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 .
Election/Restrictions
Claims 5-6 and 9-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/16/2025. A complete action on the merits of pending claims 1-4, 7-8, and 12-22 appears below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 8 and 12-21 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.
Claim 8 recites “…an expandable guide catheter comprising an outer cover, wherein the outer cover is configured to be retained within a groove of a hub of the expandable guide catheter.” Claim 1, from which claim 8 depends, already recites “a catheter comprising: an expandable funnel; and a shaft…” The specification uses “expandable guide catheter” and “catheter” interchangeably to refer to the same structure (see, e.g., paragraphs [0018], [0020], [0209]-[0210], FIGS. 9-24, 39-42). It is unclear whether the “expandable guide catheter” of claim 8 is the same catheter already recited in claim 1 or a second, distinct catheter. The claim is therefore indefinite. For purposes of examination, this limitation will be interpreted as reciting the same catheter already introduced in claim 1.
Claim 12 recites “wherein the one or more tensioners are configured to be adjusted by at least turning a control knob to lock a sheath in any position along a groove in a handle.” Neither claim 1 nor claim 12 previously recites any “sheath” or “handle.” Although the specification describes an outer sheath (first member) and control handle with grooves (paragraphs [0062]-[0063], [0166]-[0167], FIGS. 25-29, 36-38), the claim fails to identify what “a sheath” or “a handle” refers to or how either element relates to the tubular body, tensioners, or catheter of claim 1. The metes and bounds of the claim are unclear; the claim is indefinite.
Claim 13 recites “further comprising: a shaft configured to receive the tubular body; a hemostasis seal configured to seal a lumen of the shaft; and a sliding loading tool configured to bypass the hemostasis seal.” Claim 1 already recites “a catheter comprising: … a shaft, wherein the tubular body is configured to be retracted into the shaft through the expandable funnel, and wherein at least part of the shaft is configured to expand.” It is unclear whether the “shaft” of claim 13 is the identical shaft of claim 1 or a different shaft. Additionally, the hemostasis seal and sliding loading tool are introduced for the first time in claim 13 as part of the “capture system” without any antecedent or clear relationship to the catheter of claim 1 (see by way of comparison paragraphs [0205]-[0212], FIGS. 41-42, where these features belong to the expandable funnel catheter). The claim is indefinite. For purposes of examination, this claim will be interpreted as redundantly reciting the shaft of claim 1, with the additional elements (hemostasis seal and sliding loading tool) having ambiguous integration into the capture system of claim 1.
Claim 14 recites “wherein a width of the shape memory body along the second expanded axial length is substantially the same as a width of the shape memory body along the first expanded axial length.” Claim 1 recites only “a tubular body”; the phrase “shape memory body” has no antecedent basis in claim 1 or claim 14. Although the specification describes the tubular body as optionally comprising shape-memory material (paragraphs [0011], [0064]), the claim language introduces new terminology without proper antecedent. The claim is indefinite. For purposes of examination, this claim will be interpreted as referring to the tubular body of claim 1.
Claims 15, 16, 18, 19, and 20 each recite “the expandable funnel tip” and/or “an expandable part of the shaft.” Claim 1 recites only “an expandable funnel” and “at least part of the shaft is configured to expand.” There is no antecedent basis for the specific term “expandable funnel tip.” Additionally, claim 15 recites “to expand the expandable shaft,” which appears to broaden “at least part of the shaft” to the entire shaft, creating inconsistency with claim 1. Claims 16, 18, 19, and 20 re-introduce “an expandable part of the shaft” after claim 1 has already provided antecedent basis for “at least part of the shaft,” rendering it unclear whether a new element is being claimed. The claims are indefinite. For purposes of examination, these claims will be interpreted as either referring to the expandable funnel and at-least-partially-expandable shaft of claim 1.
Claim 17 is rejected by virtue of its dependency on claim 16.
