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 .
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments, filed 5/12/2026, with respect to the objections to the Nucleotide and/or Amino Acid Sequence Disclosures have been fully considered but they are not persuasive. A CRF does not appear to have been included as part of the original filing, see boxed region below (as found in PCT Request document, filed 11/18/2022, Pg 6):
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As a result, the objections have been modified/maintained herein.
Applicant’s arguments, filed 5/12/2026, with respect to claim 16 being withdrawn have been fully considered and are persuasive. Claim 16 is now under consideration on the merits.
Applicant's arguments filed 5/12/2026 with respect to the claim rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant’s position is that one skilled in the art would not be motivated to select methylparaben as the viscosity modifier as Kulkarni does not recommend one excipient over any other excipient listed; moreover, one would not be motivated to select hydroxypropyl methylcellulose (HEC) because Kulkarni teaches away from using it based upon its distortion of plume geometry (see Remarks, Pg 8). This argument is not found persuasive because independent claim 12 in both the amended and prior claim sets merely recites the inclusion of a preservative and a viscosity modifier; in other words, the claim limitations are met by any preservative and any viscosity modifier. Thus, because claim 12 did not and still does not recite specifically methylparaben or HEC, a obviousness rejection under 35 U.S.C. 103 can be met by a motivation and rationale to include any preservative and any viscosity modifier into the claimed nasal spray. The teachings of Kulkarni meet this threshold. Thus, the rejection has been maintained/modified below.
Because of the above, the double patenting rejections have been maintained/modified herein.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 12-20, drawn to an intranasal spray formulation comprising a modified griffithsin polypeptide in the reply filed on 9/5/2025 is acknowledged.
Applicant’s election of a griffithsin polypeptide wherein X1 is M, X2 is E, X3 is Q, X4 is S, X5 is A, X6 is I, and X7 is E; the compatible preservative is methylparaben; and the compatible viscosity modifier is hydroxyethyl cellulose (HEC) in the reply filed on 9/5/2025 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)).
Claim Status
Claims 12-20 and 22-28 are pending. Claims 26 and 27 are withdrawn as non-elected species. Claims 12, 13, 15, 16, and 17 are currently amended. Claims 1-11 and 21 are cancelled. Claims 22-28 are new.
Priority
The instant application is the 371 national stage entry of PCT/US21/33009, filed 5/18/2022, which claims priority to provisional applications 63/070,375, filed 8/26/2020, and 63/026,375, filed 5/18/2020. The priority date of 5/18/2020 is acknowledged.
Maintained/Modified - Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 12-20, 22-24, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over O’Keefe et al. (WO 2016/130628 A1, published 8/18/2016) and Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012).
O’Keefe teaches griffithsin polypeptides and methods of inhibiting viral infection (Abstract). As part of the method for prophylactically or therapeutically inhibiting a viral infection, particularly a coronavirus (e.g. SARS or MERS), O’Keefe teaches topically administering to the host an effective amount of a griffithsin polypeptide or composition thereof to the host, preferably as an aerosol or microparticulate powder ([0051]).
O’Keefe does not teach that the griffithsin polypeptide is formulated as an intranasal spray including a compatible preservative and a compatible viscosity modifier.
Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests (Abstract). Kulkarni teaches that the nasal cavity of an average adult has substantial surface area and is highly vascularized with microvilli epithelial cells, conferring quick bioavailability and fast onset of drug action (Pg 1, left column). Critical parameters affecting nasal spray formulation performance and bioavailability include physical properties of formulations, pH and buffer, osmolality, viscosity, excipient selection, and improving the resistance time in the nasal cavity, all of which can impact nasal spray plumes (entire document). In particular, viscosity impacts residence time of the spray in the nasal cavity (Pg 2, “Viscosity”), and preservatives are important for maintaining non-sterile products (Pg 2, “Excipient selection”). Thus, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation (Pg 5, Conclusion).
The instant specification teaches preservatives compatible with griffithsin polypeptides include methylparaben, chlorobutanol, benzalkonium chloride, and benzyl alcohol (Pg 7, lines 34-36). The instant specification also teaches viscosity modifiers compatible with griffithsin polypeptides include water soluble cellulose, such as hydroxyethyl cellulose (Pg 8, lines 21-22). All of these compounds are taught by Kulkarni (Table 2; (“Improving residence time in the nasal cavity”, Pg 2).
