Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/18/26 has been entered.
Claims 2-14, 17-22 and 24-31 are pending and have been examined.
The indicated allowability of claims 7-9, 11-14, 17 and 22 is withdrawn in view of the newly discovered reference(s) to Shelton and Malinouskas. Rejections based on the newly cited reference(s) follow.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/23/26 was filed after the mailing date of the Final Rejection on 03/19/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 12-14 and 18-21 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.
At the end of claim 12, the limitation of “the handle assembly” lacks antecedent basis.
Regarding claim 18, the limitation of "...activating a first motor ... to thereby actuate a first instrument portion ... activating a second motor ... to thereby actuate a second instrument portion ... activating a third motor ... to thereby actuate a third instrument portion..." render the claim indefinite because the claim fails to identify what structures constitute the first, second, and third instrument portions. The claim does not previously introduce these elements or otherwise define whether they correspond to the shaft assembly, the end effector, the articulation joint, a closure mechanism, a firing mechanism, or other components of the surgical instrument. Thereby, it is unclear what subject matter is encompassed by these limitations and the metes and bounds of the claim cannot be determined with reasonable certainty.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 2-6, 10 and 18-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Whitman et al. (8,241,322) in view of Malinouskas et al. (2011/0125138).
Regarding claims 2-6 and 10, Whitman discloses a surgical instrument, comprising: a handle assembly (1103; Fig. 3a) configured to be gripped by a user, the handle assembly including: a first motor (2023; Fig. 2b) and a first rotary output (2022) operably coupled with the first motor, a second motor (2013; Fig. 2b) and a second rotary output (2012) operably coupled with the second motor, and a third motor (100; Fig. 2b) and a third rotary output (98) operably coupled with the third motor (Fig. 11); a shaft assembly (1101; Fig. 3a) configured to operably couple with the handle assembly, the shaft assembly including: a first rotary input (202) configured to releasably operably couple with the first rotary output (2022), a second rotary input (201) configured to releasably operably couple with the second rotary output (2012), and a third rotary input (102) configured to releasably operably couple with the third rotary output (98); and an end effector (11a; Fig. 3a) operably coupled with the shaft assembly and configured to clamp and fasten tissue with a plurality of surgical fasteners, wherein each of the first motor, the second motor, and the third motor is operable to actuate a respective portion of the shaft assembly or the end effector (Figs. 2b, 11); wherein the shaft assembly further includes a shaft (1101; Fig. 3a), wherein the first motor (2023) is operable to drive the first rotary output (2022) and the first rotary input (202) to thereby rotate at least one of the shaft or the end effector relative to the handle assembly (par. 44); wherein the second motor (2013) is operable to drive the second rotary output (2012) and the second rotary input (201) to thereby articulate the end effector relative to the shaft assembly (pivot about axis B; par. 44); wherein the third motor (100) is operable to drive the third rotary output (98) and the third rotary input (102) to thereby close and fire the end effector (par. 42); wherein the end effector is configured to selectively decouple from the shaft assembly (as shown in Fig. 6a); wherein the end effector includes a first jaw (80) configured to receive a staple cartridge having a plurality of surgical staples, and a second jaw (50) configured to form the surgical staples when ejected from the staple cartridge (Fig. 2b).
