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 Species I in the reply filed on 5/20/26 is acknowledged.
Claims 3 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/20/26.
Claims 9-24 are cancelled.
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 32 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 32 recites the limitation "the axial distance" in line 1 and “the axial distance” in line 3. There is insufficient antecedent basis for this limitation in the claim.
The Applicant’s representative is positively claiming two different “axial distance”. In order to avoid ambiguity, the Examiner suggests to identify the two axial distances with different names, such as, “a first axial distance” and “a second axial distance”.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-8 and 25, 27-32 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Carmi et al US Patent Pub 2023/0089738A1.
The applied reference has a common Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Carmi et al clearly discloses most of the structural limitations as claimed. Carmi et al discloses a prosthetic heart valve (100) having a valve frame (106) comprising a plurality of struts and a leaflet assembly. Additionally, the implant discloses a leaflet engagement frame (104) comprising a frame first rung (see Fig. 4B, section III), the first rung having a plurality of spikes that extends in a distal direction (See figure below). The distal spikes are capable of engaging with one or more native leaflets and is capable of folding the native leaflets when the valve expands (see Figs. 7-11).
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Regarding claims 2, 6, 27 and 28, see paragraph 93 disclosing the different angles of the spikes.
Regarding claim 4, see Fig4B disclosing spikes extending proximally in section III, see elements (124).
Regarding claim 5 and 8, see below for the Examiner’s interpretation of the additional rung of struts without spikes.
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Regarding claim 25, see Fig. 15.
Regarding claim 29, see first figure above showing the two frames overlapping and aligned with the struts and see figure below showing the outflow rung, the inflow rung and the intermediate rungs.
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Regarding claim 30, see figure above showing the first intermediate rung, the second intermediate rung and the third intermediate rung. Additionally, see figure above showing the distal axial struts.
Regarding claim 31, see Figure 1 showing the engagement frame first rung are aligned with the struts of the valve frame first intermediate rung.
Regarding claim 32, see the first figure above disclosing the differences of axial distance between the first axial distance and the second axial distance.
Claims 1, 2, 4-6, 8, 27 and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bergin US Patent Pub. 2022/0313428A1.
Bergin discloses a prosthetic heart valve (200) having a valve frame (205) comprising a plurality of struts and a leaflet assembly. Additionally, the implant discloses a leaflet engagement frame (201) comprising a frame first rung (211d), the first rung having a plurality of spikes (208, see paragraph 60) that extends in a distal direction (See figure below). The distal spikes are capable of engaging with one or more native leaflets and is capable of folding the native leaflets when the valve expands (see paragraph 50 disclosing that the barbs hook upwardly back toward the inflow end). Therefore, the bards are capable of folding the naturally occurring leaflets.
Regarding claims 2, 6, 27 and 28, even though the written specification does not disclose the angle of the distally and proximally spikes, spikes 208 are clearly showing an angle between 20-40 degrees, the proximally spikes (222) do not show an angle however, it is inherent to have at least an angle around 20 degrees.
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Regarding claim 4, see above for the additional rung comprising a plurality of proximally extending spikes.
Regarding claims 5 and 8, see figure above showing the circled additional rung showing struts without extending spikes and between the additional rung and the first rung.
Allowable Subject Matter
Claim 26 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 7/30/26
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