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 .
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.
Response to Amendment
This Action is responsive to the Reply filed on 27 October 2025 (“Reply”). As directed in the Reply:
Claim 19 has have been amended;
Claims 1-18 and 20 have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 19 and 21-36 are presently pending in this application, with Claims 29, 31, 32, 35, and 36 having been previously withdrawn from consideration.
Response to Arguments
Applicant's arguments filed in the Reply have been fully considered but they are not persuasive.
Applicant argues (Reply, pg. 6, beginning at the fifth full paragraph) that Honebrink alone does not anticipate the subject matters of newly amended Claims 19 and 28, and therefore Claims 19 and 35 do not lack unity of invention. Claims 19 and 35 still lack unity, however, because: (1) Claim 35 was not amended, and thus their common subject matter has not changed; and (2) Claim 19 is not patentable to Applicant, and thus there can be no “special technical feature” within the meaning of PCT Rule 13, as detailed below.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Receipt is acknowledged of certified copies of papers required by 37 C.F.R. § 1.55.
Drawings
Two sets of drawings were filed on 2 June 2022, neither with a header stating “Replacement Sheets,” and the Preliminary Amendment of the same date did not mention the drawings, and thus did not include an instruction to replace the original drawings with any attached drawings. Accordingly, the drawings used at this stage of examination will be those without the PCT markings in the header.
The drawings are objected to as failing to comply with 37 C.F.R. § 1.84(p)(4) because reference character “52” has been used to designate both a knot and a weld seam.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: at pg. 10, line 15, “elongated” is misspelled.
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.
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 23 and 33 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.
In Claim 23, line 2, the clause “under a form” renders the scope of the claim indefinite, because it uses an unknown idiom; the clause has been treated as “having a form.”
In Claim 33, line 2, the phrase “such as” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim has been treated as not including the text after “such as,” because that is the broadest reasonable interpretation of the claim.
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.
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.
Claims 19, 21-23, 25-28, 30, 33, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. 2012/0053569, by Honebrink et al. (“Honebrink”) in view of both U.S. Patent Nos. 5,562,619, granted to Mirarchi et al. (“Mirarchi”), and 6,607,496, granted to Poor et al. (“Poor”), as evinced by “PEBAX by Arkema, A polymer in Motion, Pebax elastomers” (Claim 33 only) (see attached PTO-892 for full citation) (“Arkema”).
Honebrink describes a device substantially as claimed by Applicant, as follows.
Claim 19: A steerable device (catheter body 100) configured to be advanced (push-pull wire 200, curving) in the lumen of a tubular element (catheter
lumen 204) (see [0041], [0042], [0044], and Figures 1 and 2), said device comprising:
a flexible axially elongated member having proximal and distal ends ((a) the deflectable distal end portion 102 of the catheter body 110, or (b) the catheter 202 of the catheter body 110; see [0041], [0044], and Figures 1 and 2),
at least one actuating means (flexible element 200 in the form of a push-pull wire) arranged alongside the periphery of said elongated member ([0042, Fig. 2),
at least one fastening means configured to fasten at least partially the at least one actuating means to the flexible elongated member distal end (connected by welding, adhesive, mechanical fasteners, etc., with (a) skirt-like anchors 220, 400A or (b) marker band 212), said fastening means being in direct contact with the at least one actuating means ([0046], [0050], Figure 2),
at least one anti-return means configured to keep the at least one actuating means from sliding alongside the periphery of the flexible elongated member distal end ((1) the sealant 214 in FIG. 2 grips the skirt 220 and enables the transmission of the pushing and pulling force of the flexible element 200, so that the space for accommodating the skirt 220 of the sealant 214, or (2) the marker band 212 configured in FIG. 2, is crimped to the catheter 202; [0046], [0051], Figure 2),
wherein the at least one anti-return means and the at least one fastening means are in axial abutting contact so as to prevent the at least one actuating means from sliding once actuated (all of the elements are secured together and abut one another; [0046], [0051], Figure 2).
Honebrink does not, however, describe that its wire 201, which is read on by the claim term “at least one actuating means,” is made of a shape memory alloy configured to bend when actuated.
