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 .
Status of Claims
Claims 1-20 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Jun. 5, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: element 134 in Fig.’s 1C and 2. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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 abstract of the disclosure is objected to because of the length of the abstract; and the comma after “such as” should be moved to be after “blood pump assemblies” for grammar. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 17 is objected to because of the following informalities: “a intracardiac blood pump” in line 1 should be changed to --an intracardiac blood pump-- and “proxim.al” in line 5 should be changed to --proximal--. Appropriate correction is required.
Claims 18-20 are objected to for being dependent on claim 17.
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: “one or more features configured to promote mechanical interlocking between the one or more features and the layer…” in claim 16.
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. For “features”, in ¶[0076] the specification discloses geometric features such as protrusions, apertures, and any 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 § 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.
Claims 1-10, 13-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gold et al. (US 5037404 A, published Aug. 6, 1991, hereinafter referred to as “Gold”).
Regarding claim 1, Gold teaches a catheter for a catheter assembly (Fig.’s 1-2 “Catheter 10” Col. 3 ln. 21), the catheter comprising: an elongate tubular body (See fig. 1, element 10 catheter, annotated below) comprising: a proximal end (Fig.’s 1-2 “proximal end 28” Col. 3, ln. 63) and a distal end (Fig. 1-2 “distal end or catheter tip 22” Col. 3, ln. 40), at least one lumen extending from the proximal end to the distal end along a longitudinal axis (Fig. 1 “inner plastic extrusion 12 being extruded on a mandrel 14” Col. 3, ln. 25-26 implying a lumen; Fig. 2 “catheter axis 23” Col. 3 ln. 45), a layer made of a first material (Fig. 1 “Inner plastic extrusion 12 may be of any appropriate material which is desirably used for a catheter such as polyethylene, nylon, PVC, polyurethane, or silicone rubber.” Col. 3, ln. 26-29), a first portion having a first length (Fig. 2 “tip section 22” Col. 3 ln. 59, see annotated Fig. 2 below), a second portion having a second length (Fig. 2 “second section 26” Col. 3, ln. 55, see annotated Fig. 2 below), wherein the first portion is proximal of the second portion (Fig. 2 “transitional area 27 is provided on the catheter … the tip section 22 to … a second catheter section 26” Col. 3, ln. 49-53), and a reinforcement structure (Fig. 1, “braised wire sheath 16” Col. 3, ln. 32) embedded in the layer (“a flexible catheter which comprises at least one resilient, flexible tubular layer in telescoping relation with and bonded to a tubular, wire sheath made of generally helically disposed, crossing wire strands.” Col. 1, ln. 50-54), wherein the reinforcement structure is configured such that the second portion of the elongate tubular body transmits a larger proportion of externally applied torque over the second length than the first portion transmits over the first length (“it might be desirable for the distal tip of the catheter to be very soft and pliable, with a low torsional rigidity, while an intermediate section of the catheter should have greater amounts of torsional rigidity to permit the transfer of torque to the tip area from the distal end.” Col. 1, ln. 25-32; Fig. 2 “second section 26 of the catheter has a lower longitudinal stiffness, and a higher torsional stiffness than tip section 22. Thus second section 26 permits the catheter to transmit torque well along its length, while tip section 22 is more yielding and resilient in terms of torque transmission.” Col. 3, ln. 55-60).
PNG
media_image1.png
425
662
media_image1.png
Greyscale
Regarding claim 2, Gold teaches wherein the reinforcement structure is made of a second material (Fig. 1, “the wire sheath 16 may be made of "memory wire" such as Nitinol brand wire” Col. 4, ln. 20-21).
Regarding claims 3-4, Gold teaches wherein the first material is a polymer, wherein the first material is a polyurethane (Fig. 1 “Inner plastic extrusion 12 may be of any appropriate material which is desirably used for a catheter such as … polyurethane” Col. 3, ln. 26-29).
Regarding claims 5-6, Gold teaches wherein the second material is a metal alloy, wherein the second material is nitinol (Fig. 1, “the wire sheath 16 may be made of "memory wire" such as Nitinol brand wire” Col. 4, ln. 20-21).
Regarding claim 7, Gold teaches wherein the reinforcement structure comprises a first portion that extends from a first end to a second end of the first portion of the elongate tubular body (catheter tip section 22 extends from transition point 27 to the distal end 22 as shown in Fig. 2), and the first portion of the reinforcement structure is configured as a coil (“The nonbraided crossing wire cylinders may have the strands of the two sets separately and sequentially wound on the flexible tubular layer” Col. 2, ln. 38-40).
Regarding claim 8, Gold teaches wherein the reinforcement structure comprises a second portion that extends from a first end to a second end of the second portion of the elongate tubular body (second catheter section 26 extends from transitional portion 27 to transitional portion 32).
