DETAILED 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 . 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.
Priority
The instant application is a continuation of PCT/US2021/054949 filed on 10/14/2021, which claims domestic benefit to US provisional application no. 63/091,452 filed on 10/14/2020.
Status of the Claims
The claim amendments and remarks filed on 03/09/2026 is acknowledged. Claims 1, 3, 9-11, and 16-18 are amended. Claim 2 is cancelled.
Accordingly, claims 1 and 3-22 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to claims 3, 11, and 18 are withdrawn in view of the removal of the duplicate “nevirapine”.
The 35 USC 112(b) rejection over claim 9 is withdrawn because claim 9 now recites “respiratory syndrome coronavirus 2 (SARS-CoV-2)”, which does not recite a broad limitation with a narrow limitation that falls within the broad limitation.
The 35 USC 112(a) rejection for claims 1-22 is withdrawn in view of the removal of the “preventing” term in the instant claims.
The 35 USC 102 rejection over Nandi for claims 1-6, 9-10, and 11-14 are withdrawn because this rejection was previously applied based on the recitation of one or more anti-viral agents. However, the amended claims now require two anti-viral agents consisting of a NNRTI and a nucleoside-analogue antiviral agent, which has changed the scope of the claims and requires further search and consideration.
The cancellation of claim 2 renders the rejections over this claim moot.
The 35 USC 103 rejection over Johnson for claims 10-13 and over Johnson in view of Nandi for claims 14-15 is withdrawn because these rejections were previously applied for a pharmaceutical composition “comprising of” NRRTI and nucleoside-analogue antiviral agents. However, the amended claims now require a pharmaceutical composition “consisting of” NRRTI and nucleoside-analogue antiviral agents, which has changed the scope of the claims and requires further search and consideration.
The following grounds of rejection are maintained, amended, or new as necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 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.
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 3-8 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.
Claims 3-8 depend from claim 2. However, claim 2 is now cancelled, making it unclear what the scope of these claims are.
For purposes of examination, claims 3, 5, and 7-8 are being interpreted as being dependent upon claim 1.
Claim 8 recites “wherein the one or more anti-viral agents are co-administered”.
There is insufficient antecedent basis for this limitation in the claim because there is no prior recitation of a “one or more anti-viral agents”.
For purpose of examination, claim 8 is being interpreted as the two anti-viral agents are co-administered.
Claim Rejections - 35 USC § 112(d)
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.
Claims 15 and 17-22 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.
Claim 15 recites “The pharmaceutical composition of claim 10, wherein the composition comprises a therapeutically effective of rilpivirine and remdesivir”.
Claim 10 (claim 15 depends from claim 10) recites “A pharmaceutical composition consisting of”. Therefore, claim 10 fails to further limit the subject matter of the claim upon which it depends because claims 10 broadens the scope of the composition by reciting the open-ended transitional phrase “comprising”.
Claim 17 recites “The method of claim 16, wherein the composition comprises …”. Claim 22 recites “The method of claim 20, wherein the composition comprises …”.
Claim 16 (claims 17 and 22 depends from claim 16) recites “a composition consisting of”. Therefore, claims 17 and 22 fail to further limit the subject matter of the claim upon which it depends because claims 17 and 22 broaden the scope of the composition by reciting the open-ended transitional phrase “comprising”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements
For purposes of examinations, claims 1 and 3-9 are being interpreted such that the administered composition can include additional unrecited components because claim 1 recites a composition “comprising” the two recited anti-viral agents.
Claims 10-15 are being interpreted such that the pharmaceutical composition consists of one or more NNRTIs and one or more nucleoside-analogue antiviral agents.
Claims 16-22 are being interpreted such that the administered composition consists of one or more anti-viral agents and a recombinant vector.
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.
Claim(s) 1 and 3-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nandi et al. (US20210369619A1 in PTO-892 dated 09/10/2025, effective filing date of 5/29/2020).
