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
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Axelrod (US 2020/0146313 A1; May 14, 2020) in view of Buckley (WO 2021/189115 A1; Sept. 30, 2021) and Koller (US Patent No. 6,060,100; May 9, 2000).
Regarding claim 1, Axelrod discloses a method of preparing an edible pet chew product comprising a first component and a second component, wherein the first component can be strips of bovine fibrous connective tissue comprising collagen fibers and the second component can be strips of bovine internal organ tissue that can be stomach tissue ([0010]-[0015], [0021]-[0023]).
Axelrod further teaches that the second component is wrapped around the first component to form an assembled product (See Figures, [0023]).
Axelrod additionally teaches that the assembled product undergoes a drying operation to reduce the moisture and allow the two components to shrink fit together, which corresponds to applicant’s “curing” step ([0018]-[0020], [0046]-[0049]).
While Axelrod teaches providing collagen strips, Axelrod fails to teach that the collagen strips are formed by providing bovine leather, removing a plurality of hairs from the bovine leather, fleshing the bovine leather, separating collagen from the bovine leather, cleaning the separated collagen, and forming collagen strips from the clean separated collagen.
Buckley teaches a method of forming a collagen composition that can be used in animal food ([0051]), wherein the method comprises providing bovine tissue, removing a plurality of hairs from the bovine tissue ([0019]-[0020]), fleshing the bovine tissue (e.g. removing residual flesh and fat [0021]), separating collagen from the bovine skin ([0040]) by size reducing to form smaller pieces ([0019]-[0023], [0040]). With respect to cleaning the separated collagen, Buckley teaches the steps of dehairing and fleshing to produce a collagen composition and therefore it would have been obvious to one of ordinary skill in the art to further clean the separated collagen if needed so as to remove any undesired material from the collagen pieces. With respect to forming strips, Buckley teaches size reducing by cutting or tearing to produce any suitable size ([0040]). It would have been obvious to forms strips out of the collagen if such shape and size was desired (See MPEP 2144.04).
As Axelrod teaches providing bovine collagen strips, it would have been obvious to one of ordinary skill in the art to have the bovine collagen strips of Axelrod be made by the process of Buckley as Buckley teaches that a process comprising providing bovine skin, removing a plurality of hairs from the bovine skin, fleshing the bovine skin, separating collagen from the bovine skin, cleaning the separated collagen, and forming collagen strips from the clean separated collagen is an obvious and well known process in the art for producing a collagen composition. Axelrod teaches using collagen strips, but fails to specifically teach how the collagen strips were made and therefore it would have been obvious to make them according to the process of Buckley in order to predictably provide a bovine collagen composition that is ready for use.
While Buckley teaches providing bovine skin and not specifically the claimed “leather”, Buckley teaches that a tanned hide, e.g. leather, can be used depending on preference ([0012]). Buckley teaches that collagen can still be extracted form a tanned hide, or leather, but comprises higher levels of salt due to the curing process ([0012]). It would have been obvious to one of ordinary skill in the art to use bovine leather if desired, e.g. if a higher amount of salt and/or cured skin was desired, as it is still well known in the art to extract collagen from a tanned hide as taught by Buckley.
Axelrod teaches that the second component can be bovine stomach tissue ([0014]), but fails to specifically teach that the bovine stomach tissue is tripe.
Koller discloses a method of preparing a pet chew comprising providing bovine tripe, cleaning the tripe, forming the tripe into a plurality of pieces, and drying the formed tripe (See Figures, col 2 lines 5-45). Koller teaches forming into pieces before drying, however, it would have been obvious to change the order of forming and drying, such that the tripe is dried before forming into a plurality of pieces. Doing so would allow the dried tripe to be formed into any desired size/shape without further shrinking due to the drying process. As stated in MPEP 2144.04, selection of any order of processing steps is obvious absent a showing that the order produces a new or unexpected product over the prior art. In the instant case, changing the order of drying and forming is not expected to result in a different product. Further, Koller teaches forming into strips and not sheets, however, it would have been obvious to one of ordinary skill in the art to form the dried tripe into any desired size. Changing the size of the plurality of pieces is merely an obvious variant over the teachings of Koller as it would not result in a different product.
