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 .
Response to Amendment
Examiner acknowledges the reply filed 09/30/2025. Claims 1, 9 and 21 were amended. Claim 22 was newly added. The amendment was accompanied by Remarks, the contents of which are addressed in the Response to Arguments section of this Office action.
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 1, 2, 4, 5, and all claims depending therefrom 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.
Regarding claim 1, the limitation “piercing a portion of the target tissue with the second treatment end at a position adjacent to the target tissue; [and] while the second treatment end is positioned adjacent to the target tissue, advancing the first treatment end from the treatment end of the surgical device” recites new matter because the original specification does not describe advancing the first treatment end from the treatment end of the surgical device prior to piercing the target tissue (which would be required in order for the advancing to occur while the second treatment end is positioned “adjacent to the target tissue” and not within the target tissue).
Regarding claim 2, the limitation “applying devascularizing material to a surface of the target tissue” recites new matter because the invention recited in claim 1 (upon which claim 2 depends) includes structure that, based on the specification, would not be able to apply devascularizing material to a surface of the target tissue. The invention recited in claim 1 appears to correspond to the embodiment shown in Figs. 4A-4C, which does not include a structure that applies devascularizing material to the surface of target tissue.
Regarding claims 4 and 5, the limitations “prior to administering the devascularizing material, the method further includes: advancing a containment device from a collapsed position to a deployed position; and positioning the containment device, in the deployed position, around the target tissue to be treated” and “wherein the treatment end further includes an application shaft having an elongated body and a nozzle positioned at a distal end of the elongated body; wherein administering the devascularizing material includes delivering the devascularizing material through the nozzle to the target tissue” recite new matter because the invention recited in claims 1 and (upon which claims 4 and 5 depend) includes structure that, based on the specification, would not include a containment device and a nozzle. The invention recited in claim 1 appears to correspond to the embodiment shown in Figs. 4A-4C, which does not include a containment device or a nozzle.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and all claims depending therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “while the second treatment end is positioned adjacent to the target tissue, advancing the first treatment end from the treatment end of the surgical device” is indefinite because it follows the step of “piercing a portion of the target tissue with the second treatment end at a position adjacent to the target tissue”; however, after the target tissue is pierced with the second treatment end, the second end treatment would no longer be “adjacent to the target tissue”—it would be within the portion of the target tissue.
Thus, the intended order of steps (to the extent that there is a prescribed order) would have been unclear to a person having ordinary skill in the art at the time of the invention. A person of ordinary skill in the art may interpret the claim so that the step of “while the second treatment end is positioned adjacent to the target tissue, advancing the first treatment end from the treatment end of the surgical device” occurs before “piercing a portion of the target tissue with the second treatment end at a position adjacent to the target tissue”. But because the former step appears in the claim after the latter step, it raises a question of whether this interpretation is consistent with Applicant’s intent.
See Claim Rejections - 35 USC § 103 for an explanation of how these limitations are interpreted for the purpose of examination.
Claim Rejections - 35 USC § 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.
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.
Claims 1, 2, 3, 6 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bagwan et al (U.S. Pub. 2016/0199045 A1, hereinafter “Bagwan”) in view of Basu et al (U.S. Pat. 9,539,410 B2, hereinafter “Basu”).
