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 .
Status of the Application
The claims filed 17 June 2025 have been entered. Claims 26-48 are pending. Claims 1-25 have been cancelled. The previous 112(b) rejections not repeated below have been withdrawn. The previous 103 rejection has been modified in view of Applicant’s amendments to the claims.
Claim Objections
Claims 31 and 42 are objected to because of the following informalities:
Claim 31, lines 4-5: both instances of “cm3” should read “cm3”
Claim 33, line 8: delete the “s” at the end of “numerals”
Claim 42, line 4: both instances of “cm3” should read “cm3”
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.
Claim 48 is 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 48 recites the limitation "the body" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 37, from which claim 48 depends, recites a sheet component, a porous material component and a final product of said edible pet chew. It is unclear on which body the ridge of claim 48 is found. The body of the sheet component, the body of the porous material component or the body of the final product of said edible pet chew. The specification indicates in one embodiment the sheet may have a continuous longitudinal ridge part attached to the sheet main body [0064]. For the purpose of examination, 48 will be interpreted as wherein said hot-melt-extrusion extruded starch-based sheet component has at least a longitudinal ridge running along the length of the body of the sheet.
Claim Interpretation
Claim 34, lines 3-4, recites “wherein at least a portion of said animal ingredient-based edible material portion is covered by said cellular material component without exposure.” The drawings, Figures 1-16, all depict configurations in which the inner layers are exposed to the outside world – air, light, moisture, etc.- either at the end of the pet chew or at the edge of the pet chew. For the purpose of examination, without exposure will be interpreted as where the inner core of animal ingredient-based edible material portion is covered at least partially by the cellular material component without total exposure of the inner core to the outside world.
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 26, 29, 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Pater (US 2019/0343078 A1).
Regarding claims 26 and 37, Pater discloses a pet chew product comprising a skin of a thermoplastic starch based material enveloping a core of a second thermoplastic starch based material, wherein the first and second thermoplastic starch based materials may be the same or different and the core has a density or hardness lower than the skin (Abstract). Pater discloses the pet chew is edible [0072]. Pater’s disclosure that the first and second thermoplastic starch based materials may be the same or different meets the claim limitations of “formed of a first extrudate” and “formed of a second extrudate, wherein said first extrudate and said second extrudate are separate extrudates”
Figure 5 (I) discloses the overall appearance of the product produced in Example 5, Sample 5.3 in a cross-section perpendicular to the flow direction. The material is regular in shape and size and the outside layer is completely regular in thickness [0077] and Figure 5 (I). Figure 5(I) also discloses the skin of the pet chew is tube shaped and the skin and the core are separate components.
Pater discloses the first thermoplastic starch material can comprise 30-95 wt% of a starch or a starch derivative [0037] and the starch may be potato starch (a plant starch) [0088], which meets the claim limitation of the starch based tube component comprising at least 20% plant starch by weight.
As to the claim language “hot melt extrusion extruded,” this is product by process claim language. 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. MPEP 2113 I. Additionally, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. MPEP 2112.01 I. In the instant case, Pater discloses extrusion molding as a process for producing a product in accordance with the invention [0028]. Pater discloses the thermoplastic starch melt can be made during an extrusion step using a twin-type extruder operating between 95 oC -180 oC [0103]. Pater discloses the pet chew extruded in an extrusion step which is the same as the extrusion used to create the thermoplastic starch (extrusion taking place between 95 oC -180 oC) [0104]. Pater’s disclosure of extrusion of the pet chew between 95 oC -180 oC meets the claim limitation of a “hot-melt-extrusion extruded” starch based component.
Pater discloses a process of making a pet chew by extrusion wherein the first thermoplastic forms the outer skin enveloping the inner core formed by the second thermoplastic starch melt [0064]. Pater discloses the second thermoplastic starch melt is allowed to produce a foamed or cellular core body [0066], which meets the claim limitation of a porous material component wherein said porous material component comprises numerous air bubbles interspersed into said porous material component . As seen in figure 5 (I), the foamed or cellular core is a separate component from the outer skin.
Pater discloses the second thermoplastic starch material can comprise 30-95 wt% of a starch or a starch derivative [0037] and the starch may be potato starch (a plant starch) [0088], which meets the claim limitation of the porous material component comprising at least 20% plant starch by weight.
As to the claim language “wherein said porous material component is prepared by an extrusion process or an injection process” this is product by process claim language. 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. MPEP 2113 I. Additionally, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. MPEP 2112.01 I. In the instant case, Pater discloses the pet chew of the disclosed invention can be made by any conventional method such as extrusion or injection molding [0127].
