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 .
Change of Examiner
The Group and/or Art Unit location of your application in the PTO has changed. All correspondence regarding this application should be directed to Examiner Lori Mattison in Group Art Unit 1619.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 5, 8-9, 12, 14 and 16) in the reply filed on 10 November 2025 is acknowledged.
Claims 19, 23 & 25-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 November 2025.
Applicant’s election without traverse of:
A) Composition: Organic acid-benzoic acid as the first acid, sorbic acid as the second acid, Antibiofilm agent-maltol, and zinc compound-zinc acetate; and
B) Product Type and Form-wet wipes preservative composition in the form of a solution in the reply filed on 10 November 2025 is acknowledged.
Claims 8 & 9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 November 2025.
Claim Status
Applicant’s claim amendments in filed 07 September 2023 are acknowledged.
Claims 1-11 & 13-20 are pending.
Claims 3, 4, 6, 7, 10, 11, 13, 15, 17, 18, 20-22, 24 & 30-40 are cancelled.
Claims 1, 2, 5, 9, 12, 14, 16, 19, 23, 25, 26 & 29 are amended.
Claims 8, 9, 19, 23 & 25-29 are withdrawn.
Claims 1, 2, 5, 12, 14 & 16 are under consideration.
Drawings
The drawings were received on 07 September 2023. These drawings are accept
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 19 September 2024 and 10 November 2025 have been fully considered by the examiner. A signed and initialed copy of each IDS is included with the instant Office Action.
Objections/Rejections
Claim Objections
Claims 5 & 12 are objected to because of the following informalities: Claim 5 recites “ zinc(II)”. A space is needed between “zinc” and “(II)”.
Claim 12 recites “salicylic acid D-Tyrosine”. A comma is needed between “salicylic acid” and “D-Tyrosine “ in claim 12 because these are two separate compounds in a list.
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 1, 2, 5, 12, 14 & 16 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 1 contains an impossible range/amount. Claim 1 requires 3 reagents (i.e. (i) an organic acid, (ii) an antibiofilm agent, and (iii) a zinc compound). However, when the recited upper limit of (i) an organic acid is selected (i.e. 95% w/w) and the lower limit for the (iii) a zinc compound is selected the sum is 105% which exceeds 100% and there is no room to include (ii) an antibiofilm agent.
Claims 2, 5, 12, 14 & 16 are rejected under 35 USC 112(b) because they ultimately depend from indefinite claim 1 and they do not rectify this issue.
Claim 2 contains an impossible range/amount. Claim 2 depends from claim 1 which requires 3 reagents (i.e. (i) an organic acid, (ii) an antibiofilm agent, and (iii) a zinc compound). However, when the recited upper limit of (i) an organic acid recited by claim 2 selected (i.e. 90% w/w) and the lower limit for the (iii) a zinc compound as recited by claim 1 is selected (10 % w/w) the sum is 100% and there is no room to include (ii) an antibiofilm agent. Further, when claim 2 upper limit of (i) an organic acid (i.e. 90%) is selected and the lower limit of (ii) antibiofilm agent is selected (i.e. 5%); the combined amount of these two reagents is 95% and there is no room to include the lower limit of required reagent (iii) zinc compound in the claim 1 recited amount of 10%.
Claim 5 contains an impossible range/amount. Claim 5 depends from claim 1. Claim 1 requires 3 reagents (i.e. (i) an organic acid, (ii) an antibiofilm agent, and (iii) a zinc compound). However, when the recited claim 1 lower limit of (i) an organic acid is selected (i.e. 15% w/w) and the recited claim 5 upper limit for the (iii) a zinc compound (i.e. 95%) is selected the sum is 110% which exceeds 100% and there is no room to include (ii) an antibiofilm agent.
Claim 14 contains an impossible range/amount. Claim 14 depends from claim 1. Claim 1 requires 3 reagents (i.e. (i) an organic acid, (ii) an antibiofilm agent, and (iii) a zinc compound). However, when the recited claim 1 lower limit of (i) an organic acid is selected (i.e. 15% w/w), recited lower limit for (iii) zinc compound is selected (10% w/w) and the recited claim 14 upper limit for the (ii) a antibiofilm agent (i.e. 80%) is selected the sum is 105% which exceeds 100% and there is no room to include (ii) an antibiofilm agent in an amount of 80%.
Claim 1 contains impossible math. The claim recites the ratio between (i) and the (iii) is between 10:1. The claim recites the upper limit for the concentration of (i) is 95% while the lower limit for the concentration of (iii) is 10% which yields a 9.5:1 ratio. A 10:1 ratio is not possible with these recited concentrations. The claim also recites the ratio between (i) and the (iii) is between 10:1 and 4:1. When the lower limit of (i) organic acid is selected (15%), it is impossible to achieve a ratio of 4:1 because the amount of (iii) zinc compound would required to be 3.75% which is below the recited lower limit of (iii).
