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 .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5-7, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over of Huron et al. (herein referred to as Huron, WO 2004014143 A) in view of Slusarczyk et al. (herein referred to as Slusarczyk, US 20160029664 A1) and Goldberg (US 10299496 B2).
With regard to Claim 1, Huron teaches a palatable support composition for administering one or more medicinal products to a feline (page 14 paragraph 2 and Claim 10). Huron teaches the composition can contain a humectant plasticizer in an amount of 5.0 percent to about 30% of the composition (Page 13 paragraph 2, Huron reads such that the composition can include glycerin, a known humectant plasticize. See applicants specification Page 4 line 30). Huron teaches the composition may also comprise protein (page 15 last paragraph).
Huron teaches the composition has a moisture content of about 0% to about 15% (page 13 last paragraph). Huron cites United States Patent No. 6,387,381, In which Huron points to where the patents states, “The water activity of the product matrix may be adjusted up or down for the active ingredient, be it pharmaceutical, nutraceutical, or a vitamin mineral complex.” The composition taught by United States Patent No. 6,387,381 and cited again by Huron sates the composition has “at least about 5% wt. water (page 4). Therefore, it would have been obvious to one with ordinary skill in the art that based on the disclosure by Huron and United States Patent No. 6,387,381, to adjust the water/moisture content to achieve the desired water activity based on the active ingredients used within the composition.
Huron teaches the composition may have different textures, crispyness, hardness, and the like (page 18 last paragraph). As such it would have been obvious to one with ordinary skill in the art to modify the composition to achieve the desired hardness.
Huron is silent to the composition comprising from about 0.5% to about 8% by weight of one or more gelling agents and from about 20% to about 50% by weight of protein, the weight percentage being expressed on a dry matter basis, the palatable support composition having a moisture content from about 20% to about 35% as fed, and wherein the composition has a cohesiveness value of from about 0.1 to about 0.5 in a compression TPA test.
Slusarczyk teaches an edible pet chew ([0001]). Slusarczyk teaches the chew may contain pharmaceuticals ([0010]). The composition contains water absorbing polymer that forms a gel when combined with water (i.e., gelling agent) in an amount of about 5 to about 45%, preferably about 10 to about 30%, more preferably about 15 to about 25% by weight ([0030], [0025], [0026] Slusarczyk reads such that the water absorbing polymer in the pet chew may be a gelling protein, a hydrocolloid, an edible hydrogel, or mixtures thereof). Slusarczyk teaches in one aspect of the disclosure the ingredients are powder and liquid ingredients are added to the mixture in downstream processing ([0040]). This aspect of the invention reads on the ingredients being measured on a dry matter basis since there is a notable absence of liquid in the powdered ingredients.
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed inventio modify Huron in view of Slusarczyk to including a gelling agent in an amount of about 5 to about 45% to form a gel when combined with water.
Continuing, the composition contains fibrous protein in an amount of about 15 to about 90%, preferably about 20 to about 80%, more preferably about 30 to about 50% by weight ([0030]) Slusarczyk teaches the fibrous protein is important in providing structural backbone of the pet chew product ([0024]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Huron in view of Slusarczyk to include protein in an amount of about 15 to about 90%, preferably about 20 to about 80%, more preferably about 30 to about 50% by weight to provide a structural backbone of the composition.
Slusarczyk teaches the cohesiveness using a TPA test ([0066], [0067], TPA is inherently a compression test). Slusarczyk teaches the untwisted samples have a cohesiveness value of 0.37±0.04 and 0.39±0.05 (Table 7). Slusarczyk teaches cohesiveness directly impacts the gumminess and chewiness of the product ([0067]). It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Huron in view of Slusarczyk to have a cohesiveness value of 0.37±0.04 and 0.39±0.05 to achieve the desired gumminess and chewiness of the product.
With regard to the shape and size, Huron teaches the size is adaptable to the organism for treatment and/or delivery of an appropriate amount of additive to the organism (page 5 last paragraph). Huron teaches the composition is made via a “knockout” which can be any size or shape and what is used to form the dough (page 17). Thus, because the “knockout” can be any size or shape, it would be obvious the product can be any desired size or shape and can be specifically adapted for the organism of interest.
Alternatively as Huron is silent to the composition having a trapezoidal cylindrical shape with a bottom end and an upper end, a height from about 5 mm to about 10 mm, a diameter from about 6 mm to about 12 mm at the bottom end, and a diameter from about 5 mm to about 10 mm at the upper end; and wherein the upper end comprises a cavity.
