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 without traverse of Group II, drawn to a process of positioning a tool within a body lumen, and Species II, embodiment drawn to Figure(s) 74A-74F, in the reply filed on 11/11/25 is acknowledged.
Claims 80-98 (now cancelled), 104, and 114-127 (now cancelled) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/11/25. Regarding with claim 104, the Examiner respectfully notes the asymmetric guide is clearly drawn to at least non-elected Species HH and the corresponding description thereof.
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 § 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) 99-103 and 105-113 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tilson et al. (WO 2020/018934 A1, hereinafter Tilson).
For claim 99, Tilson discloses a method of positioning a tool within a body lumen (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]), comprising inter alia:
inserting a rigidizing device (609) and an outer tube (exterior of Fig 45D) into a body lumen while the rigidizing device is in a flexible configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]), wherein the outer tube comprises one or more expandable channels therein (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]);
supplying vacuum or pressure to the rigidizing device to transition the rigidizing device from the flexible configuration to a rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]);
inserting a tool through a channel (655) of the one or more expandable channels while the rigidizing device is in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]); and
performing a medical procedure in the body lumen with the tool (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 100, Tilson discloses the method of claim 99, further comprising inserting a guide through the channel of the one or more expandable channels while the rigidizing device is in the rigid configuration and prior to inserting the tool (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 101, Tilson discloses the method of claim 100, further comprising: removing the tool from the guide (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]); and removing the guide from the channel (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 102, Tilson discloses the method of claim 101, wherein removing the guide from the channel causes the channel to collapse radially inwards (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 103, Tilson discloses the method of claim 100, wherein a shape of the rigidizing device in the rigid configuration remains fixed during the step of inserting the guide (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 105, Tilson discloses the method of claim 100, wherein the step of inserting the tool comprises inserting the tool such that the tool extends through a preset bend in a lumen of the guide and points towards a central axis of the rigidizing device (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 106, Tilson discloses the method of claim 100, wherein inserting the guide through the channel causes the channel to expand radially outwards from a collapsed configuration to an expanded configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 107, Tilson discloses the method of claim 100, wherein the at least one guide has a higher stiffness than the rigidizing device in the flexible configuration and a lower stiffness than the rigidizing device in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 108, Tilson discloses the method of claim 99, wherein the step of supplying vacuum or pressure to the rigidizing device comprises supplying vacuum or pressure to a wall of the rigidizing device (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 109, Tilson discloses the method of claim 99, wherein the step of performing a medical procedure is performed while the rigidizing device is in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 110, Tilson discloses the method of claim 99, wherein the tool has a higher stiffness than the rigidizing device in the flexible configuration and a lower stiffness than the rigidizing device in the rigid configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 111, Tilson discloses the method of claim 99, further comprising passing a scope through the rigidizing device while the rigidizing device is in a rigidized configuration (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 112, Tilson discloses the method of claim 100, wherein a shape of the rigidizing device in the rigid configuration remains fixed during the step of inserting the tool (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
For claim 113, Tilson discloses the method of claim 99, further comprising selecting the channel of the one or more channels prior to inserting the guide (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]), wherein selecting the channel comprises selecting based upon a proximal marker indicating a distal circumferential position of the channel (Figs 45A-D, 72A-72D, 81A-F) ([0153-0169, 0191-0234, 0262-0265, 0322-0341, 0359-0380]).
Conclusion
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