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 .
This Office Action is in response to the applicant’s filing on 03/11/2025.
Claims 1-17 are pending and examined below.
Election/Restrictions
This application contains claims directed to the following patentably distinct species:
Species I, the embodiment shown in Figures 1-2, 8A-14B, and 21A-21C, disclose a surgical instrument with a rotation mechanism; and
Species II, the embodiment shown in Figures 3-7B, 15-20B, and 21D-21G, disclose a surgical instrument with an articulation mechanism.
The species are independent or distinct because the different species have mutually exclusive characteristics for each identified species. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the species or groupings of patentably indistinct species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with John Heal on 3/18/2026 a provisional election was made without traverse to prosecute the invention of Species II, the embodiment shown in Figures 3-7B, 15-20B, and 21D-21G. Affirmation of this election must be made by applicant in replying to this Office action.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5, 7, and 9 of U.S. Patent No. 12,279,767. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the US Patent disclose all the same limitations as claimed in the present claims.
Regarding claims 11-15, claim 5 of the U.S. Patent No. 12,279,767 disclose all the same limitations.
Regarding claim 16, claim 7 of the U.S. Patent No. 12,279,767 disclose all the same limitations.
Regarding claim 17, claim 9 of the U.S. Patent No. 12,279,767 disclose all the same limitations.
Claims 1, 4-5, and 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-12 of U.S. Patent No. 12,279,767 in view of reference Zergiebel et al. (9,782,187).
Regarding claims 1 and 4-5, claim 10 of the U.S. Patent No. 12,279,767 disclose most of the limitations. However, claim 10 of the U.S. Patent No. 12,279,767 do not disclose a shaft coupling firing lockout mechanism.
Zergiebel et al. disclose a surgical stapler (100) comprising: a button mechanism (282); and a lockout mechanism (284), wherein lockout mechanism (284) is configured to prevent actuation of the button mechanism (282) when no instrument shaft (300) is coupled, and to allow actuation of the button mechanism (282) when the instrument shaft (300) is coupled. (Figure 1 and Column 13 lines 9-20, 63-67, Column 14 lines 6-11)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified handle assembly of U.S. Patent No. 12,279,767 by incorporating the lockout mechanism as taught by Zergiebel et al., since column 1 line 67 through column 2 lines 1-2 of Zergiebel et al. states such a modification would prevent accidental actuation of the rotation mechanism.
Regarding claim 7, claim 11 of the U.S. Patent No. 12,279,767 modified by Zergiebel et al. disclose all the same limitations.
Regarding claim 8, claim 12 of the U.S. Patent No. 12,279,767 modified by Zergiebel et al. disclose all the same limitations.
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.
Claim 10 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 10, the phrase “the at least one lockout arm is engageable with the rotation mechanism” renders claim 10 vague and indefinite because it is unclear how the articulation lockout mechanism is engaging the actuation shaft. Claim 10 is dependent of claim 9 which is dependent of claim 4. Claim 4 disclose the lockout sleeve is part of the articulation lockout mechanism. The articulation lockout mechanism is understood to prevent operation of the articulation mechanism. The shaft coupling firing lockout mechanism is understood to prevent rotation of the actuation shaft. It is unclear how the articulation lockout mechanism is preventing rotation of the actuation shaft. For examining purposes, the phrase is interpreted as “the shaft coupling firing lockout mechanism comprises at least one lockout arm engageable with the rotation mechanism”.
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.
Claims 11-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over reference Schober et al. (10,517,597) in view of reference Zergiebel et al. (9,782,187).
Regarding claim 11, Schober et al. disclose a handle assembly (40) for a surgical stapler (10), the handle assembly (40) comprising:
a handle body (42, 44) comprising a stationary handle (42) and a movable handle (44) pivotably coupled to the handle body,
wherein the handle body comprises a coupler (46) configured to removably couple to an instrument shaft (20);
an actuation shaft (60) mechanically coupled to the movable handle (44) for manual actuation thereof,
wherein the actuation shaft (60) is slidable within the handle body along a longitudinal axis, and
wherein the actuation shaft (60) rotatable relative to the longitudinal axis to selectively position the actuation shaft (60) in one of a firing orientation and a reverse orientation; and
a rotation mechanism (70) to selectively rotate the actuation shaft the firing orientation and the reverse orientation,
whereon the rotation mechanism (70) comprising a gear (78) rotatably fixed to the actuation shaft (60).
(Figure 3-7B and Column 5 lines 10-18, 37-49, Column 6 lines 59-64, Column 7 lines 4-6, 14-18)
However, Schober et al. do not disclose a shaft coupling firing lockout mechanism.
