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
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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 03/29/2023 has been considered.
Claim Status
The preliminary amendment filed March 29, 2023 has been entered. Claims 16-19 are new. Thus, claims 1-19 as amended are examined on the merits herein.
Claim Interpretation
(I) Claim 1, lines 1-2 recite the phrase “for the production of a nasal rinse” and line 3 recites the phrase “for use in the local treatment of the human nasal zone”.
(II) Claim 2, lines 2-4, recite “wherein the drug is used as prophylaxis against a bacterial and/or viral disease of the nasal zone and/or in the treatment of a bacterial and/or viral disease of the nasal zone”.
(III) Claim 12, lines 2-3, recite “wherein the drug is used in preparing a nasal rinse”.
(IV) Claim 18, lines 2-3, recite “wherein the nasal rinse is available in the form of an aqueous or aqueous-organic, isotone or hypertone solution.
(V) Claim 13, lines 2-3, recite “wherein the drug is used in a device for introducing a liquid into the human nasal zone”.
(VI) Claim 19, line 2, recites “wherein the device comprises a nasal douche”.
The Examiner reasonably interprets the recitations (I)-(III) discussed above are an intended use of the single-dose, water-soluble or water-miscible drug as recited in claim 1, line 1 and the recitations (IV)-(VI) are intended forms of the intended use of a nasal rinse as recited in claim 1, lines 1-2.
Therefore, the water-soluble or water-miscible drug provides the critical structure required for the functional consequence wherein said drug can be used in the production of a nasal rinse as required in claim 1, lines 1-2.
Additionally, the Examiner respectfully notes that MPEP 2111.02 states “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”.
Thus, in view of the foregoing reasons discussed above, the Examiner reasonably interprets the recitations discussed within (I)-(III) are intended uses and within (IV)-(VI) are intended forms of the nasal rinse comprising the single-dose, water-soluble or water-miscible drug recited in claim 1, line 1;and are not required limitations of their respective claims and are of no significance to claim construction.
Claim Objections
Claims 4, 7, 11 and 15 are objected to because of the following informalities:
Claim 4, lines 3-4, recite “0.8 weight-% to20 weight-%” and Claim 15, line 3, recites “0.0003 weight-% to 0.09 weight-%”, wherein a superfluous hyphen is recited immediately before each percent symbol (“%”) for claim 4 and claim 15 discussed above. Thus, to promote clarity the Examiner suggests deleting the hyphen that appears before each percent symbol (“%”) as discussed above.
Claim 7, line 4, recites “against viruses with envelope” referring to the antiviral pharmaceutical substance in line 3. However, line 3 is clearly missing the article “an” immediately before the recitation “envelope” as recited above. Thus, to improve clarity the Examiner suggests inserting the word “an” immediately before the word “envelope” as discussed above.
Claim 11, lines 1-2, recite “a single-dosed, water-soluble or water-miscible drug according to claim 1”. However, the Examiner respectfully notes that the recitation of a single-dosed, water-soluble or water-miscible drug” is already recited in claim 1, lines 1-2. Thus, to promote clarity the Examiner suggests replacing the word “a” recited immediately before “single-dosed” with the word “the”.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-8, 10-14 and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ho et al. (Published 12 May 2016, WO-2016072939-A1, IDS filed 03/29/2023) as evidenced by PubChem (Available on 16 January 2020, PubChem Database, Cetylpyridinium Chloride, CID=31239, accessed on 27 August 2025, PTO-892) and Shen et al. (Published 29 May 2019, Journal of Virology, Vol. 93, Issue 12, pp. 1-15, PTO-892).
Regarding claims 1-3, 5-8, 10-14 and 17-19, Ho teaches the use of a composition comprising antimicrobial agents for the prevention or treatment of infections (e.g. prophylaxis or treatment of a bacterial and or viral disease, required in claim 2), see paragraph [02].
Ho teaches examples of an antimicrobial agent includes antibacterial agents, antibiotics, fungicides, antiseptic agents (e.g. the anti-infective pharmaceutical substance, required in claim 5); wherein the antimicrobial agent may be chlorhexidine acetate, cetylpyridinium chloride and combinations thereof (e.g. halogenated compounds, required in claims 6 and 14); and wherein combinations of various antimicrobial agents may also be used, wherein these combinations may comprise at least one or more antimicrobial agents, for example two or more antimicrobial agents, see paragraph [047].
As evidenced by PubChem, the compound known as cetylpyridinium chloride has a molar mass of 340.0 g/mol (e.g. the molar mass, required in claim 8), see pg. 1, molecular weight. Thus, the Examiner respectfully notes when the composition contains one antimicrobial agent, and wherein the antimicrobial agent is cetylpyridinium chloride it reads on the molar mass range of the anti-infective pharmaceutical substance as recited in claim 8.
