DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 3/11/2023 March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a CON of 17/383,664 07/23/2021 ABN
17/383,664 is a CON of 16/044,276 07/24/2018 PAT 11,071,745
16/044,276 is a CON of 14/793,550 07/07/2015 PAT 10,052,329
14/793,550 has PRO 62/021,589 07/07/2014.
This claim to priority is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements filed 9/9/2026, 8/22/2024, and 11/3/2023 have been considered by the Examiner. The submissions are in compliance with the provisions of 37 CFR §§ 1.97 and 1.98. Enclosed with this Office Action is a return-copy of the Forms PTO-1449 with the Examiner’s signature and indication of those references that have been considered.
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, 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, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to an invention where any antiviral agent, generally, is used for the prevention of HSV infection in an HSV seronegative subject prior to physical contact with an HSV seropositive partner. However, the specification fails to adequately describe the claimed invention as generically presented. The lack of written description is exacerbated by 1) the many different species of antiviral agents having unrelated structures such as peptide-fatty acid conjugates, interferon cytokines, pyridinyl ketones, ionic metals, etc.
The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See, e.g., In re Wilder, 22 USPQ 369, 372-3 (Fed. Cir. 1984). (Holding that a claim was not adequately described because the specification did ‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.’)
Mere indistinct terms (such as “antiviral agent” used herein), however, may not suffice to meet the written description requirement. This is particularly true when a compound is claimed in purely functional terms. See Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886 (CAFC 2004) at 1892, stating:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
Conversely, a description of a chemical genus will usually comprise a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. See Univ. of Calf. V. Eli Lilly, 43 USPQ 2d 1398, 1406 (Fed. Cir. 1997). This is analogous to enablement of a genus under Section 112(a), by showing the enablement of a representative number of species within the genus.
A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus as claimed. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. See MPEP 2163. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. See MPEP § 2163. However, the genus of “antiviral agents” comprises substantial variance and encompasses agents unrelated by structure, physical and/or chemical properties. The term “antiviral agent” encompasses a multitude of different agents with distinct molecular structures including:
peptide-fatty acid conjugates having the structure
PNG
media_image1.png
97
323
media_image1.png
Greyscale
(see US 5,837,249; col. 1),
antibodies such as SEQ ID 1 (see US 2019/0185546; abstract; p. 3; Claim 1),
ionic metals such as ionic zinc (see US 2020/0397791; 0157),
interferon cytokines (see US 4,507,281; abstract; Claim 10),
nucleoside analogs such as acyclovir, Ara A, trifluridine, and ribavirin (see US 7,091,190; Claims 16-19, 26-31),
amido-substituted heterocycle (see US 2023/0077499; title; abstract; Claim 1),
imidazo[1,2-a]pyridine compounds (see US 2005/0228004; title; abstract; Claim 18) and
pyridinyl ketones (see US 4,479,958; title; abstract).
Clearly, the genus “antiviral agent” has substantial variance in structural and chemical characteristics.
(NOTE: references 1-7 were submitted with 11/03/2023 IDS.)
Here, the specification does not provide a reasonably representative disclosure of useful “antiviral agent” generally, a potentially huge genus inclusive of many different compounds having widely divergent structures and chemical functions. Specifically, the specification discloses only a limited number of antiviral agent species at 0010 and 0011, and these are not viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus. Moreover, regarding the actual prevention of HSV infection in a seronegative subject as claimed, the specification does not provide results for any antiviral agent. Thus, it is clear that the specification does not describe a representative number of species of antiviral agents for preventing HSV infection in a seropositive subject.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102a1 as being anticipated by Stanberry et al. (“Glycoprotein-D–Adjuvant Vaccine to Prevent Genital Herpes.”; N Engl J Med (2002); 347:1652-1661. DOI: 10.1056/NEJMoa011915.)
Claimed invention
The claim is drawn to method of preventing HSV infection in an HSV seronegative subject comprising administering to the subject a therapeutically effective amount of a first antiviral agent prior to physical contact with a partner who is seropositive for HSV.
