Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claims 12-13 are canceled. Claim 23 is new. Claims 1-11 and 14-23 are pending and under consideration in this action.
Priority
All claims of the instant application are entitled to the effective filing date of 10/13/2020 because the priority document, GB2016195.6, filed on 04/10/2023 is in English.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-11, 14-16 and 20-21 are 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.
Claims 1 and 20 recite “a dehydrated collagen gel” in line 1, “partially hydrolyzed collagen” in line 3, and “fully hydrolyzed collagen” in lines 3-4. The claim term “dehydrated” and the term “hydrolyzed” refer to opposite physical states, rendering the structural limitations indefinite. The claimed product cannot be dehydrated and hydrolyzed at the same time.
Claims 2-11, 14-16 and 21 depend from claim 1 or 20 and are rejected for the reason set forth above.
The term “leather-like” in claims 20-21 is a relative term which renders the claims indefinite because it is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree of a leather-like characteristic, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Response to Arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
§112(b)
Applicant argues that paragraph [0015] of the instant specification discloses that collagen refers to the triple helix collagen protein. This triple helix collagen protein can be partially hydrolyzed to separate the three strands into the individual single strains, and the product so formed is known as partially hydrolyzed. Partially hydrolyzed collagen itself can be further hydrolyzed into peptides or amino acids, and the product so formed is fully hydrolyzed. See the remarks, the paragraph spanning p. 1-2. Therefore, in this context “hydrolyzed” refers to components which have been previously hydrolyzed (as compared to collagen itself), and it does not mean that the component cannot be dehydrated. Therefore, the terms “hydrolyzed” and “dehydrated” are not inconsistent. See the remarks p.2 paragraph 1.
This argument is not persuasive because “hydrolyzed” and “dehydrated” are opposite physical states of collagen. The plain meaning of “hydrolyzed collagen” is collagen that has been broken down as a result of a reaction with water, whereas the term “dehydrated” describes a state in which water is removed. In example 5, the instant specification teaches making biomaterial using partially hydrolyzed and fully hydrolyzed collagen. See [0105]. The specification teaches purchasing partially hydrolyzed and fully hydrolyzed collagen. See [0106]. The protein mixture is dissolved in water and sonicated. Glycerin and glutaraldehyde are added, and the solution is mixed before it is poured into a mold. Hydrogel forms at room temperature. See [0107]. Then in a separate step, the collagen hydrogel is dehydrated. See [0108]. The instant product claims require a biomaterial structure that is simultaneously a dehydrated collagen gel and a collagen gel that comprises (i) at least 30% by weight of a partially hydrolyzed collagen and (ii) a fully hydrolyzed collagen. Yet, based on the instant specification, those states do not occur simultaneously.
Applicant argues that the term “leather-like” is described in paragraph [0071] of the specification, where it states that a leather-like material which has physical properties similar to those of natural leather. Typically a leather-like material is strong and flexible. The leather-like material may exhibit no cracks when the material is double-folded. See the remarks p. 2 second to last full paragraph.
This argument is not persuasive because MPEP 2111.01(II) states that “[t]hough understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim”. The definition in paragraph [0071] is insufficient. As argued by Applicant, paragraph [0071] discloses that typically a leather-like material is strong and flexible. However it is unclear whether the claimed “leather-like” material is required to be strong and flexible. The specification does not set forth a definition of “leather-like” material, such that one of ordinary skill in the art can ascertain the metes and bounds encompassed by the term.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 6-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 6-7 fail to include all the limitations of the claim upon which it depends. Claim 1 requires a collagen composition comprising (i) at least 30% by weight of a partially hydrolyzed collagen and (ii) a fully hydrolyzed collagen. Claims 2 and 6-7 recite “one or a mixture of a collagen and/or fully hydrolyzed collagen” in lines 2-3. Therefore, claims 2 and 6-7 encompass collagen compositions that do not include fully hydrolyzed collagen and fail to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-8 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO 2020/169612, published August 27, 2020), with evidence from Rifleman (What is Drum Drying in Food Processing? 2025).
Regarding claims 1 and 3, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (i.e. fully hydrolyzed collagen) on dry basis of the composition and b. from 10 to 55 wt% dry basis of amorphous gelatin (i.e. partially hydrolyzed collagen), characterized in that the composition is non-agglomerated. See claim 1 of Wu and pages 2-3. Wu teaches that collagen may be processed to produce gelatin, which is obtained by irreversible, partial hydrolysis of collagen. The gelatin can be further hydrolyzed to shorter protein chains to produce collagen hydrolysate, losing its ability to form gel. See the last paragraph on page 3. Amorphous gelatin may be produced for example by drum drying (i.e. dehydration). See lines 20-21 on page 3.
