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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 28, 2026, that includes a response to the Final Office Action mailed April 28, 2026, has been entered. Claims 1, 36, and 37 have been amended; and claims 2, 3, 7-10, 15-21, 27-31, 33-35, 38, 40, 41, 43-46, 48, 49, 55, 88, 90, and 91 have been canceled. Claims 4-6, 11-14, 22-26, 32, 47, 50-54, 56-87, 89, 92, and 93 have been withdrawn. Claims 1, 36, 37, 39, and 42 are currently under examination.
Withdrawal of Prior Claim Rejections - 35 USC § 112(b)
Claims 27, 30, and 40 have been canceled. Therefore, the 35 USC 112(b) rejection presented in the Final Office Action mailed April 28, 2026 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 112(d)
Claims 27-29 have been canceled. Therefore, the 35 USC 112(d) rejection presented in the Final Office Action mailed April 28, 2026 is hereby withdrawn.
Claim Objections
Claim 1 is objected to because of the following:
1. Claim 1 recites the phrase “wherein the liquid disinfectant composition has a pH of about 6.5 to about 7.0, does not comprise nanoparticles, wherein the liquid disinfectant composition…”, which is awkward and is in improper English grammatical format.
Appropriate correction is required.
Claim 3 has been canceled. Therefore, the objection to claim 3 presented in the Final Office Action mailed April 28, 2026 is hereby withdrawn.
Claim Rejections - 35 USC § 112(b)
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.
Claim 36 is 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.
Claim 36, which depends from claim 1, stipulates in a wherein clause that “a weight to volume ratio of zinc acetate to water ranges from about 0.001:100 to about 0.1:100”. Claim 1 provides that the composition is a liquid, that zinc acetate is present in the amount of 0.01-1 wt%, and that water is present in the amount of 90-99.9 wt%. Water thus represents about 100% of the volume of the composition. One of ordinary skill in the art would thus recognize that “a weight to volume ratio of zinc acetate to water ranges from about 0.001:100 to about 0.1:100” would essentially mean that the zinc acetate is present in the amount of about 0.001-0.1 wt%. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 37, which depends from claim 1, stipulates in a wherein clause that “a weight to volume ratio of PVP K-30 to water ranges from about 0.1:100 to about 5:100”. Claim 1 provides that the composition is a liquid, that PVP K-30 is present in the amount of 0.1-5 wt%, and that water is present in the amount of 90-99.9 wt%. Water thus represents about 100% of the volume of the composition. One of ordinary skill in the art would thus recognize that “a weight to volume ratio of PVP K-30 to water ranges from about 0.1:100 to about 5:100” would essentially mean that the PVP K-30 is present in the amount of about 0.1-5 wt%. Hence, claim 37 does not appear to further limit claim 1 from which it depends.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 36, 37, and 42 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 36, which depends from claim 1, stipulates in a wherein clause that “a weight to volume ratio of zinc acetate to water ranges from about 0.001:100 to about 0.1:100”. Claim 1 provides that the composition is a liquid, that zinc acetate is present in the amount of 0.01-1 wt%, and that water is present in the amount of 90-99.9 wt%. Water thus represents about 100% of the volume of the composition. One of ordinary skill in the art would thus recognize that “a weight to volume ratio of zinc acetate to water ranges from about 0.001:100 to about 0.1:100” would essentially mean that the zinc acetate is present in the amount of about 0.001-0.1 wt%. Hence, claim 36 appears to be broader in scope than claim 1 from which it depends.
Claim 37, which depends from claim 1, stipulates in a wherein clause that “a weight to volume ratio of PVP K-30 to water ranges from about 0.1:100 to about 5:100”. Claim 1 provides that the composition is a liquid, that PVP K-30 is present in the amount of 0.1-5 wt%, and that water is present in the amount of 90-99.9 wt%. Water thus represents about 100% of the volume of the composition. One of ordinary skill in the art would thus recognize that “a weight to volume ratio of PVP K-30 to water ranges from about 0.1:100 to about 5:100” would essentially mean that the PVP K-30 is present in the amount of about 0.1-5 wt%. Hence, claim 37 does not appear to further limit claim 1 from which it depends.
Claim 42, which depends from claim 1, stipulates rather generically in a wherein clause that “the composition maintains contact with a variety of surfaces”. Claim 1 requires that the composition “retains its disinfectant properties for up to 60 days on a surface of an article”. Claim 42 thus appears to be broader in scope than claim 1 from which it depends. Claim 42 is so broad and generic that maintaining contact specifically with the surface of “an article” is merely optional.
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 1, 36, 37, 39, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Rennie et al. (U.S. Patent Application Pub. No. 2004/0033260), in view of Haslwanter et al. (U.S. Patent No. 5,897,858).
***The present rejection addresses the elected subject matter.
Applicant Claims
Applicant’s elected subject matter is directed to a liquid composition comprising 0.001-5 wt%, or 0.01-1 wt%, zinc ion; 0.1-5 wt% PVP K-30, and 90-99.9 wt% water; wherein the liquid composition does not comprise nanoparticles; wherein the composition further comprises 1-20 wt%, or 1-10 wt%, EDTA; and wherein the composition has a pH of about 6-8
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Rennie et al. disclose e.g. a liquid composition, for use as a nasal spray, comprising preferably 0.05-5 wt% ionic zinc compound; preferably 0.1-20 wt% mucoadhesive polymer, which can be PVP; and preferably 80-99.95 wt% water; wherein the liquid composition need not comprise nanoparticles; wherein the composition can further comprise 0.01-10 wt%, EDTA; and wherein the composition has a pH preferably of about 3-5.5 (abstract; paragraphs 0011, 0026-0029; 0038-0040, 0042, 0061, 0064, 0069, 0079, 0081, 0084, 0085).
