DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. This action is responsive to the Preliminary Amendment filed on 09/01/2023.
Claims 1-17 are pending, and have been examined on the merits.
Claim Objections
3. Claims 1-3, 10, 14, 16, & 17 are objected to because of the following informalities:
a. In claim 1, line 9, the recitation of “when the inner tubular member is rotated to a first range of angular positions” should instead recite --when the inner tubular member is rotated to a first angular position in a first range of angular positions-- for grammatical reasons, since a tubular member cannot be rotated to a range (as currently written).
b. In claim 1, line 12, the recitation of “when the inner tubular member is rotated to a second range of angular positions” should instead recite --when the inner tubular member is rotated to a second angular position in a second range of angular positions-- for grammatical reasons, since a tubular member cannot be rotated to a range (as currently written).
c. In claim 2, line 9, the recitation of “when the inner tubular member is rotated to a first range of angular positions” should instead recite --when the inner tubular member is rotated to a first angular position in a first range of angular positions-- for grammatical reasons, since a tubular member cannot be rotated to a range (as currently written).
d. In claim 2, line 12, the recitation of “when the inner tubular member is rotated to a second range of angular positions” should instead recite --when the inner tubular member is rotated to a second angular position in a second range of angular positions-- for grammatical reasons, since a tubular member cannot be rotated to a range (as currently written).
e. In claim 3, line 9, the recitation of “when the inner tubular member is rotated to a first range of angular positions” should instead recite --when the inner tubular member is rotated to a first angular position in a first range of angular positions-- for grammatical reasons, since a tubular member cannot be rotated to a range (as currently written).
f. In claim 3, line 12, the recitation of “when the inner tubular member is rotated to a second range of angular positions” should instead recite --when the inner tubular member is rotated to a second angular position in a second range of angular positions-- for grammatical reasons, since a tubular member cannot be rotated to a range (as currently written).
g. In claim 10, line 1, the recitation of “the arrangement” should instead recite --the rotary shaver arrangement--.
h. In claim 14, line 3, the recitation of “a rotary shaver arrangement according to claim 1” should instead recite --the rotary shaver arrangement according to claim 1--.
i. In claim 16, line 2, the recitation of “an end effector according to claim 14” should instead recite --the end effector according to claim 14--.
j. In claim 17, line 4, the recitation of “an electrosurgical instrument according to claim 16” should instead recite --the electrosurgical instrument according to claim 16--.
k. In claim 17, line 7, the recitation of “the electrode” should instead recite --the active electrode--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 1-17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
6. Claim 1 recites the limitation “the distal end” in line 3. There is insufficient antecedent basis for this recitation in the claim.
7. Claim 1 recites the limitation “the distal end” in line 6. There is insufficient antecedent basis for this recitation in the claim.
8. Claim 1 recites the limitation “wherein, the first and/or second cutting window comprises a first shaped region, the first shaped region being a spline-shaped region to permit the second range of angular positions to be greater than if the first shaped region was notch-shaped having angular discontinuities” in lines 15-17 (emphasis added). This recitation renders the claim indefinite, as the claim is attempting to define a limitation of the “first shaped region” with reference to an object, i.e., a notch-shaped (region) having angular discontinuities, that is variable, or, at the least, not sufficiently defined. Stated another way, the claim specifies neither dimensions of the notch-shaped (region), nor the number or configuration of any “angular discontinuities” in any sufficient detail so as to allow for any valid comparison between the spline-shaped region and a notch-shaped region. See MPEP § 2173.05(b)(II) (“A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined”)]. As such, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required. NOTE: For purposes of examination, this limitation will be interpreted as “wherein, the first and/or second cutting window comprises a first shaped region, the first shaped region being a spline-shaped region.”
9. Claims 5-17 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
10. Claim 2 recites the limitation “the distal end” in line 3. There is insufficient antecedent basis for this recitation in the claim.
11. Claim 2 recites the limitation “the distal end” in line 6. There is insufficient antecedent basis for this recitation in the claim.
12. Claim 2 recites the limitation “wherein, the first and/or second cutting window comprises a spline-shaped region such that the second range of angular positions is greater than 12°.”