As evidenced by Rifleman (p. 2 para. 1), drum drying causes dehydration.
Wu does not explicitly teach a collagen composition comprising at least 30% by weight of partially hydrolyzed collagen (relevant to instant claim 1). However, Wu teaches a 10 to 55 wt% of amorphous gelatin range that overlaps with at least 30% as instantly required.
Wu does not explicitly teach a collagen composition comprising from 50% to 95% by weight of partially hydrolyzed collagen (relevant to instant claim 3).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the 10 to 55 wt% workable range of the amorphous gelatin taught by Wu. One would be motivated to do so because Wu suggests that the gelling ability of the gelatin affects the texture of the product, and the texture is important for maintaining the shape of the product, maintaining the stability of the product, and for providing a certain hardness to the product (page 1 lines 25-29). There would be a reasonable expectation of success because the 10 to 55 wt% amorphous gelatin weight range taught by Wu includes a subrange of 50-55 wt%, which is at least 30% as required in instant claim 1, and within the 50-95% range of instant claim 3. MPEP 2144.05(I) indicates that “[i]n the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Regarding claim 2, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (i.e. fully hydrolyzed collagen) on dry basis of the composition, which is at least 5% by weight as required in instant claim 2. See claim 1 of Wu and pages 2-3.
Regarding claims 4-8, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (i.e. fully hydrolyzed collagen) on dry basis of the composition and b. from 10 to 55 wt% dry basis of amorphous gelatin (i.e. partially hydrolyzed collagen). See claim 1 of Wu and pages 2-3. Wu teaches a gelatin composition that is advantageous for use in various food products by providing high amount of collagen hydrolysate, while at the same time providing different texture possibilities. See page 6 lines 2-5. Wu discloses that collagen hydrolysate is a product of the hydrolysis of gelatin to the extent that it is no longer capable of gelling contrary to gelatin which as at least some gelling ability. This property of collagen hydrolysate (i.e. fully hydrolyzed collagen) limits its use in these applications where texture plays an important role. See lines 21-25 on page 1.
Wu does not teach a collagen composition that comprises from 70% to 95% by weight of partially hydrolyzed collagen (relevant to instant claim 4).
Wu does not teach a collagen composition that comprises from 80% to 95% by weight of partially hydrolyzed collagen (relevant to instant claim 5).
Wu does not teach a collagen composition comprising from 5% to 30% by weight of one or a mixture of collagen and/or fully hydrolyzed collagen (relevant to instant claim 6).
Wu does not teach a collagen composition comprising from 5% to 20% by weight of one or a mixture of collagen and/or fully hydrolyzed collagen (relevant to instant claim 7).
Wu does not teach a collagen composition that comprises from 5% to 30% by weight of fully hydrolyzed collagen (relevant to instant claim 8).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to increase the amorphous gelatin weight percentage taught by Wu (relevant to instant claims 4-5) and in the process decrease the collagen hydrolysate weight percentage taught by Wu (relevant to instant claims 6-8). One would be motivated to increase the amorphous gelatin (i.e. partially hydrolyzed collagen) weight percentage of Wu because Wu suggests that it is the gelling capability of the amorphous gelatin that allows the composition to provide different texture possibilities. There would be a reasonable expectation of success because Wu provides a starting amorphous gelatin concentration range from which one could reasonably optimize. In the process one would reasonably expect the collagen hydrolysate weight percentage to decrease because Wu teaches a composition characterized in that the weight percentages of the collagen hydrolysate (i.e. fully hydrolyzed collagen) and the amorphous gelatin (i.e. partially hydrolyzed collagen) amount to 100% of the composition. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “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).
Regarding claim 20-21, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (i.e. fully hydrolyzed collagen) on dry basis of the composition and b. from 10 to 55 wt% dry basis of amorphous gelatin (i.e. partially hydrolyzed collagen), characterized in that the composition is non-agglomerated. See claim 1 of Wu and pages 2-3. Wu teaches a gelatin composition that is advantageous for use in various food products by providing high amount of collagen hydrolysate, while at the same time providing different texture possibilities. See page 6 lines 2-5.
Wu does not explicitly teach a collagen composition comprising at least 30% by weight of partially hydrolyzed collagen (relevant to instant claim 20). However, Wu teaches a 10 to 55 wt% of amorphous gelatin range that overlaps with at least 30% as instantly required.
