Therefore a 2%(v/v) solution of lactic acid buffer is computed to have a concentration of about 267mM. Regarding claim 11, as discussed with respect to claim 1, the “medium molecular weight chitosan” recited by Oliveira is interpreted as having a molecular weight of 150-310 kDa.
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 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.
Claims 1, 3-5, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Palmeira De Oliveira et al. US pre-grant publication 2017/0224749, cited in PTO-1449, herein referred to as Oliveira)
The disclosure of Oliveira is discussed above. While Oliveira is considered to anticipate the present claims, even assuming for the sake of argument that Oliveira does not specifically disclose a composition having the exact molecular weight of 90-350 kDa as recited in claim 1 or 11, the present claims would still have been obvious over Oliveira. Specifically, Oliveira discloses that the mw of the chitosan van be between 10-350 kDa, a range which substantially overlaps the ranges recited in present claims 1 and 11. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to determine the optimal molecular weight of the chitosan to use in the invention of Oliveira, given that the mw has been disclosed as a result-effective variable.
Therefore the invention taken as a whole is prima facie obvious.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira as applied to claims 1, 3-5, 9, and 11 above, and further in view of Maslarska et al. (Reference of record in previous action)
The disclosure of Oliveira is discussed above. Oliveira does not disclose the compositions as containing a preservative. However, Maslarska et al. discloses that preservatives such as methylparaben and propylparaben are used in vaginal formulations. (p. 127 left column) It would therefore have been obvious to one of ordinary skill in The art at the time of the invention to include a preservative in the formulations described by Oliveira. One of ordinary skill in the art would have found this to be obvious in view of the disclosure by Maslarska et al. that preservatives are included in such formulations.
Therefore the invention taken as a whole is prima facie obvious.
Claims 12, 17-19, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira as applied to claims 1, 3-5, 9, and 11 above, and further in view of Smith. (US patent 4474769, cited in PTO-1449)
The disclosure of Oliveira is discussed above. Oliveira does not disclose using chitosan-containing compositions as contraceptives. However, Smith discloses that locally administered chitosan can act to prevent sperm from fertilizing the ovum, and therefore be used as a contraceptive. (column 1 lines 31-35) Smith further discloses chitosan as being about 80% deacetylated. (column 2 lines 25-29) Chitosan concentrations of about 1-5% are suggested. (column 3 lines 1-3) A preferred molecular weight for the chitosan is about 30-300 kDa. (column 3 lines 31-36)
It would have been obvious to one of ordinary skill in the art at the time of the invention to use a chitosan-containing vaginal composition such as that described by Oliveira and Smith for the purpose of contraception. One of ordinary skill in the art would have seen this to be obvious based on the disclosure by Smith that topical chitosan-containing compositions are also useful for the purpose of contraception.
Therefore the invention taken as a whole is prima facie obvious.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Oliveira in view of Smith as applied to claims 12, 17-19, and 23 above, and further in view of Maslarska et al. (Reference of record in previous action)
The disclosures of Oliveira and Smith are discussed above. Oliveira in view of Smith does not disclose the compositions as containing a preservative. However, Maslarska et al. discloses that preservatives such as methylparaben and propylparaben are used in vaginal formulations. (p. 127 left column) It would therefore have been obvious to one of ordinary skill in The art at the time of the invention to include a preservative in the formulations described by Oliveira and Smith. One of ordinary skill in the art would have found this to be obvious in view of the disclosure by Maslarska et al. that preservatives are included in such formulations.
Therefore the invention taken as a whole is prima facie obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims 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 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, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5-8 of copending Application No. 17/766206 (reference application, US pre-grant publication 2024/0082293, cited in PTO-892, herein referred to as ‘206). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘206 render the present claims obvious.
