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 Arguments
Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The combination of references cited meets the amendments to the claims submitted in the response of 1/2/2026. Examiner notes that the instantly recited imaging window region, while implying a difference from the rest of the catheter, is disclosed in the spec as being up to the entire length of the device (0047-0050). Examiner notes that while this allows for the instant rejection, elements of the spec, specifying the imaging window, length, composition, and overlap/implementation of elements at joints appears to differ from the art of record (though it is not currently claimed). Should Applicant wish to discuss this, Examiner is welcome to an interview to review specifics.
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.
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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al (US 2014/0180122) in view of Gregorich (US 2014/0276109).
With respect to claims 1-5, 8, and 13-15, and 20, Stigall et al discloses and teaches an IVUS (0057, Claims 18-19)/intravascular imaging device (With OCT, 0057) including a catheter shaft with telescoping assembly and catheter body (Fig 1-4, 0052-0057), the catheter body includes a hypotube section (Fig 3-4), an imaging window (Fig 3), and distal end with guidewire lumen (Fig 1-4). The hypotube region includes “slots” therein, and the IVUS includes a translatable ultrasonic imaging element (Fig 3)) within the catheter (Fig 3-4). Finally, the proximal portion of the hypotube region of Stigall et al is free from slots (Fig 2, and a portion of the hypotube includes slots). Finally, the device includes a polymer jacket over the proximal end of the imaging window and the distal end of the abutting hypotube region (0065-0073, Fig 7, 8, 16-18,). Stigall et al fails to disclose or teach multiple groups of “slots” at multiple locations along the hypo tube.
Attention is hereby directed to the teaching reference to Gregorich (US 2014/0276109) which discloses and teaches intravascular hypotube device a catheter shaft with telescoping assembly and catheter body (0028-0029, Fig 5), the catheter body includes a hypotube section (Fig 5, 348), proximal section (Fig 5), and distal end with guidewire lumen (Fig 5, 312). The hypotube region includes “slots” therein, specifically such that multiple arrangements are possible to customize the flexibility of the tube (Fig 2, 3, 5, 0030, 0033-0034, 0037, 0040). Finally, the proximal portion of the hypotube region of Gregorich et al is free from slots (Fig 5, 0045-0046, and a portion of the hypotube includes slots, 318). Gregorich includes disclosure for multiple possibilities for imaging implementation (0062-0063) and it would be obvious to one of ordinary skill in the art at the time of the invention to have utilized the teachings of Gregorich for hypotube slots to improve flexibility in the system of Stigall et al for the purpose of enabling varying thickness of walls (for the aforementioned flexibility, abs, 0045, Gregorich).
Regarding claims 9-12 and 16-19, Stigall et al discloses what is listed above, and additionally discloses the distal portion of the hypotube including the slots (Fig 3-5, 10-11), the slots are formed in a helical pattern, and lie within a plane normal to the longitudinal axis (0054, 0045-0046, Fig 5, Fig 11 (Helical or spiral pattern)). Finally, the proximal region of the imaging window region is disposed along an outer or inner surface of the hypotube region (Fig 5, 0045-0050, can be either, 0055 for variable stiffness/transmissiveness) and the device includes a polymer jacket over the proximal end of the imaging window and the distal end of the hypotube region (0065-0073, Fig 7, 8, 16-18, with 0069 for spiral cut).
With respect to claims 6-7, Stigall et al discloses and teaches the system of claim 1, and further that the slots are along a particular portion of the hypotube region (and not others, see above, Fig 2-4), but does not specify the distance-based length over which the hypotube slots cover from proximal/distal (in cm). Nevertheless, Stigall et al specifically does teach the slots being disposed along sections and not other sections of the hypotube region (as desired to the variable stiffness). Therefore, it would be obvious to one of ordinary skill in the art at the time of the invention to set the section of the hypotube which includes the slots to be whichever length of the hypotube is desired for the given modular stiffness (variable stiffness) desired as a result (See Stigall, 0005-0011, fig 5-15, including midsection assemblies and hypotube specifics (Fig 5, 8a-b, 9)).
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 JOEL M. LAMPRECHT whose telephone number is (571)272-3250. The examiner can normally be reached Mon - Fri 9:00-5:30.
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, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOEL LAMPRECHT/Primary Examiner, Art Unit 3798