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 1, drawn to a medical device system, in the reply filed on 10/28/25 is acknowledged.
Claims 11-13, 15, 16, 18, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 10/28/25.
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) 1-10 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Butcher et al. (US 2020/0046217 A1, hereinafter Butcher).
For claim 1, Butcher discloses a medical device system (100) (Figs 8-14) ([0025-0042]), comprising inter alia:
a guide sheath (105) comprising a steerable lumen (interior lumen(s) of 105) (Figs 8-14) ([0025-0042]); and
an endoscope (1200, 105) (Figs 8-14) ([0025-0042, especially 0026, 0040]) comprising inter alia:
an elongate shaft (1200, 105) extending between a proximal end portion and a distal end face (Figs 8-14) ([0025-0042, especially 0026, 0040]), the elongate shaft configured for displacement along the steerable lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]);
a working tool lumen (first of the three lumens of 1200) (Figs 8-14) ([0025-0042, especially 0026, 0040]) extending along the elongate shaft and exiting at the distal end face (Figs 8-14) ([0025-0042]);
an anchor lumen (second of three lumens of 1200) (Figs 8-14) ([0025-0042, especially 0026, 0040]) entering the elongate shaft between the proximal end portion and the distal end face and exiting the elongate shaft at the distal end face (Figs 8-14) ([0025-0042, especially 0026, 0040]); and
a non-axial lumen (third of the three lumens of 1200 and lumen of 150) (Figs 8-14) ([0025-0042, especially 0026, 0040])extending from the working tool lumen to an exterior of the elongate shaft at the distal end face (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 2, Butcher discloses the medical device system of claim 1, further comprising an anchor wire (806 via 1000) ([0040[) extending through the anchor wire lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 3, Butcher discloses the medical device system of claim 2, wherein the anchor wire comprises: an elongate cable (806) (Figs 8-14) ([0025-0042, especially 0026, 0040]); and a tissue anchor (802, 804, 810) (Figs 8-14) ([0025-0042, especially 0026, 0040]) located proximate a distal end of the anchor wire (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 4, Butcher discloses the medical device system of claim 1, further comprising a tissue retrieval device (840) (Figs 8-14) ([0025-0042, especially 0026, 0040]) extendable from the working tool lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 5, Butcher discloses the medical device system of claim 4, wherein the tissue retrieval device comprises a shaft capable of resiliently bending from extending along the working tool lumen to extending along the working tool lumen and into the non-axial lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 6, Butcher discloses the medical device system of claim 5, wherein the tissue retrieval device comprises forceps (840) (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 7, Butcher discloses the medical device system of claim 1, wherein the non-axial lumen comprises a slit (side openings of 150 extending towards 1200) (Figs 8-14) ([0025-0042, especially 0026, 0040]) at the distal end face extending along the elongate shaft to intersect the working tool lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 8, Butcher discloses the medical device system of claim 7, wherein the non-axial lumen extends through a side surface of the elongate shaft (side openings of 150 extending towards 1200) (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 9, Butcher discloses the medical device system of claim 1, wherein the non-axial lumen extends within the distal-most ten percent of the length of the elongate shaft (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 10, Butcher discloses the medical device system of claim 1, wherein the endoscope includes steering capabilities (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 21, Butcher discloses a medical device system (100) (Figs 8-14) ([0025-0042, especially 0026, 0040]), comprising inter alia:
a guide sheath (105) (Figs 8-14) ([0025-0042, especially 0026, 0040]) comprising a steerable lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]); and
an endoscope (1200,105) (Figs 8-14) ([0025-0042, especially 0026, 0040]) comprising inter alia:
an elongate shaft (1200, 105) (Figs 8-14) ([0025-0042, especially 0026, 0040]) extending between a proximal end portion and a distal end face (Figs 8-14) ([0025-0042, especially 0026, 0040]), the elongate shaft configured for displacement along the steerable lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]);
a working tool lumen (first of the three lumens of 1200) (Figs 8-14) ([0025-0042, especially 0026, 0040]) extending along the elongate shaft and exiting at the distal end face; and
an anchor lumen (second of the three lumens of 1200) (Figs 8-14) ([0025-0042, especially 0026, 0040]) entering the elongate shaft between the proximal end portion and the distal end face and exiting the elongate shaft at the distal end face (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 22, Butcher discloses the medical device system of claim 21, further comprising a slot (lateral opening(s) of 105) (Figs 8-14) ([0025-0042, especially 0026, 0040]) extending from the working tool lumen to an exterior of the elongate shaft at the distal end face to allow an instrument (e.g. 840, 1000) extending through the working tool lumen to be bent radially (Figs 8-14) ([0025-0042, especially 0026, 0040]).
For claim 23, Butcher discloses the medical device system of claim 22, further comprising:
an anchor wire (806) (Figs 8-14) ([0025-0042, especially 0026, 0040]) extending through the anchor lumen (Figs 8-14) ([0025-0042, especially 0026, 0040]), wherein the anchor wire comprises:
an elongate cable (806) (Figs 8-14) ([0025-0042, especially 0026, 0040]); and a tissue anchor (802, 804, 810) ([0025-0042, especially 0026, 0040]) located proximate a distal end of the anchor wire ([0025-0042, especially 0026, 0040]); and
a tissue retrieval (840) ([0025-0042, especially 0026, 0040]) device extendable from the working tool lumen ([0025-0042, especially 0026, 0040]), wherein the tissue retrieval device comprises a shaft (shaft of 840) ([0025-0042, especially 0026, 0040]) capable of resiliently bending from extending along the working tool lumen to extending along the working tool lumen and into the slot ([0025-0042, especially 0026, 0040]).
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