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 .
Response to Amendment
The amendment filed April 20, 2026 has been entered.
Claims 1-9 are currently pending.
Claim Objections
Claim 1 is objected to because of the following informalities: The claim has been amended to positively recite a vascular graft in line 2, thus line 11 should be amended to recite “…disposed around [[a]] the vascular graft…” to maintain proper antecedent basis. Appropriate correction is required.
Claims 2-9 are objected due to their dependency on claim 1.
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 1-9 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 recites in part “an assembly….comprising a clamp and a vascular graft” (lines 1-2)…. “wherein the clamp includes a first configuration that allows the tubular body of the vascular graft to receive an introducer sheath of a valve” (lines 13-14). Thus, the introducer sheath of a valve and a valve are not positively recited and the clamp must only be capable of allowing the tubular body to receive the introducer sheath. However, the claim further recites “wherein the clamp includes a second configuration that clamps the tubular body of the vascular graft against the introducer sheath when the introducer sheath is received into the tubular body of the vascular graft” (lines 15-17), now appearing to attempt to positively recite introducer sheath. Thus, it is unclear if Applicant is intending to positively recite introducer sheath of the valve or merely have the clamp and vascular graft be capable of being used with an introducer sheath of a valve, rendering the metes and bounds of the claim unclear. For the purpose of examination, the claim is interpreted such that the clamp and vascular graft are capable of clamping to an introducer sheath.
Claims 2-9 are rejected due to their dependency on claim 1.
Claim Rejections - 35 USC § 103
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 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) 1-6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrig (US 2013/0060268, hereinafter “Herrig”) in view of Current (US 5,305,978, hereinafter “Current”).
Regarding claim 1, Herrig discloses the invention substantially as claimed including an assembly for use in a system for providing vascular access in a patient's body (Figs 9A-9E, 10), comprising a clamp (270/370) and a vascular graft (inflow component 362) (para [0062-0070]; Inflow component "can be any of a variety of blood conduits that are able to be connected to the vascular system to receive blood into the vascular access system. Such blood conduits can have a construction similar to a vascular graft made of ePTFE, Dacron, or other suitable materials." - para [0024])), the clamp comprising a clamshell structure that has first and second ends with overlapping sides disposed around the vascular graft (362) (Figs 9C-9F), wherein the vascular graft comprises a tubular body (para [0062-0070, 0024]); wherein the clamp includes a first configuration that allows the tubular body of the vascular graft to receive an introducer sheath of a valve (Fig 9C – when clamp is open, tubular body 362 is fully capable of receiving an introducer sheath of a valve. It is noted the introducer sheath and valve are not positively recited.); wherein the clamp includes a second configuration that clamps the tubular body of the vascular graft against the introducer sheath when the introducer sheath is received into the tubular body of the vascular graft (Fig 9F – when clamp is closed, clamp clamps against the tubular body and is fully capable of clamping the tubular against an introducer sheath if an introducer sheath is received into the tubular body of the vascular graft. It is noted the introducer sheath and valve are not positively recited.); and wherein the first and second 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 (clamshell clamping configuration with adjustable teeth – Figs 9D-F; para [0036, 0066]).
However, Herrig fails to disclose the claimed details of the clamp. Herrig teaches several different embodiments of the clamp (170, 270, 370, 410, 500, 600, 770) and further teaches: “In some embodiments, the connecting device 166 can have a clamshell structure. The term clamshell structure is a broad term intended to cover a combination of a plurality of members, at least one of which can pivot away from and toward the other, wherein when pivoted together a closed configuration is formed, and is not limited to structures with clamshell type shapes or edge-to-edge contact around a perimeter. For example, in some embodiments, the hinge-type mechanism can have arcuate finger-shaped members or have members with outer diameters or surfaces that are more angular or square in shape and inner diameters or surfaces more tubular or cylindrical in shape. In this manner, the connecting device 166 may be any configuration that performs its intended function.” – para [0028].
Current discloses a similar clamp (40) having a clamshell structure, 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, In 43-51; col 3, In 11-65); wherein the clamp is configured to be disposed around a tubular member (50) (Fig 1) and includes a first configuration (open configuration - Fig 2) that allows movement of the tubular member and includes a second configuration (closed configuration - Fig 3) that allows clamping of the tubular member; 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, In 11-65).
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 clamshell structure of Herrig’s clamp to comprise at least one annular body comprising a first circumferential end that overlaps a second circumferential end; a first handle extending radially outwards from the annular body near the first circumferential end; a second handle extending radially outwards from the annular body near the second circumferential end; and a third handle extending radially outwards from the annular body adjacent the first circumferential end and being spaced from the first handle, as taught by Current, to provide an equivalent clamshell type clamp and since Herrig teaches “the connecting device 166 may be any configuration that performs its intended function.” – para [0028]”. The substitution of one known element (clamshell type clamp of Current) for another (clamshell type clamp of Herrig) providing the same function would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the clamshell type clamp shown in Current would have yielded predictable results.
