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Claims 12-14 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 13 February 2026.
The examiner has unified Species A and B as previously enumerated for the elected species.
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) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pre-Grant Publication 2013/0197497 to Wittenberger et al. (Wittenberger hereinafter).
Regarding claim 1, Wittenberger teaches fluid evacuation device for a balloon catheter (10) comprising: at least one spine (48) comprising a curved proximal portion and a straight distal portion (see Fig. 6, straight portion attached to 42) extending along a longitudinal axis; a first coupler (between 12 and 18) coupled to the curved proximal portion of the spine to constrain at least one spine to move along the longitudinal axis; and a second coupler (42) attached to the distal portion of the at least one spine so that:
(a) in a first operational mode, the curved proximal portion of the at least one spine is expanded to a first outer profile; and
(b) in a second operational mode, the curved proximal portion of the at least one spine is compressed to a smaller outer profile (analogous to Fig. 4) than the first outer profile such that the at least one spine moves the second coupler along the longitudinal axis.
Hauck teaches fluid evacuation device for a balloon catheter (10) comprising a balloon (94), a tubular shaft (82), a
Regarding claim 2, Wittenberger teaches a sheath (not shown, paragraph 19, last sentence), the at least one spine being one of a plurality of spines forming a cage (see Fig. 6), each of the plurality of spines having a curved proximal portion and a straight distal portion, the curved proximal portion configured to transition from the first outer profile to the smaller outer profile responsive to a sliding retraction of the cage into the sheath.
Regarding claims 3 and 5, Wittenberg teaches a tubular shaft (54), a sleeve (12) configured to constrain the curved proximal portion to move relative to the first coupler.
Regarding claim 4, Wittenberg teaches a guidewire lumen (16).
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) 6-11, 15-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wittenberger in view of US Pre-Grant Publication 2021/0145421 to Hauck et al. (Hauck).
Regarding claim 6, Wittenberger teaches fluid evacuation device for a balloon catheter (10) comprising: at least one spine (48) comprising a curved proximal portion and a straight distal portion (see Fig. 6, straight portion attached to 42) extending along a longitudinal axis; a first coupler (between 12 and 18) coupled to the curved proximal portion of the spine to constrain at least one spine to move along the longitudinal axis; and a second coupler (42) attached to the distal portion of the at least one spine. Wittenberger does not teach that movement of the second coupler prevents or allows fluid from flowing through a fluid port. Hauck teaches a tubular shaft (54), a fluid port (14), and a second coupler (134) which moves to seal and unseal a port (104) for inflation and deflation of the balloon. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a port and second coupler (which would be at least indirectly attached to the spines) in order to positively control inflation of the balloon of Wittenberger.
Regarding claim 15, Wittenberger teaches fluid evacuation device for a balloon catheter (10) comprising: at least one spine (48) comprising a curved proximal portion and a straight distal portion (see Fig. 6, straight portion attached to 42) extending along a longitudinal axis; a first coupler (between 12 and 18) coupled to the curved proximal portion of the spine to constrain at least one spine to move along the longitudinal axis; and a second coupler (42) attached to the distal portion of the at least one spine. Wittenberger does not teach that movement of the second coupler prevents or allows fluid from flowing through a fluid port. Hauck teaches a tubular shaft (54), a fluid port (14), and a second coupler (134) which moves to seal and unseal a port (104) for inflation and deflation of the balloon. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to use a port and second coupler (which would be at least indirectly attached to the spines) in order to positively control inflation of the balloon of Wittenberger.
Regarding claim 20, the previously applied references are silent to multiple ports. However, it has been held that the mere duplication of previously known parts does not constitute a patentable distinction (MPEP 2144.04 VI. B). Since the provision of a plurality of irrigation ports is merely the repetition of the port (134) of Hauck, it would have been obvious to one of ordinary skill to provide the plurality as the mere repetition of previously known parts.
Allowable Subject Matter
Claims 7-11, 16-18 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 limitations of a balloon catheter having first and second couplers wherein the second coupler opens and closes an inflation port, further wherein a spine of the balloon is configured to slide the second coupler from the closed to the open position.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 30 May 2026
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