Detailed Office 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
Acknowledgement is hereby made of receipt and entry of the communication filed 14 April, 2026. Claims 1-6, 11, 12, 15-17, 19, 24, 26, 29, 34, 43, 49, 59, and 60 are pending in the instant application. Applicants’ election of Group I (claims 1-6, 11, 12, 15-17, 19, 24, and 26) without traverse is noted. Claims 29, 34, 43, 49, 59, and 60 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
37 C.F.R. § 1.98
The information disclosure statements filed 14 March, 2023, and 18 December, 2025, have been placed in the application file and the information referred to therein has been considered.
37 C.F.R. § 1.84
The drawings filed 28 April, 2025, have been reviewed and are acceptable.
35 U.S.C. § 112(b)
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.
Claims 1-6, 11, 12, 15-17, 19, 24, and 26 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
The claims reference an antiviral peptide conjugate comprising a fusion inhibitory peptide (FIP) and C-terminal heptad repeat (HRC) peptide (FIP-HRC). However, the precise structural configuration of the peptide is not readily manifest. Are the claims directed toward a fusion protein conjugate wherein a first FIP peptide is fused to a second HRC peptide to form a fusion protein, FIP-HRC? Alternatively, are the claims directed toward a single protein comprising both regions in the same sequence? For example, some antiviral peptides contain fusion inhibitory activity as a result of the HRC sequence (Berkhout et al., 2012). In this scenario, two different domains have not been fused together. Perusal of the disclosure appears to support the first scenario wherein an FFG antiviral peptide is fused to an HRC peptide to produce a fusion protein (FIP-HRC). This fusion peptide can be conjugated to various other functional groups (e.g., cholesterol, palmityl, tocopherol, etc.). Appropriate correction is required.
Claim 15 is also vague and indefinite for referencing the HRC peptide “reg10n”. Perusal of the disclosure failed to provide an amino acid sequence or other identifying information that would enable the skilled artisan to determine the metes and bounds of the patent protection desired.
35 U.S.C. § 112(a)
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written Description
Claims 1-6, 11, 12, 15-17, 19, 24, and 26 are rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, at the time the application was filed, had possession of the claimed invention. Amgen, Inc. v. Sanofi, 872 F.3d 1367, 124 U.S.P.Q.2d 1354 (Fed. Cir. 2017). AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 111 U.S.P.Q.2d 1780 (Fed. Cir. 2014). Univ. of Rochester v. G.D. Searle & Co., Inc., 358 F.3d 916, 920, 69 U.S.P.Q.2d 1886, (Fed. Cir. 2004). Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316, 63 U.S.P.Q.2d 1609, (Fed. Cir. 2002). Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 U.S.P.Q.2d 1398, (Fed. Cir. 1997). Fiers v. Revel Co., 984 F.2d 1164, 25 U.S.P.Q.2d 1601, (Fed. Cir. 1993). Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 U.S.P.Q.2d 1016, (Fed. Cir. 1991). In re Rasmussen, 650 F.2d 1212, 211 U.S.P.Q. 323 (C.C.P.A. 1981). In re Wertheim, 541 F.2d 257, 191 U.S.P.Q. 90 (C.C.P.A. 1976).
The crux of the statutory requirement governing written description is whether one skilled in the art, familiar with the practice of the art at the time of the filing date, could reasonably have found the later claimed invention in the specification as filed. In re Kaslow, 707 F.2d 1366, 1375, 217 U.S.P.Q. 1089, 1096 (Fed. Cir. 1983). In re Wilder, 736 F.2d 1516, 1520 222 U.S.P.Q. 349, 372 (Fed. Cir. 1984, cert. denied, 469 U.S. 1209 (1985). Texas Instruments, Inc. v. International Trade Comm’n, 871 F.2d 1054, 1063, 10 U.S.P.Q.2d 1257, 1263 (Fed. Cir. 1989). Moreover, the courts have stated that the evaluation of written description is highly fact-specific, and that broadly articulated rules are inappropriate. In re Wertheim, 541 F.2d 257, 263, 191 U.S.P.Q. 90, 97 (C.C.P.A. 1976). In re Driscoll, 562 F.2d 1245, 1250, 195 U.S.P.Q. 434, 438 (C.C.P.A. 1977). It is also important to remember that the true issue in question is not whether the specification enables one of ordinary skill in the art to make the later claimed invention, but whether or not the disclosure is sufficiently clear that those skilled in the art will conclude that the applicant made the invention having the specific claim limitations. Martin v. Mayer, 823 F2d 500, 505, 3 U.S.P.Q.2d 1333, 1337 (Fed. Cir. 1987).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor has possession of the claimed invention. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 U.S.P.Q.2d at 1116. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 U.S.P.Q.2d 1961, 1966 (Fed. Cir. 1997). The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 U.S.P.Q.2d 1895, 1905 (Fed. Cir. 1996).
