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 1, 4, 7-9, 14, 16-17, 19, 23- 24, and 31) in the reply filed on April 2nd, 2026 is acknowledged. Claims 37, 39- 42, and 46- 48 are withdrawn for being drawn to an unelected invention.
Claim Objections
Claims 1, 4, 7-9, 14, 16- 17, 19, 23, 24, and 31 are objected to because of the following informalities:
Claim 1, Line 7 states “with a tissue construct”, it is suggested to change this to “with the tissue construct”.
Claims 4, 7-9, 14, 16- 17, 19, 23, 24, and 31 are objected to for being dependent on or from objected claim 1.
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.
Claim 24 is 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 24 recites the limitation “tubular or conical projections, and wherein each lumen is contained within one of the tubular or conical projections”, it is unclear whether applicant intends to further the limitation of one or more lumens to include two or more lumens, or whether the tubular or conical projections are one or more projections correlating to the number of lumens. For purposes of examination, the broadest reasonable interpretation for this limitation is herein considered to be one or more tubular conical projections, wherein each lumen is contained within one of the tubular or conical projections.
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, 4, 7, 14, 17, 19, 24, and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jang et al. (KR 101748551 English Machine Translation) as evidenced by TheFreeDictionary.com.
Regarding claim 1, Jang (Jang et al.) teaches a suturable cuff (body 100) for integrating a tissue construct in vivo with a host organ or vasculature (Paragraphs 0002, 0016, and 0025), the suturable cuff comprising:
A hollow body (outer layer tube 102) having an anastomotic end, an anchoring end, and one or more lumens (blood channel 105), each lumen extending through the hollow body from a proximal opening at the anastomotic end to a distal opening at the anchoring end (see annotated Fig. 1 below), the anastomotic end being configured for integration with one or more body vessels (Paragraph 0036, see Figs. 3(a)- 3(c)), and the anchoring end including one or more anchoring features (plurality of microneedles 103).
Regarding the one or more anchoring features for connection with a tissue construct, the broadest reasonable interpretation of a construct comes from the definition, that is that a construct is “something formed or constructed from parts”. Therefore, as vessel tissue is composed of various cells or parts, it is a tissue construct. Since Jang teaches that the one or more anchoring features connect with vessel tissue (Paragraph 0025 and 0029), then the one or more anchoring features connect with a tissue construct.
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Regarding claim 4, Jang teaches the suturable cuff as discussed above.
Jang further teaches wherein the one or more anchoring features include one or more prongs (plurality of microneedles 103)(Paragraph 0025).
Regarding claim 7, Jang teaches the suturable cuff as discussed above.
Jang further teaches wherein the one or more anchoring features (plurality of microneedles 103) are bioresorbable (Paragraph 0028).
Regarding claim 14, Jang teaches the suturable cuff as discussed above.
Jang further teaches wherein the hollow body (outer layer tube 102) comprises a natural or synthetic polymer (Paragraph 0033).
Regarding claim 17, Jang teaches the suturable cuff as discussed above.
Jang further teaches the cuff further comprising a catheter liner (inner layer tube 101) contained within the hollow body (Paragraph 0030), the catheter liner extending from the distal opening to the proximal opening of the hollow body and surrounding the lumen (see annotated Fig. 1 below)(Paragraph 0026), wherein the catheter liner comprises polyurethane (Paragraphs 0031 and 0032).
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Regarding claim 19, Jang teaches the suturable cuff as discussed above.
Jang further teaches wherein the catheter liner (inner layer tube 101) includes on an inner surface thereof an anti-coagulant drug (Paragraph 0043).
Regarding claim 24, Jang teaches the suturable cuff as discussed above.
Jang further teaches wherein the anastomotic end of the hollow body includes a tubular projection, and wherein the lumen (105) is contained within the tubular projection (see annotated Fig. 1 below).
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Regarding claim 31, Jang teaches the suturable cuff as discussed above.
Jang further teaches wherein the lumen and an outer surface of the hollow body includes a functional coating comprising an anti-coagulant drug (Paragraph 0043).