Nandi et al. discloses a transmucosal dosage forms such as sublingual pharmaceutical compositions comprising antiviral molecules such as favipiravir, remdesivir, baloxavir marboxil, molnupiravir, besifovir, raltegravir, GS-441524, ravidasvir, and other antiviral drugs (see Abstract).
Nandi et al. discloses their compositions are useful in the treatment of viral infections including coronavirus infection (COVID-19) (see Abstract). Nandi et al. discloses in other embodiments, the viral infection is coronavirus infection caused by alpha, beta, gamma, and delta virus families, coronavirus infection (Severe Acute Respiratory Syndrome and common cold), and among others (see paragraph 0044).
Nandi et al. discloses that Remdesivir is presently approved in many countries in the form of an injectable dosage form in the strength of 100 mg by Gilead Sciences for the treatment of infection caused by coronavirus disease 2019 (COVID-19) in humans (see paragraphs 0007-0009). Nandi et al. further discloses that their invention can also include several other antiviral drugs and their combinations for use in their compositions and lists rilpivirine and among others (see paragraph 0033).
Nandi et al. does not specifically teach the co-administration of rilpivirine and remdesivir. However, it would have been prima facie obvious before the effective filing date of the claimed invention to have included rilpivirine as disclosed in Nandi to the remdesivir composition of Nandi to treat a coronavirus infection. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Nandi et al. discloses these two compounds as anti-viral drugs that can be combined and used in their compositions for treating COVID-19 in a subject. Therefore, an ordinary skilled artisan could have chosen from a finite number of identified, predictable solutions of anti-viral drugs to co-administer, with a reasonable expectation of success.
Claim(s) 1, 3-5, 8-9, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US20190062785A1 in IDS filed 04/14/2020).
Johnson et al. recites a multivalent vaccine effective to protect against both rabies and at least one coronavirus, comprising a recombinant rabies virus vector that expresses at least one immunogenic glycoprotein or fragment thereof of at least one coronavirus (see claim 16). Johnson et al. recites the coronavirus is at least one of MERS-CoV, SARS-CoV, or both (see claim 17). Johnson et al. discloses that the immunogenic glycoprotein fragment is of a coronavirus spike glycoprotein (see claim 18). Johnson et al. discloses BNSP333-S1 is a replication-competent, recombinant rabies virus vector vaccine expressing a chimeric protein comprising the S1 domain of the S glycoprotein of MERS-CoV and the ectodomain domain, transmembrane domain, and cytoplasmic domain of RABV G (see paragraph 0035). Johnson et al. demonstrates in Example 6 that BNSP333-S1 is immunogenic in mice and protects against challenge with pathogenic MERS-CoV (see paragraphs 0178-0185 and Tables 2-3 in paragraph 0179). Johnson et al. discloses certain embodiments as pharmaceutical compositions, in which their compounds can be used with one or more additional therapeutic agents individually, sequentially, or in combination (see paragraph 0123). Johnson et al. discloses several additional therapeutic agents that include antiviral drugs and lists etravirine, efavirenz, nevirapine, rilpivirine, delavirdine, ribavirin, lamivudine, zidovudine, and among others in paragraph 0123.
Johnson et al. does not specifically teach the co-administration of their recombinant vector with one or more recited anti-viral agents. However, it would have been prima facie obvious before the effective filing date of the claimed invention to have co-administered the BNSP333-S1 recombinant vector of Johnson et al. with anti-viral drugs such as rilpivirine and ribavirin to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Johnson et al. provides guidance that their compositions can contain additional anti-viral drugs such as rilpivirine and ribavirin. Therefore, an ordinary skilled artisan could have chosen from a finite number of identified, predictable solutions of anti-viral drugs to co-administer, with a reasonable expectation of success.
Furthermore, the Johnson composition as described above meets the composition recited in claim 1 because the administered composition “comprises” the two anti-viral agents, which means unrecited, additional components such as the recombinant vector can be included.