Regarding claim 1, Bagwan discloses a method for treating a target tissue, e.g., 405 (see Fig. 4a), the method comprising:
introducing a portion of a surgical device 100 into a patient (see para [0042]), the surgical device having a treatment end (the area of the device distal to the locator flange 135-2; see Fig. 3a);
positioning the treatment end of the surgical device adjacent to the target tissue 405 (see Fig. 4a);
wherein the treatment end includes:
a first treatment end (distal end of 155; see Fig. 4A), the first treatment end is configured to be extended from a portion of the treatment end (such as the distal end of the cannula 145) towards the target tissue (see para [0029], disclosing that the first treatment end 155 may be free to move relative to the cannula 145; see also Figs. 3a-3b showing this movement);
wherein the first treatment end includes a sharp distal tip (see Fig. 3a); and
a second treatment end, e.g., the end of the cannula 145 (see Fig. 3a) positioned along a longitudinal axis of the treatment end, the second treatment end adjacent to the first treatment end (see Fig. 3a);
wherein the second treatment end includes a sharp distal end configured to pierce the target tissue (see para [0029] disclosing that the cannula protrudes into tissue);
positioning the second treatment end adjacent to the target tissue (see para [0043] disclosing that the cannula 145 is pushed inside the body to reach the target tissue, which implicitly requires positioning the second treatment end adjacent to the target issue before the cannula 145 is pushed inside the body);
piercing a portion of the target tissue with the second treatment end at a position adjacent to the target tissue (see para [0043] disclosing that the cannula 145 is pushed inside the body, to reach the target tissue);
while the second treatment end is positioned adjacent to the target tissue (interpreted to during or after piercing a portion of the target tissue with the second treatment end at a position adjacent to the target tissue, because the second treatment end has already pierced the target tissue), advancing the first treatment end from the treatment end of the surgical device (see para [0044], disclosing that the plunger 120 moves the secondary component 155 forward to push it inside the target site 405, which is understood to require the first treatment end to be advanced from the surgical device treatment end);
inserting the sharp distal tip of the first treatment end into the target tissue (a continuation of the previous step; the secondary component 155 is “pushed inside the target site”);
and administering a devascularizing material with at least one of the first treatment end or the second treatment end to the target tissue(see para [0045], disclosing the delivery of material with the treatment end; and see para [0021] disclosing that the material may be a devascularizing material such as fibrin glue or cyano-acrylate).
It is noted that Bagwan does not appear to disclose that the first treatment end offset from a longitudinal axis of the surgical device.
Basu discloses a device for delivering a material to a target tissue, comprising a treatment end which has a first treatment end (the distal end of a delivery needle 420) and a second treatment end (the distal end of the auxiliary needle 450), wherein the first can either be coaxial with the second treatment end (thus coaxial with the longitudinal axis of the surgical device) or alternatively, radially offset from the second treatment end device (thus radially offset from the longitudinal axis of the surgical device); see col. 13, lines 32-43.
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Bagwan, so that the first treatment end is offset from a longitudinal axis of the surgical device, as taught in Basu, in order to vary the flow characteristics of the material delivered from the treatment end as may be desirable, and to account for normal manufacturing tolerances (see Basu at col. 13, lines 38-43), with a reasonable expectation of success.
Regarding claim 2, Bagwan, in view of Basu, discloses that administering the devascularizing material includes injecting the devascularizing material into the target tissue (see Bagwan at para [0045]).
Regarding claim 3, Bagwan, in view of Basu, discloses that the devascularizing material includes a cyanoacrylate (see Bagwan at para [0021]).
Regarding claim 6, Bagwan, in view of Basu, discloses that when the administering the devascularizing material includes injecting the devascularizing material directly into the target tissue, the method includes: advancing an injection needle from an outer shaft 205 (see Fig. 2a) and into the target tissue.
