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
The preliminary amendment dated 14 July 2023, in which claims 5, 8-10, 13 have been amended, claims 1-4, 6-7, 18-33 have been cancelled, and new claims 34-36 have been added, is acknowledged.
The preliminary amendment dated 11 June 2026, in which claim 5 has been amended, is acknowledged.
Claims 5, 8-17, 34-36 are pending in the instant application.
Claims 13-17, 34-36 are withdrawn, as being drawn to a non-elected invention.
Claims 5, 8-12 are being examined on their merits herein.
Priority
The instant application is a National Stage entry of International Application No. PCT/US2021/40275, filed on 2 July 2021, claiming priority to U.S. Provisional Patent Applications No. 63/141,271, filed on 25 January 2021; 63/123,069, filed on 9 December 2020; 63/110,151, filed on 5 November 2020; 63/090,913, filed on 13 October 2020; 63/059,584, filed on 31 July 2020; and 63/047,672, filed on 2 July 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 7 April 2023 is acknowledged and considered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 5, 8-12, drawn to a method of a method of treating an infection or treating diarrhea associated with an infection, the method comprising administering to a patient an effective amount of a composition comprising isoamyl hexanoates and at least one acid selected from the group consisting of lactic acid, propanoic acid, isobutyric acid, acetic acid, citric acid, oxalic acid, uric acid, malic acid, tartaric acid, and combinations thereof, in the reply filed on 11 June 2026, is acknowledged. Claims 13-17, 34-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Applicant’s election without traverse of viral infection as the disease to be treated; the election of COVID-19 as the specific viral disease to be treated; and the election of propanoic acid as the specific acid to be administered in the method, in the reply filed on 11 June 2026, is acknowledged. Claims 5, 8-12 read on the elected species.
Since the election was made without traverse, the restriction/election requirement is maintained and is herein made FINAL.
Claims 5, 8-12 have been examined to the extent they read on the elected species, and the following objections are rejections are made below.
Objection to the Drawings
The drawings of 3 January 2023 are objected to for the following reason: the text in Figures 13-15 is not clear.
Objection to the Specification
The Specification is objected to because it states
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while the instant application is a National Stage entry of International Application No. PCT/US2021/40275, filed on 2 July 2021, claiming priority to U.S. Provisional Patent Applications No. 63/141,271, filed on 25 January 2021; 63/123,069, filed on 9 December 2020; 63/110,151, filed on 5 November 2020; 63/090,913, filed on 13 October 2020; 63/059,584, filed on 31 July 2020; and 63/047,672, filed on 2 July 2020.
Applicant is required to correct the priority statement in the Specification.
Claim Objection
Claim 5 is objected to because it is confusing. Claim 5 is drawn to a method of treating a viral infection and comprises determining that a patient suffers from a condition. The recitation “a condition” is unnecessary. Claim 5 also recites “an appropriate dose” (what constitutes an “appropriate” dose versus perhaps an inappropriate dose?). We further learn about an effective amount comprised in said dose.
Further, claim 5 recites “at least one acid selected from […], [..], […], and combinations thereof”. This is confusing because the recitation “at least one acid” already includes any combination of the acids listed.
It is suggested that, for better clarity, claim 5 recites --a method of treating a viral infection in a patient in need thereof, comprising administering to the patient a therapeutically effective amount of a composition comprising isoamyl hexanoate and at least one acid selected from the group consisting of lactic acid, propanoic acid, isobutyric acid, acetic acid, citric acid, oxalic acid, uric acid, malic acid, and tartaric acid.--
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.
Claims 5, 8-12 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 pre-AIA the applicant regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “viral infection”, and the claim also recites “COVID-19, influenza”, which are the narrower statements of the range/limitation.
Further, claim 5 recites the broad recitation “treating an infection”, and the claim also recites “treating diarrhea associated with an infection” (diarrhea is a symptom of the infection treated), which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 8 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 pre-AIA the applicant regards as the invention.
Claim 8 depends on claim 5, and recites that the condition is selected from the group consisting of a fungal infection, infection with protozoa, coronavirus disease 2019 (COVID-19), mastitis, rain rot, scald, foot rot, an ear infection, ring worm, dermatitis, a bacterial infection, a parasitic infection, a viral infection, diarrhea, a Streptomyces avermitilis infection, vaginitis, an oral infection, a nasal infection, a throat infection, jock itch, vaginosis, a toenail infection, a fingernail infection, an eye infection, and combinations thereof. Yet, claim 5 recites a condition selected from the group consisting of coronavirus disease 2019 (COVID-19), influenza, viral infection, and combinations thereof. As such, there is insufficient antecedent basis for the conditions a fungal infection, infection with protozoa, mastitis, rain rot, scald, foot rot, an ear infection, ring worm, dermatitis, a bacterial infection, a parasitic infection, diarrhea, a Streptomyces avermitilis infection, vaginitis, an oral infection, a nasal infection, a throat infection, jock itch, vaginosis, a toenail infection, a fingernail infection, an eye infection, and combinations thereof, of claim 8, in claim 5.
