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 .
This office action is in response to the amendment and remarks filed 12/19/2025.
Election/Restrictions
Applicant’s election without traverse of Species I (claims 1-5, 8, 11, 13 and 17-20) in the reply filed on 12/19/2025 is acknowledged. Claims 1-5, 8, 11, 13 and 17-20 are being examined. Claims 6, 7, 9, 10, 12 and 14-16 are withdrawn as being directed to a non-elected invention.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 5, 13 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chou et al. (US 2021/0212707) in view of Gross (US 4,784,647).
In regards to Independent Claim 1, and with particular reference to Figures 2A and 2B, Chou discloses an intravascular access system for facilitation of intraluminal medical procedures within a vasculature (pars, 13, 18, claim 1), the system comprising:
an outer catheter 200 comprising a tubular distal portion 222 having a lumen 223 and a proximal extension 230 without a lumen;
an inner catheter 300 comprising a flexible elongate body (360 and 366); and
at least one coupler (334; par. 199) configured to be affixed to at least a portion of the proximal extension 230 and at least a portion of the flexible elongate body (the portion 366 of the flexible elongate body 360/366) to accommodate different relative positions between the outer catheter and the inner catheter during movement of the inner catheter and the outer catheter through the vasculature (par. 199 teaches upon inserting the proximal portion 366 [of the inner catheter] into the coupling feature “coupler” 334 the catheter advancement element 300 and the catheter 200 [inner catheter] can still be slideably adjusted relative to one another along a longitudinal axis of the system; that is the outer catheter 200 and the inner catheter 300 can still be slideably adjusted relative to one another along a longitudinal axis of the system),
wherein the at least one coupler 334 comprises at least one slot (par. 199, 200 teaches the coupler can be a C-shaped element; the slot being the open section of the C-shaped element) configured to receive and retain the proximal extension 230 and the flexible elongate body (the portion 366 of the flexible elongate body 360/366; refer to par. 199),
Further Chou teaches that the coupler 334 can be of any type, for example a clip, clamp, c-shaped element or other connector configured to hold together the outer and inner catheters (par. 199, 200).
Chou does not teach the at least one coupler comprises a unitary elastic body.
Gross teaches (refer to figures 1 and 2) a catheter system similar to Chou comprising at least one coupler 26 having a unitary elastic body (in col. 2 lines 52-54 Gross teaches the coupler 26 may be made from a sponge-like foam block of material such as foam rubber or the like) with at least one slot 35. Further Gross teaches that the coupler 26 provides a friction fit between the coupler and the catheter. The friction fit acts as an anti-slip means to resist sliding down the catheter away from the patient during normal minor body movement (col. 3 lines 5-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace/substitute Chou’s coupler with the coupler as taught by Gross, because it has been held that a simple substitution of one known element (in this case, the elastic coupler of Gross) for another (in this case, Chou’s coupler, particularly given that Chou teaches that the coupler can be of any type; par. 199, 200 in Chou) to obtain predictable results (in this case, to provide a friction fit between the coupler and the catheter to resist sliding down the catheter away from the patient during normal minor body movement; col. 3 lines 5-17 in Gross) was an obvious extension of prior art teachings, KSR, 550 U.S. at 418, 82 USPQ2d at 1396, MPEP 2141 III B.
Regarding dependent Claim 4, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 1 including the at least one coupler comprises a unitary elastic body with at least one slot configured to receive and retain the proximal extension and the flexible elongate body (refer to the rejection of claim 1 above for details).
Chou in view of Gross do not teach plural couplers. Particularly, wherein the system includes at least two couplers.
It has been held that "the mere duplication of parts has no patentable significance unless a new and unexpected result is produced." In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 VI(B).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the system of Chou-Gross with at least two couplers because to do so would be simply duplicating the components already present in the prior art with the expected result of providing an additional or back-up holder to hold together the outer and inner catheters.
Regarding dependent Claim 5, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 1 and Chou as modified by Gross further teaches preventing bacterial migration into the patient (par. 216 in Chou; col. 3 lines 18-21, 25-27), which implies that the system (catheters, couplers) must be sterilized, that is come in an sterile package to avoid contaminating the patient.
Regarding dependent Claim 13, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 1 and Chou as modified by Gross further teaches wherein the at least one slot (35 in Gross) defines a clamp (as shown in figure 2 of Gross, the C shaped coupler has a slot 35) configured to secure at least one of the proximal extension and the flexible elongate body (refer to the rejection of claim 1 for details).
Regarding dependent Claim 17, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 1 and Chou as modified by Gross further teaches wherein the at least one coupler 26 is removable such that the at least one coupler is configured to be removably affixed to at least the portion of the proximal extension 230 and at least the portion of the flexible elongate body 366 (refer to the rejection of claim 1 above for details).
