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
This action is in response to papers filed August 11, 2025. Applicant’s reply to the restriction/election requirement of June 9, 2025 has been entered. Claims 7, 44, 45, 48, 55, 88, 90, and 91 have been canceled. Claims 1-6, 8-43, 46, 47, 49-54, 56-87, 89, 92, and 93 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed U.S. Provisional Patent Application Nos. 63/233,161 and 63/234,593, filed August 13, 2021 and August 18, 2021, respectively, under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, 8-43, 46, 47, 49, and 50, is acknowledged. Applicant’s elections of i) “zinc” as the species of metal ion, ii) “PVP K-30” as the species of hydrophilic polymer, iii) “chelating agent” as the species of further constituent, iv) “polyaminocarboxylic acid” as the species of chelating agent, v) “EDTA” as the species of polyaminocarboxylic acid, vi) “benzalkonium chloride” as the species of surfactant, vii) “wetting agent” as the species of additive, viii) “melamine” as the species of binding agent, and ix) “pathogenic sterility” as the species of method of use are all also acknowledged. The Examiner has determined that claims 1-3, 8-10, 15-21, 27-31, 33-43, 46, and 49 read on the elected subject matter.
Accordingly, claims 4-6, 11-14, 22-26, 32, 47, 50-54, 56-87, 89, 92, and 93 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on August 11, 2025. Claims 1-3, 8-10, 15-21, 2731, 33-43, 46, and 49 are currently under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract merely informs the reader that the invention is a liquid disinfectant composition that does not contain nanoparticles. These are nothing new to the art at all. Indeed, liquid disinfectant compositions have been well known in the art, and even among common laypersons, for many decades, including those that do not contain nanoparticles.
3. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. However, this is precisely what the present abstract does.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 15, 31, 33, 43, 46, and 49 are objected to because of the following:
i). In claim 1, the expression “weight% (wt%)” is awkward and misplaced. Applicant is advised that there is no need to establish the formal name for the abbreviation “wt%” which is common and well understood in this context, and even if this were done it should be done the first time “wt%” is employed, which would be for 0.001 wt%, not 5.0 wt%.
ii). In claim 15, the term “glycerols” appears to be a typographical error for the intended compound “glycerol”.
iii). In claim 31, the expression “the least one chelating agent” appears to be a typographical error for the intended expression “the at least one chelating agent”.
iv). In claim 33, the expression “more_metal” has an extraneous underscore between “more” and “metal”.
v) For claims 43 and 49, the preamble is inconsistent with the preamble of the other claims. The preamble should be “the liquid disinfectant composition”, not “the composition”, and not “the disinfectant”.
vi) Claim 46, which depends from claim 1, stipulates in a wherein clause that “the liquid disinfectant composition does not comprise nanoparticles”. This is redundant and entirely unnecessary, as claim 1 already makes this stipulation.
vii) In claim 49, the expression “in 1.0 wt% to 10.0 wt%” makes no sense, and thus appears to be a typographical error for another intended expression, such as e.g. “in the amount of 1.0 wt% to 10.0 wt%”.
Appropriate correction is required.
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.
Claims 3, 9, 10, 15, 16, 18, 19, 27-29, 33, 34, 36, and 38-41 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.
Claim 3 is indefinite for the following reasons:
1. Claim 3, which depends from claim 2, stipulates in a wherein clause that the element “the chelating agent, the surfactant, or the combination of both” is effectively optional by the expression “when present”. However, claim 2, from which claim 3 depends, requires this element. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
2. Claim 3 stipulates that the element “the chelating agent, the surfactant, or the combination of both” “has a weight%”. One of ordinary skill in the art would not understand this at all. What does it mean that a chelating agent “has a weight%”, and what reference is this value a percent of? One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 9, 10, 15, 18, 19 are in improper Markush format and are thus indefinite. Applicant is advised that a proper Markush claim has the general format “selected from the group consisting of A, B, C, and D”, not “selected from a group consisting of A, B, C, and D”.
Claim 16 stipulates that the PVP “has a high or low molecular weight”, which renders the claim indefinite. The terms “high” and “low” are arbitrary, relative, and subjective, and are not defined by the claim. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “high” and “low”. Moreover, one of ordinary skill in the art cannot definitively ascertain if there is a range of PVP molecular weights that are neither “high” nor “low”, or rather is any molecular weight that is not “high” simply “low” such that this limitation is effectively meaningless as it would thus cover all molecular weights. For example, is a PVP molecular weight of 4,000 Da “high”, “low”, or neither?
