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 1, 3-4, 6, 8-9, 16, and 19-26 are pending and under examination on their merits.
Response to Arguments
Applicant's arguments filed 6/4/2026 have been fully considered but they are not persuasive.
Applicant argues against the rejection of claims under 35 U.S.C. 103 on the grounds that Takeuchi teaches an additional step of washing the collagen fibers with an organic solvent, an alcohol ([0014]-[0016]), prior to drying the fibers, whereas the claimed method does not include a step of washing the protein material with an organic solvent (Arguments, page 7, paragraph 2).
In response, this argument is unpersuasive because the claimed method is open (recites the open transitional phrase “comprising”). Therefore, the claimed method does not exclude additional steps of washing the protein material with an organic solvent.
Applicant argues against the rejection under 35 U.S.C. 103 on the grounds that Yaari’s Young’s Modulus appears to reach a maximum of 4 GPa at a draw ratio of 1:8.1 and decreases at higher draw ratios (Arguments, page 7, bottom paragraph).
In response, the Young’s Modulus is a property of the protein material that results from performing the claimed method steps. Here, the claimed method is obvious over Takeuchi in view of Ahmed et al. (American Journal of Physiology-Cell Physiology 320.6 (2021): C1112-C1124; first published April 14, 2021), Li, and Yaari, thus the protein material necessarily has the required Young’s Modulus. Furthermore, even if the Young’s Modulus of Yaari reaches a maximum of 4 GPa at a draw ratio of 1:8.1, a Young’s Modulus of 4 GPa is a value approaching the claimed range of 4.5 GPa to 8 GPa.
Claim Objections
Applicant is advised that should claims 3, 6, 8-9, and 16 be found allowable, claims 20 and 22-26 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. 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
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.
(New Rejection Necessitated by the Amendment) Claims 1, 3-4, 6, 8-9, 16, and 19-26 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 19 recite the broad recitation “wherein the water-based medium does not contain an organic solvent,” and the claim also recites “wherein the water-based medium consists of ultrapure water, pure water or distilled water,” which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 1 and 19 further recite an definite range, “wherein the elastic modulus of the protein material is 4.5 GPa to 8 GPa or higher.” It is unclear whether the alternative “higher” refers to 4.5 GPa or 8 GPa.
Claims 1 and 19 are further indefinite for the limitation “homogenizing a solution containing a protein raw material in phosphate buffered saline under cooling.” There are at least two different reasonable interpretations of this limitation, rendering the claims indefinite. In one interpretation, the solution contains the protein raw material and phosphate buffered saline and homogenizing is performed while cooling the solution. In a second interpretation, the step of homogenizing the solution containing the protein raw material is performed under cooling and in phosphate buffered saline. Under the second interpretation, cooled phosphate buffered saline could be the outer jacket of a sample tube placed in a homogenizer (i.e. the solution itself does not contain the phosphate buffered saline).
Claim 21 depends from cancelled claim 17, thus rendering the claim indefinite.
Claims 3-4, 6, 8-9, 16, and 20-26 are rejected for depending from a rejected base claim and not rectifying the source of indefiniteness discussed above.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following rejections are necessitated by the amendment.
Claims 1, 3-4, 6, 8-9, and 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. (JPH0835193; cited on the IDS filed 5/17/2024) in view of Ahmed et al. (American Journal of Physiology-Cell Physiology 320.6 (2021): C1112-C1124; first published April 14, 2021), Li et al. (Materials Science and Engineering: C 29.5 (2009): 1643-1649) and Yaari et al. (ACS Biomaterials Science & Engineering 2.3 (2016): 349-360) and as evidenced by Shetty et al. (Journal of clinical orthopaedics and trauma 7.3 (2016): 164-169).
Takeuchi teaches a method for obtaining collagen fibers comprising discharging a solubilized collagen dissolved in an acidic aqueous solution in fixed amounts from a spinneret into a concentrated salt solution in a spinning bath ([0011]). The pH of the acidic aqueous solution is from pH 1.5 to 5.0, although the exact pH depends on the isooelectric point of the collagen used ([0011]). The concentrated salt solution is aqueous and does not contain organic solvents ([0012]). Takeuchi teaches removing the fibers and then drying the collagen fibers under reduced pressure to obtain a collagen fiber nonwoven sheet ([0025]). Takeuchi teaches preparing a homogeneous collagen solution ([0011]) at 0 °C to 35 °C ([0012]), thus Takeuchi teaches homogenizing the collagen solution while cooling (any temperature less than room temperature involves cooling). The collagen fibers obtained are in the form of a gel ([0014]). Takeuchi teaches that the collagen concentration is 0.5 to 10 wt% ([0011]), which overlaps with the claimed range of 1 to 2 wt%.
Takeuchi’s collagen is atelocollagen ([0024]), which is a type I collagen as evidenced by Shetty (page 169, left column, first full paragraph).
The pH of the acidic aqueous solution comprising solubilized collagen is less than the claimed range of 7.0 to 8.0.
Takeuchi does not teach the solution containing the solubilized collagen in
Takeuchi does not teach dispersing the solution containing the protein raw material into pure water.
Ahmed teaches forming collagen I fibers by rapidly bringing a cold neutralized collagen solution to physiological temperatures through the addition of water (page C1118, left column, bottom paragraph).
