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 amendment filing on 07/07/2026.
Claims 1-17 are pending and examined below.
Election/Restrictions
Applicant’s election without traverse of Species II, the embodiment shown in Figures 3-7B, 15-20B, and 21D-21G, in the reply filed on 07/07/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/07/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 § 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 between 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)
Response to Arguments
The Amendments filed on 07/07/2026 have been entered. Claims 1-17 are pending and examined below.
In response to the arguments of the rejections under 35 U.S.C. 112(b), in view of the amendments to the claims, Examiner withdraws the 112(b) rejections.
In response to the arguments of the rejections under 35 U.S.C. 103 with reference Schober et al. (10,517,597) modified by reference Zergiebel et al. (9,782,187), Examiner finds the arguments not persuasive.
Applicant states:
But, Zergiebel does not disclose or suggest that the operability of the release button (282) is related to prevention of “rotation of the actuation shaft when no instrument shaft is connected to the coupled,” as recited with respect to the shaft coupled firing lockout mechanism of Claim 11.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Zergiebel et al. is not relied upon for the teaching of a rotation mechanism comprising a gear. Zergiebel et al. is relied upon for the teaching of a lockout mechanism that prevents the actuation of a separate mechanism when no instrument is coupled, and allows actuation of said separate mechanism when the instrument is coupled. Schober et al. is relied upon for the teaching of a handle assembly comprising a rotation mechanism comprising a gear rotatably fixed to the actuation shaft. When modifying Schober et al. in view of Zergiebel et al., the handle assembly is interpreted to comprise: a rotation mechanism comprising a gear rotatably fixed to the actuation shaft; and a lockout mechanism that prevents actuation of the rotation mechanism when no instrument is coupled, and allows actuation of the rotation mechanism when the instrument is coupled.
Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant states:
Additionally, Zergiebel fails to disclose or suggest a shaft coupling firing lockout mechanism “engageable with the gear to prevent rotation of the actuation shaft when no instrument shaft is coupled to the coupler,” as recited in Claim 11.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Zergiebel et al. is not relied upon for the teaching of a rotation mechanism comprising a gear. Zergiebel et al. is relied upon for the teaching of a lockout mechanism comprising a lockout tab, wherein the lockout tab engages a separate mechanism preventing the actuation of said separate mechanism when no instrument is coupled. Schober et al. is relied upon for the teaching of a handle assembly comprising a rotation mechanism comprising a gear rotatably fixed to the actuation shaft. When modifying Schober et al. in view of Zergiebel et al., the handle assembly is interpreted to comprise: a rotation mechanism comprising a gear rotatably fixed to the actuation shaft; and a lockout mechanism comprising a lockout tab, wherein the lockout tab engages gear of the rotation mechanism preventing the actuation of said rotation mechanism when no instrument is coupled.
Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to the arguments of the rejections under 35 U.S.C. 103 with reference Schober et al. (10,517,597) modified by references Nelson et al. (2019/0261984) and Zergiebel et al. (9,782,187), Examiner finds the arguments not persuasive.
Applicant states:
However, as discussed in further detail regarding Claim 11, Zergiebel fails to disclose or suggest a shaft coupling firing lockout mechanism as recited in Claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Zergiebel et al. is not relied upon for the teaching of an actuation shaft that is selectively rotatable between a firing orientation and a reverse orientation. Zergiebel et al. is relied upon for the teaching of a lockout mechanism that prevents the actuation of a separate mechanism when no instrument is coupled, and allows actuation of said separate mechanism when the instrument is coupled. Schober et al. is relied upon for the teaching of a handle assembly comprising an actuation shaft that is selectively rotatable between a firing orientation and a reverse orientation. When modifying Schober et al. in view of Zergiebel et al., the handle assembly is interpreted to comprise: an actuation shaft that is selectively rotatable between a firing orientation and a reverse orientation; and a lockout mechanism that prevents rotation of the actuation shaft when no instrument is coupled, and allows rotation of the actuation shaft when the instrument is coupled.
Furthermore, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelley Self can be reached at (571) 272-4524. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK B FRY/Examiner, Art Unit 3731 September 10, 2026
/SHELLEY M SELF/Supervisory Patent Examiner, Art Unit 3731
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