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 2 and 11-12 are cancelled. Claims 1, 3-10, and 13-18 are pending and under examination on their merits.
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.
Claims 6, 14, and 17 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.
Claim 6 recites both a “sheet-like material” and a “steric material.” The person of ordinary skill in the art would have been unable to determine the metes and bounds of the claim as there is no metric for determining what is “sheet-like” provided in the specification, nor is there a metric for determining what constitutes “a steric material.” The specification does not provide a definition for each claim term but exemplifies a “steric material” as organ-like, block-like, or container-like material. These examples are insufficient for the person of ordinary skill in the art to determine the metes and bounds of the claim without the use of subjective judgment.
Claim 14 is indefinite because it is unclear whether the method includes additional non-organic components in the water. The method preamble is open but the claim recites “dispensing a solution containing a protein material raw material into a water-based medium, wherein the water-based medium is water, wherein the water-based medium does not contain an organic solvent.” Thus, in one interpretation, the claim requires dispensing the solution into a water-based medium consisting of water, whereas in another interpretation, the claim requires dispensing the solution into a water-based medium comprising water but excluding any organic solvent. Under the second interpretation, a water-based medium comprising water and salts would fall within the claim scope because salts are not organic solvents.
Claim 17 recites “the dispensing has a spinning speed of 0.1 mL/min to 10 mL/min.” Spinning refers to the act of rotation and is typically measured in units of rpm (rotations per minute). Therefore, it is unclear whether the dispensing involves rotation (spinning) or merely the act of dispensing a volume at a given rate (mL/min).
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.
Claims 1, 3-6, 9, 13-15, and 18 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 Li et al. (Materials Science and Engineering: C 29.5 (2009): 1643-1649).
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 drying the collagen fibers under reduced pressure to obtain a collagen fiber nonwoven sheet ([0025]).
The pH of the acidic aqueous solution comprising solubilized collagen is less than the claimed range of 6.0 to 9.0.
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).
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 pH of the collagen solution in the method of Takeuchi based on the teachings of Li. The person of ordinary skill in the art would have recognized pH as a results-effective variable controlling both the rate of fibrillogenesis and the diameter of the resulting fibrils. The person of ordinary skill in the art would have had a reasonable expectation of success in the optimization of the pH.
Regarding claim 3, 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.
Regarding claim 4, 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.
Regarding claim 5, Takeuchi teaches that the collagen concentration is 0.5 to 10 wt% ([0011]), which overlaps with the claimed range of 0.1 to 5 wt%.
Regarding claim 6, 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 claim 9, Takeuchi teaches drying the collagen fibers under reduced pressure to obtain a collagen fiber nonwoven sheet ([0025]).
Regarding claims 13 and 15, 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).
Regarding claim 14, the claim is interpreted as open (additional components are allowed in the water except for organic solvents). Takeuchi teaches that the concentrated salt solution is aqueous ([0012]).
Regarding claim 18, Takeuchi does not teach that the solution containing the solubilized collagen (“protein material raw material”) is phosphate buffered saline.
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 mix Takeuchi’s solubilized collagen with phosphate-buffered saline prior to discharging from the spinneret in order to maintain the pH at the desired level of fibrillogenesis. The person of ordinary skill in the art would have had a reasonable expectation of success in mixing phosphate-buffered saline with the solubilized collagen solution.
Claims 7-8 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 Li et al. (Materials Science and Engineering: C 29.5 (2009): 1643-1649), as applied to claims 1, 3-6, 9, 13-15, and 18 above, and as evidenced by Shetty et al. (Journal of clinical orthopaedics and trauma 7.3 (2016): 164-169).
The teachings of Takeuchi and Li are incorporated into this rejection as well.
Regarding claims 7-8, Takeuchi’s collagen is atelocollagen ([0024]), which is a type I collagen as evidenced by Shetty (page 169, left column, first full paragraph).
Claims 10 and 17 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 Li et al. (Materials Science and Engineering: C 29.5 (2009): 1643-1649), as applied to claims 1, 3-6, 9, 13-15, and 18 above, further in view of Yaari et al. (ACS Biomaterials Science & Engineering 2.3 (2016): 349-360).
See discussion of Takeuchi and Li above, which is incorporated into this rejection as well.
Regarding claim 10, Takeuchi does not teach the elastic modulus of the protein material. However, Takeuchi teaches that the protein material is cross-linked ([0014]).
Yaari teaches a method of wet spinning and drawing collagen comprising injecting collagen through a syringe into a coagulation bath to produce a fiber and drawing the fiber onto a rotating spool (Figure 1(i)). Yaari teaches cross-linking the fiber with 0.1% glutaraldehyde after it is drawn on the spool (Figure 1(ii); page 358 left column, top paragraph). Yaari presents the Young’s modulus (synonym for elastic modulus) for the cross-linked fiber produced by different draw ratios (Figure 5B). All fibers have an elastic modulus greater than 1 GPa (Figure 5B).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Takeuchi and Li by drawing the fiber onto a spool and subsequently cross-linking with glutaraldehyde. The person of ordinary skill in the art would have been motivated to modify Takeuchi and Li’s fiber to improve mechanical properties such as a high elastic modulus. The person of ordinary skill in the art would have had a reasonable expectation of success in these modifications.
Regarding claim 17, Takeuchi does not teach the dispensing rate 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 (“dispensing rate”) 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).
Claim 16 is 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 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 applied to claims 10 and 17 above, and as evidenced by Central Infusion Authority (2026, website).
See discussion of Takeuchi and Li above, which is incorporated into this rejection as well.
Regarding claim 16, 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
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