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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 6, 2026, has been entered.
Claims 1-20 are pending.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “attachment member” in claims 15 and 18 (disclosed as 3a/3b).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 2, 4, and 14 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Nozue (US 2005/0043584).
Regarding Claim 1, Nozue discloses:
A positioning aid comprising:
an opening (see Figs. 3-4 showing the hollow portion of 30 for receiving an endoscope; see also Figs. 1-2 showing the hollow portion 20 receiving scope 10) configured to receive a distal end portion of an endoscope (shown in Figs. 3-4 with scope 10 being inserted into 30; shown in Figs. 1-2 with 10 inserted into 20);
an abutting surface (32 in Figs. 3-4 or 23 in Figs. 1-2) extending radially inward from an inner surface of the opening (see Fig. 4 showing the ridge 32 extending inward from the inner surface of the opening of 30; see Paragraph 0059 describing how the slope 32 is thickest at 31 and thinnest at 30a; see Figs. 1-2 showing 23 extending radially inward to abut the scope): and
a window (33 in Figs. 3-4 and the open area in Figs. 1-2 not abutting the scope 10) located on the abutting surface configured to be aligned with a particular alignment subject on a distal end surface of the endoscope (see Figs. 3-4 showing the window 33 aligning with the opening 16a; see Figs. 1-2 showing that there is a window that align with features, including at 25 where the window aligns with 16).
Regarding Claim 2, Nozue further discloses wherein the abutting surface is configured to abut the distal end surface of the endoscope (see Figs. 3-4 showing the proximal surface of 32 abutting the distal end of scope 10; see Figs. 1-2 showing the proximal surface of 23 abutting the distal end of scope 10).
Regarding Claim 4, Nozue further discloses wherein the window penetrates the abutting surface in a direction parallel to a center axis of the opening (see Figs. 3-4 showing the window going through the abutting surface parallel to the center axis of the hollow opening of 30; see Fig. 1-2 showing the window being parallel to the center axis of the hollow opening of 20).
Regarding Claim 14, Nozue further discloses wherein the window is configured to line up with the particular alignment subject in a longitudinal direction of the endoscope in a state where the endoscope inserted into the opening and a guide sheath are arranged to have a particular positional relationship in a circumferential direction about a longitudinal axis of the endoscope (the guide sheath and endoscope are not structural elements of the claim; Nozue’s window lines up with the opening 16 as seen in Figs. 1-4 in a circumferential direction about the longitudinal axis of the scope).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 6-7, 9, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nozue (US 2005/0043584) in view of Jones (US 5,386,817).
Nozue discloses the invention substantially as claimed as stated above.
Regarding Claim 6, Nozue discloses:
A positioning aid system comprising:
a positioning aid (20/30) configured to be attached to the guide sheath wherein the positioning aid includes:
an opening (see Figs. 3-4 showing the hollow portion of 30 for receiving an endoscope; see also Figs. 1-2 showing the hollow portion 20 receiving scope 10) configured to receive a distal end portion of the endoscope (shown in Figs. 3-4 with scope 10 being inserted into 30; see also Figs. 1-2 showing the hollow portion 20 receiving scope 10);
an abutting surface (32 in Figs. 3-4 or 23 in Figs. 1-2) extending radially inward from an inner surface of the opening (see Fig. 4 showing the ridge 32 extending inward from the inner surface of the opening of 30; see Paragraph 0059 describing how the slope 32 is thickest at 31 and thinnest at 30a; see Figs. 1-2 showing 23 extending radially inward to abut the scope); and
a window (33 in Figs. 3-4 and the open area in Figs. 1-2 not abutting the scope 10) located on the abutting surface and configured to be aligned with a particular alignment subject on a distal end surface of the endoscope (see Figs. 3-4 showing the window 33 aligning with the opening 16a; see Figs. 1-2 showing that there is a window that align with features, including at 25 where the window aligns with 16).
Nozue does not explicitly disclose a guide sheath configured to receive an endoscope. Jones teaches using an outer sheath (36 or 94) surrounding the scope and other components as is known in the art. Such tubes are common and serve to protect the endoscope during insertion. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Nozue’s system to include Jones’s sheath. Such a modification provides a means to protect the outer surface of the endoscope during insertion as is known in the art.
Regarding Claim 7, Nozue further discloses wherein the abutting surface is configured to abut the distal end surface of the endoscope (see Figs. 3-4 showing the proximal surface of 32 abutting the distal end of scope 10; see Figs. 1-2 showing the proximal surface of 23 abutting the distal end of scope 10).
Regarding Claim 9, Nozue further discloses the window penetrates the abutting surface in a direction parallel to a center axis of the opening (see Figs. 3-4 showing the window going through the abutting surface parallel to the center axis of the hollow opening of 30; see Fig. 1-2 showing the window being parallel to the center axis of the hollow opening of 20
Regarding Claim 17, Nozue as modified further discloses wherein the window is configured to line up with the particular alignment subject in a longitudinal direction of the endoscope in a state where the endoscope inserted into the opening and the guide sheath are arranged to have a particular positional relationship in a circumferential direction about a longitudinal axis of the endoscope (Nozue’s window lines up with the opening 16 as seen in Figs. 1-4 in a circumferential direction about the longitudinal axis of the scope).
Allowable Subject Matter
Claims 11-13 are allowed.
Claims 3, 5, 8, 10, 15-16, and 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
As for dependent claims 3 and 8, Nozue only includes one additional abutting surface (31), and not multiple second abutting surfaces. The Examiner does not see how Nozue would be modified to take the ridge 31 (the second abutting surface) and turn it into multiple surfaces.
Claims 5, 10, and 20 are directed to the mark, which was discussed in the prior Office Action dated June 20, 2025.
Claims 11-13 require the positioning aid to be detached before insertion. This is not the case in Nozue or Jones. The positioning aid is a hood designed to be placed on the device and inserted with the device. Removing the aid prior to insertion would defeat the purpose of the hood.
Claims 15-16 and 18-19 require an attachment member as claimed. These members correspond to elements 3a/3b of Applicant’s disclosure. The Examiner sees no reason to modify Nozue to include such features as the attachment portion 21 in Nozue is designed to secure around another tubular member. Adding protrusions like 3a/3b would prevent the hood from being attachable to the other tubular member.
For at least these reasons, the claims overcome the prior art of record.
Response to Arguments
Applicant's arguments filed January 16, 2026, have been fully considered but they are not persuasive.
Applicant argues that “attachment member” does not invoke 112f because “attachment member” has not been deemed a nonce term. The Examiner notes that “member” is not a structural term and is considered a replacement for means. The word “attachment” does not have a structural meaning. The inclusion of structure in a dependent claim does not change the meaning of the parent claim. The invocation remains.
Applicant argues that Nozue’s abutting surface 32a extends inward from an inner surface of a different opening, not the one used to receive the endoscope. The Examiner has clarified the rejection. The Examiner also notes that Figs. 2 and 4 are cross-sections going through the window. The abutting portion has been removed at the window such that the drawings do not show the abutting portion fully in that view. There is clearly an abutting portion in the opening in that the scope contacts a shoulder and does not extend fully through the opening. That shoulder does not cover the entirety of the opening. The remaining opening is the window. Nozue happens to include a notch that is substantially similar to Applicant’s, but even without the notch, the reference has a window.
The application is not in condition for allowance at this time.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795