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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 22, 2025 has been entered.
Claims 1-9 are currently pending.
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)(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) 1-4 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Current (US 5,305,978, hereinafter “Current”).
Regarding claim 1, Current discloses a clamp (40) for use in a system for providing vascular access in a patient's body (fully capable of being used in a system for providing vascular access in a patient’s body), the clamp comprising:
at least one annular body comprising a first circumferential end (70) that overlaps a second circumferential end (72); a first handle (86) extending radially outwards from the annular body near the first circumferential end; a second handle (88) extending radially outwards from the annular body near the second circumferential end; a third handle (84) extending radially outwards from the annular body adjacent the first circumferential end and being spaced from the first handle (Figs 2-3; col 2, ln 43-51; col 3, ln 11-65);
wherein the clamp is configured to be disposed around a vascular graft (fully capable of being disposed around a vascular graft; it is noted the vascular graft is not positively recited);
wherein the clamp includes a first configuration (open configuration - Fig 2) that allows insertion of an introducer sheath of a valve into the vascular graft (fully capable of allowing insertion of an introducer sheath of a valve into a vascular graft; it is noted the introducer sheath, valve, and vascular graft are not positively recited);
wherein the clamp includes a second configuration (closed configuration – Fig 3) that allows clamping of the vascular graft against the introducer sheath when the introducer sheath is inserted in the vascular graft (fully capable of allowing clamping of a vascular graft against an introducer sheath when the introducer sheath is inserted in the vascular graft; it is noted the introducer sheath and vascular graft are not positively recited); and
wherein the first (70) and second (72) circumferential ends adjustably overlap so as to permit variation of an inner diameter of the at least one annular body when the clamp is moved between the first and second configurations (Figs 2-3; through ratcheting mechanism of teeth - col 3, ln 11-65).
Regarding claim 2, wherein the first (70) and second (72) circumferential ends of the annular body have mating tooth structures (74, 74’) that together form an adjustable ratchet mechanism (col 3, ln 11-65).
Regarding claim 3, wherein movement of the first handle (86) and the second handle (88) toward each other causes a decrease of the inner diameter of the annular body (Figs 2-3; Fig 6; col 3, ln 11-65).
Regarding claim 4, wherein movement of the first handle (86) and the third handle (84) towards each other causes the first circumferential end to flex radially outwards, thereby allowing release of the ratchet mechanism (col 3, ln 33-37).
Regarding claim 9, wherein the first circumferential end further comprises a release band (edge of handle 84 forms release band or portion of annular body adjacent handle 84 forms release band; Figs 2-3; col 3, ln 33-37).
Claim Rejections - 35 USC § 102/103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Current (US 5,305,978) or, in the alternative, under 35 U.S.C. 103 as obvious over Current (US 5,305,978) in view of Whitaker et al. (US 2012/0227221).
Regarding claim 5, Current teaches the annular body includes a longitudinal notch forming a predetermined breaking line (notch at hinge 68; Fig 2) to allow breaking of the clamp along a longitudinal direction intermediate the first and second circumferential ends (fully capable of breaking the clamp along the hinge line depending on force applied), wherein the notch is disposed in the annular body opposite the ratchet mechanism (notch at hinge 68; Fig 2).
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Alternatively, Whitaker teaches a similar clamp with two alterative hinge mechanisms. In a first embodiment, the hinge mechanism is similar to Current wherein two halves of the annular body are joined at a pivot hinge (116) (Figs 1-2). In a second embodiment, the hinge mechanism joining the two halves of the annular body is a living hinge (516) including a longitudinal notch forming a predetermined breaking line opposite the ratchet mechanism (Figs 19-20, wherein the notch is fully capable of allowing the clamp to break along the hinge line depending on the force applied). Therefore, it would have alternatively been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Current to have a living hinge connecting the two halves of the annular body including a longitudinal notch as claimed, since substitution of one known element (pivot hinge) for another element (living hinge) providing the same function (hinge mechanism of clamp) to yield predictable results would have been obvious to one of ordinary skill in the art at the time of the invention. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 at 416, 82 USPQ2d 1385 at 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Current (US 5,305,978), as applied to claim 1 above, in view of Conklin (US 2013/0282028, hereinafter “Conklin”). Current discloses the invention substantially as claimed, as shown above, but fails to disclose at least two annular bodies as claimed and further wherein a circumferential notch is circumferentially disposed between the annular bodies to forma breaking line, as claimed. Conklin discloses a series of clamps (50) (Fig 11B) including at least two annular bodies (Fig 11A) joined together by mechanical or physical forces to form a single integral body (stacked series 116) (para[0052]). The series of clamps (50) may be bonded together (Fig 13) with a weakened point at a junction between each clamp forming a circumferential notch circumferentially disposed between at least two of the annular bodies to form a predetermined breaking line, the notch configured to allow separation of the annular bodies (Fig 14; para[0061-0062]). Conklin teaches “the advantage of bonding or otherwise linking the clamps 50 together is that it greatly reduces the chance of losing one of the clamps 50 during a surgery” (para[0063]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Current such that it included multiple clamps or annular bodies (40; Figs 2-3) since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 and since one of ordinary skill in the art would be motivated to provide enough clamps as necessary for a task or to manufacture a plurality of clamps together for simplicity of manufacture. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Current such that at least two clamps or annular bodies were joined together by mechanical or physical forces with a circumferential notch disposed between the two annular bodies to form a predetermined breaking line, the notch configured to allow separation of the annular bodies, as taught by Conklin. Thus, the at least two annular bodies may initially joined together for ease of use, but also easily separated for deployment.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771