Wu does not teach a collagen composition that comprises from 5% to 30% by weight of fully hydrolyzed collagen (relevant to instant claim 21).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the 10 to 55 wt% workable range of the amorphous gelatin taught by Wu and to further decrease collagen hydrolysate weight percentage taught by Wu. One would be motivated to optimize the 10 to 55 wt% workable range of the amorphous gelatin taught by Wu, because Wu suggests that the gelatin affects the texture of the composition. There would be a reasonable expectation of success because the 10 to 55 wt% taught by Wu overlaps with at least 30% as instantly required. One would be further motivated to decrease the collagen hydrolysate percentage taught by Wu, because Wu suggests that collagen hydrolysate has limited use in applications where texture plays an important role because the collagen hydrolysate does not gel. There would be a reasonable expectation of success because Wu teaches a 45 to 90 wt% collagen hydrolysate percentage from which one could optimize. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “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).
Claims 9-11, 17, 19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO 2020/169612, published August 27, 2020), as applied to claims 1-8, 12 and 20-21 above, and further in view of Suzuki (JP 2008104398), with evidence from Rifleman (What is Drum Drying in Food Processing? 2025). The translation of Suzuki obtained from Espacenet is provided herein.
The teachings of Wu with respect to instant claims 1 and 12 are discussed above.
Claim Interpretation: The term “marine” recited claims 9-11, and 13 is interpreted in light of the specification, because the description in the specification. The specification teaches that “[f]or example the marine product may be any part of a marine animal which contains collagen. As used herein, a marine animal may be any animal that exists primarily or exclusively in a water-based environment, and may include animals that are found in freshwater environments as well as in oceans”. See p. 6 lines 10-13 of the specification. According to the specification the marine animal may be selected from a list that includes tilapia. See page 6 line 15.
Regarding claims 9-11, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (fully hydrolyzed collagen) on dry basis of the composition and b. from 10 to 55 wt% dry basis of amorphous gelatin (partially hydrolyzed collagen), characterized in that the composition is non-agglomerated. See claim 1 of Wu and pages 2-3. Gelatin is defined as the product obtained from acid, alkaline or enzymatic hydrolysis of collagen, the main protein component of the skin, bones and connective tissue of animals, including fish and poultry. See lines 30-33 on page 3. Wu teaches a gelatin composition that is advantageous for use in various food products by providing high amount of collagen hydrolysate, while at the same time providing different texture possibilities. See page 6 lines 2-5.
Wu does not teach at least one of the partially hydrolyzed collagen, collagen and fully hydrolyzed collagen that is extracted from a marine product (relevant to instant claim 9). However, Wu suggests that by definition gelatin can be obtained from fish.
Wu does not teach a marine product that is a freshwater fish product, a saltwater fish product, an invertebrate product or an arthropod product (relevant to instant claim 10).
Wu does not teach partially hydrolyzed collage that is partially hydrolyzed marine collagen (relevant to instant claim 11).
Suzuki teaches a gelatin that is obtained by drying a gelling-capable fish-derived gelatin raw material in an amorphous molecular state. See claim 4. In example 1, Suzuki teaches manufacturing gelatin from tilapia scales. See [0065]. During the process, Suzuki teaches applying a gelatin aqueous solution to a drum surface of a drum dryer and drying to obtain an amorphous sheet-like fish-derived gelatin (partially hydrolyzed collagen). See [0067]. Suzuki teaches fish-derived gelatin that has a practical jelly strength and is free from the opaque appearance and gritty feeling in the mouth when eaten. See [0001] and [0039]. Suzuki suggests that all types of fish, whether marine or freshwater, have a jelly strength that can be used. See [0044]. Suzuki teaches hydrolyzed gelatin obtained by partially hydrolyzing collagen and more preferably fish-derived collagen. See [0054].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to use the amorphous tilapia fish-derived gelatin of Suzuki as the amorphous gelatin (i.e. partially hydrolyzed gelatin) in the composition of Wu. Doing so is merely substituting one known amorphous gelatin for another. One would be motivated to do so because Suzuki suggests that such tilapia fish-derived gelatin does not have a gritty feeling in the mouth when eaten. There would be a reasonable expectation of success because Suzuki demonstrates obtaining an amorphous gelatin from tilapia and Wu teaches a composition comprising amorphous gelatin and collagen hydrolysate.
Regarding claim 17, Wu teaches a process to produce (i.e. form) a non-agglomerated gelatin composition comprising blending with 45 to 90 wt% of collagen hydrolysate and from 10 to 55 wt% of amorphous gelatin. See claim 9 of Wu. Wu teaches a composition that preferably has a moisture content of 2 to 8 wt%. See lines 27-28 on page 5.
Wu does not explicitly teach a collagen composition comprising at least 30% by weight of partially hydrolyzed collagen.
Wu does not teach dehydrating the collagen gel to form the biomaterial.
