DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicants’ amendment to the claims filed on 10/2/2024 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 28, 31, 33, 35, 37-38, 56 are pending.
Claims 3-5, 7, 12-16, 18, 20, 24-25, 27, 29-30, 32, 34, 36, 39-55 are cancelled.
Priority
Acknowledgement is made of this national stage entry of PCT/US22/33374 filed on 6/14/2022 which claims domestic priority to U.S. application 18/568,728, filed on 6/14/2022 which claims domestic priority to provisional US application 63/210,483, filed on 6/14/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/7/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 12/8/2023 are acknowledged and accepted by the examiner.
Claim Objections
Claims 9, 28 are objected to because of the following informalities: ‘100 sec-1’ Appropriate correction is suggested.
Claim 56 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 38. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 8-9, 11, 19, 26, 28, 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.
The phrase “is limited in” in claim 8 is a relative phrase which renders the claim indefinite. The phrase “is limited in” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase " is limited in” is a relative term that renders the claim indefinite because it is unclear whether it is broad or limited. See MPEP § 2173.05(b) III A. Appropriate correction is suggested.
The phrase “does not vary more than about 20C” in claim 9 is a relative phrase which renders the claim indefinite. The phrase “does not vary more than about 20C” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase "does not vary more than about 20C” is a relative term that renders the claim indefinite because it is unclear whether it is broad or limited. See MPEP § 2173.05(b) III A. Appropriate correction is suggested.
The phrase “not substantially” in claim 11 is a relative phrase which renders the claim indefinite. The phrase “not substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The phrase " not substantially” is a relative phrase that renders the claim indefinite because it is unclear whether it is broad or limited. See MPEP § 2173.05(b) III A. Appropriate correction is suggested.
Regarding claim 26, the recitation of the phrases ‘90% of the method’ and ‘95% of the method’ are indefinite because it is unclear what the scope of the phrase is intended to encompass structurally. It is unclear what the ‘‘90% of the method’ and ‘95% of the method’ is intended to encompass. It is unclear from the claims and specification what the ‘90% of the method’ and ‘95% of the method’ is referring to structurally. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that applicant clarify the meaning of the claims.
Regarding claim 28, the recitation of the phrase ‘70% of the method’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally. It is unclear what the phrase ‘‘70% of the method’ is intended to encompass. It is unclear from the claims and specification what the phrase ‘70% of the method’ is referring to structurally. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that applicant clarify the meaning of the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 31, 33, 35, 37-38, 56 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Buckley et al (WO 2021189115 A1, Date of Filing: 29 March 2021, Examiner cited) {herein Buckley}.
Claims 1-2, 6, 8-11, 17, 19, 21-23, 26, are drawn to a method for extracting collagen from isolated animal tissue, said method comprising: mechanically and/or hydrodynamically shearing an animal tissue that comprises collagen in an aqueous media, thereby separating a collagen-containing liquid fraction comprising extracted collagen from a solid fraction, wherein the shearing is conducted under controlled conditions of temperature, pressure, and hydrodynamic energy such that at least about 5% of the extracted collagen in the collagen-containing liquid fraction is in a nondenatured form.
Claim 31 is drawn to a collagen-containing liquid prepared by the method of claim 1, wherein at least about 5% of the extracted collagen is in the nondenatured form; and/or greater than about 50% of the extracted collagen is in the nondenatured form.
Claim 33 is drawn to a composition comprising isolated collagen, wherein said isolated collagen is extracted collagen that is purified from the collagen-containing liquid according to claim 31; and the extracted collagen comprises a molecular weight greater than about 220 kDa.
Claim 35 is drawn to a composition comprising isolated collagen, wherein greater than about 50% of said collagen is in a nondenatured form comprising a molecular weight greater than about 220 kDa.
Claim 37 is drawn to a food, nutritional supplement, nutraceutical, animal feed, pharmaceutical dosing, drug delivery or gene carrier formulation, wound or burn care dressing, cosmetic additive in a gel, cream, salve, drop, ointment or topical dressing, cosmeceutical, collagen cell culture scaffold, cultivated meat or meat analogue, additive manufacturing 3-D printable matrix, 3-D bio-ink for tissue engineering, cell carrier, and/or medical device component, or container or packaging material, comprising a composition according to claim 33.
