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 with traverse of the invention of Group I and Species A in the reply filed 6/23/2026, is acknowledged.
Applicant's traversal is on the grounds that search and examination of the entire application can be made without serious burden to the Examiner. Applicant's traversal has been carefully considered, but fails to establish error in the propriety of the present requirement for restriction and election.
Though Applicant asserts that examination of all pending claims would not pose an undue burden on the Examiner, such is not an accurate assertion in light of the disparate nature of the presently claimed subject matter as noted in the Requirement for Restriction of 4/23/2026. Consideration of the plurality of inventions that Applicant has claimed would significantly compromise and preclude a quality examination on the merits. Furthermore, execution of a search encompassing the entirety of Applicant's inventions and species would not only constitute an undue burden on the Examiner, but consideration of the findings of such a search in accordance with the requirements of the law under 35 U.S.C. §§101, 102, 103 and 112 would be unduly onerous.
Moreover, it is further noted that a comprehensive search for the presently claimed subject matter is not solely limited to a search of the classes and subclasses in which they are classified. Therefore, it is obvious that a comprehensive search of the copious amounts of patent and non-patent literature for each of the patentably distinct inventions and their permutations presently claimed would necessarily place an undue burden on the Examiner.
Therefore, for the reasons above and those made of record in the Requirement for Restriction of 4/23/2026, the restriction requirement is deemed proper and is made FINAL.
Claims 33-35 and 39-42 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being to non-elected inventions and species embodiments, there being no allowable generic or linking claim.
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.
Claims 23, 32, 38, and their 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 23 states that the receptacle at least partially is in contact with the tubular bodily structure. Claim 32 states that a central channel encloses the tubular bodily structure. Claim 38 states that the channel encloses said tubular body structure. This language positively recites a part of the human body. It is recommended that the Applicant use functional language such as adapted to/for or configured to/for to overcome this rejection. 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 25, 29-30, 32, 36, 38, and their dependent claims 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. Regarding claims 25, 29-30, 36,the term "preferably" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is required.
Claims 32 and 38 recite that the perivascular implant comprises a channel adapted for partially embracing the tubular bodily structure; and a central channel enclosing the tubular bodily structure. It is unclear if the channel and the central channel are intended to be the same or different elements. Appropriate correction and/or clarification is required.
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) 23-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morrison et al. (WO 02/15914 A1; hereinafter “Morrison”).
Morrison discloses the following regarding claim 23: a perivascular implant (Figs. 1-4) comprising: (i) a housing (please see, for example, the annotated Figure A below; Figs. 1-4) comprising a receptacle (Figure A; Figs. 1-4) for an effector matrix (Figs. 1-4, where the receptacles are fully capable of containing an effector matrix); and (ii) a fastening element (Figs. 1-4; pgs. 14-15) adapted for at least partially embracing a tubular bodily structure (Figs. 1-4; pgs. 14-15, where the fastening element at least partially surrounds the contained vein and artery tubular body structures), wherein the housing, the receptacle for an effector matrix, and the fastening element are arranged such that after implantation of the perivascular implant the receptacle for an effector matrix at least partially is in contact with the tubular bodily structure and/or a vasculature originating from the tubular bodily structure (Figs. 1-4).
PNG
media_image1.png
263
358
media_image1.png
Greyscale
Figure A.
Morrison discloses the following regarding claim 24: the perivascular implant of claim 23, wherein the tubular bodily structure comprises at least one blood vessel (Figs. 1-4).
Morrison discloses the following regarding claim 25: the perivascular implant of claim 23, wherein the tubular bodily structure is a vascular bundle (Figs. 1-4) (where the vascular bundle is being interpreted as a group of vascular objects, i.e., the vein and the artery), preferably an epigastric pedicle.
Morrison discloses the following regarding claim 26: the perivascular implant of claim 23, wherein the fastening element is formed by the housing and/or the receptacle for an effector matrix (Figs. 1-4; pgs. 14-15).
Morrison discloses the following regarding claim 27: the perivascular implant of claim 23, wherein the housing, the receptacle for an effector matrix and the effector matrix form a channel (space holding the vein and artery) (Figs. 1-4) adapted for at least partially embracing the tubular bodily structure (Figs. 1-4).