Pater discloses in Figure 5 (I) the hot-melt extrusion extruded starch based tube component and the porous material component are separate components used to form a final product of an edible pet chew wherein the hot-melt-extrusion extruded starch-based tube component and the porous material component are assembled together in a predetermined relationship, wherein in the assembly at least a portion of the porous material component is covered by the hot-melt-extrusion extruded starch based tube component. Pater also discloses the first and second thermoplastic starches are extruded in a way such that the first thermoplastic starch forms the outer skin enveloping the inner core formed by the thermoplastic starch [0064].
As to the claim limitations of:
-a hot melt extrusion extruded starch-based tube component being a separate component (lines2-3)
-a porous material component being a separate component (line 7)
-wherein said hot melt extrusion extruded starch based tube component and said porous material component are separate and distinct components to form a final product of said edible pet chew together and are separate and distinct components in the final product (lines 13-15)
Pater discloses Figure 5 (I) which discloses the overall appearance of the product produced in Example 5, Sample 5.3 in a cross-section perpendicular to the flow direction. The material is regular in shape and size and the outside layer is completely regular in thickness [0077] and Figure 5 (I). Pater discloses the first and second thermoplastic starch based materials may be the same or different and the core has a density or hardness lower than the skin (Abstract). Figure 5(I) also discloses the skin of the pet chew is tube shaped and the skin and the core are separate components.
Pater does not disclose making the components separately and then assembling them together. However, it is prima facie obvious to make separable that which the prior art discloses as continuous if it is considered desirable for any reason to have the components be separate, it would be obvious to do so. MPEP 2144.04 V. C.
As to the claim limitation “wherein said hot melt extrusion extruded starch based component is a long hollow object.” Pater discloses a pet chew which is a skin-core product with a skin thickness of 1.8 mm of a non-cellular material and the core consisting of a homogeneous foamed material. The outer shape is smooth and regular with the dimensions of 220 mm length, 20 mm width, 7.3 mm thickness [0137]. This meets the claim limitation of a long tube object. Pater does not disclose skin portion of the pet chew is hollow before it is filled with the foamed material. However, it is noted that the claims are drawn to the final product and not to the intermediate products or starting materials. The instant claims require in the final product that the ot-melt-extrusion extruded starch-based tube component and said porous material component are assembled together in a predetermined relationship, wherein in the assembly, at least a portion of said porous material component is covered by said hot-melt-extrusion extruded starch-based tube component. Patels skin-core pet chew of Figure 5 and [0137] meet the claim limitation of the final product where the tube/skin portion is wrapped about the foamed inner core.
As to the claim 37 limitation that the hot-melt extrusion extruded starch based component is a sheet as opposed to the tube of Pater, the selection of a change in shape is an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape is significant. MPEP 2144.04 IV. B.
Regarding claims 29 and 40, Pater discloses the first and second thermoplastic starch materials (hot-melt-extrusion extruded starch based tube/sheet and porous material component) comprise 30-95 wt% starch or starch derivative [0037] which overlaps with the claimed ranges of at least 50% plant ingredient totally by weight of the hot-melt-extrusion extruded starch based tube/sheet and cellular material component. 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.
Pater discloses the starch can be potato, wheat, corn, tapioca, rice and pea starch (plant ingredient) [0088]. Pater does not require rawhide as an ingredient in the pet chew and is therefore considered to be free of rawhide.
Claims 27, 28, 30, 31, 33-36, 38, 39, 41, 42 and 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Pater (US 2019/0343078 A1) as applied to claims 26 and 37 above, and further in view of Unlu (US 2006/0188611 A1).
Regarding claims 27 and 38, Pater discloses the pet chew of claims 26 and 37, as discussed above, including the inner core made of the porous material component.
Pater does not disclose an additional layer comprising an animal ingredient based edible material portion.
Unlu, in the field of pet chews, discloses a pet chew comprised of multiple layers wherein one layer may be a relatively light density inner layer enclosed by a smooth, dense outer layer [0054] and Figure 1, #20 and #22. Unlu discloses the pet chew comprises more than one layer [0017] and can be formed by extrusion [0026]. Unlu discloses the pet chew can comprise three layers [0017]. Unlu discloses that in the case of more than two layers the additional layers may be incorporated between the inner and outer layers [0134] and that the order of the layers may be changed depending upon the desired textural attributes of the pet chew [0094]. Unlu discloses the pet chew may be coextruded requiring at least two extruders with similar or different capabilities [0132].
