CTNF 18/935,084 CTNF 100507 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 08-25-02 Applicant’s election of Invention I corresponding to claims 1-6 in the reply filed on 4/24/2026 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the election has been treated as an election without traverse (MPEP § 818.01(a)). 08-06 AIA Claim s 7-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Inventions II and III , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/24/2026 . Drawings The drawings are objected to under 37 CFR 1.84(t). The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in 37 CFR 1.84(g). 06-22 Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections 07-29-01 AIA Claim 18 is objected to because of the following informalities: In claim 18, line 2, “with first tissue” should read “with the first tissue”. This suggested modification would eliminate potential 112(b) issues arising from a lack of antecedent basis . Appropriate correction is required. 07-30-03-h AIA Claim Interpretation 07-30-03 AIA 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. 07-30-05 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. 07-30-06 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 limitations are: “the cutting device is configured to cut through a surface of the tissue at a location between two portions of the distal surface engaging the tissue” in claim 15 as described in Para. [0058] of Applicant’s specification. 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 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (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. The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art. 07-15 AIA Claim s 1-3 and 5-6 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by U.S. Patent Appl. Publ. No. 2002/0035311 A1 to Ouchi (“Ouchi”) . Regarding claim 1, Ouchi discloses a cap (tip hood 10; Fig. 1, paragraph 0022) for a flexible elongate member insertable into a body (Fig. 1 shows the tip portion of an endoscope according to a first embodiment of the invention. It comprises an insertion portion 1 in a flexible tubular form that is fitted with a cylindrical tip body 2 at the distal end; Fig. 1, paragraph 0018) , comprising: a proximal end configured to couple with the flexible elongate member (indicated by 10a is a circumferential projection that is formed on the inner periphery of the tip hood 10 at the rear end in such a way that it deforms elastically to come into or out of engagement with a groove formed in the outer periphery of the tip body 2; Fig. 1, paragraph 0023) ; a distal end defining a first inner diameter (distal end of the tip hood 10 is opposite the rear end and has a first inner diameter; Fig. 1) ; a lumen extending between the proximal end and the distal end (the tip hood 10 is a cylindrical member; Fig. 1, paragraph 0022) ; and a protrusion located between the proximal end and the distal end (in the intermediate position of the tip hood which is between the distal end face of the tip body 2 corresponding to the bottom plane of the tip hood 10 and its distal end, an aspirated mucosa moving regulating portion 11 is formed; Fig. 1, paragraph 0024) and defining a second inner diameter that is smaller than the first inner diameter (the aspirated mucosa movement regulating portion 11 is an annular wall formed along the inner periphery of the tip hood 10 to project inwardly as a flange and it is formed as an integral part of the tip hood 10; Fig. 1, paragraph 0025) , and wherein the protrusion is configured to engage tissue received in the lumen through the distal end (the sucked portion of the mucosa becomes like a “polyp” in shape but its projecting end contacts the aspirated mucosa movement regulating portion 11, it will not be further aspirated into the tip hood 10 but maintains a certain distance from the viewing window 3; Fig. 2, paragraph 0026-0027) . Regarding claim 2, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the protrusion is configured to be spaced distally apart from a distal end of the flexible elongate member when the proximal end is coupled with the flexible elongate member (in the intermediate position of the tip hood which is between the distal end face of the tip body 2 corresponding to the bottom plane of the tip hood 10 and its distal end, an aspirated mucosa moving regulating portion 11 is formed in order to ensure that the mucosa aspirated from the distal end of the tip hood 10 toward the aspiration port 5 will not get to the viewing window 3; Fig. 1, paragraph 0024) . Regarding claim 3, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the protrusion extends circumferentially around the lumen (the aspirated mucosa movement regulating portion 11 is an annular wall formed along the inner periphery of the tip hood 10 to project inwardly as a flange and it is formed as an integral part of the tip hood 10; Fig. 1, paragraph 0025) . Regarding claim 5, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the protrusion defines a circular end of the lumen (the aspirated mucosa movement regulating portion 11 is an annular wall formed along the inner periphery of the tip hood 10 to project inwardly as a flange and it is formed as an integral part of the tip hood 10; Fig. 1, paragraph 0025) . Regarding claim 6, Ouchi discloses the cap according to claim 1. Ouchi further discloses wherein the distal end is made from a substantially transparent material (the tip hood 10 is a cylindrical member formed typically of an elastic transparent material; Fig. 1, paragraph 0022) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ouchi . Regarding claim 4, Ouchi discloses the cap according to claim 1. However, Ouchi does not disclose wherein the protrusion defines a non-circular end of the lumen. Ouchi does not disclose a protrusion defining a non-circular end of the lumen such as an oval end of the lumen, but Ouchi does disclose said protrusion defining a circular end of the lumen. It is noted, that there is no significant difference between a circular and oval shape, as both shapes have continuously curved, closed perimeters without corner or edges. Further, oval shaped lumens were well known in the art at the time the invention was made. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the cap of Ouchi to have a non-circular end of the lumen, as such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey , 357 F.2d 669, 149 USPQ 47 (CCPA 1966) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2019/0125165 A1 to Orntoft et al. teaches a variety of cap shapes for a cap on a distal tip of a gastroscope as described in the abstract and following descriptive text . Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET. 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, Michael Carey can be reached at 5712707235. 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. /OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795 /MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795 Application/Control Number: 18/935,084 Page 2 Art Unit: 3795 Application/Control Number: 18/935,084 Page 3 Art Unit: 3795 Application/Control Number: 18/935,084 Page 4 Art Unit: 3795 Application/Control Number: 18/935,084 Page 5 Art Unit: 3795 Application/Control Number: 18/935,084 Page 6 Art Unit: 3795 Application/Control Number: 18/935,084 Page 7 Art Unit: 3795 Application/Control Number: 18/935,084 Page 8 Art Unit: 3795 Application/Control Number: 18/935,084 Page 9 Art Unit: 3795 Application/Control Number: 18/935,084 Page 10 Art Unit: 3795 Application/Control Number: 18/935,084 Page 11 Art Unit: 3795 Application/Control Number: 18/935,084 Page 12 Art Unit: 3795
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