The claimed phrase “the second portion of the reinforcement structure is laser cut according to a predetermined pattern” is being treated as a product by process limitation; that is “a structure formed by laser cutting”. 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. See MPEP 2113.
Regarding claim 9, Gold teaches wherein the predetermined pattern comprises apertures in the reinforcement structure that are arranged such that a first spiral torque path and a second spiral torque path are formed by material of the reinforcement structure between the apertures (“One set of strands defines a clockwise helix, and the other set a counterclockwise helix, so that the respective strands cross each other in straight manner, and bonded together.” Col. 2, ln. 51-53; there are inherently apertures between the reinforcement structure wires).
Regarding claim 10, Gold teaches wherein the first spiral torque path and second spiral torque path are wound about the longitudinal axis in opposing directions (“One set of strands defines a clockwise helix, and the other set a counterclockwise helix, so that the respective strands cross each other in straight manner, and bonded together.” Col. 2, ln. 51-53).
Regarding claim 13, Gold teaches wherein the reinforcement structure has an elongate tubular shape (“flexible catheter which comprises at least one resilient, flexible tubular layer in telescoping relation with and bonded to a tubular, wire sheath made of generally helically disposed, crossing wire strands” Col. 1, ln. 50-54).
Regarding claim 14, Gold teaches wherein the reinforcement structure is coaxial with the elongate tubular body (“tubular products such as catheters are disclosed which comprise an extruded plastic coating having a tubular, braided wire sheath disposed tightly about a plastic coating in telescoping relation therewith” Col. 1, ln. 7-10).
Regarding claim 16, the claimed phrase “wherein the elongate tubular body is formed by reflowing the first material onto the reinforcement structure and the intermediate portion of the reinforcement structure includes one or more features configured to promote mechanical interlocking between the one or more features and the layer when the first material is reflowed onto the reinforcement structure” is being treated as a product by process limitation; that is “a structure formed by reflowing”. 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. See MPEP 2113.
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.
Claims 11-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Gold, as applied to claims 8 and 9 above, in view of Wainwright et al. (US 20240198039 A1, published Jun. 20, 2024, EFD Dec. 14, 2023, hereinafter referred to as “Wainwright”).
Regarding claim 11, Gold teaches the catheter of claim 9. Gold does not teach wherein the apertures are each diamond-shaped.
Wainwright’s invention relates to catheters suitable for use in a patient's vasculature (¶[0002]). The laser cuts can be adjusted to cut a more diamond-like shape, or other shape corresponding to further removed portions of metal with greater flexibility, rather than a line of the laser beam width, for example, to form cuts of similar shape as formed by the stretch (¶(0066).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to make the apertures diamond shaped as taught by Wainwright in the catheter of Gold in order to vary the flexibility of the catheter (¶[0007]).
Regarding claim 12, Gold teaches the catheter of claim 8. Gold does not teach wherein the predetermined pattern comprises a lattice structure.
Wainwright teaches in Fig. 10 that sections A, C, and E have a consistent laser cut pattern, and Sections B and D have a transitional cut pattern to transition between two adjacent sections with a consistent laser cut pattern (¶[0096]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have a lattice structure as the pattern as taught by Wainwright in the catheter of Gold in order to vary the flexibility of the catheter (¶[0007]).
Regarding claim 15, Gold does not disclose wherein the elongate tubular body further comprises an intermediate portion disposed between the first portion and the second portion and the reinforcement structure further comprises an intermediate portion that extends from a first end to a second end of the intermediate portion of the elongate tubular body.
Wainwright teaches the laser cut hypotube may further comprise a plurality of sections, each of the plurality of sections having a distinct laser cut pattern. The distinct laser cut pattern may be associated with a flexibility of the corresponding section (¶[0007]). Fig. 10 shows sections A, C, and E which have a consistent laser cut pattern, and Sections B and D have a transitional cut pattern to transition between two adjacent sections with a consistent laser cut pattern (¶[0096]). See annotated Fig. 10 below
PNG
media_image2.png
276
587
media_image2.png
Greyscale
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have an intermediate portion between two portions that extend from a first end to a second end as taught by Wainwright in order to adjust the flexibility at different regions along the catheter.
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tao (US 20200406001 A1, published Dec. 31, 2020, hereinafter referred to as “Tao”) in view of Gold.