Further, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 8 recites the broad recitation “viral infection”, and the claim also recites “COVID-19”, which is the narrower statement of the range/limitation. Further, claim 8 recites the broad recitation “a bacterial infection”, and the claim also recites “a Streptomyces avermitilis infection, foot rot, rain rot, vaginosis”, which are the narrower statements of the range/limitation. Further, claim 8 recites the broad recitation “a fungal infection”, and the claim also recites “ring worm, jock itch”, which are the narrower statements of the range/limitation.
Further, claim 8 recites the broad recitation “treating an infection”, and the claim also recites “treating diarrhea associated with an infection” (diarrhea is a symptom of the infection treated), which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Appropriate correction is required.
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.
(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 5, 8-12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Strobel et al. (US 2016/0250167, cited in PTO-892).
Strobel (US 2016/0250167) teaches (Case 5, [0281]-[0284]) a method of treating porcine epidemic diarrhea caused by the porcine epidemic diseases PED virus, which is a viral infection, as in instant claims 5, 8, by administering to piglets a therapeutically effective amount of a composition comprising [0270]-[0273] isoamyl hexanoate and propanoic acid, as in the instant claims.
The piglets are animal patients, as in instant claim 10, and the composition is administered to piglets orally ([0282], line 10), as in instant claim 12.
Strobel teaches [0115] that the compositions of the invention are used to treat viral gut infections in people and animals, as in instant claims 9, 10. Strobel teaches [0115] that all ingredients of Systems 1-4 are GRAS listed and are safe; in particular, 10 ml of S-3, which is a mixture of propanoic acid and isoamyl hexanoate in a 7:2 ratio [0241], has been consumed by a human (as in instant claim 9) with no adverse effects.
Strobel teaches [0165] that the compositions of the invention include solutions for oral administration, as in instant claim 12, or aerosolized formulations for inhalation, where the composition is administered in a gaseous phase, as in instant claim 11.
As such, a method of instant claims 5, 8-12 is anticipated by Strobel.
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.
Claims 5, 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Strobel et al. (US 2016/0250167, cited in PTO-892), in view of Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144, cited in PTO-892) and Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020, cited in PTO-892).
Strobel (US 2016/0250167) teaches (Case 5, [0281]-[0284]) a method of treating porcine epidemic diarrhea caused by the porcine epidemic diseases PED virus, which is a viral infection, as in instant claims 5, 8, by administering to piglets a therapeutically effective amount of a composition comprising [0270]-[0273] isoamyl hexanoate and propanoic acid, as in the instant claims.
The piglets are animal patients, as in instant claim 10, and the composition is administered to piglets orally ([0282], line 10), as in instant claim 12.
Strobel teaches [0115] that the compositions of the invention are used to treat viral gut infections in people and animals, as in instant claims 9, 10. Strobel teaches [0115] that all ingredients of Systems 1-4 are GRAS listed and are safe; in particular, 10 ml of S-3, which is a mixture of propanoic acid and isoamyl hexanoate in a 7:2 ratio [0241], has been consumed by a human (as in instant claim 9) with no adverse effects.
Strobel teaches [0165] that the compositions of the invention include solutions for oral administration, as in instant claim 12, or aerosolized formulations for inhalation, where the composition is administered in a gaseous phase, as in instant claim 11.
Strobel does not teach a method of treating COVID-19 (Applicant’s elected species of a viral infection) with a composition comprising propanoic acid and isoamyl hexanoate.
Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144) teach that porcine epidemic diarrhea PED virus is a corona virus (Title, page 137). Kocherhans teaches (page 137, right column, second paragraph) that Coronaviruses are single stranded RNA viruses.
Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020) teach that COVID-19 is a coronavirus (Abstract).
It would have been obvious to a person of ordinary skill in the art to test a composition comprising propanoic acid and isoamyl hexanoate disclosed by Strobel in a method of treating COVID-19.
The person of ordinary skill in the art would have been motivated to test a composition comprising propanoic acid and isoamyl hexanoate against COVID-19, because Strobel teaches a method for treating an infection by a coronavirus which is porcine epidemic diarrhea PED virus comprising administering to a subject in need thereof a composition comprising propanoic acid and isoamyl hexanoate, and Zhu teaches that COVID-19 is a coronavirus.
Thus, the person of ordinary skill in the art would have tested a composition comprising propanoic acid and isoamyl hexanoate, known to have antiviral properties against coronavirus PED virus, in a method of inhibiting viral activity of a coronavirus other than PED virus, such as COVID-19, with the expectation of achieving therapeutic effect.