This recitation renders the claim indefinite, as the claimed range of “greater than 12°” is an open-ended range that does not have a clear, defined upper limit. It is noted that such a range also appears inconsistent with Applicant’s disclosed range of angular positions having an upper limit of 66° [i.e., +/- 33°] [see, e.g., ¶[0075] of Applicant’s published Specification (U.S. 2024/0081851) (“In contrast, embodiments of the present disclosure provide an inner tubular member/blade 500 with a modified geometry comprising a spline-shaped region at its distal end such that a much greater angular tolerance is provided when closing the cutting window, and therefore provide a larger opening angle threshold of up to around ±33°. For example, the cutting window can be completely closed (no unwanted secondary suction pathway) when the inner tubular member 500 is positioned at an angle of around 147° to 213° with respect to the outer tubular member 630”)]. Clarification is required.
13. Claim 3 recites the limitation “the distal end” in line 3. There is insufficient antecedent basis for this recitation in the claim.
14. Claim 3 recites the limitation “the distal end” in line 6. There is insufficient antecedent basis for this recitation in the claim.
15. Claim 3 recites the limitation “second cutting window comprises a spline-shaped region such that the inner tubular member can be rotated more than 6°” in lines 15-16. The recitation of “can be” renders the claim indefinite, because it is susceptible to more than one plausible construction. It is unclear, for example, whether the limitation refers to a capability that is required to be present in the invention, or, whether it refers to a capability that is a mere possibility that is not required. As such, one of ordinary skill in the art would not be
reasonably apprised of the scope of the invention. Clarification is required.
16. Claim 3 recites the limitation “the inner tubular member can be rotated more than 6° from a position where the first and second cutting windows are antialigned without the opening of the central suction lumen forming” in lines 15-18. This recitation renders the claim indefinite, as the claimed range of “more than 6°” is an open-ended range that does not have a clear, defined upper limit. It is noted that such a range also appears inconsistent with Applicant’s disclosed range of angular positions having an upper limit of 66° [i.e., +/- 33°] [see, e.g., ¶[0075] of Applicant’s published Specification (U.S. 2024/0081851) (“In contrast, embodiments of the present disclosure provide an inner tubular member/blade 500 with a modified geometry comprising a spline-shaped region at its distal end such that a much greater angular tolerance is provided when closing the cutting window, and therefore provide a larger opening angle threshold of up to around ±33°. For example, the cutting window can be completely closed (no unwanted secondary suction pathway) when the inner tubular member 500 is positioned at an angle of around 147° to 213° with respect to the outer tubular member 630”)]. Clarification is required.
17. Claim 4 is rejected as ultimately depending from a claim (claim 3) rejected under 35 U.S.C. 112(b).
18. Claim 4 recites the limitation “wherein the inner tubular member can be rotated” in lines 1-2. The recitation of “can be” renders the claim indefinite, because it is susceptible to more than one plausible construction. It is unclear, for example, whether the limitation refers to a capability that is required to be present in the invention, or, whether it refers to a capability that is a mere possibility that is not required. As such, one of ordinary skill in the art would not be
reasonably apprised of the scope of the invention. Clarification is required.
19. Claim 4 recites the limitation “wherein the inner tubular member can be rotated more than 10, 15, 20, 25, 30 or 33 degrees from the position where the first and second cutting windows are antialigned without the opening of the central suction lumen forming” in lines 1-4.
This recitation renders the claim indefinite, as the claimed range of “more than…33 degrees” is an open-ended range that does not have a clear, defined upper limit. It is noted that such a range also appears inconsistent with Applicant’s disclosed range of angular positions having an upper limit of 66° [i.e., +/- 33°] [see, e.g., ¶[0075] of Applicant’s published Specification (U.S. 2024/0081851) (“In contrast, embodiments of the present disclosure provide an inner tubular member/blade 500 with a modified geometry comprising a spline-shaped region at its distal end such that a much greater angular tolerance is provided when closing the cutting window, and therefore provide a larger opening angle threshold of up to around ±33°. For example, the cutting window can be completely closed (no unwanted secondary suction pathway) when the inner tubular member 500 is positioned at an angle of around 147° to 213° with respect to the outer tubular member 630”)]. Clarification is required.