Suzuki teaches a method for producing fish-derived gelatin that dissolves in cold water and gels instantly, which method includes a drying and pulverizing step in which the gelling-capable fish gelatin is dried while remaining in an amorphous molecular state. See [0022]. Suzuki teaches applying a gelatin aqueous solution to a drum surface of a drum dryer and drying (i.e. dehydrating) to obtain an amorphous sheet-like fish-derived gelatin. See [0067]. For evidence that drum drying causes dehydration, see page 2 of evidentiary reference Rifleman.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to optimize the 10 to 55 wt% workable range of the amorphous gelatin taught by Wu, and to further apply the drying technique of Suzuki to the optimized non-agglomerated gelatin composition of Wu. One would be motivated to optimize the workable range of the amorphous gelatin (i.e. partially hydrolyzed gelatin) because Wu suggests that gelatin contributes to the texture of the product (page 1 lines 25-29). There would be a reasonable expectation of success because the 10 to 55 wt% amorphous gelatin weight range taught by Wu overlaps with at least 30% as instantly required. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “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). One would be further prompted and motivated to apply the drum drying technique of Suzuki because Wu suggests that the non-agglomerated composition preferably has a moisture content between 2-8wt%, and Suzuki suggests that such drying will not affect the amorphous molecular state. There would be a reasonable expectation of success because Suzuki demonstrates applying the drum drying technique to a applying the drum drying method to gelatin.
Regarding claim 19, in example 1, Suzuki teaches applying aqueous gelatin solution to the drum surface of a drum dryer and drying to obtain an amorphous sheet-like fish-derived gelatin. The obtained amorphous sheet-like fish-derived gelatin is then pulverized at a rotation speed of 14,000 rpm and passed through a 50-mesh sieve to obtain amorphous powdery fish-derived gelatin. See [0067]. Suzuki teaches a method comprising a drying and pulverizing step in which the gelling-capable fish gelatin is dried while remaining in an amorphous molecular state. See [0022].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to further apply Suzuki’s pulverization to the dried non-agglomerated gelatin composition of Wu and Suzuki discussed above. One would be motivated to do so, because Suzuki suggests that both the drying and pulverizing steps do not affect the amorphous molecular state. There would be a reasonable expectation of success because Suzuki demonstrates pulverizing an amorphous sheet-like fish-derived gelatin.
Regarding claim 22, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (fully hydrolyzed collagen) on dry basis of the composition and b. from 10 to 55 wt% dry basis of amorphous gelatin (partially hydrolyzed collagen). See claim 1 of Wu and pages 2-3. Wu discloses that collagen hydrolysate is a product of the hydrolysis of gelatin to the extent that it is no longer capable of gelling contrary to gelatin which as at least some gelling ability. This property of collagen hydrolysate (fully hydrolyzed collagen) limits its use in these applications where texture plays an important role. See lines 21-25 on page 1.
Wu does not teach a collagen composition that comprises from 5% to 30% by weight of fully hydrolyzed collagen.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to decrease the collagen hydrolysate weight percentage taught by Wu. One would be motivated to decrease the collagen hydrolysate percentage taught by Wu, because Wu suggests that collagen hydrolysate has limited use in application where texture plays an important role because the collagen hydrolysate does not gel. There would be a reasonable expectation of success because Wu teaches a 45 to 90 wt% collagen hydrolysate percentage from which one could optimize. MPEP 2144.05(II) indicates that differences in concentration generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “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).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO 2020/169612, published August 27, 2020), as applied to claims 1-8 and 12 above, and further in view of Lehmann (GB 216411).
The teachings of Wu with respect to instant claim 1 are discussed above.
Regarding claim 14, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (fully hydrolyzed collagen) on dry basis of the composition and b. from 10 to 55 wt% dry basis of amorphous gelatin (partially hydrolyzed collagen), characterized in that the composition is non-agglomerated. See claim 1 of Wu and pages 2-3. Amorphous gelatin is also referred to as cold soluble gelatin or instant gelatin and is able to be dissolved in cold water. See page 3 lines 18-20. Wu teaches a process for preparing a food product, which comprises combining with further food ingredients, pet food ingredients, cosmetic ingredients or pharmaceutical ingredients. See claim 13 of Wu.
Wu does not teach a collagen composition that further comprises an antifoam agent.
Lehmann teaches the use of amorphous gelatin has led to problems of clumping, poor dispersibility and/or foaming when the gelatin particles are mixed with cold water via simple mixing techniques such as stirring with spoon or fork. See page 1 lines 27-29. In example 2, Lehmann teaches preparing a cold-water soluble and dispersible, sugar-free gelatin dessert mix by blending ingredients including amorphous gelatin and antifoam <0.1 wt%. See page 3 lines 39-64. Lehmann suggests that functional ingredients can include antifoaming agents. See page 2 line 29.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the composition of Wu with the antifoam of Lehmann. One would be motivated to do so because Lehmann suggests that problems such as foaming can occur when using amorphous gelatin. There would be a reasonable expectation of success because Lehmann demonstrates combining an antifoam with amorphous gel to prepare a dessert (a food product) and Wu suggests combining the composition with additional food ingredients.
