CLAIMS 33-61 ARE PRESENTED FOR EXAMINATION
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 .
Applicant’s Preliminary Amendment filed July 08, 2024 and Information Disclosure Statements filed January 23, 2024, May 08, 2025 and August 11, 2025 has been received and entered into the application. Accordingly, the application papers have been amended as directed by Applicant. Also, as reflected by the attached, completed copies of form PTO/SB/08, the cited references have been considered by the Examiner.
Claim Rejections - 35 USC § 112
(A) 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.
Claims 33-61 are 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.
“The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.” (see MPEP 2173).
In the pharmaceutical art, compositions are defined by their physical characteristics, e.g., the composition form, the color, the density, the total weight or volume and/or the weight or volume of the ingredients therein. Applicant’s claims are not seen to define any particular dosage amount of the active agents contained in the composition or else define the composition by its form, ingredients and amounts thereof because rates of administration, i.e., mg/kg, are set forth rather than absolute amounts, i.e., dosages. Also, in the rate of administration expression “mg/kg”, the “kg” term references a component which is not defined in or else finds antecedent basis in the claim.
Therefore, the claims do not meet either the tenor or express requirements of 35 U.S.C. § 112, (b) or second paragraph and are being properly rejected.
(B) The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 61 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In particular, claim 61 depends upon a claim defining a composition of matter but sets forth intended use elements directed to non-physical or otherwise tangible features which thus fail to further limit the composition defined by the claim on which claim 61 depends, i.e., claim 33.
Claim Rejection - 35 USC § 102
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 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.
Claims 33-61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/007538 A1 (Checcone et al., hereinafter “Checcone”, cited by Applicant), (01/14/2016).
Checcone discloses a method for preventing HSV (Herpes Simplex Virus) infection in
HSV seronegative subjects, comprising administering to a subject a first antiviral agent such
as valacyclovir, famciclovir, acyclovir or a salt or solvate thereof, or a combination thereof
(para. (0008)-[0009]).
In addition, the subject can be administered with a second antiviral agent such as an HIV
antiviral agent, for example tenofovir (para. [0010]).
Checcone further discloses that the invention can further comprise administration of
contraceptive such as estradiol (para. [0011]).
Moreover, Checcone discloses that the antiviral agents can suppress HSV in a
seropositive subject (para. [0018]). According to Checcone, therapeutically effective amount of the first antiviral agent is an amount useful for treatment of an outbreak of HSV in a seropositive
subject (para. [0019]).
The antiviral agents and the additional active agents are formulated as a pharmaceutical
composition with one or more pharmaceutically acceptable excipients, diluents, carriers
and/or adjuvants (para. [0194]).
The herpes virus treated in document D1 includes herpes simplex virus- 1, herpes simplex virus-2, varicella-zoster, Epstein-Barr (human herpes virus 4), cytomegalovirus (human
herpes virus 5), roseolovirus (human herpes virus 6 and 7), and Karposi's sarcoma-associated
herpes virus (human herpes virus 8) (para. [0073]).
In addition, Checcone discloses that the dosage of valacyclovir, or a salt or solvate
thereof, is 500 mg to 1500 mg, 1 time per day, 2 times per day, 3 times per day, 4 times per
day, or continuously (para. [0125]). The dosage of famciclovir is 200mg to 500mg twice per
day (para. [0156]). The dosage of acyclovir is 400 mg to 1600mg twice per day (para.[0154]).
document D1 further discloses that the antiviral agents can be administered prior to or after
the exposure of the seronegative subject to HSV in order to reduce the risk for HSV infection,
wherein the antiviral agent is administered in a very high dose ranging from 500 to 5000 mg
(para, [0008], [0011], [0180]).
It is noted that Applicant’s claims are not presently limited to any particular absolute amounts, but rather are dependent on a host that has not been claim specified. It is clear that if one were to consider a range of kg weights contemplated for a “subject” having “body weight”, (present claim terminology), one could immediately envision non-human animals or else human neonates having sub-kg body weights which would reasonably place the absolute dosage amounts in the claimed compositions in line with those dosage amounts set forth in Checcone, as outlined above.
Finally, Checcone further teaches that the antiviral agents can be administered as an oral tablet, oral capsule, or oral solution, or in a delivery device such as an injection device, intravaginal ring, transdermal patch, or a combination thereof (para. [0036]).
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 33-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 20 and 21 of U.S. Patent No. 11,696,918, (cited by the Examiner).
Although the claims at issue are not identical, they are not patentably distinct from each other because while the present claims do not specify absolute dosage amounts present in the composition, one could immediately envision a range of body weights for various types of subjects which would have the dosage amounts of the patented claim set clearly make obvious those of the present claims.
For the above reasons, the presently claimed subject matter is deemed properly rejected and none of the present claims are currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 March 02, 2026