Specifically, claim 1 of ‘206 claims a vaginal contraceptive composition comprising an active ingredient and a gelling agent. The active ingredient is defined as a mucoadhesive polymer, wherein the mucoadhesive polymer has at least 50% of the monomer units containing amines. Dependent claims 5-8 further define the monomer units as glucosamines. The claims of ‘206 differ from the present claims in that claim 1 of ‘206 claims a molecular weight range 0f 20-100 kDa as opposed to the range of 90-350 kDa recited in present claim 1. However, the range claimed in the reference application overlaps with the presently claimed range. Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to determine the appropriate molecular weight to use in order to practice the claimed invention, within the range disclosed by the prior art, rendering the present claims obvious. See MPEP 2144.05(I), “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”
Regarding claim 12, because claim 1 of ‘206 describes the composition as a vaginal contraceptive composition, it would have been obvious to one of ordinary skill in the art at the time of the invention to use it in this manner, by administering it vaginally for the purpose of contraception.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments, submitted June 4, 2026, with respect to the above grounds of rejection, have been fully considered and not found to be persuasive to remove the rejection. Regarding the rejection for anticipation under 35 USC 102, Applicant argues that the compositions described by Oliviera do not include a gelling agent. In particular, they argue that the HPMC polymer included in Oliviera’s composition is not a gelling agent but rather a film former of matrix polymer. However, looking at the disclosure of Oliviera, p. 2 paragraphs 20-22 indicate that the film functions by forming a gel upon contact with vaginal fluids. Therefore the composition is considered to contain a gelling agent, and to exist as a gel in its therapeutically active form. Applicant further makes reference to the specification to describe alleged differences between the invention and the compositions described by Oliviera. However, features described in the specification are not considered to be claim limitations and cannot be used to differentiate the claims from the prior art.
Regarding the rejections under 35 USC 103 over Oliviera or Oliviera in view of Maslarska, Applicant relies upon the same arguments as those made with respect to the rejection under 35 USC 102, which are found to be not persuasive for the same reasons. than that recited in the present claims in order to overcome binding to mucosal proteins.
Regarding the rejection under 35 USC 103 over Oliviera in view of Smith, Applicant argues that the disclosure of Smith differs from that of the present claims in that in the present invention the chitosan functions by reacting with the mucosal proteins in order to reinforce the mucosal barrier, as opposed to the disclosure of Smith, which describes the contraceptive activity as being due to free chitosan which is not bound to mucosal proteins. However, in practical terms, such a difference would only be relevant if Smith’s invention were to require an amount of chitosan greater than that recited in the present claims. In matter of fact, Smith discloses a preferred range of 1-5%. (column 3 lines 1-3) By contrast, the present claims specify concentrations for the physiologically acceptable carrier and the gelling agent, but not the mucoadhesive polymer. Furthermore Oliviera’s compositions have similar concentration of chitosan to Smith’s compositions. (see p. 6 table 1) Therefore any difference in the mechanism of the presently disclosed invention and that of the prior art is not reflected in the claims in such a way as to clearly differentiate the claims from the prior art.
Still further, Applicant argues that Smith discloses the molecular weight of the chitosan as relevant only to the viscosity of the resulting composition and not to the contraceptive activity. In particular, Applicant argues that the data provided in the specification point to the contraceptive effect of chitosan in the present invention as being molecular weight dependent. This appears to be an argument based on unexpected results, namely the specific claimed mw range being unexpectedly effective compared to lower molecular weight chitosan. A review of the data in the specification, including table 1 on p. 36, lines 7-17 on p. 40, and figures 1-13 in the drawings, shows that compositions having a molecular weight of between 102.3 and 315.9 kDa have superior effectiveness to lower molecular weight chitosans having a mw of 1.4-18.9 kDa. It is noted that, for comparison the medium mw chitosans described by Oliviera have a mw of about 150-310 kDa, falling squarely within the range described in the specification as having superior activity. Even the low molecular weight chitosans described by Smith have a mw of at least 30 kDa, which is still greater than any of the low mw chitosans described in the specification as having inferior activity. Therefore the evidence of unexpected results is not persuasive to overcome the finding of obviousness.
Finally, Applicant argues that the compositions described by Smith do not use a buffer. However, as admitted by Applicant, the compositions do use ascorbic acid as an acidic solvent. Looking to the relevant portion of the specification, Smith specifically names lactic acid as one of the acids that can be used to dissolve the chitosan. (column 2 lines 48-51) Lactic acid is the same buffer described by Oliviera. Furthermore its function in the compositions described by Smith is clearly to maintain an acidic pH. Therefore it is reasonably considered to function as a buffer regardless of whether or not it is specifically referred to as one by Smith.
Therefore all of the above rejections are seemed proper and maintained. Regarding the rejection made on the grounds of double patenting over the claims of 17/766206, Applicant does not traverse this rejection but merely requests that it be held in abeyance. Therefore the rejection is maintained.
Conclusion
No claims are allowed in this action. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 7/24/2026
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