DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-21, drawn to a guide extension catheter, classified in A61M20256/0024.
II. Claims 22-23, drawn to a method for accessing a coronary artery, classified in A61B17/00.
The inventions are independent or distinct, each from the other because:
Inventions II and I are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the products as claimed in group I can be used to practice another materially different method that does not require any or all of the elements recited in group II such as “advancing the guide catheter through a blood vessel to a position adjacent to an ostium of the coronary artery” and “advancing the guide extension catheter through the guide catheter to a position where at least a portion of the tubular membrane extends distally beyond a distal end of the guide catheter and into the coronary artery”.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art in view of their different classification;
(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter;
(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries)
the process differences between the separate inventions require divergent search queries; and the inventions above are separately classified.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Eric Nyre on 07/28/2026 a provisional election was made without traverse to prosecute the invention of group I, claims 1-21. Affirmation of this election must be made by applicant in replying to this Office action. Claims 22 and 23 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 2, 4-6 and 21 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.
The term “effective column strength” in claim 2 is a relative term which renders the claim indefinite. The term “effective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Par. 59 explains that such effective strength provides no effective resistance. However this does not provide additional clarity regarding whether one of ordinary skill in the art would understand when the claim is infringed.
The term “effective radial strength” in claim 2 is a relative term which renders the claim indefinite. The term “effective” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Par. 59 explains that such effective strength provides no effective resistance. However this does not provide additional clarity regarding whether one of ordinary skill in the art would understand when the claim is infringed.
Regarding claim 4, the phrase "guidewire-like distal end" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). For example one of ordinary skill in the art would understand guidewire-like to include a distal ends (of push members) that are guidewires and distal ends that are like guidewires or similar to guidewires. However one of ordinary skill would not understand the scope of push member tips that are guidewire-like. Applicant par. 65 discusses this. However there does not appear to be sufficient clarification such that there is a reasonable scope regarding what distal tips are encompassed by guidewire-like.
Claim 21 recites the limitation "the tubular member's entire length" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claims dependent thereon are rejected for the same reasons.
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(s) 1-4, 7-9 and 11-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 5,911,702 (Romley).
Regarding claim 1, Romley discloses (see figs. 1-4) a guide extension catheter 18,4 positionable within (see annotated figure below) a guide catheter (see annotated figure below) and configured to receive an interventional device 6,10 (other such devices are shown at col. 3, l. 66 to col. 4, l. 3) for insertion into vasculature (see col. 3, ll. 50-55: “occluding member 10, which is preferably a balloon, to occlude the patient's ascending aorta”), the guide extension catheter 18,4 comprising: a push member 46; a first reinforcement member 18 in contact (the push member “holds” membrane 4 and thus push member 27, the reinforcement member 18 and the membrane 4 are all at least indirectly in contact with each other; see col. 7, ll. 20-25) with the push member 27; and a radially-collapsible (compare figs. 1 and 2), tubular membrane 4 in contact with the push member 46 and the first reinforcement member 18, the tubular membrane 4 positioned distal (see fig. 1) to the first reinforcement member 18 and collapsed or wrapped about (see figs. 9-11 wherein fig. 9 shows membrane 4 wrapped around tube 56 of push member 46) the push member prior to receiving the interventional device (see col. 7, ll. 20-30; the tip 54 of push member is inserted into the vascular while clamping the membrane; then the push member is withdrawn from the vascular and the membrane 4 expands; then the interventional device 6 is passed through the membrane 4; see col. 7, ll. 35-45 and col. 4, ll. 15-25: “The expandable portion 4 is particularly useful when passing the catheter 6 … since the expandable portion 4 makes it possible to provide a longer cannula 2 to protect the vessel through which the catheter 6 is advanced while retaining adequate fluid flow characteristics”).
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It is noted that the embodiment of fig. 17 is also included in the claim 1 rejection including membrane 4F and push member 92 wherein retainer 110 holds the membrane in the collapsed position before expansion (as opposed to the clamping discussed above for the fig. 1 push member 46).
It is noted that the embodiment of fig. 14-15 is also included in the claim 1 rejection including membrane 4D and push member 92 (see col. 8, ll. 65-67).
Regarding claim 2, Romley discloses (see figs. 1-2) wherein the tubular membrane 4 has no effective column strength (membrane 4 can be a fabric or nylon; see col. 5, ll. 15-35), no effective radial strength (membrane 4 can be a fabric or nylon; see col. 5, ll. 15-35), no independent bend stiffness (membrane 4 can be a fabric or nylon; see col. 5, ll. 15-35), and a tensile strength sufficient to prevent tearing (see col. 7, ll. 25-35; there is application of tensile force during standard operations and thus tearing would be prevented) during insertion of the interventional device 6.
Regarding claim 3, Romley discloses (see figs. 9-11) wherein a distal end (end of tip 46 at location 78 in fig. 9) of the push member 46,56 extends distally of a distal end (see end portion of membrane 4 within tip 46 in fig. 9) of the tubular membrane 4.
