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 Objections
Claims 46- 51 are objected to because of the following informalities:
Claims 46- 51, Line 1 state “The system”, it is suggested to change this to “The clipping system”.
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.
Examiner’s Note: There is no prior art that reads on claims 38- 40 and 43- 51.
Claim(s) 36- 37 and 41- 42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shikhman et al. (WO 2019/135958).
Regarding claim 36, Shikhman (Shikhman et al.) teaches a system (Figs. 22A- 28) for treating tissue (abstract, Paragraphs 0070- 0082 and 0144- 0146), comprising:
An adapter (sheath 214) extending longitudinally from a proximal end to a distal end, the adapter configured to be mounted over a distal end of an insertion device (Paragraph 0145);
A clip (230) including first and second jaws (see annotated Fig. 23B below) hinged to one another for movement between an insertion configuration, in which the first and second jaws are separated from one another and a closed configuration in which the first and second jaws are drawn toward one another to grip tissue (Paragraphs 0144, 0147, and 0150);
A deployment member (second clip engagement member 229, elongated member 226) releasably coupled to the clip (Paragraph 0150) and extending from a proximal end coupled to an actuator to a distal end (Paragraph 0146), the deployment member being configured to move the clip distally off the adapter to the closed configuration and to retract the clip from the closed configuration onto the adapter in the insertion configuration (Paragraphs 0147 and 0150); and
A first extending member (first clip engagement member 227, elongated member 227) releasably coupled to the clip (Paragraph 0150), the first extending member configured to permit withdrawal of the adapter proximally away from the clip while the first extending member remains coupled to the clip to place the system in a review configuration in which the clip is physically separated from the adapter to enhance visual observation of the clip (Paragraphs 0147- 0150).
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Regarding claim 37, Shikhman teaches the system as discussed above.
Shikhman further teaches wherein the first extending member is releasably coupled to the clip so that, when the clip is observed to be in a desired position, the clip can be finally deployed from the system by separating the first extending member from the clip (Paragraph 0150).
Regarding claim 41, Shikhman teaches the system as discussed above.
Shikhman further teaches wherein a proximal end of the deployment member and a proximal end of the first extending member are manipulable to control movement of the clip between the insertion configuration, an initial deployment configuration and the review configuration (Paragraph 0146).
Regarding claim 42, Shikhman teaches the system as discussed above.
Shikhman further teaches wherein a distal portion of the adapter, over which the clip is configured to be mounted, includes a flat portion extending along an exterior surface thereof corresponding to a desired orientation of the clip on the adapter (see annotated Fig. 26c below)(Paragraph 0144).
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Double Patenting
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 45- 49 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11- 15 of U.S. Patent No. 12,178,445 (‘445). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current invention are broader in scope than the listed patent, requiring the deployment member to move the clip distally off of the adapter from the insertion configuration.
Regarding claim 45, ‘445 claims a clipping system for treating tissue (claim 11 of ‘445), comprising: an adapter including a proximal portion configured to be mounted over a distal end of a shaft of an insertion instrument so that a distal portion of the adapter extends distally away from the distal end of the insertion instrument (claim 11 of ‘445); a clip removably received on the adapter (claim 11 of ‘445) and including a pair of curved jaws hingedly coupled to one another so that the jaws are movable between an open insertion configuration in which the jaws are separated from one another and a closed configuration in which the jaws are moved toward one another to grip tissue (claim 11 of ‘445); a deployment member configured to move the clip distally off of the adapter from the insertion configuration so that, as the clip moves off of the adapter the clip is moved to the closed configuration (claim 11 of ‘445); and first and second extending members extending from proximal ends accessible to a user via a user interface at the proximal end of the shaft to distal ends releasably coupled to the clip, so that distal movement of the first and second extending members relative to an endoscope moves the clip distally away from a distal end of the adapter from an initial deployed configuration to a review configuration by a distance selected so that the clip is visible via the endoscope (claim 11 of ‘445).
Regarding claim 46, ‘445 claims the clipping system of claim 45.
‘445 further claims wherein the first extending member releasably coupled to the clip and the second extending member is releasably coupled to the clip opposite the first extending member (claim 12 of ‘445, which depends from claim 11 of ‘445).
Regarding claim 47, ‘445 claims the clipping system of claim 46.
