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 .
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Seiss et al (US 2019/0046702, hereinafter “Siess”).
Regarding claim 1, Seiss discloses an inlet device for use in a mechanical circulatory support system, the inlet device (pars 0004-0006) comprising: an inlet portion for admitting a body fluid of a patient into the inlet device (see figure 1, element 11; par 0036); and a transfer portion connected to and in fluid communication with the inlet portion and having a support structure, wherein the transfer portion is deformably formed (see figure 1, element 3 and distal end portion EP; par 0036-0037).
Regarding claim 2, Seiss discloses that the transfer portion comprises a transition portion adjacent to and in fluid communication with the inlet portion (par 0036-0037).
Regarding claim 3, Seiss discloses the transition portion comprises
a variable cross-sectional area and/or variable diameter (see figures 1-6 for various cross sections of the distal end; par 0036-0037).
Regarding claim 4, Seiss discloses the variable cross-sectional area
and/or variable diameter of the transition portion increases away from the inlet portion (see figures 1-6 for various cross sections of the distal end which include increases in diameter towards the distal portion and away from the inlet portion 11; par 0036-0037).
Regarding claim 5, Seiss discloses a cross-sectional area and/or diameter of the transfer portion is greater than a cross-sectional area and/or diameter of the inlet portion (see figures 1-6 for various cross sections of the distal end which include increases in diameter towards the distal portion and away from the inlet portion 11 such that a cross-sectional area and/or diameter of the transfer portion is greater than a cross-sectional area and/or diameter of the inlet portion; par 0036-0037).
Regarding claim 6, Seiss discloses the cross-sectional area and/or the diameter of the transfer portion is 25% to 35% greater than the cross-sectional area and/or diameter of the inlet portion (see figures 1-6 for various cross sections of the distal end which include increases in diameter towards the distal portion and away from the inlet portion 11 such that a cross-sectional area and/or diameter of the transfer portion is greater than a cross-sectional area and/or diameter of the inlet portion, wherein the cross-sectional area and/or the diameter of the transfer portion is 25% to 35% greater than the cross-sectional area and/or diameter of the inlet portion; par 0036-0037).
Regarding claim 7, Seiss discloses an inner and/or an outer surface of the transfer portion comprises a polymer coating and/or a polymeric sleeve (pars 0038-0043).
Regarding claim 8, Seiss discloses the support structure of the transfer portion is formed from a plurality of serrated and/or zig-zagged structural elements (pars 0020, 0044).
Regarding claim 9, Seiss discloses the serrated and/or zig-zagged structural elements are arranged substantially obliquely to a longitudinal axis of the transfer portion and comprise finger elements (pars 0020, 0044; see figures 6-7).
Regarding claim 10, Seiss discloses the support structure of the transfer portion is formed from a plurality of structural elements arranged substantially obliquely to a longitudinal axis of the transfer portion (pars 0020, 0044; see figures 6-7).
Regarding claim 11, Seiss discloses the support structure of the transfer portion is at least partially wound (pars 0020, 0044; see figures 6-7).
Regarding claim 12, Seiss discloses the inlet device is at least partially wound (pars 0020, 0044; see figures 6-7).
Regarding claim 13, Seiss discloses the support structure comprises a super-elastic material (pars 0020, 0044; see figures 6-7).
Regarding claim 14, Seiss discloses an inlet device according to Claim 13, wherein the super-elastic material comprises Nitinol (pars 0020, 0044; see figures 6-7).
Regarding claim 15, Seiss discloses the inlet device comprises a super-elastic material (pars 0020, 0044; see figures 6-7).
Regarding claim 16, Seiss discloses the super-elastic material comprises Nitinol (pars 0020, 0044; see figures 6-7).
Regarding claim 17, Seiss discloses the support structure prevents collapse of the transfer section while a body fluid of a patient is transferred through the inlet device (pars 0007-0008, 0019).
Regarding claim 18, Seiss discloses the body fluid is blood (par 0036).
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.
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.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Seiss in view of Mitze et al (US 2022/0161021, hereinafter “Mitze”).
Regarding claims 19 and 20, Seiss discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the transfer portion comprises a plurality of cuts configured to increase flexibility of the transfer portion, nor a width between adjacent cuts decreases from a proximal section of the inlet device to a distal section of the inlet device. Mitze is analogous art in regard to known structures for blood pumps (see figures 1, 9A-B). Mitze discloses it was known in the art to provide a plurality of cuts configured to increase flexibility of an elongated portion, where it was further known to modify the shape to affect a ratio of flexibility and rigidity (par 0065, 0139), where a width between adjacent cuts can decrease from a proximal section of the inlet device to a distal section of the inlet device (see figures 9A-B, par 0075). Applied to the invention of Seiss, the features of Mitze would provide a plurality of cuts configured to increase flexibility of the transfer portion, further including a width between adjacent cuts decreases from a proximal section of the inlet device to a distal section of the inlet device as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the features of Mitze in the invention of Seiss, since such a modification would provide the predictable results of a conventionally known flexible body that promotes for minimally invasive implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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, Niketa Patel can be reached at (571) 272-4156. 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.
Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799
Prosecution Insights