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 Applicant’s amendment filed September 23, 2025 in reply to the Non-final Office Action mailed March 26, 2025. Claims 1, 8, 17, and 19 have been amended; and no claims have been canceled or newly added. Claims 3-5, 8, 9, 12, 13, 16, and 17 have been withdrawn. Claims 1, 2, 6, 7, 10, 11, 14, 15, 18, and 19 are under examination.
Withdrawal of Prior Claim Rejections - 35 USC § 112(a)
Claim 19 has been satisfactorily amended. Therefore, the 35 USC 112(a) rejection presented in the Non-final Office Action mailed March 26, 2025 is hereby withdrawn.
Withdrawal of Prior Claim Rejections - 35 USC § 112(b)
Claim 1 has been satisfactorily amended. Therefore, the 35 USC 112(b) rejection presented in the Non-final Office Action mailed March 26, 2025 is hereby withdrawn.
Claim Rejections - 35 USC § 103 (I and II)
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.
I. Claims 1, 2, 6, 7, 10, 11, 14, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Westfall (U.S. Patent No. 6,183,785), in view of Kleine et al. (U.S. Patent Application Pub. No. 2018/0177189).
I. Applicant Claims
Applicant’s elected subject matter is directed to a composition for treating mastitis comprising zinc gluconate, glycerin, a viscosity control agent, and water; wherein the composition can further comprise a colorant, has a viscosity of 3-5 cP, and is sprayable; wherein zinc ions are present in the amount of 10,000-25,000 ppm; wherein the glycerin is present in the amount of 5-20 wt%; wherein the viscosity control agent is polyvinyl alcohol and is present in the amount of 2-4 wt%; and wherein the glycerin/polyvinyl alcohol weight ratio is 1.5 to 5.
I. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Westfall discloses a sprayable composition for treating mastitis comprising e.g. zinc gluconate, chlorhexidine, glycerin, and water; wherein the composition can further comprise a dye (i.e. a colorant), wherein zinc is present in the amount of 0.01-5 wt% (i.e. 100 to 50,000 ppm), and wherein the glycerin is present in the amount of e.g.10 wt% (abstract; Col. 2, lines 20-31, 38-44, 49-51; Col. 3, lines 19-36, 55-67; Col. 4, lines 3-5, 14-17; examples).
Kleine et al. disclose a sprayable composition for treating mastitis comprising e.g. an antimicrobial agent (e.g. chlorhexidine), glycerin, polyvinyl alcohol, and water; wherein the composition can further comprise a dye/colorant; wherein the polyvinyl alcohol is present in the amount of e.g. 2-4.5 wt%; and wherein the viscosity is preferably 1-5 cPs (abstract; paragraphs 0032-0045; 0048, 0051, 0053, 0072, 0074, 0081, 0091, 0094, 0097, 0099, 0198, 0200).
I. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Westfall does not explicitly disclose that the composition contains polyvinyl alcohol in the amount of 2-4 wt%. This deficiency is cured by the teachings of Kleine et al.
I. 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 Westfall and Kleine et al., outlined supra, to devise Applicant’s claimed composition.
Westfall discloses a sprayable composition for treating mastitis comprising e.g. zinc gluconate, chlorhexidine, glycerin, and water; wherein the composition can further comprise a dye (i.e. a colorant), and can be sprayed onto the skin of the teat of a cow to treat or prevent mastitis. Since Kleine et al. disclose that a sprayable composition for treating or preventing mastitis in a cow, which comprises an antimicrobial (e.g. chlorhexidine), glycerin, and water, further advantageously comprises about 2-4.5 wt% polyvinyl alcohol, which composition adheres to the teat skin and dries quickly to form a sealant coating that is flexible and resists cracking, which is resistant to premature loss under a variety of field conditions, but yet which can be rapidly removed at the time of milking; one of ordinary skill in the art would thus be motivated to include 2-4.5 wt% polyvinyl alcohol in the Westfall composition, with the reasonable expectation that the resulting composition can be sprayed onto the skin of the teat, whereby the composition adheres to the teat skin and dries quickly to form a sealant coating that is flexible and resists cracking, which is resistant to premature loss under a variety of field conditions, but yet which can be rapidly removed at the time of milking, to thus better treat and prevent mastitis in the cow.