Regarding claims 15-16, in example 2, Lehmann teaches preparing a cold-water soluble and dispersible, sugar-free gelatin dessert mix by blending ingredients including amorphous gelatin and antifoam <0.1 wt%. See page 3 lines 39-64.
Wu and Lehmann do not teach an antifoam agent that is present in an amount from 0.001% to 5% w/w (relevant to instant claim 15) or from 0.1% to 2% w/w (relevant to instant claim 16).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the composition of Wu with the antifoam of Lehmann, as discussed above, and to further optimize the amount of the antifoam in view of the <0.1 wt% taught by Lehmann. A person of ordinary skill in the art has good reason to pursue the known options within their technical grasp. As such, one could reasonably add 0.1 wt% of antifoam in view of Lehmann and in the process arrive at a weight percentage that is within the instantly required 0.001% to 5% w/w (relevant to instant claim 15) and 0.1 to 2% w/v (relevant to instant claim 16) ranges, because the <0.1 wt% taught by Lehmann overlaps with the instantly claimed ranges.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO 2020/169612, published August 27, 2020), and Suzuki (JP 2008104398), as applied to claims 9-11, 13, 17 and 19 above, and further in view of Sano (JP 2001181580). Translation of Sano obtained from Espacenet and provided herein.
The teachings of Wu and Suzuki with respect to instant claim 17 are discussed above.
Regarding claim 18, Wu teaches a process to produce (form) a non-agglomerated gelatin composition comprising blending with 45 to 90 wt% of collagen hydrolysate and from 10 to 55 wt% of amorphous gelatin. See claim 9 of Wu. Wu teaches a composition that preferably has a moisture content of 2 to 8 wt%. See lines 27-28 on page 5.
Suzuki teaches that a water-soluble substance as a binder increases the speed at which the particles are wetted, resulting in granules with good dispersibility. See [0054]. Suzuki suggests that using a water-soluble substance as a binder promotes water dispersibility and can improve cold water solubility of gelatin. See [0015].
Wu and Suzuki do not teach a forming step comprising adding a fatliquoring component and/or a dye or pigment to the collagen composition.
Sano teaches a cold water-soluble granular gelatin obtained by granulating powdered amorphous gelatin using a water-soluble substance as a binder. See claim 1 of Sano. Sano discloses that examples of water-soluble substances that include dyes, e.g. Red No. 2, No. 3, No. 102, No. 105, No. 106, Yellow No. 4, No. 5, Blue No. 2, and the like. See [0020]. Sano teaches a granulation step in which powdered amorphous gelatin is mixed with an aqueous solution of a water-soluble substance of an appropriate concentration, followed by drying and granulation. See [0031]. Sano suggests that as the amount of water-soluble substance is increased the hygroscopicity of the granulated amorphous gelatin increases and fluidity decreases. See [0021].
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine the non-agglomerated gelatin composition of Wu with a water-soluble substance, including the dye of Sano, prior to applying the drum drying step of Suzuki. One would be prompted to include a water-soluble substance because Suzuki suggests that water-soluble substances can improve the cold water solubility of gelatin. One would be motivated to use a water-soluble substance taught by Sano because Sano teaches cold water-soluble granular gelatin. In the process, one could reasonably select dye as the water-soluble substance taught by Sano, because Sano teaches a finite list of water-soluble substances to choose from.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (WO 2020/169612, published August 27, 2020), as applied to claims 1-8 and 12 above, and further in view of He (Macromol. Res. 28, 861–868; published June 26, 2020).
Claim interpretation: instant claim 23 requires a collagen. According to the instant specification, collagen is a generic term for a family of at least 28 distinct collagen types, which are all characterized by a repeating triplet of amino acids, -(Gly-X-Y)n-. The structure may consist of entwined triple units of peptide chains. See p. 1lines 17-22.
Regarding claim 23, Wu teaches a composition characterized in that it comprises a. from 45 to 90 wt% collagen hydrolysate (i.e. fully hydrolyzed collagen) on dry basis of the composition and b. from 10 to 55 wt% dry basis of amorphous gelatin (i.e. partially hydrolyzed collagen), characterized in that the composition is non-agglomerated. See claim 1 of Wu and pages 2-3.
Wu does not explicitly teach a collagen composition comprising a collagen.
He teaches mixing a collagen solution and gelatin powder to obtain a gelatin-collagen mixed solution. See p. 862 section 2.2 paragraph 1. He suggests that the gelatin-collagen mixed solution has collagen-like assembly characteristics and kinetics. See the abstract.