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.
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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (KR 101748551 English Machine Translation) in view of Bettuchi et al. (US 2006/0085030).
Regarding claim 8, Jang teaches the suturable cuff as discussed above.
Jang does not teach wherein the one or more anchoring features are coated with one or more molecules to promote adhesion to the tissue construct, the one or more molecules being selected from the group consisting of: polylactic acid, chitosan, alginate, silanes functionalized with N-hydroxysuccinimide, and aldehydes.
Bettuchi (Bettuchi et al.) teaches a device (seal element 10)(Figs. 1- 4) for use in an anastomosis (abstract, Paragraph 0003) wherein the device is made of a material (material 12, material 14)(Paragraph 0020) that can have a coating of alginate, chitosan, and other polysaccharides that are surgically useful (Paragraph 0025, Bettuchi teaches that the molecules can be loaded onto the element, therefore the molecules can be a coating onto a different material.).
It would have been obvious to one of ordinary skill in the art to modify the one or more anchoring features as taught by Jang to be coated with alginate, chitosan, or other polysaccharides as taught by Bettuchi, since Bettuchi teaches that these molecules are medically and surgically useful (Paragraph 0025).
Regarding wherein the molecules promote adhesion, since the combination teaches the same material as applicant, one would expect the same results, i.e. promoting adhesion.
Regarding claim 16, Jang teaches the suturable cuff as discussed above.
Jang does not teach wherein the hollow body comprises an extracellular matrix protein or material selected from the group consisting of collagen, fibrin, fibronectin, gelatin, an elastin.
Bettuchi (Bettuchi et al.) teaches a device (seal element 10)(Figs. 1- 4) for use in an anastomosis (abstract, Paragraph 0003) wherein the device is made of a material (material 12, material 14)(Paragraph 0020) that can be made of an extracellular matrix material such as collagen or fibronectin (Paragraph 0025).
It would have been obvious to one of ordinary skill in the art to modify the hollow body as taught by Jang to comprise an extracellular matrix material as taught by Bettuchi, since Bettuchi teaches that these materials are medically and surgically useful (Paragraph 0025).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (KR 101748551 English Machine Translation) in view of Askari et al. (US 2014/0271767).
Regarding claim 9, Jang teaches the suturable cuff as discussed above.
Jang does not teach the suturable cuff further comprising a buffer hydrogel positioned at the anchoring end to promote adhesion to the tissue construct.
Askari (Askari et al.) teaches a bioabsorbable material for use within the body near a wound (Paragraph 0002) and to promote cell growth (Paragraph 0005), wherein the bioabsorbable material comprises a buffer hydrogel (Paragraphs 0039 and 0045- 0046).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the suturable cuff as taught by Jang to have a buffer hydrogel as taught by Askari, since Jang teaches that the device can be made of any biodegradable/bioabsorbable material (Jang, Paragraph 0028), and Askari teaches that the buffer hydrogel is a bioabsorbable material (Askari, Paragraphs 0016 and 0039), that the material supports cell growth (Askari, Paragraph 0004), and the material aids in sealing the wound (Askari, Paragraph 0042).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al. (KR 101748551 English Machine Translation) in view of Brustad et al. (US 2004/0097881).
Regarding claim 23, Jang teaches the suturable cuff as discussed above.
Jang does not teach wherein, prior to integration with the hollow body, the one or more catheter liners are etched on outer surface(s) thereof to promote adhesion to the hollow body.
Brustad (Brustad et al.) teaches a known process in the art of etching an outer surface of an inner liner prior to being placed within an outer tube and for a mechanical connection between the inner tube and the outer tube (Paragraph 0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the outer surface of the catheter liner as taught by Jang to have an etched outer surface as taught by Brustad, since Brustad teaches that it is a known form of manufacturing a multiple layered tube device and acts as a connection point between the outer layer and the inner layer (Paragraph 0004).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Anwar (Anwar et al., US 7,722,665) teaches a similar suturable cuff (abstract).
Dubson (WO 2005/065578) teaches a similar suturable cuff (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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