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 .
Receipt is acknowledged for response to restriction/election requirement filed 01/29/2025 and IDS filed 05/06/2026.
Original claims 1-8 are pending.
Election/Restrictions
In response to the election requirement, applicant has elected without traverse heparin as the anti-coagulant, polyether ether-ketone (PEEK) for the polymer (see claim 2), cyclic HGGVRLY that is within SEQ ID Nos. 6-28 of claims 4-5. However, SEQ ID Nos 6-28 is claim 5 because claim 4 requires SEQ ID Nos 1, 2, 3, 4, and 5. Applicant identifies claims 1-5, 7 and 8 as reading on the elected species. Claim 4 should have been withdrawn.
Therefore, claims 4 and 6 should be withdrawn without traverse.
However, the election/restriction is withdrawn. Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 10/29/2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
This application claims benefit of 63/341,741 filed 05/13/2022.
Information Disclosure Statement
The IDS filed 05/06/2026 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1, 3, 5 and 7-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Page 2, lines 27-29 of the as filed specification describe the polymer to include polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE) and polyether ether-ketone (PEEK). The scope of polymer in claim 1 is broader than the scope of the polymer described in the as filed specification. Thus applicant does not have possession of the full scope of polymer in claim 1.
Claims 1-3 and 7-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for cell specific binding peptides listed on Table 1 as SEQ ID Nos. 1-51, does not reasonably provide enablement for all cell specific binding peptide. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
For example, cell specific binding peptides are not limited to the those disclosed in the as filed specification. The Table in paragraph [0049] of Preisler (US 20030134342 A1) lists other peptides having Sequences that are different form Sequences 1-51 of the as filed specification. The as filed specification does not disclose the full scope of cell specific binding peptides.
Amendment to claim 1 claiming polymer that is described in the as filed specification and in claim 2, and SEQ ID Nos that meet the scope of what is disclosed such as those listed in claims 4, 5 and 6 will overcome the rejection.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dae-Hyun Kim et al. “Microneedle Vascular Couplers with Heparin-Immobilized Surface Improve Suture-Free Anastomosis Performance” in Biomaterials Science and Engineering, 2018, 4, pp 3848-3853.
While applicant has elected specific anticoagulant and specific cell specific binding peptide and specific polymer, claims 1 upon which claims 2-8 depend from has not been amended.
Claim 1 is a device. “For joining a first and second end of a vascular vessel” is the intended use of the device. It has been established that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). In the instant case, the body of the claim fully sets forth the limitations of the claimed device.
The moiety covalently attached to the surface is anti-coagulant or cell specific binding peptide.
For claim 1, Dae-Hyun Kim discloses microneedle Vascular Couplers having heparin immobilized on the surface improving suture-free anastomosis performance (see the whole document with emphasis on the Title and abstract). Dae-Hyun Kim tubular construct comprising microneedles for suture-free anastomosis (see the whole document with emphasis on the paragraph under the conclusion on page 3852). The tubular vascular coupler comprises polyester or expanded polytetrafluoroethylene (ePTFE) having heparin coated onto (see the whole document with emphasis on Fig. 1; paragraph bridging left and right columns of page 3849; page 3850; third full paragraph, left column of page 3852). The microneedle reads of bristles. The coupler has two ends as end-to-end connection of vessels is achieved (see at least the paragraph bridging right and left columns of page 3852; lines 6-8, left column of page 3850 and abstract).
For claim 2, the ePTFE meets the requirement of the claim.
For claim 3, heparin anticoagulant meet the requirement of the claim.
Therefore, Dae-Hyun Kim teaches claims 1-3.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hunter et al. (WO 2005/018683 A2).
While applicant has elected specific anticoagulant and specific cell specific binding peptide and specific polymer, claims 1 upon which claims 2-8 depend from has not been amended.
Claim 1 is a device. “For joining a first and second end of a vascular vessel” is the intended use of the device. It has been established that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999); Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). In the instant case, the body of the claim fully sets forth the limitations of the claimed device.
The moiety covalently attached to the surface is anti-coagulant or cell specific binding peptide.
For claim 1, Hunter discloses anastomotic connector devices comprising anastomotic coupling device and anti-scarring agent for release of therapeutic agent (see at least page 2, lines 22-29; page 182, lines 27-29; page 183, lines 25-29; page 184, lines 1-2, 4-16) and further comprises anti-thrombogenic and/or anti-platelet agent, namely heparin (page 3, lines 7-9, and 28-30; page 125, lines 7-9). Anastomosis and anastomotic connector device are defined on page 5, lines 7-9; page 164, line 12). The anastomotic connector devices is made from polymers including polyesters, polyurethanes, polytetrafluoroethylene (PTFE), poly(phenyl ether ether ketone) (PEEK), poly(arylene ether ether ketone) (page 165, lines 6-19) and ePTFE (page 182, line 25. The anastomotic coupling device includes proximal and distal connectors and graft delivery system having inner and outer ring of struts or flanges for attaching blood vessels (page 174, lines 13-14, 20-23; page 178, lines 10-15). The anastomotic device may be anchored to blood vessels in a variety of ways including hooks, barbs, pins, claims, flanges, and lips for coupling the device to site of anastomosis (page 178, lines 16-18, 28-30; page 179, lines 28-30) without the use of sutures (page 178, line 18; page 183, line 1).
For claim 2, the ePTFE and PEEK meet the requirements of claim 2.
For claim 3, heparin, which is anticoagulant meet the requirement of the claim.
Therefore, Hunter teaches claims 1-3.
The following art is brought to applicant’s attention: Sreejalekshmi et al., “Biomimeticity in tissue engineering scaffolds through synthetic peptide modifications --- Altering chemistry for enhanced biological response” in Journal of Biomedical Materials Research, Am 2010, Vol. 96, No. 2m pp 471-491, submitted by applicant on Form 1449, teaches scaffold comprising peptide sequences, namely RGD, YIGSR, IKVAV and others on PET, PFTE, PEG, polycaprolactone, acrylate, chitosan and others for vascular tissue growth and regeneration (see the whole document). The peptides in Sreejalekshmi meet the limitation of cell specific binding peptides of claim 1 and the specific peptides of claim 4. No specific cell specific binding peptide is named in claim 1 and no specific polymer is named in claim 1.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLESSING M FUBARA whose telephone number is (571)272-0594. The examiner can normally be reached 7:30 am-6 pm (M-T).
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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