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instantly claimed invention to combine Wu’s collagen hydrolysate (fully hydrolyzed collagen) and amorphous gelatin (partially hydrolyzed collagen) composition with He’s collagen solution based on He’s suggestion. One of ordinary skill in the art would have been motivated to do so because He suggests that gelatin-collagen mixed solution may have collagen-like assembly characteristics and kinetics. There would have been a reasonable expectation of success because Wu demonstrates a composition comprising amorphous gelatin, and He demonstrates mixing gelatin with the collagen solution.
Response to arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
§103 of claims 1-8, 12, 20 and 21 over Wu with evidence from Rifleman
Applicant argues that instant claim 1 differs from Wu in that the instant claim is directed to a dehydrated gel. See p. 3 paragraph 6 of the remarks.
This argument is not persuasive because Wu discloses that amorphous gelatin may be produced for example by drum drying (i.e. dehydration). See lines 20-21 on page 3. Therefore, the way in which the instantly claimed dehydrated collagen gel differs structurally compared to Wu’s drum dried amorphous gelatin is unclear based on Applicant’s argument.
Applicant argues that a biomaterial comprising at least 30% by weight of partially hydrolyzed collagen and which also comprises fully hydrolyzed collagen forms a dehydrated gel with excellent tensile strength. In table 1, the instant specification teaches entry 13 which tests 90% gelatin, 10% collagen hydrolysate and entry 14 which tests 80% gelatin and 20% collagen hydrolysate. Both possesses excellent tensile strength. See the paragraph spanning pages 3-4 of the remark.
This argument is not persuasive because it is not commensurate in scope with the instant claims. Table 1 (p. 37) entry 13 specifically describes a composition comprising 90% partially hydrolyzed marine collagen with 10% fully hydrolyzed marine collagen; and entry 14 specifically describes 80% partially hydrolyzed marine collagen with 20% fully hydrolyzed marine collagen. These entries are not commensurate in scope with the instant claims. Independent claim 1 does not limit the partially hydrolyzed collagen percentage to 90% or 80% as described in entries 13 and 14 respectively. Independent claim 1 does not limit the percentage of the fully hydrolyzed collagen component in anyway. Furthermore, claim 1 does not require the collagen to be marine collagen, as described in entries 13 and 14. As such, the results relied upon by Applicant are not commensurate in scope with the instant claims.
Applicant argues that Wu relates to the different technical field of food texturizing, and the skilled person seeking to prepare a gelled biomaterial would not have consulted Wu without the use of hindsight. See p. 4 paragraph 1 of the remarks.
This argument is unpersuasive because the teachings of Wu are not limited to food texturizing, as argued. Rather, Wu discloses that “[t]he invention is also useful in the production of pet food products, cosmetic products or pharmaceutical products”. See p. 1 lines 10-11 of Wu. Furthermore, in response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, every limitation is accounted for in the prior art, so nothing is gleaned from the instant disclosure.
Applicant argues that Wu describes a product that is non-agglomerated for use as a food texturing agent. This is very different from the claimed product where the collagen composition is in the form of a gel. See p. 4 paragraph 2.
This argument is not persuasive because the instant claims do not exclude non-agglomerated elements. Instant claim 1 recites the open-ended term “comprising” in line 2. Therefore, the claims encompass additional components not explicitly recited in the instant claims, such as non-agglomerated components.
Applicant argues that Wu teaches that collagen hydrolysate does not form gels. Therefore, the skilled person, starting from Wu, would not have been motivation to prepare a gel comprising fully hydrolyzed collagen and would not have a reasonable expectation that the gelled product comprising fully hydrolyzed collagen could be prepared. However, contrary to such expectation Applicant has found that such gels can be prepared. See the paragraph spanning p. 4-5 of the remarks.
This argument is not persuasive because Wu teaches a “gelatin composition” comprising collagen hydrolysate and amorphous gelatin. See claim 9 of Wu. A reference is presumed to be operable until applicant provides facts rebutting the presumption of operability. See MPEP 2121.
Applicant argues that Wu teaches that amorphous gelatin may be optionally prepared by drum drying. However, partially hydrolyzed collagen is not the only component in the claimed biomaterial or in the product of Wu, and Wu does not teach that the overall product is dehydrated. Wu teaches toward the use of drum dried amorphous gelatin as a component of the product, because of its ability to be dissolved in water. Therefore, this does not provide any teaching towards the preparation of a dehydrated gel product, and the skilled person would not arrive at the claimed dehydrated gel without the use of impermissible hindsight. See p. 5 paragraph 1.