As Koller teaches that it is known in the art to use bovine tripe in a pet chew and Axelrod teaches that the second component comprises stomach tissue, it would have been obvious to one of ordinary skill in the art to have the second component of Axelrod be bovine tripe made by the process of Koller. This would predictably provide the method of Axelrod with stomach tissue that is well known in the art and suitable for use as a pet chew.
Therefore, as Axelrod teaches an assembled pet chew product comprising two components, a first component that is collagen and a second component wrapped around the first component, wherein the second component stomach tissue, it would have bee obvious to have the collagen of Axelrod made by the process of Buckley and the stomach tissue of Axelrod be tripe and made by the process of Koller for the reasons stated above, wherein such processes are well known in the art and suitable for making pet chew products.
Regarding claim 2, Axelrod teaches that the finished product is produced utilizing no artificial ingredients as Axelrod teaches that the pet chew contains natural components ([0003]).
Regarding claims 3-6, as stated above with respect to claim 1, Buckley teaches a method of fleshing the bovine skin, wherein the fleshing includes removing residual flesh and fat ([0021]). As both subcutaneous connective tissue and meat fall within the scope of “residual flesh”, it would have bene obvious to remove any fat, any meat and any subcutaneous connective tissue during the fleshing step of Buckley.
Regarding claim 7, Axelrod teaches that the collagen strips having an initial moisture content of 50-80%, which is higher than the claimed moisture content of about 35%. However, it would have been obvious to one of ordinary skill in the art to process the collagen in such a way to provide cleaned collagen having a desired moisture content. Buckley teaches that the collagen can be dried ([0019]) and therefore it would have been obvious to one of ordinary skill in the art to dry the cleaned separated collagen to result in a desired moisture content. Further, the examiner moisture content would have been obvious depending on the texture of the collagen. One of ordinary skill in the art can vary the processing conditions through routine experimentation to result in separated collagen having a moisture content of about 35%.
Further, as stated in MPEP 2144.05: Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
Regarding claims 8-9, Buckley teaches that the collagen can be dried ([0019]), but fails to teach the claimed moisture content. It would have been obvious to dry to any desired moisture content. One of ordinary skill in the art can vary the processing conditions through routine experimentation to result in dried collagen having a moisture content of about 20%.
With respect to the order of drying the cleaned separated collagen, wherein the drying is performed immediately after the cleaning step, it would have been obvious to one of ordinary skill in the art to dry the clean separated collagen of Buckley immediately after the cleaning step in order to result in a final collagen product having a desired moisture content. Buckley already teaches drying, and therefore changing the order of processing steps such that the drying occurs immediately after the cleaning step is obvious to one of ordinary skill in the art as it ensures the final product has the desired moisture content (See MPEP 2144.04: Change in order of processing steps).
Regarding claims 10-11, Axelrod teaches a drying step, wherein the formed collagen strips are dried to a moisture content of 0.1-20% by weight ([0019]). This step in Axelrod is considered to meet the claimed baking step, wherein the formed collagen strips are baked to having a moisture content of about 10%. The moisture content of Axelrod overlaps the claimed moisture content. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 12, the prior art as described above renders obvious an edible pet chew produced by the method of claim 1. The prior art renders obvious a product consisting of an elongated collagen stick, or strip, of bovine collagen (e.g. the first component in Axelrod), and a bovine tripe sheet that is wrapped around the elongated collagen stick (e.g. the second component in Axelrod: stomach tissue that can be bovine tripe as taught by Koller, see claim 1 above) (See Axelrod: [0010]-[0015], [0021]-[0023], Figures: See Koller: col 2 lines 5-45).
Axelrod further teaches that the second component, or tripe sheet, can have a moisture content ranging from 0.01-20% ([0020]), thus overlapping the claimed range of less than 10%. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791