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
The amendment filed 01/21/2026 has been entered. Claim 30 has been amended. Claim 35 has been cancelled. Claims 19-34 remain pending in this application. Claims 19-29 are withdrawn.
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
Applicant argues that Brannan and Lazarus cannot be combined. Applicant points to the distal tip 15 of Brannan being a tissue dissector and argues that if the tissue dissector were bendable, the surrounding anatomy could be damaged. However, Brannan discloses that the distal tip may be rounded or dull to prevent unintentional damage (¶ 0031). Thus, such modification to the tip of Brannan such that it is angularly steerable relative to the central axis would provide the advantage of allowing the catheter to be steerable through body lumena or cavities, as taught by Lazarus. Such modification would not damage the surrounding anatomy since the tip of Brannan can be round or dull to prevent unintentional damage (¶ 0031).
Accordingly, claims 30-34 are obvious over Brannan in view of Lazarus.
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) 30-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brannan et al. (Pub. No.: US 2012/0203220 A1) in view of Lazarus et al. (US Pat. No.: 5,415,633).
Regarding claim 30, Brannan discloses (fig. 1-3) a catheter (tissue dissector 6) comprising:
A central tube (cannula 8), the central tube having a side wall defining a first outer diameter (fig. 2) and an open distal end (11) (¶ 0022, fig. 2);
A tip (distal end 19 of introducer 10) movable with respect to the central tube (¶ 0023), wherein the tip is adjustable between a retracted position, in which the tip is positioned in the central tube (fig. 2, ¶ 0024), and an extended position, in which the tip is positioned beyond the distal end (fig. 3, ¶ 0024), and wherein the tip has a second outer diameter that is larger than the first outer diameter when the tip is in the extended position (fig. 3, see diameter of inflatable balloon 22),
Wherein the central tube defines a central axis (longitudinal axis “A-A”, ¶ 0024).
Brannan fails to disclose wherein the tip is angularly steerable relative to the central axis.
Lazarus teaches (fig. 1-2) a catheter (steerable catheterization device 10) and thus in the same field of endeavor, comprising: a tip (16), wherein the tip is angularly steerable relative to the central axis (axis “A”, fig. 1, col. 3, ln. 65-67) in order to allow the catheter to be steerable through body lumena or cavities (col. 1, ln. 8-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tip of Brannan such that it is angularly steerable relative to the central axis, as taught by Lazarus, in order to allow the catheter to be steerable through body lumena or cavities (Lazarus col. 1, ln. 8-10).
Regarding claim 31, Brannan discloses wherein at least a portion of the tip (inflatable balloon 22) is inflated when in the extended position (fig. 3, ¶ 0033).
Regarding claim 32, Brannan discloses wherein the tip includes a first portion (shaft 18) and a pouch (inflatable balloon 22) extending around the circumference of the first portion (fig. 3).
Regarding claim 33, Brannan in view of Lazarus fail to explicitly disclose wherein the pouch is inflated to lock the tip in the extended position.
However, such limitation of claim 33 relates to the intended use of the system, which, in this case, imparts no further limitations on the structure of the device. The pouch of Brannan inflates (fig. 3, ¶ 0033) and is capable of locking the tip in the extended position and using the device for this purpose requires only routine skill in the art (See § MPEP 2114 II). Further, it can be seen in fig. 3 that when the pouch is inflated, the tip is unable to retract into the retracted position.
Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the device of Brannan in view of Lazarus such that the pouch is inflated to lock the tip in the extended position, in order to maintain the tip in the extended position.
Regarding claim 34¸ Brannan in view of Lazarus fail to disclose wherein the tip includes a bimorph actuator encapsulated therein.
Lazarus further teaches (fig. 1-3A) wherein the tip includes a bimorph actuator encapsulated therein (col. 4, ln. 25-27) in order to steer the catheter through body lumena or cavities (Lazarus col. 1, ln. 8-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tip of Brannan in view of Lazarus such that it includes a bimorph actuator encapsulated therein, as taught by Lazarus, in order to steer the catheter through body lumena or cavities (Lazarus col. 1, ln. 8-10).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Osypka et al. (Pub. No.: US 2019/0255292 A1) discloses a catheter comprising a tip that is angularly steerable. Kline (Pat. No.: 5,376,094) discloses a catheter comprising a tip movable with respect to a central tube.
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.
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/MEAGAN NGO/Examiner, Art Unit 3781
/PHILIP R WIEST/Primary Examiner, Art Unit 3781