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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/13/2026 has been entered.
Status of the Claims
Claims 17-19 and 21-38 are pending and under current examination. Claim 20 is cancelled.
Withdrawn Claim Rejections
All rejections pertaining to claim 20 are moot because the claim is cancelled in the amendments filed 1/13/2026.
All rejections not reiterated have been withdrawn.
Claim Objections
Claims 27 and 28 objected to because of the following informalities:
Claim 27 recites “…wherein the composition comprises a transferrin”. Transferrin is not required by the independent claim so it is suggested to amend claim 27 to read “…wherein the composition further comprises a transferrin”.
Claim 28 recites “…wherein the composition comprises a lactoferrin”. Lactoferrin is not required by the independent claim so it is suggested to amend claim 28 to read “…wherein the composition further comprises a lactoferrin”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 17-19 and 21-38 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 17, 33, and 38 recite a weight percentage range of hydroxyapatite, anionic surfactant, and polyalcohol but do not recite what weight the percentage is relative to, i.e. total weight of the composition. This renders the claims indefinite because it is impossible to discern what percentage the weight percentage ranges describe.
Claim 21 and 22 recite a weight percentage of anionic surfactant but do not recite what weight the percentage is relative to, i.e. total weight of the composition. This renders the claims indefinite because it is impossible to discern what percentage the weight percentage ranges describe.
Claim 24 recites a weight percentage of ethanol but does not recite what weight the percentage is relative to, i.e. total weight of the composition. This renders the claim indefinite because it is impossible to discern what percentage the weight percentage range describes.
Claim 25 recites a weight percentage of essential oil but does not recite what weight the percentage is relative to, i.e. total weight of the composition. This renders the claim indefinite because it is impossible to discern what percentage the weight percentage range describes.
Claim 26 recites a weight percentage of zinc salt but does not recite what weight the percentage is relative to, i.e. total weight of the composition. This renders the claim indefinite because it is impossible to discern what percentage the weight percentage range describes.
Claim 31 recites a weight percentage range of hydroxyapatite, anionic surfactant, polyalcohol, and zinc salt but does not recite what weight the percentage is relative to, i.e. total weight of the composition. This renders the claim indefinite because it is impossible to discern what percentage the weight percentage ranges describe.
Regarding claims 18, 19, 23, 27-30, 32, and 34-37, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
Claim Rejections - 35 USC § 102
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 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 17-19 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiao (CN106924103A, publication year: 2017, citations refer to machine translation).
Regarding claim 17, Jiao discloses a deodorizing bactericidal toothpaste comprising 6 wt.% hydroxyapatite, 2 wt.% sodium lauryl sulfate, and 0.25 wt. % xylitol (pg. 1-2, final paragraph). With regards to the “wherein the composition is 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%” limitations of instant claim 17, the prior art teaches the same composition as claimed and therefore, the antiviral 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.”
Regarding claims 18 and 19, Jiao discloses a deodorizing bactericidal toothpaste comprising 6 wt.% hydroxyapatite, 2 wt.% sodium lauryl sulfate, and 0.25 wt. % xylitol (pg. 1-2, final paragraph).
Regarding claim 23, it is noted that Jiao is silent with regards to ethanol and therefore reads on the “does not comprise ethanol” limitation of instant claim 23.
Claims 17-19, 21-23, 26, 30, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leonhardt (U.S. Patent Application No. 2019/0008746, publication year: 2019), as evidenced by Jaracz (U.S. Patent Application No. 2017/0354578, publication year: 2017).
Regarding claim 17, Leonhardt discloses a prophy paste containing 0.5% hydroxyapatite crystals, 1% sodium lauryl sulfate, and 2% sorbitol [0157-0171]. With regards to the “wherein the composition is 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%” limitations of instant claim 17, the prior art teaches the same composition as claimed and therefore, the antiviral 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.”
Regarding claims 18 and 19, Leonhardt discloses a prophy paste containing 0.5% hydroxyapatite crystals, 1% sodium lauryl sulfate, and 2% sorbitol [0157-0171].
Regarding claims 21 and 22, Leonhardt discloses a prophy paste containing 1% sodium lauryl sulfate [0157-0171].
Regarding claim 23, it is noted that Leonhardt is silent with regards to ethanol and therefore reads on the “does not comprise ethanol” limitation of instant claim 23.
Regarding claim 26, Leonhardt discloses a prophy paste containing 2% zinc citrate trihydrate [0164].
Regarding claim 30, Leonhardt discloses a prophy paste containing 2% zinc citrate trihydrate [0164]. Jaracz teaches that zinc citrate is poorly soluble in water [0001].
Regarding claim 31, Leonhardt discloses a prophy paste containing 0.5% hydroxyapatite crystals, 2% zinc citrate trihydrate, 1% sodium lauryl sulfate, and 2% sorbitol [0157-0171]. With regards to the “wherein the composition is 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%” limitations of instant claim 31, the prior art teaches the same composition as claimed and therefore, the antiviral 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.”
Claim Rejections - 35 USC § 103
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).
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 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 1/13/2026 have been fully considered but they are not persuasive.
On pages 6 and 7, Applicant argues that Burch does not disclose a composition having the formulation or amounts as required by the presently amended claims. This is not found persuasive. As described in the obviousness rejection above, Burch discloses an oral care composition that may contain hydroxyapatite, sodium lauryl sulfate, and xylitol. The amounts of hydroxyapatite and sodium lauryl sulfate are results effective parameters that a person of ordinary skill in the art would routinely optimize. Therefore, the argument is not persuasive and the rejection is maintained.
On pages 6-7, Applicant argues that Burch does not teach or suggest that hydroxyapatite is effective in treating or reducing viral infections. This is not found persuasive. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the efficacy of hydroxyapatite in reducing viral infections) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Furthermore, 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 teaches the same hydroxyapatite as claimed and therefore, the antiviral properties are necessarily present. Therefore, the argument is not persuasive and the rejection is maintained.
On page 8, Applicant argues that because Burch teaches that hydroxyapatite is an inactive agent in their composition, there is no teaching that modifying the amounts of hydroxyapatite in conjunction with the anionic surfactant and polyalcohol would lead to improved antimicrobial properties. This is not found persuasive. As described in the obviousness rejection above, Burch discloses an oral care composition that may contain hydroxyapatite, sodium lauryl sulfate, and xylitol. The amounts of hydroxyapatite and sodium lauryl sulfate are results effective parameters that a person of ordinary skill in the art would routinely optimize. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the improved antimicrobial properties rendered by the specific weight percentages of hydroxyapatite, anionic surfactant, and polyalcohol) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, the argument is not persuasive and the rejection is maintained.
On page 8, Applicant argues that Burch does not teach the inclusion of a transferrin or a lactoferrin in the oral composition. This is not found persuasive. As described in the obviousness rejection above, Burch teaches that the composition may include lactoferrin [0065] and Farnaud teaches that lactoferrins are members of the transferrin family (pg. 395, Introduction, first paragraph).
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 1/13/2026 have been fully considered but they are not persuasive.
On page 9, Applicant argues that Burch teaches that hydroxyapatite is an inactive agent and does not teach that hydroxyapatite has any antiviral effect, therefore it would not have been obvious to incorporate hydroxyapatite into the claimed compositions of the ‘098 application. This is not found persuasive. As described in the double patenting rejection above, it would have been 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. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the antiviral effects of hydroxyapatite) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
No claims are allowed.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614