Li teaches that the fibrillogenesis of collagen fibers is pH-dependent, and that fibrillogenesis rate increases with increasing pH from 6.6 to 9.2 (Abstract). Lower pH results in small fibrils with a smaller diameters and higher pH results in larger diameter fibrils (Abstract). Li teaches phosphate-buffered saline at a pH of 7.4 (page 1644, left column, 2. Materials and methods paragraph 1). Li then adjusts the pH with NaOH prior to fibrillogenesis (page 1644, left column, 2.1 Effect of pH on kinetics of fibrillogenesis).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Takeuchi by mixing the cooled homogenous collagen solution of Takeuchi with Li’s phosphate-buffered saline at pH 7.4 to produce a cold neutralized collagen solution and then discharging the solution into a water bath at physiological temperature in order to produce collagen fibers. The person of ordinary skill in the art would have been motivated to do so because Ahmed teaches forming collagen fibers without relying on a concentrated salt bath. The person of ordinary skill in the art would have had a reasonable expectation of success in the modification based on the teachings of Ahmed and Li.
Takeuchi does not teach the speed of dispensation is 0.1 mL/min to 10 mL/min (100 µL/min to 10,000 µL/min).
However, Yaari teaches that the draw ratio, which is the ratio of the injection rate to the take-up rate by the spool (Figure 1 caption), controls the mechanical properties of the fiber, including the Young’s Modulus (Figure 5B). Yaari also produces an undrawn fiber by injecting at a rate of 30 µL/min (page 350, right column, bottom paragraph).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the injection rate (“speed of dispensation”) relative to the take-up rate by routine experimentation in order to control the mechanical properties of the resulting fibers. The person of ordinary skill in the art would have had a reasonable expectation of success given that the draw ratio (the ratio of the injecting velocity to take-up velocity) is a results-effective variable (see Figure 5B).
Regarding the elastic modulus of the protein material, this is an inherent characteristic of the protein material that directly results from performing the claimed method steps.
Regarding the purity of the water, although Ahmed does not specify the purity of water, Yaari teaches washing collagen fibers with purified water (page 351, left column, paragraph 3).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to discharge the collagen solution into purified water (“pure water”) in order to avoid introducing any contaminants into the collagen fiber. The person of ordinary skill in the art would have had a reasonable expectation of success in dispensing the collagen solution into pure water.
Claim 21 is interpreted as depending from claim 1.
Regarding claims 3-4 and 20-21, Takeuchi teaches that the spinning temperature is 10 °C to 40 °C ([0012]), which overlaps with the claimed range of 4 °C to 53 °C. Takeuchi teaches that the temperature of the collagen acidic solution is 0 °C to 35 °C ([0012]), which overlaps with the claimed range of 4 °C to 37 °C.
However, these temperatures pertain to the collagen acidic solution and the concentrated salt bath (spinning bath).
Ahmed teaches forming collagen I fibers by rapidly bringing a cold neutralized collagen solution to physiological temperatures through the addition of water (page C1118, left column, bottom paragraph).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the temperature of the collagen solution as well as the water bath in the method of Takeuchi modified by Ahmed, Li, and Yaari. The person of ordinary skill in the art would have had a reasonable expectation of success given that Ahmed already gives guidance regarding the temperature of both the collagen solution and the temperature of the water.
Regarding claims 6 and 22, Takeuchi obtains collagen fibers, so the protein material is a fibrous material. Takeuchi also prepares a nonwoven sheet from the fibers ([0025]), so the material is a sheet-like material.
Regarding claims 8 and 23, Takeuchi’s collagen is atelocollagen ([0024]), which is a type I collagen as evidenced by Shetty (page 169, left column, first full paragraph).
Regarding claims 9 and 24, Takeuchi teaches drying the collagen fibers under reduced pressure to obtain a collagen fiber nonwoven sheet ([0025]).
Claim 16 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Takeuchi et al. (JPH0835193; cited on the IDS filed 5/17/2024) in view of Ahmed et al. (American Journal of Physiology-Cell Physiology 320.6 (2021): C1112-C1124; first published April 14, 2021), Li et al. (Materials Science and Engineering: C 29.5 (2009): 1643-1649) and Yaari et al. (ACS Biomaterials Science & Engineering 2.3 (2016): 349-360) as evidenced by Shetty et al. (Journal of clinical orthopaedics and trauma 7.3 (2016): 164-169), as applied to claims 1, 3-4, 6, 8-9, and 19-24 above, and further evidenced by Central Infusion Authority (2026, website).
See discussion of Takeuchi, Ahmed, Li, and Yaari above, which is incorporated into this rejection as well.
Regarding claims 16 and 25-26, Takeuchi teaches that the collagen solution is extruded from a spinneret with a hole diameter of 100 micron and 200 holes into a spinning bath ([0024]).
A 100 micron hole is less than a 20 gauge needle, which has a 600 micron inner diameter as evidenced by Central Infusion Authority (page 4; What Factors Determine the Needle Sizes?, inner diameter).
Yaari teaches an orifice of 30 microns in diameter to produce fibers comparable in diameter to cotton or textile polymer fibers (page 350, right column, 2.4 Fiber Wet Spinning, paragraph 1). Yaari teaches that smaller diameter dies resulted in frequent clogging and necessitated high injection pressures and was therefore avoided (page 350, right column, 2.4 Fiber Wet Spinning, paragraph 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize by routine experimentation the size of the spinneret opening based on the desired size of the collagen fibers. The person of ordinary skill in the art would have had a reasonable expectation of success in optimizing the spinneret opening.
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 CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at (571)272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657
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