Thus, regarding claim 12, O’Keefe teaches griffithsin polypeptides and compositions useful for preventing and/or treating coronavirus infections that can be administered to subjects via aerosols and microparticulate powder. Kulkarni teaches that administration of drugs to the nasal cavity has biological advantages and parameters such as viscosity and preservative selection are important to consider; Kulkarni further teaches several preservatives and viscosity modifiers that are compatible with griffithsin polypeptides. Therefore, it would be prima facie obvious to formulate a nasal spray comprising a griffithsin polypeptide so that it can be more easily and rapidly administered to treat respiratory infections (coronaviruses). One skilled in the art would have a reasonable expectation of success as it was known that griffithsin polypeptide could be formulated as aerosols and/or microparticulate powder, as taught by O’Keefe, and Kulkarni teaches formulating other drugs to treat respiratory diseases comprising preservatives and viscosity modifiers compatible with griffithsin polypeptides.
Regarding claim 13, Kulkarni teaches methylparaben as a preservative (Table 2).
Regarding claims 14 and 28, Kulkarni teaches hydroxymethylcellulose (HEC) is a muco-adhesive and gelling agent (“Improving residence time in the nasal cavity”, Pg 2).
Regarding claims 15, 22, and 23, O’Keefe teaches solutions of griffithsin polypeptide mutants with concentrations >6mg/ml ([0076 and Table 3]).
Regarding claims 16-18, O’Keefe teaches the same griffithsin polypeptide formula ([0005]). O’Keefe teaches SEQ ID NO: 18, which is the same as the elected species recited in claim 16, wherein X1 is M, X2 is E, X3 is Q, X4 is S, X5 is A, X6 is I, and X7 is E (Sequence Listing).
Regarding claim 19, Kulkarni teaches hydrochloric acid as a pH adjusting agent (Table 2).
Regarding claim 20, Kulkarni teaches that intranasal spray doses are administered via nasal spray devices (“Characterization of nasal sprays”, left column of Pg 4).
Regarding claim 24, O’Keefe teaches that the composition comprising the griffithsin polypeptide is present in an antiviral effective amount, wherein an effective amount means an amount sufficient to inhibit the infectivity of the virus ([0042]).
Claim(s) 12-20, 22-25, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over O’Keefe et al. (WO 2016/130628 A1, published 8/18/2016) and Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012), as applied to claims 12-20, 22-24, and 28, further in view of Zhu et al. (From SARS and MERS to COVID-19: a brief summary and comparison of severe acute respiratory infections caused by three highly pathogenic human coronaviruses. Respir Res 21, 224 (2020)).
The teachings of O’Keefe and Kulkarni have been set forth above, including O’Keefe teaching a method for prophylactically or therapeutically inhibiting a viral infection, particularly a coronavirus (e.g. SARS or MERS). O’Keefe and Kulkarni do not explicitly teach the intranasal spray formulation is present in an amount effective to prevent or treat SARS-CoV-2.
Zhu teaches that SARS-CoV-2 shares many similarities with SARS-CoV and MERS-CoV, especially between SARS-CoV-2 and SARS-CoV (Abstract; Table 1).
Based on these teachings, regarding claim 25, it would be prima facie obvious to use the intranasal spray comprising a griffithsin polypeptide taught by O’Keefe and Kulkarni to prevent or treat SARS-CoV-2 as taught by Zhu. One skilled in the art would be motivated to do so in order to prevent and/or treat additional viruses similar to SARS-CoV and MERS. One would have a reasonable expectation of success as Zhu teaches that SARS-CoV, MERS, and SARS-CoV-2 are phylogenetically similar.
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 12-14, 17-20, 24-25, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, 11, and 13-16 of U.S. Patent No. US10,501,507 (‘507) in view of Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘507 recites a polypeptide comprising the amino acid sequence of SLTHRKFGGSGGSPFSGLSSIAVRSGSYLDAIIIDGVHHGGSGGNLSPTFTFGSGEYISN X1TIRSGDYIDNISFX2TNX3GRRFGPYGGSGGSANTLSNVKVIQINGX4X5GDYLDSLD X6YYX7QY (SEQ ID NO: 1), wherein X1 can be M or V, X2 is Q, X3 can be M, A, K, V, F, L, I, Q, R, or G, X4 can be S or R, X5 can be A or S, X6 can be I or F, and X7 can be E or Q provided that the polypeptide does not comprise the amino acid sequence of SEQ ID NO: 2. SEQ ID NO: 1 reads on the sequence recited in claims 17 and 18.