Regarding claim 3, Romley discloses (see figs. 17-18) wherein a distal end (tip 94 at location 78 in fig. 9) of the push member 92 extends distally of a distal end (see end portion of membrane 4F in fig. 18) of the tubular membrane 4.
Regarding claim 4, Romley discloses (see figs. 17-19) wherein the distal end 94 of the push member 92 includes an atraumatic (see col. 9, ll. 60-65), guidewire-like (this includes a tapering consistent with applicant par. 65; in addition the tip 94 retains via retainer 110 the collapsed membrane 4F and “guides” such membrane to the ) distal end 94.
Regarding claim 7, Romley discloses (see figs. 9-11) wherein a distal end (end of tip 46 at location 78 in fig. 9) of the push member 46 terminates at or adjacent (see fig. 9) to a distal end (see end portion of membrane 4 within tip 46 in fig. 9) of the tubular membrane 4.
Regarding claim 8, Romley discloses (see figs. 9-11 and fig. 18) wherein the push member tapers in one or more dimensions along a portion of its length (see tip 54 and tip 94 taper longitudinally).
Regarding claim 9, Romley discloses (see figs. 1-2) wherein the first reinforcement member 18 includes a deployable loop (see loops of coil 18 wherein coil 18 is deployed into artery as shown in fig. 4; see col. 2, ll. 25-30).
Regarding claim 11, Romley discloses (see figs. 1-2 and 9-11) wherein the push member 46,56 is in contact (see fig. 9) with an inner surface (see fig. 9) of the tubular membrane 4.
Regarding claim 12, Romley discloses (see figs. 1-2 and 9) wherein the push member 46 is in contact with an outer surface (see fig. 9) of the tubular membrane 4.
Regarding claim 13, Romley discloses (see figs. 1-2 and 9-11) wherein the push member 46,56 is affixed along a plane of an outer wall (see outer portion of membrane 4 affixed at push member portion 56 in fig. 9) of the tubular membrane 4.
Regarding claim 14, Romley discloses (see figs. 9-11) wherein the tubular membrane 4 is configured to be folded (see col. 7, ll. 60-65) about the push member 46,56 prior to receiving the interventional device 6. It is noted that the membrane 4 is capable of being folded near the push member 27 for example when the physician handles the structure shown in fig. 1 for example during training or sales.
Regarding claim 15, Romley discloses (see figs. 1-2 and 9-11) wherein the first reinforcement member 18 is affixed to (via the membrane 4) the push member 46,56 and configured to maintain patency (reinforcement member 18 is bonded to membrane 4, see col. 6, ll. 40-45; member 18 is “wire-reinforced” and thus maintains patency of lumen at transition from 18 to 4) of a lumen leading into a proximal end (i.e. at the location of the bonding at the transition from member 18 to membrane 4; see col. 6, ll. 40-45) of the tubular membrane 4.
Regarding claim 16, Romley discloses (see figs. 1-2 and 9-11) a second reinforcement (tip 46 reinforces or makes more rigid the distal end of membrane 4 by holding such distal end between outer and inner tubes 56,58 during maneuvering of such distal end) member 46 disposed at a distal end (the end shown in fig. 9) of the tubular membrane 4, the second reinforcement member (platinum or gold along the member 4 in combination with tubes 56,58 of tip in figs. 9-11; see) configured to maintain patency of the lumen (via tubes platinum/gold that is applied to membrane 4, see col. 6, ll. 35-40; one of ordinary skill would understand that such reinforcement is used to maintain the latency when viewing figs. 1-2; this is discussed in the Pertinent Prior Art infra) at the distal end of the tubular membrane 4.
Regarding claim 17, Romley discloses (see figs. 1-2 and 9-11) wherein the second reinforcement member (portion 46) is configured to selectively (see col. 7, ll. 35-45) open or close (compare figs. 9 and 10) the distal end of the tubular membrane 4.
Regarding claim 18, Romley discloses (see fig. 17) wherein the tubular membrane 4F includes a wall thickness (0.01”; see col. 9, ll. 35-40) and an outer diameter (ID can be 0.27”, see col. 9, ll. 28-33 and col. 6, ll. 15-20; thus OD is ID plus 2*thickness = 0.29”), wherein a ratio of the outer diameter to the wall thickness ranges from 10:1 to 50:1 (such ratio is 29:1), inclusive.
Regarding claim 19, Romley discloses wherein the tubular membrane 4 is lubricious (see col. 6, ll. 40-45) on one or both of an inner surface or an outer surface.
Claim(s) 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pub. No.: US 2022/0280709 A1 (Kapur).
