DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 15 is rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 14 of prior U.S. Patent No. 11,844,491. This is a statutory double patenting rejection.
Claim 15 of App. 19/391,234
Claim 14 of US 11,844,491
15. A handle assembly for a surgical stapler, the handle assembly comprising:
a stationary handle;
a movable handle pivotably coupled to the stationary handle and movable from an open position spaced apart from the stationary handle to a closed position adjacent the stationary handle; and
an actuation mechanism comprising:
an advancing driver operably coupled to the movable handle and longitudinally translatable in a first direction responsive to movement of the movable handle from the open position to the closed position;
a reversing driver operably coupled to the movable handle and longitudinally translatable in a second direction opposite the first direction responsive to movement of the movable handle from the open position to the closed position;
an actuation shaft having a longitudinal axis, the actuation shaft longitudinally slidable relative to the stationary handle and selectively rotatable about the longitudinal axis between a first orientation and a second orientation.
14. A handle assembly for a surgical stapler comprising:
a stationary handle;
a movable handle pivotably coupled to the stationary handle and pivotable between an open position spaced apart from the stationary handle and a closed position adjacent the stationary handle;
an actuation mechanism comprising:
an advancing driver operably coupled to the movable handle and translatable in a first longitudinal direction with respect to the longitudinal axis responsive to movement of the movable handle from the open position to the closed position;
a reversing driver operably coupled to the advancing driver and translatable in a second direction with respect to the longitudinal axis responsive to movement of the movable handle from the open position to the closed position, the second direction opposite the first direction; and a gear operably coupling the advancing driver to the reversing driver; and
an actuation shaft defining a longitudinal axis; wherein the actuation shaft is longitudinally translatable along the longitudinal axis relative to the stationary handle; and wherein the actuation shaft is selectably rotatable about the longitudinal axis between a first orientation in which the advancing driver engages the actuation shaft to advance the actuation shaft longitudinally distally and a second orientation in which the reversing driver engages the actuation shaft to retract the actuation shaft longitudinally proximally.
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.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 9,668,732. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of US 9,668,732 discloses all of the claimed limitations of claim 15 of the instant application.
Claim 15 of App. 19/391,234
Claim 7 of US 9,668,732
15. A handle assembly for a surgical stapler, the handle assembly comprising:
a stationary handle;
a movable handle pivotably coupled to the stationary handle and movable from an open position spaced apart from the stationary handle to a closed position adjacent the stationary handle; and
an actuation mechanism comprising:
an advancing driver operably coupled to the movable handle and longitudinally translatable in a first direction responsive to movement of the movable handle from the open position to the closed position;
a reversing driver operably coupled to the movable handle and longitudinally translatable in a second direction opposite the first direction responsive to movement of the movable handle from the open position to the closed position;
an actuation shaft having a longitudinal axis, the actuation shaft longitudinally slidable relative to the stationary handle and selectively rotatable about the longitudinal axis between a first orientation and a second orientation.
7. A handle assembly for a surgical stapler comprising
a stationary handle disposed on the housing;
a movable handle pivotably coupled to the housing and pivotable between an open position spaced apart from the stationary handle and a closed position adjacent the stationary handle;
an actuation mechanism comprising:
an advancing driver operably coupled to the movable handle and translatable distally with respect to the longitudinal axis responsive to movement of the movable handle from the open position to the closed position;
a reversing driver operably coupled to the movable handle and translatable proximally with respect to the longitudinal axis responsive to movement of the movable handle from the open position to the closed position; and
an actuation shaft extending along the longitudinal axis, the actuation shaft rotatably coupled to the housing with respect to the longitudinal axis, and
wherein the actuation shaft is rotatable with respect to the longitudinal axis between a first orientation in which the advancing driver engages the advancing surface and a second orientation in which the reversing driver engages the reversing surface.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 9,668,732. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 8 of US 9,668,732 discloses all of the claimed limitations of claim 16 of the instant application.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a rotation mechanism” in claim 2 (interpreted to be a switch and a hub collar).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 4-10 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.
Regarding claim 4, “the housing” lacks antecedent basis.