This argument is not persuasive. The claim amendment filed 03/04/2026 clarified that the biomaterial composition comprises a dehydrated collagen gel. However, under the broadest reasonable interpretation, the claims encompass any extent of dehydration. Wu teaches amorphous gelatin produced by drum drying. See p. 3 lines 20-21. Thus, Wu suggests a collagen gel dehydrated via drum drying. Wu further teaches a composition comprising collagen hydrolysate and amorphous gelatin. See claim 1 of Wu. It is unclear, based on Applicant’s argument, how Wu’s composition as a whole cannot be considered dehydrated when a composition comprising collagen hydrolysate and a dehydrated amorphous gelatin is dehydrated compared to an equivalent composition that did not undergo any dehydration via the drum drying. Furthermore, the instant claims are composition claims, not product claims. Therefore, the instant claims do not require actively dehydrating the (i) partially hydrolyzed collagen and (ii) fully hydrolyzed collagen. Rather, the claims require the implied structure.
Applicant argues that a skilled person would not arrive at the claimed ranges without disregarding the teachings of Wu. See p. 6 paragraph 3 of the remarks.
This argument is not persuasive because MPEP 2144.05(II)(A) indicates that differences in concentration or temperature generally amount to “routine optimization” and will not support patentability unless there is evidence indicating the claimed feature is critical. “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).
Applicant argues that claims 20-21 are nonobvious over Wu. Wu does not mention leather-like materials. See p. 6 paragraph 4 of the remarks.
This argument is unpersuasive because the instant specification discloses that a leather-like material refers to a material which has physical properties similar to those of natural leather. See p.26 line 30 to p. 27 line 1. The instant specification discloses that natural leather is formed mainly of collagen. See p. 1 lines 16-17. Since Wu teaches a composition comprising collagen hydrolysate and amorphous gelatin (partially hydrolyzed collagen), the composition of Wu can reasonably be considered leather-like. Applicant has not pointed to a claimed structural component that distinguishes the claimed composition from that of Wu. Therefore, the argument is not persuasive.
§103 of claims 9-11, 13, 17, 19 and 22 over Wu in view of Suzuki with evidence from Rifleman
Applicant argues that Suzuki relates to a different technical field of food texturizing. See the paragraph spanning pages 6-7 of the remarks.
This argument is not persuasive because Suzuki is in the art of gelatin. As such, Suzuki is not disparate, as argued.
Applicant argues that Suzuki teaches that fish-derived gelatin has poor gel stability. See [0033] of Suzuki. Therefore, there is no motivation to combine the teachings of Wu and Suzuki. See p. 7 paragraph 1 of the remarks. Applicant argues that Suzuki describes that when fish gelatin is further hydrolyzed the product obtained does not gel. Therefore, a skilled person would not have any motivation to prepare a gel comprising fully hydrolyzed collagen and there would not have been a reasonable expectation that a gelled product comprising fully hydrolyzed collagen could be prepared. See p. 7 paragraph 2 of the remarks.
This argument is not persuasive because Suzuki teaches fish-derived gelatin that has a practical jelly strength and is free from the opaque appearance and gritty feeling in the mouth when eaten. See [0001]. Thus, Suzuki does not teach way from fish-derived gelatin. Furthermore, in example 1, Suzuki teaches applying a gelatin aqueous solution to a drum dryer and obtaining an amorphous sheet-like fish-derived gelatin. See [0067]. Thus, one could reasonably expect to obtain a gelatin based on the teachings and suggestions of Suzuki.
§103 of claims 14-16 over Wu in view of Lehmann
Applicant argues that the dependent claims 14-16 are nonobvious for at least the reasons set out above in relation to independent claim 1. Lehmann describes adding an antifoam agent to a gelatin dessert mix. However, it does not describe the preparation of a biomaterial comprising a collagen gel. See p. 8 paragraph 3 of the remarks.
This argument is not persuasive because claims 14-16 are composition claims not process claims. Therefore, Lehmann is not relied upon for describing a preparation of a biomaterial comprising a collagen gel, as argued.
§103 of claim 18 over Wu, Suzuki and further in view of Sano
Applicant argues that the dependent claim 18 is nonobvious for at least the reasons set out above in relation to independent claim 1. Sano describes adding a dye as an optional component to powdered gelatin. However, it does not describe the preparation of a biomaterial comprising a collagen gel. See the paragraph spanning p.8-9 of the remarks.
This argument is not persuasive because claim 18 is a composition claim not a process claim. Therefore, Sano is not relied upon for describing a preparation of a biomaterial comprising a collagen gel, as argued.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11, 14-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 18/855,134. Although the claims at issue are not identical, they are not patentably distinct from each other because the narrow scope of copending claims 1-25 of Ding ‘134 anticipates the instant claims.
