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
Claims 1-35 are cancelled. Claims 36-52 are pending and under examination.
Benefit
The application claims benefit as a Continuation of US Benefit is acknowledged to 17/815816 (28 July 2022), issued as US Patent 12,310,596 (27 May 2025) which claims benefit to US Provisional 63/230412 filed 19 August 2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 15 January 2026 has been considered by the examiner. A signed copy is 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 Objections – Duplicate Claims
Claims 47-50 and 52 are objected to. Claims 47 and 48 are objected to under 37 CFR 1.75 as being a substantial duplicates of each other. Claims 47 and 48 are both dependent on claim 46 and both claims contain the same claim language. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Applicant is also advised that the claims 49, 50, and 52 are directly or indirectly dependent on claim 48. Applicant is advised to correct the dependencies as applicable when claims 47 and 48 are corrected.
Non-Statutory Obviousness-Type Double Patenting Rejections
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 36, 38, 39, 41, 46-50 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, 9, and 10 of U.S. Patent No. 12,310,596 (27 May 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 36, 38, 39, 41, 46-50 and 52 are broader than and are anticipated by claims 1, 2, 4-6, 9 and 10 of the ‘596 patent. A side-by-side comparison chart is provided below with the relevant anticipatory portions of the ‘596 patent claims emphasized for ease of reference.
The repositioning element and the deployment element of claims 36 and 46-48 of the application are called “control elements” in claims 1, 2, and 4 of the ‘596 patent but are described in the claim specific functional language in both the application and the ‘596 patent. The ‘596 patent claims a control element for repositioning (movement from the insertion configuration to the review configuration) and a control element for deployment (movement from the review configuration to the deployment configuration).
The first actuator assembly of claims 36, 47, and 48 of the application is anticipated by claim 2 of the ‘596 patent. Similarly, the second actuator assembly of claim 36, 47, and 48 of the application is anticipated by claim 4 of the ‘596 patent.
Application 19/192,924
US Patent 12,210,596
36. A device for clipping tissue, comprising: a cap extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, the cap being configured to be mounted over a distal portion of an endoscope;
a clip including first and second jaws movably connected to one another via hinges, at least one of the hinges being biased to draw the first and second jaws toward one another,
the clip being mountable over the cap such that the first and second jaws extend over opposing portions of the cap so that the first and second jaws are separated from one another to receive target tissue therebetween, the cap being configured so that distal movement of the cap relative to the endoscope moves the clip from an insertion configuration
to a review configuration in which at least a portion of the clip extends distally into a field of view of an optical device of the endoscope and distal movement of the clip relative to the cap moves the clip from the review configuration
to a deployed configuration in which the clip is moved distally off of the cap so that the first and second jaws are drawn toward one another under the bias of the at least one of the hinges to close over tissue received therebetween;
a repositioning element extending from a distal end coupled to the cap, through the channel of the cap to a proximal end which, in use, remains outside a living body, the repositioning element being configured so that moving the repositioning element proximally moves the cap distally along the endoscope from the insertion configuration to the review configuration;
a deployment element extending from a distal end releasably coupled to the clip, through the channel of the cap, to a proximal end which, in use, remains outside the living body, the deployment element being configured so that proximal movement of the deployment element moves the clip distally relative to the cap to the deployed configuration;
and an actuator assembly including a first actuator configured to control movement of the repositioning element
and a second actuator configured to control movement of the deployment element.
