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
Claim Status
Claims 1, 3-6, 8-9, 11, 13-14, 16-17 and 19-24 are pending. Claims 2 and 12 have been canceled. Claims 1, 11, 13 and 16-17 have been amended. Claims 1, 3-4, 8-9, 19-20 and 23-24 are being examined in this application. In the response to the restriction requirement, Applicants elected Group I, diphenhydramine, no additional active ingredient, no H2 receptor blocking antihistamine, acetaminophen, and SARS-CoV-2. Claims 5-6, 11, 13-14, 16-17 and 21-22 are withdrawn as being drawn to a nonelected species/invention.
Claim Rejections - 35 USC § 102
The rejection of claims 1, 3, 8-9 and 19-20 under 35 U.S.C. 102(a)(1) as being anticipated by Ming et al. is withdrawn in view of the amendments to the claims.
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.
This rejection is maintained.
Claims 1, 3-4, 8-9 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Reznikov et al. (Biochem Biophys Res Commun. 2020 Dec 3;538:173-179) and Wang et al. (Exp Ther Med. 2020 Oct 27;20(6):272).
With respect to claims 1, 3, 8-9 and 19-20, Reznikov et al. teach that diphenhydramine exhibited direct antiviral activity against SARS-CoV-2 in vitro (abstract).
Reznikov et al. also teach that “[u]sage of select antihistamines, including diphenhydramine, hydroxyzine, and azelastine, was associated with reduced incidence of SARS-CoV-2 positivity in a large population. These three drugs exhibited direct antiviral activity in vitro. Randomized placebo controlled clinical trials will be required to determine if specific antihistamines have beneficial effects for prevention or treatment of COVID-19” (para bridging pages 178-179).
Reznikov et al. do not teach administering lactoferrin.
Wang et al. teach that “[L]actoferrin (LF) is a safe iron-binding glycoprotein that is present in the milk of the majority of mammals and exhibits broad-spectrum antiviral activity, including against coro-naviruses. In addition, LF also exhibits anti-inflammatory, anti-infective and immune-regulating properties, which are in line with the treatment requirements for SARS-CoV-2 infection. Therefore, the use of LF may be of value in the prevention and/or management of COVID-19” (abstract).
The MPEP 2144.06 states that "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 them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that diphenhydramine and lactoferrin are effective in treating SARS-CoV-2 infection, it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in treating SARS-CoV-2 infection. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 4, Wang et al. teach that “[i]t remains unknown which state of LF is more effective in treating SARS-CoV-2, namely unsaturated vs. saturated, human-derived vs. bovine-derived”. Therefore, one of ordinary skill in the art would have been motivated to test both human-derived and bovine-derived lactoferrin in the treatment of SARS-CoV-2.
Response to Arguments
Applicant’s arguments filed on 7/23/2026 have been fully considered but they are not persuasive.
Applicant argues that “[T]he art teaches a very large variety of drugs that might be suitable for use in treating SARS- CoV. Except by impermissible hindsight, using Applicant's disclosure as a guide, there is no teaching or suggestion either of Reznikov or Wang, either alone or in combination, that the combination of lactoferrin and diphenhydramine would have a synergistic effect in treating SARS- CoV-related betacoronavirus infection”.
Applicant’s arguments are not persuasive.
The MPEP 716.02(d) states that unexpected results must be commensurate in scope with the claimed invention.
In the instant case, they are not.
The claimed synergistic effect relates to the effect of unsaturated iron lactoferrin (hLF) and diphenhydramine, whereas the claims are broadly drawn to any lactoferrin in combination with diphenhydramine.
Furthermore, the claimed synergistic effect relates to the inhibition of SARS-CoV-2 induced cytotoxicity, whereas the claims are broadly drawn to the treatment of each and every possible SARS-CoV-related betacoronavirus-related illness.
For the reasons stated above the rejection is maintained.
This rejection is maintained.
Claims 1, 3-4, 8-9, 19-20 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Exp Ther Med. 2020 Oct 27;20(6):272) in view of UNL Health Center (downloaded from URL:<https://health.unl.edu/covid-flu-cold/ >, Oct 9, 2020).