Claim(s) 6-7, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US20190062785A1 in IDS filed 04/14/2020), as applied to claims 1, 5, 16-17, and 20 above, and further in view of Nandi et al. (US20210369619A1 in PTO-802 dated 09/10/2025, effective filing date of 5/29/2020).
Johnson et al. teaches the method of claims 1, 5, 16-17, and 20 as discussed above.
The difference between Johnson and the claimed invention is that Johnson does not disclose remdesivir.
The teachings of Nandi et al. are as described above.
It would have been prima facie obvious to combine the BNSP333-S1 recombinant vector and rilpivirine and ribavirin composition of Johnson et al. as described above with the remdesivir composition of Nandi et al. before the effective filing date of the claimed invention. One of ordinary skill in the art would have made this combination with a reasonable expectation of success because both Johnson and Nandi disclose their respective compositions are useful for the same purpose of treating a coronavirus infection. See In re Kerkhoven, MPEP 2144.06 section I. Furthermore, both Johnson and Nandi suggest various combinations of anti-viral agents for the treatment of coronavirus as described above, and Nandi et al. provides further guidance of co-administering remdesivir and rilpivirine as described above. Therefore, an ordinary skilled artisan could have predictably considered adding additional anti-viral agents such as the remdesivir of Nandi to the composition of Johnson.
Response to Arguments
Applicant’s arguments filed on 03/09/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states in response to the previous 35 USC 102 rejection that independent claims 1 and 11 were amended to recite that the treatment consists of a therapeutically effective amount of NNRTI and a nucleoside-analogue antiviral. Therefore, Applicant states that Nandi does not anticipate the instant claimed invention.
Claim 1 has been narrowed from one or more antiviral agents to the two recited anti-viral agents, which overcomes the previous 35 USC 102 rejection as described in the withdrawn rejection section above. However, it is noted that claim 1 still recites a composition “comprising” the two recited antiviral agents, which means additional unrecited components can still be included in the administered composition and not just the two recited antiviral agents that Applicant has indicated here.
Applicant states that Nandi discloses a laundry list of drugs, and from this list the combination of drugs that can be used are dolutegravir/rilpivirine and emtricitabine/ rilpivirine (paragraph 0033). Applicant states that therefore an ordinary skilled artisan would not be motivated to combine the combination of drugs recited in the claims, and that Nandi fails to provide any guidance out of the infinite number of choices as to which combination of drugs would be effective.
Applicant’s arguments described above were not found persuasive because explicit motivation in the art is not required in order to establish obviousness. See MPEP 2143. Therefore, even though Nandi discloses several agents that can be combined with remdesivir and does not provide an explicit motivation to select the recited agent, the new rejection over Nandi relies on KSR (E) to establish obviousness, in which Nandi discloses a finite list of additional antiviral agents that can be combined to treat COVID-19 and explicitly discloses rilpivirine within this list of antiviral agents. It is noted that rilpivirine is listed separately without the dolutegravir and emtricitabine. Therefore, an ordinary skilled artisan would have chosen from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Applicant states that Johnson also provides a laundry list of drugs and fails to teach, disclose, or otherwise suggest the combination of drugs taught by Applicant. Applicant states that Johnson fails to provide any guidance out of the infinite number of choices as to which combination of drugs would be effective such as the choice of a vector and which coronavirus proteins that can be combined with drug combination.
Applicant’s arguments described above were not found persuasive because Johnson discloses and demonstrates that the recombinant vector BNSP333-S1 was immunogenic in mice and protects against challenge with pathogenic MERS-CoV. Furthermore, Johnson discloses a finite list of additional anti-viral drugs and lists rilpivirine and ribavirin that can be combined in their compositions. Therefore, an ordinary skilled artisan would have chosen from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Conclusion
No claim is found allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H CHO whose telephone number is (571)270-0691. The examiner can normally be reached M-F 8AM-5PM.
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, Scarlett Goon can be reached at 571-270-5241. 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.
/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693
Prosecution Insights