Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group I (surgical method) and species B (jaws engage slot) in the reply filed on 1/26/26 is acknowledged.
Claims 8,11,13-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/26/26.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-4,6 are rejected under pre-AIA 35 U.S.C. 102 b) as being anticipated by Hoarau et al. (Hoarau) US 2011/0118829 A1.
Regarding claim 1, Hoarau discloses the invention substantially as claimed (see Figures 1-7b,27a-b,40a-40i, and paragraphs [0171], [0172] and [0173]) comprising a method for coupling a ventricular assist device to a heart, the method comprising: holding a ventricular cuff with a surgical tool (radial clamp 24) that is reconfigurable between an unclamped configuration and a clamped configuration, wherein the surgical tool comprises handles (Figures 40a-g elements 36,69) with opposing clamp jaws connected to the handles, and wherein the opposing clamp jaws are configured for clamping onto the ventricular cuff in the clamped configuration; attaching a sewing ring 19,21 of the ventricular cuff to the heart while the ventricular cuff is held by the surgical tool, wherein the ventricular cuff comprises an attachment component attached to the sewing ring [0094], and wherein the attachment component comprises an inlet opening configured to accommodate an inlet cannula(figure 40i, element 10) of the ventricular assist device; and coupling the ventricular assist device to the heart by inserting the inlet cannula into the inlet opening while the ventricular cuff is held by the surgical tool cuff ([0213-0214], [0171] and [0173], figure 40i).
Regarding claim 2, Hoarau disclose retaining the ventricular assist device to the ventricular cuff via engagement of one or more retention features of the inlet cannula with one or more retention features of the attachment component. [0110]
Regarding claim 3, Hoarau disclose wherein: the one or more retention features of the inlet cannula comprise axially tapered surfaces; and the one or more retention features of the attachment component comprise flexible extensions that are engaged by the axially tapered surfaces to retain the ventricular assist device to the ventricular cuff. [0108-0114].
Regarding claim 4, Hoarau disclose an insertion force required to insert the inlet cannula into the inlet opening is less than an extraction force required to pull the inlet cannula out of the inlet opening (after clamping the force is inherently greater).
Regarding claim 6, Hoarau disclose the surgical tool comprises locking features connected to the handles, wherein the locking features are configured to engage to maintain relative positioning of the handles in the clamped configuration, and further comprising actuating the locking features to disengage the locking features to reconfigure the surgical tool from the clamped configuration to the unclamped configuration.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 5,7,9,10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoarau as applied to claims 1-4,6 above.
Hoarau meet the limitations of claims 5,7,9,10 but lack disclosure of the claimed interlocking arrangements. However, Hoarau teaches other embodiments comprising protusions for engaging slots or grooves to interlock and prevent rotation or movement. See paragraphs 0125,0144. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the male/female interlocking arrangement of the inlet cannula and ring and handles of the clamps in order to provide enhanced interlocking and anti-rotational movement as taught in Hoarau.
Claim 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hoarau as applied to claims 1-4,6 above.
Hoarau meet the limitations of claim 12 but lack disclosure of the claimed length of the clamp handles. However, Hoarau teaches relative dimensions in paragraph 0092 that suggest the length may be in the range as claimed (3-10cm), and further it has been held where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the handle length to be within 3-10cm as the claimed range would be expected to be in the optimum or workable ranges determined by routine experimentation and considering the dimensions suggested in Hoarau.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H MATTHEWS whose telephone number is (571)272-4753. The examiner can normally be reached Monday-Friday (9-5).
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, Jerrah Edwards can be reached at 408-918-7557. 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.
/WILLIAM H MATTHEWS/ Primary Examiner, Art Unit 3774