Unlu discloses the pet chew comprises carbohydrates from 20-80% and the carbohydrate may comprise starch from 20-80%, which may be potato starch (plant ingredient) [0082], which results in a final starch content of 4-64% starch in the pet chew. Unlu discloses the pet chew comprises 5-50 wt% protein and the protein may be animal protein [0006] and [0008]. Unlu discloses the pet chew comprises 1-20% fat and the fat may be tallow, lard and/or butter (animal ingredients) [0088]. Unlu discloses the amount of the individual macronutrients in each layer can be similar in all the layer or the amounts may vary to alter the texture [0090].
Therefore a third layer of the pet chew disclosed by Unlu can comprise 5-50 wt% animal based protein and 1-20 wt% animal based fat, for a total of 6-70 wt% animal based ingredient, which overlaps with the claimed range of the animal ingredient based edible material portion comprises at least 10% animal ingredient by weight. 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.
Unlu discloses a two layered pet chew where one layer is infilled inside another layer (Figure 1, #20 and #22). Unlu discloses these layers can be co-extruded [0050]. Unlu discloses the pet chew can comprise three layers [0017]. Unlu discloses that in the case of more than two layers the additional layers may be incorporated between the inner and outer layers [0134].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the pet chew of Pater with the third layer of animal based ingredients of Unlu because both are drawn to pet chews with multiple layers, comprising plant starch and a low density inner core relative to a higher density outer skin. Unlu discloses it is appropriate to include multiple other layers in the pet chew, including one comprising animal based ingredients.
One of ordinary skill in the art would have had a reasonable expectation of success because both Pater and Unlu are drawn to pet chews with high density outer layers and lower density inner layers and Unlu discloses multiple additional layers are appropriate for pets.
As to the claim language “obtained by a co-extrusion process together forming a co- extruded composite material, wherein said porous material component is pretreated by hot melt extrusion process and said animal ingredient-based edible material portion is pretreated by cold extrusion process before their being co-extruded together” this is product by process claim language. 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. MPEP 2113 I. Additionally, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. MPEP 2112.01 I.
In the instant case, Unlu discloses the layers may be co-extruded to form a composite material [0050] [0132] and Figure 1. Unlu further discloses extrusion temperature is critical for monitoring and controlling the pet chew cooking process. Independent temperature control of each section of the extruder is desirable, including a temperature range from 40-140oC [0135]. Unlu’s temperature range in separate extruder sections ranging from 40-140oC would allow for either hot or cold extrusion for any of the disclosed layers. Including an animal ingredient based edible portion and a cellular material component, which Pater discloses can be prepared from a thermoplastic starch melt [0094].
Regarding claims 28 and 39, Pater discloses the edible pet chew of claims 26 and 37, as discussed above, including the hot-melt-extrusion extruded starch based tube/sheet component (outer skin of Pater) and the porous material component (core of Pater). Pater discloses the pet chew has an outer skin having a first density enveloping an inner core having a second density that is lower than that of the outer skin [0029] and the pet chew inner core and outer skin may be extruded [0061]. Pater discloses the outer skin consists of non-cellular material [0137], which meets the claim limitation of being generally free of air bubbles.
Pater does not disclose a bulk density of said high-density tube/sheet component is at least 10% larger than that of said extruded cellular low-density plant-based material component.
Unlu, in the field of pet chews, discloses a pet chew comprised of multiple layers wherein one layer may be a relatively light density inner layer enclosed by a smooth, dense outer layer [0054] and Figure 1, #20 and #22. Unlu discloses the pet chew comprises more than one layer [0017] and can be formed by extrusion [0026]. Unlu discloses the pet chew comprises carbohydrates from 20-80% and the carbohydrate may comprise starch from 20-80%, which may be potato starch (plant ingredient) [0082], which results in a final starch content of 4-64% starch in the pet chew.
Unlu discloses further distinction between the layers may be achieved by expanding the product inside [0056] and the two components, or layers, of the product have different densities and at least one of the two components has a density that is at least 10% greater than that of the other component [0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the layered pet chew with a low density core of Pater with the layered pet chew of Unlu with a low density inner layer and at least 10% greater density outer skin because both are drawn to pet chews with multiple layers, comprising plant starch and a low density inner core relative to a higher density outer skin.
One of ordinary skill in the art would have had a reasonable expectation of success because both Pater and Unlu are drawn to pet chews with high density outer layers and lower density inner layers and Unlu discloses a greater than 10% difference in density between the layers is appropriate for pets.
Unlu’s disclosure of a pet chew with a light density inner layer enclosed by a smooth, dense outer layer [0054] where one layer has a density at least 10% greater than that of the other component combined with the pet chew of Pater meets the claim limitation of: wherein a bulk density of said hot melt extrusion extruded starch based tube/sheet component is at least 10% larger than that of said porous material component.