20. Claim 5 recites the limitation “wherein the second range of angular positions is greater than 15, 20, 25, 30, 40, 50, 60 or 66 degrees” in lines 1-2. This recitation renders the claim indefinite, as the claimed range of “greater than…66 degrees” is an open-ended range that does not have a clear, defined upper limit. It is noted that such a range also appears inconsistent with Applicant’s disclosed range of angular positions having an upper limit of 66° [i.e., +/- 33°] [see, e.g., ¶[0075] of Applicant’s published Specification (U.S. 2024/0081851) (“In contrast, embodiments of the present disclosure provide an inner tubular member/blade 500 with a modified geometry comprising a spline-shaped region at its distal end such that a much greater angular tolerance is provided when closing the cutting window, and therefore provide a larger opening angle threshold of up to around ±33°. For example, the cutting window can be completely closed (no unwanted secondary suction pathway) when the inner tubular member 500 is positioned at an angle of around 147° to 213° with respect to the outer tubular member 630”)]. Clarification is required.
21. Claim 7 recites the limitation “the longitudinal axis” in line 3. There is insufficient antecedent basis for this recitation in the claim.
22. Claim 8 recites the limitation “the projection” in line 1. There is insufficient antecedent basis for this recitation in the claim.
23. Claim 10 recites the limitation “the cutting blade” in line 3. There is insufficient antecedent basis for this recitation in the claim.
24. Claim 13 recites the limitation “a substantially oval-shaped interface” in line 2. The term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such, one of ordinary skill in the art would not be
reasonably apprised of the scope of the invention. Clarification is required.
25. Claim 15 recites the limitation “the direction” in line 3. There is insufficient antecedent basis for this recitation in the claim.
Claim Rejections - 35 USC § 102
26. 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.
27. Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2022/0160425 to Doll et al. (“Doll”).
28. Regarding claim 1, and as best understood [see rejection(s) under § 112(b) above], Doll discloses a rotary shaver arrangement for a surgical instrument, the rotary shaver arrangement comprising:
an outer tubular member [outer sleeve (310) - ¶[[0049]; FIGS. 3A-3C] with a first cutting window [opening (320) - ¶[[0049]; FIGS. 3A-3B] at the distal end thereof [FIGS. 3A-3B]; and
an inner tubular member [inner sleeve (410) - ¶[[0049]; FIGS. 3A-3C] rotatably mounted in a central passageway of the outer tubular member [¶[0047]], the inner tubular member [(410)] providing a central suction lumen [¶[0049]], the inner tubular member [(410)] having a second cutting window [opening (420) - ¶[[0049]; FIG. 3A] at the distal end of the inner tubular member [FIG. 3A];
wherein, the first [(320)] and second [(420)] cutting windows are arranged such that:
(i) when the inner tubular member [(410)] is rotated to a first range of angular positions, the first [(320)] and second [(420)] cutting windows overlap to form an opening of the central suction lumen [¶[0055]]; and
(ii) when the inner tubular member [(410)] is rotated to a second range of angular positions, the first [(320)] and second [(420)] cutting windows do not overlap and thus do not form the opening of the central suction lumen [¶[0054]]; and
wherein, the first and/or second cutting window [(420)] comprises a first shaped region, the first shaped region being a spline-shaped region [as broadly as claimed, and with reference to FIG. 3A, the distal end of inner sleeve (410) that forms opening (420) is spline-shaped] to permit the second range of angular positions to be greater than if the first shaped region was notch-shaped having angular discontinuities [NOTE: It is the Examiner's position that Doll satisfies this claim limitation because it comprises the same structure as the claimed device (i.e., Doll discloses all of the structural limitations of the claimed device for the reasons set forth above), and would therefore be expected to perform in the same manner as the claimed device. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. MPEP § 2112.01].