Determination of adequate written description requires the Examiner to read and analyze the specification for compliance with 35 U.S.C. § 112(a). In particular, each claim should be analyzed to determine its broadest reasonable interpretation consistent with written description. Each claim should be evaluated to determine if sufficient structures, acts, or functions are recited to make clear the scope and meaning of the claim, including the weight to be given the preamble. The entire application should be reviewed including the specific embodiments, figures, and sequence listings, to understand how applicant provides support for the various features of the claimed invention. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated that the inventor was in possession of the claimed invention. Such a review is conducted from the standpoint of one of ordinary skill in the art at the time the application was filed (see, e.g., Wang Labs., Inc. v. Toshiba Corp., 993 F.2d 858, 865, 26 USPQ2d 1767, 1774 (Fed. Cir. 1993)) and should include a determination of the field of the invention and the level of skill and knowledge in the art. Finally, the Examiner should determine whether there is sufficient written description to inform a skilled artisan that the inventor was in possession of the claimed invention as a whole at the time of filing.
The claims are broadly directed toward a large genus of poorly defined antiviral peptide conjugates that comprise a fusion inhibitory peptide (FIP) and a C-terminal heptad repeat (HRC) (FIP-HRC). The term antiviral peptide encompasses a large genus of peptides with disparate structures and modes of action. The reference to an HRC peptide also encompasses a large genus of structurally unrelated peptides. Additionally, the term conjugate encompasses an inordinate number of other partners with different structures and functions. Moreover, the claims also fail to identify any particular viral target of the antiviral. Perusal of the disclosure only identified a single FIP (FFG) and limited number of MeV HRC peptides (e.g., SEQ ID NOS.: 8 and 9). Furthermore, the conjugates were limited to those with membrane localizing properties such as cholesterol. The difficulties associated with the development of HRC-based antivirals has also been well-documented in the prior art (Plemper et al., 2005). The authors reported that large heptad repeat-derived peptides (e.g., T-20) often suffer from solubility and purification problems, making large-scale manufacturing difficult. HR-derived peptides also tend to display poor absorption and bioavailability in the gastrointestinal tract, necessitating delivery through injection. Virus-derived peptides also have potential to be immunogenic in vivo and may induce adverse events in some cases.
Accordingly, considering the claim breadth, the failure to isolate and characterize additional FIP-HRC peptide conjugates, and the uncertainty associated with antiviral drug development, the skilled artisan would reasonably conclude that Applicants were not in possession of a sufficient number of species to support the full breadth of the patent protection desired.
SEQ 8/9 only MeV HRC peptides
Joint Inventors, Common Ownership Presumed
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed 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.
35 U.S.C. § 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 of this title, 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, 11, 12, 15-17, 19, 24, and 26 are rejected under 35 U.S.C. § 103 as being unpatentable over Mathieu et al. (2015) in view of Hashiguchi et al. (2018). The claims are directed toward an antiviral peptide conjugate comprising a fusion inhibitory peptide (FIP) and a C-terminal heptad repeat (HRC) peptide (FIP-HRC) (claim 1). Claims 2-4 reference a membrane localizing moiety (e.g., cholesterol) that is conjugated to the HRC peptide. Claims 5 and 6 reference a linker (e.g., polyethylene glycol (PEG)). Claims 11 and 12 reference an antiviral peptide conjugate wherein the linker region comprises PEG and is conjugated to the HRC C-terminus. Claims 15 and 16 reference an antiviral dimer wherein first and second FIP-HRCs are conjugated to the linker region. Claim 17 requires the utilization of Gly-Ser linker. Claims 24 and 26 provide sequences for the FIP (FFG) and HRC (SEQ ID NO.: 9).
Mathieu et al. (2015) disclose the preparation of MeV inhibitory antiviral peptides (e.g., See Table 1 (below), p. 1146) comprising MeV HRC peptides comprising SEQ ID NO.: 8, a linker (e.g., GSGSG), and membrane localizing moiety (PEG4-Chol). These peptides were capable of inhibiting MV entry (see Fig. 1, p. 1146). This teaching does not disclose a conjugate comprising both a FIP and HRC-related peptide.
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Hashiguchi et al. (2018) provided detailed structural analysis about the MeV-F protein bound to well-known antivirals, including the FIP Phe-Phe-Gly (FFG) (see Results, Structure Determination and Overall Structures, p. 2497; Fig. 1 (next page), p. 2497; and Fig. 3, p. 2499). Inhibitory studies were clearly set forth (see Fig. 3, p. 2499). This teaching does not disclose an antiviral peptide conjugate comprising FIP and an HRC.
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However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the HRC-conjugates of Mathieu et al. (2015), with the FIP antiviral peptide of Hashiguchi et al. (2018), to generate a robust and highly effective antiviral. One of ordinary skill in the art would have expected an FIP-HRC conjugate to display increased antiviral activity because each peptide utilizes a different inhibitory mechanism. FIP peptides bind to the MeV F hydrophobic pocket and inhibit viral entry during the prefusion state. HRC peptides interact with MeV F to inhibit transition into a postfusion state. Including both of these MeV F inhibitors into a single peptide conjugate would reasonably be expected to increase antiviral activity.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 27 June, 2026
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