Claim 17 recites “the inner layer being configured to provide a decreased surface area, a decreased surface contact, or a decreased friction relative to a solid inner wall.” The phrase “a solid inner wall” has no antecedent basis in claim 17 or its parent claim and is not a positively recited element of the claimed system. The specification merely uses the phrase as a comparative example (paragraph [0234]), not as a claimed structure. It is unclear what structure, if any, “a solid inner wall” refers to or how it limits the claim. The claim is indefinite. For purposes of examination, this claim will be interpreted as comparing the inner layer to a hypothetical or unclaimed solid inner wall, leaving unclear what structure (if any) is required by the claim.
Claim 21 recites “an outer sheath configured to maintain the funnel in a collapse[d] (should be amended to collapsed) configuration during introduction of the funnel into a blood vessel.” Claim 1 recites “the expandable funnel.” The claim introduces the unqualified term “the funnel,” which lacks clear antecedent basis and creates ambiguity as to whether it refers to the expandable funnel of claim 1. The claim is indefinite. For purposes of examination, this claim will be interpreted as referring to either the expandable funnel of claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 7-8, and 12-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 107-126 of copending Application No. 18/940,398 in view of Nguyen (US 2017/0035445 A1).
Claim 1 of the instant application recites a capture system comprising a tubular body with a first end having an opening and a capture guide, one or more tensioners coupled to the capture guide, and a catheter comprising an expandable funnel and a shaft (with the tubular body configured to be retracted into the shaft through the expandable funnel, and at least part of the shaft configured to expand). The tubular body has a first configuration (first end and capture guide expanded, tensioners activated, second end and majority compressed, first expanded axial length and width) and is transformable to a second configuration with a greater second expanded axial length (and a second width along that length).
Copending claim 107 recites a medical device with a tubular body having a first end defining an opening, an inner shaft coupled to the tubular body, an outer shaft defining a lumen that receives the inner shaft and tubular body, and a plurality of tensioners (at least first and second) that, when activated, limit or prevent deflection of the first end relative to when deactivated. The tubular body has the identical first configuration (first end expanded, tensioners activated, second end and portion compressed, first expanded axial length) and is transformable to a second configuration with a greater second expanded axial length. Specific attachment points for the tensioners to the first end and to the outer shaft are recited.
The differences between instant claim 1 and copending claim 107 are de minimis and amount to obvious variations:
The instant “catheter comprising an expandable funnel and a shaft” (with retraction of the tubular body through the funnel into the shaft, and at least part of the shaft expandable) is an obvious variant of the copending “inner shaft/outer shaft” arrangement that receives the tubular body. An expandable funnel tip is a known equivalent structure for facilitating retraction of an expanded capture device while minimizing trauma or loss of captured material (see also Nguyen, cited in the 102 rejection of claim 1, which discloses an analogous expandable guide catheter with funnel tip and expandable shaft for the same purpose).
The instant “one or more tensioners” and “capture guide” correspond directly to the copending “plurality of tensioners” (first and second) attached to the first end (with spaced attachment points) that prevent deflection when activated.
The first and second configurations, axial lengthening while maintaining width (implicit in the copending claims and consistent with the shared specification disclosure), and tensioner activation to control rigidity/deflection are identical in scope and function.
A person of ordinary skill in the art (POSITA) would have found it obvious to combine the copending inner/outer shaft and dual-tensioner arrangement with a known expandable funnel tip and partially expandable shaft (as taught by Nguyen and routine in the art for large-volume thrombus retrieval) to arrive at the instant claim 1. The remaining limitations in dependent claims 2-4, 7-8, and 12-22 (control knob/grooves, outer cover/groove retention, hemostasis seal/sliding loading tool, dual-layer/braid/coated constructions, outer sheath, obturator) are either expressly supported in the copending claims (e.g., control handle via outer-shaft movement in copending claim 115) or amount to obvious, conventional catheter features that a POSITA would predictably apply to the copending device without producing a patentably distinct result.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 7-8, and 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,793,531 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 and U.S. Patent No. 11,793,531 B2 claim 1 both recite a capture system with a tubular body having the identical first configuration (first end/capture guide expanded, tensioners activated, majority compressed) and second axially-lengthened configuration, tensioners that limit/prevent deflection when activated, and a funnel system (U.S. Patent No. 11,793,531 B2)/catheter with expandable funnel and shaft (instant) configured to receive/retract the tubular body. U.S. Patent No. 11,793,531 B2 further claims the expandable funnel tip and shaft, control handle with longitudinal slot and lateral slots for tension adjustment via a control member, and related features.