Regarding claims 30 and 41, Pater discloses the porous material component (inner core) as discussed in claims 26 and 37 above. Pater further discloses the inner core is extruded [0064] and the outer skin of a first thermoplastic starch material having a first density or hardness, enveloping an inner core of a second thermoplastic starch material having a second density or hardness that is lower than that of the outer skin [0029]. Pater discloses the thermoplastic starch material of the second layer comprises starch from 30-95 wt% [0037] and can further comprise animal oils and fats (animal ingredient) up to 10 wt% [0098]. These disclosures of Pater meet the claim limitations of: wherein said porous material component is an extruded porous animal ingredient-based material component and wherein said extruded porous animal ingredient-based material component comprises substantially at least 10% animal ingredient and 5%-49.9% plant ingredient by weight.
The up to 10 wt% animal oils and fats of Pater overlaps with the claimed range of at least 10% animal ingredient and the 30-95% starch overlaps with the claimed range of 5-49.9 wt% plant ingredient. 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.
Pater does not require rawhide as an ingredient, and therefore the extruded porous animal ingredient-based component is free considered free of a rawhide ingredient.
Pater does not disclose a bulk density of said hot-melt-extrusion extruded starch based tube/sheet component is at least 10% larger than that of said extruded porous animal ingredient based material component.
Unlu, in the field of pet chews, discloses a pet chew comprised of multiple layers wherein one layer may be a relatively light density inner layer enclosed by a smooth, dense outer layer [0054] and Figure 1, #20 and #22. Unlu discloses the pet chew comprises more than one layer [0017] and can be formed by extrusion [0026]. Unlu discloses the pet chew comprises carbohydrates from 20-80% and the carbohydrate may comprise starch from 20-80%, which may be potato starch (plant ingredient) [0082], which results in a final starch content of 4-64% starch in the pet chew.
Unlu discloses further distinction between the layers may be achieved by expanding the product inside [0056] and the two components, or layers, of the product have different densities and at least one of the two components has a density that is at least 10% greater than that of the other component [0052].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the layered pet chew with a low density core of Pater with the layered pet chew of Unlu with a low density inner layer and at least 10% greater density outer skin because both are drawn to pet chews with multiple layers, comprising plant starch and a low density inner core relative to a higher density outer skin.
One of ordinary skill in the art would have had a reasonable expectation of success because both Pater and Unlu are drawn to pet chews with high density outer layers and lower density inner layers and Unlu discloses a greater than 10% difference in density between the layers is appropriate for pets.
Unlu’s disclosure of a pet chew with a light density inner layer enclosed by a smooth, dense outer layer [0054] where one layer has a density at least 10% greater than that of the other component combined with the pet chew of Pater meets the claim limitation of: wherein a bulk density of said hot-melt-extrusion extruded starch based tube/sheet component is at least 10% larger than that of said extruded porous animal ingredient based material component.
Regarding claims 31 and 42, Pater discloses the pet chew of Figure 5(I) is maximal regular in shape and size and the outside layer (high density tube/sheet component) is completely regular in thickness [0077], which meets the claim limitation of wall thickness substantially homogeneous throughout the material.
Pater discloses the outer skin envelopes the inner core and the inner core has a lower density than that of the outer skin [0029].
Pater does not disclose the densities of the inner core and the outer skin.
Unlu, in the field of pet chews, discloses a pet chew comprised of multiple layers wherein one layer may be a relatively light density inner layer enclosed by a smooth, dense outer layer [0054] and Figure 1, #20 and #22. Unlu discloses the pet chew comprises more than one layer [0017] and can be formed by extrusion [0026]. Unlu discloses the pet chew comprises carbohydrates from 20-80% and the carbohydrate may comprise starch from 20-80%, which may be potato starch (plant ingredient) [0082], which results in a final starch content of 4-64% starch in the pet chew.
Unlu discloses further distinction between the layers may be achieved by expanding the product inside [0056] and the two components, or layers, of the product have different densities [0052]. Unlu disclose the pet chew comprises a density of 0.9-1.5 g/cm3 [0020]. Unlu does not disclose the specific densities of each layer, aside from the preference that a relatively light density inner layer be enclosed by a smooth, dense outer layer [0054].
One of ordinary skill in the art would have been led by Unlu to create a pet chew with at least two layers, each layer having a density which falls within the disclosed density range of 0.9-1.5 g/cm3 of Unlu in order to achieve the final bulk density of the pet chew as disclosed by Unlu. The density disclosed by Unlu overlaps with the claimed ranges of 0.8-2 g/cm3 and 0.15-1 g/cm3. 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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the layered pet chew with a low density core of Pater with the layered pet chew of Unlu with the disclosed densities because both are drawn to pet chews with multiple layers, comprising plant starch and a low density inner core relative to a higher density outer skin.
