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
Election/Restrictions
Applicant’s election without traverse of Group I, diphenhydramine, no additional active ingredient, no H2 receptor blocking antihistamine, acetaminophen, and SARS-CoV-2 in the reply filed on 3/2/2026 is acknowledged.
Claims 5-6, 11-14, 16-17 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/2/2026.
Status of the Claims
Claims 1-6, 8-9, 11-14, 16-17 and 19-24 are pending in this application.
Claims 5-6, 11-14, 16-17 and 21-22 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1-4, 8-9, 19-20 and 23-24 are presently under consideration as being drawn to the elected species/invention.
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.
Claims 1, 3, 8-9 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ming et al. (CN103446587A).
It is noted that the only active step is to administer a composition comprising diphenhydramine and lactoferrin. Once administered, the composition would inherently prevent infection by SARS-CoV-related betacoronavirus, such as SARS-CoV-2.
Ming et al. teach a pharmaceutical composition for the prevention or treatment of influenza infection comprising administering a H1 receptor antagonist (i.e. a H1 receptor blocking antihistamine) and lactoferrin, wherein the H1 receptor antagonist is diphenhydramine (claims 1-8).
With respect to claim 8, it is noted that anyone is at risk of being exposed to a SARS-CoV-related betacoronavirus. Thus, the claim is anticipated.
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.
Claims 1-4, 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.
Claims 1-4, 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.
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 1-4, 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.
Claims 1-4, 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 1-4, 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.
Claims 1-4, 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.
Claims 1-4, 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 1-4, 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.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
Prosecution Insights