DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 in the reply filed on 12/23/2025 is acknowledged.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025.
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.
Claim 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 6 recites a composition of claim 1 comprising “sodium, preferably 25 mM sodium.” The phrase “preferably” renders this claim indefinite, because it is not clear whether “25 mM” limits the claim or merely suggests a best mode. See MPEP § 2173.05(d). For examination purposes, the claim is interpreted as only requiring the broader limitation “comprising sodium”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ensign‒Hodges, L., “Mucus‒Penetrating Nanoparticles for Vaginal and Gastrointestinal Drug Delivery,” dissertation, Johns Hopkins University, November 2012. See NPL Cite No. 335 of 07/25/2023 IDS.
Ensign‒Hodges tests a hypotonic composition comprising acyclovir monophosphate (ACVp), a microbiocide, against HSV‒2 infection, and concludes that while hypotonic delivery improved immediate protection as compared to isotonic delivery, osmotic flow through the epithelium removed ACVp from the vagina decreased protection (pp. 48‒49, 4.3.3).
Claims 1-2 are rejected under 35 U.S.C. 102((a)(1)/(a)(2)) as being anticipated by WO2013110028. See Foreign Patent Cite No. 261 of 07/25/2023 IDS.
WO2013110028 likewise tests a hypotonic composition comprising acyclovir monophosphate (ACVp), a microbiocide, against HSV‒2 infection, and concludes that while hypotonic delivery improved immediate protection as compared to isotonic delivery, osmotic flow through the epithelium removed ACVp from the vagina decreased protection. (pp. 75‒76, Effect of tonicity on prevention of vaginal HSV‒2 infection).
Claims 1-2 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Date, et al., Antiviral Res., 96:430 (Dec. 2012). See NPL Cite No. 319 of 07/25/2023 IDS.
Date discloses development of a thermosensitive vaginal gel comprising the microbiocides raltegravir and efavirenz, using a combination of poloxamer 188 (Pluronic F-68) and poloxamer 407 (Pluronic F-68). (Abstract). Date recognizes osmolality as an important criteria in successful vaginal formulations and notes the 1% tenofovir gel used in the CAPRISA-004 trial was hyperosmolar (3111 mOsm/kg), resulting in epithelial stripping of polarized explants. (p. 6, Discussion). Thus, Date creates hypotonic microbiocidal thermosensitive gels having less than 500 mOsm in order to be well tolerated as compared to the hypertonic 1% tenofovir gel. Id.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ensign‒Hodges.
Ensign‒Hodges tests a hypotonic composition comprising acyclovir monophosphate (ACVp), a microbiocide, against HSV‒2 infection, and concludes that while hypotonic delivery improved immediate protection as compared to isotonic delivery, osmotic flow through the epithelium removed ACVp from the vagina decreased protection. (p. 48‒9, 4.3.3). Ensign‒Hodges overcomes vaginal removal of hypotonically delivered ACVp as a free drug, by using mucus‒penetrating particles that penetrate vaginal mucus and coat the entire vaginal surface within 10 mins of delivery in a hypotonic solution:
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(p. 49‒51, 4.3.4‒4.3.6).
These osmolarity ranges overlap with those of present claims 4 and 5. Claimed ranges overlapping or lying inside of ranges disclosed in the prior art creates a prima facie case of obviousness. 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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Regarding claims 6-7, sodium and potassium are well-known tonicity adjusters and would have been obvious to a PHOSITA to include in order to achieve the desired osmolarity. Regarding claim 10, Ensign-Hodges demonstrates the usefulness of the mucus-penetrating particles in rectal administration to provide effective delivery to the colon. (pp. iii, 115-119, 121, 123, 124, 127). Furthermore, rectal administration is commonly performed via enema. Regarding claim 11, the composition is a solution.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ensign-Hodges as applied to claims 1-2, 4-7 and 10-11 above, and further in view of Lisco et al. See NPL Cite No. 411 of 07/25/2023 IDS.
Ensign-Hodges differs from claim 3 in that it utilizes ACVp rather than tenofovir. However, evidence suggests ACV may be considered a nucleoside reverse transcription inhibitor. For example, Lisco, et al. describe monophosphorylated ACV as capable of HIV-1 inhibition upon phosphorylation to triphosphorylated ACV, which suppresses reverse transcriptase. Cell Host Microbe., 4:260 (2008 September 11); (p. 261; Fig. 3). In function, then, ACVp would appear to be equivalent to tenofovir. The claimed invention merely applies tenofovir rather than ACVp to the concepts of established by Ensign-Hodges, which cannot sustain a patent even if the substitution of ACVp for tenofovir produces better results. (See, e.g., Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied,493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929)).