Prior art
Stanberry teaches prevention of herpes simplex virus type 2 (HSV-2) by administering a glycoprotein-D–subunit vaccine with alum and 3-O-deacylated-monophosphoryl lipid A to HSV seronegative subjects whose regular sexual partners had a history of genital herpes. These sexual partners were referred to as “source partners” and their infected status was clinically confirmed, i.e., inferring seropositive (see abstract; see also ‘Vaccination and Design of the Studies’, p. 1653):
We conducted two double-blind, randomized trials of a herpes simplex virus type 2 (HSV-2) glycoprotein-D–subunit vaccine with alum and 3-O-deacylated-monophosphoryl lipid A in subjects whose regular sexual partners had a history of genital herpes. In Study 1, subjects were seronegative for herpes simplex virus type 1 (HSV-1) and HSV-2; in Study 2, subjects were of any HSV serologic status.
See abstract. Emphasis added.
All subjects had a regular sexual partner (the “source partner”) with clinically confirmed genital herpes, were randomly assigned to receive either vaccine or a control preparation by intramuscular injection in the deltoid area at months 0, 1, and 6, and were followed for a total of 19 months. The primary efficacy end point, the occurrence of genital herpes disease, was defined as genital signs or symptoms (e.g., pain, itching, swelling, papules, vesicles, ulcers, or crusts) with either a positive HSV culture or detection of HSV DNA by polymerase chain reaction (PCR) and HSV seroconversion. A secondary efficacy end point, HSV infection, was defined as genital herpes disease or asymptomatic seroconversion to HSV antigens not contained in the vaccine.
See ‘Vaccination and Design of the Studies’, p. 1653. Emphasis added.
Some of the source partners agreed to not use suppressive antiviral therapy. See ‘Vaccination and Design of the Studies’, p. 1653. Condom use was recommended to reduce the risk of transmission. See ‘Assessments of Efficacy’ at p. 1653. The subjects further indicated whether they used condoms and, if so, how often (see Table 1 at p. 1654):
PNG
media_image2.png
601
917
media_image2.png
Greyscale
Thus, treatment occurred prior to contacts with a source partner.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Kern (US 4719235).
Claimed invention
The claim is drawn to method of preventing HSV infection in an HSV seronegative subject comprising administering to the subject a therapeutically effective amount of a first antiviral agent prior to physical contact with a partner who is seropositive for HSV.
Prior art
Kern is drawn to treating and preventing viral infections including HSV (HSV-1 or HSV-2 – see col. 1:~30; see Claim 6) infection. See col. 1:~14-16; see col. 2:33-36; see Claim 8. Kern discloses methods for preventing virus from infecting a cell and thereby preventing infection in a person susceptible thereto by administering an effective amount of dioctyl sodium sulfosuccinate. See Claims 9, 10, 12, 13 and 16. Deterring the virus from infecting a human after entry has been made is suggested as a way to prevent infection. See col. 13, lines ~50-55.
While Kern teaches that the antiviral agent, dioctyl sodium sulfosuccinate, can be used to protect a subject from contracting HSV infection, Kern does not teach that the subject is seronegative and has a seropositive partner.
Given that the antiviral is taught to be given to persons prior to a virus infecting their cells, one of ordinary skill in the art would have found it obvious to administer the antiviral agent to those subjects who are not infected with HSV, i.e., seronegative, to prevent them from becoming infected with the HSV. Further given that the antiviral is administered to those subjects who are susceptible to infection, one of ordinary skill in the art would have found it obvious to administer the antiviral agent to a subject who has an HSV seropositive partner, that would make them susceptible to HSV infection. The artisan would have reasonably sought to prevent infection of the seronegative subject due to HSV from a seropositive partner by taking advantage of the effectiveness of the antiviral agent in preventing infection. Therefore, the claimed invention as a whole would have been prima facie obvious over the prior art.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,052,329. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claim and the patented claims are drawn to the use of an antiviral composition for preventing HSV infection in a seronegative subject who has a seropositive partner.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11,071,745. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claim and the patented claims are drawn to the use of an antiviral composition for preventing HSV infection in a seronegative subject who has a seropositive partner.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims, 1-46 of U.S. Patent No. 11,071,745 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the current claim and the copending claims are drawn to the use of an antiviral composition for preventing HSV infection in a seronegative subject who has a seropositive partner.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