One of ordinary skill in the art would have had a reasonable expectation of success because both Pater and Unlu are drawn to pet chews with high density outer layers and lower density inner layers and Unlu teaches the disclosed densities are appropriate for pets.
Regarding claims 33 and 44, Pater discloses the extruded porous plant based material component is wrapped about by said hot-melt-extrusion extruded starch-based tube/sheet component. Pater also discloses wherein cross section outline shape of said hot-melt-extrusion extruded starch-based tube/sheet component is a rectangular shape (Figure 5(I) and [0064]). Pater discloses the outer skin of the pet chew has a thickness of 0.3-10mm [0036].
Pater does not disclose the proportion of said hot-melt-extrusion extruded starch-based tube/sheet component to said extruded porous plant-based material component is in the range between 1:20 and 30:1 by weight in finished product.
Unlu, in the field of pet chews, discloses a pet chew comprised of multiple layers wherein one layer may be a relatively light density inner layer enclosed by a smooth, dense outer layer [0054] and Figure 1, #20 and #22. Unlu discloses the pet chew comprises more than one layer [0017] and can be formed by extrusion [0026]. Unlu discloses the pet chew comprises carbohydrates from 20-80% and the carbohydrate may comprise starch from 20-80%, which may be potato starch (plant ingredient) [0082], which results in a final starch content of 4-64% starch in the pet chew.
Unlu discloses further distinction between the layers may be achieved by expanding the product inside [0056] and the two components, or layers, of the product have different densities and at least one of the two components has a density that is at least 10% greater than that of the other component [0052].
Unlu discloses the pet chew comprises two layer in which the relative weight ratios are 5:95% to about 95:5%, which is equivalent to 1:19 to 19:1, which overlaps with the claimed range of between 1:20 and 30:1. 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.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the layered pet chew with a low density core of Pater with the layered pet chew of Unlu with disclosed ratio of layers because both are drawn to pet chews with multiple layers, comprising plant starch and a low density inner core relative to a higher density outer skin.
One of ordinary skill in the art would have had a reasonable expectation of success because both Pater and Unlu are drawn to pet chews with high density outer layers and lower density inner layers and Unlu discloses the disclosed proportions of layers are appropriate for pets.
Regarding claims 34 and 45, Pater in view of Unlu discloses the pet chew of claims 27 and 38, as discussed above, including an animal ingredient-based edible material layer, a porous material component and a hot melt extrusion extruded starch based tube/sheet component.
Unlu, in the field of pet chews, further discloses a pet chew comprised of multiple layers wherein one layer may be a relatively light density inner layer enclosed by a smooth, dense outer layer [0054] and Figure 1, #20 and #22. Unlu discloses a two layered pet chew where one layer is infilled inside another layer (Figure 1, #20 and #22). Unlu discloses these layers can be co-extruded [0050]. Unlu discloses the pet chew can comprise three layers [0017]. Unlu discloses that in the case of more than two layers the additional layers may be incorporated between the inner and outer layers [0134] and that the order of the layers may be changed depending upon the desired textural attributes of the pet chew [0094]. Unlu discloses the pet chew may be coextruded requiring at least two extruders with similar or different capabilities [0132].
Unlu’s disclosure of three layers where the order of layers may be changed, the layers may be co-extruded and incorporated between the inner and outer layers and the image of a pet chew in Figure 1 meet the claim limitation of: wherein said animal ingredient-based edible material portion is wrapped about by said porous material component, wherein at least a portion of said animal ingredient-based edible material portion is covered by said cellular material component without exposure.
As to the claim language: wherein each of said hot-melt-extrusion extruded starch-based tube/sheet component, said cellular material component and said animal ingredient-based edible material portion provides their respectively different functions that can be distinctly defined to final product, wherein said hot-melt-extrusion extruded starch-based tube/sheet component provides primary chewing durability function to final product, wherein said porous material component provides tooth cleaning function with its porous structure to final product, and wherein said animal ingredient-based edible material portion provides concealed attractant function to final product, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. MPEP 2112.01 I. In the instant case Pater in view of Unlu discloses the composition of the instant claims, therefore the product of the prior art also provides the claimed durability layer, tooth cleaning layer and attractant layer.