Claims 2, 5, 12, 14 & 16 are rejected under 35 USC 112(b) because they ultimately depend from indefinite claim 1 but do not rectify these issues.
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.
Claim 5 is 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 5 depends from claim 1. Claim 1 recites that the (iii) zinc compound is present in a weight per weight concentration “ between 10% and 25%”. Claim 5 expands the range of the zinc compound by reciting the composition comprises “between 0.5% and 95% (w/w) of said zinc compound”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1, 2, 5, 12, 14 & 16 are rejected under 35 U.S.C. 103 as being unpatentable over Premachandran (WO 2016/164555; Published: 10/13/2016).
Claim Interpretation: Claim 5 is interpreted as only needing a zinc compound in an amount between 0.5% and 95% (w/w) with the optional “zinc (II) cation…” and “further optionally …zinc acetate..” not required.
Claim 12 recite salicylic acid is an antibiofilm agent; claim 16 recites salicylic acid is an organic acid. As such salicylic acid may be interpreted as antibiofilm agent or an organic acid for the mathematical calculations.
The claim 12 recitation of “optionally wherein said pyrone is selected from the group consisting of maltol…” is interpreted as not being required to meet the limitations of the claim because these are optional components
Claim 14 is interpreted as only needing one antibiofilm agent to meet the limitations of the claim in light of Applicant’s species election.
Claim 16 is interpreted as only needing an organic acid comprising between 1 and 7 carbon atoms because the “organic acid comprises C1-C7 carboxylic acid” is optional and “said organic acid is selected from the group consisting of: benzoic acid…” is optional.
*With regard to claim 5, please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. zinc pyrithione a species in the genus to which the elected species of zinc acetate belongs) and in an effort to expedite prosecution, this art has been applied.
**With regard to claim 12, please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims [i.e. dehydroacetic acid (a pyrone derivative) and salicylic acid which are species in the genus to which the elected species of maltol belongs] and in an effort to expedite prosecution, this art has been applied.
Premachandra teaches synergistic preservative compositions which may be delivered as a solution (title; [0018]). With regard to claim 1, Premachandra teaches their synergistic preservative compositions comprise “(i) about 0.1 wt.% to about 99.9 wt.% of propylene carbonate; (ii) about 0.1 wt.% to about 99.9 wt.% of one or more organic compounds, and wherein, inclusion of each additional organic compound is capable of demonstrating cumulative synergistic effect; and (iii) optionally about 0.1 wt.% to 99.0 wt.% of one or more preservative compounds” (abstract). With regard to claims 1(i), 2, & 16, Premachandra teaches the compositions of their invention comprise about 51 wt. % to about 60 wt. % organic compounds which are organic acids that include benzoic acid, salicylic acid, lactic acid, and citric acid and in Example 16 teaches 10% benzoic acid, in Example 28 teaches 8 % benzoic acid, and in Example 14 teaches 10% salicylic acid ([0052], [0086] & [0088]). With regard to claims 1 (iii) & 5, Premachandra teaches the compositions of their invention comprise addition preservatives in “an amount of about 11 wt. % to about 20 wt. %” and that zinc pyrithione is an additional preservative ([0058] & [0060]). With regard to claim 1, this yields a ratio between (i) and (iii) of 4.63: 1 to 5.45: 1 [Math: 51 organic acid: 11 zinc pyrithione= 4.63: 1; 60 organic acid: 11 zinc pyrithione = 5.45:1]. With regard to claim 12 & 14, in additional embodiments, Premachandra teaches inclusion of dehydroacetic acid (i.e. a pyrone derivative) and salicylic acid (i.e. antibiofilm agent) as preservatives and exemplifies dehydroacetic acid in an amount of 5.25% in Example 15 and 8% in Example 28 and salicylic acid in an amount of 10% in Example 14 ([0086], [0087] [00100]). With regard to claims 1, 2, 12, & 14, it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have looked to Premachandran’s teachings and added dehydroacetic acid in an amount of 5.25% and salicylic acid in an amount of 10% (yielding 15.25% antibiofilm agents) because Premachandra teaches and exemplifies embodiments in which dehydroacetic acid and salicylic acid are taught a preservatives suitable for the invention and it is obvious to use two compounds taught for the same purpose of preserving compositions together. With regard to claim 1, the ratio of (ii) and (iii) is between 1.38 and 1:1.31 [Math: 15.25 (salicylic acid + dehydroacetic acid): 11 (zinc pyrithione additional preservative) = 1.38:1; 15.25 (salicylic acid + dehydroacetic acid): 20 (zinc pyrithione additional preservative) = 1: 1.31]. With regard to claim 16, Premachandra teaches inclusion of “addition preservatives” in an amount of “about “0.1 wt. % to about 10 wt. % … about 91 wt. % to about 99.9 wt. %” which may be sorbic acid and in Example 13 teaches inclusion of sorbic acid in an amount of 10% ([0058], [0060] & [0085]). With regard to the elected species, it would be obvious to combine benzoic acid and sorbic acid because benzoic is taught and exemplified as a suitable organic acid and sorbic acid is taught at suitable preservative for practicing the invention.
