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 Species A, embodiment directed to Figure(s) 1, in the reply filed on 10/28/25 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)).
Further, and in the interest of advancing compact prosecution, the examiner respectfully notes that although Applicant’s 10/28/25 response appears non-responsive to the election of Species requirements, lacking any indication of which claims corresponded to only the elected species, examination on the merits will nonetheless be completed as set forth hereinbelow.
Claims 4, 5, 7-9, 17, 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Given Applicant’s lack of species-claim indication, the Examiner respectfully notes claims 4 and 17 are drawn to nonelected Species D (Figs 4A-4D), claims 5 and 18 are drawn to nonelected Species E (Figs 5A-D), and claims 7-9 are drawn to nonelected Species B (Fig 2). Election was made without traverse in the reply filed on 10/28/25.
Information Disclosure Statement
The information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
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 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 Objections
Claim 2 is objected to because of the following informalities: the positive recitation of “a distance” should apparently read “the distance”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the positive recitation of “multiple wave cut segments” should apparently read “the multiple wave cut segments”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: the positive recitation of “of the wave cut segment” should apparently read “each of the multiple wave cut segments”. Appropriate correction is required.
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 10-16 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 10 positively recites inter alia “a pitch (distance between wave cuts) and/or an angle (direction of the wave cut)”. The scope of the claim is indeterminate in the presence of the parenthetical language. It is unclear if the clarifying parenthetical phrases may explicitly, inherently, implicitly, and/or inferentially be required or excluded by the recitation from the scope of invention. One of ordinary skill in the art would not be apprised of the scope of the invention and whether or not the parenthetical language is or is not included in the scope of invention. For the purposes of examination and consistent with the instant Specification, the examiner is treating the terms on the merits as required by the claim. Depending claims 11-16 inherit and do not remedy the indefiniteness.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, 10-16, 19, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cottone et al. (US 2019/0160259 A1, hereinafter Cottone).
For claim 1, Cottone discloses a flexible hypotube comprising: an elongated body (1005) (Figs 8a-8c) ([0109-0119]); multiple wave cut segments (zones 1-7) (Figs 8a-8c) ([0109-0119]) cut in the elongated body, each wave cut segment having a continuous wave cut around the elongated body forming a pattern of wave cuts configured to vary the flexibility of the elongated body by varying a distance between wave cuts and changing an angle direction between wave cut sets (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 2, Cottone discloses the flexible hypotube of claim 1, wherein varying the distance between wave cuts incudes varying a pitch between wave cuts (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 3, Cottone discloses the flexible hypotube of claim 1, wherein changing a direction between wave cuts includes wave cut sets angled proximally and wave cut sets angled distally (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 6, Cottone discloses the hypotube of claim 1, wherein the multiple wave cut segments include a distal wave cut segment (zone 7), a middle wave cut segment (zone 4) and a proximal wave cut segment (zone 1) (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 10, Cottone discloses a flexible hypotube comprising: an elongated body 1005) (Figs 8a-8c) ([0109-0119]); and a continuous wave (any of zones 1-7) 1005) (Figs 8a-8c) ([0109-0119]) cut around the elongated body forming a wave cut pattern having a pitch as a distance between wave cuts and/or an angle as a direction of the wave cut between wave cuts to provide flexibility to the elongated body (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 11, Cottone discloses the flexible hypotube of claim 10, wherein varying the pitch varies the flexibility along the elongated body (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 12, XX Cottone X discloses the flexible hypotube of claim 10, wherein varying the angle varies the flexibility along the elongated body (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 13, Cottone discloses the flexible hypotube of claim 10, wherein the elongated body includes multiple wave cut segments (zones 1-7) with each wave cut segment having a wave cut pattern (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 14, Cottone discloses the flexible hypotube of claim 13, wherein flexibility of each of the wave cut segment depends on the pitch of the wave cut and/or the angle of wave cut (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 15, Cottone discloses the flexible hypotube of claim 14, wherein the multiple wave cut segments have the same wave cut pattern with the same flexibility to provide constant flexibility to the hypotube body (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 16, Cottone discloses the flexible hypotube of claim 14, wherein the multiple wave cut segments have a different wave cut pattern with a different flexibility to provide varied flexibility to the hypotube body (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 19, Cottone discloses a flexible hypotube comprising: an elongated body (1005) (Figs 8a-8c) ([0109-0119]) having multiple segments (zones 1-7) (Figs 8a-8c) ([0109-0119]); and each segment having a continuous wave cut around the elongated body forming multiple segment wave cut patterns with each segment wave cut pattern having a different flexibility to provide varied flexibility to the elongated body (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
For claim 20, Cottone discloses the flexible hypotube of claim 13, wherein the different flexibility includes varying a distance and/or an angle direction between wave cuts (Figs 8a-8c) ([0109-0119, especially 0115-0117]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, including means for configuring varying flexibility along the length of an elongate tube for traversing a patient’s vasculature.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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, Charles A. Marmor II can be reached at (571)272-4730. 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.
Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791