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 the Claims
Claims 17-19 and 21-38 are pending and under current examination. Claim 20 is cancelled.
Withdrawn Claim Objections and Rejections
All objections to claims 27 and 28 are withdrawn in view of the amendments to the claims filed 4/27/2026.
All rejections under 35 U.S.C. 112(b) are withdrawn in view of the amendments to the claims filed 4/27/2026.
All rejections under 35 U.S.C. 102 are withdrawn in view of the amendments to the claims filed 4/27/2026.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 4/27/2026 have necessitated the new grounds of rejection.
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 17-19, 21-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Burch (U.S. Patent Application No. 2019/0388465, publication date: 12/26/2019, of record), as evidenced by ACS Molecule of the Week (available 9/23/2014, of record), Farnaud et. al. (Molecular Immunology, pages 395-405; publication year: 2003, of record), and Prenzno (Food Product Design, publication year: 2011, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claim 17, Burch teaches an oral composition intended to treat viral infection [0005] that may contain hydroxyapatite as a polishing agent or remineralizer [0067 and 0070]. The oral composition may contain xylitol in an amount of 0.1-15 wt.% [0090]. Burch also teaches that the oral composition may contain sodium lauryl sulfate as an anti-plaque agent [0061] or as a detergent [0068]. Burch also teaches that inactive ingredients may be present in the composition at 3.88 wt.% (pg. 10-11, Examples 1-12). The composition may be delivered as a mouth rinse or spray [0106]. The Examiner considers the phrase “inactive ingredients” to read on the hydroxyapatite as a polishing agent or remineralizer and sodium lauryl sulfate as an anti-plaque agent. Burch also teaches that the composition inhibits or reduces the occurrence or duration of the common cold [0200]. The Examiner considers the phrase “inhibits or reduces the occurrence or duration of the common cold” to read on the “reduce the viral count of an enveloped virus infection in the nose, mouth, and/or throat of a subject by at least 55%” limitation of the instant claim.
Regarding claims 18 and 19, Burch teaches that the oral composition may contain xylitol [0090].
Regarding claims 21 and 22, Burch teaches that the oral composition may contain sodium lauryl sulfate as an anti-plaque agent [0061] or as a detergent [0068]. Burch also teaches that inactive ingredients may be present in the composition at 3.88wt% (pg. 10-11, Examples 8-9). The Examiner considers the phrase “inactive ingredients” to read on sodium lauryl sulfate as an anti-plaque agent.
Regarding claim 23, Burch teaches that in any embodiment, the oral composition may contain ethanol as an anti-plaque agent [0061]. The Examiner interprets the term “in any embodiment” to encompass an embodiment of the oral composition that does not contain ethanol.
Regarding claim 24, Burch teaches that in any embodiment, the oral composition may contain ethanol as an anti-plaque agent [0061]. Burch also teaches that inactive ingredients may be present in the composition at 3.88wt% (pg. 10-11, Examples 8-9).
Regarding claim 25, Burch teaches that the oral composition may contain essential oils such as eucalyptol, menthol, and thymol [0054]. Burch also teaches that eucalyptol may be present in the composition as an antimicrobial agent [0057] or flavoring agent [0074]. Burch also teaches that inactive ingredients may be present in the composition at 3.88wt% (pg. 10-11, Examples 8-9).
Regarding claim 26, Burch teaches that zinc acetate and zinc chloride may be present in the composition and that the zinc ion resulting from dissolution of these compounds in water may be present in the composition in a concentration from about 0.02-1% by weight [0033].
Regarding claims 27 and 28, Burch teaches that the composition may include lactoferrin [0065]. Farnaud teaches that lactoferrins are members of the transferrin family (pg. 395, Introduction, first paragraph).
Regarding claim 29, Burch teaches that the oral composition may contain cellulose gum [0065]. Prenzno teaches that cellulose gum is also known as sodium carboxymethyl cellulose (CMC) (pg. 1, The clear solution). With regards to the “film-forming polymer” limitations of instant claim 29, the prior art teaches the same polymer as claimed and therefore, the film-forming properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” Burch also teaches that the oral composition may contain a film-forming agent [0052].
