DETAILED ACTION
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, presently claims 1-6 and 9, in the reply filed on 8/04/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious search burden to examine all of the claims. This is not found persuasive because search burden is not a consideration in finding of lack of inventive unity; rather, according to M.P.E.P. §1850, the only consideration is whether the inventions share a special technical feature and none of Applicant’s arguments at this time persuasively set forth that the different groups of inventions as set forth in the Restriction requirement dated 2/04/2026 possess unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s species election of collagen in the reply filed on 8/04/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 16, 22-24, 28, 40, 51-53, 57, 60, and 64 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8/04/2026.
Claims 1-6 and 9 are under consideration on the merits.
Claim Rejections - 35 USC § 102
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 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nonaka et al. (US 2010/0047826; provided in the IDS dated 12/01/2023).
This rejection addresses the embodiment of the first force in the method is the flow produced by shaking the system during the nucleation phase. The second force in the method is the force of gravity acting on the culture while standing overnight during the elongation phase for claim 1. Other species were found during the search, and so this rejection addresses the embodiment of α-synuclein for the biomaterial of claim 1.
Nonaka teaches a method of polymerization α-synuclein fibrils, the method comprising culturing recombinant E. coil expressing α-synuclein, isolating the α-synuclein protein, and inducing α-synuclein fibrilization (e.g. polymerization) ([00090]-[0093]), anticipating claims 1 and 2.
Regarding the preamble and thereby clause of claim 1, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See M.P.E.P. § 2111.02 and 2111.04. In the instant case, claim 1 recites a manipulatively complete process and the preamble and thereby clause does not further limit the method steps of the claimed process as such statements amounts to an intended outcome, and so is afforded no patentable weight. Alternatively, because Nonaka teaches every manipulative limitation of claim 1, then Nonaka is reasonably presumed capable of meeting the intended outcome of claim 1 absent any showing to the contrary. See M.P.E.P. § 2112.
Claims 1-6 are rejected under 35 U.S.C. 102 as being anticipated by Paukshto et al. (WO 2010/019625; Reference N).
This rejection addresses the embodiment of the first force in the method is horizonal laminar Couette flow during the nucleation phase for claim 1. The second force in the method is the force of gravity acting on the system during the elongation phase for claims 1 and 6.
Paukshto teaches a method of making a collagen fibers/fibrils, the method comprising rotationally extruding the biopolymeric material through a shearing gap in a hollow cylinder mandrel by (horizontal) laminar Couette flow and thus forming collagen fibers/fibrils of varying orientation ([0047] and [0088]-[0089], anticipating claims 1-6. Paukshto teaches the cylindrical system comprises a planar surface ([0086] and Fig. 9), and so the rotation as cited above anticipates the “promote the adsorption” of claim 5.
Regarding the preamble and thereby clause of claim 1, claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See M.P.E.P. § 2111.02 and 2111.04. In the instant case, claim 1 recites a manipulatively complete process and the preamble and thereby clause does not further limit the method steps of the claimed process as such statements amounts to an intended outcome, and so is afforded no patentable weight. Alternatively, because Paukshto teaches every manipulative limitation of claim 1, then Paukshto is reasonably presumed capable of meeting the intended outcome of claim 1 absent any showing to the contrary. See M.P.E.P. § 2112.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-6 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Paukshto et al. (WO 2010/019625; Reference N).
The teachings of Paukshto are relied upon as set forth above in rejecting claims 1-6 as anticipated under 35 U.S.C. § 102.
In a separate embodiment, Paukshto teaches collagen type I ([0026]) and reading on claim 9. Therefore, It would have been obvious to a person of ordinary skill in the art before the invention was filed to further substitute collagen type I for the generic/unspecified collagen of Paukshto. A person of ordinary skill in the art would have had a reasonable expectation of success and the skilled artisan would have been motivated to do so because Paukshto expressly considers collagen type I as an exemplary species of collagen in Paukshto’s method of producing a collagen fibers/fibrils; see M.P.E.P. § 2143(A) and/or (B).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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