The differences are obvious variations: the instant claim 1 integrates the funnel system directly into the “catheter” element and recites “at least part of the shaft is configured to expand,” which is expressly taught in U.S. Patent No. 11,793,531 B2 claim 16 (“the funnel tip and the shaft are expandable”). Dependent limitations concerning the control knob/grooves (instant claims 2-4, 12), layered braid/coatings (claims 16-20), covers/sheaths (claims 8, 15, 21), hemostasis/sliding tool (claim 13), and obturator (claim 22) are either present in U.S. Patent No. 11,793,531 B2 or obvious routine enhancements to the shared capture-and-funnel system. A POSITA would have found the instant claims obvious over U.S. Patent No. 11,793,531 B2 because they merely specify known implementation details of the same thrombus-capture-and-retrieval invention without a patentably distinct result.
Claims 1-4, 7-8, and 12-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12,171,448 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 and U.S. Patent No. 12,171,448 B2 claim 1 both recite the core capture system with tubular body in the first (expanded-end, tensioners-activated) and second (axially-lengthened) configurations, plus tensioners that limit/prevent deflection when activated, and a control handle with longitudinal slot and lateral slots for tension adjustment. U.S. Patent No. 12,171,448 B2 further claims the inner/outer shaft arrangement and specific tensioner attachments.
The instant “catheter comprising expandable funnel and shaft” is an obvious variant of U.S. Patent No. 12,171,448 B2’s inner/outer shaft that receives the tubular body; adding a known expandable funnel tip (as in Nguyen and standard in the art) for facilitated retraction would have been obvious to a POSITA. The remaining dependent limitations are obvious implementations or conventional features.
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, 7-8, and 13-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US 2017/0035445 A1).
Regarding claim 1, Nguyen discloses, a capture system (Figure 1, catheter system (35); Paragraphs [0070]-[0071]) comprising:
a tubular body (Figures 1, 3, 8, & 12, axial lengthening thrombus capture (ALTC) device/tubular mesh (8); Paragraph [0071]) comprising a first end (Figure 12, proximal end (800) with proximal-facing opening (802); Paragraph [0084]), a second end (Figure 12, end at dynamic fold point (88) seen in the figure), and an axial length therebetween (Figure 12, length (L12A); Paragraph [0088]), the first end having an opening (Figure 12, proximal-facing opening (802); Paragraph [0084]) and a capture guide (Figures 3, 5, 8, & 12, capture guide (11); Paragraphs [0073] and [0084]);
one or more tensioners (Figures 1, 5, 8, & 12, capture pullwire (10)) coupled to the capture guide (capture guide (11)) (Paragraph [0076]); and
a catheter (Figures 20-21, expanding guide catheter (50); Paragraph [0100]) comprising:
an expandable funnel (Figures 20B-20C & 21A, distal expandable funnel tip (52); Paragraph [0100]); and
a shaft (Figures 20-21, expandable shaft section (53); Paragraph [0100]), wherein the tubular body (tubular mesh (8)) is configured to be retracted into the shaft (expandable shaft section (53)) through the expandable funnel (distal expandable funnel tip (52)) (Paragraph [0101]), and wherein at least part of the shaft (expandable shaft section (53)) is configured to expand (Paragraphs [0100]-[0101]),
wherein the tubular body (tubular mesh (8)) has a first configuration in which the first end (proximal end (800)) and the capture guide (capture guide (11)) are expanded and the one or more tensioners (capture pullwire (10)) are activated while the second end and a majority of the tubular body remains compressed and the tubular body has a first expanded axial length (length (L12A)) and a first width (Figure 12) along the first expanded axial length (Paragraph [0073], “…the proximal end opening of the ALTC device 8 … radially expandable… while… a significant portion of the surface area and/or the axial length of the mesh of the ALTC device remains in a compressed configuration within the lumen of the capture catheter 4 …”; Paragraph [0088], L12A as first expanded axial length between end (800) and dynamic fold point (88) (majority reserve compressed); and Paragraph [0094]-[0095], tensioners/pull wires activated to control expansion and maintain guide rigidity),
wherein the tubular body (tubular mesh (8)) is transformable to a second configuration, the tubular body has a second expanded axial length greater than the first expanded axial length and the tubular body has a second width along the second expanded axial length (Paragraph [0078], “it can also be possible to lengthen the ALTC Device 8… by pushing the capture catheter 12 relative to the guidewire shaft 6, thereby allowing additional reserve radially compressed length of the tubular mesh 8 to radially expand… to axially lengthen the Thrombus Capture Device 8 and maintain its constant or substantially constant diameter through a working range.”; Paragraph [0085], “…he tubular mesh structure 8 can axially lengthen or shorten without reducing or substantially reducing its diameter through a working length/axial range…”; Paragraph [0093], “…dynamic fold point 88… moves axially proximally when the expanded segment of the tubular mesh 8 axially lengthens.”; and Paragraph [0094], “…axial elongation of the expanded tubular mesh 8 results in an increase in the axial distance D… D3 is greater than D2…”).