Additionally, Pater discloses the soft core allows further penetration of the teeth into the underlying material and the resulting friction between tooth surface and pet chew skin results in strong mechanical interaction with the surface of the pet's teeth over its entire length. A pet chew product of the present invention is therefore very effective in removing plaque, or even tartar and stain from the teeth of an animal, even at the difficult-to-reach locations at the base of the teeth [0081]. Pater also discloses the pet chew has a high density outer layer [0021] which would provide primary chewing durability compared to the lower density inner core of Pater.
Regarding claims 35 and 46, Pater in view of Unlu discloses the multi-layered pet chew of claims 34 and 45 as discussed above.
Unlu further discloses the pet chew comprises carbohydrates from 20-80% and the carbohydrate may comprise starch from 20-80%, which may be potato starch (plant ingredient) [0082], which results in a final starch content of 4-64% starch in the pet chew. Unlu discloses the pet chew comprises 5-50 wt% protein and the protein may be animal protein [0006] and [0008]. Unlu discloses the pet chew comprises 1-20% fat and the fat may be tallow, lard and/or butter (animal ingredients) [0088]. Unlu discloses the amount of the individual macronutrients in each layer can be similar in all the layer or the amounts may vary to alter the texture [0090].
Therefore a third layer of the pet chew disclosed by Unlu (the animal ingredient based edible material portion) can comprise 5-50 wt% animal based protein and 1-20 wt% animal based fat, for a total of 6-70 wt% animal based ingredient, which overlaps with the claimed range of the animal ingredient based edible material portion comprises a total animal ingredient proportion by weight greater than any single non-animal ingredient. 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 claims 36 and 47, Pater discloses the edible pet chew of claims 26 and 37 as discussed above.
Pater does not disclose an edible material component formed from a flavored material comprising a plant ingredient and a flavor ingredient selected from a meat ingredient, a meat by-products ingredient, a chicken liver, a hydrolyzed animal protein, a poultry digest, a chicken digest, an artificial beef flavor, an artificial pork flavor and a brewer yeast.
Unlu, in the field of pet chews, discloses a pet chew comprised of multiple layers wherein one layer may be a relatively light density inner layer enclosed by a smooth, dense outer layer [0054] and Figure 1, #20 and #22. Unlu discloses the pet chew comprises more than one layer [0017] and can be formed by extrusion [0026]. Unlu discloses the pet chew comprises carbohydrates from 20-80% and the carbohydrate may comprise starch from 20-80%, which may be potato starch (plant ingredient) [0082], which results in a final starch content of 4-64% starch in the pet chew.
Unlu discloses further distinction between the layers may be achieved by expanding the product inside [0056] and the two components, or layers, of the product have different densities and at least one of the two components has a density that is at least 10% greater than that of the other component [0052].
Unlu further discloses the pet chew comprises an edible coating (an edible material component formed from a flavored material), wherein the coating comprises corn zein (plant ingredient) and natural or artificial flavor where the natural or artificial flavor may be selected from beef, chicken, chicken liver or pork [0025]. Unlu discloses the coating gives the pet chew an appealing sheen [0118]. The coating of Unlu comprising corn zein and beef, chicken, chicken liver and/or pork flavor meets the claim limitation of: wherein said flavored material is formed from a plant-based material comprising a plant ingredient and a flavor ingredient.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combined the layered pet chew with a low density core of Pater with the layered pet chew of Unlu comprising the coating of Unlu because both are drawn to pet chews with multiple layers, comprising plant starch and a low density inner core relative to a higher density outer skin and Unlu discloses the coating provides and alluring sheen.
One of ordinary skill in the art would have had a reasonable expectation of success because both Pater and Unlu are drawn to pet chews with high density outer layers and lower density inner layers and Unlu discloses the coating is appropriate and appealing for pets.
Claims 32 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Pater (US 2019/0343078 A1) as applied to claims 26 and 37 above, and further in view of Unlu (US 2006/0188611 A1) as evidenced by Duarah et al. (Humectants up shelf life of foods by lowering microbial activity, July 2020, https://fnbnews.com/Top-News/humectants-up-shelf-life-of-foods-by-lowering-microbial-activity-59432).
Regarding claims 32 and 43, Pater discloses the hot-melt-extrusion extruded starch based tube/sheet component of claims 26 and 37 as discussed above. Pater discloses the first thermoplastic starch mixture comprises 30-95 wt% starch which is extruded to form a thermoplastic starch based melt [0062] and [0064] which is then extruded to form the outer skin of the pet chew. This disclosure by Pater meets the claim limitation of: wherein said hot-melt-extrusion extruded starch-based tube/sheet component is formed from a first starch-based composite, wherein said first starch-based composite comprises at least 20% plant starch ingredient.