‘445 further claims wherein the distal ends of each of the first and second extending members are biased radially away from a longitudinal axis of the adapter so that, when the first and second extending members are coupled to the clip, the distal ends of the first and second extending members are restrained toward an engaging configuration, and, when the distal ends of the first and second extending members are disengaged from the clip, the distal ends of the first and second extending members revert to their biased configuration to release the clip therefrom in a final deployed configuration (claim 13 of ‘445, which depends from claim 12 of ‘445).
Regarding claim 48, ‘445 claims the clipping system of claim 45.
‘445 further claims wherein the jaws are biased toward the closed configuration so that, when the clip is circumferentially mounted over the adapter, an exterior surface of the adapter holds the jaws toward the insertion configuration and, when the clip is moved toward the initial deployed configuration, the jaws are permitted to revert to the closed configuration (claim 14 of ‘445, which depends from claim 11 of ‘445).
Regarding claim 49, ‘445 claims the clipping system of claim 45.
‘445 further claims the system further comprising first and second lumens extending proximally from the adapter to the user interface, each of the first and second extending members extending through a corresponding one of the first and second lumens so that the extending members are longitudinally movable relative to the first and second lumens, the first and second lumens extending along opposing sides of the shaft of the endoscope (claim 15 of ‘445, which depends from claim 11 of ‘445).
Claims 36-44 and 50- 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 15 of U.S. Patent No. 12, 178,445 (‘445) in view of Ho et al. (US 2011/0190578).
Regarding claim 36, ‘445 claims a system for treating tissue (claim 1 of ‘445), comprising: an adapter extending longitudinally from a proximal end to a distal end, the adapter configured to be mounted over a distal end of an insertion device (claim 1 of ‘445); a clip including first and second jaws hinged to one another for movement between an insertion configuration, in which the first and second jaws are separated from one another and a closed configuration in which the first and second jaws are drawn toward one another to grip tissue (claim 1 of ‘445); a deployment member coupled to the clip, the deployment member being configured to move the clip distally off the adapter to the closed configuration and to retract the clip from the closed configuration onto the adapter in the insertion configuration (claim 1 of ‘445); and a first extending member releasably coupled to the clip, the first extending member configured to permit withdrawal of the adapter proximally away from the clip while the first extending member remains coupled to the clip to place the system in a review configuration in which the clip is physically separated from the adapter to enhance visual observation of the clip (claim 1 of ‘445).
‘445 does not claim wherein a deployment member is releasably coupled to the clip and extending from a proximal end coupled to an actuator to a distal end.
Ho (Ho et al.) teaches a similar system (Figs. 2-5c) for treating tissue (abstract), comprising: an adapter (endoscope cap 1), the adapter configured to be mounted over a distal end of an insertion device (Paragraph 0022); a clip (4) configured to grip tissue (Paragraph 0033); a deployment member (thread 11) releasably coupled to the clip (Paragraphs 0032 and 0033) extending from a proximal end coupled to an actuator to a distal end (Paragraph 0029 and 0033), the deployment member being configured to move the clip distally off the adapter to the closed configuration and to retract the clip from the closed configuration onto the adapter in the insertion configuration (Paragraph 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the deployment member as claimed by ‘445 to have it be releasably coupled to the clip as taught by Ho, since Ho teaches this is a way to deploy a clip within the body and that the releasable deployment member is “adapted to exert sufficiently high displacing forces” (Paragraph 0013).
Regarding claim 37, ‘445 and Ho make obvious the system of claim 36.
‘445 further claims wherein the first extending member is releasably coupled to the clip so that, when the clip is observed to be in a desired position, the clip can be finally deployed from the system by separating the first extending member from the clip (claim 2 of ‘445, which depends from claim 1 of ‘445).
Regarding claim 38, ‘445 and Ho make obvious the system of claim 37.
‘445 further claims the system further comprising a second extending member releasably coupled to the clip opposite the first extending member and movably connected to the adapter, the second extending member being configured to remain coupled to the clip while the system is moved to the review configuration, the second extending member being operable to cooperate with the first extending member to retract the clip proximally over the adapter from one of the review configuration and an initial deployment configuration (claim 3 of ‘445, which depends from claim 2 of ‘445).
Regarding claim 39, ‘445 and Ho make obvious the system of claim 38.
