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 .
This office action is in response to the application filed on October 31, 2022. The earliest effective filing date of the application is November 1, 2021.
Status of Claims
The amendment filed December 9, 2025 with the Response to Election/Restriction Requirement has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 11 and 16 – 24
Previously cancelled claims: 12 – 15
Amended claims: 1, 3, 9 – 11, and 19
Claims currently under examination: 1 – 11 and 16 – 24
The status of the objections and rejections regarding the disclosure upon entry of the present amendment stands as follows:
Objections: The objections to claim 1 and 9 – 11 are withdrawn in light of applicant’s amendments.
Withdrawn Rejections: The previous rejection under 35 U.S.C. § 112(b) of claim 19 is withdrawn in light of applicant’s amendments.
35 U.S.C. § 103 Rejections: The previous rejections under 35 U.S.C. § 103 of claims 1 – 11 and 16 – 24 in view of Denesuk are adjusted with respect to applicant’s amendments while the original grounds is maintained.
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 – 11 and 16 – 24 are rejected under 35 U.S.C. 103 as being unpatentable over Denesuk et al. (US 6178922 B1) in view of Davison et al. (US 6638918 B2 – IDS Filed on May 8, 2025).
Regarding claim 1, Denesuk teaches a method of making a microbe-inhibiting mastication article for a domestic animal (i.e., pet chew), the method comprising:
forming the mastication article (i.e., pet chew) from at least one tough, chew resistant material selected from the group including nylon, polyurethane, polyolefins and blends thereof (i.e., polymers – col. 4, lines 24 – 32); wherein the tough, chew resistant material of the mastication article (i.e., polymer-based chew toy) is molded from a molten or substantially liquid state into the desired form (col. 4, lines 63 – 67; col 5, lines 1 – 6); then
incorporating a microbe-inhibiting agent into the mastication article (i.e., pet chew) by soaking the tough, chew resistant material in a microbe-inhibiting agent solution after the article has been formed (col. 5, lines 6 – 9).
As stated in the instant specification, a preferred procedure for impregnating the surface of the polymer-based pet chew with chitosan is to immerse (i.e., soak) the pet chew in the chitosan/water mixture ([0011]). Therefore, step (b), incorporating a microbe-inhibiting agent into the mastication article (i.e., pet chew) by soaking, as taught by Denesuk, impregnates the mastication article (i.e., pet chew) with a microbe-inhibiting agent solution.
Denesuk teaches microbe-inhibiting agents incorporated into the material may be selected from triclosan, diiodomethyl-p-tolylsulphone, tri-n-butyltin maleate, chlorine dioxide, garlic, and turmeric, however other microbe-inhibiting agents may be used without departing from the spirit of the invention (col. 5, lines 9 – 17; col. 11, lines 13 – 14).
Denesuk does not teach the microbe-inhibiting agent comprises chitosan at a level of 0.1 % by weight to 10.0 % by weight in water.
Davison teaches a process for forming a chitosan composition (col. 5, lines 63 – 64). Davison teaches the process involves the steps of forming an aqueous solution of chitosan by dissolving chitosan in an aqueous lactic acidic solution followed by partially neutralizing said solution by means of a neutralizing agent (col. 5, lines 65 – 67; col. 6 line 1; Example 1). Davison teaches after neutralization, deionised water is added to obtain 1000 g total and produce 1 kg of a solution comprising 2% by weight of nano-sized chitosan in water (Example 1). Davison teaches due to the improved anti-microbial, substantivity, film forming, and solubility properties of the chitosan composition as well as the excellent safety profile and natural origin, the chitosan composition is suitable for use in oral and denture care including improvement of general gum and teeth health, treatment of halitosis and gingivitis, stain reduction, and for providing anti-caries, anti-plaque and anti-calculus benefits, in humans or other animals (col 18, lines 16 - 23). Davison teaches the chitosan composition (i.e., a mixture of chitosan and water) can be applied to the surface of dog toys or dog chews, which would allow for the chitosan to stay in contact with the dog oral cavity for a length of time sufficient to provide halitosis benefits as well as general gum and teeth health benefits (col. 24, lines 58 – 65).
