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 .
DETAILED ACTION
Claims 1-23 are pending.
Election/Restrictions
Applicant’s election without traverse of Group III, claims 22-23, and the species of HPV, in the reply filed on 4/1/2026 is acknowledged.
The requirement for election of species is withdrawn because a search of the prior art for the elected species HPV also resulted in finding the non-elected species of a viral skin disease and warts.
Claims 1-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/1/2026.
Claims 22-23 are examined herein.
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 23 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.
Claim 23 does not present a closed group of alternatives in the Markush group. Applicant may consider amending the claim to recite “The method of claim 22, wherein said viral disease is selected from the group consisting of a viral skin disease; herpes zoster; chickenpox; molluscum contagiosum; warts; measles; hand, foot and mouth disease, human papillomavirus (HPV) infection, and any combination thereof.”
Claim Rejections - 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 22-23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Squiquera (US 20200179493 A1).
Squiquera teaches topically applying a composition comprising ranpirnase in order to treat HSV (“a viral skin disease”), HPV, or warts in a subject ([008]-[009], [0048]). In one embodiment, the composition further comprises a pharmaceutically acceptable excipient such as propylene glycol ([0013], [0035]).
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 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.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Squiquera et al. (Antiviral therapy 22.3 (2017): 247-255; hereafter Squiquera 2017) in view of Chiou et al. (US 20110183011 A1).
Squiquera 2017 teaches treating HPV and healing anogenital warts in subjects by topically administering a composition comprising ranpirnase (Title, Abstract Background and Methods; page 249, right column, Drug Preparation and Application paragraph). HPV is the causative agent of anogenital warts (Abstract Background).
Squiquera 2017 teaches that the drug is prepared from a frozen liquid stock or a lyophilized stock and suspended in two different inert carrier ointments to yield three different proprietary formulations (page 249, right column, Drug Preparation and Application paragraph).
However, Squiquera 2017 does not teach that the composition comprises a polyol.
Chiou teaches a topical composition comprising propylene glycol (“polyol”) with antiviral activity that is useful in treating skin lesions (Abstract). Chiou teaches that the skin lesions include warts ([0028]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine Squiquera’s composition with Chiou’s antiviral propylene glycol composition in order to further increase the antiviral efficacy of the composition. The person of ordinary skill in the art would have had a reasonable expectation of success in combining Squiquera’s composition, which specifically treats HPV and warts, with Chiou’s composition, which is useful in treating skin lesions such as warts.
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 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 27 of copending Application No. 17/996,577 (‘577) in view of Squiquera (US 20200179493 A1).
Claim 13 of ‘577 recites a product combination comprising ranpirnase and a therapeutically effective amount of one or more additional therapeutic agents, wherein the additional therapeutic agent is a vasoconstrictor, an antibiotic, an immunomodulatory compound, a steroid, or a combination thereof. The product combination inhibits viral conjunctivitis caused by herpes simplex virus.
Claim 27 of ‘577 recites a method for of reducing or inhibiting ocular infection in a subject comprising: selecting a subject in need of reduction or inhibition of an ocular infection and administering ranpirnase and a therapeutically effective amount of a vasoconstrictor, an antibiotic, an immunomodulatory compound, a steroid or a combination thereof.
Claims 13 and 27 of ‘577 do not recite that the composition further comprises a polyol. Claims 13 and 27 of ‘577 do not recite administering the product combination to a subject to treat a viral skin disease.
Squiquera teaches topically applying a composition comprising ranpirnase to the in order to treat herpes simplex virus (“viral skin disease”) in a subject ([008]-[009], [0048]). In one embodiment, the composition further comprises a pharmaceutically acceptable excipient such as propylene glycol ([0013], [0035]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to formulate the product combination of claim 13 of ‘577 with the pharmaceutically acceptable excipient propylene glycol and to administer the composition to treat herpes simplex virus (“a viral skin disease”), per the teaching of Squiquera. The person of ordinary skill in the art would have been motivated to expand the market for the product combination by formulating the product combination for topical delivery rather than ophthalmic delivery. Regarding the presence of the additional therapeutic agent present in the product combination, the person of ordinary skill in the art would have been motivated to include the antibiotic in a topical formulation in order to treat any concurrent bacterial infections in the subject.
Similarly, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 27 of ‘577 by adding a step of administering the ranpirnase, antibiotic, and Squiquera’s propylene glycol to the subject in order to treat HSV (“viral skin disease”) in the skin in addition to the eyes of the subject. The person of ordinary skill in the art would have been motivated to treat the HSV virus in all locations of infection, which include the skin per the teaching of Squiquera, as well as the eyes (claim 13 of ‘’577 recites a product combination intended to treat an ocular infection caused by HSV).
This is a provisional nonstatutory double patenting rejection.
Claims 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 27 of copending Application No. 17/996,577 (‘577) in view of Squiquera et al. (Antiviral therapy 22.3 (2017): 247-255; hereafter Squiquera 2017) in view of Chiou et al. (US 20110183011 A1).
Claim 13 of ‘577 recites a product combination comprising ranpirnase and a therapeutically effective amount of one or more additional therapeutic agents, wherein the additional therapeutic agent is a vasoconstrictor, an antibiotic, an immunomodulatory compound, a steroid, or a combination thereof.
Claim 27 of ‘577 recites a method for of reducing or inhibiting ocular infection in a subject comprising: selecting a subject in need of reduction or inhibition of an ocular infection and administering ranpirnase and a therapeutically effective amount of a vasoconstrictor, an antibiotic, an immunomodulatory compound, a steroid or a combination thereof.
Claims 13 and 27 of ‘577 do not recite that the composition further comprises a polyol. Claims 13 and 27 of ‘577 do not recite administering the product combination to a subject to treat HPV or warts.
Squiquera 2017 teaches treating HPV and healing anogenital warts in subjects by topically administering a composition comprising ranpirnase (Title, Abstract Background and Methods; page 249, right column, Drug Preparation and Application paragraph). HPV is the causative agent of anogenital warts (Abstract Background). Squiquera 2017 teaches that the drug is prepared from a frozen liquid stock or a lyophilized stock and suspended in two different inert carrier ointments to yield three different proprietary formulations (page 249, right column, Drug Preparation and Application paragraph). However, Squiquera 2017 does not teach that the composition comprises a polyol.
Chiou teaches a topical composition comprising propylene glycol (“polyol”) with antiviral activity that is useful in treating skin lesions (Abstract). Chiou teaches that the skin lesions include warts ([0028]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the product combination of claim 13 of ‘577 with Chiou’s topical composition comprising propylene glycol and to topically administer the composition to a subject with HPV or warts, per the teaching of Squiquera 2017. The person of ordinary skill in the art would have been motivated to expand the market for the product combination by formulating the product combination for topical delivery to treat other viruses.
Similarly, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of claim 27 of ‘577 by selecting a patient with HPV or warts and topically administering the composition treating HPV or warts. It would have been further obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to combine the composition with Chiou’s topical composition comprising propylene glycol in order to further increase the antiviral efficacy of the composition against HPV or warts. The person of ordinary skill in the art would have had a reasonable expectation of success in modifying the method of claim 27 of ‘577 to treat HPV or warts because Squiquera 2017 teaches that ranpirnase, which is the active ingredient in the method of claim 27 ‘577, is also effective against both HPV and warts.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
Prosecution Insights