With respect to claims 1, 3, 8-9, 19-20 and 23-24, Wang et al. teach that “[L]actoferrin (LF) is a safe iron-binding glycoprotein that is present in the milk of the majority of mammals and exhibits broad-spectrum antiviral activity, including against coro-naviruses. In addition, LF also exhibits anti-inflammatory, anti-infective and immune-regulating properties, which are in line with the treatment requirements for SARS-CoV-2 infection. Therefore, the use of LF may be of value in the prevention and/or management of COVID-19” (abstract).
Wang et al. do not teach administering diphenhydramine.
UNL Health Center teaches that certain over-the-counter items such as Diphenhydramine and acetaminophen can help manage COVID-19 symptoms (page 1, 3rd para; Table on page 2).
The MPEP 2144.06 states that "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 them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that diphenhydramine, acetaminophen and lactoferrin are effective in treating COVID-19 (i.e. SARS-CoV-2 infection), it would have been obvious to combine the three compounds with the expectation that such a combination would be effective in treating SARS-CoV-2 infection. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 4, Wang et al. teach that “[i]t remains unknown which state of LF is more effective in treating SARS-CoV-2, namely unsaturated vs. saturated, human-derived vs. bovine-derived”. Therefore, one of ordinary skill in the art would have been motivated to test both human-derived and bovine-derived lactoferrin in the treatment of SARS-CoV-2.
Response to Arguments
Applicant’s arguments filed on 7/23/2026 have been fully considered but they are not persuasive.
Applicant argues that “[E]xcept by impermissible hindsight, using Applicant's disclosure as a guide, there is no teaching or suggestion either of Wang or UNL Health Center, either alone or in combination, that the combination of lactoferrin and diphenhydramine would have a synergistic effect in treating SARS-CoV-related betacoronavirus infection”.
Applicant’s arguments are not persuasive.
The MPEP 716.02(d) states that unexpected results must be commensurate in scope with the claimed invention.
In the instant case, they are not.
The claimed synergistic effect relates to the effect of unsaturated iron lactoferrin (hLF) and diphenhydramine, whereas the claims are broadly drawn to any lactoferrin in combination with diphenhydramine.
Furthermore, the claimed synergistic effect relates to the inhibition of SARS-CoV-2 induced cytotoxicity, whereas the claims are broadly drawn to the treatment of each and every possible SARS-CoV-related betacoronavirus-related illness.
For the reasons stated above the rejection is maintained.
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.
This rejection is maintained.
Claims 1, 3-4, 8-9 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 17-20 and 39 of copending Application No. 17/995,050 in view of Wang et al. (Exp Ther Med. 2020 Oct 27;20(6):272).
With respect to claims 1, 3, 8 and 19-20, ‘050 teaches 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 therapeutically effective amount of diphenhydramine and azelastine (claim 1), wherein treating the subject susceptible to infection by the SARS-CoV-related betacoronavirus comprises preventing infection by the SARS-CoV-related betacoronavirus (claim 3).
’050 further teach that the method further comprises administering one or more additional therapeutic agents (claim 17).
‘050 does not teach lactoferrin.
Wang et al. teach that “[L]actoferrin (LF) is a safe iron-binding glycoprotein that is present in the milk of the majority of mammals and exhibits broad-spectrum antiviral activity, including against coro-naviruses. In addition, LF also exhibits anti-inflammatory, anti-infective and immune-regulating properties, which are in line with the treatment requirements for SARS-CoV-2 infection. Therefore, the use of LF may be of value in the prevention and/or management of COVID-19” (abstract).
The MPEP 2144.06 states that "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 them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that diphenhydramine and lactoferrin are effective in treating COVID-19 (i.e. SARS-CoV-2 infection), it would have been obvious to combine the two compounds with the expectation that such a combination would be effective in treating SARS-CoV-2 infection. Thus, combining them flows logically from them having been individually taught in prior art.
With respect to claim 4, Wang et al. teach that “[i]t remains unknown which state of LF is more effective in treating SARS-CoV-2, namely unsaturated vs. saturated, human-derived vs. bovine-derived”. Therefore, one of ordinary skill in the art would have been motivated to test both human-derived and bovine-derived lactoferrin in the treatment of SARS-CoV-2.
With respect to claim 9, ‘050 teaches that the SARS-CoV-related betacoronavirus is SARS-CoV-2 (claim 20).
This is a provisional nonstatutory double patenting rejection.
