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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19, 23, 31, 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Independent claims 16, 29 and 32 have been amended to recite that the biasing section of the device biases the tips of the legs away from each other. This limitation in combination with dependent claims 19, 23, 31, 34 which recite that the biasing section biases the legs towards each other was not disclosed in the original specification. There is no embodiment of the traction device wherein the legs are both biased towards and away from each other as is required by scope of claims 19, 23, 31, 34. Therefore claims 19, 23, 31, 34 constitute new matter.
Claims 19, 23, 31, 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Independent claims 16, 29 and 32 have been amended to recite that the biasing section of the device biases the tips of the legs away from each other. This limitation in combination with dependent claims 19, 23, 31, 34 which recite that the biasing section biases the legs towards each other was not disclosed in the original specification. However there is no feasible configuration wherein the legs can be biased both towards and away from each other as is required by scope of claims 19, 23, 31, 34. Considering the Wands Factors, and the question of Does the specification provide enough information so that one of ordinary skill in the art can make and/or use the full scope of the claimed invention without “undue experimentation”? it would appear impossible to one of ordinary skill to make a traction device which is both biased with the legs towards each other and away from each other. Therefore the subject matter of claims 19, 23, 31, 34 is not enabled by the disclosure.
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.
Claim(s) 16-18, 20-22, 25-26, 29, 30, 32, 33, 35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kass et al. (US Publication No. 2018/0235592 A1).
Regarding Claim 16, Kass discloses a tissue traction system [0175] comprising: a tissue traction device (10, Fig. 3) comprising a pair of legs (34, 34’) biased with respect to each other by a biasing section (11) [0129, 0100, 0176]; and a delivery shaft defining a lumen (“”delivery apparatus” and “surgical portal”) within which said tissue traction device is deliverable to a treatment site [0175]; wherein: said tissue traction device is shiftable between a delivery configuration (compressed, low profile , [0176]) and a deployment configuration (open, [0176]; said tissue traction device legs include tissue-engaging tips (29, 29’, Fig. 3) configured to engage tissue [0128]; said delivery shaft is configured to maintain said tissue traction device in the delivery configuration at least within the lumen of said delivery shaft [0175, see response to arguments below]; and in the deployment configuration, said biasing section of said tissue traction device biases said tissue-engaging tips of said tissue traction device legs away from each other [0176] (Fig. 50D) to cause said tissue traction device legs to exert traction on tissue through said tissue traction device legs to lift tissue away from a treatment site to facilitate access to the treatment site [0176].
Regarding Claim 17, the biasing section (11) joins the legs (34, 34’) together (Fig. 3).
Regarding Claim 18, Kass discloses the device as described in the rejection of claim 16 above. Kass discloses that the spring mechanism 16 making up the biasing section 11 can be a coil spring [0117].
Regarding Claim 20, wherein at least one of said tissue- engaging tips (29, 29’) extends from one of said legs (34, 34’) transverse to said one of said legs and in a direction in which said biasing section biases said one of said legs (shown by solid arrows below).
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Regarding Claim 21, said at least one of said tissue- engaging tip (29, 29’) extends from a free end of said one of said legs (34, 34’) (shown above).
Regarding Claim 22, said biasing section (11) biases said legs (34, 34’) of said tissue traction device away from each other [0176], and a tissue-engaging tip (29, 29’) extends from a free end of each of said legs in a direction away from the other of said legs (shown in figure above).
Regarding Claim 25, further comprising a pusher (handle of delivery apparatus disclosed in [0175]) to push the device out of the delivery shaft (handle facilitates movement of device 10 through portal, i.e. through lumen).
Regarding Claim 26, the pusher (handle) is separable coupled with the device (10) (“device 10 is mounted onto delivery apparatus separately from being passed through portal as described in [0175]).
