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 Species d (Fig. 3c) in the reply filed on 6/1/26 is acknowledged. The traversal is on the ground(s) that each species is a structure and not a method and the claims are directed to a method therefore there would be no burden. This is not found persuasive because even though the claims are directed to a method is claimed using the different structure which would be a burden to the examiner since the species would require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without traverse of Subspecies ii (Fig. 6b) in the reply filed on 6/1/26 is acknowledged.
Claims 2-7, 11, 12, 14-16, and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/1/26.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1, 8, and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bright et al. (2021/0315587).
Bright discloses the following claimed limitations:
Claim 1: A method of facilitating nerve growth ([0035], [0080], and claim 1), the method comprising: positioning a scaffold (the bioresorbable/biodegradable form described in [0082] and [0326-327]) in at least a portion of a cavity (18, 68) defined by a form (10) (Fig. 1a-3b, [0082] and [0326-327]); positioning a first nerve end (24) of a first nerve at least partially onto the scaffold in the cavity (Fig. 1a-1f, abstract, and claim 1, [0082] and [0326-327] where the scaffold is the bioresorbable form described in [0082] which would already be there when the method in claim 1 is performed); introducing an in situ forming media in contact with the first nerve end and the scaffold (Fig. 1a-1f, abstract, and claim 1 where the scaffold is the bioresorbable form described in [0082] which would already be there when the method in claim 1 is performed); and permitting the in situ forming media to undergo a transformation from a first, relatively flowable state to a second, relatively non-flowable state to form a protective barrier surrounding the first nerve end (Fig. 1a-1f, abstract, and claim 1 where the scaffold is the bioresorbable form described in [0082] which would already be there when the method in claim 1 is performed).
Claim 8: wherein the scaffold has a plurality of pores ([0073]).
Claim 9: wherein the scaffold comprises a natural monofilament, polydioxanone, poly(lactic-co-glycolic acid), poliglecaprone, polyglactin, polyglycolic acid, polyglycolide fiber, polylactide fiber, collagen, alginate, chitosan, cellulose, or carboxymethylcellulose ([0082] and [0454]).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 10 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bright et al. (2021/0315587) in view of Offermann et al. (2004/0266000).
Claim 10:
Bright discloses all the claimed limitations discussed above; however, Bright does not disclose that the scaffold comprises polyglycolide fiber.
Offermann discloses that resorbable material can be made from a fiber of chitosan or polyglycolide ([0016]).
It would have been obvious to one of ordinary skill in the art to modify the scaffold of Bright to be made of a polyglycolide fiber in view of Offermann, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to use a polyglycolide fiber, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 13:
Bright discloses all the claimed limitations discussed above; however, Bright does not disclose that the scaffold is formed of a woven material.
Offermann discloses that resorbable material can be nonwoven or woven ([0016]).
It would have been obvious to one of ordinary skill in the art to modify the scaffold of Bright to be woven in view of Offermann, since it has been held that a simple substitution of one known element for another will yield predictable results. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bright et al. (2021/0315587).
Bright discloses the claimed invention except for the plurality of pores of the scaffold are about 0.8 mm2 to about 1.2 mm2 in cross-sectional area.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to have pores about 0.8 mm2 to about 1.2 mm2 in cross-sectional area, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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