Regarding claim 22, Bagwan discloses a method for treating a target tissue, e.g., 405 (see Fig. 4a), the method comprising:
introducing a portion of a surgical device 100 into a patient (see para [0042]), the surgical device having an outer shaft 145 including a treatment end (the area of the device distal to the locator flange 135-2; see Fig. 3a);
positioning the outer shaft adjacent to the target tissue 405 (see Fig. 4a);
the outer shaft including a bore extending along a body of the outer shaft, the bore including an opening within a distal portion of the outer shaft (such as the bore of the through which 155 is inserted);
the treatment end including:
a first treatment end (distal end of 155; see Fig. 4A), the first treatment end is disposed within the bore and configured to be extended from a portion of the treatment end (such as the distal end of the cannula 145) towards the target tissue (see para [0029], disclosing that the first treatment end 155 may be free to move relative to the cannula 145; see also Figs. 3a-3b showing this movement);
wherein the first treatment end includes a sharp distal tip (see Fig. 3a); and
a second treatment end, e.g., the end of the cannula 145 (see Fig. 3a) positioned along a longitudinal axis of the treatment end, the second treatment end adjacent to the first treatment end (see Fig. 3a);
wherein the second treatment end includes a sharp distal end configured to pierce the target tissue (see para [0029] disclosing that the cannula protrudes into tissue);
advancing one of the first treatment end or second treatment end from the treatment end (see para [0043] disclosing that the cannula 145 is pushed inside the body to reach the target tissue, which implicitly requires positioning the second treatment end adjacent to the target issue before the cannula 145 is pushed inside the body);
piercing a portion of the target tissue with the second treatment end at a position adjacent to the target tissue (see para [0043] disclosing that the cannula 145 is pushed inside the body, to reach the target tissue);
inserting the sharp distal tip of the first treatment end into the target tissue (see para [0044], disclosing that the plunger 120 moves the secondary component 155 forward to push it inside the target site 405, which is understood to require the first treatment end to be advanced from the surgical device treatment; then the secondary component 155 is “pushed inside the target site”);
and administering a devascularizing material with at least one of the first treatment end or the second treatment end to the target tissue (see para [0045], disclosing the delivery of material with the treatment end; and see para [0021] disclosing that the material may be a devascularizing material such as fibrin glue or cyano-acrylate).
It is noted that Bagwan does not appear to disclose that the bore if offset from a longitudinal axis of the surgical device.
Basu discloses a device for delivering a material to a target tissue, comprising an outer shaft (auxiliary needle 450) and a bore, through which a delivery needle 420 can be inserted, that is radially offset from the longitudinal axis of the outer shaft (thus radially offset from the longitudinal axis of the surgical device; see col. 13, lines 32-43).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Bagwan, so that the bore is offset from a longitudinal axis of the surgical device, as taught in Basu, in order to vary the flow characteristics of the material delivered from the treatment end as may be desirable, and to account for normal manufacturing tolerances (see Basu at col. 13, lines 38-43), with a reasonable expectation of success.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Bagwan, in view of Basu, further in view of Mickley et al (U.S. Pub. 2010/0145306 A1, hereinafter “Mickley”).
Regarding claims 4 and 5, Bagwan does not appear to disclose:
prior to administering the devascularizing material, the method further includes:
advancing a containment device from a collapsed position to a deployed position;
and positioning the containment device, in the deployed position, around the target tissue to be treated (as per claim 4); and
wherein the treatment end further includes an application shaft having an elongated body and a nozzle positioned at a distal end of the elongated body;
wherein administering the devascularizing material includes delivering the devascularizing material through the nozzle to the target tissue (as per claim 5).
Mickley discloses a device for delivering material to a target tissue, comprising method steps of prior to administering the material, advancing a containment device, e.g., 16 (see also containment devices 34, 44, 54, 75/76 or 86/87/88) from a collapsed position (see Fig. 1A) to a deployed position (see Fig. 1B);
and positioning the containment device, in the deployed position, around the target tissue to be treated (see para [0030] disclosing that the containment device 16 can be further expanded by compressing it against the tissue surface; and see para [0032] disclosing that after positioning the containment device on the target tissue, the agent is then delivered to the target tissue through an injection needle 20).
Further, regarding claim 5, Mickley discloses that the treatment end further includes an application shaft 14 (see Fig. 1C) having an elongated body and a nozzle (the aforementioned containment device 16) positioned at a distal end of the elongated body;
wherein administering the material includes delivering the material through the nozzle to the target tissue (the material is delivered within the needle 20 which extends through the nozzle; therefore, the material is delivered “through the nozzle”).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Bagwan, in view of Basu, to perform the method steps recited in claims 4 and 5, based on the teaching in Mickley that these features would be useful for providing a larger surface area over which the device engages the tissue, with a reasonable expectation of success in reducing traumatic injury to the tissue (see Mickley at paras [0004], [0022] and [0023]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bagwan, in view of Basu, further in view of Hoffman et al (U.S. Pub. 2014/0276051 A1, hereinafter “Hoffman”).