Claim 38 is drawn to a food, nutritional supplement, nutraceutical, animal feed, pharmaceutical dosing, drug delivery or gene carrier formulation, wound or burn care dressing, cosmetic additive in a gel, cream, salve, drop, ointment or topical dressing, cosmeceutical, collagen cell culture scaffold, cultivated meat or meat analogue, additive manufacturing 3-D printable matrix, 3-D bio-ink for tissue engineering, cell carrier, and/or medical device component, or container or packaging material, comprising a collagen- containing liquid according claim 31.
Claim 56 is drawn to a food, nutritional supplement, nutraceutical, animal feed, pharmaceutical dosing, drug delivery or gene carrier formulation, wound or burn care dressing, cosmetic additive in a gel, cream, salve, drop, ointment or topical dressing, cosmeceutical, collagen cell culture scaffold, cultivated meat or meat analogue, additive manufacturing 3-D printable matrix, 3-D bio-ink for tissue engineering, cell carrier, and/or medical device component, or container or packaging material, comprising a collagen- containing liquid according to claim 31.
With respect to claims 1-2, 23, Buckley teaches a method wherein animal tissue is contacted with high pressure potable water free of chemicals for producing a collagen composition (para 0036). Absent evidence otherwise, it is the Examiner’s position that the recited ‘hydrodynamically shearing’ in claim 1 of the instant application is the same as ‘contacted with high pressure potable water’ as taught by Buckley since both involve the breaking down of the animal tissue by the utilization of high pressurized water. Since the art teaches the structure of a method of extracting collagen from animal tissue via high pressure potable water (hydrodynamically shearing), it is the Examiner’s position that the method would necessarily result in separating a collagen-containing liquid fraction comprising extracted collagen from a solid fraction, as recited in claim 1 of the instant application. Furthermore, it is the Examiners position that the method would necessarily result in “one or more of the following conditions is met: a) greater than about 50% of the extracted collagen in the collagen-containing liquid fraction is in the nondenatured or hydrolyzed form; b) the extracted nondenatured collagen comprises a molecular weight greater than about 220 kDa; and/or c) at least about 5% of the extracted collagen in the collagen-containing liquid fraction is in a denatured or hydrolyzed form.”
With respect to claim 6, since the art teaches the structure of a method of extracting collagen from animal tissue via high pressure potable water ‘hydrodynamically shearing’, it is the Examiners position that the method would necessarily result in “the collagen-containing liquid fraction comprising greater than about 5% of the collagen content in the isolated animal tissue from which it is extracted.”
With respect to claim 8, Buckley teaches the degradation of collagen by enzymatic digestion (para 0013) with the teaching of the enzyme at least partially hydrolyzes the collagen (para 0013). As such, absent evidence otherwise, it is the Examiner’s position that the teaching of ‘at least partial enzymatic digestion of collagen,’ (para 0013) by Buckley is the same as the recited ‘enzymatic degradation of collagen is limited’ within the instant application claim 8. Furthermore, it is the Examiners position that the enzymatic digestion of collagen taught by Buckley would necessarily be ‘limited in comparison to an isolated animal tissue raw material that is not maintained at a temperature less than about 10C’ as recited in the instant application since Buckley teaches the structure of the partial enzymatic digestion of collagen from animal tissue (para 0013).
With respect to claim 11, Buckley teaches drying of the obtained collagen is carried out by microwave driers and radio frequency driers (para 0037). It is known by those of average skill in the art that radio frequency driers operate by subjecting materials to alternating electrical fields. As such, absent evidence otherwise, it is the Examiner’s position that the ‘alternating electrical fields’ applied by radio frequency are the same as ‘pulse electrical field’ recited within the instant application as both confer alternating electrical frequencies.