Claims 1-2, 4-7 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over WO2013110028.
WO2013110028 discloses hypotonic formulations ranging from 20-220 mOsm/kg that provide rapid delivery of mucus-penetrating nanoparticles to the vaginal folds. (Abstract). WO2013110028 tests a hypotonic composition comprising acyclovir monophosphate (ACVp), a microbiocide, against HSV‒2 infection, and concludes that while hypotonic delivery improved immediate protection as compared to isotonic delivery, osmotic flow through the epithelium removed ACVp from the vagina decreased protection. (pp. 75-76). WO2013110028 overcomes vaginal removal of hypotonically delivered ACVp as a free drug, by using mucus‒penetrating particles that penetrate vaginal mucus and coat the entire vaginal surface within 10 mins of delivery in a hypotonic solution:
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(p. 78).
These ranges overlap with those of present claims 4 and 5. Claimed ranges overlapping or lying inside of ranges disclosed in the prior art creates a prima facie case of obviousness. 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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997).
Regarding claims 6-7, WO2013110028 provides preferred embodiments wherein the formulation for application to the colon or rectum has an osmolality between about 20 mOsm/kg and 450 mOsm/kg, including sodium ions. (pp. 5; 30). In addition, WO2013110028 notes that potassium chloride and sodium chloride are useful in adjusting tonicity of the MPPs in pharmaceutical carriers appropriate for mucosal surface administration. (pp. 29; 32). Regarding claims 10 and 11, WO2013110028 demonstrates the usefulness of the mucus-penetrating particles in rectal administration to provide effective delivery to the colon. (pp. 79-80, Example 9).Furthermore, rectal administration is commonly performed via enema. Regarding claim 11, the composition is a solution.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over WO2013110028 as applied to claims 1-2, 4-7 and 10-11 above, and further in view of Lisco et al.
WO2013110028 differs from claim 3 in that it utilizes ACVp rather than tenofovir. However, evidence suggests ACV may be considered a nucleoside reverse transcription inhibitor. For example, Lisco, et al. describe monophosphorylated ACV as capable of HIV-1 inhibition upon phosphorylation to triphosphorylated ACV, which suppresses reverse transcriptase. Cell Host Microbe., 4:260 (2008 September 11); (p. 261; Fig. 3). In function, ACVp would appear to be equivalent to tenofovir. The claimed invention merely applies tenofovir rather than ACVp to the concepts of established by WO2013110028, which cannot sustain a patent even if the substitution of ACVp for tenofovir produces better results. (See, e.g., Merck & Co. Inc.v.Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied,493 U.S. 975 (1989); In reKulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree “will not sustain a patent”); In re Williams, 36 F.2d 436, 438 (CCPA 1929)).
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 1-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10092509.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to compositions comprising an effective amount of a microbiocide and a carrier having an osmolarity between 50 and 280 mOsm comprising hydrogel forming polymer and methods of use thereof. The issued claims are further drawn to individual components including a NRTI of claim 3, sodium and potassium of claims 5-7, and ranges of claims 1, 4, 7 and 15 which overlap with those instantly claimed. Issued claim 8 is drawn to the instantly claimed hydrogen-forming polymers. Accordingly, the issued claims anticipate and/or render obvious the instantly claimed composition.
Claims 1-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10646434.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to compositions comprising an effective amount of a microbiocide and a carrier wherein the composition has an osmolarity between 50 and 290 mOsm. The issued claims are drawn to individual components including a NRTI of claim 3, sodium and potassium of claims 6-7, and ranges of claims 1, 4-5 and 15 which overlap with those instantly claimed. Accordingly, the issued claims anticipate and/or render obvious the instantly claimed composition.
Claims 1-11 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11633350.
Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims are drawn to compositions comprising an effective amount of a therapeutic agent and a carrier having an osmolarity between 20 and 290 mOsm and methods of use thereof. The issued claims are drawn to individual components including a NRTI of claim 3, sodium and potassium of claims 7-8, and ranges of claims 1 and 5-6 which overlap with those instantly claimed. Issued claims 12-13 are drawn to the instantly claimed hydrogen-forming polymers. Accordingly, the issued claims anticipate and/or render obvious the instantly claimed composition.
Conclusion
Claims 1-11 are rejected.
Claims 12-15 are withdrawn.
This is a continuation of applicant's earlier Application No. 15/120,852. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the earlier application. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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 JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
Examiner interviews 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, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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