Regarding claims 18-21, Whitman's surgical instrument is capable of perform the method steps of attaching a shaft assembly to the handle assembly such that: a first rotary output of the handle assembly operably couples with a first rotary input of the shaft assembly, a second rotary output of the handle assembly operably couples with a second rotary input of the shaft assembly, and a third rotary output of the handle assembly operably couples with a third rotary input of the shaft assembly; activating a first motor of the handle assembly to drive the first rotary output and the first rotary input to thereby actuate a first instrument portion of the surgical instrument; activating a second motor of the handle assembly to drive the second rotary output and the second rotary input to thereby actuate a second instrument portion of the surgical instrument; and activating a third motor of the handle assembly to drive the third rotary output and the third rotary input to thereby actuate a third instrument portion of the surgical instrument, wherein actuating one of the first instrument portion, the second instrument portion, or the third instrument portion includes ejecting a plurality of surgical fasteners from the end effector (as disclosed above); detaching the shaft assembly (decoupling 1104 from shaft not shown) from the handle assembly and thereby operably decoupling the first rotary input from the first rotary output, the second rotary input from the second rotary output, and the third rotary input from the third rotary output; and, wherein the shaft assembly includes a shaft operably coupled with the end effector, wherein actuating the first instrument portion includes rotating at least one of the shaft or the end effector relative to the handle assembly, actuating the second instrument portion includes articulating the end effector relative to the shaft, and actuating the third instrument portion includes closing the end effector and ejecting the surgical fasteners (as disclosed above); operably coupling the end effector with a distal end of the shaft assembly or operably decoupling the end effector with the distal end of the shaft assembly (upon coupling or decoupling the loading unit).
Regarding claims 2 and 18, Whitman fails to disclose a latch operable to provide selective attachment and detachment of the shaft assembly relative to the handle assembly. Malinouskas teaches a latch (par. 137) operable to provide selective attachment and detachment of a shaft assembly (600) relative to a handle assembly (500). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided these features to Whitman’s instrument for the purposes achieving a strong, reliable connection during operation while allowing fast, convenient removal of the shaft when needed.
Regarding claim 18, it is noted that the motors could be arranged in the handle assembly (as disclosed in 09/510923, incorporated by reference; col. 22, lines 51-56).
Regarding claim 22, it is deemed that Malinouskas latch is actuatable by a user.
Claim(s) 7-9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Whitman et al. (8,241,322) in view of Malinouskas et al. (2011/0125138), as applied above in claim 6, and further in view of Shelton, IV et al. (2012/0071711).
Regarding claim 7, Whitman discloses the invention substantially as claimed comprising a shaft assembly, as discussed above, wherein the shaft assembly further includes a shaft (as best shown in Fig. 3a), an articulation joint (11c) configured to provide articulation of the end effector relative to the shaft (Fig. 3a), but fails to disclose a coupler distal to the articulation joint and configured to provide selective operable coupling and decoupling of the end effector relative to the shaft assembly. Shelton teaches a surgical instrument comprising a coupler (58) distal to an articulation joint (14; Figs. 2 and 4-5) and configured to provide selective operable coupling and decoupling of the end effector relative to the shaft assembly. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided Whitman’s instrument with these features, as taught by Shelton in order to achieve a strong, reliable connection between the end effector and the shaft assembly during operation while allowing fast, convenient removal when needed.
Regarding claim 8, Shelton also discloses wherein the coupler includes a rotary output (54) and the end effector includes a rotary input (36, 56; Fig. 6) configured to releasably operably couple together when the end effector is operably coupled with the coupler, wherein the rotary input (36) is actuatable by the rotary output to drive firing of the end effector (by axially translating sled 33).
Regarding claim 9, Whitman discloses wherein the shaft assembly further includes a drive assembly (1102; Fig. 2b-3a) that defines a proximal end of the shaft assembly and rotatably supports the first rotary input, the second rotary input, and the third rotary input, wherein the drive assembly is configured to releasably operably couple with a distal end of the handle assembly.
Claim(s) 11-14, 17, 24-25 and 27-30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Whitman et al. (8,241,322) in view of Shelton, IV et al. (2012/0071711).
