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 application is a national stage application of PCT/DK2022/050071, filed April 7, 2022, which claims priority to foreign application DK PA202170167, filed April 12, 2021. Claims 1-12 and 16-23 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted September 22, 2023, is acknowledged wherein claims 3-8 and 10-12 are amended, claims 13-15 are canceled, and 16-23 are introduced.
Claim Rejections - 35 USC § 112
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.
Claims 3-5, 9, 11, 17-19, and 23 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Regarding the aforementioned claims, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This claim depends from independent claim 1, which defines the claimed composition as a vaginal contraceptive composition. However claim 7 includes as its sole additional limitation that the claimed composition is a contraceptive, a limitation already present in claim 1. Therefore claim 7 fails to further limit the base claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-9 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. Therefore Oliveira anticipates claims 1 and 2.
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 6, these compositions can be prepared as films or sponges, which are not foams. (see p. 2 paragraph 19) Regarding claim 7, this claim merely recites the limitation that the compositions are contraceptive compositions, which is already present in base claim 1. Regarding claim 8, the 2% lactic acid is a buffer. 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 1-9 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 1-9 and 11 above, and further in view of Maslarska et al. (Reference included with PTO-892)
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, 16-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira as applied to claims 1-9 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, 16-21, and 23 above, and further in view of Maslarska et al. (Reference included with PTO-892)
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, 6, 7, 12, and 20 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 claims 12 and 20, 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.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 1/29/2025