Claim 18 stipulates in a wherein clause that the chelating agent is selected from those recited, which includes “an organic compound” and “a salt of an organic compound”. Clearly, not every organic compound known to man is a chelating agent, and one of ordinary skill in the art cannot definitively ascertain which subset of all the organic compounds known to man serve as a “chelating agent” in the context of Applicant’s invention. Indeed, this is like requiring a third party to complete the invention, as if there must be some other organic compounds that could work but Applicant just can’t actually name any specific ones and is leaving that to one of ordinary skill in the art to figure out on their own. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 27 is indefinite for the following reasons:
1. Claim 27, which depends from claim 1 makes reference in a wherein clause to “at least one metal salt”. Claim 1, however, says nothing at all about “at least one metal salt”. There is insufficient antecedent basis for this limitation in the claim.
2. Claim 27 stipulates in a wherein clause that the metal salt “has a mole%”. One of ordinary skill in the art would not understand this at all. What does it mean that a metal salt “has a mole%”? Or what reference is this value a percent of? One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims 28 and 29 stipulate in a wherein clause that the hydrophilic polymer and the solvent, respectively, “has a mole%”. Just like the situation for claim 27, one of ordinary skill in the art would not understand this at all. What does it mean that a hydrophilic polymer, or that a solvent, “has a mole%”? Or what reference is this value a percent of? One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims, 33, 34, and 36, all of which depend (ultimately) from claim 1, make reference in a wherein clause to “the at least one metal salt”. Indeed, claim 34 does even further, making reference to “the at least one metal salt containing composition”. Claim 1, however, says nothing at all about any metal salt or any metal salt containing composition. There is insufficient antecedent basis for this limitation in the claim.
Claim 38, which depends from claim 1, stipulates in a wherein clause that the composition has a pH of about 6-8 “in water”. Claim 1 never says anything at all about “water”, but does require a solvent, which, in light of the specification, could be water. One of ordinary skill in the art thus cannot definitively ascertain what “in water” means. Is claim 38 effectively limited to the solvent being water? Or what?
Claim 39, which depends from claim 1, stipulates in a wherein clause that the composition is “non-toxic and non-corrosive”. This appears to be nothing more than an arbitrary and undefined statement, and one of ordinary skill in the art cannot definitively ascertain how this statement necessarily limits the actual claimed composition itself. Non-toxic and non-corrosive to what? Compared to what? By what standard or reference? How does this further limit the requisite constituents and their amounts recited in claim 1?
Claim 40, which depends from claim 1, stipulates in a wherein clause that “the composition is light and heat stable”, which renders the claim indefinite. First, the term “stable” is arbitrary, relative, and subjective, and is not defined by the claim. Stable in what way, and compared to what? What are the metes and bounds of “light”? Does light constitute e.g. EM waves in the visible spectrum only? Or EM waves ranging from the IR spectrum to gamma rays? What are the metes and bounds of “heat”. Is room temperature “heat”. Is 32 C “heat”. What about 42C? What constitutes the metes and bounds of “light stable”? If one shines a flashlight upon the composition and it does not explode? If one shines a flashlight on the composition and it does not change color within 30 seconds? Or what? How does claim 40 further limit the actual composition of claim 1, i.e. the requisite constituent elements and their requisite amounts? One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 41, which depends from claim 1, stipulates in a wherein clause that hydrophilic polymer “prevents oxidation and/or moisture contact” of the metal ion. One of ordinary skill in the art cannot make heads or tails out of this. The composition of claim 1 is a liquid, and the composition comprises 89.9 wt% to 99.9 wt% solvent, presumed to be a liquid. How does the hydrophilic polymer “prevent” the metal ion from moisture contact? Of all the hydrophilic polymers known to man, one of ordinary skill in the art would not know which ones, if any, can “prevent” the metal ion from moisture contact in a liquid composition. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claims
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 3, 30, and 43 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 3, which depends from claim 2, stipulates in a wherein clause that the element “the chelating agent, the surfactant, or the combination of both” is effectively optional by the expression “when present”. However, claim 2, from which claim 3 depends, requires this element. Therefore, claim 3 does not appear to include all the limitations of claim 2 from which it depends.
Claim 30, which depends from claim 2, stipulates in a wherein clause that the element “the chelating agent, the surfactant, or the combination of both” is effectively optional by the expression “when present”. However, claim 2, from which claim 30 depends, requires this element. Therefore, claim 30 does not appear to include all the limitations of claim 2 from which it depends.
Claim 43, which depends from claim 1, stipulates in a wherein clause that “the liquid disinfectant composition exhibits antimicrobial properties, antibacterial properties, antifungal properties, antiviral properties, or a combination thereof against a variety of pathogens”. Claim 1 already stipulates that the claimed composition is a “disinfectant composition”, and one of ordinary skill in the art would no doubt understand from this that the composition has this broad and generic property already. Therefore, claim 43 does not further limit claim 1 from which it depends.
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 1-3, 8-10, 15-21, 27-31, 33-43, 46, and 49 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.
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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/DAVID BROWE/Primary Examiner, Art Unit 1617