29. Regarding claim 2, Doll discloses a rotary shaver arrangement for a surgical instrument, the rotary shaver arrangement comprising:
an outer tubular member [outer sleeve (310) - ¶[[0049]; FIGS. 3A-3C] with a first cutting window [opening (320) - ¶[[0049]; FIGS. 3A-3B] at the distal end thereof [FIGS. 3A-3B];
an inner tubular member [inner sleeve (410) - ¶[[0049]; FIGS. 3A-3C] rotatably mounted in a central passageway of the outer tubular member [¶[0047]], the inner tubular member [(410)] providing a central suction lumen [¶[0049]], the inner tubular member [(410)] having a second cutting window [opening (420) - ¶[[0049]; FIG. 3A] at the distal end of the inner tubular member [FIG. 3A];
wherein, the first [(320)] and second [(420)] cutting windows are arranged such that:
(i) when the inner tubular member [(410)] is rotated to a first range of angular positions, the first [(320)] and second [(420)] cutting windows overlap to form an opening of the central suction lumen [¶[0055]];
(ii) when the inner tubular member [(410)] is rotated to a second range of angular positions, the first [(320)] and second [(420)] cutting windows do not overlap and thus do not form the opening of the central suction lumen [¶[0054]]; and
wherein, the first and/or second cutting window [(420)] comprises a spline-shaped region [as broadly as claimed, and with reference to FIG. 3A, the distal end of inner sleeve (410) that forms opening (420) is spline-shaped] such that the second range of angular positions is greater than 12° [NOTE: with reference to annotated FIG. 3C of Doll (provided below), which shows four 90° quadrants, it is the Examiner’s position that the inner sleeve (410) can be rotated greater than 12° and still maintain the closed central suction lumen - such as, e.g., 13° in either direction].
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Annotated FIG. 3C of Doll
30. Regarding claim 3, Doll discloses a rotary shaver arrangement for a surgical instrument, the rotary shaver arrangement comprising:
an outer tubular member [outer sleeve (310) - ¶[[0049]; FIGS. 3A-3C] with a first cutting window [opening (320) - ¶[[0049]; FIGS. 3A-3B] at the distal end thereof [FIGS. 3A-3B];
an inner tubular member [inner sleeve (410) - ¶[[0049]; FIGS. 3A-3C] rotatably mounted in a central passageway of the outer tubular member [¶[0047]], the inner tubular member [(410)] providing a central suction lumen [¶[0049]], the inner tubular member [(410)] having a second cutting window [opening (420) - ¶[[0049]; FIG. 3A] at the distal end of the inner tubular member [FIG. 3A];
the first [(320)] and second [(420)] cutting windows are arranged such that:
when the inner tubular member [(410)] is rotated to a first range of angular positions, the first [(320)] and second [(420)] cutting windows overlap to form an opening of the central suction lumen [¶[0055]]; and
when the inner tubular member [(410)] is rotated to a second range of angular positions, the first [(320)] and second [(420)] cutting windows do not overlap and thus do not form the opening of the central suction lumen [¶[0054]]; and
wherein, the first and/or second cutting window [(420)] comprises a spline-shaped region [as broadly as claimed, and with reference to FIG. 3A, the distal end of inner sleeve (410) that forms opening (420) is spline-shaped] such that the inner tubular member [(410)] can be rotated more than 6° from a position where the first [(320)] and second [(420)] cutting windows are antialigned without the opening of the central suction lumen forming [NOTE: with reference to annotated FIG. 3C of Doll (provided below), which shows four 90° quadrants, it is the Examiner’s position that the inner tubular member (410) can be rotated more than 6° from a position where the first (320) and second (420) cutting windows are antialigned (do not overlap) without the opening of the central suction lumen forming - such as, e.g., 6.5° in either direction].
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Annotated FIG. 3C of Doll
31. Regarding claim 4, Doll discloses all of the limitations of claim 3 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the inner tubular member [(410)] can be rotated more than 10, 15, 20, 25, 30 or 33 degrees from the position where the first [(320)] and second [(420)] cutting windows are antialigned (do not overlap) without the opening of the central suction lumen forming [NOTE: with reference to annotated FIG. 3C of Doll (provided above), which shows four 90° quadrants, it is the Examiner’s position that the inner tubular member (410) can be rotated more than 10° from a position where the first (320) and second (420) cutting windows are antialigned (do not overlap) without the opening of the central suction lumen forming - such as, e.g., 11°].
