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 .
Formal Matters
Claim 1 is are cancelled. Claims 2-21 are pending and under examination.
Benefit
The instant application claims benefit as a Continuation to 17/787,232 (17 June 2022) issued as US 12,234,589 (10 June 2025) which claims benefit as a National Stage application under 35 USC 371 of PCT/US2021/012284, filed 6 January 2021, claiming benefit to US Provisional 62/958195 filed 7 January 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9 May 2025, 13 June 2025, 15 July 2025, 6 August 2025, 3 October 2025, 4 February 2026, 12 February 2026, and 15 May 2026 have been considered by the examiner. Signed copies are attached.
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.
Claim Rejections - 35 USC § 102/103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Scott et al., US 20190231350 (1 August 2019).
Regarding independent claim 2, Scott teaches a cartridge (FIG 11, cartridge, ¶98) configured to be received in a surgical instrument (FIGs 11-15, end effector 1100) that employs a drive element (feed bar 1130, ¶87) for applying clips (FIG 11, surgical clips 1110a-f; ¶82),
the surgical instrument (1100) including first (FIG 11, jaw 1111a) and second (FIG 11, jaw 1111b) jaws movable between open and closed positions (¶92) and a drive element (1130),
the cartridge (¶98) comprising: a first plurality of clips (FIG 11, “surgical clips 1110a-c packed in a first layer and surgical clips 1110d-f packed in a second layer”, ¶82) arranged longitudinally (¶84) in a first row of clips (1110a-c) in the cartridge (¶98),
each one of the first plurality of clips (FIG 11, 1110a-c; ¶82) configured to be sequentially (¶86) formed via actuation of the drive element (1130) of the surgical instrument (¶86); and
a member (FIG 11, clip feeder 1102) extending from the cartridge and configured to displace the drive element (via biasing element 1122; ¶85) into a position at which the drive element (1130) is aligned with the first row of clips (1110a-c) (¶85).
Scott teaches that “surgical clips 1110a-f or another suitable number of surgical clips may be added to end effector 1100 in a cartridges, magazines, and similar structures” (¶98). Accordingly, Scott teaches cartridges as an obvious alternative carrier or container for the multiple clips (e.g. 1110a-f).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the alternative embodiments of Scott as applied to end effector 1100 (FIG 11) given that the prior art included each element claimed, although not necessarily in a single embodiment. Instead, the container types are taught as obvious equivalents. Scott expressly teaches a finite list of equivalent container types, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the teachings of Scott.
Regarding claim 3, Scott teaches the cartridge of claim 2, as set forth above, for the reasons set forth above.
Scott teaches wherein the member is an inclined surface (FIG 13, grooves 1160; ¶90) that engages the drive element (feedbar 1130) so as to laterally displace (¶90) the drive element (1130) into the position at which the drive element (1130) is aligned with the row of clips (¶90).
Regarding claim 4, Scott teaches the cartridge of claim 2, as set forth above, for the reasons set forth above.
Scott teaches wherein the cartridge (¶98) is configured to be received in a channel of the surgical instrument (clip track 1131).
Regarding claim 5, Scott teaches the cartridge of claim 4, as set forth above, for the reasons set forth above.
Scott teaches wherein the member is a proximal tab (FIG 11, spring shoe 1120). extending into the channel (clip track 1131).
Regarding claim 6, Scott teaches the cartridge of claim 5, as set forth above, for the reasons set forth above.
Scott teaches the cartridge (¶98) further comprising a second plurality of clips arranged longitudinally in a second row of the cartridge (FIG 11, “surgical clips 1110d-f packed in a second layer”, ¶82).
Regarding claim 7, Scott teaches the cartridge of claim 6, as set forth above, for the reasons set forth above.
Scott teaches wherein each one of the second plurality of clips (FIG 11, 1110d-f; ¶82) is
configured to be sequentially (¶86) formed via actuation of the drive element (1130) of the surgical instrument (¶86); and
Regarding claim 8, Scott teaches the cartridge of claim 6, as set forth above, for the reasons set forth above.
Scott teaches wherein the second plurality of clips (FIG 11, 1110d-f; ¶82) is configured to be sequentially (¶86) formed on a condition that all of the clips of the first plurality of clips have been sequentially formed (¶83, “surgical clip feeder 1102 includes upper retainer plate 1116, lower retainer plate 1117, and forward stop 1118 to aid in maintaining surgical clips 1110a-f therein until their dispensation is desired”).
Regarding claim 9, Scott teaches the cartridge of claim 6, as set forth above, for the reasons set forth above.
Scott teaches wherein the second row of clips (FIG 11, 1110d-f; ¶82) is disposed adjacent to the first row of clips (FIG 11, 1110a-c; ¶82) such that the second row of clips can be formed upon displacement of the drive element (¶¶83-84).
Regarding claim 10, Scott teaches the cartridge of claim 2, as set forth above, for the reasons set forth above.
Scott teaches the cartridge further comprising a locking feature for locking the cartridge in the first jaw (FIG 11, forward stop 1118, ¶88).
Regarding claim 11, Scott teaches the cartridge of claim 2, as set forth above, for the reasons set forth above.
Scott teaches wherein the first plurality of clips (FIG 11, “surgical clips 1110a-c packed in a first layer and surgical clips 1110d-f packed in a second layer”, ¶82) is configured to be sequentially (¶86) formed via actuation of the drive element (1130) via a robotic control system (FIG 1 , ¶25).