Regarding claim 17, Tao teaches an intracardiac blood pump assembly (“FIG. 1 shows an illustrative blood pump assembly 100” ¶[0032]), comprising: a blood pump (Fig. 1 “pump 102” ¶[0032]) comprising a proximal portion and a distal portion (see annotated Fig. 1 below); and a catheter comprising an elongate tubular body (Fig. 1 “catheter 110” ¶[0032]), the elongate tubular body comprising: a proximal end and a distal end (Fig. 1 “catheter 110 having a distal end 112” ¶[0032]), wherein the distal end of the elongate tubular body is coupled to the proximal portion of the blood pump (see annotated Fig. 1).
PNG
media_image3.png
478
592
media_image3.png
Greyscale
Tao does not disclose the catheter having at least one lumen extending from the proximal end to the distal end along a longitudinal axis, a layer made of a first material, a first portion having a first length, a second portion having a second length, wherein the first portion is proximal of the second portion, and a reinforcement structure embedded in the layer, wherein the reinforcement structure is configured such that the second portion of the elongate tubular body transmits a larger proportion of externally applied torque over the second length than the first portion transmits over the first length.
Gold’s invention relates to a flexible catheter which comprises at least one resilient, flexible layer in telescoping relation with and bonded to a tubular, wire sheath made of generally helically disposed, crossing wire stands (Col. 1, ln. 51-54). Fig. 1 shows an inner plastic extrusion 12 being extruded on a mandrel 14 (Col. 3, ln. 25-26) which implies a lumen and Fig. 2 shows catheter axis 23 (Col. 3 ln. 45). Inner plastic extrusion 12 may be of any appropriate material which is desirably used for a catheter such as polyethylene, nylon, PVC, polyurethane, or silicone rubber (Col. 3, ln. 26-29). A transitional area 27 is provided on the catheter … the tip section 22 to … a second catheter section 26 (first and second portions that are proximal each other) (Col. 3, ln. 49-53). Annotated Fig.’s showing the first and second portions with varying lengths can be seen in the claim 1 USC 102 rejection above. It might be desirable for the distal tip of the catheter to be very soft and pliable, with a low torsional rigidity, while an intermediate section of the catheter should have greater amounts of torsional rigidity to permit the transfer of torque to the tip area from the distal end (Col. 1, ln. 25-32). The second section 26 of the catheter has a lower longitudinal stiffness, and a higher torsional stiffness than tip section 22. Thus second section 26 permits the catheter to transmit torque well along its length, while tip section 22 is more yielding and resilient in terms of torque transmission (Col. 3, ln. 55-60).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to replace the catheter of Tao with the catheter taught by Gold in order to produce various torsional profiles throughout the catheter based on the desired application.
Regarding claim 18, Gold teaches wherein the reinforcement structure comprises a first portion that extends from a first end to a second end of the first portion of the elongate tubular body (catheter tip section 22 extends from transition point 27 to the distal end 22 as shown in Fig. 2), and the first portion of the reinforcement structure is configured as a coil (“The nonbraided crossing wire cylinders may have the strands of the two sets separately and sequentially wound on the flexible tubular layer” Col. 2, ln. 38-40).
Regarding claim 19, Gold teaches wherein the reinforcement structure comprises a second portion that extends from a first end to a second end of the second portion of the elongate tubular body, (second catheter section 26 extends from transitional portion 27 to transitional portion 32).
The claimed phrase “the second portion of the reinforcement structure is laser cut according to a predetermined pattern” is being treated as a product by process limitation; that is “a structure formed by laser cutting”. 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. See MPEP 2113.
Regarding claim 20, Gold teaches wherein the predetermined pattern comprises apertures in the reinforcement structure that are arranged such that a first spiral torque path and a second spiral torque path are formed by material of the reinforcement structure between the apertures(“One set of strands defines a clockwise helix, and the other set a counterclockwise helix, so that the respective strands cross each other in straight manner, and bonded together.” Col. 2, ln. 51-53; there are inherently apertures between the reinforcement structure wires. Wainwright also teaches apertures that are formed by the material of the reinforcement structure as this is the holes that are being laser cut out), wherein the first spiral torque path and second spiral torque path are wound about the longitudinal axis in opposing directions (“One set of strands defines a clockwise helix, and the other set a counterclockwise helix, so that the respective strands cross each other in straight manner, and bonded together.” Col. 2, ln. 51-53).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Chien et al. (US 6165163 A) – catheter with reinforcement that varies
Al-Marashi et al. (US 20080147001 A1) – benefits of laser cut
Tanioka et al. (US 20080188832 A1) – gradually changing the stiffness changes the torque transmission
Storbek et al. (US 20150290423 A1) – two different reinforcement levels throughout catheter
Aboul-Hosn et al. (US 9789238 B2) – catheter and pump
Chou et al. (US 10864350 B2) – gap between two reinforcement areas
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET.
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, Unsu Jung can be reached at (571) 272-8506. 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.
/E.N.C./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
Prosecution Insights