Zergiebel et al. disclose a surgical stapler (100) comprising: a button mechanism (282); and a lockout mechanism (284), wherein lockout mechanism (284) is configured to prevent actuation of the button mechanism (282) when no instrument shaft (300) is coupled, and to allow actuation of the button mechanism (282) when the instrument shaft (300) is coupled. (Figure 1 and Column 13 lines 9-20, 63-67, Column 14 lines 6-11)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified handle assembly of Schober et al. by incorporating the lockout mechanism as taught by Zergiebel et al., since column 1 line 67 through column 2 lines 1-2 of Zergiebel et al. states such a modification would prevent accidental actuation of the rotation mechanism.
Regarding claim 12, Schober et al. modified by Zergiebel et al. disclose the shaft coupling firing lockout mechanism (Zergiebel et al. – 284) comprises at least one lockout arm (Zergiebel et al. – see figure 21 below) comprising a lockout tab (Zergiebel et al. – see figure 21 below), wherein the lockout tab (Zergiebel et al. – see figure 21 below) engages the gear (Schober et al. – 78) when no instrument shaft (Schober et al. – 20) is coupled to the coupler (Schober et al. – 46). (Schober et al. – Column 7 lines 14-18) (Zergiebel et al. – Figure 21)
[AltContent: textbox (Lockout Sleeve)][AltContent: ][AltContent: textbox (Lockout Arm)][AltContent: textbox (Lockout Tab)][AltContent: ][AltContent: ][AltContent: textbox (Zergiebel et al.)]
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Regarding claim 13, Schober et al. modified by Zergiebel et al. disclose the at least one lockout arm (Zergiebel et al. – see figure 21 above) is coupled to the coupler (Schober et al. – 46) such that the lockout tab (Zergiebel et al. – see figure 21 below) is disengaged from the gear (Schober et al. – 78). Schober et al. – Column 7 lines 14-18) (Zergiebel et al. – Figure 21 and Column 13 lines 14-16)
Regarding claim 15, Schober et al. modified by Zergiebel et al. disclose the shaft coupling firing lockout mechanism comprises a lockout sleeve (Zergiebel et al. – see figure 21 above) positioned adjacent the coupler (Schober et al. – 46), wherein the lockout sleeve (Zergiebel et al. – see figure 21 above) is coupled to the lockout arm (Zergiebel et al. – see figure 21 above). (Zergiebel et al. – Figure 21 and Column 13 lines 26-34)
Regarding claim 16, Schober et al. modified by Zergiebel et al. disclose the lockout sleeve (Zergiebel et al. – see figure 21 above) is longitudinally movable when the instrument shaft (Schober et al. – 20) is coupled to the coupler (Schober et al. – 46). (Zergiebel et al. – Column 14 lines 2-6)
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over reference Schober et al. (10,517,597) in view of references Nelson et al. (2019/0261984) and Zergiebel et al. (9,782,187).
Regarding claim 1, Schober et al. disclose a handle assembly (40) for a surgical stapler (10), the handle assembly (40) comprising:
a handle body (42, 44) comprising a stationary handle (42) and a movable handle (44) pivotably coupled to the handle body,
wherein the handle body comprises a coupler (46) configured to removably couple to an instrument shaft (20) having a stapler jaw assembly (30);
an actuation shaft (60) mechanically coupled to the movable handle (44) for manual actuation thereof,
wherein the actuation shaft (60) is slidable within the handle body along a longitudinal axis, and
wherein the actuation shaft (60) selectively rotatable in a firing orientation in which movement of the movable handle (44) longitudinally slides the actuation shaft (60) a first direction, and a reverse orientation in which movement of the movable handle (44) longitudinally slides the actuation shaft (60) a second direction opposite the first direction; and
an articulation mechanism (column 5 lines 37-42) configured to articulate the stapler jaw assembly (30) relative to the instrument shaft (20) when the instrument shaft (20) is coupled to the handle body.
(Figure 3-7B and Column 5 lines 10-18, 37-49, Column 6 lines 59-64, Column 7 lines 4-6)
However, Schober et al. do not disclose an articulation lockout mechanism and a shaft coupling firing lockout mechanism.
Nelson et al. disclose a handle assembly (40) comprising: an articulation mechanism (page 7 paragraph 107); and an articulation lockout mechanism (300) preventing operation of the articulation mechanism (page 7 paragraph 107) when no instrument shaft is coupled to the coupler and allowing operation of the articulation mechanism (page 7 paragraph 107) when the instrument shaft is coupled to the coupler. (Figure 16-17 and Page 7 paragraph 107 and Page 8 paragraph 118)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified the handle assembly of Schober et al. by incorporating the articulation lockout mechanism as taught by Nelson et al., since page 8 paragraph 118 of Nelson et al. states such a modification would make it easier to couple the instrument shaft to the coupler.