Regarding claim 21, Kapur discloses (see fig. 2) a guide extension catheter 12’ for use with (see fig. 4C) a guide catheter 60, comprising: a radially-collapsible, tubular membrane 12’ defining a lumen (see fig. 2) when biased to an open position (biased via support hoop 19’, see par. 77), the lumen including a central axis (longitudinal axis of instant lumen); and a push member 17’ in contact with (see fig. 2) the tubular membrane 12’ along the tubular member's entire length (see fig. 2) and extending proximal of the tubular membrane (see handle 15’ proximal from membrane 12’) for slidably positioning the tubular membrane within and partially beyond a distal end of the guide catheter (see fig. 4C showing membrane extending proximally from distal end of guide catheter 60), wherein the tubular membrane 12’ has no effective radial strength (membrane 4 can be a fabric or nylon; see col. 5, ll. 15-35) and is configured to collapse toward the central axis when subject to a radially-inward biasing force (such membrane is collapsed when within deliver sheath 40 when delivery sheath is delivered to the vascular; subsequently membrane 40 is expanded when it is deployed from delivery sheath 40; see fig. 5, step 53), the tubular membrane including a tensile strength sufficient to prevent tearing during (see col. 7, ll. 25-35; there is application of tensile force during standard operations and thus tearing would be prevented) insertion of an interventional cardiology (see “coronary arteries” in par. 95) device (delivery sheath 40 that is discussed at step 51 of fig. 5 and also at par. 75 and par. 77, middle).
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.
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.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romley in view of US 5395332 (Ressemann).
Regarding claims 5-6, Romley discloses the current invention as claimed and discussed above. Romley discloses (see figs. 18-21) wherein the atraumatic, guidewire-like (this can include a “tapered” core; see applicant par. 65) distal end 94 includes a tapered core (see tapering of tip 94 in fig. 18). Kapur does not disclose the distal end is configured to receive and maintain a user-induced curve; and the core surrounded by a coil.
Ressemann teaches (see fig. 12) member 78a (similar to Romley push member 46) and further teaches (see col. 14, ll. 35-45) a distal end is configured to receive and maintain a user-induced curve (during maneuvering by surgeon and thus user-induced); and coil 78B surrounding atraumatic tip core 78A.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Romley with the distal end is configured to receive and maintain a user-induced curve; and the core surrounded by a coil as taught by Ressemann in order to facilitate improved protection of the atraumatic tip during deflections and during handling by physician and good tip movement (see Ressemann col. 14, ll. 40-45).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romley in view of US 2008/0015625 A1 (Leeflang).
Regarding claim 10, Romley discloses the current invention as claimed and discussed above. Romley discloses (see figs. 1-2) the first reinforcement member 18 defines has a greater column strength and a greater radial strength than that of the tubular membrane 4 (reinforcement member 18 is “wire-reinforced tube”, see col. 4, ll. 30-35 and membrane 4 is fabric that can be “yarn”, see col. 2, l. 8). Romley does not disclose the first reinforcement member 18 defines a concave track leading into the tubular membrane 4.
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Leeflang teaches a radially collapsable guide extension catheter 30 and further teaches a reinforced member 10 (coil reinforced tube, see par. 63, similar to coil reinforced tube 18 of Romley) defines a concave track (see annotated figure above wherein cross section of tube at bevel is concave; this is similar to applicant fig. 3 and par. 56) leading into the tubular membrane 30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Romley with the first reinforcement member 18 defines a concave track leading into the tubular membrane 4 as taught by Leeflang in order to facilitate improved mobility (see Leeflang par. 75)
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Romley in view of US 2006/0135981 A (Lenker).
Regarding claim 20, Romley discloses the current invention as claimed and discussed above. Romley discloses wherein the tubular membrane 4 is composed of a lubricious layer (see col. 6, ll. 40-45), a non-crosslinked (there is no discussion of cross-linking in Romley; thus one or ordinary skill in the art would understand there to be an embodiment without cross-linking) polymer layer (polyester, polyethylene, nylon, polyolefin, polypropylene, PTFE and polyurethane; see col. 6, ll. 40-45). Romley does not disclose a crosslinked polymer layer.
Lenker teaches (see fig. 13A) a collapsible/expandable membrane 1300 (for introduction into the body, see abstract) and further teaches (see par. 103) a crosslinked polymer layer 1308 (see “crosslinked” regarding “polyethylene, polypropylene, polyurethane, polyvinyl chloride, Pebax, Hytrel, PET, FEP, PTFE”) (among multiple layers; see par. 103).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to provide Romley with a crosslinked polymer layer as taught by Lenker in order to facilitate providing biasing in the appropriate dimension (for example this can help to bias the distal end regarding figs. 2 or 15) (see Lenker par. 103).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
lumen within guidewire: US 20190240461 (par. 32); US 6004279
gold is reinforcing member: US 20060293706 (par. 34), US 20070021648 A1 (par. 54).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC J AMAR whose telephone number is (571)272-9948. The examiner can normally be reached M-F 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at (571) 272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARC AMAR/Examiner, Art Unit 3741
/DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
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