Denesuk and Davison are combinable because they are concerned with the same field of endeavor, namely, impregnating pet toys with anti-microbial compositions. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have used the chitosan composition (i.e., a mixture of chitosan and water) of Davison as the microbe-inhibiting agent in the method of Denesuk, thereby exposing the mastication article (i.e., polymer-based pet chew) to the chitosan composition (i.e., chitosan and water mixture) and impregnating the surface of the mastication article (i.e., polymer-based pet chew) with the chitosan composition (i.e., chitosan and water mixture). One of ordinary skill in the art would have been motivated to do so because the chitosan composition of Davison is an anti-microbial composition that also provides halitosis, gum, and teeth health benefits to dogs.
While Denesuk is silent with respect to the depth of impregnation of the anti-microbial agent (i.e., chitosan and water mixture) into the mastication article (i.e., polymer-based pet chew), one of ordinary skill in the art would have adjusted the impregnation thickness of the anti-microbial agent (i.e., chitosan and water mixture) into the mastication article (i.e., polymer-based pet chew) during routine optimization to find the chitosan-impregnated chew toy that provides the best anti-microbial activity balanced with gum, teeth, and halitosis benefits to dogs. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed chitosan impregnation thickness, 0.1 mm to 10.0 mm, would thus be obvious.
Regarding claim 2, Denesuk teaches the microbe-inhibiting agent is incorporated into the material by soaking the tough, chew resistant material in the solution after the article has been formed (col 5, lines 6 – 9). By soaking the mastication article (i.e., polymer-based chew toy) in the antimicrobial agent (i.e., chitosan and water mixture), it is necessarily contained in a vessel to facilitate soaking. Denesuk teaches it is often preferred to perform soak treatments under elevated temperatures and/or pressures (col. 8, lines 8 – 9).
Regarding claim 3, Denesuk teaches the microbe-inhibiting agent is incorporated into the material by soaking the tough, chew resistant material in the solution after the article has been formed (col 5, lines 6 – 9).
While Denesuk is silent with respect to the amount of time the mastication article (i.e., polymer-based pet chew) is immersed in the anti-microbial agent (i.e., chitosan and water mixture), one of ordinary skill in the art would have adjusted the amount of time the mastication article (i.e., polymer-based pet chew) is immersed in the anti-microbial agent (i.e., chitosan and water mixture) during routine optimization to find the chitosan-impregnated chew toy that provides the best anti-microbial activity balanced with gum, teeth, and halitosis benefits to dogs. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed chitosan soaking (i.e., immersion) time, up to 120 hours, would thus be obvious.
Regarding claim 4, Davison teaches the solution is partially neutralized up to the point in which the solution becomes a precipitate suspension, the pH preferably being in the range of from about 6.5 to about 7.5 (col. 6, lines 48 – 51).
The range of chitosan composition pH, about 6.5 to about 7.5, as disclosed by Davison, overlaps with the claimed range of 6.5 or lower. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 5, Davison teaches the solution is partially neutralized up to the point in which the solution becomes a precipitate suspension, the pH preferably being in the range of from about 6.5 to about 7.5 (col. 6, lines 48 – 51).
The range of chitosan composition pH, about 6.5 to about 7.5, as disclosed by Davison, overlaps with the claimed range of 3.0 – 6.5. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 6, Davison teaches the chitosan composition is produced by dissolving chitosan in an aqueous lactic acidic solution (Example 1).
Regarding claim 7, Davison teaches the chitosan composition may comprise a coloring agent (i.e., colorant – col. 19, lines 7 – 44).
Regarding claim 8, Davison teaches the chitosan composition may comprise flavoring agents (i.e., flavoring – col. 22, line 43).
Regarding claim 9, while Denesuk is silent with respect to the depth of impregnation of the anti-microbial agent (i.e., chitosan and water mixture) into the mastication article (i.e., polymer-based pet chew), one of ordinary skill in the art would have adjusted the impregnation depth of the anti-microbial agent (i.e., chitosan and water mixture) into the mastication article (i.e., polymer-based pet chew) during routine optimization to find the chitosan-impregnated chew toy that provides the best anti-microbial activity balanced with gum, teeth, and halitosis benefits to dogs. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed chitosan impregnation depth, 1.0 mm to 5.0 mm, would thus be obvious.
