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 II in the reply filed on 2/09/2026 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)).
Drawings
The drawings are objected to because: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. This applies to shading. Solid black shading areas are not permitted, expect when used to represent bar graphs or color. See for example, Figures 1, 4, 5A-5D, 6A, 6C, 7-9 and 10A-10B.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “364” has been used to designate both the coupler. 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.
Claim Objections
Claim 29 is objected to because of the following informalities: Claim 29 recites “an inner cutter” in line 1 and “an outer cutter” in lines 1-2 which should read “the inner cutter” and “the outer cutter”, respectively. Appropriate correction is required.
Claim 31 is objected to because of the following informalities: Claim 31 recites “a distal end” in line 1 which should read “the distal end”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “an inner cutting tube concentrically positioned and rotatable within a lumen of the outer cutting tube…applying the negative pressure to the lumen” in lines 8-9 and 12. Applicant defines the cutting assembly as a “dual lumen cutting tube assembly 380” formed of a lumen in the outer cutting tube 384 and a lumen in the inner cutting tube 382 ([0046]; Fig. 7). Thus, the lumen within the inner cutting tube and the lumen between the outer surface of the inner cutting tube and the inner surface of the outer cutting tube. The specification further states that irrigation (understood to mean suction, as discussed in the 112(b) rejection below) occurs through an inner lumen of the inner cutting tube 382 such that cut tissue is suctioned through an interior of the inner cutting tube, into the irrigation chamber 360 and out of the port 364 ([0046]; [0051]). Because the cylinder 362 is “sealed”, it is sealed to the internal lumen of the inner cutting tube 382 in order to suction tissue out of the port 364. Accordingly, negative pressure is not applied to the lumen of the outer tube (i.e., the space between the outer surface of the inner cutting tube and the inner surface of the outer cutting tube), as claimed. Instead, negative pressure is applied to the lumen of the inner cutting tube, not the outer cutting tube. Because claim 21 was added after the original set of claims filed 5/30/2024, the claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
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 31 and 33-36 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “irrigation” in claims 31 and 36 and “irrigating” in claim 33 is used by the claim to mean “suction,” while the accepted meaning is “to flush (a body part) with a stream of liquid.” The term is indefinite because the specification does not clearly redefine the term.
Claims 34-35 are rejected based on their dependency on rejected claim 33.
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.
Claim(s) 25 and 29-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams et al. (US 2017/0027611 A1).
Regarding claim 25, Adams discloses a method of resecting tissue (removing uterine polyps via a hysteroscopic resectoscope; [0044]), comprising: placing a cutting instrument (polypectomy device 100 of Fig. 1A with the distal end 806 as shown in Figs. 8A-8B; [0114]) near tissue to be resected (see for example, Fig. 4); advancing the cutting instrument (as polypectomy device 100 is advanced through hysteroscope 300; Fig. 4; [0070]); rotating an inner cutter (inner tubular member 214) relative to an outer cutter (outer tubular member 804) of the cutting instrument (as 214 is caused to rotate with respect to 804; [0115]; Figs. 8A-8B); applying vacuum pressure to the cutting instrument (as the doctor can activate the vacuum source to remove a polyp through the openings of 214 and 804 similar to the openings 108 of the distal end 106; [0055]); and, thereby resecting the tissue ([0073]; [0114]).
Regarding claim 29, Adams discloses wherein the rotating an inner cutter (214) relative to an outer cutter (804) comprises rotating a cutting window of the inner cutter relative to a cutting window of the outer cutter (windows of 214 and 804 as shown in Figs. 8A-8B).
Regarding claim 30, Adams discloses wherein applying vacuum pressure to the cutting instrument comprises pulling fluid through a distal end of the cutting instrument (as fluid is pulled through the openings in 214 and 808 similar to the openings 108 described in the distal end 106; [0055]).
Regarding claim 31, Adams discloses wherein the pulling fluid through a distal end of the cutting instrument comprises suction irrigation (wherein irrigation is understood to mean suction based on applicants specification, as discussed above) through the cutting instrument each time the rotation of the cutting window of the inner cutter relative to the cutting window of the outer cutter results in closure of the cutting window of the outer cutter (as the openings in 214, 804 are temporarily blocked by rotation of 214 relative to 204 and the vacuum suction is continuous; [0055]; Figs. 8A-8B).