Regarding dependent Claim 18, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 1 including the coupler 26 configured to hold together the outer and inner catheters (refer to the rejection of claim 1 above for details).
Chou in view of Gross do not teach the at least one coupler is integrally formed with one of the proximal extension and the flexible elongate body.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to integrally form the coupler with one of the proximal extension and the flexible elongate body, since it has been held that use of a one piece construction instead of the structure disclosed in the prior art would be merely a matter of obvious engineering choice (In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)). MPEP 2144.04 V B.
Regarding dependent Claim 19, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 18 and Chou as modified by Gross further teaches wherein the at least one coupler 26 comprises a coupling feature (the slot 35) configured to receive the other one of the proximal extension 230 and the flexible elongate body 366 (refer to the rejection of claim 1 above for details).
Regarding dependent Claim 20, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 19 and Chou as modified by Gross further teaches wherein the coupling features includes the at least one slot 35 (refer to the rejection of claim 1 above for details).
Claims 2, 3, 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Chou in view of Gross and further in view of Cofer (US 2008/0092349) or Auth (US 4,829,999).
Regarding dependent Claim 2, Chou in view of Gross teaches the invention as claimed and as disclosed above for claim 1 including the coupler (26 of Gross).
Chou in view of Gross do not teach wherein the at least one coupler further comprises a pair of wings configured to be manipulated to open the coupler.
Cofer (figures 1-3) and/or Auth (figures 1-3) teach a coupler (1 in Cofer; 10 in Auth) comprising a pair of wings (6 and 7 in Cofer; 22 and 24 in Auth) configured to be manipulated to open the coupler. Cofer and Auth teach the coupler can be used in medical applications (abstract in Cofer; abstract in Auth).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have provided the coupler of Chou-Gross with a pair of wings, as taught by either Cofer or Auth, because it has been held that applying a known technique to a known device ready for improvement, in this case providing a pair of wings to the coupler of Chou-Gross, to achieve predictable results, in this case, to provide a means of easily opening and closing the coupler without touching the medical tubing in order to avoid bacterial contamination to the patient, was an obvious extension of the prior art teachings. See KSR; MPEP 2143 (I).
Regarding dependent Claim 3, Chou-Gross in view of either Cofer or Auth teaches the invention as claimed and as disclosed above for claim 2 including the coupler comprising a pair of wings.
Chou as modified by Gross and either Cofer or Auth do not teach the coupler having a V shape.
It has been held that the configuration of the shape of an apparatus is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed apparatus is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the coupler of Chou-Gross-Cofer to have V shape, as taught by Cofer, since it has been held that the configuration of the shape of an apparatus is a matter of choice absent persuasive evidence that the particular configuration of the claimed apparatus is significant*.See MPEP 2144.04 IV(B).
*The instant application in figures 2-8 seems to imply the device will perform equally well with any shape of coupler. Further, the primary reference to Chou teaches the coupler can be of any type/shape (par. 199, 200 in Chou).
Further, the Examiner additionally notes that "[i]t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438 (CCPA 1929); MPEP 2144.05(II)(A).
Regarding dependent Claim 8, Chou-Gross in view of either Cofer or Auth teaches the invention as claimed and as disclosed above for claim 2 and Chou-Gross as modified by either Cofer or Auth (refer to the rejection of claim 2 above for details) further teaches wherein the at least one slot (slot shown wide open in figure 3 of Cofer; 14 in auth) is positioned on a side of the coupler (1 in Cofer; 10 in Auth), and wherein the pair of wings (6 and 7 in Cofer; 22 and 24 in Auth) are positioned on the side (refer to figures 1-3 in Cofer; shown in figure 1 of Auth).
Regarding dependent Claim 11, Chou-Gross in view of either Cofer or Auth teaches the invention as claimed and as disclosed above for claim 2 and Chou-Gross as modified by either Cofer or Auth (refer to the rejection of claim 2 above for details) further teaches wherein manipulation of the pair of wings (6 and 7 in Cofer; 22 and 24 in Auth) away from one another (away interpreted as not being in contact with each other by there is a gap between the wings) is configured to cause the at least one slot to unlock (slot shown wide open in figure 3 of Cofer; 14 in auth), thereby allowing the proximal extension and/or the flexible elongate body to be positioned within the at least one slot or removed from the at least one slot (as shown in figures 1-3 of Cofer or Auth).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H RODRIGUEZ whose telephone number is (571)272-4831. The examiner can normally be reached Mon-Fri 8:30-6:30.
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/William H Rodriguez/Primary Examiner, Art Unit 3741