Regarding claim 7, it is noted that Bagwan, in view of Basu, does not appear to disclose that the administering the devascularizing material includes a plurality of injections into the target tissue, and wherein each injection of the plurality of injections includes administering an amount of the devascularizing material.
Hoffman discloses a method of administering material into a target tissue, comprising extending a treatment end into the tissue and then administering devascularizing material as a plurality of injections (such as by injecting the material through multiple holes or slits in a needle; see para [0149]).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Bagwan, in view of Basu, so that the administering the devascularizing material includes a plurality of injections into the target tissue, and wherein each injection of the plurality of injections includes administering an amount of the devascularizing material, in order can facilitate fluid communication between the treatment end lumen and the tissue into which the treatment end is deployed, with a reasonable expectation of success (see Hoffman at para [0149]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bagwan, in view of Basu, further in view of Lanphere et al (U.S Pat. 7,963,287 B2, hereinafter “Lanphere”).
Regarding claim 8, it is noted that Bagwan, in view of Basu, does not appear to disclose that the target tissue is uterine tissue that includes a uterine abnormality.
However, Bagwan teaches that its device is useful for diagnosing and treating various health conditions such as those associated with the liver, stomach, kidneys, or other areas where malignant or benign tumors may appear (see para [0002]). Bagwan teaches that its device is suitable to perform a medical procedure in a highly vascularized organ (e.g., spleen, kidneys, brain and lungs; see para [0003]).
Lanphere also teaches a device for having a similar structure of a treatment end that is used to puncture and deliver material to the target tissue, and teaches that the target tissue can be cancerous tissue or healthy tissue such as bodily vessel tissue, bladder tissue, bone tissue, brain tissue, breast tissue, bronchi tissue, diaphragm tissue, esophagus tissue, gall bladder tissue, heart tissue, intestine tissue, kidney tissue, larynx tissue, liver tissue, lung tissue, lymph vessel tissue, lymph node tissue, nerve tissue, ovary tissue, pancreas tissue, prostate tissue, skin tissue, stomach tissue, and thyroid tissue, trachea tissue, urethra tissue, ureter tissue, uterus tissue, and vertebral disc tissue.
A skilled artisan would understand that the uterus is a location where abnormal conditions commonly arise, and that it is a highly vascularized organ, and accordingly, would have found it suitable to perform the method of Bagwan in uterine tissue to treat the abnormal condition, with a reasonable expectation of success.
Moreover, in light of the teaching in Lanphere of a similar treatment device used to treat health conditions in many types of tissue including the uterus, a skilled artisan would have found it obvious to try performing the method in a uterine tissue to treat a uterine abnormality; doing so would have amounted to choosing from a finite number of identified, predictable locations for tissue treatment with a reasonable expectation of success.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Bagwan, in view of Basu, further in view of Rajagopalan et al (U.S. Pub. 2017/0007310 A1, hereinafter “Rajagopalan”).
Regarding claim 9, it is noted that Bagwan, in view of Basu, does not appear to disclose that prior to positioning the surgical device adjacent to the target tissue, the method includes distending a body cavity with a distension member.
Rajagopalan discloses a method of delivering a material to a target tissue using a surgical device, and prior to positioning the surgical device adjacent to the target tissue, distending a body cavity with a distension member (see para [0131], disclosing that delivery of insufflation fluids can be performed to manipulate tissue, such as to distend and/or elongate tissue).
A skilled artisan would have found it obvious at the time of the invention to modify the invention of Bagwan, in view of Basu, so that prior to positioning the surgical device adjacent to the target tissue, the method includes distending a body cavity with a distension member, in order to manipulate the tissue to improve delivery of the material, with a reasonable expectation of success (see Rajagopalan at para [0131]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Van Oepen et al (U.S. Pat. 7,942,854, hereinafter “Von Oepen”) in view of Lanphere, further in view of Bagwan.
