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 .
Support for the amendments is within the instant application specification.
Applicant’s amendment to the claims filed on 5/4/2026 in response to the Non-Final Rejection mailed on 2/4/2026 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 are pending.
Claims 3-5, 7, 12-16, 18, 20, 24-25, 27, 29-30, 32, 34, 36, 39-56 are canceled.
Applicant’s remarks filed on 5/4/2026 in response to the Non-Final Rejection mailed on 2/4/2026 have been fully considered and are deemed persuasive to overcome at least one of the rejections and/or objections as previously applied.
The text of those sections of Title 35 U.S. Code not included in the instant action can be found in the prior Office Action.
Withdrawn Objections
The objection of claims 9, 28 because of the following informalities: ‘100 sec-1’ is withdrawn in view of Applicant’s amendment of claims 9, 28 to recite ‘100 sec-1 .
The objection to claim 56 under 37 CFR 1.75 as being a substantial duplicate of claim 38 is withdrawn in view of cancellation of claim 56.
Withdrawn Rejections
The 112(b) rejection of claim 8 is withdrawn in view of Applicant’s amendment of the claim to delete the recitation ‘is limited in.’
The 112(b) rejection of claim 9 is withdrawn in view of Applicant’s amendment of claim 9 to delete the recitation ‘does not vary more.’
The 112(b) rejection of claim 11 is withdrawn in view of Applicant’s amendment of claim 11 to delete the recitation ‘substantially.’
The 112(b) rejection of claim 26 is withdrawn in view of Applicant’s amendment of claim 26 to delete the recitation ‘90% of the method’ and ‘95% of the method.’
The 112(b) rejection of claim 28 is withdrawn in view of Applicant’s amendment of claim 28 to delete the recitation ‘of the method.’
The rejection of claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 31, 33, 35, 37-38, 56 under 35 U.S.C. 102(a)(2) as being anticipated by Buckley et al (WO 2021189115 A1, Date of Filing: 29 March 2021, cited on PTO-892 dated 2/4/2026) {herein Buckley} is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘wherein the input of energy disrupts non-covalent inter-molecular bonds that bind collagen to tissue’ and cancellation of claim 56.
The rejection of claims 28 under 35 U.S.C. 103 as being unpatentable over Buckley et al (WO 2021189115 A1, Date of Filing: 29 March 2021, cited on PTO-892 dated 2/4/2026) {herein Buckley} is withdrawn in view of Applicant’s amendment of claim 1 to recite ‘wherein the input of energy disrupts non-covalent inter-molecular bonds that bind collagen to tissue’ and cancellation of claim 56.
New 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6, 8, 11, 21-23, 26, 28, 31, 33, 35, 37-38 are newly rejected under 35 U.S.C. 102(a1) as being anticipated by Kim et al (2013, Food Science and Technology, Examiner cited) {herein Kim). The new rejection is necessitated by Applicant’s amendment of claim 1 to recite ‘wherein the input of energy disrupts non-covalent inter-molecular bonds that bind collagen to tissue.’
Claims 1-2, 6, 8, 11, 21-23, 26, 28, are drawn to a method for extracting collagen from isolated animal tissue, said method comprising: treating isolated animal tissue that comprises collagen with an input of energy in an aqueous medium, wherein the input of energy disrupts non-covalent inter-molecular bonds that bind collagen to tissue and wherein the temperature of the isolated animal tissue remains below a collagen denaturation temperature; and mechanically applying compression and shearing force to the treated isolated animal tissue in an aqueous medium, thereby separating a collagen-containing liquid fraction comprising extracted collagen from a solid fraction, wherein the compression and shearing force is conducted under controlled conditions of temperature and pressure 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 isolated from an animal tissue, wherein greater than about 50% of said isolated 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- 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 to claim 31.