Pater discloses the starch can comprise potato, wheat, corn, tapioca, rice and pea starches [0088].
Pater discloses the extruded porous plant-based material component of claims 28 and 39 as discussed above. Pater discloses the second thermoplastic starch mixture comprises 30-95 wt% starch which is extruded to form a thermoplastic starch based melt [0063] and [0064] which is then extruded to form the inner core of the pet chew. This disclosure by Pater meets the claim limitation of: wherein said extruded porous plant-based material component is formed from a second starch-based composite, wherein said second starch-based composite comprises a plant starch ingredient.
Pater discloses the starch can comprise potato, wheat, corn, tapioca, rice and pea starches [0088].
Pater discloses the starch of either layer of the pet chew can be mixed with a plasticizer including sorbitol or glycerol [0095]. As evidenced by Duarah et al. sorbitol and glycerol are commonly used humectants in food (p4, para 2).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Pater (US 2019/0343078 A1) as applied to claim 37 above, and further in view of Barnvos (WO 2015/138938 A1).
Regarding claim 48, Pater does not disclose at least a longitudinal ridge part running along the length of the body.
Barnvos, in the field of pet chews, discloses pet chews comprising edible starch from plants [0008]. Barnvos discloses the shape of the chews, such as including ridges, can enhance dental efficacy and their attractiveness as chewing substrates for animals [0019].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the pet chew of Pater with the ridges on a pet chew of Barnvos because Barnvos discloses the ridges are advantageous for enhancing dental efficacy and improving the attractiveness of the chewing substrate.
As to the claim limitation that the ridge be longitudinal, Barnvos does not disclose the directionality of the ridges. However, changes of shape are a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape is significant. MPEP 2144.04 IV. B.
Response to Arguments
Applicant's arguments filed 17 June 2025 have been fully considered. To the extent they apply to the above rejection they are not persuasive.
Applicant states claim 34 was amended to delete the phrase “without exposure” in order to overcome the previous 112(b) rejection. Remarks p20.
This amendment seems to have been overlooked and the previous 112(b) rejection of claim 34 has been maintained.
Applicant argues claims 26 and 37 are drawn to pet chews made of two separate components (Aspect 1 and Aspect 2 presented on p23) which are assembled together in a certain relationship. While Aspect 3 and Aspect 4 (not claimed) are co-extruded plural layer structured components which are an indivisible whole. Applicant argues Pater teaches away from Aspects 3 and 4. Remarks pp22-25.
This argument is not persuasive. No substantial argument is presented with respect to the prior art. Applicant aims to point out that the starch based tube component and the porous material component are separate components assembled together. As addressed in the rejection above, Pater discloses the pet chew with the outer skin in a tube shape and an inner porous core. Pater discloses Figure 5 (I) which discloses the overall appearance of the product produced in Example 5, Sample 5.3 in a cross-section perpendicular to the flow direction. The material is regular in shape and size and the outside layer is completely regular in thickness [0077] and Figure 5 (I). Pater discloses the first and second thermoplastic starch based materials may be the same or different and the core has a density or hardness lower than the skin (Abstract). Figure 5(I) also discloses the skin of the pet chew is tube shaped and the skin and the core are separate components. Pater does not disclose making the components separately and then assembling them together. However, it is prima facie obvious to make separable that which the prior art discloses as continuous if it is considered desirable for any reason to have the components be separate, it would be obvious to do so. MPEP 2144.04 V. C.
Arguments with respect to Pater and Aspects 3 and 4 will not be addressed since, as Applicant notes, Aspects 3 and 4 are not claimed.
Applicant goes on to define and explain extrusion, injection molding and coextrusion. Applicant argues that the coextrusion and injection molding of Pater do not produce a pet chew made of separate components as claimed. Remarks pp25-33.
This argument is not persuasive. As discussed above, if the coextrusion and/or injection molding of Pater did not produce a pet chew made of two separate components it would still be prima facie obvious to make separable that which the prior art discloses as continuous if it is considered desirable for any reason to have the components be separate, it would be obvious to do so. MPEP 2144.04 V. C.
Applicant goes on to define “sheet” and “tube.” Applicant argues whether the pet chew member is a tube should be determined by whether or not the object has a hollow body and no by the cross-section outline shape. The skin of Pater is not a tube nor a thin flat sheet. Remarks pp33-39.