Zergiebel et al. disclose a surgical stapler (100) comprising: a button mechanism (282); and a lockout mechanism (284), wherein lockout mechanism (284) is configured to prevent actuation of the button mechanism (282) when no instrument shaft (300) is coupled, and to allow actuation of the button mechanism (282) when the instrument shaft (300) is coupled. (Figure 1 and Column 13 lines 9-20, 63-67, Column 14 lines 6-11)
It would have been obvious to the person of ordinary skill in the art, before the effective filing date of the applicant’s claimed invention, to have modified handle assembly of Schober et al. by incorporating the lockout mechanism as taught by Zergiebel et al., since column 1 line 67 through column 2 lines 1-2 of Zergiebel et al. states such a modification would prevent accidental actuation of the rotation mechanism.
Regarding claim 2, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the articulation mechanism comprises a release mechanism (Schober et al. – column 11 lines 10-14) operable to disengage the articulation mechanism (Schober et al. – column 5 lines 37-42) and reset the stapler jaw assembly (Schober et al. – 30) to a longitudinally centered position relative to the instrument shaft (Schober et al. – 20). (Schober et al. – Figure 17A-17F and Column 11 lines 10-17)
Regarding claim 3, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the articulation lockout mechanism (Nelson et al. – 300) engages the release mechanism (Schober et al. – column 11 lines 10-14) of the articulation mechanism (Schober et al. – column 5 lines 37-42) when no instrument shaft (Schober et al. – 20) is coupled to the coupler (Schober et al. – 46). (Nelson et al. – Page 8 paragraph 119)
Regarding claim 4, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the articulation lockout mechanism (Nelson et al. – 300) comprises a lockout sleeve (Nelson et al. – 302) at the coupler (Schober et al. – 46) of the handle body, and at least one lockout arm (Nelson et al. – 304) coupled to the lockout sleeve (Nelson et al. – 302) and extending proximally from the lockout sleeve (Nelson et al. – 302) to a proximal end, and a locking sleeve (Nelson et al. – 196) at the proximal end of the at least one lockout arm (Nelson et al. – 304). (Nelson et al. – Figures 16-17 and Page 8 paragraph 119)
Regarding claim 5, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the locking sleeve (Nelson et al. – 302) engages the articulation mechanism (Schober et al. – column 5 lines 37-42) to prevent operation of the articulation mechanism (Schober et al. – column 5 lines 37-42) with no instrument shaft (Schober et al. – 20) is coupled to the coupler (Schober et al. – 46). (Nelson et al. – Page 8 paragraph 120)
Regarding claim 6, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the at least one lockout arm (Nelson et al. – 304) comprises two lockout arms coupled to the lockout sleeve (Nelson et al. – 302) and each extending proximally from the lockout sleeve (Nelson et al. – 302). (Nelson et al. – Page 8 paragraph 119)
Regarding claim 7, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the lockout sleeve (Nelson et al. – 302), the at least one lockout arm (Nelson et al. – 304), and the locking sleeve (Nelson et al. – 196) are biased distally with no instrument shaft (Schober et al. – 20) is coupled to the coupler (Schober et al. – 46). (Nelson et al. – Page 8 paragraph 120)
Regarding claim 8, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the lockout sleeve (Nelson et al. – 302) is moved proximally when the instrument shaft (Schober et al. – 20) is coupled to the coupler (Schober et al. – 46). (Nelson et al. – Page 8 paragraph 120)
Regarding claim 9, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose a rotation mechanism (Schober et al. – 70) to selectively position the actuation shaft (Schober et al. – 60) in one of the firing position and reversing position. (Schober et al. – Column 7 lines 4-14)
Regarding claim 10, Schober et al. modified by Nelson et al. and Zergiebel et al. disclose the shaft coupling firing lockout mechanism (Zergiebel et al. – 284) comprises at least one lockout arm (Zergiebel et al. – see figure 21 below) engageable with the rotation mechanism (Schober et al. – 70) to prevent rotation of the actuation shaft (Schober et al. – 60) to the firing orientation when no instrument shaft (Schober et al. – 20) is coupled to the coupler (Schober et al. – 46). (Schober et al. – Column 7 lines 14-18) (Zergiebel et al. – Figure 21)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK B FRY whose telephone number is (571)272-0396. The examiner can normally be reached on Mon-Thur 7am-4pm.
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/PATRICK B FRY/Examiner, Art Unit 3731 April 2, 2026
/SHELLEY M SELF/Supervisory Patent Examiner, Art Unit 3731