As such, claims 5, 8-12 are rejected as prima facie obvious.
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 5, 8-12 are provisionally rejected under the judicially created doctrine of obviousness type double patenting as being unpatentable at least over claims 1-6, 14-18 of co-pending Application 18/415,537 (cited in PTO-892), in view of Strobel et al. (US 2016/0250167, cited in PTO-892), Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144, cited in PTO-892) and Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020, cited in PTO-892).
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-6, 14-18 of co-pending Application 18/415,537 render obvious instant claims.
Claims 1-6, 14-18 of co-pending Application 18/415,537 are drawn to a composition comprising isoamyl hexanoate and organic component propionic acid (claims 2, 3, 16, 17).
Strobel (US 2016/0250167) teaches (Case 5, [0281]-[0284]) that compositions comprising [0270]-[0273] isoamyl hexanoate and propanoic acid are effective to treat porcine epidemic diarrhea caused by the porcine epidemic diseases PED virus, which is a viral infection, as in instant claims 5, 8.
Strobel teaches [0115] that the compositions of the invention are used to treat viral gut infections in people and animals, as in instant claims 9, 10. Strobel teaches [0165] that the compositions of the invention include solutions for oral administration, as in instant claim 12, or aerosolized formulations for inhalation, where the composition is administered in a gaseous phase, as in instant claim 11.
Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144) teach that porcine epidemic diarrhea PED virus is a corona virus (Title, page 137).
Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020) teach that COVID-19 is a coronavirus (Abstract).
It would have been obvious to a person of ordinary skill in the art to test a composition comprising propanoic acid and isoamyl hexanoate disclosed by claims 1-6, 14-18 of co-pending Application 18/415,537 in a method of treating COVID-19.
The person of ordinary skill in the art would have been motivated to test a composition comprising propanoic acid and isoamyl hexanoate against COVID-19, because Strobel teaches the antiviral properties of a composition comprising propanoic acid and isoamyl hexanoate against a coronavirus which is porcine epidemic diarrhea PED virus, and Zhu teaches that COVID-19 is a coronavirus. Thus, the person of ordinary skill in the art would have tested a composition comprising propanoic acid and isoamyl hexanoate, known to have antiviral properties against coronavirus PED virus, in a method of inhibiting viral activity of a coronavirus other than PED virus, such as COVID-19, with the expectation of achieving therapeutic effect.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 5, 8-12 are rejected under the judicially created doctrine of obviousness type double patenting as being unpatentable over claims 1-11, 14-17 of U.S. patent 10,117,841 (cited in PTO-892), in view of Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144, cited in PTO-892) and Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020, cited in PTO-892). Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-11, 14-17 of U.S. patent 10,117,841 render obvious instant claims.
Claims 1-11, 14-17 of U.S. patent 10,117,841 are drawn to a composition comprising isoamyl hexanoate and propionic acid.
The Specification of U.S. patent 10,117,841 teaches (Case 5) that compositions comprising isoamyl hexanoate and propanoic acid are effective to treat porcine epidemic diarrhea caused by the porcine epidemic diseases PED virus, which is a viral infection, as in instant claims 5, 8.
Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144) teach that porcine epidemic diarrhea PED virus is a corona virus (Title, page 137).
Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020) teach that COVID-19 is a coronavirus (Abstract).
It would have been obvious to a person of ordinary skill in the art to test a composition comprising propanoic acid and isoamyl hexanoate disclosed by claims 1-11, 14-17 of U.S. patent 10,117,841 in a method of treating COVID-19.
The person of ordinary skill in the art would have been motivated to test a composition comprising propanoic acid and isoamyl hexanoate against COVID-19, because the Specification of U.S. patent 10,117,841 teaches the antiviral properties of a composition comprising propanoic acid and isoamyl hexanoate against a coronavirus which is porcine epidemic diarrhea PED virus, and Zhu teaches that COVID-19 is a coronavirus. Thus, the person of ordinary skill in the art would have tested a composition comprising propanoic acid and isoamyl hexanoate, known to have antiviral properties against coronavirus PED virus, in a method of inhibiting viral activity of a coronavirus other than PED virus, such as COVID-19, with the expectation of achieving therapeutic effect.
For similar reasons, instant claims 5, 8-12 are rejected under the judicially created doctrine of obviousness type double patenting as being unpatentable over at least claims 1-5, 14, 15 of U.S. patent 11,285,120 (cited in PTO-892), in view of Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144, cited in PTO-892) and Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020, cited in PTO-892); and
over at least claims 1-6, 20 of U.S. patent 11,285,122 (cited in PTO-892), in view of Kocherhans et al. (Virus Genes 2001, 23 (2), 137-144, cited in PTO-892) and Zhu et al. (N Engl J Med 2020, 382, 727-733, published 24 January 2020, cited in PTO-892).
Conclusion
Claims 5, 8-12 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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