1. A clipping system for treating tissue, comprising: a cap configured to be mounted over a distal end of an endoscope, the cap extending longitudinally from a proximal end to a distal end and including a channel extending therethrough so that the cap may be located adjacent to target tissue within a living body;
a clip configured to be mounted over the cap, the clip including first and second jaws movably connected to one via a hinge biased to draw the first and second jaws toward one another,
the clip movable relative to the cap between: (a) an insertion configuration, in which the first and second jaws extend over the cap so that the first and second jaws are separated from one another to receive a target tissue therebetween and so that obstruction of an optical system of the endoscope on which the cap is mounted is minimized;
(b) a review configuration, in which the clip is moved distally relative to the cap so that a portion of the clip extends distally until at least a portion of the clip extends into a field of view of the optical system on which the cap is mounted;
and (c) a deployed configuration in which the clip is moved distally off of the cap so that the first and second jaws are drawn toward one another under the bias of the hinge to close and clip tissue received between the first and second jaws; and
a control element extending from a distal end releasably coupled to the clip, through the channel of the cap and the endoscope to which it is connected, to a proximal end which, in use, remains outside the living body while the cap is adjacent to the target tissue, the control element being configured so that movement of the control element proximally through the cap moves the clip distally relative to the cap,
the control element being configured so that movement of the control element proximally through the cap via a first distance moves the clip from the insertion configuration to the review configuration and movement of the control element proximally through the cap via a second distance moves the clip from the review configuration to the deployed configuration.
2. The system of claim 1, further comprising an actuator assembly connected to a proximal end of the control element, the actuator assembly including a first actuator configured so that, when actuated, the control element is moved proximally through the endoscope via the first distance to move the clip from the insertion configuration to the review configuration.
4. The system of claim 2, wherein the actuator assembly further includes a second actuator configured so that, when actuated, the control element is moved proximally through the endoscope via the second distance to move the clip from the review configuration to the deployed configuration.
38. (New) The device of claim 37, wherein the first actuator includes a lever pivotally coupled to a handle, the proximal end of the repositioning element connected to a portion of the handle so that, movement of the lever relative to the housing draws the repositioning element proximally to move the cap and the clip distally from the insertion configuration toward the review configuration.
9. The system of claim 2, wherein the first actuator includes a handle portion configured to be gripped via an operator of the system and a lever movably coupled thereto, the proximal end of the control element connected to the lever so that, when the lever is pressed against the handle portion, the control element is moved proximally through the endoscope via the first distance to move the clip from the insertion configuration toward the review configuration.
39. (New) The device of claim 37, wherein the second actuator includes a push button extending into the housing and connected to the proximal end of the deployment element so that, when the push button is pressed further into the housing, the deployment element is moved proximally to move the clip distally relative to the cap from the review configuration toward the deployed configuration.
6. The system of claim 4, wherein the second actuator includes a push button including a tab extending into a housing of the actuator assembly such that when the clip is in the review configuration, the tab engages a portion of the control element so that pushing the push button exerts an additional tension along the control element which moves the clip from the review configuration toward the deployed configuration.
41. (New) The device of claim 38, further comprising a biasing element extending between a distal end of the cap and a stop configured to be positioned at a distal-most end of the endoscope on which the cap is mounted, the biasing element biasing the cap toward the insertion configuration so that when the lever is released, the cap and the clip revert to the insertion configuration.
10. The system of claim 9, further comprising: a biasing element extending between a distal end of the cap and a stop at a distal-most end of the endoscope on which the cap is mounted, the biasing element biasing the cap toward the insertion configuration, in which an entirety of the clip mounted over the cap is proximal of the distal-most end of the endoscope so that when the lever is released, the cap and the clip revert toward the insertion configuration.
46. (New) A device for clipping tissue, comprising: a cap extending longitudinally from a proximal end to a distal end and including a channel extending therethrough, the cap being configured to be mounted over a distal portion of an endoscope;
a clip including first and second jaws biased toward a tissue clipping position in which the first and second jaws are adjacent to one another, the clip being mountable, in an insertion configuration, over the cap with the first and second jaws maintained spread apart from one another on an outer surface of the cap so that tissue drawn into a distal end of the cap is positioned between the first and second jaws,
the cap being configured to be movable relative to the endoscope on which it is mounted so that distal movement of the cap relative to the endoscope moves the clip from the insertion configuration to a review configuration in which at least a portion of the clip extends distally beyond a distal end of the endoscope into a field of view of an optical device of the endoscope;
a repositioning element extending from a distal end coupled to the cap, through the channel of the cap to a proximal end which, in use, remains outside a living body, the repositioning element being configured to move the cap distally along the endoscope from the insertion configuration to the review configuration; and
a deployment element extending from a distal end releasably coupled to the clip, through the channel of the cap, to a proximal end which, in use, remains outside the living body, the deployment element being releasably coupled to the clip so that movement of the deployment element moves the clip distally off the cap to a deployed configuration in which the first and second jaws are drawn toward one another under the bias of the first and second jaws to close over tissue received therebetween.