Regarding Claim 29, Kass discloses a tissue traction device (10, Fig. 3) comprising a pair of legs (34, 34’) biased with respect to each other by a biasing section (11) [0129, 0100], wherein: said tissue traction device (10) is shiftable between a delivery configuration (compressed shown in Fig. 50C) in which said tissue traction device is fully capable of being delivered through a lumen of a delivery shaft (the compressed device can slide through a tube of appropriate size like the portal described in [0175]), and a deployment configuration (shown in Fig. 50D) in which said biasing section of said tissue traction device biases said tissue-engaging tips of said tissue traction device legs away from each other [0176] (Fig. 50D) to cause said tissue traction device legs to exert traction on tissue to lift the tissue away from a treatment site to facilitate access to the treatment site [0181]; and at least one of said tissue traction device legs includes a tissue-engaging tip (29, 29’) configured to engage tissue and extending from a free end of said at least one of said legs and transverse to said at least one of said legs [0128] (Fig. 3).
Regarding Claim 30, said biasing section (11) biases said legs (34, 34’) of said tissue traction device away from each other(“open state”, [0100-0101]), and said tissue-engaging tip extends from a free end of said at least one of said tissue traction device legs in a direction away from the other of said tissue traction device legs (shown in Fig. 3-4) [0110].
Regarding Claim 32, Kass discloses a method of applying traction to tissue to draw the tissue away from a treatment site to allow unimpeded access to the treatment site, said method comprising: delivering a tissue traction device (10, Fig. 3) through a lumen defined thorough a delivery shaft (“portal” [0175]) (“Through a surgical portal smaller than the expanded device” is disclosure of the portal having a lumen/opening/channel which is smaller than the expanded device. ), the tissue traction device having a pair of legs (34, 34’) biased with respect to each other by a biasing section (11) [0100-0101, 0110] to the treatment site (fig. 50c);
engaging a tissue-engaging portion (29, 29’) extending from one of the pair of legs of the tissue traction device with tissue to be drawn away from the treatment site (fig. 50C);
engaging a tissue-engaging portion extending from the other of the pair of legs with tissue separate from the tissue to be drawn away from the treatment site (29 on top surface will engage skin flap in Fig. 50C while 29 on bottom surface will engage underlying tissue in Fig. 50C); and
allowing the biasing section to exert a biasing force to bias the tissue-engaging tips of the tissue traction device legs away from each other (Fig. 50D) to apply traction to lift the tissue away from the treatment site to facilitate access to the treatment site [0110].
Regarding Claim 33, wherein: engaging a tissue-engaging portion of the other of the pair of legs comprises engaging the tissue- engaging portion of the other of the pair of legs with tissue at the treatment site and cut with respect to the tissue to be drawn away from the treatment site (Fig. 50C-D); and allowing the biasing section (11) to exert a biasing force comprises allowing the legs to be moved apart from each other by the biasing section [0110].
Regarding Claim 35, wherein engaging a tissue- engaging portion of at least one of the legs with tissue comprises engaging the tissue-engaging portion with tissue in a direction in which the biasing section exerts a biasing force with respect to the leg from which the tissue-engaging portion extends (shown engaged in Fig. 50C-D, direction shown by solid arrows below).
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Claim Rejections - 35 USC § 103
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.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kass et al. (US Publication No. 2018/0235592 A1) in view of Hester et al. (US Publication No. 2013/0331839 A1).
Regarding Claim 27, Kass discloses the device as described in the rejection of claim 16 above. Kass discloses the traction device (10) can be loaded into a delivery apparatus to facilitate the device's insertion [0175] and a plurality of devices (10) may be compressed and introduced at spaced apart locations to assist the medical professional with retraction and propping of the skin flap as the surgical operation continues [0179, 0184-0186]. However, Kass is silent to the configuration where a plurality of tissue traction devices are maintained in delivery configurations within the lumen of said delivery shaft for delivery to a treatment site.
Hester discloses a device for deploying a surgical fastener in the analogous art of minimally invasive surgical deployment devices which is configured to deliver multiple surgical devices (fasteners) one after another and holds them in a compressed (delivery) configuration within the lumen of the deployment device so that the pusher of the tool can sequentially insert the devices without needed to be moved away from the patient [0066, 0069].