Westfall discloses that zinc gluconate in particular is preferably present in the amount of “at least 0.5 wt%, typically greater than 1 wt%”. Westfall goes on to more generally disclose that zinc is present in the amount of 0.01-5 wt%, which is 100 to 50,000 ppm zinc. Moreover, Westfall also provides that “preferably, the disinfectant is present in a range of about 0.1% to 4% by weight of the total teat dip composition, most preferably about 0.5%; and that the zinc and disinfectant are typically present in the composition at a ratio of about 1:2 to 4:1 zinc:disinfectant, preferably about 2 or 3:1. At 4 wt% disinfectant, with a 4:1 zinc:disinfectant ratio, the zinc amount is thus 16 wt%, or 160,000 ppm. Even more preferred, with the “most preferred” amount of disinfectant, i.e. 0.5%, with a preferred 3:1 zinc:disinfectant ratio, the zinc amount is thus 1.5 wt%, or 15,000 ppm. Clearly, Westfall provides for a zinc amount that falls within the claimed range of 10,000 to 25,000 ppm.
Moreover, the composition one of ordinary skill in the art would thus arrive at in following the teachings of the cited prior art will thus contain e.g. 10 wt% glycerin, and 2-8 wt% polyvinyl alcohol. The glycerin/polyvinyl alcohol weight ratio is thus 1.25 to 5, which is certainly not patentably distinct from the claimed weight ratio of 1.5 to 5.
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.
II. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Westfall (U.S. Patent No. 6,183,785), in view of Kleine et al. (U.S. Patent Application Pub. No. 2018/0177189), Abendrot et al. (Int. J Cosmetic Sci. 2018; 40: 319-327), and Watts et al. (J Allergy Clin Immunil Pract. 2018; 6: 254-255).
II. Applicant Claims
Applicant’s elected subject matter is directed to a composition for treating mastitis comprising zinc gluconate, glycerin, a viscosity control agent, and water; wherein the composition can further comprise a colorant, has a viscosity of 3-5 cP, and is sprayable; wherein the viscosity control agent is polyvinyl alcohol, and wherein zinc gluconate and optionally other zinc salts are the only biocidal agents present in the composition.
II. Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Westfall discloses a sprayable composition for treating mastitis comprising e.g. zinc gluconate, chlorhexidine, glycerin, and water; wherein the composition can further comprise a dye (i.e. a colorant), wherein zinc is present in the amount of 0.01-5 wt% (i.e. 100 to 50,000 ppm), and wherein the glycerin is present in the amount of e.g.10 wt% (abstract; Col. 2, lines 20-31, 38-44, 49-51; Col. 3, lines 19-36, 55-67; Col. 4, lines 3-5, 14-17; examples).
Kleine et al. disclose a sprayable composition for treating mastitis comprising e.g. an antimicrobial agent (e.g. chlorhexidine), glycerin, polyvinyl alcohol, and water; wherein the composition can further comprise a dye/colorant; wherein the polyvinyl alcohol is present in the amount of e.g. 2-4.5 wt%; and wherein the viscosity is preferably 1-5 cPs (abstract; paragraphs 0032-0045; 0048, 0051, 0053, 0072, 0074, 0081, 0091, 0094, 0097, 0099, 0198, 0200).
Abendrot et al. disclose that zinc-containing compounds, including zinc gluconate and other zinc salts, are topically applied for personal care applications and provide potent antimicrobial action, as well as antioxidant, anti-inflammatory, anti-odor, cleansing, and stabilizing effects.
Watts et al. disclose that chlorhexidine, e.g. chlorhexidine gluconate, can cause contact allergic dermatitis and hypersensitivity reactions, including anaphylaxis; that contact allergic dermatitis can be characterized by erythema, vesicles, and lichenified hyperpigmented popular plaque-like eruptions; and that chlorhexidine could be considered a potential hidden contact allergen.
II. Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Westfall does not explicitly disclose that the composition contains a “viscosity control agent”, and that zinc salts are the only biocidal ingredients in the composition. These deficiencies are cured by the teachings of Kleine et al., Abendrot et al., and Watts et al.
II. 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 Westfall, Kleine et al., Abendrot et al., and Watts et al., outlined supra, to devise Applicant’s claimed composition.
Westfall discloses a sprayable composition for treating mastitis comprising e.g. zinc gluconate, chlorhexidine, glycerin, and water; wherein the composition can further comprise a dye (i.e. a colorant), and can be sprayed onto the skin of the teat of a cow to treat or prevent mastitis. Since Kleine et al. disclose that a sprayable composition for treating or preventing mastitis in a cow, which comprises an antimicrobial (e.g. chlorhexidine), glycerin, and water, further advantageously comprises about 2-4.5 wt% polyvinyl alcohol, which composition adheres to the teat skin and dries quickly to form a sealant coating that is flexible and resists cracking, which is resistant to premature loss under a variety of field conditions, but yet which can be rapidly removed at the time of milking; one of ordinary skill in the art would thus be motivated to include 2-4.5 wt% polyvinyl alcohol in the Westfall composition, with the reasonable expectation that the resulting composition can be sprayed onto the skin of the teat, whereby the composition adheres to the teat skin and dries quickly to form a sealant coating that is flexible and resists cracking, which is resistant to premature loss under a variety of field conditions, but yet which can be rapidly removed at the time of milking, to thus better treat and prevent mastitis in the cow.