Both Mirarchi and Poor relate to pull wire steerable medical devices and are therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims; in addition, they are representative of a large number of similar disclosures of the use of shape memory alloy materials, including NiTi alloys, for the pull wires of such devices, because of their superelasticity which greatly improves the safety and efficacy of the medical device because they are far less prone to rupture or become inelastically deformed in use. Both Mirarchi and Poor teach that NiTi
It 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, to make Honebrink’s wire 201, which is read on by the claim term “at least one actuating means,” of a shape memory alloy configured to bend when actuated, because both Mirarchi and Poor teach doing so in closely related steerable medical devices, in order to improve the safety and functionality of the pull wire. Furthermore, the selection of a shape memory alloy, such as NiTi, is the mere substitution of equivalents known for the same purpose (see M.P.E.P. § 2144.06(II)), and the simple substitution of one known element for another to obtain predictable results (see M.P.E.P. § 2143(I)(B)), as evinced by Mirarchi and Poor.
Claim 21: (The steerable device according to claim 19,) wherein the at least one actuating means comprises a spring or a wire (wire 201).
Claim 22: (The steerable device according to claim 19,) wherein the at least one flexible axially elongated member is wire (tube 110 is shaped as a hollow wire) or blade shaped.
Claim 23: (The steerable device according to claim 19,) wherein the flexible axially elongated member has a cross-section profile under a form (see treatment above) selected from star, circular (tube 110 has a circular cross-sectional profile), semicircular, square, rectangular, triangle, pyramidal or any combinations thereof.
Claim 25: (The steerable device according to claim 19,) wherein the anti- return means is a tube (60), either glue filled or crimped (crimped, [0069]), the actuating means going through said tube (Fig. 6).
Claim 26: (The steerable device according to claim 19,) further comprising a second anti-return means made integral with the flexible elongated member so as to maintain the fastening means in place (the second crimp 604 in Fig. 6 is a second anti-return means).
Claim 27: (The steerable device according to claim 26,) wherein the anti- return means is a recess built into the flexible elongated member and configured to host the at least one fastening means (the space occupied by tube 600 is a recess in the encapsulant).
Claim 28: (The steerable device according to claim 19,) wherein the anti-return means is made integral with the actuating means (as used in this application, “integral” includes a weld or one element clamped to another, see Claim 29; since the flexible element 200 in the form of a push-pull wire is connected to the marker band 212 by welding, adhesive, mechanical fastener, etc., regarding the connection portion, the non-return means - marker band 212 - is therefore integral with the operating means - flexible element 200).
Claim 30: (The steerable device according to claim 28,) wherein the at least one anti-return means is a knot, a weld (a weld, see [0003], [0046]) or any local reinforcement located at the at least one actuating means distal end (id.).
Claim 33: (The steerable device according to claim 19,) wherein the at least one actuating means is inside an electrically isolating material (Honebrink’s encapsulant is PEBAX, see [0047]; Arkema discloses that PEBAX is an electrically isolating material) such as a tube or a coating (see treatment above).
Claim 34: (The steerable device according to claim 19,) wherein the at least one actuating means is arranged alongside the external periphery of the elongated member (wire 201 is “alongside” the exterior surface of 110, 214, inasmuch as they are adjacent each other).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Honebrink, Mirarchi, and Poor as applied to Claim 19, above, and further in view of U.S. Patent No. 6,126,633, granted to Kaji et al. (“Kaji”).
Honebrink, Mirarchi, and Poor together describe a device substantially as claimed by Applicant; they do not, however, disclose that its “fastening means” can be a ligation around the flexible elongated member.
Kaji relates to pull wire steerable medical devices and are therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Kaji teaches (Fig. 2 and col. 6, lines 1-13) that the pull wire (4) of a steerable catheter (1) can be secured to the catheter via a loop in a groove in the catheter (19), which secures the pull wire in place, and is therefore a ligation around the flexible elongated member, so that “the groove portion that is fixedly wound with the string 4 cannot axially slide with respect to the tube 2, so that the tube 2 can be bent in the manner indicated by broken line by pulling the string 4 to the handling side” (id.).
It 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, to make Honebrink’s “fastening means” as a ligation around the flexible elongated member, because Kaji teaches doing so in a closely related pull wire steerable catheter, for the foregoing reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent No. 5,480,382 discloses the use of grooves to help retain pull wires in steerable catheters.
The balance of the documents cited with this Office Action relate generally to pull wire steerable catheters and the distal fixation of the pull wires.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866.217.9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800.786.9199 (IN USA OR CANADA) or 571.272.1000.
/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783