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 .
Specification
The amendments to the Abstract filed 12/9/2025 overcome the objection set forth in the last Office Action and is acceptable.
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hawkins (PG PUB 2009/0125003).
Re claim 1, Hawkins discloses an adjustable cuff 1+6 (Fig 7) comprising: a) a cuff body 1 (Fig 7,9) comprising a cylindrical surface (the outer surface of body 1, labeled in Fig A below) with a slit 24 (Fig 8,9), said cuff body having grooved edges (at section 3, seen in Fig 9 and labeled in Fig 1) on either side of the slit (as seen in Fig 9), wherein the cuff body is a single piece (as seen in Fig 10) that fits around a catheter lumen and is slidable along the catheter lumen to allow custom positioning of the adjustable cuff along the catheter lumen when the cuff is unlocked (Para 35); and b) a cuff key 6 (Fig 2,3,7) comprising projections (the upward extending arms of grip 7, as seen in Fig 2 and labeled in Fig B below) that fit into the grooved edges at a complementary receiving location for the cuff key (as seen in Fig 3,7), wherein inserting the cuff key into the grooved edges at the receiving location locks the cuff and secures the cuff to the catheter such that the cuff is no longer slidable along the catheter lumen (Para 35).
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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.
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (PG PUB 2009/0125003) in view of DiMatteo (PG PUB 2004/0186461).
Re claim 2, Hawkins discloses all the claimed features except that a layer of adhesive on an inner surface of the cuff body. DiMatteo, however, teaches providing a cuff body 10 (Fig 1A,9B) with a layer of adhesive on an inner surface 43 (Fig 9B) of the cuff body (Para 64, “adhesives can be applied, for example, between the interior surface 43 of the cuff and a portion of the catheter 11”) for the purpose of facilitating secure placement of the cuff body on a catheter (Para 64). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Hawkins to include a layer of adhesive on the inner surface of the cuff body, as taught by DiMatteo, for the purpose of facilitating secure placement of the cuff body on the catheter (Para 64).
Re claim 3, Hawkins as modified by DiMatteo in the rejection of claim 2 above discloses all the claimed features with DiMatteo further teaching that the inner surface of the cuff body comprises a depression 16 (Fig 1A) comprising a complementary receiving location for the adhesive (based on Para 64) for the purpose of mounting upon a projection indicating a location at which the cuff body is intended to be attached to the catheter (Para 6). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Hawkins to include a depression comprising a complementary receiving location for the adhesive, as taught by DiMatteo, for the purpose of mounting upon a projection indicating a location at which the cuff body is intended to be attached to the catheter (Para 6).
Re claim 4, Hawkins as modified by DiMatteo in the rejection of claim 2 above teaches that the adhesive is biocompatible (Para 14 of DiMatteo) but does not explicitly teach that the biocompatible adhesive is silicone. However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Hawkins/DiMatteo to include compatible adhesive as a compatible silicone adhesive since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hawkins (PG PUB 2009/0125003)/DiMatteo (PG PUB 2004/0186461) in view of Borsanyi et al. (US Pat 4,278,092).
Re claim 4, as set forth in the rejection immediately above, Hawkins/DiMatteo teaches that the adhesive is biocompatible (Para 14 of DiMatteo) but do not explicitly teach that the biocompatible adhesive is silicone. Borsanyi, however, teaches using a biocompatible silicone adhesive to attach a cuff 14 to catheter 13 (as seen in Fig 2; Col 2, Lines 64-66) for the purpose of forming a permanent attachment (Col 2, Lines 64-66). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Hawkins/DiMatteo to include the biocompatible adhesive as a biocompatible silicone adhesive, as taught by Borsanyi, for the purpose of forming a permanent attachment between the cuff and the catheter (Col 2, Lines 64-66).
Response to Arguments
Applicant's arguments filed 12/9/2025 have been fully considered but are moot in view of the present rejections that utilize the newly cited Hawkins reference.
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 KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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