Copending claim 1 recites a biomaterial comprising a dehydrated collagen gel wherein the collagen gel comprises: a. a collagen composition; and b. a polymer; wherein the collagen composition comprises: i. at least 30% by weight of partially hydrolyzed collagen; and ii. collagen and/or fully hydrolyzed collagen.
Copending claim 2 recites the biomaterial according to claim 1 wherein the collagen composition comprises at least 5% by weight of one or a mixture of collagen and/or fully hydrolyzed collagen.
Copending claim 3 recites the biomaterial according to claim 1 [[or 2]] wherein the collagen composition comprises from 50% to 95% by weight of partially hydrolyzed collagen.
Copending claim 4 recites the biomaterial according to claim 3 wherein the collagen composition comprises from 70% to 95% by weight of partially hydrolyzed collagen.
Copending claim 5 recites the biomaterial according to claim 4 wherein the collagen composition comprises from 80% to 95% by weight of partially hydrolyzed collagen.
Copending claim 6 recites the biomaterial according to claim 4 wherein the collagen composition comprises from 5% to 30% by weight of one or a mixture of collagen and/or fully hydrolyzed collagen.
Copending claim 7 recites the biomaterial according to claim 5wherein the collagen composition comprises from 5% to 20% by weight of one or a mixture of collagen and/or fully hydrolyzed collagen.
Copending claim 8 recites the biomaterial according to claim 1 wherein the collagen composition comprises from 5% to 30% by weight of fully hydrolyzed collagen, preferably wherein the collagen composition comprises from 5% to 20% by weight of fully hydrolyzed collagen.
Copending claim 9 recites the biomaterial according to claim 1 wherein the collagen gel comprises a polymer blend comprising the collagen composition and the polymer.
Copending claim 10 recites the biomaterial according to claim 9 wherein the polymer is selected from starch, pectin, alginate, chitosan, agarose, gellan gum, and gum arabic.
Copending claim 11 recites the biomaterial according to claim 1 wherein the collagen gel comprises a composite material comprising the collagen composition and the polymer.
Copending claim 12 recites the biomaterial according to claim 11 wherein the polymer is selected from cellulose fiber, cotton fiber, collagen fiber, and keratin fiber.
Copending claim 13 recites the biomaterial according to claim 12 wherein the cellulose fiber is microcellulose fiber or nanocellulose fiber.
Copending claim 14 recites the biomaterial according to claim 1 wherein the collagen composition further comprises an antifoam agent.
Copending claim 15 recites the biomaterial according to claim 14 wherein the antifoam agent is present in an amount from 0.001% to 5% w/w.
Copending claim 16 recites the biomaterial according to claim 15 wherein the antifoam agent is present in an amount from 0.1% to 2% w/w.
Copending claim 17 recites the biomaterial according to claim 1 wherein at least one of the partially hydrolyzed collagen, collagen and fully hydrolyzed collagen is extracted from a marine product.
Copending claim 18 recites a method for producing a biomaterial, the method comprising: a. forming a collagen gel comprising a collagen composition and a polymer wherein the collagen composition comprises: i. at least 30% by weight of partially hydrolyzed collagen; and ii. collagen and/or fully hydrolyzed collagen; and b. dehydrating the collagen gel to form the biomaterial.
Copending claim 19 recites the method according to claim 18 wherein the forming step comprises adding a fat-liquoring component and/or a dye or pigment to the collagen composition and/or polymer.
Copending claim 20 recites the method according to claim 18 wherein the method further comprises processing the biomaterial to form a processed biomaterial.
Copending claim 21 recites a leather-like processed biomaterial comprising a dehydrated collagen gel wherein the collagen gel comprises: a. a collagen composition; and b. a polymer; wherein the collagen composition comprises: i. at least 30% by weight of partially hydrolyzed collagen; and ii. collagen and/or fully hydrolyzed collagen.
Copending claim 22 recites the biomaterial according to claim 1 wherein the polymer does not contain collagen.
Copending claim 23 recites the biomaterial according to claim 1 further comprising a textile backing.
Copending claim 24 recites the biomaterial according to claim 8 wherein the collagen composition comprises from 5% to 20% by weight of fully hydrolyzed collagen.
Copending claim 25 recites the method according to claim 18 wherein the method further comprises adding a textile backing to the biomaterial.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
Provisional Double Patenting Rejection of claims 1-22
Applicant states that “Applicant is willing to submit a terminal disclaimer over the granted patent upon notification of allowance of the present claims”. See p. 9 paragraph 3 of the remarks.
Since no terminal disclaimer has been filed, the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIMBERLY C BREEN whose telephone number is (571)272-0980. The examiner can normally be reached M-Th 7:30-4:30, F 8:30-1:30 (EDT/EST).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/K.C.B./Examiner, Art Unit 1657
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