It would have been obvious to one having ordinary skill in the art before the effective filing date to configure the delivery apparatus with multiple compressed devices of Kass in order to insert the plurality of compressed devices with a single tool and pusher without needing constantly pull the tool away from the patient as taught by Hester.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kass et al. (US Publication No. 2018/0235592 A1) in view of Wales et al. (US Publication No. 2018/0279869 A1)
Regarding Claim 24, Kass discloses the device as described in the rejection of claim 16 above. However, Kass is silent to the tips of the device being positioned within a seat in the delivery shaft.
Wales discloses a traction system in the same field of endeavor comprising a biased traction device (302) with legs and tissue engaging tips (306) seated within a delivery instrument (316+308). The tips of the traction device (306) are positioned within a seat (dedicated space 314) in the delivery shaft (Fig. 3A-3C) [0049] for the purpose of accommodating the shape of the tips while being pushed through the delivery device. It would have been obvious to one having ordinary skill in the art before the effective filing date to modify the delivery shaft of Kass to include a seat (dedicated space) for the tips as taught by Wales in order to accommodate the shape of the tips during translation of the traction device via the delivery device.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kass et al. (US Publication No. 2018/0235592 A1) in view of Sharma (US Publication No. 2021/0205006 A1).
Regarding Claim 28, Kass discloses the device as described in the rejection of claim 16 above. However, Kass is silent to the system further comprising an endoscope having a working channel, said delivery shaft configured for delivery to a treatment site through the working channel of said endoscope.
Sharma discloses a traction system in the same field of endeavor comprising : a tissue traction device (100, Fig. 1) comprising a pair of legs (see below) biased with respect to each other by a biasing section (104) [0071] (fig. 1); and a delivery shaft (deployment catheter 105) [0070] (fig. 1) defining a lumen (106) within which said tissue traction device is deliverable to a treatment site [0070]. Sharma teaches the system further comprising an endoscope having a working channel, said delivery shaft configured for delivery to a treatment site through the working channel of said endoscope (“ In some embodiments, the deployment catheter is passed through a channel of an endoscope”, [0103]).
It would have been obvious to one having ordinary skill in the art before the effective date of the claimed invention to configure the delivery shaft of Kass to be used through a working channel of an endoscope and include an endoscope in the system as taught by Sharma in order to use a visualization tool during placement of the traction device allowing the appropriate positioning of the traction device.
Response to Arguments
Applicant’s amendments have overcome the previous ground of rejection under 35 USC 102(a)(1) as anticipated by Sharma (US Publication No. 2021/0205006). Applicant's arguments filed 3/23/2026 with regards to the rejection under 35 USC 102(a)(1) as anticipated by Kass (US Publication No. 2018/0235592) have been fully considered but they are not persuasive.
Applicant argues that Kass does not disclose a delivery shaft which has a lumen within which device 10 is deliverable and that the surgical portal disclosed by Kass is not description of a lumen of a delivery shaft. This is not found persuasive because a surgical portal necessarily has a lumen. This is an inherent feature of a surgical portal and implicitly referred to by Kass. Kass discloses that “the device 10 can be compressed into a smaller initial form and mounted onto a delivery apparatus such as a long handle or other gripping apparatus, for example, to facilitate the introduction of the device 10 through a surgical portal that is smaller than the expanded (device 10 in a non-closed state) device 10.” [0175]. “Through a surgical portal smaller than the expanded device” is disclosure of the portal having a lumen/opening/channel which is smaller than the expanded device. This lumen through which the compressed device is delivered would be able to keep the device 10 in a compressed condition since the lumen is smaller than the expanded form of the device. Further, the delivery shaft as mapped is not purely the portal with small lumen, it is the combination of the portal and the delivery apparatus. The delivery apparatus also functions to maintain the device 10 in delivery configuration (compressed state) within the lumen (the opening/channel of the portal), stated in the disclosure as “mounted onto a delivery apparatus such as a long handle or other gripping apparatus, for example, to facilitate the introduction of the device 10 through a surgical portal that is smaller than the expanded (device 10 in a non-closed state) device 10.”
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773
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