Morrison discloses the following regarding claim 28: the perivascular implant of claim 23, wherein the perivascular implant further comprises an effector matrix (pgs. 6-8).
Morrison discloses the following regarding claim 29: the perivascular implant of claim 23, wherein the effector matrix comprises a matrix material and effector cells (pgs. 6-8), preferably wherein the effector matrix, and optionally the perivascular implant, can be explanted and resected without leaving effector cells within the body of the subject.
Morrison discloses the following regarding claim 30: the perivascular implant of claims 23, wherein the housing is at least partially coated with at least one modulator compound (pgs. 6-8, 10-11), preferably wherein the modulator compound is heparin and/or a growth factor, preferably basic fibroblast growth factor (bFGF), nerve growth factor (NGF), and/or vascular endothelial growth factor (VEGF).
Morrison discloses the following regarding claim 31: the perivascular implant of claim 23, wherein the perivascular implant is comprised of two essentially half-cylindrical elements together forming a central channel (groove holding the vein and artery) enclosing the tubular bodily structure (Figs. 3-4).
As best interpreted, Morrison discloses the following regarding claim 32: the perivascular implant of claim 23, wherein the perivascular implant further comprises an effector matrix (pgs. 6-8), wherein: (a) the housing, the receptacle for an effector matrix and the effector matrix form a channel (space holding the vein and artery) (Figs. 1-4) adapted for at least partially embracing the tubular bodily structure (Figs. 1-4), (b) the perivascular implant is comprised of two essentially half-cylindrical elements (Figs. 3-4) together forming a central channel (central space holding the vein and the artery) enclosing the tubular bodily structure (Figs. 3-4), and (c) the tubular bodily structure comprises at least one blood vessel (Figs. 3-4).
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) 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morrison in view of Kuraguntla et al. (US Pat. No.: 10,542,931; hereinafter “Kuraguntla”).
Morrison discloses the limitations of the claimed invention, as described above. However, it does not recite the perivascular implant comprising at least one sensor element. Kuraguntla teaches that it is well known in the art that vascular implants comprise at least one sensor element (col. 5, lines 30-64), for the purpose of monitoring fluid flow and providing additional diagnostic information. It would have been obvious to one having ordinary skill in the art to modify the device of Morrison to comprise a sensor, as taught by Kuraguntla, in order to monitor fluid flow and provide additional diagnostic information regarding the patient. Such a modification would be made with a reasonable expectation of success.
Claim(s) 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morrison in view of Zhang et al. (Pub. No.: US 2019/0030212 A1; hereinafter “Zhang”).
Morrison discloses the limitations of the claimed invention, as described above. However, it does not recite the implant comprising a matrix material having gelatin methacrylate blend hydrogel. Zhang teaches that it is well known in the art that vascular implants comprise a gelatin methacrylate hydrogel blend (paras. 0031-0032, 0051-0054), for the purpose of utilizing the material’s biomimetic properties. It would have been obvious to one having ordinary skill in the art to modify the device of Morrison to comprise a gelatin methacrylate hydrogel blend, as taught by Zhang, in order to utilize the material’s biomimetic properties. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of matrix material for another, is generally considered to be within the level of ordinary skill in the art.
Morrison teaches the following regarding claim 37: the perivascular implant of claim 28, wherein: and/or (b) the effector cells secrete at least one of insulin, glucagon, a growth hormone, and a cytokine (pg. 7).
Morrison teaches the following regarding claim 38: the perivascular implant of claim 23, wherein the perivascular implant further comprises an effector matrix (pgs. 6-8) comprising a matrix material and effector cells (pgs. 6-8), wherein: (b) the effector cells secrete at least one of insulin, glucagon, a growth hormone, and a cytokine (pg. 7), (c) the housing, the receptacle for an effector matrix and the effector matrix form a channel (groove holding the vein and artery) adapted for at least partially embracing said tubular bodily structure (Figs. 1-4), (d) the perivascular implant is comprised of two essentially half-cylindrical elements together forming a central channel (central opening holding the vein and artery) enclosing said tubular bodily structure (Figs. 3-4), and (e) the tubular bodily structure comprises at least one blood vessel (Figs. 3-4).
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774
Prosecution Insights