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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/25/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 has been amended to recite “a cuff body comprising a cylindrical surface with a longitudinal slit having grooved edges on either side thereof”. The use of the term “thereof” renders the claim indefinite because it is unclear if this term refers to the “cuff body”, the “cylindrical surface” or the “longitudinal slit”. For the sake of examination, the term “thereof” is interpreted as referring to the “longitudinal slit”; accordingly, it is suggested to amend claim 1 to recite “a cuff body comprising a cylindrical surface with a longitudinal slit having grooved edges on either side of the longitudinal slit”.
Claims 2-4 are rejected due to their dependence on claim 1.
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 longitudinal slit 24 (Fig 8,9) having grooved edges (at section 3, seen in Fig 9 and labeled in Fig 1) on either side thereof (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 slot into1 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 causes the cuff body to clamp down on the catheter lumen, thereby locking the cuff and securing 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 a 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 biocompatible 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 6/25/2026 have been fully considered but are not persuasive.
Regarding the claim 1 limitation of “a longitudinal slit having grooved edges on either side thereof”:
Applicant argues that “the slit 24 in Hawkins does not have grooved edges” and that that the reduced-diameter middle section 3 of Hawkins – used to read upon the claimed “groove edges” – “cannot be properly equated to grooved edges of a longitudinal slit that extend along the sides of the slit”. This argument is not persuasive because claim 1 does not recite that the slit has to possess the “grooved edges”. Rather, claim 1 states that the grooved edges are “on either side of” the slit. As seen in Fig 9 and 10 of Hawkins, the two halves of the reduced-diameter middle section 3 are “on either side” of slit 24, reading on the amendment to claim 1.
Regarding the claim 1 limitation of “projections that slot into the grooved edges”:
Applicant argues that the projections of Hawkins grip 7 do not “slot into” the grooved edges of reduced-diameter middle section 3, but rather “engage” the grooved edges of reduced-diameter middle section 3 “by wrapping or clipping around the circumferential reduced-diameter section”. This argument is not persuasive because – although the Examiner agrees that the projections of grip 7 engage the grooved edges by wrapping or clipping around the reduced-diameter middle section 3, this engaging meets the definition of “slot[ting] into” under broadest reasonable interpretation of this phrase in light of the specification. Specifically, the phrase “slot into” is defined as meaning “to put someone or something in a particular position” (Cambridge Dictionary. https://dictionary.cambridge.org/dictionary/english/slot), “to fit in or into to take up a position in a space or slot” (Oxford English Dictionary. https://www.oed.com/dictionary/slot_v2), and “if you slot something into something else, or if it slots into it, you put it into a space where it fits” (Collins Dictionary. https://www.collinsdictionary.com/dictionary/english/slot). One of ordinary skill in the art would recognize that the wrapping/clipping of the projections of grip 7 into the reduced-diameter middle section 3 of Hawkins is putting the projections into a particular position in the reduced-diameter middle section (as defined by Cambridge Dictionary), is fitting projections into a position in the space formed by the reduced-diameter middle section (as defined by Oxford English Dictionary), and is putting the projections into a space in the reduced-diameter middle section where they fit (as defined by Collins Dictionary). Applicant’s own disclosure does not define the phrase “slot into” in a manner that requires it to be more specific than these definitions.
If Applicant wishes to further limit what the phrase “slot into” means, the Examiner suggests they amend the claim to more specifically recite the structure/shape of the grooved edges and the corresponding structure/shape of the cuff key. Currently, claim 1 does not recite any significant description as to the structure/shape of either the grooved edges nor the projections [of the cuff key].
Regarding the claim 1 limitation of “wherein inserting the cuff key into the grooved edges at the receiving location causes the cuff body to clamp down on the catheter lumen, thereby locking the cup and securing the cuff to the catheter lumen so that the cuff is no longer slidable along the catheter lumen”:
Applicant argues that “the grip [of Hawkins] does not clamp or compress the housing onto the tube itself” and “has no mechanism by which inserting a component into grooves at the slit causes the housing secure directly to the tube”. This argument is not persuasive since the “catheter lumen” is only functionally recited and not a part of the claimed invention. Therefore, the claim only requires that the cuff body be capable of clamping down on a catheter lumen, thereby securing the cuff to the catheter lumen such that the cuff is no longer slidable along the catheter lumen. This functional limitation is met because Hawkin’s adjustable cuff is structurally capable of being used with a catheter lumen that is compressible and has a larger outer diameter the inner diameter of the cuff body when the cuff body is closed; In this instance, if Hawkin’s adjustable cuff were to be used with such a catheter, the cuff – upon closure – would be secured to the catheter lumen such that the cuff would not be slidable along the catheter lumen; therefore, this functional limitation is met.
Applicant argues that “Hawkins’ housing is designed so that the tube slides freely within in”, “Hawkins requires the tube to remain adjustable within the housing even after placement” and “a skilled person reading Hawkins would therefore not interpret the grip as performing a clamping function, because clamping the housing onto the tube would defeat Hawkins’ express purpose of allowing tube length adjustment”. This argument is not persuasive since, as set forth above, the “catheter lumen” is not a part of the claimed invention and the claim is an apparatus claim. Since the claim is an apparatus claim and Hawkins discloses the structural elements that are positively claimed, Hawkin’s properly anticipates claim 1 under 35 U.S.C. 102 (see MPEP 2114, section I and II). Additionally, it is noted that Paragraph 35 (which Applicant cites) states that the length of the catheter can be modified or adjusted, but does not state when this occurs relative to the cuff body and cuff key being attached; on the other hand, Paragraph 12 states that length is adjusted prior to securing the tube to the insertion site (“an apparatus that allows for the adjustment of the inserted length of a flexible tube or catheter and then for the secure attachment of the flexible tube proximal to the insertion site).
Regarding the arguments directed to the DiMatteo and Borsanyi references:
Applicant asserts that neither DiMatteo or Borsanyi cure the supposed deficiencies of Hawkins regarding claim 1. This argument is moot as DiMatteo and Borsanyi are not used in the rejection of claim 1 and are simply used to teach an adhesive.
Conclusion
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
1 The phrase “slot into” is defined under broadest reasonable interpretation as meaning “to put someone or something in a particular position” (Cambridge Dictionary. https://dictionary.cambridge.org/dictionary/english/slot), “to fit in or into to take up a position in a space or slot” (Oxford English Dictionary. https://www.oed.com/dictionary/slot_v2), and “if you slot something into something else, or if it slots into it, you put it into a space where it fits” (Collins Dictionary. https://www.collinsdictionary.com/dictionary/english/slot).
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