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 in the reply filed on 11/11/2025 is acknowledged. The requirement is deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 and its dependent claims are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 positively claims parts of the human body in the language “the graft is contracted to be adhered to outer peripheral surfaces of biological tubes when heat is applied to the graft in a state, in which portions of the biological tubes are inserted into the openings of the graft.” This issue is also found in the language of claims 11 and 13. It is recommended that the Applicant use functional language such as “configured to” or “configured for” to overcome the present rejection.
Claim Rejections - 35 USC § 102
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) 1-6, 9, and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Clements et al. (Pub. No. US 2018/0064931 A1; hereinafter “Clements”).
Clements discloses the following regarding claim 1: a graft for a biological tube, comprising: a graft (e.g., 100, 200) having a hollow of a specific length (e.g., Fig. 1), having openings at opposite ends along a lengthwise direction thereof (e.g., Fig. 1), and being contractible (paras. 0061-0063, 0111-0113), wherein the graft is contracted to be adhered to outer peripheral surfaces of biological tubes when heat is applied to the graft in a state (e.g., Fig. 1; paras. 0111-0113), in which portions of the biological tubes are inserted into the openings of the graft (e.g., Fig. 1; paras. 0061-0063).
Clements discloses the following regarding claim 2: the graft of claim 1, comprising: a protrusion (e.g., 110) formed on an inner peripheral surface of the graft and protruding to a radially inner side (e.g., Fig. 1).
Clements discloses the following regarding claim 3: the graft of claim 2, wherein the protrusion is curved toward a center of the graft at a specific curvature (e.g., Figs. 1, 2, 4B, 9B, 10A, 11A).
Clements discloses the following regarding claim 4: the graft of claim 3, wherein the protrusion includes a sharp portion (para. 0108), a width of which becomes gradually smaller as it goes farther away from the graft (e.g., Figs. 1, 2, 4B, 9B, 10A, 11A).
Clements discloses the following regarding claim 5: the graft of claim 1, wherein a diameter of the graft is larger than a diameter of the biological tube such that the biological tubes are inserted into the openings at a room temperature (Fig. 1; paras. 0061-0063, 0111-0113). Please note regarding claims 5, 9, and 14, the method of using or making a device is not considered germane to the patentability of the device itself. Method limitations in article claims are considered to the extent that they further define the structure of the claimed apparatus. As presently worded, the scope of the subject matter of these claims fails to structurally distinguish the present claim language over the prior art.
Clements discloses the following regarding claim 6: the graft of claim 1, comprising: a film layer (interior-facing carrier layers) formed on an inner peripheral surface of the graft and being broken when heat is applied thereto (as the protrusions are heated and move out of their initial plane and into an activated position) (paras. 0099-0102, 0111-0113, 0157).
Clements discloses the following regarding claim 9: the graft of claim 1, wherein a photo-reactive material is applied to the graft (paras. 0134, 0155), and the graft is contracted when a laser light irradiated from the laser light emitting part is applied to the photo-reactive material (paras. 0134, 0155).
Clements discloses the following regarding claim 11: the graft of claim 9, wherein the photo-reactive material is formed in partial areas adhered to the biological tubes (paras. 0134, 0155).
Clements discloses the following regarding claim 12: the graft of claim 9, wherein the photo- reactive material is formed in an entire area of the graft (paras. 0090, 0127, 0134, 0154-0155, 0159).
Clements discloses the following regarding claim 13: the graft of claim 1, further comprising: grippers (interpreted as the proximal and distal-most ends of element 100) configured to grip opposite ends of the biological tubes along a lengthwise direction thereof (e.g., Fig. 1). Regarding claims 13 and 14, please note that the claims are directed to towards the invention of a graft device and not a system or a kit. Claim language directed towards separate and/or additional devices is not germane to patentability of the claimed apparatus.
Clements discloses the following regarding claim 14: the graft of claim 9, wherein the laser light has a wavelength of 650 nm to 900 nm (paras. 0134, 0155).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clements in view of Boden et al. (Pub. No.: US 2010/0166820 A1; hereinafter “Boden”).
Clements discloses the limitations of the claimed invention, as described above. Clements further recites that its graft comprises drugs positioned between an inner-most film layer and the outer-most peripheral surface of the graft (paras. 0025, 0094, 0173). However, it does not explicitly recite that the drug is a chemical for restraining tissue fibrosis. Boden teaches that it is well known in the art that grafts comprise chemical drug agents that inhibit tissue fibrosis (paras. 0072-0073, 0077-0078), for the purpose of promoting proper healing at the implantation site. It would have been obvious to one having ordinary skill in the art to modify the graft of Clements to comprise the type of drug taught by Boden, in order to promote proper healing at the implantation site. Such a modification would be made with a reasonable expectation of success.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clements in view of Chiattello et al. (Pub. No.: US 2018/0028431 A1; hereinafter “Chiattello”).
Clements discloses the limitations of the claimed invention, as described above. However, it does not explicitly recite that the photo-reactive material is photo-reactive metallic nano particles. Chiattello teaches that it is well known in the art that grafts comprise photo-reactive metallic nano particles (paras. 0095-0099, 0161), for the purpose of utilizing the materials’ antimicrobial properties. It would have been obvious to one having ordinary skill in the art to modify the graft of Clements to comprise photo-reactive metallic nano particles as taught by Chiattello, in order to utilize the materials’ antimicrobial properties. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774