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
Applicant’s election of Group I, claims 1-14, in the reply filed on 1/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claims 7 and 10 are objected to because of the following informalities: Claim 7 recites “the axial direction” in lines 2-3 and claim 10 recites “the axial direction” in line 4 which should read “an axial direction”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a feature in claim 5 and a driving unit in claim 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 10-12 and 14 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.
Claims 2-4 and 11 recite “the control wire” in line 1, respectively. It is unclear if “the control wire” is further limiting only a single one of the previously recited “at least one control wire” or if it applies to all control wires.
Claim 10 recites “the outer wire has an anchor” in line 1 and “the inner wire has an anchor” in line 2. Claim 10 ultimately depends from claim 1 which recites “an anchor” in line 6. It is unclear if the anchor of the outer wire and/or the anchor of the inner wire is intended to be the same anchor of claim 1 or in additional thereto.
Claim 10 recites the limitation "the inner wires" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim as only a single inner wire is required by the claim.
Regarding claim 12, the phrase "derivatives thereof" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "derivatives thereof"), thereby rendering the scope of the claim(s) unascertainable in a manner similar to that of the addition of the phrase “or the like”. See MPEP § 2173.05(d).
Claim 14 recites “the wire guides” in line 2. It is unclear if “the wire guides” are further limiting only two of the previously recited “at least two wire guides” or if it applies to all wire guides.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-11 and 13-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nguyen (US 6,571,131 B1).
Regarding claim 1, Nguyen discloses a medical apparatus (catheter 10; Fig. 1) comprising: a bendable body (deflectable tip section 13) comprising: a hollow cavity (central lumen 18) extending the length of the bendable body (Figs. 1-4); and a wall (wall of 13 and/or 12 including at least tubing 21) formed about the hollow cavity (Figs. 1-4); at least one control wire (puller wire 31) slideably situated in the wall (as puller wires are moved longitudinally by the control handle 14; column 6, lines 58-63); and an anchor (anchor 35; Figs. 4, 5A-5B) configured on the at least one control wire (as anchor is fixedly attached to the distal end of the puller wire; Figs. 4, 5A, 5B; columns 5-6, lines 64-67, 1), wherein, the anchor is affixed within the wall (cross-piece 38 of anchor 35 lies within the notch 39 of the wall of the tip section 13; Fig. 4; column 6, lines 9-19).
Regarding claim 2, Nguyen discloses wherein the anchor (35) is affixed to the control wire (31) by crimping (anchor 35 made from metal tube 37 may be fixedly attached to the puller wire 31 by crimping; column 6, lines 1-5).
Regarding claim 5, Nguyen discloses wherein the anchor (35) further comprises a feature (interpreted under 112(f) as a notch, a hole, a fissure, a loop, and equivalents thereof, and Nguyen discloses anchor 35 includes a cross-piece 38 that creates a notch between 38 and metal tube 37; Fig. 5A) creating additional surface area (surface area of 38) on an outside surface of the anchor for increasing an attachment strength of the anchor to the wall (Figs. 4, 5A).
Regarding claim 6, Nguyen discloses wherein the feature creating additional surface area on the outside surface of the anchor is selected from the groups consisting of a notch, a hole, a fissure, a loop, and combinations thereof (as anchor 35 includes a cross-piece 38 that creates a notch between 38 and metal tube 37; Fig. 5A).
Regarding claim 7, Nguyen discloses wherein the at least one control wire (31) includes a plurality of anchors (distal anchors 35 and proximal anchors 42; Figs. 4, 5A-5B, 7), wherein the position of each anchor is different along the axial direction of the bendable body (as anchors 35 are positioned distally within tip section 13 and anchors 42 are positioned proximally within barrel 70; Figs. 4, 7).
Regarding claim 8, Nguyen discloses a driving unit (interpreted under 112(f) as a driver and equivalents thereof and Nguyen discloses a driver comprising rotation knob 96 and sleeve 44) in communication with the at least one control wire (31), configured to actuate the at least one control wire in the wall (column 8, lines 37-61).
Regarding claim 9, Nguyen discloses wherein the at least one control wire further comprises an outer wire (coil 33) and an inner wire (31; Fig. 3), wherein the inner wire (31) is slideably nested within the outer wire (as coil 33 is glued to the catheter 12 at glue joint 34 and puller wire 31 extends through coil 33 to anchor 42 which are pulled to deflect the tip section 13; column 5, lines 26-28, 41-43; column 6, lines 58-63).
