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 without traverse of Group I, claims 22-25 in the reply filed on 06/12/2026 is acknowledged.
Claims 26-39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/12/2026.
Claims 22-25 are under current examination.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities:
The examiner recommends deleting the word “the” from the phrase “the complete coagulation” in claim 22, lines 6-7.
The examiner recommends amending claim 2, line 2 to recite “said film or sheet” to fully reflect the scope of the phrase “film or sheet” recited previously in the claim.
The examiner recommends amending claim 25 to recite “…wherein said connective tissue portion comprises .
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 22-25 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 recites the limitation "the subject" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above.
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.
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.
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Murray (US20200171203; publication date: 06/04/2020) in view of Shetty et al. (US20060084338; publication date: 04/20/2026).
With regard to claim 22, Murray teaches a method of repairing torn or ruptured connective tissue (i.e. a damaged connective tissue portion; 0002) by contacting the torn ends of the connective tissue with a scaffold and introducing a repair material, specifically a blood composition into the scaffold (0036; 0014). The blood composition may be autologous blood (i.e. whole blood withdrawn from the subject; 0013). ”Contacting the ends of the connective tissue with a scaffold” embraces contacting a flat sheet that is rolled into a tube so as to define a hollow cavity (i.e. a lumen) and in some examples the scaffold may be formed into a tube shape and wrapped around a ligament (i.e. connective tissue; 0038). This corresponds to fitting a connective tissue guidance conduit having a lumen over said connective tissue portion such that said portion is within said lumen. Autologous blood can be added to the scaffold prior to or after the scaffold is placed over the affected area of connective tissue (0058; 0062).
Murray teaches the following benefits to the disclosed method of healing connective tissue:
[0003] Intra-articular tissues, such as the anterior cruciate ligament (ACL), do not heal after rupture. In addition, the meniscus and the articular cartilage in human joints also often fail to heal after an injury. Tissues found outside of joints heal by forming a fibrin clot, which connects the ruptured tissue ends and is subsequently remodeled to form scar, which heals the tissue. Inside a synovial joint, a fibrin clot either fails to form or is quickly lysed after injury to the knee, thus preventing joint arthrosis and stiffness after minor injury. Joints contain synovial fluid which, as part of normal joint activity, naturally prevent clot formation in joints. This fibrinolytic process results in premature loss of the fibrin clot scaffold and disruption of the healing process for tissues within the joint or within intra-articular tissues.
Murray teaches further “An implanted scaffold can either protect the blood from the synovial fluid environment and allow it to form a clot in the wound site to stimulate healing, or may contain other biologic stimuli to stimulate ligament healing” (0043). Murray also teaches including platelets (i.e. clot forming cells) as the repair material or platelet rich plasma (0063), that the scaffold may be a bioengineered substitute for a fibrin clot (0039), and that the scaffold itself can be formed from, inter alia, fibrin (0045). Murray teaches further including thrombin in the repair material that is injected into the scaffold (0062).
Thus, the purpose of Murray is to protect an injured ligament (or other connective tissue) and promote the clot formation step that is required for effective healing.
Murray does not disclose a mixture of whole blood withdrawn from the subject and a coagulating agent and/or anti-anticoagulating agent.
Shetty, in the analogous art of surgical devices (abstract, 0002), teaches that thrombin has procoagulant effects.
It would have been prima facie obvious to combine the autologous blood in Murray’s method with thrombin and inject this mixture into the scaffold. The artisan of ordinary skill would have been motivated to add thrombin in order to enhance formation of the blood clot around the connective tissue that promotes healing of the damaged area. The skilled artisan would have had reasonable expectation of success because Murray teaches using both of these substances, as discussed above. It would have been obvious to perform this step prior to complete coagulation so that the mixture remains liquid and injectable during the procedure.
With regard to claim 23, as noted above, the scaffold may be a sheet and may be folded around (i.e. envelope) the tear in the connective tissue.
Claims 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Murray (US20200171203; publication date: 06/04/2020) and Shetty et al. (US20060084338; publication date: 04/20/2026) as applied to claims 22 and 23 above and further in view of VanKampen et al. (US20110224702; publication date: 09/15/2011).
The relevant disclosures of Murray and Shetty are set forth above. Neither disclose a method in which the connective tissue has been cut.
Van Kampen teaches that in some protocols an accepted practice involves prior to reconnecting the tendon via sutures, cutting the tendon (connective tissue) also can include the placement of scaffolds and patches over the repaired tendon to shield the sutured or repaired tendon area from anatomical load during rehabilitation (0009).
With regard to claim 24, it would have been prima facie obvious to cut the connective tissue in Murray’s method because this was a routine step as of the instant effective filing date (see MPEP 2143(I)(D)).
With regard to claim 25, as noted above, the cut ends are reconnected via sutures, i.e. they are surgically joined together or brought into proximity.
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 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8, 9, and 19-25 of copending Application No. 19159593 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘593 patent embrace a method for treating damaged connective tissue portion comprising fitting a support matrix that may be a film, tube, or wrap around the damaged portion and injecting a mixture of whole blood and one or more coagulating agents prior to complete coagulation to form a mass over the damaged portion within the support matrix.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 22-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-24 of copending Application No. 18277511 (reference application) as evidenced by Friel (US 20190381144; publication date: 12/19/2019).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims render obvious the instant claims.
Inter alia, the claims of the ‘511 patent embrace a method for treating damaged nerve portion comprising fitting 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 and introducing a mixture comprising whole blood withdrawn from the subject one or more coagulating inducers, into said lumen prior to its complete coagulation; and permitting the whole blood to coagulate in said lumen. The claims of the cited application embrace a method of treating damaged nerves; however, this method inherently embraces treating, inducing growth, or regenerating connective tissue because nerves are comprised of multiple neurons bound together by connective tissue (Friel: 0018). In reforming the nerve, one necessarily treats, induces growth, or regenerates connective tissue.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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