Regarding claim 30, Burch teaches that the oral composition may contain zinc oxide [0061]. ACS Molecule of the Week teaches that zinc oxide is water insoluble (pg. 1, first paragraph).
Regarding claim 31, Burch teaches the relevant limitations as described above for claim 17. Burch also teaches that zinc acetate and zinc chloride may be present in the composition and that the zinc ion resulting from dissolution of these compounds in water may be present in the composition in a concentration from about 0.02-1% by weight [0033].
Regarding claim 32, Burch teaches that the oral composition may be in a kit comprising the oral composition and one or more dosage cups/containers for delivery of the proper amount of the oral composition [0114].
Regarding claims 33 and 34, Burch teaches the relevant limitations as described above for claim 17. Burch also teaches that the composition may be used in a method for inhibiting, reducing the occurrence or number of, or shortening the duration of microbial infections comprising delivering the oral composition to the oral cavity of a subject [0092-00094]. The composition may be delivered as a mouth rinse or spray [0106].
Regarding claim 35, Burch teaches that the composition may include a mineralizer or remineralizer such as organic apatite and hydroxyapatite salts [0070]. It is noted that Burch is silent with regards to zinc hydroxyapatite and therefore reads on the “does not contain zinc hydroxyapatite” limitations of instant claim 35.
Regarding claim 36, Burch teaches that the oral composition may be used to treat coronavirus [0018].
Regarding claim 38, Burch teaches the relevant limitations as described above for claim 17. Burch also teaches that the composition inhibits or reduces the occurrence or duration of the common cold [0200]. The Examiner considers the phrase “inhibits or reduces the occurrence or duration of the common cold” to read on the “reduce the viral count of an enveloped virus infection in the nose, mouth, and/or throat of a subject by at least 90%” limitation of the instant claim.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 17, 21, 22, 31, 33, and 38, Burch does not teach a specific weight percentage of hydroxyapatite or anionic surfactant present in the composition.
Regarding claim 25, Burch does not teach a specific weight percentage of essential oil present in the composition.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 17, 21, 22, 31, 33, and 38, the weight percentages of hydroxyapatite and anionic surfactant present in the composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide advantageous detergency, anti-plaque, polishing, or remineralizing effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Burch teaches that inactive ingredients may be present in the composition at 3.88 wt.% (pg. 10-11, Examples 1-12) and that hydroxyapatite may act as a polishing agent or remineralizer [0067 and 0070] and that sodium lauryl sulfate may act as an anti-plaque agent [0061] or as a detergent [0068]. The Examiner considers it prima facie obvious to optimize the weight percentages of hydroxyapatite and anionic surfactant present in the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the weight percentages of hydroxyapatite and sodium lauryl sulfate would have a direct effect on the polishing, remineralizing, anti-plaque, and detergency properties of the composition and therefore be an optimizable variable.
Regarding claim 25, the weight percentage of essential oil present in the composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide advantageous antimicrobial or flavoring effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Burch teaches that inactive ingredients may be present in the composition at 3.88 wt.% (pg. 10-11, Examples 1-12) and that eucalyptol may be present in the composition as an antimicrobial agent [0057] or flavoring agent [0074]. The Examiner considers it prima facie obvious to optimize the weight percentage of eucalyptol present in the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the weight percentage of eucalyptol would have a direct effect on the antimicrobial properties or flavor of the composition and therefore be an optimizable variable.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Burch (U.S. Patent Application No. 2019/0388465, publication date: 12/26/2019, of record), as applied to claims 17-19, 21-36, and 38 above, and further in view of Wu et. al. (International Journal of Infectious Diseases, pg. 44-48; publication date: 5/2020, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Burch teaches that the oral composition may be used to treat coronavirus [0018].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Burch does not teach that the oral composition may be used to treat SARS-CoV-2. However, this deficiency is cured by Wu.