Regarding claim 10, while Denesuk is silent with respect to the depth of impregnation of the anti-microbial agent (i.e., chitosan and water mixture, which contains colorants) into the mastication article (i.e., polymer-based pet chew), one of ordinary skill in the art would have adjusted the impregnation depth of the anti-microbial agent (i.e., chitosan and water mixture, which contains colorants) into the mastication article (i.e., polymer-based pet chew) during routine optimization to find the chitosan-impregnated chew toy that provides the best anti-microbial activity balanced with gum, teeth, and halitosis benefits to dogs. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed colorant impregnation depth, 0.1 mm to 10.0 mm, would thus be obvious.
Regarding claim 11, while Denesuk is silent with respect to the depth of impregnation of the anti-microbial agent (i.e., chitosan and water mixture, which contains flavoring) into the mastication article (i.e., polymer-based pet chew), one of ordinary skill in the art would have adjusted the impregnation depth of the anti-microbial agent (i.e., chitosan and water mixture, which contains flavoring) into the mastication article (i.e., polymer-based pet chew) during routine optimization to find the chitosan-impregnated chew toy that provides the best anti-microbial activity balanced with gum, teeth, and halitosis benefits to dogs. MPEP §2144.05(II) states where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The claimed flavoring impregnation depth, 0.1 mm to 10.0 mm, would thus be obvious.
Regarding claim 16, Denesuk teaches the tough, chew resistant material of the mastication article (i.e., polymer-based chew toy) is molded from a molten or substantially liquid state into the desired form (col. 4, lines 63 – 67; col 5, lines 1 – 6).
While the combination of Denesuk and Davison does not teach the mastication article (i.e., polymer-based chew toy) is injection molded, this recitation is directed toward a method of making the polymer-based pet chew supplied in the method of claim 1. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claim 16 has been considered when assessing the patentability of the product.
The structure implied by claim 16 is interpreted to be a molded polymer-based pet chew.
The molded mastication article (i.e., polymer-based chew toy), as taught by Denesuk, is encompassed by claim 16. Therefore, the product of claim 16 is rendered obvious by Denesuk and Davison.
Regarding claim 17, Denesuk teaches the tough, chew resistant material of the mastication article (i.e., polymer-based chew toy) is molded from a molten or substantially liquid state into the desired form (col. 4, lines 63 – 67; col 5, lines 1 – 6).
While the combination of Denesuk and Davison does not teach the mastication article (i.e., polymer-based chew toy) is compression molded, this recitation is directed toward a method of making the polymer-based pet chew supplied in the method of claim 1. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claim 17 has been considered when assessing the patentability of the product.
The structure implied by claim 17 is interpreted to be a molded polymer-based pet chew.
The molded mastication article (i.e., polymer-based chew toy), as taught by Denesuk, is encompassed by claim 17. Therefore, the product of claim 17 is rendered obvious by Denesuk and Davison.
Regarding claim 18, Denesuk teaches the tough, chew resistant material of the mastication article (i.e., polymer-based chew toy) is molded from a molten or substantially liquid state into the desired form (col. 4, lines 63 – 67; col 5, lines 1 – 6).
While the combination of Denesuk and Davison does not teach the mastication article (i.e., polymer-based pet chew) is extruded, this recitation is directed toward a method of making the polymer-based pet chew supplied in the method of claim 1. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claim 18 has been considered when assessing the patentability of the product.
The structure implied by claim 18 is interpreted to be a molded polymer-based pet chew.
The molded mastication article (i.e., polymer-based chew toy), as taught by Denesuk, is encompassed by claim 18. Therefore, the product of claim 18 is rendered obvious by Denesuk and Davison.
Regarding claim 19, Denesuk teaches the mastication article (i.e., pet chew) is made of at least one material selected from the group including nylon, polyurethane, polyolefins and blends thereof (col. 4, lines 24 – 32). Denesuk teaches the tough, chew resistant material of the mastication article (i.e., polymer-based chew toy) is molded from a molten or substantially liquid state into the desired form (i.e., the polymer material is a resin – col. 4, lines 63 – 67; col 5, lines 1 – 6).
