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 .
Priority
This application claims priority from provisional application 62/361,953 filed 07/13/2016.
Status of Claims
Claims 1-17 are pending.
Claims 5 and 11-17 have been withdrawn from consideration.
Election/Restrictions
Applicant's election with traverse of Species 5 (Figures 4A-F), Species 1B (Figures 1 and 2), Species A (Figures 2A), and Species AA (Figures 5A-D) in the reply filed on 07/17/2025 is acknowledged. The traversal is on the ground(s) that there is no undue burden upon the examiner. This is not found persuasive because each disclosed embodiment has multiple different features and functions in different manners that would each require a separate search. Searching for all of these separate embodiments creates an undue burden upon the examiner.
Upon further review claims 5 and 11-17 have been withdrawn as being directed at non-elected embodiments. Claim 5 requires the valve grasping elements to be parallel to a common axis when unbiased, but in the elected embodiment they are angled. This claim is directed at the species shown in Figures 17A-B. Claims 11-17 require the delivery system to include tethers, but the elected embodiment is not described or depicted with the tethers. The tethers are described after introducing and describing the elected delivery system shown in Figures 5A-D. These claims are directed at the species shown in Figures 8A-B.
The requirement is still deemed proper and is therefore made FINAL.
The applicant is advised to maintain/update these withdrawn claims during the course of examination so they are consistent with the pending claims such that they can be rejoined should the case be placed in condition for allowance.
Specification
The disclosure is objected to because of the following informalities: missing/outdated priority information. Since the filing of this application at least one of the parent applications have been issued patent numbers. Additionally there is a blank space providing no numbers. The priority information within the first line of the specification must be amended to disclose these patent numbers.
Appropriate correction is required.
Information Disclosure Statement
The Information Disclosure Statements filed on 01/04/22, 10/24/22, 10/04/23, 08/22/24, and 06/12/25 have been considered by the examiner.
Applicant should note that the large number of references (400 references) in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). It appears that not all of the cited references are relevant to the patentability of the claims. For example cited reference US 6,663,068 HUANG is directed at a beverage holder. 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.
Additionally the information disclosure statement has numerous citations stricken through. The applicant has cited both whole US applications and individual documents instead of the relevant references from prosecution of these applications. This is the equivalent to citing an author or the entire work of an author rather than an individual book.
They are also stricken through because the office actions and other correspondence within those applications are not documents relevant to the patentability of the current claims. These documents may have citations to relevant documents, but the documents themselves are not relevant. They are not addressing the same claim language and were not drafted with the current claims in mind.
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 2-4 and 6-10 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.
All of the dependent claims 2-5 and 7-17 as well as independent claim 6 are rendered indefinite for antecedent basis issues. Each claim refers back to the valve clip of claim 1, but uses “a” instead of “the”. The preambles for each dependent claim should be amended to recite “The valve clip”. Additionally, line 3 of claim 6 should be amended to recite “the valve clip” and line 4 should be amended to recite “the deployment shaft of claim 1”.
Claim 4 is rendered indefinite because the last line appears to be an incomplete clause. It is unclear what the applicant intended by the recitation “the outer and inner arms pairs”. The applicant is advised to delete this phrase
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) 1-4 and 6-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ketai et al (Ketai) US 2013/0066341 A1.
1. Ketai discloses a valve clip 58 (Figure 29) comprising: a hub 69 configured to be removably attached to a deployment shaft 12; a first pair of leaf capture arms 18A/16A comprising a first inner arm 16A and a first outer arm 18A coupled to the hub (Figure 29); and a second pair of leaf capture arms 18B/16B comprising a second inner 16B arm and a second outer arm 18B coupled to the hub (Figure 29); wherein the outer and inner arms are configured to be biased apart to create a leaf capture space therebetween (tethers bias the inner arms away from the outer arms as shown in Figure 29) and to self-close over a valve leaflet when unbiased after the leaflet has been captured (Figure 36 shows the tethers released allowing them to self-close and capture leaflets placed therein).
2. Ketai discloses the leaf capture arms 18AB/16AB are formed as a leaf spring (they are thin flat flexing strips which read on the broadest reasonable definition of a leaf spring) with a resilient base attached to the hub and a less-resilient valve-grasping element extending from the base (Figure 29).
3. Ketai discloses the valve-grasping elements diverge from the base to form a V-shape when the outer and inner arms are unbiased (Figure 36).
4. Ketai discloses the base is curved and the valve grasping element is straight (16AB Figure 29).
6. Ketai discloses a system for delivering a valve clip to heart or venous valve (Figure 29), the system comprising: a valve clip as claim 1 (see description of claim 1 above) and a deployment shaft 12/19 configured to be removably attached to the hub of the valve clip.
7. Ketai discloses a steerable deployment catheter coupled to the deployment shaft ([0095] discloses the catheter used is a guide catheter which is fully capable of being steered to the implant site).
8. and 9. Ketai discloses inferior/superior end of the deployment shaft is configured to be coupled to the steerable deployment catheter ([0095] discloses the tools are coupled to the guide catheter, in reference to the superior or inferior ends, the claims fail to quantify which ends of the device or implant are superior or inferior. Furthermore these descriptors are dependent upon the user’s perspective. Therefore one of ordinary skill in the art could interpret the upper end of the tool to be either the superior or inferior ends.
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ketai in view of Zentgraf et al (Zentgraf) US 2013/0150710 A1.
Ketai discloses the invention substantially as claimed being described above. However, Ketai does not disclose the catheter includes an imaging component.
Zentgraf teaches the use of catheters comprising imaging systems using imaging probes [0009]-[0010] in the same field of endeavor for the purpose of providing the surgeon with real time imaging.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the catheter imaging system of Zentgraf with Ketai in order to provide the operator with real time imaging to ensure proper implantation and functionality prior to completely releasing or withdrawing any tools/implants.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
Prosecution Insights