Goldberg teaches treats for pets and, more particularly, to novel systems and methods for treats designed to hide or otherwise contain tablets, pills, capsules, and the like administered as medicine or other supplements to pets (Col 1, Lines 14-16). Goldberg teaches a medicine wrapper which operates as a treat (Col 6, lines 8-13). With regard to shape, Goldberg teaches one embodiment in which the wrapper is a frustum (Col 16, lines 22-29, See figure 15 label 20e). The shape of a frustum reads on the instant claims limitation of “a trapezoidal cylindrical shape”) In terms of size, The dimensions of the wrappers may be adapted to the particular patient or animal that will receive the medicament in a wrapper or a treat (Col 6, lines 42-44). Goldberg teaches the upper end comprises a cavity (Col 16, lines 22-29, Figure 15 label 20e) Goldberg teaches at least two sizes may be created, one suitable for small dogs and for cats, another for larger dogs (Col 4, lines 6-8). Goldberg teaches cats may swallow treats whole, but may more often chew or tear them. If the taste and smell of the treat are appropriate, they will typically be gulped down (Col 3, lines 19-21)
It would have been obvious to one with ordinary skill in the art to modify Huron in view of Goldberg to modify the shape of the composition to be suitable for cats because the dimensions can be adapted to a particular patient or animal (Col 4, lines 6-8, Col 6, lines 42-44) See MPEP 2144.05(II)(A) Optimization Within Prior Art Conditions or Through Routine Experimentation and MPEP 2144.04(IV)(A) Changes in Size/Proportion “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”
With regard to Claim 2, Huron teaches the humectant plasticizer is glycerin (Page 13 paragraph 2).
With regard to Claim 5, Huron teaches the size is adaptable to the organism for treatment and/or delivery of an appropriate amount of additive to the organism (pag3 5 last paragraph). Huron teaches the composition is made via a “knockout” which can be any size or shape and what is used to form the dough (page 17). Thus, because the “knockout” can be any size or shape, it would be obvious the product can be any desired size or shape and can be specifically adapted for the organism of interest. In one embodiment, Huron teaches the product made for an equine which had a weight of 4850.0 mg (4.85 g) (Page 21, “physical characteristics of the soft chew). Therefore, it would have been obvious to one with ordinary skill in the art to decrease the size, thus decreasing the weight, of the product for a feline. See MPEP 2144.05(II)(A) Optimization Within Prior Art Conditions or Through Routine Experimentation and MPEP 2144.04(IV)(A) Changes in Size/Proportion “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”
With regard to Claim 6, Huron is silent to wherein the one or more gelling agents comprise gum Arabic, xanthan gum, guar gum, locust bean gum, carob gum, carrageenan, or a combination thereof.
Slusarczyk teaches the composition contains a water absorbing polymer in the pet chew may be a gelling protein, a hydrocolloid, an edible hydrogel, or mixtures thereof ([0025]). Slusarczyk teaches exemplary hydrocolloids include carrageenan, xanthan gum, and guar gum. ([0026]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed inventio modify Huron in view of Slusarczyk to including carrageenan, xanthan gum, and/or guar gum to form a gel when combined with water.
With regard to Claim 7, Huron teaches the composition further comprises oil (i.e., fat) in an amount of about 1.0 to about 40 percent (Claim 1).
With regard to Claim 9, Huron teaches the composition comprises a flavoring component wherein the flavoring is chosen to improve the palatability of the soft chew (page 5 paragraph 1). Thus reading such that the flavoring is a palatability enhancer. Huron teaches a flavoring component is typically chosen based upon consideration related to the organism that will be ingesting the soft chew (page 12 last paragraph).
Therefore, it would have been obvious to one with ordinary skill in the to include flavoring (i.e., palatability enhancer) in an amount to achieve the desired palatability for to the organism that will be ingesting the soft chew.
With regard to Claim 10, Huron teaches the composition is a functional supplement (page 5 first paragraph Huron reads such that the composition delivers an additive that is functional such as a pharmaceutical, a nutraceutical, a vitamin and/or a mineral).
With regard to Claim 11, Huron teaches the feline is a cat (page 9 paragraph 2)
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Huron (WO 2004014143 A) in view of Slusarczyk (US 20160029664 A1), Goldberg (US 10299496 B2), and Niceron et al. (herein referred to as Niceron, US 20140227386 A1)
With regard to Claim 8, Huron teaches the composition may also comprise protein (page 15 last paragraph). In addition, Slusarczyk teaches the protein originates from fibrous protein derived from animals ([0024]). However, The combination of Huron and Slusarczyk is silent to the protein originates from one or more protein sources comprising chicken, poultry, fish, or a combination thereof.
Niceron teaches a palatability-enhancing composition for pet food, especially for producing pet foods having enhanced palatability, and specifically focused on cat food (abstract). Niceron teaches the composition contains proteins from animal proteins such as animal digests ([0062]). The term “animal digest” includes by-products from chicken, poultry, fish and more ([0052]). These digests are additionally used as palatability-enhancing ingredients ([0062]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Huron and Slusarczyk in view of Niceron to use chicken, poultry, or fish as a protein source because in addition to being a protein source, they are palatability-enhancing ingredients making the composition more desirable to pets and specifically cats ([0062]).
Response to Arguments
Applicant's arguments filed 17 February 2026 have been fully considered but they are not persuasive.