With respect to claims 1-2, 6, 8, 11, 21-22, 23, 26, 28, 37-38 Kim teaches a method wherein collagen is extracted from skin, scales, bones and fins of fish via ultrasonic treatment (abstract, page 849, column 2, para 1). The samples were frozen sea bass (page 850, column 1, para 1). Samples were sliced into 1.0 X 1.0 cm segments (page 850, column 1, para 1) and placed in a 0.5 M NaCl solution and stirred for 10min (page 850, column 1, para 1). It is the Examiner’s position that the act of slicing necessarily includes a mechanical compression and a shearing force as slicing a material is essentially a localized combination of both mechanical compression and shearing. As such, it is the Examiner’s position that the teaching by Kim of ‘slicing’ is the same as the recited ‘mechanically applying compression and shearing force’ as recited in the instant application claims 1, 8. The precipitate was centrifuged and the process was repeated 3 additional times (page 850, column 1, para 1). All processes were performed at temperatures below 4C (page 850, column 1, para 1), thereby they are non-thermal, as recited in the instant application claim 2. It is the Examiner’s position that performing the collagen extraction at temperatures below 4C would necessarily result in at least about 5% of the extracted collagen in the collagen-containing liquid fraction being in a nondenatured form as 4C is well-below the temperature at which collagen denatures. Subsequently, an ultrasonic processor was used for ultrasonic treatment (page 850, column 1, para 2). The purified samples were soaked in 0.1, 0.05 or 0.01 M acetic acid with a sample/solution ratio of 1:200 (w/v, based on dry weight of the sample) (page 850, column 1, para 2). Collagen was subsequently extracted by ultrasonic treatment at a frequency of 20 kHz for 1-24h at 4C (page 850, column 1, para 2). Said ultrasonic treatment is inherently an input of energy that disrupts non-covalent inter-molecular bonds that bind collagen to tissue, as recited in the instant application claim 1. Kim further teaches to prevent an increase in temperature induced by the ultrasonic treatment, the sample jacket was cooled by a circulating water bath maintained at 4C (page 850, column 1, para 2). Collagen yields reached 90.4% after 24hr ultrasonic treatment (page 851, column 1, para 1). Said method does not comprise energy, chemical, and/or enzymatic conditions that intentionally denature or hydrolyze collagen, as recited in the instant application claim 23.
With respect to claims 31, 33, 35, Kim teaches collagen is extracted from skin, scales, bones and fins of fish via ultrasonic treatment (abstract, page 849, column 2, para 1), sliced into 1.0 X 1.0 cm segments (page 850, column 1, para 1), placed in a 0.5 M NaCl solution (page 850, column 1, para 1) and precipitated (page 850, column 1, para 1), resulting in a purified collagen sample (page 850, column 1, para 2). The purified collagen is greater than about 220kDa (fig 2). 80% of the isolated collagen was extracted by ultrasonication (fig, 2f). Since no heat and denaturing chemicals were applied to the animal tissue during isolation, it is the Examiner’s position that said extract would necessarily be nondenatured. Furthermore, since Kim teaches the structure of extracted collagen from animal tissue via ultrasonication, it is the Examiner’s position that the ultrasonic purification would necessarily result in at least about 5% of the extracted collagen being in the nondenatured form; and/or greater than about 50% of the extracted collagen in the nondenatured form. Kim further teaches the collagen is used in medical products, functional cosmetics and functional foods (page 849, column 2, para 1).
For the reasons stated herein, the teachings of Kim anticipate claims 1-2, 6, 8, 11, 21-23, 26, 28, 31, 33, 35, 37-38.
RESPONSE TO REMARKS: Beginning on p. 9 of Applicant’s remarks, Applicant in summary contends that the instant Applicant has been amended to require, in sequence, (1) subjecting isolated animal tissue in an aqueous medium to an input of energy (e.g., electric field and/or acoustic energy) under temperature conditions that do not raise the tissue or medium above about 30°C; and
(2) mechanically applying compression and shearing force to the tissue in the aqueous medium to separate a collagen-containing liquid fraction from a solid fraction, wherein at least about 5% of the extracted collagen in the liquid fraction is in a nondenatured form. Applicant contends that the Office Action's anticipation theory was directed primarily to "hydrodynamically shearing." Applicant contends that claim 1 positively recites a pretreatment step using an input of energy, followed by mechanically applying compression and shearing force to obtain a collagen-containing liquid fraction.
This argument is found to be moot in view of the new rejection set forth. Examiner contends that Kim anticipates a method of extracting collagen from isolated animal tissue via ultrasonication and the application of mechanical compression and a shearing force. It is noted that Examiner contends that as recited, the steps of (1) subjecting isolated animal tissue in an aqueous medium to an input of energy (e.g., electric field and/or acoustic energy) under temperature conditions that do not raise the tissue or medium above about 30°C; and (2) mechanically applying compression and shearing force to the tissue in the aqueous medium to separate a collagen-containing liquid fraction from a solid fraction, wherein at least about 5% of the extracted collagen in the liquid fraction is in a nondenatured form do not require the steps be completed in ‘sequential’ order because the specific sequence and inclusion of steps vary based on the raw material and desired purity.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 9-10, 17, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (2013, Food Science and Technology, Examiner cited) {herein Kim), as applied to claims 1-2, 6, 8, 11, 21-23, 26, 28, 31, 33, 35, 37-38, in view of Huang et al (2016, Food Chemistry, Examiner cited) {herein Huang}. The new rejection is necessitated by Applicant’s amendment of claim 1 to recite ‘wherein the input of energy disrupts non-covalent inter-molecular bonds that bind collagen to tissue.’