Regarding claim 21, Von Oepen discloses a method for treating a target tissue, the method comprising:
introducing a portion of a surgical device into a patient, the surgical device having a treatment end;
positioning an outer shaft 116-D (catheter shaft 2 having a catheter distal section 114 with a distal catheter shaft 116-D; see Fig. 5) of the treatment end of the surgical device adjacent to the target tissue, the treatment end including:
an introducer shaft 50 (see Fig. 8A-8B) translatably positioned within the outer shaft;
a first extendable treatment end 30 (see Fig. 8A-8B) including a needle configured to be advanced from the introducer shaft; and
a second treatment end 20 (see Fig. 8B) positioned at a distal portion of the introducer shaft and along a longitudinal axis of the outer shaft (see Figs. 8A-8B);
the second treatment end including a sharp end portion (see Figs. 8A-8B), the second treatment end is arranged adjacent to the first extendable treatment end (see Fig. 8B);
translating the introducer shaft from the outer shaft (see Fig. 8B showing the introducer shaft moved relative to its position in Fig. 8A);
penetrating the target tissue with the second treatment end (see col. 13, lines 35-38);
while penetrating the target tissue with the second treatment end, advancing the first extendable treatment end from the introducer shaft (see col. 13, line 39; the advancement occurs while the second treatment end is anchored in the tissue);
extending the first extendable treatment end from the outer shaft (this movement occurs at the same time as the first extendable treatment end is advanced from the introducer shaft);
piercing the target tissue with the first extendable treatment end and injecting a material to the target tissue through the first extendable treatment end (see col. 13, lines 39-40, disclosing that the prescribed dose of the agent is injected into the tissue, which requires the tissue to be pierced with the first extendable treatment end as it exits the second treatment end, as shown in Fig. 8B).
It is noted that Von Oepen does not disclose that the introducing step comprises introducing the device into a uterus of a patient, and the injection of material is a devascularizing material.
Lanphere teaches a device for having a similar structure of a treatment end that is used to puncture and deliver material to the target tissue, and teaches that the target tissue can be cancerous tissue or healthy tissue such as bodily vessel tissue, bladder tissue, bone tissue, brain tissue, breast tissue, bronchi tissue, diaphragm tissue, esophagus tissue, gall bladder tissue, heart tissue, intestine tissue, kidney tissue, larynx tissue, liver tissue, lung tissue, lymph vessel tissue, lymph node tissue, nerve tissue, ovary tissue, pancreas tissue, prostate tissue, skin tissue, stomach tissue, and thyroid tissue, trachea tissue, urethra tissue, ureter tissue, uterus tissue, and vertebral disc tissue.
A skilled artisan would understand that the uterus is a location where abnormal conditions commonly arise, and that it comprises tissue that would benefit from injection of therapeutic material, and accordingly, would have found it suitable to perform the method of Von Oepen in uterine tissue to treat the abnormal condition, with a reasonable expectation of success.
Moreover, in light of the teaching in Lanphere of a similar treatment device used to treat health conditions in many types of tissue including the uterus, a skilled artisan would have found it obvious to try performing the method in a uterine tissue to treat a uterine abnormality; doing so would have amounted to choosing from a finite number of identified, predictable locations for tissue treatment with a reasonable expectation of success.
Further, Bagwan discloses a method for treating a target tissue, e.g., 405 (see Fig. 4a), the method comprising:
introducing a portion of a surgical device 100 into a patient (see para [0042]), the surgical device having a treatment end (the area of the device distal to the locator flange 135-2; see Fig. 3a);
positioning the treatment end of the surgical device adjacent to the target tissue 405 (see Fig. 4a);
and administering a devascularizing material with at least one of the first treatment end or the second treatment end to the target tissue, wherein the devascularizing material is able to devascularize the target tissue (see para [0045], disclosing the delivery of material with the treatment end; and see para [0021] disclosing that the material may be a devascularizing material such as fibrin glue or cyano-acrylate).
A skilled artisan would understand that the uterus is a location where abnormal conditions commonly arise, and that it comprises tissue that would benefit from injection of devascularizing material depending on the condition, and accordingly, would have found it obvious to administer the devascularizing material using the device of Van Oepen in uterine tissue with a reasonable expectation of success. Specifically, Van Oepen teaches that its device is suitable for delivering “a wide range of therapeutic agent or biologic such as cells, drugs or other fluids”. A skilled artisan would have a reasonable expectation of success delivering devascularizing agent in place of the agents already disclosed in Van Oepen.
