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 .
Status of Claims
The amended claims filed 01/21/2026 are acknowledged and entered.
Claims 1, 18, and 20 have been amended
Claims 4-16, 21-38 and 40-44 are cancelled
Claims 1-3, 17-20, and 39 are pending and examined on their merits.
Response to Amendment
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Claim Rejections - 35 USC § 102 withdrawn
1. The rejections of claims 1-4, 7, and 17-20 under 35 U.S.C. 102(a)(b) as anticipated by Tay (previously cited) are withdrawn in view of Applicant’s amendments to claims 1, 18 and 20 and cancellation of claims 4 and 7.
Rejections Maintained
Claim Rejections - 35 USC § 103 - Maintained
Claims 1-3, 17-20, and 39 remain rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Tay in view of Glick (previously cited) and Welliver (previously cited).
Applicant’s arguments have been fully considered and are not persuasive. Therefore, the rejection is maintained.
Applicant’s Arguments:
Claim 1 has been amended to recite diphenhydramine and azelastine.
Claim 18 have been amended to depend from claim 17.
Claim 20 has been amended to depend from claim 1.
- (a) Tay does not teach the combination of diphenhydramine and azelastine. Glick is cited for disclosing a combination of or more therapeutic for treating COVID-19. Glick is further cited for disclosing the second therapeutic can be diphenhydramine or azelastine. Welliver is cited for teaching that antihistamines can be used to treat upper respiratory tract infections. None of Tay, Glick, and Welliver teaches or suggests the specific combination of diphenhydramine and azelastine.
- (b) Further, the synergistic activity of the specific combination of diphenhydramine and azelastine (Example 13) could not have been predicted based on the teachings of any of Tay, Glick, and Welliver, alone or in combination.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
- Regarding item (a): As mentioned in the Non-Final rejection dated 10/23/2025, the combination of the teachings of Tay with Glick to combine two antihistamines such as azelastine and diphenhydramine (or remdesivir instant claim 39)) for the treatment or prevention of a SARS-CoV-related coronavirus is obvious. Both Tay and Glick disclose the use of the antihistamine azelastine as an API to treat coronavirus infections. It would further be obvious to combine two antihistamines such as azelastine and diphenhydramine because viruses can induce histamine release and antihistamines are commonly used in URIs (as taught by Welliver), and severe acute respiratory syndrome (SARS) viruses cause respiratory diseases as taught by Tay. It would also be obvious to further administered remdesivir. The agents of both Tay and Glick are shown to be effective for the treatment or prevention of a SARS-CoV-related coronavirus, they are taught in the prior art for the same purpose and so it is obvious to
combine them in the same therapy regimen to achieve that purpose. “It is prima facie obvious to
combine two compositions each of which is taught by the prior art to be useful for the same
purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea
of combining them flows logically from their having been individually taught in the prior art.” In re
Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). In
addition, one cannot show nonobviousness by attacking references individually where the
rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ
871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).Whereas Tay teaches the administration of azelastine, Glick teaches the administration of diphenhydramine and remdesivir. Applicant has not sufficiently described why there is no prima facie case for obviousness.
- Regarding item (b): The data obtained from Example 13 is shown in Fig 19. It does not appear as if the data has been analyzed statistically (there is no standard deviation or p values shown) and it is unclear what T0DMSO and T2DMSO represent, if an untreated control was included in the analysis, or if the data was reproducible in several independent studies. In addition, there is no data for the triple therapy: azelastine and diphenhydramine and a third agent (either promethazine or remdesivir). A showing of unexpected results (synergy) must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements that claimed compound possesses unusually low immune response or unexpected biological activity that is unsupported by comparative data held insufficient to overcome prima facie case of obviousness). MPEP § 2145. A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue.” In re Corkill, 711 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). MPEP 716.02 (a). The evidence relied * > upon < should establish “that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance.” Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). MPEP 716.02 (b). Applicant must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). MPEP 716.02 (b). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c). Applicant has shown data that demonstrate that providing two agent shows an improvement over monotherapy but has failed to provide evidence of unexpected results based on clear synergistic, and not additive, outcomes as there is no statistical analysis clearly showing significant, consistent and reproducible synergy. Evidence of results already described in the art or already expected because most combination therapies will be likely to be an improvement over monotherapy is not evidence of unexpected results (greater than expected results). Applicant has failed to provide statistical evidence of such synergy.
Applicant argues as set forth above. Thus, for the reasons set forth above and the reasons of record, the rejection is maintained.
Double Patenting- Maintained
Claims 1-3, 17-20, and 39 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 15 16, 22 and 24 of reference Application No. 18/275,692.
Claims 1-3, 17-20, and 39 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 13-14, 19-21 of reference Application No. 18/257,237.
Applicant’s arguments have been fully considered and are not persuasive. Therefore, the rejections are maintained.
Applicant’s Arguments:
The rejection is moot in view of the amendments to the claims. Neither US18/275,692 nor US18/257,237 claims a combination of diphenhydramine and azelastine. Accordingly, Applicant respectfully requests reconsideration and withdrawal of the rejection.
Examiner’s Response to Traversal:
- The claims of 18/275,692 are drawn to methods for treating or preventing SARS-CoV-2 infection or symptoms of SARS-Cov-2 in a subject, comprising administration to the subject of a compound having sigma receptor binding affinity, including diphenhydramine (Benadryl), and further comprising administration of an additional therapeutic agent. Therefore, the reference application claims (monotherapy with Benadryl and a combination therapy of Benadryl plus and additional compound (genus)) render the instant application claims (a combination therapy of Benadryl plus and additional compound being azelastine (species)) obvious.
Since the agents of both Tay and Glick are shown to be effective for the treatment or
prevention of a SARS-CoV-related coronavirus, they are taught in the prior art for the same
purpose and so it is obvious to combine them in the same therapy regimen to achieve that
purpose. “It is prima facie obvious to combine two compositions each of which is taught by the
prior art to be useful for the same purpose, in order to form a third composition to be used for
the very same purpose.... [T]he idea of combining them flows logically from their having been
individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072
(CCPA 1980) (citations omitted).
- The claims of 18/257,237 are drawn to a method of treating a subject suffering from infection by or susceptible to infection by a SARS-CoV-related betacoronavirus comprising administering to a subject a pharmaceutical composition comprising a therapeutically effective amount of diphenhydramine and lactoferrin, and further comprising one or more therapeutic agents (such as an H1 receptor blocking antihistamine (such as azelastine)). Therefore, the co-pending application claims drawn to a triple combination therapy (diphenhydramine and lactoferrin and azelastine) species anticipate the instant application claims drawn to the diphenhydramine and azelastine combination therapy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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.
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/IMMA BARRERA/
Examiner, Art Unit 1671
/Michael Allen/ Supervisory Patent Examiner, Art Unit 1671