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, drawn to a vine robot catheter device, in the reply filed on 4/14/26 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)). The Examiner respectfully agrees with Applicant, noting the eligibility of Group II for rejoinder.
Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/14/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying 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 Rejections - 35 USC § 112(b)
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 6-13 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.
The term “preferably” in each of claims 6-13 is a relative term which renders the claims indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of each of claims 6-13 is indeterminate because it is unclear if the limitation following “preferably” is explicitly, implicitly, inherently, and/or inferentially required or excluded from the scope of invention. One of ordinary skill in light of the instant Specification would not be apprised of the metes and bounds of the scope of the claimed invention because of the ambiguity arising from the term “preferably” and whether the subsequent claimed dimensions or materials is/are required or not required and instead optional.
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) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bacich et al. (US 2020/0023162 A1, hereinafter Bacich).
For claim 1, Bacich discloses a vine robot catheter device (10) (Figs 1A-1F) ([0066-0071]), comprising inter alia:
an elongate outer catheter (outer catheter 18) dimensioned according to a lumen path to reach a region of a targeted anatomy (Figs 1A-1F) ([0066-0071]),
an inverted vine robot extension (everting membrane 25) having its proximal end attached to the outer catheter and its distal end partially or fully inverted into itself within the outer catheter during delivery to a target site (Figs 1A-1F) ([0066-0071]), and
a fluid path (hydraulic energy path of [0069] that actuates everting membrane 25) in the outer catheter to apply fluid pressure to the vine robot extension to actuate the vine robot extension to evert and extend the distal end out of and beyond the outer catheter (Figs 1A-1F) ([0066-0071]).
For claim 2, Bacich discloses the vine robot catheter device of claim 1, comprising an elongate inner element (inner catheter 16) within a lumen of the outer catheter (Figs 1A-1F) ([0066-0071]), the inner element being attached to the distal end of the inverted vine robot extension (Figs 1A-1F) ([0066-0071]).
For claim 3, Bacich discloses the vine robot catheter device of claim 2, wherein the inner element comprises an inner catheter (inner catheter 16) tube defining a lumen (Figs 1A-1F) ([0066-0071]).
For claim 4, Bacich discloses the vine robot catheter device of claim 3, comprising a guide wire (guided elongate biopsy device 30) within the inner catheter tube that is extendable to guide a path of growth of the vine robot extension to follow an anatomical path (Figs 1A-1F) ([0066-0071]).
For claim 5, Bacich discloses the vine robot catheter device of claim 1, comprising a pre-bent section (everting membrane is initially bent as it is rolled or folded prior to eversion) (Figs 1A-1F) ([0066-0071]) in the vine robot extension that forms a predetermined shape (straight and/or repositioned with other biopsy devices of [0070]) during eversion to follow an anatomical path (Figs 1A-1F) ([0066-0071]).
For claim 6, Bacich discloses the catheter device of claim 1, wherein the vine robot catheter extension is dimensioned for the upper gastrointestinal tract with a 5 mm outer diameter (Figs 1A-1F) ([0066-0071, especially 0071]).
For claim 7, Bacich discloses the catheter device of claim 1, wherein the vine robot catheter extension is dimensioned for the lower gastrointestinal tract with a 5 mm outer diameter (Figs 1A-1F) ([0066-0071, especially 0071]).
For claim 8, Bacich discloses the catheter device of claim 1, wherein the vine robot catheter extension is dimensioned for the biliopancreatic tract with a 5 mm outer diameter (Figs 1A-1F) ([0066-0071, especially 0071]).
For claim , Bacich discloses the catheter device of claim 1, wherein the vine robot catheter extension is dimensioned for the urinary tract with a 1-5 mm outer diameter (Figs 1A-1F) ([0066-0071, especially 0071]).
For claim 10, Bacich discloses the catheter device of of claim 1, wherein the vine robot catheter extension is dimensioned for the respiratory tract with a 5 mm outer diameter (Figs 1A-1F) ([0066-0071, especially 0071]).
For claim 11, Bacich discloses the catheter device of any of claim 1, wherein the vine robot catheter extension is dimensioned for the uterine cavity with a 5 mm outer diameter (Figs 1A-1F) ([0066-0071, especially 0071]).
For claim 12, Bacich discloses the catheter device of any of claim 1, wherein the vine robot catheter extension is dimensioned for the vessels with a 5 mm outer diameter (Figs 1A-1F) ([0066-0071, especially 0071]).
For claim 13, Bacich discloses the catheter device of of claim 1, wherein the vine robot extension is made of a material selected from the group of plastics and fabrics, preferably thermoplastic polyurethane, dyneema, PTFE, or ripstop nylon fabric with silicone or urethane coating (Figs 1A-1F) ([0066-0071, especially 0071]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for providing an inverted catheter operable with fluid-based extension and directable to a targeted anatomical location.
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
Prosecution Insights