Response to Arguments
Applicant's arguments filed 09/30/2025 have been fully considered.
The Rejection of Claims Under § 112
Applicant argued that the rejection of claims 2 and 13 under 35 U.S.C. 112(a) is improper because claims 2 and 13 “do not necessarily ‘correspond to the embodiment shown in Figs. 4A-4C’ as alleged in the Office Action” (see Remarks, pg. 11).
Initially, it is noted that the present Office Action removes consideration of claim 13 because claim 13 has been withdrawn.
Applicant’s argument, regarding claim 2, is not found persuasive because claim 1, upon which claim 2 depends, necessarily corresponds to the embodiment shown in Figs. 4A-4C, and there is no written support for the embodiment of the device shown in Figs. 4A-4C being used to apply devascularizing material to the surface of target tissue.
Applicant then argued that para [0054]1 of the present application provides support for claim 2 (see Remarks, pg. 10); but it is not clear how this disclosure would support the limitation of claim 2 specifically requiring “applying the devascularizing material to a surface of the target tissue”.
Applicant then argued that para [0032]2 discloses that “Treatment end 36 can comprise an introducer shaft 38 and an injection needle” (see Remarks, pg. 11). However, this disclosure relates to Fig. 2, not Figs. 4A-4C.
Applicant then argued that para [0037]3 discloses that “treatment end 62 can apply the treatment material directly to the surface of the target tissue” (see Remarks, pg. 11). However, this disclosure relates to Fig. 3, not Figs. 4A-4C.
Applicant argued that the rejection of claims 4 and 5 under 35 U.S.C. 112(a) is improper for substantially the same reasons as discussed with respect to claim 2 (see Remarks, pg. 11). But as noted above, the portions of Applicant’s specification relate to different embodiments than those that cover the invention recited in claim 1.
The Rejection of Claims Under § 103
Applicant argued that cannula 145 of Bagwan does not pierce the target tissue with its second treatment end while the second treatment end is positioned adjacent to the target tissue, and advancing the first treatment end from the treatment end (see Remarks, pgs. 12-13). Applicant cited para [0029] of Bagwan (see Remarks, pg. 13), but Applicant did not clearly set forth how this disclosure distinguishes the claimed invention from Bagwan.
Applicant then argued that a skilled artisan would not have looked to Basu to modify Bagwan based on a teaching of Bagwan at para [0015] (see Remarks, pg. 14). But Applicant did not clearly set forth how this disclosure distinguishes the claimed invention from Bagwan, or why a skilled artisan would not have sought to modify the first treatment end to be offset from a longitudinal axis of the surgical device.
Applicant argued that claims 4, 5, 7, 8 and 9 were patentable based on claim 1, but were otherwise not argued on their merits (see Remarks, pgs. 14-15).
Regarding claim 21, Applicant argued that Van Oepen does not disclose a first extendable treatment end advanced from an introducer shaft; instead, a needle 20 is advanced from first extendable treatment end (needle 30; see Remarks, pg. 16).
This argument is not found persuasive because Van Oepen discloses a first extendable treatment end 30 (see Fig. 8A-8B) including a needle configured to be advanced from the introducer shaft; and a second treatment end 20 (see Fig. 8B) positioned at a distal portion of the introducer shaft and along a longitudinal axis of the outer shaft (see Figs. 8A-8B). Van Oepen further discloses penetrating the target tissue with the second treatment end (see col. 13, lines 35-38), and while penetrating the target tissue with the second treatment end, advancing the first extendable treatment end from the introducer shaft (see col. 13, line 39; the advancement occurs while the second treatment end is anchored in the tissue).
For these reasons, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
01/20/2026
1 Applicant appears to cite paragraph numbers from the published application, U.S. PG Pub. US20210187261A1.
2 See note 1, above.
3 See note 1, above.