Dependent claims include additional variants of the polypeptide (claims 2, 14, 15, and 16), a composition thereof (claim 10), and methods of prophylactically or therapeutically treating a viral infection (claims 11, 13). The instant specification of US ‘507 indicates virus that can be treated with the polypeptide as claimed include coronavirus/SARS virus (Col. 10, line 66).
US ‘507 does not teach that the polypeptide or composition thereof is formulated as a nasal spray with a griffithsin-compatible preservative and viscosity modifier.
Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests. In particular, viscosity impacts residence time of the spray in the nasal cavity, and preservatives are important to maintain non-sterile products. Therefore, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation. Kulkarni further teaches several griffithsin-compatible preservatives and viscosity modifiers.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Kulkarni into US ‘507, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Kulkarni teaches means to formulate effective nasal sprays with griffithsin-compatible preservatives and viscosity modifiers. Thus, the claims are obvious in view of US ‘507.
Claims 12-14, 16-20, 24-25, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. US11,339,195 (‘195) in view of Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘195 recites a polypeptide consisting of the amino acid sequence SEQ ID NO: 18. SEQ ID NO: 18 is identical to the elected species recited in claims 16-18. The instant specification of US ‘195 indicates virus that can be treated with the polypeptide as claimed include coronavirus/SARS virus (Col. 11, line 3).
US ‘195 does not teach that the polypeptide is formulated as a nasal spray with a griffithsin-compatible preservative and viscosity modifier.
Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests. In particular, viscosity impacts residence time of the spray in the nasal cavity, and preservatives are important to maintain non-sterile products. Therefore, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation. Kulkarni further teaches several griffithsin-compatible preservatives and viscosity modifiers.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Kulkarni into US ‘195, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Kulkarni teaches means to formulate effective nasal sprays with griffithsin-compatible preservatives and viscosity modifiers. Thus, the claims are obvious in view of US ‘195.
Claims 12-14, 16-20, 24-25, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 7-12 of U.S. Patent No. US12,384,820 (‘820) in view of Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
Claim 1 of US ‘820 recites a polypeptide comprising the amino acid sequence of
SLTHRKFGGSGGSPFSGLSSIAVRSGSYLDAIIIDGVHHGGSGGNLSPTFTFGSGE YISNX1TIRSGDYIDNISFX2TNX3GRRFGPYGGSGGSANTLSNVKVIQINGX4X5GDYLDSLD X6YYX7QY (SEQ ID NO: 1), wherein X1 can be M or V, X2 can be E or Q, X3 can be M, A, K, V, F, L, I, Q, R, or G, X4 can be S or R, X5 can be A or S, X6 can be I or F, and X7 can be E or Q;
provided that the polypeptide does not comprise the amino acid sequence of SEQ ID NO: 2; and provided that the polypeptide does not include any amino acid preceding the initial serine (S) recited as the first amino acid in SEQ ID NO: 1; and wherein X3 is Q. SEQ ID NO: 1 reads on the sequence recited in claims 16-18.
Dependent claims include additional variants of SEQ ID NO: 1 (claims 2 and 7-12). The instant specification of US ‘820 indicates virus that can be treated with the polypeptide as claimed include coronavirus/SARS virus (Col. 11, line 65).
US ‘820 does not teach that the polypeptide is formulated as a nasal spray with a griffithsin-compatible preservative and viscosity modifier.
Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests. In particular, viscosity impacts residence time of the spray in the nasal cavity, and preservatives are important to maintain non-sterile products. Therefore, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation. Kulkarni further teaches several griffithsin-compatible preservatives and viscosity modifiers.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Kulkarni into US ‘820, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Kulkarni teaches means to formulate effective nasal sprays with griffithsin-compatible preservatives and viscosity modifiers. Thus, the claims are obvious in view of US ‘820.
Claims 12-14, 16-20, 24-25, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3 of copending Application No. 18/030,174 (‘174; claim set filed 4/4/2023) in view of O’Keefe et al. (WO 2016/130628 A1, published 8/18/2016) and Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012).
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
Claim 1 of copending Application No. ‘174 recites a method of treating or preventing a Rhabdoviridae virus infection in a mammal comprising administering griffithsin, or a fragment or mutant thereof, to the mammal.
Dependent claims include the griffithsin polypeptide sequence and variants thereof (claim 3) that read on the polypeptides recited in instant claims 16-18.
Copending Application No. ‘174 does not teach that the polypeptide is formulated as a nasal spray with a griffithsin-compatible preservative and viscosity modifier.
