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
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/13/2026.
The restriction requirement was directed towards species and subspecies. Claims 12-20 are directed towards a species which includes a slider with a stop. This is not found in figure 3 which was elected.
IDS
Applicant should note that the large number of references in the attached IDS have been considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Drawings
The drawings are objected to because drawings 1-12 are grainy and details cannot be discerned from the drawings. For instance in figure 2elements such as the pull cord, pull cord driver, implant and cable junction are labeled in the drawing however there is no detail that can be seen. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Element 322 found in figures 2-5 is labeled as “actuation” in paragraphs 0110, 0113 and 0119; however paragraph states “increased tension 322”. The elements in the drawing should be labeled consistently.
Element 615 is labeled as a “transfer device” in paragraph 0027 however in paragraph 0128 element 615 is labeled as a “sling”. The elements in the drawing should be labeled consistently.
Element 625 is labeled as “sling 625” in paragraphs 0128-0129, however also in paragraph 0129 element 625 is referred to as a “loop”. The elements in the drawing should be labeled consistently.
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 1-11 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 1 recites “in which the fastening device is configured to release the implant”. This language could mean that the fastening device releases the implant and the fastening device and implant are no longer connected or it could mean that the fastening device and implant are releasable from the implant location. The language is indefinite in that the meaning is unclear.
Claims 2-11 are also rejected in that they depend from claim 1, which is rejected.
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.
Claims 1-4 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Struthers et al. US 2021/0052793.
Regarding claim 1: Struthers discloses an implantable device 202 (figure 3) for use as a heart support system (“circulatory support pump”, abstract), the implant device 202 comprising:
an implant comprising a heart pump 206 (“blood pump”, figure 3) configured for implanting in a vascular canal (“According to embodiments, the circulatory support device 102 may be a ventricular assist device, such as a pump, that is configured to pump blood from a left ventricle 108 of a subject into the subject's aorta 110.”);
a fastening device 204 (anchoring device, figure 3) connected to the implant (the anchoring device 204 is connected to the blood pump 206 at the distal end of the blood pump 208); the fastening device 204 has a fastening position when the anchor is expanded as in figure 3; the fastening device further can be collapsed for implant (a sleeve, sheath or catheter can be used to constrain the anchor (paragraph 0061) or figures 7A/7B show the anchor 502 both expanded and collapsed via a push pull rod 510); and
a transfer device 510 (figures 7A/7B, push-pull rod) coupled to the fastening device and adapted to cause the fastening device to move between the fastening position and the release position in response to actuation (movement of arrow 510).
Regarding claim 2: Struthers discloses that the fastening device 204 (figure 3) is foldable and considered to be a foldable frame (figures 7A/7B, paragraph 0080).
Regarding claim 3: Struthers discloses that the transfer device 510 (figures 7A/7B) includes a pull cord 510 (“push-pull rod”, figures 7A/7B), the pull cord 510 is responsible for actuation via a pulling or pushing movement to transfer the anchor 502 from an expanded position 7A to a collapsed position 7B.
Regarding claim 4: Struthers discloses that the fastening device 510( figures 7A/7B) has three arms 216A/216B/216C (figure 3) which are shaped to radially contact the vascular canal at three points (paragraph 0063).
Regarding claim 11: Struthers discloses a sleeve (“sleeve, a sheath, a catheter”, paragraph 0061) shaped to receive the fastening device in the release position and the implant (paragraph 0061).
Allowable Subject Matter
Claims 5-10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Upon allowance a detailed reasons for allowance will be provided. However, claims 5 and 9 appear to have allowable subject matter. Claim 5 includes a holding frame with feet and X-ray markers. Claim 9 includes a sling shaped to wrap around the fastening device. These appear to be unique concepts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796