While there is not a single example comprising each of the claimed components, the organic acids (i)/ benzoic acid, dehydroacetic acid, sorbic acid, salicylic acid, lactic acid, and citric acid are taught among short lists of organic acids and preservatives suitable for practicing the invention; the antibiofilm agent (ii)/salicylic acid and dehydroacetic acid are taught among short lists of preservatives suitable for practicing the invention; and zinc compound (iii)/zinc pyrithione is taught among a short list of additional preservative to practice the invention. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
With regard to the recited ratio between the organic acid (i) and the zinc compound (iii), the recited ratio between the antibiofilm agent (ii) and the zinc compound (iii), weight concentration of the organic acid (i), the weight concentration of the zinc compound (iii), and the weight concentration of the antibiofilm agent (ii), Premachandra teaches these parameters with values which fall within the recited ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Premachandran as applied to claims 1, 2, 5, 12, 14 & 16 above, and further in view of Duffield (US 2007/0202315; Published: 08/30/2007).
Claim Interpretation: Claims 5, 12, 14 & 16 are interpreted as above.
*With regard to claim 5, please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. zinc pyrithione a species in the genus to which the elected species of zinc acetate belongs) and in an effort to expedite prosecution, this art has been applied.
* This claim 5 rejection addresses the elected species of zinc acetate.
**With regard to claim 12, please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims [i.e. dehydroacetic acid (a pyrone derivative) and salicylic acid which are species in the genus to which the elected species of maltol belongs] and in an effort to expedite prosecution, this art has been applied.
The teachings of Premachandran are described above. Premachandran teaches a preservative composition which may be applied to wipes (Example 66 –[00149] & [00150]). The wipe may contain zinc pyrithione as an additional preservative.
Premachandran does not teach the composition comprises zinc acetate.
In the same field of invention of wipes, Duffield teaches zinc acetate and zinc pyrithione are biocides suitable for the wipe (title; [0033]). The composition is reasonably for application to the skin since the composition is taught to contain active materials which are penetration enhancers and skin conditioning materials (Duffield’s claim 13).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified Premachandran’s composition by adding Duffield’s zinc acetate to the composition because zinc acetate and zinc pyrithione are both biocides applied to wipes which may be used on the skin as taught by Duffield. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to alter the biocidal activity of the preserving composition through inclusion of an additional biocide, zinc acid, to the preservative composition which is suitable for wipes used on the skin.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Premachandran as applied to claims 1, 2, 5, 12, 14 & 16 above, and further in view of Shannon (US 2011/0081528; Published: 04/07/2011).
Claim Interpretation: Claims 5, 12, 14 & 16 are interpreted as above.
*With regard to claim 5, please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. zinc pyrithione a species in the genus to which the elected species of zinc acetate belongs) and in an effort to expedite prosecution, this art has been applied.
** The rejection addresses the elected species of maltol.
The teachings of Premachandran are described above. Premachandran teaches a preservative composition which may be applied to wipes (Example 66 –[00149] & [00150]). The wipe contains fragrance (Example 66 –[00149] & [00150]). Premachandran tests their inventive compositions against gram (+) bacteria, gram (–) bacteria, mold, and yeast (i.e. germs; Table 1-pg. 41)
Premachandran does not teach the composition comprises maltol.
In the same field of invention of wipes which control germs, Shannon teaches maltol as an additional aromatic substance for inclusion in their invention (title; [0033]).
Here, at least rationale (B) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan before the effective filing date to have modified Premachandran’s composition by substituting Premachandran’s fragrance with maltol because Premachandran’s fragrance and maltol are both aromatic substance which are used to obtain the predictable result of a composition having an aroma which may be applied to wipes as suggested by the combined teachings of Premachandran and Shannon. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to alter the fragrance of the preservative composition which may be applied to a wipe.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David J Blanchard can be reached at 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LORI K MATTISON/ Examiner, Art Unit 1619
/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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