Regarding claim 10, Nguyen discloses wherein the outer wire (33) has an anchor (glue joint 34) for affixing the outer wire to the wall (column 5, lines 54-61) and the inner wire (31) has an anchor (35) for affixing the inner wire to the wall (Fig. 4), wherein the position of the anchor (34) for the outer wire (33) and the inner wire (31) are different along the axial direction of the bendable body (Figs. 3-4).
Regarding claim 11, Nguyen discloses wherein the control wire (31) and anchor (35) comprise of a radio opaque material (as 31 may be made of stainless steel or nitinol and 35 is formed by a metal tube 37, and metals are radio opaque; column 5, lines 16-18; column 6, lines 1-3).
Regarding claim 13, the claimed phrase “heating the wall and anchor to create a thermal fusion” is being treated as a product by process limitation; that is the process of affixing the anchor to the wall. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In the instant case, Nguyen discloses the anchor (35) is affixed to the wall (Fig. 4); therefore, the structure of Nguyen is found equivalent to that claimed and additional process steps are irrelevant.
Regarding claim 14, Nguyen discloses wherein the wall comprises at least two wire guides (lumens 17), wherein the wire guides are spaced a distance from one another (Fig. 2).
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 6,571,131 B1).
Regarding claim 3, Nguyen fails to explicitly disclose wherein the anchor is affixed to the control wire by welding. Instead, Nguyen discloses wherein the anchor (35) is affixed to the control wire (31) by crimping (anchor 35 made from metal tube 37 may be fixedly attached to the puller wire 31 by crimping; column 6, lines 1-5).
However, Nguyen teaches an anchor (anchor 42) may be crimped to the control wire (31) or alternatively may be welded to the control wire (31; as cross-member of the anchor 42 may be welded to the proximal end of the puller wire 31; columns 10-11, lines 67, 1-10). Nguyen further teaches any suitable mechanism for anchoring the control wire to the anchor (42) may be used (column 11, lines 10-12).
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 anchor of Nguyen to be affixed to the control wire by welding in light of the teachings of Nguyen. 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 would have yielded the predictable result of affixing the control wire to the anchor.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 6,571,131 B1) in view of Hanenburg (US 2019/0351189 A1).
Regarding claim 4, Nguyen fails to explicitly disclose wherein the anchor is affixed to the control wire by crimping and welding. Instead, Nguyen discloses wherein the anchor (35) is affixed to the control wire (31) by crimping (anchor 35 made from metal tube 37 may be fixedly attached to the puller wire 31 by crimping; column 6, lines 1-5).
However, Nguyen teaches an anchor (anchor 42) may be crimped to the control wire (31) or alternatively may be welded to the control wire (31; as cross-member of the anchor 42 may be welded to the proximal end of the puller wire 31; columns 10-11, lines 67, 1-10). Nguyen further teaches any suitable mechanism for anchoring the control wire to the anchor (42) may be used (column 11, lines 10-12).
Hanenburg teaches a medical apparatus (catheter 10; Fig. 1) comprising a bendable body (deflectable catheter shaft section 12; Fig. 1) with at least one control wire (pullwire 150; Fig. 4A); and an anchor (anchor feature 152) configured on the at least one control wire (Fig. 4A), wherein the anchor (152) is affixed to the control wire by both crimping and welding (as a bead of weld can be used to attach the rounded end 158 of the anchor feature 152 onto the pullwire distal end 156 and/or the rounded end 158 can be press fit and/or crimped onto the pullwire distal end 156; [0041]).
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 anchor of Nguyen to be affixed to the control wire by crimping and welding in light of the teachings of Nguyen and Hanenburg. 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 would have yielded the predictable result of affixing the control wire to the anchor.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (US 6,571,131 B1) in view of Kowshik (US 2016/0067540 A1).
Regarding claim 12, Nguyen discloses a functional probe (as catheter 10 includes ring electrodes 28 along the length of the tip section 13) but fails to disclose the functional probe selected from the group consisting of a position tracking sensor, a shape sensor, an endoscopic imaging probe, derivations thereof, and combinations therefrom.
However, Kowshick teaches a medical apparatus (instrument system 200; Fig. 2) with a bendable body (elongated flexible body 216) and a functional probe comprising a shape sensor (shape sensor 222) for determining the position, orientation, speed, pose, and/or shape of the catheter tip at the distal end (218) and/or one or more segments along the body ([0045]-[0046]).
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 medical apparatus of Nguyen to further include the shape sensor as taught by Kowshick in order to determine the position, orientation, speed, pose, and/or shape of the bendable body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ninni et al. (US 2021/0121162 A1) is noted for teaching a bendable body similar to that claimed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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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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/SARAH A LONG/Primary Examiner, Art Unit 3771