Moreover, Westfall’s liquid composition for treating mastitis comprising e.g. zinc gluconate further contains chlorhexidine as an antimicrobial agent. However, Westfall explicitly discloses that zinc itself exerts an antimicrobial effect in their composition (see e.g. Col. 6, lines 12-13), and indeed it would have been common knowledge in the art at the time of filing the present application that zinc salts generally have antimicrobial effects. Since Abendrot et al. disclose that zinc-containing compounds, including zinc gluconate and other zinc salts, are topically applied for personal care applications and provide potent antimicrobial action, as well as antioxidant, anti-inflammatory, anti-odor, cleansing, and stabilizing effects; and since Watts et al. disclose that chlorhexidine, e.g. chlorhexidine gluconate, can cause contact allergic dermatitis and hypersensitivity reactions, including anaphylaxis; that contact allergic dermatitis can be characterized by erythema, vesicles, and lichenified hyperpigmented popular plaque-like eruptions; and that chlorhexidine could be considered a potential hidden contact allergen; one of ordinary skill in the art would thus be motivated to modify the composition of Westfall by eliminating the chlorhexidine, and replacing the chlorhexidine with zinc gluconate and/or other zinc salts, with the reasonable expectation that the resulting composition will successfully treat mastitis, including providing an effective antimicrobial effect.
Westfall discloses that zinc gluconate in particular is preferably present in the amount of “at least 0.5 wt%, typically greater than 1 wt%”. Westfall goes on to more generally disclose that zinc is present in the amount of 0.01-5 wt%, which is 100 to 50,000 ppm zinc. Moreover, Westfall also provides that “preferably, the disinfectant is present in a range of about 0.1% to 4% by weight of the total teat dip composition, most preferably about 0.5%; and that the zinc and disinfectant are typically present in the composition at a ratio of about 1:2 to 4:1 zinc:disinfectant, preferably about 2 or 3:1. At 4 wt% disinfectant, with a 4:1 zinc:disinfectant ratio, the zinc amount is thus 16 wt%, or 160,000 ppm. Even more preferred, with the “most preferred” amount of disinfectant, i.e. 0.5%, and with a preferred 3:1 zinc:disinfectant ratio, the zinc amount is thus 1.5 wt%, or 15,000 ppm. Clearly, Westfall provides for a zinc amount that falls within the claimed range of 10,000 to 25,000 ppm.
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 September 23, 2025 have been fully considered but they are not found persuasive.
i) Applicant contends that “neither Westfall nor Kleine discloses or suggests a concentration of zinc ions in a range of 10,000 to 25,000 ppm”; that “the zinc ion concentration of Comparative Example 12 at 7,000 ppm is the maximum zinc ion concentration disclosed by Westfall”; and that “it was determined in the present application that there is no need to add another antimicrobial agent, such as chlorhexidine or copper sulfate, to the composition” with “a concentration of zinc ions in a range of 10,000 to 25,000 ppm”.
The Examiner, however, would like to point out the following:
1. Neither Westfall nor Kleine is limited to the specific examples or the preferred embodiments, and these do not constitute a teaching away from the broader disclosure or even the non-preferred embodiments.
2. While Westfall discloses that in a preferred embodiment, zinc gluconate is present in the amount of 0.01-5 wt%, Westfall more broadly teaches that zinc gluconate can preferably be present in the amount of “at least 0.5 wt%, typically greater than 1 wt%”. The zinc gluconate amount provided is thus open ended and there really is no maximum limit to the amount of zinc gluconate that can be present.
3. Westfall goes on to more generally disclose that zinc is present in the amount of 0.01-5 wt%, which is 100 to 50,000 ppm zinc. Moreover, Westfall also provides that “preferably, the disinfectant is present in a range of about 0.1% to 4% by weight of the total teat dip composition, most preferably about 0.5%; and that the zinc and disinfectant are typically present in the composition at a ratio of about 1:2 to 4:1 zinc:disinfectant, preferably about 2 or 3:1.
4. Hence, at 4 wt% disinfectant, with a 4:1 zinc:disinfectant ratio, the zinc amount is thus 16 wt%, or 160,000 ppm. Even with the “most preferred” amount of disinfectant, i.e. 0.5%, and with a preferred 3:1 zinc:disinfectant ratio, the zinc amount is thus 1.5 wt%, or 15,000 ppm. Clearly, Westfall provides for a zinc amount that falls within the claimed range of 10,000 to 25,000 ppm.
5. The present claims do not necessarily exclude another antimicrobial agent, such as chlorhexidine or copper sulfate.
For the foregoing reasons, the 35 USC 103 rejections are hereby maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DAVID BROWE/Primary Examiner, Art Unit 1617