Regarding claim 7, Nguyen further discloses, wherein the one or more tensioners (capture pullwire (10)) reinforce the opening (proximal-facing opening (802)) (The capture pullwires (10) couple to and reinforce the capture guide (11) at the proximal opening, holding it rigid and preventing deflection. See Paragraph [0076], “…the pullwire 10 can be pushed or pulled allow a user to control, such as adjust the axial length of the ALTC device 8… the thrombus capture guide 11 can… be formed from nitinol… can circumscribe or otherwise form an outer diameter, and define the proximal-most end of the ALTC Device 8.”; Paragraphs [0073] & [0076] indicate that the pull wires maintain the shape and rigidity of the opening during retraction/expansion; and Paragraphs [0075]-[0076] state that the tensioners/pullwires keep the guide fixed and unable to deflect, reinforcing the opening for scraping high-resistance clot).
Regarding claim 8, as best understood in view of the 112(b) rejection above, Nguyen further discloses, wherein the catheter (expanding guide catheter (50)) further comprises an outer cover (Figures 20A-20D, outer sheath/shaft/catheter (49); Paragraph [0100]), wherein the outer cover (outer sheath (49)) is configured to be retained within a groove of a hub of the catheter (outer sheath (49) of the expanding guide catheter (50) is coupled at its proximal end to a hub/seal/connector (55), as clearly illustrated in Figures 20A and 20C. Paragraph [0100] further states that the outer sheath (49) includes a port on the proximal end and is retractable to deploy the expandable funnel tip and proximal segment of the inner catheter (54). Paragraph [0101] further describes the outer sheath (49) sliding proximally relative to the inner catheter to expand the distal features. Because the outer sheath (49) is operably coupled to and originates from hub (55) in a manner that permits controlled axial sliding and retraction (Paragraphs [0100]-[0101]), the structure is reasonably interpreted under the broadest reasonable interpretation (BRI) as being configured to be retained within a groove of a hub of the catheter. Functional claim language “configured to” requires only that the disclosed structure be capable of performing the recited function, and the proximal hub connection shown and described inherently provides the necessary retention and controlled axial movement of the outer sheath. The presence of a hub (55) coupled to the outer sheath satisfies the limitation).
Regarding claim 13, as best understood in view of the 112(b) rejection above, Nguyen further discloses, further comprising:
the shaft (expandable shaft section (53)) configured to receive the tubular body (axial lengthening thrombus capture (ALTC) device/tubular mesh (8)) (Paragraphs [0100]-[0101]);
a hemostasis seal (Figures 20-21, seal (55)) configured to seal a lumen of the shaft (Paragraphs [0090], [0097], & [0099]-[0100]); and
a sliding loading tool (Figures 20-21, obturator (51)) configured to bypass the hemostasis seal (Paragraphs [0100]-[0101]).