This argument is not persuasive. As discussed above, Pater discloses a pet chew which is a skin-core product with a skin thickness of 1.8 mm of a non-cellular material and the core consisting of a homogeneous foamed material. The outer shape is smooth and regular with the dimensions of 220 mm length, 20 mm width, 7.3 mm thickness [0137]. This meets the claim limitation of a long tube object. Pater does not disclose skin portion of the pet chew is hollow before it is filled with the foamed material. However, it is noted that the claims are drawn to the final product and not to the intermediate products or starting materials. The instant claims require in the final product that the hot-melt-extrusion extruded starch-based tube component and said porous material component are assembled together in a predetermined relationship, wherein in the assembly, at least a portion of said porous material component is covered by said hot-melt-extrusion extruded starch-based tube component. Pater’s skin-core pet chew of Figure 5 and [0137] meets the claim limitation of the final product where the tube/skin portion is wrapped about the foamed inner core. Additionally, as discussed above, the selection of a change in shape is an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape is significant. MPEP 2144.04 IV. B. Applicant has presented no persuasive evidence that the particular shape is significant.
Applicant argues Pater’s pet chew is a single indivisible piece while the pet chew of the invention is made of separate components. Applicant argues the skin of Pater is neither a hollow tube nor a thin flat object. Remarks pp39-44.
This argument is not persuasive for the same reasons discussed above. If the coextrusion and/or injection molding of Pater did not produce a pet chew made of two separate components it would still be prima facie obvious to make separable that which the prior art discloses as continuous if it is considered desirable for any reason to have the components be separate, it would be obvious to do so. MPEP 2144.04 V. C.
Pater discloses a pet chew which is a skin-core product with a skin thickness of 1.8 mm of a non-cellular material and the core consisting of a homogeneous foamed material. The outer shape is smooth and regular with the dimensions of 220 mm length, 20 mm width, 7.3 mm thickness [0137]. This meets the claim limitation of a long tube object. Pater does not disclose skin portion of the pet chew is hollow before it is filled with the foamed material. However, it is noted that the claims are drawn to the final product and not to the intermediate products or starting materials. The instant claims require in the final product that the hot-melt-extrusion extruded starch-based tube component and said porous material component are assembled together in a predetermined relationship, wherein in the assembly, at least a portion of said porous material component is covered by said hot-melt-extrusion extruded starch-based tube component. Pater’s skin-core pet chew of Figure 5 and [0137] meets the claim limitation of the final product where the tube/skin portion is wrapped about the foamed inner core. Additionally, as discussed above, the selection of a change in shape is an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape is significant. MPEP 2144.04 IV. B. Applicant has presented no persuasive evidence that the particular shape is significant.
Applicant argues Pater fails to teach separate components. Applicant argues Pater’s disclosure deters or discourages separate components. Pater encourages only a single processing step, which is interpreted as Pater discouraging pet chews made with multiple processing steps. Pater goes on to further encourage a single processing cycle. Remarks pp44-47.
This argument is not persuasive for the same reasons discussed above. If the coextrusion and/or injection molding of Pater did not produce a pet chew made of two separate components it would still be prima facie obvious to make separable that which the prior art discloses as continuous if it is considered desirable for any reason to have the components be separate, it would be obvious to do so. MPEP 2144.04 V. C.
Applicant argues Pater’s pet chew is a single indivisible piece while the pet chew of the invention is made of separate components. Applicant argues the skin of Pater is neither a hollow tube nor a thin flat object. Remarks pp47-49.
This argument is not persuasive for the same reasons discussed above. If the coextrusion and/or injection molding of Pater did not produce a pet chew made of two separate components it would still be prima facie obvious to make separable that which the prior art discloses as continuous if it is considered desirable for any reason to have the components be separate, it would be obvious to do so. MPEP 2144.04 V. C.
Pater discloses a pet chew which is a skin-core product with a skin thickness of 1.8 mm of a non-cellular material and the core consisting of a homogeneous foamed material. The outer shape is smooth and regular with the dimensions of 220 mm length, 20 mm width, 7.3 mm thickness [0137]. This meets the claim limitation of a long tube object. Pater does not disclose skin portion of the pet chew is hollow before it is filled with the foamed material. However, it is noted that the claims are drawn to the final product and not to the intermediate products or starting materials. The instant claims require in the final product that the hot-melt-extrusion extruded starch-based tube component and said porous material component are assembled together in a predetermined relationship, wherein in the assembly, at least a portion of said porous material component is covered by said hot-melt-extrusion extruded starch-based tube component. Pater’s skin-core pet chew of Figure 5 and [0137] meets the claim limitation of the final product where the tube/skin portion is wrapped about the foamed inner core. Additionally, as discussed above, the selection of a change in shape is an obvious matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape is significant. MPEP 2144.04 IV. B. Applicant has presented no persuasive evidence that the particular shape is significant.
Conclusion
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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/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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