1. A clipping system for treating tissue, comprising: a cap configured to be mounted over a distal end of an endoscope, the cap extending longitudinally from a proximal end to a distal end and including a channel extending therethrough so that the cap may be located adjacent to target tissue within a living body;
a clip configured to be mounted over the cap, the clip including first and second jaws movably connected to one via a hinge biased to draw the first and second jaws toward one another,
the clip movable relative to the cap between: (a) an insertion configuration, in which the first and second jaws extend over the cap so that the first and second jaws are separated from one another to receive a target tissue therebetween and so that obstruction of an optical system of the endoscope on which the cap is mounted is minimized;
(b) a review configuration, in which the clip is moved distally relative to the cap so that a portion of the clip extends distally until at least a portion of the clip extends into a field of view of the optical system on which the cap is mounted;
and (c) a deployed configuration in which the clip is moved distally off of the cap so that the first and second jaws are drawn toward one another under the bias of the hinge to close and clip tissue received between the first and second jaws; and
a control element extending from a distal end releasably coupled to the clip, through the channel of the cap and the endoscope to which it is connected, to a proximal end which, in use, remains outside the living body while the cap is adjacent to the target tissue, the control element being configured so that movement of the control element proximally through the cap moves the clip distally relative to the cap,
the control element being configured so that movement of the control element proximally through the cap via a first distance moves the clip from the insertion configuration to the review configuration and movement of the control element proximally through the cap via a second distance moves the clip from the review configuration to the deployed configuration.
47. (New) The device of claim 46, further comprising an actuator assembly including a first actuator configured to control movement of the repositioning element and a second actuator configured to control movement of the deployment element.
2. The system of claim 1, further comprising an actuator assembly connected to a proximal end of the control element, the actuator assembly including a first actuator configured so that, when actuated, the control element is moved proximally through the endoscope via the first distance to move the clip from the insertion configuration to the review configuration.
4. The system of claim 2, wherein the actuator assembly further includes a second actuator configured so that, when actuated, the control element is moved proximally through the endoscope via the second distance to move the clip from the review configuration to the deployed configuration.
48. (New) The device of claim 46 further comprising an actuator assembly including a first actuator configured to control movement of the repositioning element and a second actuator configured to control movement of the deployment element.
2. The system of claim 1, further comprising an actuator assembly connected to a proximal end of the control element, the actuator assembly including a first actuator configured so that, when actuated, the control element is moved proximally through the endoscope via the first distance to move the clip from the insertion configuration to the review configuration.
4. The system of claim 2, wherein the actuator assembly further includes a second actuator configured so that, when actuated, the control element is moved proximally through the endoscope via the second distance to move the clip from the review configuration to the deployed configuration.
49. (New) The device of claim 48, wherein the actuator assembly further includes a housing and wherein the first actuator includes a lever pivotally coupled to a handle, the proximal end of the repositioning element connected to a portion of the handle so that, movement of the lever relative to the housing draws the repositioning element proximally to move the cap distally from the insertion configuration to the review configuration.
9. The system of claim 2, wherein the first actuator includes a handle portion configured to be gripped via an operator of the system and a lever movably coupled thereto, the proximal end of the control element connected to the lever so that, when the lever is pressed against the handle portion, the control element is moved proximally through the endoscope via the first distance to move the clip from the insertion configuration toward the review configuration.
50. (New) The device of claim 49, wherein the second actuator includes a push button extending into the housing and connected to the proximal end of the deployment element so that, when the push button is pressed further into the housing, the deployment element is moved proximally to move the clip distally relative to the cap from the review configuration to the deployed configuration.