‘445 further claims wherein a distal end of the first extending member includes a loop configured to be hooked to the clip and wherein the distal end of the first extending member is biased radially away from a longitudinal axis of the adapter so that, when the loop of the first extending member is released from the clip, the distal end of the first extending member springs laterally outward to disengage from the clip (claim 5 of ‘445, which depends from claim 4 of ‘445)(Claim 4 of ‘445 claims wherein a distal end of the first extending member includes a loop.).
Regarding claim 40, ‘445 and Ho make obvious the system of claim 39.
‘445 further claims wherein the loop of the first extending member is configured to engage the clip so that a distally directed force applied to the first extending member is transmitted to the clip to move the clip distally over and off of the adapter, the loop of the first extending member being configured so that, when the clip applies a proximally directed force of at least a predetermined magnitude to the first extending member, the loop of the first extending member slides off of the clip to disengage the clip from the first extending member (claim 6 of ‘445, which depends from claim 5 of ‘445).
Regarding claim 41, ‘445 and Ho make obvious the system of claim 36.
‘445 further claims wherein a proximal end of the deployment member and a proximal end of the first extending member are manipulable to control movement of the clip between the insertion configuration, an initial deployment configuration and the review configuration (claim 7 of ‘445, which depends from claim 1 of ‘445)(As claim 7 of ‘445 claims a user interface, one of ordinary skill in the art would recognize that the user interface would enable a user to manipulate and control the movement of the clip.).
Regarding claim 42, ‘445 and Ho make obvious the system of claim 36.
‘445 further claims wherein a distal portion of the adapter, over which the clip is configured to be mounted, includes a flat portion extending along an exterior surface thereof corresponding to a desired orientation of the clip on the adapter (claim 10 of ‘445, which depends from claim 1 of ‘445).
Regarding claim 43, ‘445 and Ho make obvious the system of claim 36.
‘445 does not claim wherein the adapter includes a tab extending distally from a proximal end thereof to create a gap between a surface of the adaptor on which the clip is supported and an inner surface of the tab, wherein in the insertion configuration the first jaw of the clip is received in the gap.
Ho (Ho et al.) teaches a similar system (Figs. 2-5c) for treating tissue (abstract), comprising: an adapter (endoscope cap 1), the adapter configured to be mounted over a distal end of an insertion device (Paragraph 0022); a clip (4) configured to grip tissue (Paragraph 0033); a deployment member (thread 11) releasably coupled to the clip (Paragraphs 0032 and 0033) extending from a proximal end coupled to an actuator to a distal end (Paragraph 0029 and 0033), the deployment member being configured to move the clip distally off the adapter to the closed configuration and to retract the clip from the closed configuration onto the adapter in the insertion configuration (Paragraph 0033) and wherein the adapter includes a tab (9) extending distally from a proximal end thereof (Paragraphs 0025 and 0033) to create a gap between a surface of the adapter on which the clip is supported and an inner surface of the tab (see annotated Fig. 2 below), wherein in the insertion configuration the first jaw of the clip is received in the gap (see Fig. 2).
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It would have been obvious to one of ordinary skill in the art before the effective fling date to modify the adaptor as claimed by ‘445 to have a tab as taught by Ho, since Ho teaches that the tab prevents the clip from slipping further proximally when the endoscope is moving through the body (Paragraph 0013) and aids in holding the clip (Paragraph 0033).
Regarding claim 44, ‘445 and Ho make obvious the system of claim 43.
‘445 does not claim wherein the adapter defines a lumen which, when the adapter is mounted on an insertion instrument in a desired configuration, opens to a working channel of the insertion instrument, the deployment member being configured to extend through a hole in the tab proximally around the first jaw and into the adapter.