32. Regarding claim 5, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the second range of angular positions is greater than 15, 20, 25, 30, 40, 50, 60 or 66 degrees [NOTE: with reference to annotated FIG. 3C of Doll (provided above), which shows four 90° quadrants, it is the Examiner’s position that the second range of angular positions is greater than 15° - e.g., 16° (or +/- 8°)].
33. Regarding claim 6, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the second range of angular positions comprises the inner tubular member [(410)] being positioned at a relative angular position of 170° to 190° to that of the outer tubular member [(310)] [e.g., 180° as shown in FIG. 3C].
34. Regarding claim 7, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the spline-shaped region is such that a projection of the distal end of the inner [(410)] and/or outer tubular member along the longitudinal axis of the inner [(410)] and/or outer tubular member comprises a continuous curve and/or non-linear cut out [see distal end of inner sleeve (410) in FIG. 3A].
35. Regarding claim 8, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the projection is part-oval [a distal end of inner sleeve (410) is part-oval - FIG. 3A].
36. Regarding claim 9, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the first and/or second cutting window has at least one sharpened edge to form a cutting blade [¶’s [0048]-[0049]].
37. Regarding claim 10, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the arrangement is such that, when in use, rotation of the inner tubular member [(410)] within the outer tubular member [(310)] causes a tissue cutting action of the cutting blade interacting with the second and/or first cutting window [¶’s [0048]-[0049]].
38. Regarding claim 11, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the second cutting window [(420)] comprises the spline-shaped region [as broadly as claimed, and with reference to FIG. 3A, the distal end of inner sleeve (410) that forms opening (420) is spline-shaped].
39. Regarding claim 12, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the spline-shaped region is U-shaped [FIG. 3A].
40. Regarding claim 13, Doll discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein when the first [(320)] and second [(420)] cutting windows align, they form a substantially oval-shaped interface [FIGS. 3A-3B; see also FIG. 4B].
41. Regarding claim 14, Doll discloses an end effector for an electrosurgical instrument, the end effector comprising:
a rotary shaver arrangement according to claim 1 [see the rejection of claim 1 set for the above, which is incorporated herein]; and
a radio frequency (RF) arrangement including an active electrode [active electrode (360) - ¶’s [0051], [0057]; FIGS. 3A-3B] comprising a suction aperture [aspiration opening (362) - ¶[0057]; FIG. 3D] in fluid communication with the central suction lumen [¶[0057]].
42. Regarding claim 15, Doll discloses all of the limitations of claim 14 for the reasons set forth in detail (above) in the Office Action.
Doll further discloses wherein the end effector is arranged such that the RF arrangement is positioned on a first side of the end effector [top side - FIGS. 3A, 3B, 3D], and the rotary shaver arrangement is positioned such that the direction of tissue shaving of the rotary shaver arrangement is on a second side of the end effector [bottom side - FIGS. 3A, 3B, 3D], the second side [bottom side] being opposite the first side [top side].
43. Regarding claim 16, Doll discloses an electrosurgical instrument comprising:
an end effector according to claim 14 [see the rejection of claim 14 set for the above, which is incorporated herein]; and
an operative shaft [MDU (112) - ¶[0040]; FIG. 1] having RF electrical connections operably connected to the active electrode [(360)] [¶[0040]], and drive componentry operably connected to the rotary shaver arrangement to drive the rotary shaver arrangement to operate in use [¶’s [0040], [0045]].
44. Regarding claim 17, Doll discloses an electrosurgical system, comprising:
an RF electrosurgical generator [RF generator (140) - ¶’s [0040], [0043]];
a suction pump [aspiration control mechanism (220) - ¶[0041]]; and
an electrosurgical instrument according to claim 16 [see the rejection of claim 16 set for the above, which is incorporated herein],
the arrangement being such that in use the RF electrosurgical generator [(140)] supplies an RF coagulation or ablation signal via the RF electrical connections to the active electrode [(360)] [see ¶’s [0040], [0044], [0046]] and the suction pump [(220)] supplies suction via the central suction lumen connecting the suction aperture [(362)] located within the electrode [(360)] to the suction pump [(220)] [e.g., ¶’s [0041], [0046], [0057]].
Conclusion
45. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794