Regarding claim 32, Adams discloses wherein applying vacuum pressure to the cutting instrument comprises pulling fluid through a distal end of the cutting instrument (as fluid is pulled through the openings in 214 and 808 similar to the openings 108 described in the distal end 106; [0055]).
Regarding claim 33, Adams discloses a method of resecting tissue (removing uterine polyps via a hysteroscopic resectoscope; [0044]), comprising: placing a cutting assembly (polypectomy device 100 of Fig. 1A with the distal end 806 as shown in Figs. 8A-8B; [0114]) adjacent tissue (polyp) to be resected (Fig. 4); advancing the cutting assembly (as polypectomy device 100 is advanced through hysteroscope 300; Fig. 4; [0070]); rotating an inner cutting body (inner tubular member 214) relative to an outer cutting body (outer tubular member 804) of the cutting assembly (as 214 is caused to rotate with respect to 804; [0115]; Figs. 8A-8B); intermittently irrigating (understood to mean suctioning, as discussed above with respect to the 112(a) rejection) through the cutting assembly according to each rotation of the inner cutting body relative the outer cutting body (as the openings in 214, 804 are temporarily blocked by rotation of 214 relative to 204 and the vacuum suction is continuous through the openings in 214 and 808 similar to the openings 108 described in the distal end 106; [0055]; Figs. 8A-8B); and, thereby resecting the tissue ([0073]; [0114]).
Regarding claim 34, Adams discloses wherein the inner cutting body (214) and the outer cutting body (804) each include a cutting window (openings in 214 and 804 as shown in Figs. 8A-8B).
Regarding claim 35, Adams discloses wherein the intermittent irrigation corresponds to closure of the cutting window of the outer cutting body by the inner cutting body (Figs. 8A-8B).
Regarding claim 36, Adams discloses wherein the intermittent irrigation comprises suction of fluid through a distal end of the cutting assembly (as the openings in 214, 804 are temporarily blocked by rotation of 214 relative to 204 and the vacuum suction is continuous through the openings in 214 and 808 similar to the openings 108 described in the distal end 106; [0055]; Figs. 8A-8B).
Claim Rejections - 35 USC § 103
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 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(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (US 2017/0027611 A1) in view of Fabro et al. (US 2013/0103067 A1).
Regarding claims 26-27, Adams discloses a button, trigger, foot pedal, and/or the like may be configured to actuate or activate a motor to cause movement of the inner cutter relative to the outer cutter ([0061]) but fails to explicitly disclose wherein rotating the inner cutter relative to the outer cutter comprises simultaneously actuating at least two switches, wherein the simultaneously actuating at least two switches comprises pressing the at least two switches by one user.
However, Fabro teaches a tissue removal device (tissue removal assembly 408; Figs. 4A-4E) comprising an inner cutter (impeller 804; Fig. 8A) rotatable relative to an outer cutter (impeller housing 807; as actuated rotatable shaft 803 will rotate impeller 804; [0069]), wherein rotating the inner cutter (804) relative to the outer cutter (807) comprises actuating a trigger (trigger 810; [0068]). Fabro further teaches the control interface i.e., actuator may comprise a trigger that may be squeezed to operate the device and/or may comprise a push button, a slide, a dial, a knob, a lever and/or a pivot member ([0043]). Thus, the actuator may comprise a trigger and a push button, both of which are pressed by a user.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Adams such that rotating the inner cutter relative to the outer cutter comprises simultaneously actuating at least two switches, wherein the simultaneously actuating at least two switches comprises pressing the at least two switches by one user in light of the teachings of Fabro in order to have an additional safety feature in which both switches need to be pressed for the cutting instrument to work.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (US 2017/0027611 A1) in view of Fabro et al. (US 2013/0103067 A1), as applied to claim 28 above, and further in view of Jenkins et al. (US 2014/0277043 A1).
Regarding claim 28, modified Adams discloses wherein the at least two switches comprise at least one trigger (810; Figs. 4A-4B) and a momentary switch (push button; [0043]), but fails to explicitly disclose the trigger being a leaf spring trigger.
However, Jenkins teaches a pivoting trigger (2628) that is biased away from a pistol grip (2624) by a leaf spring (resilient member comprising a leaf spring; [0216]; Figs. 32, 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the trigger of modified Adams to be a leaf spring trigger as taught by Jenkins in order to resiliently bias the trigger in the uncompressed position to prevent inadvertent actuation thereof.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sahney et al. (US 2012/0078038 A1) is noted for teaching a hysteroscopic system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771