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 .
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22-39 of copending Application No. 18/723,323 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because Application 18/723,323 has been found to anticipate each and every element of the present invention for instance both providing a kit for use in inducing growth or regeneration of a damaged tissue portion of a subject, the kit comprising: a tissue enveloping hollowed element for enveloping a damaged tissue portion; one or more blood withdrawal devices for withdrawing blood from the subject; one or more blood collection receptacles for receiving the blood withdrawn from the subject; one or more coagulating agents; a coagulation assembly configured for mixing the withdrawn blood with the one or more coagulation agents for initiating a coagulation process of the withdrawn blood; and an applicator for introducing the incomplete coagulated blood into said lumen.
As set forth above, the present invention is not viewed to be patentably distinct from the co-pending application 18/723,323.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1-2 and 4-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wiberg et al. (US 20100076465 A1).
As to claims 1 and 7, Wiberg et al. discloses inducing growth or regenerating a damaged nerve portion of a subject (Abstract) comprising: a nerve enveloping hollow element having a lumen for enveloping said damaged nerve portion such that said portion resides in at least a portion of said lumen (conduit; Abstract; [0019]; Figures 2-3). Additionally, Wiberg et al. discloses “bioresorbable fibrin-based nerve repair conduit produced from tissue glue is provided. The term "bioresorbable" is used herein as an expression for a material that is resorbed by the body within a time period of a few months, when placed therein. The term "fibrin-based" is used herein to indicate that the main component of the conduit is fibrin but other components, especially blood or plasma components, may be present in the conduit. Tissue glue is used herein as a reference to a fibrinogen-containing mixture that is converted into fibrin. The tissue glue may be of endogenous origin, whereby it would be manufactured from plasma components of the patient's own blood, with the facultative addition of additional components, dependent on the cleavage system used for the conversion of fibrinogen into fibrin.”([0004]). As such, Wiberg et al. further discloses one or more blood withdrawal devices for allowing withdrawal of blood from the subject and one or more blood collection receptacles for receiving the blood withdrawn from the subject ([0004]).
Wiberg et al. discloses “Nerve repair conduits according to the invention may be fabricated from fibrinogen and thrombin containing fluids, e.g. from conventional, commercially available fibrin-based tissue glue, below referred to as fibrin glue (e.g. Tisseel.RTM.) according to the Examples below. Fibrin glue is used widely in surgical practice. It helps surgeons to adapt tissues and to obtain haemostasis in difficult situations. It has also been used in coaptation of nerve-ends with good results. Fibrin glue can be fabricated autologously from individual donors and is alternatively commercially available from different companies for clinical use. Fibrin glue can be diluted specifically to change its dissolving and coagulation characteristics. Fibrin glue also has good biocompatibility and has been used also in bone tissue engineering. The important active components in conventional fibrin glue, i.e. fibrinogen and thrombin, are also commercially available separately”([0019]). Thus, Wiberg et al. discloses “a coagulation assembly configured for permitting mixture of the withdrawn blood with one or more coagulation inducers for initiating coagulation process of the withdrawn blood” in order to fabricate fibrin glue for individual donors and affect the coagulation process and “an applicator for introducing the incomplete coagulated blood into said lumen” ([0004, 0019-0021]).
As to claim 2, Wiberg et al. discloses the coagulation assembly necessarily comprises a volume for introducing the withdrawn blood, said volume is contactable with one or more coagulation agents ([0004, 0019-0022]).
As to claim 4, Wiberg et al. discloses a film or sheet for placing over said damaged nerve portion for forming said nerve enveloping hollow element ([0005, 0012]).
As to claim 5, Wiberg et al. discloses said nerve enveloping hollow element is a nerve guidance conduit ([0016-0017]).
As to claim 6, Wiberg et al. discloses securing elements for securing said damaged nerve portion to the nerve enveloping hollow element (Abstract; [0003, 0016, 0032]).
As to claim 8, Wiberg et al. discloses regenerating a nerve in or across a damaged nerve portion, comprising: fitting a nerve guidance conduit having a lumen to envelope said nerve portion to reside in said lumen (conduit; Abstract; [0003-0005, 0016-0019]; Figures 2-3); and introducing a mixture of whole blood withdrawn from the subject with one or more coagulating inducers into said lumen prior to its complete coagulation ([0004, 0019-0021]).
As to claim 9, Wiberg et al. discloses said fitting comprises placing a film or sheet over said portion and enveloping said portion with said sheet to form said conduit ([0005, 0012]).
As to claim 10, Wiberg et al. discloses inducing growth of nerve fibers across a damaged nerve portion, comprising: fitting a nerve guidance conduit to envelope said nerve portion (conduit; Abstract; [0003-0005, 0016-0019]; Figures 2-3); and introducing a mixture of whole blood withdrawn from the subject with one or more coagulating inducers into said lumen prior to its complete coagulation ([0004, 0019-0021]).
As to claim 11, Wiberg et al. discloses the damaged nerve portion comprises cut nerve fibers (nerve stumps; [0003, 0016, 0032]; Abstract).
As to claim 12, Wiberg et al. discloses said nerve portion includes two cut nerve stumps that are surgically joined or brought into proximity (Abstract; [0003, 0016, 0032]).
As to claim 13, Wiberg et al. discloses placing a film or sheet over said portion and enveloping said portion with said sheet to form said conduit ([0005, 0012]).
As to claim 14, Wiberg et al. discloses said fitting comprises: introducing the two nerve stumps into said conduit, one from each end of the conduit (Abstract; [0003, 0016, 0032]); and bringing the two stumps into proximity to one another within said conduit (Abstract; [0003, 0016, 0032]).
As to claim 15, Wiberg et al. discloses said bringing, comprises securing the two stumps within said conduit by suturing ([0020, 0032]).
As to claim 16, Wiberg et al. discloses said introducing comprises filling a portion of the conduit's lumen with the mixture such that it comes into contacts with said nerve portion ([0003, 0008, 0017-0018]).
As to claim 17, Wiberg et al. discloses said nerve portion includes two cut nerve stumps and said introducing is carried out such that said mixture comes into tight contact with said stumps (Abstract; [0016, 0032]).
As to claim 18, Wiberg et al. discloses mixing the blood, prior to said introducing, with one or more autologous cells ([0003, 0008, 0017-0018]).
As to claim 19, Wiberg et al. discloses one or more autologous cells comprise Schwann cell ([0003, 0008, 0017-0018]).
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wiberg et al. (US 20100076465 A1). Wiberg et al. discloses the invention substantially as claimed but does not explicitly disclose introducing one or more anti-coagulation agents for mixing with the withdrawn blood. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the agents employed by the Wiberg et al. system to incorporate anti-coagulation agents, since anti-coagulation agents are extremely well known in the medical device art. Furthermore, such a modification would provide the predictable results of modifying the invention to meet specific patient therapeutic needs and requirements.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796