Haslwanter et al. disclose e.g. a liquid composition, for use as a nasal spray, comprising an active; 0.5-15 wt%, preferably 0.5-2.5 wt%, PVP; EDTA; and water; wherein the PVP can be PVP K-30, and wherein the pH is 4-8.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Rennie et al. do not explicitly disclose that the PVP is PVP K-30. This deficiency is cured by the teachings of Haslwanter et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Rennie et al. and Haslwanter et al., outlined supra, to devise the claimed composition.
Rennie et al. disclose a liquid composition, for use as a nasal spray, comprising preferably 0.05-5 wt% ionic zinc compound; preferably 0.1-20 wt% mucoadhesive polymer, which can be PVP; 0.01-10 wt%, EDTA, and preferably 80-99.95 wt% water; wherein the liquid composition need not comprise nanoparticles, and wherein the mucoadhesive polymer, i.e. PVP, should provide for improved retention of the composition in the nasal cavity (see paragraph 0061). Since Haslwanter et al. disclose e.g. a liquid composition, for use as a nasal spray, comprising an active; 0.5-15 wt%, preferably 0.5-2.5 wt%, PVP; EDTA; and water; wherein the pH can be 4-8, and wherein the PVP most preferably is PVP K-30 to extend muco-cilia clearance times of the nasal spray (i.e. improve retention of the composition in the nasal cavity); one of ordinary skill in the art would thus be motivated to employ specifically PVP K-30 as the PVP polymer in the Rennie et al. nasal spray composition, with the reasonable expectation that the resulting composition will successfully exhibit optimal retention time in the nasal cavity.
One of ordinary skill in the art in view of the cited prior art would thus arrive at the presently claimed composition with a reasonable expectation of success. Since the composition is not patentably distinct, the properties must essentially be the same as well, and Applicant has provided no evidence to the contrary.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed August 28, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that while “Renne identifies PVP…none of Rennie’s exemplified zinc compositions contain PVP K-30” and Rennie does not disclose “a PVP K-30 to zinc acetate weight ratio of about 50:1…because none of its exemplified zinc acetate compositions contain PVP K-30”; that while “Haslwanter…uses PVP-K to prolong nasal retention”, that “Haslwanter does not disclose the ratio because it contains no zinc acetate”; that neither reference identifies “the relative amount of PVP K-30 to zinc acetate as a variable affecting rapid or persistent surface disinfection performance” and “the Office Action does not identify the PVP K-30 to zinc acetate ratio as a results effective variable…to produce the recited residual and rapid kill properties”; and thus “the cited combination does not teach or suggest amended claim 1 as a whole…including the claimed ratio and pH”.
The Examiner would like to point out the following:
1. Neither Rennie nor Haslwanter has been cited for individually anticipating the presently claimed subject matter under 35 USC 102. Rather, the prior art rejection is under 35 USC 103, based on the combination of Rennie and Haslwanter, and what these references expressly disclose and reasonably suggest to one of ordinary skill in the art, who is one of ordinary creativity and not an automaton. Moreover, neither Rennie not Haslwanter is limited to the specific examples or even the preferred embodiments, and these do not constitute a teaching away from the broader disclosure.
2. One of ordinary skill in the art, in view of the cited prior art, could have arrived at the presently claimed composition itself, i.e. a liquid comprising zinc acetate, PVP K-30, and water, in the recited amounts and at the recited pH, and this is sufficient to preclude the actual claimed composition itself. The claimed composition itself is prima facie obvious, and this does not change merely because Applicant may have found a new use for the composition, or identified a specific property of the composition.
3. Both Rennie and Haslwanter disclose a liquid composition for use as a nasal spray. Haslwanter expressly discloses a suitable pH is 4-8. Rennie et al. disclose e.g. a liquid composition, for use as a nasal spray, comprising preferably 0.05-5 wt% ionic zinc compound; preferably 0.1-20 wt% mucoadhesive polymer, which can be PVP; and preferably 80-99.95 wt% water. Haslwanter discloses that, for a liquid nasal spray, 0.5-15 wt%, preferably 0.5-2.5 wt%, PVP, wherein the PVP most preferably is PVP K-30, extends muco-cilia clearance times of the nasal spray. In other words, PVP K-30 improves retention of the composition at the intended site of action. Indeed, Rennie is using PVP as a mucoadhesive polymer, which has long been well known in the art to improve the retention of a composition at a mucosal site.
4. There is certainly no “unexpected results” here. Applicant’s composition comprises zinc acetate and PVP K-30. Zinc has long been well recognized in the art for decades, and even among many laypersons generally, to have antimicrobial and disinfectant effects. PVP K-30 is a mucoadhesive polymer that improves the retention of the composition at an intended site of action. Obviously, the zinc will have the disinfectant effect and the PVP K-30 will improve this effect by helping to retain the zinc at the site of action.
5. Contrary to Applicant’s assertion, the amount of PVP K-30 is a results-effective variable. Obviously, the PVP K-30 amount will affect the retention time of the composition. For a greater retention time, the PVP K-30 amount will be made higher. No doubt one of ordinary skill in the art could arrive at a PVP K-30 to zinc acetate weight ratio of 50:1 from employing a greater amount of PVP K-30 to aid retention and employing a minimal amount of zinc acetate to achieve the effect without any unwanted side effects.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
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