Regarding claims 11 and 27, Whitman discloses a surgical instrument, comprising: a motor assembly including: a first motor (2023; Fig. 2b) and a first rotary output (2022) operably coupled with the first motor, a second motor (2013; Fig. 2b) and a second rotary output (2012) operably coupled with the second motor, and a third motor (100; Fig. 2b) and a third rotary output (102) operably coupled with the third motor (Fig. 11); a drive assembly (1101; Fig. 2b) including: a first rotary input (202) configured to releasably operably couple with the first rotary output (2022), a second rotary input (201) configured to releasably operably couple with the second rotary output (2012), and a third rotary input (98) configured to releasably operably couple with the third rotary output; a shaft extending distally from the drive assembly (Fig. 3a); an end effector (11a; Fig. 3a) operably coupled with the shaft, the end effector including a first jaw and a second jaw (Fig. 3a), wherein each of the first motor, the second motor, and the third motor is operable to actuate a respective portion of the shaft or the end effector (Figs. 2b, 11); an articulation joint (11c) configured to provide articulation of the end effector relative to the shaft (Fig. 3a), but fails to disclose a coupler distal to the articulation joint and configured to provide selective operable coupling and decoupling of the end effector relative to the shaft. Shelton teaches a surgical instrument comprising a coupler (58) distal to an articulation joint (14; Figs. 2 and 4-5) and configured to provide selective operable coupling and decoupling of the end effector relative to the shaft assembly. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided Whitman’s instrument with these features, as taught by Shelton in order to achieve a strong, reliable connection between the end effector and the shaft assembly during operation while allowing fast, convenient removal when needed.
Regarding claims 12-14, Whitman discloses wherein the first motor (2023) is operable to drive the first rotary output (2022) and the first rotary input (202) to thereby rotate at least one of the shaft or the end effector relative to the handle assembly (par. 44); wherein the second motor (2013) is operable to drive the second rotary output (2012) and the second rotary input (201) to thereby articulate the end effector relative to the shaft assembly (pivot about axis B; par. 44); wherein the third motor (100) is operable to drive the third rotary output (102) and the third rotary input (98) to thereby close and fire the end effector (par. 42).
Regarding claim 17, Shelton also discloses wherein the coupler includes a rotary output (54) and the end effector includes a rotary input (36, 56; Fig. 6) configured to releasably operably couple together when the end effector is operably coupled with the coupler, wherein the rotary input (36) is actuatable by the rotary output to drive firing of the end effector (by axially translating sled 33).
Regarding claims 24-25 and 29, the modified invention of Whitman discloses a surgical instrument comprising a body (1102) that houses a motor assembly (Fig. 2b); an attachment (1101) that includes the drive assembly, the shaft, the end effector, and the articulation joint, wherein the body comprises a handle (1103), but fails to disclose wherein the attachment includes a coupler. Shelton teaches a surgical instrument comprising an attachment (i.e. shaft 8) comprising a coupler (58) distal to an articulation joint (14; Figs. 2 and 4-5), configured to provide selective operable coupling and decoupling of an end effector relative to the shaft assembly. It would have been obvious to one having ordinary skills in the art before the effective filing date of the claimed invention to have provided Whitman’s instrument with these features, as taught by Shelton in order to achieve a strong, reliable connection between the end effector and the shaft assembly during operation while allowing fast, convenient removal when needed.
Regarding claim 28, Whitman discloses wherein the third rotary input (98) is actuatable to eject surgical fasteners from the end effector (par. 42).
Regarding claim 30, Whitman discloses wherein the body comprises a handle (1103) configured to be gripped by a user.
Claim(s) 26 and 31 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over Whitman et al. (8,241,322) in view of Shelton, IV et al. (2012/0071711), as applied above in claim 24 and 29, and further in view of Malinouskas et al. (2011/0125138).
Regarding claims 26 and 31, the modified invention of Whitman discloses a surgical instrument comprising an attachment (via shaft assembly 1101) operable coupled to a body (i.e. handle assembly 1103), as taught by Whitman, but fails to disclose a latch operable to provide relative attachment and detachment of the attachment relative to the body. Malinouskas teaches a surgical instrument comprising a latch (par. 137) operable to provide selective attachment and detachment of an attachment (shaft assembly 600; Figs. 5a-5b) relative to a body (500). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided these features to Whitman’s instrument for the purposes achieving a strong, reliable connection during operation while allowing fast, convenient removal of the shaft when needed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE LOPEZ whose telephone number is (571)272-4464. The examiner can normally be reached Monday thru Friday 8:30 am to 4:30 pm.
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/MICHELLE LOPEZ/ Primary Examiner, Art Unit 3731
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