Regarding claim 14, as best understood in view of the 112(b) rejection above, Nguyen further discloses, wherein a width of the tubular body (axial lengthening thrombus capture (ALTC) device/tubular mesh (8)) along the second expanded axial length is substantially the same as a width of the tubular body along the first expanded axial length (Paragraph [0078], “…axially lengthen the Thrombus Capture Device 8 and maintain its constant or substantially constant diameter through a working range.”; Paragraph [0085], “…the tubular mesh structure 8 can axially lengthen or shorten without reducing or substantially reducing its diameter through a working length/axial range…”; and Paragraph [0094], second width substantially the same as first width).
Regarding claim 15, as best understood in view of the 112(b) rejection above, Nguyen further discloses, further comprising a cover (outer sheath/shaft/catheter (49)) disposed over the shaft (expandable shaft section (53)) and the expandable funnel (distal expandable funnel tip (52)), wherein the cover is configured to be removed to expand the expandable part of the shaft and the expandable funnel (Paragraphs [0100]-[0101]).
Regarding claim 16, as best understood in view of the 112(b) rejection above, Nguyen further discloses, wherein at least one of the expandable funnel (distal expandable funnel tip (52)) or the expandable part of the shaft (expandable shaft section (53)) comprises a dual layer structure (Paragraph [0100], where it is disclosed that both distal expandable funnel tip (52) and expandable shaft section (53) can comprise a dual layer structure).
Regarding claim 17, as best understood in view of the 112(b) rejection above, Nguyen further discloses, wherein the dual layer structure comprises an inner layer and an outer layer, the inner layer being configured to provide a decreased surface area, or a decreased surface contact relative to a solid inner wall (Paragraph [0100] discloses that the funnel distal segment (52) of the expanding guide catheter can comprise two layers and includes openings or holes (perforations) along the side to allow blood flow. Because a perforated or braided inner layer necessarily presents less solid material than a continuous solid inner wall, the structure is capable of providing a decreased surface area (and correspondingly decreased surface contact) relative to a solid inner wall. The functional claim language “configured to” is therefore met).
Regarding claim 18, as best understood in view of the 112(b) rejection above, Nguyen further discloses, wherein at least one of the expandable funnel (distal expandable funnel tip (52)) or the expandable part of the shaft (expandable shaft section (53)) comprises an inner braid layer and an outer braid layer (Paragraph [0100], where it is disclosed that both distal expandable funnel tip (52) and expandable shaft section (53) can comprise an inner braid layer and an outer braid layer).
Regarding claim 19, as best understood in view of the 112(b) rejection above, Nguyen further discloses, wherein at least one of the expandable funnel (distal expandable funnel tip (52)) or the expandable part of the shaft (expandable shaft section (53)) comprises at least one coated layer (Paragraph [0100], where it is disclosed that both distal expandable funnel tip (52) and expandable shaft section (53) can be coated).
Regarding claim 20, as best understood in view of the 112(b) rejection above, Nguyen further discloses, wherein at least one of the expandable funnel (distal expandable funnel tip (52)) or the expandable part of the shaft (expandable shaft section (53)) comprises a braided layer (Paragraph [0100], it is disclosed that both distal expandable funnel tip (52) and expandable shaft section (53) comprise braided layers).
Regarding claim 21, as best understood in view of the 112(b) rejection above, Nguyen further discloses, further comprising an outer sheath (outer sheath/shaft/catheter (49)) configured to maintain the expandable funnel (distal expandable funnel tip (52)) in a collapsed configuration during introduction of the expandable funnel (distal expandable funnel tip (52)) into a blood vessel (Paragraphs [0100]-[0101]).
Regarding claim 22, Nguyen further discloses, further comprising an obturator (Figures 20-21, obturator (51)) configured to be received within a lumen of the shaft (expandable shaft section (53)) (Paragraphs [0100]-[0101]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2-4 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen, in view of Winston (US 6752800 B1).
Regarding claim 2, Nguyen teaches, the one or more tensioners (capture pullwire (10)) coupled to the capture guide (capture guide (11)) that are manually pushed or pulled at the proximal end to control axial lengthening/deployment and maintain rigidity/tension of the tubular body (axial lengthening thrombus capture (ALTC) device/tubular mesh (8)) and capture guide (Paragraphs [0076]).
Nguyen fails to teach, comprising a control knob configured to adjust the tension of one or more tensioners.
