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, readable on Claims 1-10 in the reply filed on 4/7/2026 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)).
Applicant's election with traverse of Species A, readable on Claims 1-10 in the reply filed on 4/7/2026 is acknowledged. The traversal is on the ground(s) that Species A and B are generic to all of the pending claims. This is not found persuasive because the species are each directed towards a retroflexion device that’s incorporated with a different surgical tool at the end and although Species A and B are generic to claims 1-10, there would still be an undue search burden on the examiner if during prosecution claims were submitted directed towards each specific surgical tool configuration in Species A and B.
The requirement is still deemed proper and is therefore made FINAL.
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
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 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shikhman et al. (US Patent Application Publication No. 2023/0389784, hereinafter Shikhman).
In regard to claim 1, Shikhman discloses a retroflexion device (300, Figs. 12,14) for retroflexing a flexible elongate member (322) of a medical device (Figs. 12,14), said retroflexion device comprising:
a distal mount (332) configured to be mounted with respect to the distal end of the flexible elongate member (Figs. 12,14);
a pivot mount (341) configured to be mounted with respect to the flexible elongate member proximal to the distal mount (Figs. 12,14); and
an elongated actuation component (372) having a proximal end and a distal end with a length extended therebetween selected to extend along the length of the flexible elongate member (Figs. 12,14);
wherein:
a proximal end of said actuation component is controllable along a proximal end of the flexible elongate member (via slider (376), Fig. 14);
a distal end of said actuation component is operatively associated with a distal end of the flexible elongate member via said distal mount (Figs. 12,14); and
an actuation region of said actuation component pivots with respect to said pivot mount when said actuation component is pulled proximally to cause the flexible elongate member to retroflex (Figs. 12,14, actuation of slider (376) backward causes the flexible elongate member to flex away from the longitudinal axis which is being considered as retroflex).
In regard to claim 2, Shikhman teaches further comprising a flexible tubular elongate member (374) having at least one lumen extending therethrough through which said actuation component extends (Figs. 12,14).
In regard to claim 3, Shikhman teaches wherein said flexible tubular elongate member is configured to be mounted along the flexible elongate member (Figs. 12,14).
In regard to claim 4, Shikhman teaches wherein: said flexible tubular elongate member has a proximal end and a distal end defining a length therebetween selected to be less than the length of the flexible elongate member; said flexible tubular elongate member is configured to be mounted with respect to the flexible elongate member with the distal end of the flexible tubular elongate member proximal to the distal end of the flexible elongate member; and the distal end of said flexible tubular elongate member forms said pivot mount for said actuation component (Fig. 14 shows the distal end of the flexible tubular elongate member forming said pivot mount for said actuation component).
In regard to claim 5, Shikhman teaches wherein said flexible tubular elongate member (the pivot mount (341) can be considered the flexible tubular elongate member) has more than one lumen (via lumen for an endoscope and lumens for cables) extending therethrough to allow additional devices to be extended through said flexible tubular elongate member (Figs. 12,14).
In regard to claim 6, Shikhman teaches wherein: said flexible tubular elongate member has a proximal end and a distal end (Figs. 12,14); and said retroflexion device further comprises a proximal mount (352) provided along the proximal end of said flexible tubular elongate member; and the proximal end of said actuation component is operatively associated with said proximal mount (Figs. 12,14).
In regard to claim 7, Shikhman teaches further comprising a proximal mount (352), the proximal end of said actuation component being operatively associated with said proximal mount (Figs. 12,14).
In regard to claim 8, Shikhman teaches further comprising a pull handle (376) on the proximal end of said actuation component (Figs. 12,14).
In regard to claim 9, Shikhman teaches wherein said proximal mount includes a pull handle mount (Figs. 12, 14 illustrate the slider (376) mounted on the proximal mount).
In regard to claim 10, Shikham teaches further comprising a locking system (376) mounted on said proximal mount and configured to temporarily retain said actuation component under tension to retroflex said flexible elongate member (movement and/or holding of the slider (376) maintains the actuation component under tension).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 April 18, 2026
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