Wu teaches that SARS-CoV-2 is a coronavirus (pg. 44, Introduction, second paragraph)
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing that the oral composition embraced by Burch may be used to treat SARS-CoV-2. One would have understood that the oral composition embraced by Burch may be used to treat coronaviruses and in view of Wu that SARS-CoV-2 is a coronavirus. It would have been obvious to one of ordinary skill in the art of filing that the oral composition embraced by Burch may be used to treat SARS-CoV-2 because it is a coronavirus. One of ordinary skill would have been motivated to use the composition embraced by Burch to treat coronavirus in order to provide a new method of treating the infection. The artisan of ordinary skill would have had reasonable expectation of success because Burch teaches that the oral composition may be used to treat coronaviruses.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive.
On page 10, Applicant argues that Burch does not teach or suggest that a combination of hydroxyapatite and an anionic surfactant could be used to successfully provide an antiviral effect when applied as a mouth rinse or as an aerosol by spraying. This is not found persuasive. In response to applicant's argument that Burch fails to teach or suggest the antiviral effect of hydroxyapatite and an anionic surfactant, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Furthermore, the Examiner respectfully draws attention to MPEP 2123 (I), which states: “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments”. Burch teaches the relevant limitations as described in the obviousness rejection above, and therefore the Examiner considers the teachings of Burch to read on the limitations of the instant claims.
On page 10, Applicant argues that Burch does not disclose any embodiment where hydroxyapatite and an anionic surfactant are both present together in the same composition. This is not found persuasive. In response, the Examiner respectfully draws attention to MPEP 2123 (II) which states: “disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).” The broad disclosure of Burch teaches the relevant limitations as described in the obviousness rejection above, and therefore the Examiner considers the teachings of Burch to read on the limitations of the instant claims.
On page 11, Applicant argues that one skilled in the art would not have predicted that combining two unrelated ingredients (hydroxyapatite and an anionic surfactant), neither of which are taught as being antiviral active agents, would have successfully produced an antiviral effect as required by the present claims. This is not found persuasive. In response to applicant's argument that one skilled in the art would not have predicted that combined two unrelated ingredients (hydroxyapatite and an anionic surfactant), would have successfully produced an antiviral effect, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Furthermore, please refer to MPEP 2141.03(I) regarding the factors to consider when determining level of ordinary skill: "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. One of ordinary skill in the art would have recognized that any virus accidentally entered through mouth, nose, and/or eyes could be stopped/inactivated at the pharynx or nasopharynx with the use of a surfactant-based gargle (see Pramod et. al, Medical Hypotheses, pg. 110081, publication date: 4/15/2020) and therefore would have reasonably understood that a mouth rinse or aerosol that contains an anionic surfactant would have an antiviral effect.
On page 11, Applicant argues that the combination of hydroxyapatite with an anionic surfactant provides a synergistic effect with regard to reducing the viral count of an enveloped virus infection. This is not found persuasive. In response, please refer to MPEP 716.02 (b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Differences in results are in fact unexpected and unobvious: The evidence of unexpected results argued by the Applicant amounts to a synergistic antiviral effect of hydroxyapatite and anionic surfactant present in the composition. However, the evidence present in the as-filed specification only demonstrates the antiviral efficiency for a composition containing both hydroxyapatite and a combination of anionic surfactants and does not clearly demonstrate that hydroxyapatite is essential to the antiviral performance of the composition. One of ordinary skill in the art would have recognized that any virus accidentally entered through mouth, nose, and/or eyes could be stopped/inactivated at the pharynx or nasopharynx with the use of a surfactant-based gargle (see Pramod et. al, Medical Hypotheses, pg. 110081, publication date: 4/15/2020). Therefore, because the applicant has not clearly demonstrated the synergistic effects of hydroxyapatite and anionic surfactant, the antiviral efficiency of the instant composition is not unexpected or unobvious due to the known antiviral activity of a surfactant-based gargle.