Additionally, as evidenced by Shen, cetylpyridinium chloride was screened as a broad-spectrum anti-coronavirus (anti-CoV) inhibitor in vitro, where because only alpha- and beta-CoVs infect humans four different coronaviruses (CoVs) were tested including middle east respiratory syndrome Cov (MERS-CoV [beta-CoV]) and HCoV-NL63 [alpha-CoV] which usually causes the common cold, see pg. 3, identification of broad-spectrum anti-CoV inhibitors in vitro, - pg. 4, paragraph 1.
Moreover, as evidenced by Shen, SARS-CoV and MERS-CoV both belong to beta-CoVs and show a high degree of conservation of essential functional domains, especially within 3CLpro, RdRp, and RNA helicase, which might represent potential targets for broad-spectrum anti-CoV drugs, see pg. 2, last paragraph of the page.
Furthermore, as evidenced by Shen, Table I indicates that cetylpyridinium chloride is an anti-infective with an EC50 against HCoV-NL63 of 2.64 µM and MERS-CoV of 0.69 µM, see pg. 4, Table 1, cetylpyridinium chloride. The Examiner respectfully notes that both MERS-CoV and HCoV-NL63 are enveloped viruses as required in claim 7.
Ho teaches the composition may also contain various pharmaceutically acceptable additives such as tolerance enhancers, see paragraph [071]; wherein Ho exemplifies tolerance enhancers include sorbitol or glycerol (e.g. the sugar alcohol, required in claim 10), see paragraph [0072].
Ho teaches the composition may be provided in the form of a dry powder or an aqueous solution, see paragraph [081].
Ho teaches the compositions may be administered nasally; when formulated for nasal administration the compositions may comprise a compound of the invention in a liquid carrier, such compositions may be administered for example in the form of a spray or as drops. The liquid carrier may be water (e.g. in the form of an aqueous solution, required in claim 18) and may contain further components to provide the desired isotonicity of the composition. See paragraph [081].
The Examiner respectfully notes the composition that is administered nasally in the form of a spray or as drops reads on the recitation of a “nasal rinse” required in claim 12, lines 2-3 and claim 14, line 1 as evidenced by the Specification which discloses a nasal rinse is typically in the form of a nasal spray or nasal drops (see paragraph [0005], pg. 2, line 2-3).
Ho teaches the compositions may be contained in a nasal applicator, see paragraph [081].
Ho teaches the composition may also be in a unit dosage form such as a tablet itself (e.g. a single-dosed drug, required in claim 1 and the solid drug, required in claim 3).
Ho teaches the unit dosage forms can be packaged compositions including pre-filled syringes or sachets containing liquids (e.g. the disposable container, required in claim 11 and claim 17), see paragraph [081].
Ho teaches examples of nasal administration include nasal irrigation and nasal sprays, see paragraph [081]; and teaches nasal douche as an example of nasal irrigation (e.g. nasal douche, required in claim 13 and claim 19), see paragraph [0106].
With respect to the limitation “water-soluble or water-miscible drug”, required in claim 1, line 1; the Examiner reasonably interprets this limitation to be a physical limitation of the recited drug, the Examiner also respectfully notes the “water-soluble or water-miscible drug” comprises at least one anti-infective pharmaceutical substance, see claim 1, line 2; wherein the Examiner further notes that claims 6 and 14 exemplify the anti-infective compound to be a halogenated compound, see claim 6, line 4-5 and claim 14, line 4. Since Ho teaches chlorhexidine acetate and cetylpyridinium chloride within the composition for preventing or treating infections; and wherein the Examiner respectfully notes both compounds comprise halogen atoms, specifically chlorine atoms within their structure; and additionally, Ho teaches the compositions may comprise a compound of the invention in a liquid carrier, such as water as discussed above; the Examiner reasonably interprets based on the foregoing reasons above the physical limitation of a “water-soluble or water-miscible drug” is met by the teachings of Ho as discussed above.
Thus, the teachings of Ho above anticipate claims 1-3, 5-8, 10-14 and 17-19.
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.
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.
(I) Claims 4 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (Published 12 May 2016, WO-2016072939-A1, IDS filed 03/29/2023) as evidenced by PubChem (Available on 16 January 2020, PubChem Database, Cetylpyridinium Chloride, CID=31239, accessed on 27 August 2025, PTO-892) and Shen et al. (Published 29 May 2019, Journal of Virology, Vol. 93, Issue 12, pp. 1-15, PTO-892) as applied to claims 1-3, 5-8, 10-14 and 17-19 above, and further in view of Ho et al. (Published 12 May 2016, WO-2016072939-A1, IDS filed 03/29/2023).
Ho as evidenced by PubChem and Shen address claims 1-3, 5-8, 10-14 and 17-19 as written above. Ho further teaches antimicrobial agents may be effective at different concentrations, wherein the concentration of the antimicrobial agent within the composition may be between about 0.1% w/v to about 10% w/v, see paragraph [052].
