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
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) 1-6 and 8-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 9,302,075 to Tejani.
Regarding claim 1, Tejani teaches an adapter, comprising: a housing, comprising a first housing part (102a, 108a) coupled to a second housing part (102b, 108b), the housing comprising a locking mechanism (11, 116); a first flexible seal (120) coupled to the first housing part and the second housing part, the first flexible seal having an inner surface configured to interact with an outer surface of a first catheter, cannula, or sheath (col. 5, ln. 35-41); wherein the housing has a first configuration (Fig. 4) where the first flexible seal is capable of being repositioned axially along the first catheter, cannula, or sheath having a first outer diameter, and a second configuration (Fig. 3) where the first flexible seal is incapable of being repositioned axially along the first catheter, cannula, or sheath without substantially deforming the first catheter, cannula, or sheath; and wherein the first flexible seal is configured to form a semicircular "C" shape around the catheter, cannula, or sheath and circumferentially surround a portion of only the first catheter, cannula, or sheath.
Regarding claim 2, Tejani teaches a hinged coupling (104).
Regarding claim 3, Tejani teaches an inner surface (110a) of the first housing part is slidably coupled to an outer surface of the second housing part.’
Regarding claims 4, Tejani teaches that the flexible seals may be polyethylene (col. 4, ln. 45-48), which is a thermoplastic polymer.
Regarding claim 5, Tejani teaches that the flexible seals may be silicone (col. 4, ln. 46-48).
Regarding claim 6, Tejani teaches a second flexible seal (also designated 120) coupled to the first housing part and the second housing part; wherein the second flexible seal is capable of being repositioned axially along a second catheter, cannula, or sheath when the housing is in the first configuration, wherein the second flexible seal is incapable of being repositioned axially along a second catheter, cannula, or sheath when the housing is in the second configuration without substantially deforming the second catheter, cannula, or sheath (see col. 4, ln. 59-60, “sized to fit a range of catheters”); wherein the second catheter, cannula, or sheath has a larger outer diameter than the first catheter, cannula, or sheath; and wherein the second flexible seal is configured to circumferentially surround a portion of both the first catheter, cannula, or sheath and the second catheter, cannula, or sheath. That is, the flexible seals (120) are configured to hold multiple catheters serially, or of multiple within the same central opening simultaneously, possibly in a compressed state.
Regarding claim 8, Tejani teaches an attachment mechanism (112, 118).
Regarding claim 9, Tejani teaches removable coupling (at least of the cover 118a).
Regarding claim 10, Tejani teaches a protrusion (110b).
Regarding claim 11, Tejani teaches a tab (110a) and a slot (lower edge of 110b).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tejani.
Regarding claim 7, the claim recites only the configuration to clamp conduits of a particular size. It has been held that where the difference between the prior art and the claimed invention is a size without a distinction in operation, the claimed device is not patentably different from the prior art (see MPEP 2144.04 IV. A). In this case, applicant has not indicated any particular operational effect of the size range, therefore the examiner concludes that the adapter is obvious over Tejani alone.
Claim(s) 12-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tejani in view of US Pre-Grant Publication 2013/0267892 to Woolford (Woolford).
Regarding claim 12, Tejani teaches the adapter according to claim 1 as discussed above, does not teach an introducer sheath or a blood pump with a catheter. Woolford teaches a pumping system (10) generally which includes blood pumping (paragraph 222, i.e. including a pump), a sheath (2014) and hub thereof, and a catheter (22/24). Woolford teaches that this provides a combined irrigation and aspiration capability for medical use. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide the pump, sheath, and catheter of Woolford in combination with the adapter of Tejani in order to perform surgical operations involving irrigation and/or aspiration.
Regarding claim 13, Woolford teaches a blood pump (paragraph 222), as well as the catheter (22/24), clamping (see discussion of Tejani regarding claim 1 above), and sheath limitations as discussed above with respect to claim 12.
Regarding claims 14-15, Tejani and Woolford teach the elements of the claimed kit as discussed above with respect to claims 12-13, and the provision of these elements together as a kit does not introduce any patentable distinction to the claimed invention relative to the sum of the claimed kit elements. For instance, no additional housing structure is claimed. Accordingly, the examiner holds that the claimed invention is obvious in view of Woolford according to the analysis set forth above with respect to claim 12.
Regarding claim 16, Tejani as modified in view of Woolford teaches the structural elements of the claim, including the housing (102), the seal (108), the catheter clamping configuration (Fig. 3), and unclamped configuration (Fig. 4). Woolford teaches a pumping system (10) generally which includes blood pumping (paragraph 222, i.e. including a pump), a sheath (2014) and hub thereof, and a catheter (22/24). Woolford teaches that this provides a combined irrigation and aspiration capability for medical use. One of ordinary skill in the art would have found it obvious before the effective filing date of the application to provide the pump, sheath, and catheter of Woolford in combination with the adapter of Tejani in order to perform surgical operations involving irrigation and/or aspiration. Thus combined, the positioning and reconfiguring steps are apparent from the drawing figures (especially Figs. 1-4) and their accompanying description in Tejani.
Response to Arguments
Applicant’s arguments, see page 6, filed 24 December 2025, with respect to the rejection(s) of claim(s) under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Tejani as set forth above.
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 PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 21 March 2026