Claim 9 is drawn to the method of claim 1, wherein said mechanical compression and shearing force applied to the isolated animal tissue that comprises collagen comprises one or more of: (i) low shear extrusion, at about 100 sec-1 or less, through an extruder that comprises an inlet, a compression screw, a barrel, and a positive displacement pump, wherein the tissue is pumped through the barrel with the compression screw under pressure of about 10 psi to about 150 psi and under temperature conditions such that the difference in temperature between the inlet and outlet is less than about 20°C, wherein extruded material that flows through the outlet is further separated into the collagen-containing liquid fraction that comprises extracted collagen and the solid fraction; (ii) compression in a perforated compression cylinder, wherein the cylinder is compressed at a pressure of about 10 psi to about 150 psi and a cycle time of about 5 sec to about 30 sec, wherein the collagen-containing liquid fraction flows through perforations on the periphery of the cylinder; or (iii) processing through a dewatering press apparatus at a pressure of about 10 psi to about 150 psi and a residence de-watering time of about 5 sec to about 30 sec.
Claim 10 is drawn to the method of claim 9, wherein the collagen-containing liquid fraction and/or the solid fraction is further processed under the same or different conditions in the same or different apparatus to improve yield and/or purity of the extracted collagen.
Claim 17 is drawn to the method of claim 1, wherein prior to mechanically applying compression and shearing force to the isolated animal tissue, the isolated animal tissue is mechanically diced, macerated, minced or ground under low shear conditions; and/or is mechanically diced or minced having an average cross-sectional area of about 0.5 square inches to about 2 square inches.
Claim 19 is drawn to the method of claim 11, wherein prior to the input of energy, the isolated animal tissue is mechanically diced or ground into smaller pieces under low shear conditions; and/or the isolated animal tissue is mechanically diced or minced into pieces that comprise an average cross-sectional area of about 0.5 square inches to about 2 square inches.
The teachings of Kim as applied to claims 1-2, 6, 8, 11, 21-23, 26, 28, 31, 33, 35, 37-38 are set forth in the 102(a)(1) rejection above.
However, Kim does not teach the method of claim 9, wherein said mechanical compression and shearing force applied to the isolated animal tissue that comprises collagen comprises one or more of: (i) low shear extrusion, at about 100 sec-1 or less, through an extruder that comprises an inlet, a compression screw, a barrel, and a positive displacement pump, wherein the tissue is pumped through the barrel with the compression screw under pressure of about 10 psi to about 150 psi and under temperature conditions such that the difference in temperature between the inlet and outlet is less than about 20°C, wherein extruded material that flows through the outlet is further separated into the collagen-containing liquid fraction that comprises extracted collagen and the solid fraction; (ii) compression in a perforated compression cylinder, wherein the cylinder is compressed at a pressure of about 10 psi to about 150 psi and a cycle time of about 5 sec to about 30 sec, wherein the collagen-containing liquid fraction flows through perforations on the periphery of the cylinder; or (iii) processing through a dewatering press apparatus at a pressure of about 10 psi to about 150 psi and a residence de-watering time of about 5 sec to about 30 sec (claim 9). Kim does not teach the method of claim 10, wherein the collagen-containing liquid fraction and/or the solid fraction is further processed under the same or different conditions in the same or different apparatus to improve yield and/or purity of the extracted collagen (claim 10). Kim does not teach the method of claim 17, wherein prior to mechanically applying compression and shearing force to the isolated animal tissue, the isolated animal tissue is mechanically diced, macerated, minced or ground under low shear conditions; and/or is mechanically diced or minced having an average cross-sectional area of about 0.5 square inches to about 2 square inches (claim 17). Kim does not teach the method of claim 19, wherein prior to the input of energy, the isolated animal tissue is mechanically diced or ground into smaller pieces under low shear conditions; and/or the isolated animal tissue is mechanically diced or minced into pieces that comprise an average cross-sectional area of about 0.5 square inches to about 2 square inches (claim 19).
