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 . 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.
Status of the Claims
The response and amendment filed 05/19/2026 is acknowledged.
Claims 1-8 are pending.
Claims 9-18 were canceled.
Applicant’s election without traverse of Group I, claims 1-3, in the reply filed on 05/19/5026 is acknowledged.
Claims 4-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/19/2026.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 1-3 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 pre-AIA the applicant regards as the invention.
1. Claim 1 includes the limitation of wherein the acellular matrix is obtained by decellularization after secretion and formation of human bone marrow mesenchymal stem cells (hBMSCs).
The phrase secretion and formation of human bone marrow mesenchymal stem cells (hBMSCs) is unclear. This appears to refer to secretion and formation of hBMSCs, but it is not clear from the specification how this would be done.
Based on the specification, e.g., embodiment 1, it appears Applicant intended that the acellular matrix is “obtained by secretion of extracellular matrix from human bone marrow mesenchymal stem cells (hBMSCs) and then decellularization by cell lysis.” Applicant’s adoption of this language by amendment would resolve this issue.
Clarification is required.
2. Claim 1 includes the limitation of: the acellular matrix is wrapped around the scaffold; wherein the acellular matrix is rolled into multiple layers and wrapped around the scaffold. It is not clear what this was intended to mean, e.g., rolled into multiple layers is confusing. This may mean the acellular matrix is rolled into a tube having multiple layers and the tube is then wrapped around the scaffold.
It is suggested to amend this limitation to say: the acellular matrix is wrapped around the scaffold multiple times to form a tubular structure with multiple layers of acellular matrix.
This suggested amendment to claim 1 would provide antecedent basis for the biodegradable scaffold having an axis in claims 2 and 3 (tubular structure).
To further clarify the rolled into issue, claim 2 may be amended by replacing “is rolled into” with “comprises.”
To further clarify the rolled into issue, claim 3 may be amended by replacing “is rolled” with “comprises.”
Clarification is required.
Claims 2-3 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 pre-AIA the applicant regards as the invention.
There is a lack of antecedent basis for an axis in claims 2-3 because claim 1 does not establish a biodegradable scaffold with an axis.
Clarification is required.
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 of this title, 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.
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 are rejected under 35 U.S.C. 103 as being unpatentable over Gu, US 20150352255 and Liang, CN 112546303.
Citations to Liang refer to the attached machine translation.
Gu teaches a nerve graft comprising a nerve conduit and an ECM secreted by cells and obtained by decellularization (Gu, e.g., 0009 and claim 9). The nerve conduit corresponds to the claimed scaffold (Gu, e.g., 0010), and the ECM secreted by cell and obtained by decellularization corresponds to the claimed acellular matrix (Gu, e.g., 0011). The ECM acellular matrix is derived from bone marrow mesenchymal stem cells (Gu, e.g., claim 10). The nerve conduit is biodegradable, e.g., based on chitosan and/or collagen (Gu, e.g., claim 11). Since Gu teaches the nerve conduit may be a combination of polymers including chitosan and collagen, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to configure the nerve conduit as a biodegradable scaffold comprising chitosan and collagen. Gu provides an express teaching which would have prompted the skilled artisan to configure the nerve conduit (scaffold) using the claimed polymers with a reasonable expectation of success. It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to use human BMSCs and collagen to reduce the risk of cross species immunogenicity and to promote nerve growth for human patients.
Gu teaches the ECM secreted by cell and obtained by decellularization corresponding to the claimed acellular matrix is coated on the inner and outer surfaces of the nerve conduit (Gu, e.g., 0005, 0019, 0068, 0070). However, Gu does not expressly teach the acellular matrix is wrapped around the nerve conduit scaffold to form multiple layers.
Liang teaches nerve repair materials like Gu, comprising a tubular shape (conduit) comprising an inner core matrix and an outer multilayered tube (Liang, e.g., claim 1), wherein the multilayer outer tube comprises 2-12 layers of decellularized (acellular) matrix (Liang, e.g., claim 2). The layer range in claim 3 is within the range suggested by Liang. Liang teaches the multilayer configuration enables a dense structure with improved barrier function (Liang, e.g., 0004), which inhibits outgrowth of nerve fibers thereby reducing the formation of neuromas (Liang, e.g., 0001, 0031, ¶ spanning pp. 19-20). This promotes the desired directional regeneration of nerve fibers (Liang, e.g., 0001).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a nerve graft known from Gu by configuring the outer acellular matrix as a multilayered construct by rolling the matrix material around the nerve conduit to improve the device in the same way suggested by Liang with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to promote desired directional regeneration of nerve fibers and reduce the risk of neuromas in the same way reported by Liang. The skilled artisan would have had a reasonable expectation of success since both references teach improvements for nerve grafts comprising an acellular matrix.
Accordingly, the subject matter of claims 1-3 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-14 of US 9492589 in view of Liang, CN 112546303.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Gu teaches a nerve graft comprising a nerve conduit and an ECM secreted by cells and obtained by decellularization (Gu, e.g., claim 9). The nerve conduit corresponds to the claimed scaffold, and the ECM secreted by cell and obtained by decellularization corresponds to the claimed acellular matrix (Gu, e.g., claim 2). The ECM acellular matrix is derived from bone marrow mesenchymal stem cells (Gu, e.g., claim 10). The nerve conduit is biodegradable, e.g., based on chitosan and/or collagen (Gu, e.g., claim 11). Since Gu teaches the nerve conduit may be a combination of polymers including chitosan and collagen, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to configure the nerve conduit as a biodegradable scaffold comprising chitosan and collagen. Gu provides an express teaching which would have prompted the skilled artisan to configure the nerve conduit (scaffold) using the claimed polymers with a reasonable expectation of success. It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to use human BMSCs and collagen to reduce the risk of cross species immunogenicity and to promote nerve growth for human patients.
Gu teaches the ECM secreted by cell and obtained by decellularization corresponding to the claimed acellular matrix is coated on the inner and outer surfaces of the nerve conduit (Gu, e.g., claim 2). However, Gu does not expressly teach the acellular matrix is wrapped around the nerve conduit scaffold to form multiple layers.
Liang teaches nerve repair materials like Gu, comprising a tubular shape (conduit) comprising an inner core matrix and an outer multilayered tube (Liang, e.g., claim 1), wherein the multilayer outer tube comprises 2-12 layers of decellularized (acellular) matrix (Liang, e.g., claim 2). The layer range in claim 3 is within the range suggested by Liang. Liang teaches the multilayer configuration enables a dense structure with improved barrier function (Liang, e.g., 0004), which inhibits outgrowth of nerve fibers thereby reducing the formation of neuromas (Liang, e.g., 0001, 0031, ¶ spanning pp. 19-20). This promotes the desired directional regeneration of nerve fibers (Liang, e.g., 0001).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify a nerve graft known from Gu by configuring the outer acellular matrix as a multilayered construct by rolling the matrix material around the nerve conduit to improve the device in the same way suggested by Liang with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to promote desired directional regeneration of nerve fibers and reduce the risk of neuromas in the same way reported by Liang. The skilled artisan would have had a reasonable expectation of success since both references teach improvements for nerve grafts comprising an acellular matrix.
Accordingly, the subject matter of claims 1-3 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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