Differences are of both practical and statistical significance: The evidence of unexpected results amounts to increased antiviral efficiency of the instant composition; therefore the differences are of practical significance. The Applicant has provided no data demonstrating the synergy of the hydroxyapatite and anionic surfactant with regard to the antiviral activity of the composition, therefore the difference are not of statistical significance.
Evidence of unexpected properties must be in commensurate scope with the claims: The instant claim 17 embraces a mouth rinse or aerosol that contains any anionic surfactant. The instant claim 22 further limits the anionic surfactant to sodium lauryl sulfate, sodium myristoyl sarcosinate, sodium methyl cocoyl taurate, or mixtures thereof. In order to be in commensurate scope with the claims, the evidence of unexpected results must demonstrate a synergistic effect rendered by hydroxyapatite in combination with each anionic surfactant individually as well as in combination. The evidence of unexpected results argued by the Applicant amounts to a synergistic antiviral effect of hydroxyapatite and sodium lauryl sulfate, sodium myristoyl sarcosinate, and sodium methyl cocoyl taurate present in the exemplary composition but does not demonstrate that the synergistic effect is present for all anionic surfactants or individually for each anionic surfactant recited by the instant claim 22. Therefore, the evidence of unexpected results is not in commensurate scope with the claims.
Additionally, no side-by-side comparison to the closest prior art is provided to establish unexpectedly superior performance. There is no nexus between the purportedly unexpected property and the differences between the instant invention, as claimed, and the closest prior art. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
On page 11, Applicant argues that the amended claims recite features (i.e., the antiviral effects of hydroxyapatite) that are not taught or suggested by any of the cited references. This is not found persuasive. In response, the Examiner respectfully draws attention to MPEP 2123 (I), which states: “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments”. As described in the obviousness rejection above, the broad disclosure of Burch teaches the limitations of the instant claims and therefore reads on the limitations of the instant claims. Furthermore, in response to applicant's argument that the prior art fails to teach the antiviral effects of hydroxyapatite, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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 17-19 and 21-38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-35 of copending Application No. 18/550,098, in view of Burch (U.S. Patent Application No. 2019/0388465, publication date: 12/26/2019, of record).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘098 application embrace a composition that comprises an anionic surfactant present at 1wt% or less. The anionic surfactant may comprise sodium lauryl sulfate. The composition may also comprise 0.001 to 5wt% of a polyalcohol selected from erythritol, arabitol, lactitol, maltitol, mannitol, sorbitol, xylitol, and mixtures thereof. It is noted that the claims of the ‘098 application are silent with regards to ethanol and therefore reads on the “does not comprise ethanol” limitation of the instant claim 23. The claims of the ‘098 application also embrace 0.001 to 5 wt.-% of an essential oil selected from eucalyptol, thymol, menthol, anise oil, fennel oil, and levomenthol. The composition may also contain 0.001 to 20 wt.-% of a water-soluble zinc salt selected from the group consisting of zinc-L-pyrrolidone-carboxylate, zinc acetate, zinc chloride, zinc histidine, zinc gluconate, zinc aspartate, zinc citrate, zinc sulfate, zinc lactate and mixtures thereof. The claims of the ‘098 application also embrace a transferrin, a lactoferrin, and a film-forming polymer selected from carrageenan, carboxymethyl cellulose (CMC) and pharmaceutically acceptable salts thereof, hydroxypropyl methylcellulose (HPMC), ethyl cellulose, methyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hyaluronic acid and pharmaceutically acceptable salts thereof, copolymers of methyl vinyl ether and maleic acid, and pharmaceutically acceptable salts thereof, carboxymethyl chitin, polyvinylpyrrolidone, chitosan, and mixtures thereof. The composition may also contain a water-insoluble zinc salt.
The claims of the ‘098 application also embrace a kit of parts comprising the composition and a spraying device or a mouth rinse device or a gargling device, for applying the composition to the mucous membranes of the nose, mouth and/or throat. The composition may be a mouth rinse or an aerosol. The claims of the ‘098 method also embrace a method of treating a coronavirus infection, including SARS-CoV-2, comprising administering the composition.