Regarding claims 5-10, claims 5-10 are rejected because they depend from rejected claim 4.
Allowable Subject Matter
Claims 2-3 and 11-14 are allowed.
Claims 4-10 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 2, the prior art of record fails to disclose, teach, or fairly suggest a handle assembly for a surgical stapler, the handle assembly comprising: a stationary handle; a movable handle coupled to the stationary handle and movable from an open position spaced apart from the stationary handle to a closed position adjacent the stationary handle; an actuation shaft having a longitudinal axis, the actuation shaft longitudinally slidable along the longitudinal axis relative to the stationary handle and selectively rotatable about the longitudinal axis between a first orientation configured for repeatable longitudinal advancement and retraction responsive to movement of the movable handle, a second orientation configured for longitudinal advancement in a first direction relative to the stationary handle, and a third orientation configured for longitudinal advancement in a second direction relative to the stationary handle, the second direction opposite to the first direction; and a rotation mechanism configured to discretely orient the actuation shaft in one of the first orientation, the second orientation, and the third orientation.
The prior art of record that comes closest to teaching these limitations is Scirica (US 2009/0145947). Scirica teaches a handle assembly for a surgical stapler, the handle assembly comprising: a stationary handle; a movable handle coupled to the stationary handle and movable from an open position spaced apart from the stationary handle to a closed position adjacent the stationary handle; an actuation shaft having a longitudinal axis, the actuation shaft longitudinally slidable along the longitudinal axis relative to the stationary handle. However, Scirica fails to teach the actuation shaft selectively rotatable about the longitudinal axis between a first orientation configured for repeatable longitudinal advancement and retraction responsive to movement of the movable handle, a second orientation configured for longitudinal advancement in a first direction relative to the stationary handle, and a third orientation configured for longitudinal advancement in a second direction relative to the stationary handle, the second direction opposite to the first direction; and a rotation mechanism configured to discretely orient the actuation shaft in one of the first orientation, the second orientation, and the third orientation. Additionally, it would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 15-16 would be allowable if rewritten or amended to overcome the above Double Patenting rejections.
Claims 17-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 15, the prior art of record fails to disclose, teach, or fairly suggest a handle assembly for a surgical stapler, the handle assembly comprising: a stationary handle; a movable handle pivotably coupled to the stationary handle and movable from an open position spaced apart from the stationary handle to a closed position adjacent the stationary handle; and an actuation mechanism comprising: an advancing driver operably coupled to the movable handle and longitudinally translatable in a first direction responsive to movement of the movable handle from the open position to the closed position; a reversing driver operably coupled to the movable handle and longitudinally translatable in a second direction opposite the first direction responsive to movement of the movable handle from the open position to the closed position; an actuation shaft having a longitudinal axis, the actuation shaft longitudinally slidable relative to the stationary handle and selectively rotatable about the longitudinal axis between a first orientation and a second orientation.
The prior art of record that comes closest to teaching these limitations is Weisenburgh (US 8,875,972) and Shelton (US 2012/0318844). Weisenburgh and Shelton teaches a handle assembly for a surgical stapler, the handle assembly comprising: a stationary handle; a movable handle pivotably coupled to the stationary handle and movable from an open position spaced apart from the stationary handle to a closed position adjacent the stationary handle; and an actuation mechanism comprising: an actuation shaft having a longitudinal axis. However, Weisenburgh and Shelton fails to teach an advancing driver operably coupled to the movable handle and longitudinally translatable in a first direction responsive to movement of the movable handle from the open position to the closed position; a reversing driver operably coupled to the movable handle and longitudinally translatable in a second direction opposite the first direction responsive to movement of the movable handle from the open position to the closed position; the actuation shaft longitudinally slidable relative to the stationary handle and selectively rotatable about the longitudinal axis between a first orientation and a second orientation. Additionally, it would require an unreasonable combination of references that would not suffice for a realistic case of obviousness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VERONICA MARTIN whose telephone number is (571)272-3541. The examiner can normally be reached Monday-Thursday 8:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anna Kinsaul can be reached at (571)270-1926. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VERONICA MARTIN/Primary Examiner, Art Unit 3731
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