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 .
Response to Amendment
In response to the amendment filed on 5/1/2026, claims 6, 14, 16-53 have been canceled, and claims 1-5, 7-13, 15 and newly added claims 54-63 are pending.
Response to Arguments
Applicant’s arguments, see page 7, filed 5/1/2/2026, with respect to the 35 U.S.C. 112 rejections have been fully considered and are persuasive. The 35 U.S.C. 112 rejections of claims 1-16 have been withdrawn.
Applicant’s arguments, see pages 7-10, filed 5/1/2026, with respect to the prior art rejections have been fully considered and are persuasive. The prior art rejections of claims 1-5, 9-12, 15 have been withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: “wherein the first rigidity is greater 40% of the second rigidity” should recite - - wherein the first rigidity is greater than 40% of the second rigidity - - to be grammatically correct (similar to how claims 54-59 are recited). Appropriate correction is required.
Claim(s) 2-5, 9-12, 15, 54-60 is/are objected as being dependent on, and failing to cure the deficiencies of, their objected respective parent claims.
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 60 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 60 recites “the first rigidity is substantially equal to the second rigidity.” However, claim 1, from which claim 60 is dependent upon, now recites as amended, “wherein the first rigidity is greater [than] 40% of the second rigidity.” Therefore, it is unclear and not understood how the first rigidity can be both greater than 40% the second rigidity (as required by claim 1), while being substantially equal to the second rigidity (as required by claim 60). The claim limitations appear to contradict one another.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al (US 2019/0125532).
Claim 61. Lee et al discloses a balloon catheter (10) (Figs. 15-17) for deploying a prosthetic valve (12) via balloon inflation ([0008], [0010])), comprising:
an inner shaft (34) ([0088]);
an outer shaft (26) surrounding the inner shaft ([0088]);
a balloon (28) disposed at a distal end of the outer shaft defining a delivery portion (622 or 624) of the balloon catheter and having an operational portion (cylindrical portion of balloon) configured to receive the prosthetic valve (12) (Figs. 15-17; [0086], [0088]);
a distal retention bumper (126) secured to the inner shaft distal of the operational portion, the distal retention bumper being sized such that the distal retention bumper extends radially outward further than the prosthetic valve crimped onto the balloon ([0107]; “the tapered member 126 can have a diameter at its proximal end that is the same as or slightly larger than the diameter of the crimped prosthetic valve”).
Lee et al fails to explicitly disclose in the embodiment of Figs. 15-17 a proximal retention bumper secured to the inner shaft proximal of the operation portion, the proximal retention bumper being sized such that the proximal retention bumper extends radially outward further than the prosthetic valve crimped onto the balloon. However, in later embodiments (Figs. 46-47), Lee et al discloses a balloon catheter comprising both a distal retention bumper (630) secured to the inner shaft distal of the operational portion, the distal retention bumper being sized such that the distal retention bumper extends radially outward further than the prosthetic valve (12) crimped onto the balloon, and a proximal retention bumper (628) secured to the inner shaft proximal of the operation portion, the proximal retention bumper being sized such that the proximal retention bumper extends radially outward further than the prosthetic valve crimped onto the balloon ([0144]-[0146]; “the maximum diameter of the members 628, 630 at their ends adjacent the ends of the prosthetic valve desirably is about the same as or slightly greater than the outer diameter of the frame of the prosthetic valve 12 when crimped onto the balloon”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the embodiment of Figs. 15-17 of Lee et al with a proximal retention bumper secured to the inner shaft proximal of the operation portion, the proximal retention bumper being sized such that the proximal retention bumper extends radially outward further than the prosthetic valve crimped onto the balloon as taught by the embodiment of Figs. 46-47 of Lee et al to shield the prosthetic valve from contact with tissue during delivery to the target site and to prevent the prosthetic valve from being inadvertently moved on the balloon during delivery.
Lee et al as modified results in a reinforcing member (140) configured to reinforce the operational portion of the balloon catheter between the proximal retention bumper and the distal retention bumper, wherein the reinforcing member causes an increase in bending stiffness of the balloon catheter at a reinforced portion ([0114]; the mounting member 124 comprises a metal coiled wire which makes that portion of the catheter stiffer and with higher bending stiffness than a remaining portion of the catheter without the metal coiled wire; mounting member 140 comprises a relatively rigid material that does not radially compress and therefore increases the bending stiffness of the balloon catheter at that portion as compared with a portion without the relatively rigid member).
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Proximal and distal retention bumpers secured to an inner shaft of a balloon catheter for deploying a prosthetic device, wherein the bumpers extend radially outward further than the prosthetic device, is well known in the art as seen in Guerin (WO 9721400), Stack et al (US 6264683), Murray et al (US 2004/0102791)
Allowable Subject Matter
Claims 7-8 are allowed.
Claims 1-5, 9-12, 54-59 would be allowable if rewritten to obviate the claim objection to claim 1 above.
Claims 13, 62 and 63 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Lee et all, discloses the invention substantially as claimed above.
In regards to claim 1, Applicant’s arguments filed 5/1/2026 have been fully considered and found persuasive. The prior art of record does not disclose or fairly suggest either singly or combination the claimed balloon catheter as presently recited in amended claim 1.
In regards to claim 7, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed balloon catheter comprising, inter alia, the reinforcing member has a first reduced stiffness portion distal of the distal retention bumper and a second reduced stiffness portion proximal of the proximal retention bumper.
In regards to claims 13, 62 and 63, the prior art of record does not disclose or fairly suggest either singly or in combination the claimed balloon catheter comprising, inter alia, the features of the reinforcing member(s) as claimed.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
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