The claims of the ‘098 application do not embrace hydroxyapatite or ethanol in the composition. The claims of the ’098 application also do not teach that the composition reduces the viral count of an enveloped virus in the nose, mouth, and/or throat of a subject by at least 55%. However, these deficiencies are cured by Burch. Burch teaches an oral composition intended to treat viral infection [0005] that may contain hydroxyapatite as a polishing agent or remineralizer [0067 and 0070]. Burch also teaches that in any embodiment, the oral composition may contain ethanol as an anti-plaque agent [0061]. The inactive ingredients may be present in the composition at 3.88wt% (pg. 10-11, Examples 8-9). Burch also teaches that the composition inhibits or reduces the occurrence or duration of the common cold [0200]. The Examiner considers the phrase “inhibits or reduces the occurrence or duration of the common cold” to read on the “reduce the viral count of an enveloped virus infection in the nose, mouth, and/or throat of a subject by at least 55%” or “…at least 90%” limitations of the instant claims 17, 31, 33, and 38.
Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the composition embraced by the claims of the ‘098 application and the composition embraced by Burch for the purpose of treating or inhibiting coronavirus infection), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
The weight percentages of hydroxyapatite and ethanol present in the composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal weight percentage in order to best achieve the desired results as such would provide advantageous anti-plaque, polishing, or remineralizing effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Burch teaches that inactive ingredients may be present in the composition at 3.88 wt.% (pg. 10-11, Examples 1-12) and that hydroxyapatite may act as a polishing agent or remineralizer [0067 and 0070] and that ethanol may act as an anti-plaque agent [0061]. The Examiner considers it prima facie obvious to optimize the weight percentages of hydroxyapatite and ethanol in the composition, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the weight percentages of hydroxyapatite and sodium lauryl sulfate would have a direct effect on the polishing, remineralizing, and anti-plaque detergency properties of the composition and therefore be an optimizable variable.
It would have been prima facie obvious to one of ordinary skill in the art of filing that the composition embraced by the claims of the ‘098 application would be able to reduce the viral count of an enveloped virus infection in the nose, mouth, and/or throat of a subject by at least 55% or 90%. One would have understood in view of Burch that a composition comprising hydroxyapatite, an anionic surfactant, and a polyalcohol inhibits or reduces the occurrence or duration of the common cold [0200]. It would have been obvious that the composition embraced by the claims of the ‘098 application is also suitable to inhibit the occurrence of an enveloped virus infection. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because the claims of the ‘098 application embrace a method for treating a corona virus infection or reducing the probability of a corona virus infection.
This is a provisional nonstatutory double patenting rejection because the copending claims have not yet been patented.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive.
On page 12, Applicant argues that Burch does not teach that hydroxyapatite has any antiviral effect and therefore it would not have been obvious to incorporate hydroxyapatite into the claimed compositions of the ‘098 application. This is not found persuasive. In response, the Examiner respectfully draws attention to MPEP 2123 (I), which states: “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments”. Given the broadest reasonable interpretation of the claims, the instant claims recite a mouth rinse with an antiviral effect that comprises hydroxyapatite and an anionic surfactant. As described in the double patenting rejection above, Burch teaches an oral composition that may contain an anionic surfactant and hydroxyapatite and that the composition inhibits or reduces the occurrence or duration of the common cold [0200]. The Examiner considers the phrase “inhibits or reduces the occurrence or duration of the common cold” to read on the “reduce the viral count of an enveloped virus infection in the nose, mouth, and/or throat of a subject by at least 55%” or “…at least 90%” limitations of the instant claims 17, 31, 33, and 38. Therefore, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to combine two compositions, each of which is taught by the prior art to be useful for the same purpose (the composition embraced by the claims of the ‘098 application and the composition embraced by Burch for the purpose of treating or inhibiting coronavirus infection), in order to form a third composition to be used for the very same purpose. See MPEP 2144.06 (I).
Conclusion
No claims are allowed.
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 ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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, Ali Soroush can be reached at 571-272-9925. 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.
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
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