Regarding claim 20, Denesuk teaches the microbe-inhibiting agent is incorporated into the material by soaking the tough, chew resistant material in the solution after the article has been formed (col 5, lines 6 – 9). By soaking the mastication article (i.e., polymer-based chew toy) in the antimicrobial agent (i.e., chitosan and water mixture), it is necessarily contained in a vessel to facilitate soaking. Denesuk teaches it is often preferred to perform soak treatments under elevated temperatures and/or pressures (col. 8, lines 8 – 9). The vessel would necessarily be a pressure vessel to perform the soaking step at elevated temperatures and pressures.
Regarding claim 21, Denesuk teaches it is often preferred to perform soak treatments under elevated temperatures and/or pressures (col. 8, lines 8 – 9).
Regarding claim 22, Denesuk teaches it is often preferred to perform soak treatments under elevated temperatures and/or pressures (col. 8, lines 8 – 9).
Regarding claim 23, Davison teaches the chitosan composition may comprise 0.001 – 0.5 wt% of a coloring agent (i.e., colorant – col. 19, lines 7 – 44).
The range of the weight percentage of coloring agent (i.e., colorant) in the chitosan composition, 0.001 – 0.5%, as disclosed by Davison, overlaps with the claimed range of 0.1 % by weight to 5.0 % by weight. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 24, Davison teaches flavoring agents (i.e., flavoring) are generally used in the chitosan compositions at levels of from about 0.001% to about 5%, by weight of the composition (col. 22, lines 49 – 51).
The range of the weight percentage of flavoring agent (i.e., flavoring) in the chitosan composition, about 0.001% to about 5%, as disclosed by Davison, overlaps with the claimed range of 0.1% by weight to 5.0 % by weight. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Response to Arguments
Applicant's arguments filed December 9, 2025 have been fully considered but they are not persuasive.
Applicant argues Denesuk falls short of actually teaching soaking a polymer-based mastication article (i.e., alleged pet chew) in a microbe- inhibiting agent solution after the article has been formed (p. 6, paragraph 2; p. 7, paragraph 3; p. 8, paragraph 2).
Applicant’s argument has been carefully considered however the argument is not persuasive. While Denesuk does not detail a specific example wherein the polymer-based mastication article (i.e., pet chew) is soaked in a microbe-inhibiting agent solution after the article has been formed, MPEP § 2141.02.IV states a prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. In this case, the entire disclosure of Denesuk suggests to one of ordinary skill in the art soaking a polymer-based mastication article in a microbe-inhibiting agent solution after the article has been formed because the polymers nylon, polyurethane, polyolefins and blends thereof from which the polymer-based mastication article (i.e., pet chew) is formed are though, chew resistant materials (col. 4, lines 24 – 32; col. 5, lines 6 – 9). Therefore, a prima facie case of obviousness has been established.
Applicant argues Denesuk makes clear that, in preparing microbe-inhibiting synthetic materials derived from polymers, the microbe-inhibiting agents are preferably added to the precursor material, while for microbe-inhibiting natural materials, the microbe-inhibiting agents are preferably either impregnated into the materials via a spray or soaking treatment (p. 9, paragraph 1).
Applicant’s argument has been carefully considered however the argument is not persuasive. While Denesuk provides alternative embodiments, the entire disclosure of Denesuk provides the suggestion to one of ordinary skill in the art soaking a polymer-based mastication article in a microbe-inhibiting agent solution after the article has been formed. Therefore, a prima facie case of obviousness has been established.
Applicant argues the POSITA may be expected to incorporate the chitosan into a resin carrier, which is then mixed with the resin for the final article, which would provide a final article with the agent dispersed relatively throughout the final article and not just at the surface of the article as proposed by the Office (p. 10, paragraph 3).
Applicant’s argument has been carefully considered however the argument is not persuasive. Such a method as described by applicant is provided by Denesuk as an alternative embodiment, however the entire disclosure of Denesuk also suggests incorporating a microbe-inhibiting agent into the mastication article (i.e., pet chew) by soaking the tough, chew resistant material in a microbe-inhibiting agent solution after the article has been formed (col 5, lines 6 – 9).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793