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 .
Status of the Claims
Claims 1-23 were originally filed January 22, 2024.
The amendment received September 8, 2026 amended claims 3 and 16-23.
Claims 1-23 are currently pending.
Claims 1-7 and 10-14 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-14 and 23) in the reply filed on September 8, 2026 is acknowledged.
Claims 15-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 8, 2026.
Applicant’s election of Q-GRFT, candidiasis, human, non-zero concentration of less than 1% by weight, topical administration to the vagina, at least twice a day for at least 3 days, and carbomer gel as the species in the reply filed on September 8, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 9, and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 8, 2026.
Priority
The present application is a 371 (National Stage) of PCT/US2022/074248 filed July 28, 2022 which claims the benefit of 63/226,234 filed July 28, 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on January 6, 2025 (2) are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the first line of the specification should include PCT/US2022/074248 filed July 28, 2022.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 5 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. Q-GRFT is not a term of art, per se, and Q-GRFT is a specific polypeptide sequence. Therefore, SEQ ID NO: 2 should be utilized with the name for clarification of the term.
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 1-6 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Markovitz et al. WO 2016/044397 published March 24, 2016 and O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018.
For present claims 1-6 and 10-13, Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
For present claims 1-6 and 10-13, O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity) for another (i.e. mannose lectins griffithsin or Q-GRFT) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-7 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Markovitz et al. WO 2016/044397 published March 24, 2016; O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018; and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
For present claims 1-7 and 10-14, Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
For present claims 1-7 and 10-14, O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
For present claims 1-7 and 10-14, Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
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 1-7 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,384,820 in view of Markovitz et al. WO 2016/044397 published March 24, 2016 and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
U.S. Patent No. 12,384,820 claims griffithsin and Q-GRFT (SEQ ID NO: 18).
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-7 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,339,195 in view of Markovitz et al. WO 2016/044397 published March 24, 2016 and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
U.S. Patent No. 11,339,195 claims Q-GRFT (SEQ ID NO: 18).
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-7 and 10-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 10,501,507 in view of Markovitz et al. WO 2016/044397 published March 24, 2016 and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
U.S. Patent No. 10,501,507 claims griffithsin and Q-GRFT and methods of administering.
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-7 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10, 14, 17, 29, and 31-33 of copending Application No. 17/291,495 in view of Markovitz et al. WO 2016/044397 published March 24, 2016; O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018; and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
Copending Application No. 17/291,495 claims methods of reducing bacteria or virus in the reproductive tract of a female comprising administering griffithsin.
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1-7 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-36 of copending Application No. 17/641,264 (Notice of Allowance mailed September 9, 2026) in view of Markovitz et al. WO 2016/044397 published March 24, 2016; O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018; and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
Copending Application No. 17/641,264 claims methods of treating viral infection comprising administering griffithsin or griffithsin mutants.
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1-7 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-21 of copending Application No. 17/913,575 in view of Markovitz et al. WO 2016/044397 published March 24, 2016; O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018; and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
Copending Application No. 17/913,575 claims griffithsin or griffithsin mutants.
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1-7 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-20 and 22-28 of copending Application No. 17/999,235 in view of Markovitz et al. WO 2016/044397 published March 24, 2016; O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018; and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
Copending Application No. 17/999,235 claims griffithsin or griffithsin mutants.
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1-7 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5, 8-11, 16-19, 21, and 22 of copending Application No. 18/030,174 in view of Markovitz et al. WO 2016/044397 published March 24, 2016; O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018; and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
Copending Application No. 18/030,174 claims methods of administering griffithsin or griffithsin mutants.
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1-7 and 10-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 19/429,802 in view of Markovitz et al. WO 2016/044397 published March 24, 2016; O’Keefe et al. U.S. Patent Application Publication 2018/0016307 published January 18, 2018; and Girard et al., 2018, Impact of the griffithsin anti-HIV microbicide and placebo gels on the rectal mucosal proteome and microbiome in non-human primates, Scientific Reports, 8: 8059 (13 pages).
Copending Application No. 19/429,802 claims methods of treating viral infection comprising administering griffithsin or griffithsin mutants.
Markovitz et al. teach methods of treating HIV and fungal infections including Candida albicans infections (i.e. candidiasis; microorganisms comprising surface mannose) via administering mutant mannose lectins and suspension carriers to human subjects topically to the vagina at an effective dose twice a day for three days (please refer to the entire specification particularly the abstract; pages 2, 3, 5, 6, 8, 12-15). Markovitz et al. also teach griffithsin (i.e. mannose lectin) (please refer to the entire specification particularly pages 15 and 23).
O’Keefe et al. teach methods of administering griffithsin mutants including M78Q (i.e. Q-GRFT; SEQ ID NO: 18) and carriers topically to the vagina to a human to prevent HIV infection and in combination with anti-fungal agents (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 7-24, 27-29, 31-34, 41-48, 50, 52, 54, 55, 58, 61-63, 67, 70, 80, 83-85; Tables 1 and 4).
Girard et al. teach 0.1% griffithsin in a carbopol gel (i.e. carbomer gel; please refer to the entire reference particularly “Methods” “gel products”).
All the claimed elements were known in the prior art (i.e. mannose lectin griffithsin, mutant mannose lectin Q-GRFT, mannose lectins have both antiviral and antifungal activity; griffithsin at 0.1% in a carbomer gel) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) and the combination would have yielded predictable results (i.e. mannose lectin griffithsin or Q-GRFT have both antifungal and antiviral activity; specific concentration and carrier) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. mannose lectin with antifungal activity; carrier and concentrations) for another (i.e. mannose lectins griffithsin or Q-GRFT; griffithsin at 0.1% in a carbomer gel) would have yielded predictable results (i.e. antifungal activity against mannose containing fungi; specific formulation) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. utilizing mannose lectins as antifungals for mannose containing fungi; griffithsin at 0.1% in a carbomer gel) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gunaydin et al., 2019, Impact of Q-Griffithsin anti-HIV microbicide gel in non-human primates: In situ analyses of epithelial and immune cell markers in rectal mucosa, Scientific Reports, 9: 18120 (12 pages).
Summers, 2011, Topical Therapy for Mucosal Yeast Infections, Curr Probl Dermatol, 40: 48-57.
Clemons et al., 2011, Efficacy of Recombinant Human Mannose Binding Lectin Alone and in Combination with Itraconazole Against Murine Candida albicans vaginitis, Immunological Investigations, 40: 553-568.
Hammad et al., 2018, Mannose-Binding Lectin: A Potential Therapeutic Candidate against Candida Infection, BioMed Research International, 8 pages.
Crakes et al., 2020, Efficacy of silk fibroin biomaterial vehicle for in vivo mucosal delivery of Griffithsin and protection against HIV and SHIV infection ex vivo, Journal of the International AIDS Society, 23: e25628 (12 pages).
Zuend et al., 2019, A Caulobacter crescentus Microbicide Protects from Vaginal Infection with HIV-1JR-CSF in Humanized Bone Marrow-Liver-Thymus Mice, Journal of Virology, 93(18): e00614-19 (16 pages).
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