Although, Ho does not teach (a) the concentration of the anti-infective pharmaceutical substance is (w/w), required in claim 4 and claim 15; and (b) the anti-infective substance is effective against SARS-CoV-2-Virus, required in claim 16.
However, in the same field of endeavor of antimicrobial compositions, with respect to limitation (a), the Examiner respectfully notes the composition of Ho may be provided in the form of a dry powder or an aqueous solution as discussed above.
Therefore, it would be well within the scope of the artisan to formulate the antimicrobial agent(s) within the dry powder as taught by Ho above with the concentration ranges as exemplified within the aqueous solution as taught by Ho above as a simple substitution of one known element for another and thus when formulated as a dry powder the composition of Ho would comprise the concentration ranges (w/w) of the anti-infective pharmaceutical substance as required in claim 4 and claim 15 based on the teachings of Ho above.
With respect to limitation (b), the Examiner reasonably interprets this limitation as a functional effect of the structure of the antiviral pharmaceutical substance. Since Ho teaches cetylpyridinium chloride within the composition is nasally administered to treat or prevent infections as discussed above; and as evidenced by Shen, cetylpyridinium chloride is an anti-infective with an EC50 against HCoV-NL63 of 2.64 µM and MERS-CoV of 0.69 µM; and wherein SARS-CoV and MERS-CoV both belong to beta-CoVs which show a high degree of conservation of essential functional domains, especially within 3CLpro, RdRp, and RNA helicase; and might represent potential targets for broad-spectrum anti-CoV drugs; the Examiner reasonably interprets in view of the evidence presented by Shen above and the teachings of Ho wherein cetylpyridinium chloride is an antimicrobial agent within the composition of Ho for the prevention or treatment of infections as discussed above have the functional effect of limitation (b).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filing date to have included the limitation “wherein the substance is effective against SARS-CoV-2-Virus”, as required in instant claim 16, within the composition as taught by Ho above as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to have included “wherein the substance is effective against SARS-CoV-2-Virus” in order to treat or prevent the infections as taught by Ho above. One of ordinary skill in the art would have had a reasonable expectation of success to have included “wherein the substance is effective against SARS-CoV-2-Virus”, as required in instant claim 16, within the composition as taught by Ho above; as Ho teaches a composition comprising antimicrobial agents for the prevention or treatment of infections; and as evidenced by Shen above, cetylpyridinium chloride is an anti-infective agent against various coronaviruses, specifically with an EC50 against HCoV-NL63 of 2.64 µM and MERS-CoV of 0.69 µM; and wherein MERS-CoV and SARS-CoV both belong to beta-CoVs which show a high degree of conservation of essential functional domains, especially within 3CLpro, RdRp, and RNA helicase, and might represent potential targets for a broad-spectrum anti-CoV drug, such as cetylpyridinium chloride as discussed above.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included limitations (a)-(b) into the composition and uses thereof as taught by Ho above as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to treat or prevent the infections as taught by Ho above. One of ordinary skill in the art would have a reasonable expectation of success to have included limitations (a)-(b) into the compositions and uses thereof as taught by Ho above; as Ho teaches the use of a composition comprising antimicrobial agents for the prevention or treatment of infections, wherein cetylpyridinium chloride is taught as an antimicrobial agent, and as evidenced by Shen above is effective against various coronaviruses as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
(II) Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (Published 12 May 2016, WO-2016072939-A1, IDS filed 03/29/2023) as evidenced by PubChem (Available on 16 January 2020, PubChem Database, Cetylpyridinium Chloride, CID=31239, accessed on 27 August 2025, PTO-892) and Shen et al. (Published 29 May 2019, Journal of Virology, Vol. 93, Issue 12, pp. 1-15, PTO-892) as applied to claims 1-3, 5-8, 10-14 and 17-19 above, and further in view of Turner et al. (Published 06 January 2011, US-20110000480-A1, PTO-892).
Ho as evidenced by PubChem and Shen address claims 1-3, 5-8, 10-14 and 17-19 as written above. Although, Ho does not teach wherein the drug is a granulate, required in claim 9.
However, in the same field of endeavor of preventing or treating an infection, Turner teaches prophylaxis or treatment of infection by a biological agent (e.g., an infectious pathogen, such as a bacteria, virus, fungus, or parasite), see paragraph [0015]. Turner teaches pharmaceutical compositions suitable for delivering a therapeutic agent can include granulates, see paragraph [0046].
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have formulated the compositiontaught by Ho above in the form of a granulate as taught by Turner above as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to use the composition of Ho as discussed above as a granulate as taught by Turner above for the prevention or treatment of infections as taught by Ho above. One of ordinary skill in the art would have had a reasonable expectation of success to have formulated the composition of Ho above in the form of a granulate as taught by Turner above, as both Ho and Turner are drawn to prevention or treatment of infections caused by microorganisms by administering compositions with antimicrobial agents as discussed in further detail above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691