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Claims 9-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Response to Arguments
Applicants argue against the prior art rejections.
Applicants argue that Cohen’s collagen is different than their collagen and does not possess the claimed length and diameter distributions at pH 1 to 2. This is not persuasive as this is a property of the collagen, and the examiner cannot determine if the collagen of Cohen would meet these limitations or not, and applicants have failed to show that the collagen of Cohen would not meet these limitations.
Applicants argue that Cohen fails to teach or suggest the claimed acidic dispersion of collagen fibers. This is not persuasive as Cohen discloses all of the limitations of the claim except the length and diameter of the collagen fibers, and applicants have failed to show that the collagen fibers of Cohen would be possess the claimed length and diameter.
Applicants argue that Cohen’s gel and rheology data relate to neutralized/gelled materials, not the acid collagen ink in claim 1, and point to example 2. This is not persuasive and it is noted that the reference is good for all that it teaches and is not limited to the specific examples or preferred embodiments.
Applicants argue that Cohen does not discloses the claimed length and diameter of the collagen at a pH of 1 to 2. Again, this is a property of the collagen, and applicants have not shown that the collagen of Cohen would not meet the claimed length and diameter limitations at a pH of 1 to 2. Further, it is noted that the pH of the claimed composition is not 1 to 2, but this is the condition under which the claimed length and diameter are obtained.
Applicants argue that examiner’s inherency argument is conclusory and unsupported. This is not persuasive as the examiner never argued that these properties were inherent, only that it could not be determined if they were inherent, and applicants have failed to show that the collagen of Cohen would not meet the claimed properties.
Applicants argue that Cohen’s method is not identical to the instant invention. This is not persuasive as: 1) a method is not claimed; and 2) the comprising language of the claims does not disallow for extra steps, and applicants have not shown that any extra steps would result in a collagen with a different length and diameter.
Applicants argue that they obtain unexpected results. However, this is not persuasive as applicants have not compared the closest prior art.
The remaining arguments have been fully considered, but are not persuasive for the same reasons given above.
Conclusion
THIS ACTION IS MADE FINAL. 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 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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