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 .
Information Disclosure Statement
None of the IDSs have been considered at this moment, since, every IDS document does not provide the signature of the applicant or representative in accordance with CFR 1.33.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 5/26/26 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/26.
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, 3, and 10-13 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 claim 2, the claim is indefinite, since, it is not clear where the receptacle is located. Does the receptacle is located in the sleeve? Clarification is required.
Regrading claim 3, claim 2 is already positively claiming the protrusion in the lock, does the applicant’s representative is trying to positively claim a different protrusion? If yes, the applicant’s representative must differentiate between each protrusion, such as, “a second protrusion” or something alike.
Regarding claim 10, the Examiner is not clear which “tube” does the Applicant’s representative is claiming. Does the “tube” is element 330 in Fig. 3C? Clarification is required.
Claim 12 recites the limitation "the second sleeve" in line 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, the Examiner suggest to add: a longitudinal movement in lines 1 and 2.
Regarding claim 11, the Examiner suggest to add: the anchor support in lines 2 and 3.
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)(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 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Desrosiers et al US Patent Pub. 2020/0113719A1.
Desrosiers et al discloses a catheter system (3600, see Figs. 11A-B) for implanting a prosthetic heart valve, the catheter system comprising: an elongated shaft (4910) comprising a proximal region and a distal region; a deployment assembly (see figure below) at the distal region of the elongated shaft. The deployment assembly comprising a sleeve (see figure below), an anchor support (4914) configured to be disposed within the sleeve during delivery to maintain at least a portion of the prosthetic heart valve in the collapsed state between the sleeve and the anchor support. A lock (7000, see Figs. 13-15B) configured to lock the sleeve to the anchor support during delivery and a handle (inherent) disposed at a proximal region of the elongated shaft, the handle configured to, when actuated, cause the lock of the deployment assembly to unlock such that the anchor support is longitudinally moveable relative to the sleeve for expanding and implanting the prosthetic heart valve (see paragraph 69 disclosing a controlled wire).
Regarding claim 2, the lock (7000) comprises a protrusion (7020) configured to extend into a receptacle (see figure below) to lock the sleeve.
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Claims 1 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schreck US Patent Pub. 2019/0175375A1.
Schreck discloses a catheter system (see Fig. 9) for implanting a prosthetic heart valve, the catheter system comprising: an elongated shaft (see Fig. 9) comprising a proximal region and a distal region; a deployment assembly (see figure 9) at the distal region of the elongated shaft. The deployment assembly comprising a sleeve (26), an anchor support (28) configured to be disposed within the sleeve during delivery to maintain at least a portion of the prosthetic heart valve in the collapsed state between the sleeve and the anchor support. A lock (the interaction between elements 26 and 28) configured to lock the sleeve to the anchor support during delivery and a handle (inherent) disposed at a proximal region of the elongated shaft, the handle configured to, when actuated, cause the lock of the deployment assembly to unlock such that the anchor support is longitudinally moveable relative to the sleeve for expanding and implanting the prosthetic heart valve (see Fig. 10).
Regarding claim 7, see Figure 10 disclosing a second sleeve (21).
Regarding claim 8, see Figure 4 showing the second sleeve holding a distal end of the implant.
Regarding claim 9, see Figure 10 showing longitudinal distal movement of the second sleeve (21) that causes the anchor support (28) to move longitudinally.
Regarding claim 10, see figure below showing the tube passing longitudinally within the anchor support and having a non-uniform outer diameter.
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Claim Rejections - 35 USC § 103
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 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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Schreck US Patent Pub. 2019/0175375A1 in view of Alon et al US Patent Pub. 2010/0049313A1.
Schreck et al discloses the invention substantially as claimed. However, Schreck et al is silent regarding a handle and does not disclose a rotating actuator.
Alon et al teaches a catheter having a handle (408) and a rotational knob (432) operable to control longitudinal movement of the main shaft.
It would have been obvious to one having ordinary skill in the art to modify the Schreck et al reference catheter by adding a rotational actuator at the handle of the Schreck et al reference to have a better control of the deployment of the stent at the deployment assembly.
Allowable Subject Matter
Claims 3-6 and 11-12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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.
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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 8/4/26