O’Keefe teaches griffithsin polypeptides and methods of inhibiting viral infection. Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests. In particular, viscosity impacts residence time of the spray in the nasal cavity, and preservatives are important to maintain non-sterile products. Therefore, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation. Kulkarni further teaches several griffithsin-compatible preservatives and viscosity modifiers.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of O’Keefe and Kulkarni into copending Application No. ‘174, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as O’Keefe teaches that griffithsin polypeptides can be used to prevent and treat a multitude of viral infections and Kulkarni teaches means to formulate effective nasal sprays with griffithsin-compatible preservatives and viscosity modifiers. Thus, the claims are obvious in view of copending Application No. ‘174.
This is a provisional nonstatutory double patenting rejection.
Claims 12-14, 19-20, 24-25, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of copending Application No. 17/913,575 (‘575; claim set filed 5/11/2026) in view of Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012).
Claim 1 of copending Application No. ‘575 recites an engineered griffithsin polypeptide lacking lysines. Copending Application No. ‘575 does not teach that the polypeptide is formulated as a nasal spray with a griffithsin-compatible preservative and viscosity modifier.
Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests. In particular, viscosity impacts residence time of the spray in the nasal cavity, and preservatives are important to maintain non-sterile products. Therefore, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation. Kulkarni further teaches several griffithsin-compatible preservatives and viscosity modifiers.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Kulkarni into copending Application No. ‘575, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Kulkarni teaches means to formulate effective nasal sprays with griffithsin-compatible preservatives and viscosity modifiers. Thus, the claims are obvious in view of copending Application No. ‘575.
This is a provisional nonstatutory double patenting rejection.
Claims 12-14, 19-20, 24-25, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-23, 31, and 35-36 of copending Application No. 17/641,264 (‘264; claim set filed 8/29/2025; allowed on 6/3/2026) in view of Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012).
Claim 20 of copending Application No. ‘264 recites a mutant griffithsin polypeptide comprising the amino acid sequence of SEQ ID NO: 1, wherein a lysine is substituted in at least one amino acid position selected from the group consisting of 1, 5, 24, 61, 64, 80, 81, and 122.
Dependent claims further include additional species of a mutant griffithsin polypeptide (claims 21-23), a therapeutic composition thereof (claim 31), and a method of treating a viral infection in an individual comprising administering said mutant griffithsin polypeptide (claims 35-36). Copending Application No. ‘264 does not teach that the polypeptide is formulated as a nasal spray with a griffithsin-compatible preservative and viscosity modifier.
Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests. In particular, viscosity impacts residence time of the spray in the nasal cavity, and preservatives are important to maintain non-sterile products. Therefore, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation. Kulkarni further teaches several griffithsin-compatible preservatives and viscosity modifiers.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Kulkarni into copending Application No. ‘264, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Kulkarni teaches means to formulate effective nasal sprays with griffithsin-compatible preservatives and viscosity modifiers. Thus, the claims are obvious in view of copending Application No. ‘264.
This is a provisional nonstatutory double patenting rejection.
Claims 12-14, 19-20, 24-25, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 12, and 17-19 of copending Application No. 19/429,802 (‘802; claim set filed 12/22/2025) in view of Kulkarni et al. (Formulation and characterization of nasal sprays, as appeared in Inhalation, June 2012).
Claim 1 of copending Application No. ‘802 recites a mutant griffithsin polypeptide comprising a lysine at at least one amino acid position selected from the group consisting of 1, 5, 24, 61, 64, 80, 81, and 122 numbered relative to SEQ ID NO: 1.
Dependent claims further include additional species of a mutant griffithsin polypeptide (claims 2-4), a therapeutic composition thereof (claim 13), and a method of treating a viral infection in an individual comprising administering said mutant griffithsin polypeptide (claims 17-19). Copending Application No. ‘802 does not teach that the polypeptide is formulated as a nasal spray with a griffithsin-compatible preservative and viscosity modifier.
Kulkarni teaches nasal spray formulation parameters and their influence on key in vitro tests. In particular, viscosity impacts residence time of the spray in the nasal cavity, and preservatives are important to maintain non-sterile products. Therefore, it is important to choose the appropriate excipients and maintain their optimum levels in a given formulation. Kulkarni further teaches several griffithsin-compatible preservatives and viscosity modifiers.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to incorporate the teachings of Kulkarni into copending Application No. ‘802, thereby arriving at the instant invention. One skilled in the art would have a reasonable expectation of success as Kulkarni teaches means to formulate effective nasal sprays with griffithsin-compatible preservatives and viscosity modifiers. Thus, the claims are obvious in view of copending Application No. ‘802.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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