Regarding claim 2, Current teaches 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, In 11-65). 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 Herrig with the additional clamp details taught by Current since Current teaches an equivalent clamshell type clamp and since Herrig teaches “the connecting device 166 may be any configuration that performs its intended function.” – para [0028]”
Regarding claim 3, Current teaches 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, In 11-65). 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 Herrig with the additional clamp details taught by Current since Current teaches an equivalent clamshell type clamp and since Herrig teaches “the connecting device 166 may be any configuration that performs its intended function.” – para [0028]”
Regarding claim 4, Current teaches 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, In 33-37). 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 Herrig with the additional clamp details taught by Current since Current teaches an equivalent clamshell type clamp and since Herrig teaches “the connecting device 166 may be any configuration that performs its intended function.” – para [0028]”
Regarding claim 9, Current teaches 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, In 33-37). 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 Herrig with the additional clamp details taught by Current since Current teaches an equivalent clamshell type clamp and since Herrig teaches “the connecting device 166 may be any configuration that performs its intended function.” – para [0028]”
Regarding claims 5-6, 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). 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 Herrig with the additional clamp details taught by Current since Current teaches an equivalent clamshell type clamp and since Herrig teaches “the connecting device 166 may be any configuration that performs its intended function.” – para [0028]”
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Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrig (US 2013/0060268) and Current (US 5,305,978), as applied to claim 2 above, further in view of Whitaker et al. (US 2012/0227221, hereinafter “Whitaker”).
In an alternative interpretation of claim 5, Whitaker teaches a similar clamp with two alterative hinge mechanisms. In a first embodiment, the hinge mechanism is similar to Herrig and 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 predetemined 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 the combination of Herrig and 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 before the effective filing date of the claimed 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(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Herrig (US 2013/0060268) and Current (US 5,305,978), as applied to claim 1 above, further in view of Conklin (US 2013/0282028, hereinafter "Conklin"). Herrig and Current disclose the invention substantially as claimed, as shown above, but fail to disclose at least two annular bodies as claimed and further wherein a circumferential notch is circumferentially disposed between the annular bodies to form a 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 combination of Herrig and Current such that it included multiple clamps or annular bodies 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 be joined together for ease of use, but also easily separated for deployment.
Response to Arguments
Applicant’s arguments, see amendment, filed April 20, 2026, with respect to the rejection(s) of claim(s) 1-4 and 9 under 35 USC 102(a)(1) as being anticipated by Current (US 5,305,978) and with respect to the rejection(s) of claim(s) 5-8 under 35 USC 103 further in view of Whitaker (US 2012/0227221) or Conklin (US 2013/0282028), 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 Herrig (US 2013/0060268), as cited in the June 26, 2024 Office Action.
Regarding claims 5-6, Applicant argues the notch within the hinge of Current, similar to the hinge of Herrig, would not be configured to form a predetermined breaking line to allow breaking of the clamp along a longitudinal direction intermediate the first and second circumferential ends. Applicant argues there is nothing in Current that teaches or suggests the hinge is otherwise redisposed to breaking as described in the present application. The Examiner respectfully disagrees and maintains the notch at the hinge may be interpreted as forming the predetermined breaking line as it is fully capable of breaking along the hinge line if enough force is applied. The hinge joint is inherently weaker than the solid portions of the annular clamp adjacent the hinge.
Furthermore, Applicant argues Whitaker, who is relied upon to teach a living hinge with a notch to substitute for a pivot hinge as taught by Herrig and Current, additionally fails to teach a predetermined breaking line to allow breaking of the clamp along a longitudinal direction intermediate the first and second circumferential ends. The Examiner respectfully disagrees and maintains the notch at the living hinge may be interpreted as forming the predetermined breaking line as it is fully capable of breaking along the hinge line if enough force is applied. The thinner portion of the clamp at the notch of the living hinge is inherently weaker than the solid portions of the annular clamp adjacent the hinge.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's argument that Current and Whitaker fail to teach the predetermined breaking line, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The pivot hinge and the living hinge each clearly have a notch fully capable of performing the intended use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Timmermans (US 4,430,081) additionally discloses an assembly for use in a system for providing vascular access in a patient’s body, comprising a clamp, a tubular member, and a valve with an introducer sheath (Figs 1-2), as discussed in the parent application 17/507,500.
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 KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771
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