This rejection is maintained.
Claims 1, 3-4, 8-9, 19-20 and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 17-20 and 39 of copending Application No. 17/995,050 in view of Wang et al. (Exp Ther Med. 2020 Oct 27;20(6):272) and UNL Health Center (downloaded from URL:<https://health.unl.edu/covid-flu-cold/ >, Oct 9, 2020).
The teachings of ‘050 and Wang et al. with respect to claims 1, 3-4, 8-9 and 19-20 have been discussed above.
‘050 further teaches further administering a non-steroidal anti-inflammatory drug (claim 39).
‘050 and Wang et al. do not specifically teach acetaminophen.
UNL Health Center teaches that certain over-the-counter items such as Diphenhydramine and acetaminophen can help manage COVID-19 symptoms (page 1, 3rd para; Table on page 2).
The MPEP 2144.06 states that "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 them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that diphenhydramine, acetaminophen and lactoferrin are effective in treating COVID-19 (i.e. SARS-CoV-2 infection), it would have been obvious to combine the three compounds with the expectation that such a combination would be effective in treating SARS-CoV-2 infection. Thus, combining them flows logically from them having been individually taught in prior art.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments filed on 7/23/2026 have been fully considered but they are not persuasive.
Applicant argues that “[1]7/995,050 claims a combination of diphenhydramine and azelastine. 17/995,050 further claims the combination of diphenhydramine and azelastine may further comprise one or more additional therapeutic agents. 17/995,050 does not claim, nor does 17/995,050 teach or suggest, w”.
Since Applicant’s arguments are incomplete, the rejection is maintained.
This rejection is maintained.
Claims 1, 3-4, 8-9 and 19-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 14-16, 18-20 and 22-28 of copending Application No. 18/275,692.
Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same method.
With respect to claims 1, 3, 8-9 and 19-20, ‘692 teaches a method for treating SARS-CoV-2 infection in a subject comprising administration to the subject of a compound, or salt thereof, having sigma receptor binding affinity (claim 1), wherein the compound, or salt thereof, is diphenhydramine (claim 15), wherein the method further comprises administration of an additional therapeutic agent (claim 16), and wherein the additional therapeutic agent is lactoferrin (claim 18).
With respect to claim 4, ‘692 teaches that lactoferrin is human lactoferrin (para [00145]). Please note that it is proper to turn to and rely on the disclosure of a patent application to ascertain what constitutes an obvious modification. This position is supported by the courts. See In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This rejection is maintained.
Claims 1, 3-4, 8-9, 19-20 and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 14-16, 18-20 and 22-28 of copending Application No. 18/275,692 in view of UNL Health Center (downloaded from URL:<https://health.unl.edu/covid-flu-cold/ >, Oct 9, 2020).
The teachings of ‘692 with respect to claims 1, 3-4, 8-9 and 19-20 have been discussed above.
‘692 further teaches the additional therapeutic agent is an anti-inflammatory agent (para [0020]).
‘692 does not specifically teach acetaminophen.
UNL Health Center teaches that certain over-the-counter items such as Diphenhydramine and acetaminophen can help manage COVID-19 symptoms (page 1, 3rd para; Table on page 2).
The MPEP 2144.06 states that "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 them having been individually taught in the prior art." In re Susi, 58 CCPA 1074, 1079-80, 440 F.2d 442, 445, 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77, 126 USPQ 186, 188 (1960). As the court explained in Crockett, the idea of combining them flows logically from them having been individually taught in prior art.
Therefore, since the references teach that diphenhydramine, acetaminophen and lactoferrin are effective in treating COVID-19 (i.e. SARS-CoV-2 infection), it would have been obvious to combine the three compounds with the expectation that such a combination would be effective in treating SARS-CoV-2 infection. Thus, combining them flows logically from them having been individually taught in prior art.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant’s arguments filed on 7/23/2026 have been fully considered but they are not persuasive.
Applicant argues that “[w]ith respect to the instant application and 18/275,692, the instant application is the earlier filed application. According to MPEP 804 I. 1. (b) (i), Provisional nonstatutory double patenting rejection is the only rejection remaining in a utility or plant application, "if a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent."”.
Since the provisional nonstatutory double patenting rejection is NOT the only rejection remaining in the instant application, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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