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 .
Claim Status
This Office action is in response to the filing of 1/28/2025. Claims 1-18 are currently pending.
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:
the “transmission assembly” of at least claims 1, 8, and 15 corresponding to drive shaft 212, drive shaft 281, and distal drive shaft 282.
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 Objections
Claim 9 is objected to because of the following informality: line 2 reads “a clamping distance stored in the storage device of the reload” when it should read “a clamping distance of the reload stored in the storage device.” Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 5, 8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton (US 2016/0256184 A1).
Regarding claim 1, Shelton discloses a surgical device (9010 – Fig. 81) comprising: a reload assembly (the assembly of 9016 and 9018 – Fig. 81) including a plurality of staples (9042 – Fig. 82; para. 0534); an anvil assembly (9014 – Fig. 81) movable relative to the reload assembly (para. 0534); a power source (90 – Fig. 4 as applied to the embodiment of Fig. 81, para. 0534; or the battery, para. 0535); a motor (9082 – Fig. 83) coupled to the power source (para. 0293 as applied to the embodiment of Fig. 81, para. 0534); a transmission assembly (the assembly of 9036 and 9038 – Fig. 82) movable by the motor and configured to move the anvil assembly relative to the reload assembly (para. 0538; “assist in spacing the anvil” is interpreted to be moving the anvil assembly relative to the reload assembly); a force sensor (9020 – Fig. 84) configured to measure a force imparted on the anvil assembly by the transmission assembly (para. 0529); a storage device (9068 – Fig. 86) storing data including a minimum clamp force limit (para. 0359 as applied to the embodiment of Fig. 81, para. 0534 in view of para. 0551); and a controller (9062 – Fig. 86) configured to: activate the motor to move the anvil assembly relative to the reload assembly (paras. 0538-0539; 9082 actuates 9036 which then assists in spacing the anvil); compare the measured force to the minimum clamp force limit (para. 0373 as applied to the embodiment of Fig. 81, para. 0534); and output an alert in response to the measured force being lower than the minimum clamp force limit (para. 0359, “warn the user”).
Shelton further discloses:
Claim 2, the data further includes a clamping distance (measurement of the gap, para. 0546 and para. 0551).
Claim 3, the controller is configured to activate the motor to move the anvil assembly relative to the reload assembly until the clamp distance is reached (since the controller moves the transmission assembly to move the anvil assembly to the clamp distance and the clamp distance is stored after the anvil assembly is in position, the controller moves the anvil assembly relative to the reload assembly unit the clamp distance is reached; note that clamping distance is not claimed as stored prior to clamping).
Claim 5, the controller is further configured to enable ejection of the plurality of staples in response to the measured force being higher than the minimum clamp force limit (para. 0359; since normal operation is above the minimum clamp force limit and in normal operation the controller enables staples to be ejected, the controller is configured to enable ejection of the plurality of staples in response to the measured force being higher than the minimum clamp force limit).
Claim 8, a method for controlling a surgical device (9010 – Fig. 81), the method comprising: receiving, at a controller (9062 – Fig. 86), a minimum clamp force limit stored in a storage device (para. 0359 as applied to the embodiment of Fig. 81, para. 0534 in view of para. 0551); activating a motor (9082 – Fig. 83) to move a transmission assembly (the assembly of 9036 and 9038 – Fig. 82) coupled to an anvil assembly (9014 – Fig. 81) that is movable relative to a reload assembly (the assembly of 9016 and 9018 – Fig. 81) having a plurality of staples (para. 0538; “assist in space the anvil” is interpreted to be moving the anvil assembly relative to the reload assembly); measuring, through a force sensor (9020 – Fig. 84), force imparted on the anvil assembly by the transmission assembly (para. 0529); comparing, at the controller, the measured force to the minimum clamp force limit (para. 0373 as applied to the embodiment of Fig. 81, para. 0534); and outputting, by the controller, an alert in response to the measured force being lower than the minimum clamp force limit (para. 0359, “warn the user”).
Claim 12, enabling ejection of the plurality of staples in response to the measured force being higher than the minimum clamp force limit (para. 0359; since normal operation is above the minimum clamp force limit and in normal operation the controller enables staples to be ejected, the controller is configured to enable ejection of the plurality of staples in response to the measured force being higher than the minimum clamp force limit).
Allowable Subject Matter
Claims 15-18 are allowed.
Claims 4, 6-7, 9-11 and 13-14 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: Shelton simply does not disclose comparing the force measured at the clamping distance to the minimum clamp force distance as required by claim 4, determining an alternative reload assembly in response to the measured force being lower than the minimum clamp force limit as required by claim 6, receiving, at the controller, a clamping distance stored in the storage device as required in claim 9, or activating the motor to move the anvil assembly relative to the reload assembly until the clamping distance is reached as required by claim 15. Furthermore, regarding claims 4, 6, and 9, there is no known reference that teaches these limitations. Regarding claim 15, even if a teaching were known that teaches activating the motor to move the anvil assembly relative to the reload assembly, claim 15 also does not disclose comparing the force measured at the clamping distance to the minimum clamp force limit.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Mozdzierz (US 2018/0353186 A1) teaches a clamp force and distance (paras. 0381 and para. 0379).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS M WITTENSCHLAEGER whose telephone number is (571)272-7012. The examiner can normally be reached MON-FRI: 9:00-5:00.
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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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/THOMAS M WITTENSCHLAEGER/Primary Examiner, Art Unit 3731
8/4/2026
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