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 .
Priority
Support for Claims 1-12 can be found in US Provisional 63/134,183 filed January 6, 2021 and as such Claim 1-12 have an effective filing date of January 6, 2021.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-7), Species B (Fig 11-11b), subspecies A – Figs 3-3b in the reply filed on February 25, 2026 is acknowledged.
Claims 8-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 25, 2026.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "208" (see Fig 5) and "135" (Fig 6f) have both been used to designate handles. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “208” has been used to designate both handle (Fig 6f) and dome shaped top surface (Fig 10). 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. 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.
Specification
The disclosure is objected to because of the following informalities:
The specification identifies the handles with two different reference numbers 135 (paragraph 70) and 208 (paragraph 67). See drawing objection above.
The specification identifies reference number 208 to be the handles (paragraph 67) and the dome shaped top surface (paragraph 99). See drawing objection above.
Appropriate correction is required.
Claim Objections
Claim 7 objected to because of the following informalities:
It appears that the end of claim 7 should recite “said proximal portion [[period]]”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a sliding element configured to slide through the proximal portion and through said longitudinal slot when the cross-sectional area of the proximal portion is sufficiently increased by a user by manipulation of said handles, thus providing access and secure placement of the sliding element within the longitudinal slot” but Claim 3 recites “wherein said elongated anoscope body and said sliding element are configured to provide access and placement of the sliding element without manipulation of the handles when the sliding element is being slid into the proximal portion.” Claim 1 requires manipulation but then claim 3 does not require manipulation and as such Claim 3 appears to contradict Claim 1. Claim 4 recites the same issue. As such the scope of the claims are unclear. Clarification is requested.
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.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Odet WO 2020217223 (see English Translation attached) in view of Rebuffat US 2008/0275306.
Regarding Claim 1, Odet discloses a system (Figs 1-7) for treating hemorrhoids (abstract), comprising:
a) an anoscope assembly (see Fig below), comprising:
i) an elongated anoscope body (see fig below) having a distal end and a proximal end (see Fig below), said anoscope body being configured to be insertable into the rectum of a patient (abstract, Fig 6-7), said elongated anoscope body, comprising:
1. a main portion having a longitudinal slot (see Fig below) configured to function as a window opening to trap hemorrhoids (abstract, page 8 lines 1-2, “When the first hemorrhoidal artery is detected….” Fig 6-7);
2. a proximal portion (see Fig below) depending proximally from said main portion, said proximal portion having handles (#30) thereon;
ii) a sliding element (#4, see Fig 1, 4) configured to slide through the proximal portion and through said longitudinal slot (Fig 5-7, last paragraph of page 7 “In Figure 5, the device is shown….”) and,
b) a treatment probe (Doppler probe #6, Fig 5-6) operably connected to said anoscope assembly (Fig 5-6), configured to provide energy to a hemorrhoid during treatment (page 7, line 5-21 where the ultrasonic energy is able to provided to the hemorrhoid).
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Odet discloses the elongated anoscope body can be made out of various materials (page 9, lines 11-16) but does not disclose 2. the handles are configured to be manipulated by a user so as to adjust the cross-sectional area of the proximal 2. The configured to slide through the proximal portion and through said longitudinal slot when the cross-sectional area of the proximal portion is sufficiently increased by a user by manipulation of said handles, thus providing access and secure placement of the sliding element within the longitudinal slot.
Rebuffat discloses an anoscope (#2, Fig 1-4) made from a suitable flexible material such as polyethylene terephthalate (paragraph 33).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the anoscope of Odet to be made out of a flexible material such as polyethylene terephthalate in view of Rebuffat above because polyethylene terephthalate is a known biologically suitable material for anoscopes.
The examiner notes that with the modification, Odet as modified discloses
2. the handles are configured to be manipulated by a user so as to adjust the cross-sectional area of the proximal portion (see annotated figure above where due to the anoscope being made from a flexible material, the handles can be manipulated towards or away from each other to adjust the cross-sectional area of the proximal portion),
ii), the sliding element is configured to slide through the proximal portion and through said longitudinal slot when the cross-sectional area of the proximal portion is sufficiently increased by a user by manipulation of said handles, thus providing access and secure placement of the sliding element within the longitudinal slot (one can manipulate the handles away to widen the slot slightly so that the sliding element can more easily slide into the slot and then secured therein, page 6 in Odet)( examiner also notes that when in use, the body is able to impart a compressive force on the anoscope and thus one can also manipulate the handles to slightly widen the slot to more easily slide the sliding element into the slot).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Odet WO 2020217223 (see English Translation attached) and Rebuffat US 2008/0275306, as applied to claim 1, and in further view of Delany US 2008/0262511.
Odet as modified discloses the claimed invention as discussed above where the hemorrhoid is treated using the anoscope assembly (page 8 lines 1-2) but does not disclose an ablation control system assembly operatively connectable to said anoscope assembly.
Delany discloses a similar system (Fig 1a) with an anoscope body (#110), a sliding element (#105) received in a longitudinal slot (Fig 1), an ablation control system assembly operatively connectable to said anoscope assembly to excise the hemorrhoid
(paragraph 37-38, “ultrasonic ablation device” or “radiofrequency ablation device” is inserted into the anoscope body to excise the hemorrhoid).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to include an ablation control assembly in view of Delany above because this provides a known way to treat and subsequently excise the hemorrhoid.
Allowable Subject Matter
Claims 5-7 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.
The following is a statement of reasons for the indication of allowable subject matter: Odet WO 2020217223 discloses a similar system (see rejection in claim 1) where the anoscope includes stop members #51 that engage with corresponding openings #50 on the sliding element but lacks the ring type structure having proximal portion teeth and the sliding element having complementary sliding element teeth as claimed in claim 5. A common feature of sliding elements in the prior art are sliding elements that are smooth/flat (see for example Delaney US 2008/026251,1 Fig 1d-1e) and lack the teeth as claimed. See PTO-892 for art of interest which shows anoscopes with a sliding element.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773