First applicant argues that the present application specifically selected the claimed hardness and cohesiveness values such that the composition would have a soft texture that can be easily molded around one or more medicinal products. Applicant is arguing that the hardness values limited in claim 1 are critical. The examiner would like to point to MPEP 2144.05(III)(A) In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205 (CCPA 1946) ("Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies."); Applicant points to paragraphs [0100] and [0125] in the published specification. However, these paragraphs do not show any data which would support the facts that it would not have been obvious to one with ordinary skill in the art to modify the hardness taught by Huron through routine optimization. Paragraph [0125] of the published specification states “The palatable support composition according to the present disclosure can have a relatively soft texture and can be easily molded around one or more medicinal products, for example, to be administered to a feline in need thereof.” This statement does no supply any evidence to highlight the criticality of the harness values limited in the claim. In addition, paragraph [0100] discusses additional ingredients and does not further add any information to support the criticality of the hardness. Applicants argument is not found to be persuasive.
Next, applicant argues that Hurons is separate and distinct from the present application. Applicant argues that Huron fails to acknowledge any such application in which the soft chew would be molded around a medicinal product. Huron does teach a palatable support composition for administering one or more medicinal products. As described in the rejection above, Huron is not relied upon to teach the shape of the product. However, Huron does teach that the composition is molded (see figure 3). But, as described in the rejection above, Huron is not relied upon to teach the shape of the composition. With regard to the shape of product, which is molded around a medicinal product, Goldberg is further relied upon to teach the shape. Applicant further argues that there would be no motivation to modify the hardness taught by Huron to achieve the claimed hardness value because Huron provides no reason to mold the composition around a pill ort tablet. This is not found to be persuasive because Huron is a molded product and Huron teaches the composition may have different hardness (page 18 last paragraph). Per MPEP 2144.05(II)(A) "[W]here 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). Therefore, Huron clearly teaches a soft chew with a hardness value that be modified to the desire value. Thus, applicant argument is not found to be persuasive.
Next, applicant argues that the “knockout” method taught by Huron cannot achieve more complex structures such as the structure that is currently claimed. The applicant acknowledges that Huron teaches the size is adaptable to the organism for treatment and/or delivery of an appropriate amount of additive to the organism (page 5 last paragraph). As discussed briefly in the argument above, Huron is not relied upon to teach the shape of the composition. However, Huron’s disclosure that the composition’s size can be adaptable provides ample motivation to look to Goldberg to find the desired shape for the composition. Applicants argument is not found to be persuasive. ‘
Continuing, applicant argues that further reliance on Slusarczyk is misplaced. Applicant argues that a skilled artisan cannot simply extrapolate the cohesiveness value of the composition disclosed in Slusarczyk and modify Huron without also imparting other textural characteristics of the composition such as hardness. This argument is not found to be persuasive Slusarczyk teaches the claimed compression values from a TPA test and ample motivation to modify Huron by teaching cohesiveness directly impacts the gumminess and chewiness of the product ([0067]). Applicant is arguing the relationship between cohesiveness and hardness are critical and the cohesiveness value directly is impacted by the hardness value. However, applicant does not provide further data on the relationship between the two values. See MPE 2144.05(III)(A) In re Wells, 56 F.2d 674, 675, 12 USPQ 430 (CCPA 1932) ("Changes in proportions of agents used in combinations . . . in order to be patentable, must be critical as compared with the proportions of the prior processes."); Therefore, it is unclear if there is any criticality between the cohesiveness and hardness parameters and applicants argument is not found to be persuasive.
With regard to Slusarczyk applicant argues that if a skilled artisan were to use the teachings of Slusarczyk to perform the necessary modifications of Huron and achieve the claimed cohesiveness value, the resulting composition would also have the hardness value as disclosed in Slusarczyk. This argument is not found to be persuasive because, as discussed above, the applicant has not shown that the relationship between the cohesiveness value and the hardness value is critical.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Goldberg provides ample motivation to utilize this shape to be suitable for cats because the dimensions can be adapted to a particular patient or animal (Col 4, lines 6-8, Col 6, lines 42-44). In addition Huron clearly teaches the size is adaptable to the organism for treatment and/or delivery of an appropriate amount of additive to the organism (page 5 last paragraph). Therefore there is ample motivation to one with ordinary skill in the art to modify the composition taught by Huron to utilize the shape as taught by Goldberg. Therefore, applicants argument is not found to be persuasive.
Lastly, applicant argues that with regard to Claim 8 Niceron fails to provide any teachings of suggestions to modify the composition to arrive at the claimed shape, dimensions, and textural properties. With regard to Niceron, the reference is merely relied upon to teach where the protein source originates and is not relied upon to teach the claimed shape, dimensions, and textural properties. The reference provides ample motivation to utilize the protein sources taught by Niceron because the protein source are palatability-enhancing ingredients making the composition more desirable to pets and specifically cats. Therefore, applicant’s argument is not found to be persuasive.
Conclusion
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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/K.I.D./ Examiner, Art Unit 1792
/ERIK KASHNIKOW/ Supervisory Patent Examiner, Art Unit 1792
Prosecution Insights