With respect to claims 9-10, 17, 19, Buckley teaches a method wherein animal tissue is dried in extruders and ground through a perforated plate prior to exposure to high pressure potable water (hydrodynamic shearing) thereby processing the tissue into smaller pieces (para 0037, 0040, 0042). Absent evidence otherwise, it is the Examiner’s position that grinding the animal tissue through a perforated plate is low-shear as it is known by those of ordinary skill in the art that said process exerts minimal force and reduced cellular strain. Additionally, since perforated plates are commonly utilized in the art for low shear extrusion, absent evidence otherwise, it is the Examiner’s position that Buckley teaches low shear extruders since Buckley teaches the utilization of extruders (para 0037) and perforated plates (para 0040) for the grinding of dried animal tissue (para 0042). The dried tissue may be processed by the same method multiple times to achieve the desired size (para 0042).
With respect to claims 21-22, Buckley teaches the animal tissue my comprise fish skin (para 0020).
With respect to claim 26, Buckley teaches a method wherein dehaired animal hides are freeze-dried for 2-4 days or until the dried animal tissue achieves a moisture content of less than or equal to 2% and/or a water activity less than or equal to 0.6 (para 0062). Absent evidence otherwise, it is the Examiner’s position that 2-3 days of freeze-drying the animal hide constitutes at least 95% of the method as Buckley teaches within 2hrs of slaughter, the hair is removed from the hide, soaked in a composition for 1hr, treated with portable water then freeze dried for 2-3 days or until the water content reaches the desires level (para 0062). It is the Examiner’s position that 2-3 days is consistent with the recitation ‘at least about 95% of the method is conducted at a temperature that does not exceed 30C.’
With respect to claims 31, 38, 56, Since the art teaches the structure of a method for extracting collagen from isolated animal tissue, it is the Examiners position that the at least about 5% of the extracted collagen is in the nondenatured form; and/or greater than about 50% of the extracted collagen is in the nondenatured form. Buckley further teaches said collagen in a pharmaceutical, nutraceutical or cosmetic composition (para 0054)
With respect to claims 33, 37, Buckley teaches collagen, in the form of gelatin, is extracted and purified from tissue (para 0013). Since the art teaches the structure of the collagen purified from animal tissue, it is the Examiners position that the extracted collagen would necessarily comprise a molecular weight greater than about 220 kDa. Buckley further teaches said collagen in a pharmaceutical, nutraceutical or cosmetic composition (para 0054)
With respect to claim 35, Buckley teaches dried animal tissue that is torn (para 0040). Absent evidence otherwise, it is the Examiner’s position that greater than 50% of said torn collagen would be nondenatured as said animal tissue has not been exposed to any denaturing environments that would result in more than 50% of the collagen being denatured. Since the art teaches the structure of the collagen from animal tissue, it is the Examiners position that the collagen would necessarily comprise a molecular weight greater than about 220 kDa. Especially since said collagen has not been exposed to any environments that would result in greater than 50% denaturation.
For the reasons stated herein, the teachings of Buckley anticipate claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 31, 33, 35, 37-38, 56.
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 28 is rejected under 35 U.S.C. 103 as being unpatentable over Buckley et al (WO 2021189115 A1, Date of Filing: 29 March 2021, Examiner cited) {herein Buckley}.
With respect to claim 28, Buckley teaches the animal tissues are cut (para 0040). Said method may comprise multiple passes to obtain the desired size (para 0040). Since said method may comprise multiple passes, it is the Examiner’s position that said step in the method is at least 70% of the method. Although the reference of Buckley does not explicitly teach the limitations of claim 28 (a mechanical shear rate that is below 100 see-1), MPEP 2144.05 states"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the mechanical shear rate depending on the particular application. It would be routine for one to arrive at the mechanical shear rate for the application they intend on using the collagen. Therefore, the above invention would have been prima facie obvious.
However, Buckley does not teach mechanically shearing (claim 28).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the manner at which the collagen is cut by applying mechanical shearing as it would result in uniform slices, increase yield and efficiency.
One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would be motivated to try mechanical shearing for processing the collagen fibers from animal tissue as it would allow for more rapid processing, uniformity in slices, reduced waste and greater structural integrity of the collagen product. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Status of Claims
Claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 28, 31, 33, 35, 37-38, 56 are pending.
Claims 3-5, 7, 12-16, 18, 20, 24-25, 27, 29-30, 32, 34, 36, 39-55 are cancelled.
Claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 28, 31, 33, 35, 37-38, 56 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656