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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-8 in the reply filed on 2/4/2026 is acknowledged. The traversal is on the ground(s) that the groups possess unity of invention. This is not found persuasive because the is no general concept that provides a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/4/2026.
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, 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al.(WO-2017/205695-A1).
Regarding claims 1, 4 and 6-7
Cohen discloses a method of harvesting collagen including processing a collagen-based biomaterial to obtain biomaterial particles, contacting the biomaterial particles with a weak acid solution to obtain a collagen- containing solution, contacting the collagen- containing solution with a salt solution to obtain a collagen precipitate, re-suspending the collagen precipitate to obtain a re- suspended collagen solution.
Cohen relates also to a bio gel composition including a collagen material harvested as described above. The bio gel composition may include collagen material in a weak acid solution. A method of preparing a three- dimensional structure from the bio gel composition is also described, including providing a bio gel composition to a modular fabrication system, such as a 3D printing device. The method includes depositing the bio gel composition to form a three-dimensional structure, where the three-dimensional structure undergoes gelation (page 1, [0005]-page 2, [0007]).
Cohen discloses the collagen material being present in an amount of 5 mg/mL to 200 mg/mL (i.e., approximately 0.5 to 20 wt %) (claim 3). As the concentration of collagen in the reference overlaps that of the claimed invention, the subject matter as a whole would have been obvious to one having ordinary skill in the art at the time the invention was made to have selected the overlapping portion of the range disclosed by the reference because overlapping ranges have been held to be a prima facie case of obviousness. In re Malagari, 182 U.S.P.Q. 549.
A suitable viscosity range of Cohen is from 10,000 centipoise (cP) to about 30,000 cP as a resting solid, or from 3,000 cps to about 10,000 cps as liquid (i.e., a range from 3 to 30 McP) (page 6, [0027]). As the viscosity of the reference overlaps that of the claimed invention, the subject matter as a whole would have been obvious to one having ordinary skill in the art at the time the invention was made to have selected the overlapping portion of the range disclosed by the reference because overlapping ranges have been held to be a prima facie case of obviousness. In re Malagari, 182 U.S.P.Q. 549. Although the temperature the measurement is taken at is not given, it would be expected to be a room temperature which is within the claimed range, making the claimed temperature obvious.
The pH of the re-suspended collagen solution is adjusted to a pH of about 2.8 to about 4 with a weak acid (page 17, [0059]).
Although the length and the diameter of the collagen fibers are not disclosed in Cohen, itis implicit that the same method will result in the same properties of the collagen fiber, therefore, it is expected that the collagen fibers of Cohen will inevitably possess the same length and diameter properties as claimed. When the reference discloses all the limitations of a claim except a property or function, and the examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). See MPEP § § 2112- 2112.02.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES E MCDONOUGH whose telephone number is (571)272-6398. The examiner can normally be reached Mon-Fri 10-10.
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JAMES E. MCDONOUGH
Examiner
Art Unit 1734
/JAMES E MCDONOUGH/Primary Examiner, Art Unit 1734
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