With respect to claims 9-10, Huang teaches a method wherein a novel extrusion–hydro-extraction (EHE) process is applied, under controlled conditions of temperature and pressure, for extraction of collagen from tilapia fish scale (abstract). Said extrusion is applied to aquatic collagen that is pretreated with NaOH (page 997, column 2, para 2; fig 1). Additionally, said method decomposes the intimate linkage between collagen and hydroxyapatite, and facilitates the release of collagen from fish scale extrudates by water extraction (page 998, column 1, para 3). It is the Examiner’s position that since the reference of Kim in view of Huang teaches a method of extracting aquatic collagen via extrusion, said method would necessarily result in separating a collagen-containing liquid fraction comprising extracted collagen from a solid fraction, as recited in the instant application claim 1. The extrusion was conducted at a temperature of 25C (sample FS14) (page 1001, column 2, para 1). Since the extrusion was conducted at 25C, which is below the temperature at which collagen denatures, it is the Examiner’s position that said extrusion would necessarily result in at least about 5% of the extracted collagen in the collagen-containing liquid fraction being in a nondenatured form. Said extruder is a model single screw
extruder equipped with a screw diameter of 74 mm, a barrel, a screw length to diameter (L/D) ratio of 3.07:1, and a rounded die opening at the end of the extruder (page 998, column 2, para 2). During the extrusion process, the collagen is partially dehydrated (page 998, column 1, para 2). It is the Examiner’s position that said extrusion device is the same as a dewatering press apparatus since it results in the partial dehydration of the collagen. Although the references of Kim in view of Huang do not explicitly teach the limitations of claim 9 (a dewatering press apparatus at a pressure of about 10 psi to about 150 psi and a residence de-watering time of about 5 sec to about 30 sec), 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 pressure and time of dewatering of the collagen depending on the particular application. It would be routine for one to arrive at the psi and time of dewatering for the application they intend on using the collagen. Therefore, the above invention would have been prima facie obvious. Said extrusion (dewatering press) further improves the yield of protein by 2-3 times over non-extruded samples (abstract)
With respect to claims 17, 19, Kim teaches a method wherein collagen is extracted from skin, scales, bones and fins of fish via ultrasonic treatment (abstract, page 849, column 2, para 1). The samples were frozen sea bass (page 850, column 1, para 1). Samples were sliced into 1.0 X 1.0 cm segments (page 850, column 1, para 1) and placed in a 0.5 M NaCl solution and stirred for 10min (page 850, column 1, para 1). It is the Examiner’s position that the act of slicing necessarily includes a mechanical compression and a shearing force as slicing a material is essentially a localized combination of both mechanical compression and shearing. As such, it is the Examiner’s position that the teaching by Kim of ‘slicing’ is the same as the recited ‘mechanically applying compression and shearing force’ as recited in the instant application claim 1. Although the reference of Kim does not explicitly teach the limitations of claims 17, 19 (is mechanically diced or minced having an average cross-sectional area of about 0.5 square inches to about 2 square inches), 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 size of the collagen pieces depending on the particular application. It would be routine for one to arrive at the size for the application they intend on using the collagen. Therefore, the above invention would have been prima facie obvious.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Kim et al of a method wherein collagen is extracted from skin, scales, bones and fins of fish by ultrasonic treatment (abstract, page 849, column 2, para 1) or combine the teachings of Huang of a method wherein a novel extrusion–hydro-extraction (EHE) process is applied, under controlled conditions of temperature and pressure, for extraction of collagen from tilapia fish scale (abstract).
One of ordinary skill in the art would be motivated to either use the teachings of Kim et al. by itself or combine the teachings of Huang because Huang provides Kim the motivation to extrude the collagen by hydro-extrusion because Huang teaches extrusion is widely used in the food industry,
and offers many advantages, such as ease of operation, continuous production, high yield, and little
waste (absent). Huang further teaches that extruded scale samples had a 2–3 times higher protein extraction yield than that of non-extruded scale samples (Huang: abstract). Huang would have a reasonable expectation of success to try extruding collagen after ultrasonication because doing do decomposes the intimate linkage between collagen and hydroxyapatite, and facilitates the release of collagen from fish scale extrudates by water extraction (page 998, column 1, para 3). The extrusion process may also alleviate the unpleasant smell of fish scale and obtain a weaker collagen odor (page 998, column 1, para 3).
One of skill in the art would have a reasonable expectation of success to make and use the claimed method for mechanically applying compression and shearing force in for form of extrusion to the treated isolated animal tissue in an aqueous medium, thereby separating a collagen-containing liquid fraction comprising extracted collagen from a solid fraction, because Kim provides the basic method of extracting collagen via ultrasonication and its uses and methods of making it. Reference of Huang teaches a method wherein a novel extrusion–hydro-extraction (EHE) process is applied, under controlled conditions of temperature and pressure, for extraction of collagen from tilapia fish scale (Huang: abstract). Therefore there would be a reasonable expectation of success to arrive at the above invention. 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.
RESPONSE TO REMARKS: Applicants remarks filed on 5/4/2026 have been fully considered; however, they are rendered moot in view of the new rejection set forth above, which is necessitated by Applicants’ amendment to the claims. Examiner contends that Kim anticipates a method of extracting collagen from isolated animal tissue via ultrasonication and the application of mechanical compression and a shearing force.
Conclusion
Status of Claims
Claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 28, 31, 33, 35, 37-38 are pending.
Claims 3-5, 7, 12-16, 18, 20, 24-25, 27, 29-30, 32, 34, 36, 39-56 are canceled.
Claims 1-2, 6, 8-11, 17, 19, 21-23, 26, 28, 31, 33, 35, 37-38 are rejected.
No claims are in condition for allowance.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
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