Regarding independent claim 12, Scott teaches a cartridge (FIG 11, cartridge, ¶98) configured to be received in a first jaw (jaws 1111a/1111b) of a clip applier (FIGs 11-15, end effector 1100) and to be actuated by a drive element (feed bar 1130, ¶87) of the clip applier (1100), the cartridge (¶98) comprising:
a first row of clips arranged longitudinally in the cartridge (FIG 11, “surgical clips 1110a-c packed in a first layer and surgical clips 1110d-f packed in a second layer”, ¶82), the clips configured to be sequentially (¶86) formed via actuation of the drive element (1130; ¶87); and
a member (FIG 11, clip feeder 1102) extending from the cartridge and configured to displace the drive element (via biasing element 1122; ¶85) into a position at which the drive element (1130) is aligned with the first row of clips (1110a-c) (¶85).
Scott teaches that “surgical clips 1110a-f or another suitable number of surgical clips may be added to end effector 1100 in a cartridges, magazines, and similar structures” (¶98). Accordingly, Scott teaches cartridges as an obvious alternative carrier or container for the multiple clips (e.g. 1110a-f).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the alternative embodiments of Scott as applied to end effector 1100 (FIG 11) given that the prior art included each element claimed, although not necessarily in a single embodiment. Instead, the container types are taught as obvious equivalents. Scott expressly teaches a finite list of equivalent container types, a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining the teachings of Scott.
Regarding claim 13, Scott teaches the cartridge of claim 12, as set forth above, for the reasons set forth above.
Scott teaches wherein the member is an inclined surface (FIG 13, grooves 1160; ¶90) that engages the drive element (feedbar 1130) so as to laterally displace (¶90) the drive element (1130) into the position at which the drive element (1130) is aligned with the first row (¶82) of clips (¶90).
Regarding claim 14, Scott teaches the cartridge of claim 12, as set forth above, for the reasons set forth above.
the cartridge (¶98) is configured to be received in a channel of the surgical instrument (clip track 1131).
Regarding claim 15, Scott teaches the cartridge of claim 14, as set forth above, for the reasons set forth above.
Scott teaches wherein the member is a proximal tab (FIG 11, spring shoe 1120). extending into the channel (clip track 1131).
Regarding claim 16, Scott teaches the cartridge of claim 12, as set forth above, for the reasons set forth above.
Scott teaches the cartridge (¶98) further comprising a second plurality of clips arranged longitudinally in the cartridge (FIG 11, “surgical clips 1110d-f packed in a second layer”, ¶82).
Regarding claim 17, Scott teaches the cartridge of claim 16, as set forth above, for the reasons set forth above.
Scott teaches wherein the clips in the second row are configured to be sequentially formed via actuation of the drive element of the surgical instrument on a condition that all of the clips of the first row of clips have been sequentially formed.
Scott teaches wherein the clips in the second row (FIG 11, 1110d-f; ¶82) are configured to be sequentially (¶86) formed via actuation of the drive element (1130) of the surgical instrument (1100) on a condition that all of the first row of clips (FIG 11, 1110a-c; ¶82) have been sequentially (¶86) formed (¶88).
Regarding claim 18, Scott teaches the cartridge of claim 17, as set forth above, for the reasons set forth above.
Scott teaches wherein the second row of clips (FIG 11, 1110d-f; ¶82) is disposed adjacent to the first row of clips (FIG 11, 1110a-c; ¶82) such that the second row of clips can be formed upon displacement of the drive element (¶¶83-84).
Regarding claim 19, Scott teaches the cartridge of claim 12, as set forth above, for the reasons set forth above.
Scott teaches wherein the first row of clips (FIG 11, “surgical clips 1110a-c packed in a first layer”, ¶82) is configured to be sequentially (¶86) formed via actuation of the drive element (1130) via a robotic (¶25) teleoperated (¶27) control system (FIG 1, ¶25).
Regarding claim 20, Scott teaches the cartridge of claim 12, as set forth above, for the reasons set forth above.
Scott teaches the cartridge further comprising a locking feature for locking the cartridge in the first jaw (FIG 11, forward stop 1118, ¶88).
Regarding claim 21, Scott teaches the cartridge of claim 20, as set forth above, for the reasons set forth above.
Scott teaches wherein the locking feature is a fin configured to engage a cutout (FIG 13, groove 1160, ¶90) in the first jaw (FIG 13, 1111a or 1111b).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Scott et al., US 20190239892 (8 August 2019), teaches surgical clip applier with wide aperture surgical clips.
Harris et al., US 20190239891 (8 August 2019) teaches surgical clip applier employing arcuate surgical clips.
Deck et al., US 20190125354 (2 May 2019) teaches surgical clip applier comprising adaptive control in response to a strain gauge circuit.
Shelton et al., US 20190125360 (2 May 2019) teaches clip applier comprising a motor controller.
Shellenberger, US 20180271532 (27 Septemhber 2018) teaches surgical clip and clip applier.
Manetakis et al., US 20070185504 (9 August 2007) teaches medical clip feeding mechanism.
Kerver et al., US 12,324,589 (10 June 2025) teaches surgical instruments for applying multiple clips.
Swayze et al., US 20130334284 (19 December 2013) teaches end effectors for e.g. endocutters for endoscopic device, has jaw comprising anvil for deforming first fastener to first fired height and second fastener to second fired height, where first fired height is different from second fired height.
McCuen et al., US 20110204119 (25 August 2011) teaches surgical instrument i.e. powered surgical stapler such as gas-powered pneumatic stapler, has measurement unit determining parameter of motion of firing rod based on sensed change in electric field.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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