Winston discloses, a catheter handle. Winston teaches, a control knob (Figure 1, control knob (120); Col. 3, line 53-55) that is manually pushed/clicked or withdrawn to adjust the position and tension/locking force applied to the internal advancement mechanism (which includes a friction wheel (180) (Figure 2) that grips and tensions the guide wire (analogous to tensioning pullwires (tensioners)) (Col. 5, line 48-50 and Col. 6, line 12-18). The knob (120) directly adjusts the braking/tension force on the internal member (friction wheel gripping the wire), which maps to/reads on adjusting tension on Nguyen’s pullwires (10).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Nguyen’s proximal pullwire/hub controls with Winston’s handle, as both references and the claimed invention are directed to precise proximal control and locking of catheter internal tension/advancement elements during vascular procedures. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nguyen’s proximal pullwire/hub controls with Winston’s handle, as such a modification would have been predictable, namely, providing a known ergonomic improvement: a single control knob that slides in a groove, locks into detent/locking positions, and adjusts tension/position while preventing unintended movement (predictable result; KSR rationale of applying a known technique to a similar device for improved usability and stable tension during retraction/scraping).
Regarding claim 3, modified Nguyen teaches, wherein the control knob is configured to slide within a main translational groove to deploy the tubular body (Winston discloses that the control knob (120) slides axially (translational movement along the long axis (152)) within the handle structure (control cylinder (170) and housing (124)) to deploy/advance the internal member. See Winston Figure 2 (control knob (120) slides relative to control cylinder (170) and chassis (150) along long axis (152)); Figure 3 (C-shaped spring element (210) and ratchet movement within the cylinder); Col. 5, line 36-39, “…control knob 120 is pushed inward toward control cylinder proximal wall 194, pedestal 230 slides up proximal ramp 236…” within indentation (232), which is a translational groove/path. This sliding deploys/advances the guide wire (analogous to deploying/lengthening Nguyen’s tubular body (8) via tensioner movement)).
Regarding claim 4, modified Nguyen teaches, wherein the control knob is configured to slide into a plurality of locking grooves to maintain the tension of the one or more tensioners at a respective tension level (Winston discloses the control knob (120) sliding into discrete locking/detent positions (plurality of grooves/ramps) that maintain tension/braking force at respective levels (braking position vs. free-movement position). See Winston Figure 2 (indentation (232) with first distal ramp (234) and second proximal ramp (236); pedestal (230) engages these to lock positions); Col. 6, line 19-20, “…control knob 120 has a groove (not shown) that pedestal 230 engages when control knob 120 is withdrawn…” to lock in the second position; Col. 6, line 12-33, “detent or braking position” that maintains friction/tension on the wire; Col. 4, line 61-Col. 5, line 9 and Col. 5, line 47-65, ratchet element (212) lock the geared drive wheel (182) at incremental tooth positions, maintaining tension. These multiple discrete locking grooves/positions maintain the tension (friction/braking force) at respective levels, mapping to maintaining tension on Nguyen’s tensioners/pullwires (10)).
Regarding claim 12, as best understood in view of the 112(b) rejection above, modified Nguyen teaches, wherein the one or more tensioners are configured to be adjusted by at least turning a control knob to lock a sheath of the catheter in any position along a groove in a handle of the catheter (Winston discloses adjusting the internal tensioning/locking elements by turning/rotating the control knob (120) (or its geared engagement) to lock the sheath/catheter components in any position along the groove/path in the handle. See Winston Figure 1, control knob/thumb wheel (120); Figure 2, control knob (120) rotates/turns geared drive wheel (182) via ratchet to lock positions; Col. 3, line 53-54, “control knob 120 or thumb wheel”; Col. 4, line 36-37, “Geared drive wheel 182 is rotatably coupled”, ratchet elements engage teeth to lock; Col. 5, line 54-56, “The second ratchet element… acts as a locking element against further, undesired rotation…” along the groove/path in the handle/control cylinder (170). This locks the sheath (catheter tubing (102) and internal hypodermic tubing portions) in position, directly mapping to locking Nguyen’s sheath (outer sheath (1)/capture catheter shaft (12)/outer sheath/shaft/catheter (49)) via tensioner adjustment).
Conclusion
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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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