Ho (Ho et al.) teaches a similar system (Figs. 2-5c) for treating tissue (abstract), comprising: an adapter (endoscope cap 1), the adapter configured to be mounted over a distal end of an insertion device (Paragraph 0022); a clip (4) configured to grip tissue (Paragraph 0033); a deployment member (thread 11) releasably coupled to the clip (Paragraphs 0032 and 0033) extending from a proximal end coupled to an actuator to a distal end (Paragraph 0029 and 0033), the deployment member being configured to move the clip distally off the adapter to the closed configuration and to retract the clip from the closed configuration onto the adapter in the insertion configuration (Paragraph 0033) and wherein the adapter includes a tab (9) extending distally from a proximal end thereof (Paragraphs 0025 and 0033) and defines a lumen which, when the adapter is mounted on an insertion instrument in a desired configuration, opens to a working channel of the insertion instrument (see annotated Fig. 3 below)(Paragraphs 0022 and 0029), the deployment member being configured to extend through a hole (10) in the tab proximally around the first jaw and into the adapter (see annotated Fig. 4 below)(Paragraph 0028).
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It would have been obvious to one of ordinary skill in the art before the effective fling date to modify the adaptor as claimed by ‘445 to have the lumen and the deployment member extend through a hole in the tab as taught by Ho, since Ho teaches that this design enables the withdrawing means of the deployment ember to “exert sufficiently high displacing forces” when deploying the clip (Paragraph 0013).
Regarding claim 50, ‘445 teaches the system of claim 45.
‘445 does not claim wherein the adapter includes a tab extending distally from a proximal end thereof to create a gap between a surface of the adaptor on which the clip is supported and an inner surface of the tab, wherein in the insertion configuration the first jaw of the clip is received in the gap.
Ho (Ho et al.) teaches a similar system (Figs. 2-5c) for treating tissue (abstract), comprising: an adapter (endoscope cap 1), the adapter configured to be mounted over a distal end of an insertion device (Paragraph 0022); a clip (4) configured to grip tissue (Paragraph 0033); a deployment member (thread 11) releasably coupled to the clip (Paragraphs 0032 and 0033) extending from a proximal end coupled to an actuator to a distal end (Paragraph 0029 and 0033), the deployment member being configured to move the clip distally off the adapter to the closed configuration and to retract the clip from the closed configuration onto the adapter in the insertion configuration (Paragraph 0033) and wherein the adapter includes a tab (9) extending distally from a proximal end thereof (Paragraphs 0025 and 0033) to create a gap between a surface of the adaptor on which the clip is supported and an inner surface of the tab (see annotated Fig. 2 below), wherein in the insertion configuration the first jaw of the clip is received in the gap (see Fig. 2).
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It would have been obvious to one of ordinary skill in the art before the effective fling date to modify the adaptor as claimed by ‘445 to have a tab as taught by Ho, since Ho teaches that the tab prevents the clip from slipping further proximally when the endoscope is moving through the body (Paragraph 0013) and aids in holding the clip (Paragraph 0033).
Regarding claim 51, ‘445 and Ho make obvious the system of claim 50.
‘445 does not claim wherein the adapter defines a lumen which, when the adapter is mounted on an insertion instrument in a desired configuration, opens to a working channel of the insertion instrument, the deployment member being configured to extend through a hole in the tab proximally around the first jaw and into the adapter.
Ho (Ho et al.) teaches a similar system (Figs. 2-5c) for treating tissue (abstract), comprising: an adapter (endoscope cap 1), the adapter configured to be mounted over a distal end of an insertion device (Paragraph 0022); a clip (4) configured to grip tissue (Paragraph 0033); a deployment member (thread 11) releasably coupled to the clip (Paragraphs 0032 and 0033) extending from a proximal end coupled to an actuator to a distal end (Paragraph 0029 and 0033), the deployment member being configured to move the clip distally off the adapter to the closed configuration and to retract the clip from the closed configuration onto the adapter in the insertion configuration (Paragraph 0033) and wherein the adapter includes a tab (9) extending distally from a proximal end thereof (Paragraphs 0025 and 0033) and defines a lumen which, when the adapter is mounted on an insertion instrument in a desired configuration, opens to a working channel of the insertion instrument (see annotated Fig. 3 below)(Paragraphs 0022 and 0029), the deployment member being configured to extend through a hole (10) in the tab proximally around the first jaw and into the adapter (see annotated Fig. 4 below)(Paragraph 0028).
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It would have been obvious to one of ordinary skill in the art before the effective fling date to modify the adaptor as claimed by ‘445 to have the lumen and the deployment member extend through a hole in the tab as taught by Ho, since Ho teaches that this design enables the withdrawing means of the deployment ember to “exert sufficiently high displacing forces” when deploying the clip (Paragraph 0013).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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