6. The system of claim 4, wherein the second actuator includes a push button including a tab extending into a housing of the actuator assembly such that when the clip is in the review configuration, the tab engages a portion of the control element so that pushing the push button exerts an additional tension along the control element which moves the clip from the review configuration toward the deployed configuration.
52. (New) The device of claim 49, further comprising a biasing element extending between a distal end of the cap and a stop configured to be positioned at a distal-most end of the endoscope on which the cap is mounted, the biasing element biasing the cap toward the insertion configuration so that when the lever is released, the cap and the clip revert to the insertion configuration.
10. The system of claim 9, further comprising: a biasing element extending between a distal end of the cap and a stop at a distal-most end of the endoscope on which the cap is mounted, the biasing element biasing the cap toward the insertion configuration, in which an entirety of the clip mounted over the cap is proximal of the distal-most end of the endoscope so that when the lever is released, the cap and the clip revert toward the insertion configuration.
Allowable Subject Matter
Claim 36-52 would be allowable when the nonstatutory double patenting rejection above and the duplicate claim objection is overcome.
The following is a statement of reasons for the indication of allowable subject matter: Jugenheimer et al., US 20140228864 (14 August 2014) is the closest prior art. Jugenheimer teaches a clipping system for treating tissue (Abstract; ¶3), comprising: a cap configured to be mounted over a distal end of an endoscope (FIGS 3-5; ¶16); a clip (surgical clip 10, ¶101) configured to be mounted over the cap (FIGs 3-5; ¶101), the clip including first and second jaws movably connected to one via a hinge biased to draw the first and second jaws toward one another (FIGs 2, 3; ¶101, first grasping surface 12, second grasping surface 14, joints 16 and 18), the clip movable relative to the cap between (FIGs 3-7, 14-16). Cable 100 is taught as being utilized to deploy the surgical clip from endoscope cap (¶105). Jugenheimer teaches an insertion configuration (FIGs 3-7; ¶104) and a deployment configuration (FIGs 3-7; ¶105), but does not teach a review configuration. The clip of Jugenheimer is set to be deployed and then is deployed, with no middle option to review the placement or configuration of the placement prior to deployment, as provided in independent claims 36 and 46.
Claims 37, 40, 42-45, and 51 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.
Conclusion
Claims 36, 38, 39, 41, 46-50, and 52 are rejected. Claims 47 and 48 are objected to as being duplicate claims. Claims 49, 50, and 52 are objected to as depending from claims that are objected to as being duplicate claims. Claims 37, 40, 42-45, and 51 are objected to as depending from rejected claims.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Adhik, et al., US 20230027249 (26 January 2023) teaches over the scope clips with repositionable capability.
Sorrentino et al., US 20130296892 (7 November 2013), teaches endoscopic surgical clip applier with clip retention.
Shikhman et al., WO 2019135958 (11 July 2019) teach surgical clip and deployment system.
Saenz Villalobos et al., US 12,533,141 (27 January 2026) teaches a repositionable over the scope clip with frangible link.
Adhikarath Balan et al., US 12,310,596 (27 May 2025) teaches an interface mechanism for repositioning and deployment of over the scope clip.
Sharma et al., US 20250057408 (20 February 2025), teaches over the scope clip.
Sharma et al., US 11,969,173 (30 April 2024) teaches repositionable over the scope clip.
Singh et al., US 20250134507 (1 May 2025) teaches over the scope clip.
Saenz Villalobos et al., US 20230277194 (7 September 2023) teaches repositionable over the scope clip with frangible link.
Shikhman et al., US 20200397445 (24 December 2020) teaches surgical clip and deployment system.
Baur et al., US 20110208210 (25 August 2011) teaches a resection device.
Jin et al., US 20210059677 (4 March 2021) teaches self-service anastomosis clamp for digestive tract and delivery systems thereof.
Zhong et al., US 11,013,518 (25 May 2021) teaches detachable endoscopic clip for anastomosis.
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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/CHERIE M POLAND/Examiner, Art Unit 3771
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