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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 23rd, 2025, has been entered.
Response to Amendment
The claims filed on December 23rd, 2025, have been entered. Claims 1-4 and 6-18 remain pending in the Application. Claims 8-18 were previously withdrawn by the Applicant.
Response to Arguments
Applicant's arguments filed December 23rd, 2025, have been fully considered but they are not persuasive.
Regarding the 112(f) interpretation, Applicant argues that “articulation adjustment mechanism” should not be interpreted under 112(f) because the term does not recite the term “means for,” the Specification demonstrates that the term is a common parlance in the art, and the claims 3, 4, and 6 recite sufficient structure in the limitations “operatively coupled to the articulating portion and configured to enable manual adjustment of the end effector’s pivot through an arc of abut 180 degrees in relation to the shaft” to rebut the interpretation. Examiner respectfully disagrees. First, the Final Rejection dated September 30th, 2025, acknowledged that “means for” was not present but that the limitation was still being interpreted under 112(f) because the limitation uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function. In this case, “mechanism” is a generic placeholder that is coupled with the functional language “articulation adjustment” without reciting any structure to perform the articulation adjustment. Applicant does not provide any citations to support their assertion that the Specification shows the limitation is common parlance; furthermore, as stated in the claim rejection in the Final Rejection dated September 30th, 2025, the absence of structure in the claims forced Examiner to turn to the Specification to determine what the mechanism was, where FIG. 3 indicated that articulation adjustment mechanism 332 is a knob. Finally, the limitations cited by Applicant are not structural limitations, but further functional limitations that do not clarify how the articulation is being adjusted, nor provide any structure for performing the claimed functions.
Regarding the 102(a)(2) rejection of claims 1-4 and 6-7 over Mumaw et al. (Pub. No. 2016/0367239), Applicant argues that the newly added limitation of “the arc of about 180 degrees occurs in a vertical direction relative to the shaft when the handle is facing down” is not disclosed by Mumaw et al. because Mumaw et al. explicitly defines the motion of articulation joint 23 as lateral in [0062]. Examiner respectfully disagrees. Mumaw et al. in [0061] discloses that the third input 16 can be used to rotate 30 about shaft 20, where the articulation rotates the cartridge receiving assembly 50 relative to the longitudinal axis of 20. When 16 articulates 20 by ninety degrees, the left and right articulation of 50 will become an up and down articulation relative to the longitudinal axis of 20 based on the position of the handle, which will still be facing down as shown in FIG. 1. Therefore, Mumaw et al. satisfies the newly added limitation.
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: articulation adjustment mechanism in claims 3-4 and 6.
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 § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4 and 6-7 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mumaw et al. (Pub. No. 2016/0367239).
Regarding claim 1, Mumaw et al. discloses a clip application device (2; [0059]; FIG. 1) comprising:
a handle (10) including an actuator (12);
a shaft (20) extending from the handle and including an articulating portion (23); and
an end effector (50; [0062]) extending distally of the articulating portion (FIG. 1: 50 extends distally from 23),
wherein the end effector is configured to apply at least one clip in response to manual actuation of the actuator ([0090] when 12 is pulled, 50 manipulates 200 to apply surgical clip 220 to tissue),
the articulating portion is configured to pivot the end effector through an arc of about 180 degrees in relation to the shaft ([0062] manual adjustments of 14 cause 50 to pivot left and right relative to 20 i.e. through an arc of 180 degrees relative to 20), and
the arc of about 180 degrees occurs in a vertical direction relative to the shaft when the handle is facing down ([0061] manual adjustments of 16 cause the left and right movement of 50 relative to 20 to become up and down relative to the downward position of the handle 10 shown in FIG. 1).
Regarding claim 2, Mumaw et al. further discloses the clip application device is a multi-fire clip applier ([0095] 200 has four clips 220a, 220b, 220c, and 220d; FIGs. 13-14A) that is configured to apply multiple clips in response to multiple manual actuations of the actuator ([0103] and FIGs. 14A-14C: 220a is deployed by a first actuation of 12, then 220b is deployed by another actuation of 12).
Regarding claim 3, Mumaw et al. further discloses an articulation adjustment mechanism (14; [0062]; FIG. 1; as indicated above, this limitation is being interpreted under 112(f) because the generic placeholder “mechanism” is being modified by the functional language “articulation adjustment” without any structure being disclosed to perform the function, and in present Specification Page 10, that limitation is denoted by 332, which in FIG. 3 is knob which can be rotated to adjust the articulation of articulating portion 330; 14 satisfies this because 14 can rotate to adjust the articulation of 23) operatively coupled to the articulating portion ([0062] 14 is manually operated to manipulate 23) and configured to enable manual adjustment of the end effector’s pivot through an arc of about 180 degrees in relation to the shaft ([0062] manual adjustments of 14 cause 23 to pivot 50 and 200 left and right around 20, including through an arc of 180 degrees relative to 20).
Regarding claim 4, Mumaw et al. further discloses manual adjustments of the articulation adjustment mechanism causes the articulating portion to pivot the end effector in relation to the shaft ([0062] manual adjustments of 14 cause 23 to pivot 50 and 200 around 20).
Regarding claim 6, Mumaw et al. further discloses the articulation adjustment mechanism is movably coupled to the handle ([0062] 14 can be rotated relative to 10, and is coupled to 10; FIG. 1).
Regarding claim 7, Mumaw et al. further discloses the manual actuation of the actuator comprises squeezing the actuator ([0061] 12 is a trigger which the operator squeezes to actuate the device).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES RYAN MCGINNITY whose telephone number is (571)272-0573. The examiner can normally be reached M-Th 8 am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771