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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/22/2026 has been entered.
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.
Claims 4, 5, and all claims depending therefrom are rejected under 35 U.S.C. 112(a), 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 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 claim 1 (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 claims 1, 4 and 5 corresponds 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.
Claim 6, 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 6, the limitation "The method of claim 1, including an outer shaft including a lumen…" is indefinite because it is not known what specific structure "includes" the claimed outer shaft.
For the purpose of examination, the claim will be interpreted to mean that the surgical device includes the outer shaft.
Claim 6 also recites "wherein the first treatment end is a distal portion of a needle…" but a needle was previously recited in the claim (i.e., "a needle extending within the introducer shaft". It is not clear if the recitation "wherein the first treatment end is a distal portion of a needle" refers back to the previously recited needle or to a new needle. For the purpose of examination, the former interpretation will be applied (referring back to the previously recited needle).
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 the longitudinal axis of the surgical device, the second treatment end including a lumen extending along a distal portion of the surgical device and adjacent to the first treatment end (see Fig. 3a, showing the lumen at the end of the cannula 145 being adjacent to the distal tip 155);
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);
wherein the first treatment end is configured to extend from the lumen of the second treatment end beyond the sharp distal end of the second treatment end (see Fig. 3a, showing the first treatment end 155 extending from the cannula 145),
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);
advancing the first treatment end from the treatment end of the surgical device toward a location distal of the sharp distal end of the second treatment end (see para [0044], disclosing that the plunger 120 moves the secondary component 155 forward to push it inside the target site 405, which is "toward" a location distal of the sharp distal end; it is noted that the claim does not require that the first treatment end be advanced to any particular location distal of the sharp distal end of the second 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 discloses the method including an outer shaft 105 (see Fig. 3a) including a lumen and an opening along a distal portion of the outer shaft, an introducer shaft 145 (see Fig. 3a) extending within the outer shaft, and a needle (distal end of 155; see Fig. 4A) extending within the introducer shaft;
wherein the introducer shaft includes a bore, the bore configured to translatably retain the needle (such as the opening of shaft 145 through which 155 extends);
wherein the first treatment end is a distal portion of a needle (distal end of 155; see Fig. 4A), and the second treatment end is a distal portion of an introducer shaft (distal portion of the end of the cannula 145; see Fig. 3a), the first treatment end is arranged parallel to the second treatment end (see Fig. 3a),
wherein the second treatment end is configured to pierce a portion of tissue adjacent to the target tissue and the first treatment end is configured to pierce a portion of the target tissue (see Fig. 3a, showing the lumen at the end of the cannula 145 being adjacent to the distal tip 155);
wherein, when the administering the devascularizing material includes injecting the devascularizing material with the first treatment end directly into the target tissue, the method includes:
advancing an injection needle from the introducer shaft and into 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 introducer shaft includes a bore offset from a longitudinal axis of the introducer shaft.
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 introducer shaft includes a bore offset from a longitudinal axis of the introducer shaft., 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 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 105 including an introducer shaft 145 that includes 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 introducer shaft 145 including a bore extending along a body of the introducer shaft 145, the bore including a bore opening formed along a distal end portion of the introducer shaft (such as the opening of shaft 145 through which 155 extends);
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 portion configured to pierce the target tissue (see para [0029] disclosing that the cannula protrudes into tissue),
wherein the first treatment end is configured to extend from the lumen of the second treatment end beyond the sharp distal end of the sharp distal end portion (see Fig. 3a, showing the first treatment end 155 extending from the cannula 145);
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 is offset from a longitudinal axis of the introducer shaft.
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 Bagwan, in view of Lanphere.
Regarding claim 21, Bagwan discloses a method for treating a target tissue, 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 an outer shaft 105 including the treatment end adjacent to the target tissue 405 (see Fig. 4a), the treatment end including:
an introducer shaft 145 including a lumen, the introducer shaft translatable positioned within the outer shaft (see Figs. 3a-3b showing this movement);
a first extendable treatment end (distal end of 155; see Fig. 4A) including a needle (see Fig. 3a) configured to be extended from a portion of the treatment end (such as the distal end of the cannula 145; see also para [0029], disclosing that the first treatment end 155 may be free to move relative to the cannula 145);
a second treatment end, e.g., the end of the cannula 145 (see Fig. 3a) positioned along a longitudinal axis of the treatment end, wherein the second treatment end includes a sharp end portion (see para [0029] disclosing that the cannula protrudes into tissue), and the second treatment end adjacent to the first treatment end (see Fig. 3a);
translating the introducer shaft from the outer shaft (see para [0043] disclosing that the cannula 145 is pushed inside the body to reach the target tissue, which implicitly requires translating it from the outer shaft);
penetrating the target tissue with the second treatment (see para [0043] disclosing that the cannula 145 is pushed inside the body, to reach the target tissue);
while penetrating the target tissue with the second treatment end, advancing the first extendable treatment end from the introducer shaft and distally beyond the sharp end portion of the second treatment end (see para [0043] disclosing that the cannula 145 is pushed inside the body, to reach the target tissue);
extending the first extendable treatment end from the outer shaft and distally beyond the sharp end portion of the second treatment end (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; then the secondary component 155 is “pushed inside the target site”);
piercing the target tissue with the first extendable treatment end (the secondary component 155 is “pushed inside the target site”);
and injecting a devascularizing material through the first extendable treatment end(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 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, in particular devascularizing material, 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.
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 4 and 5 under 35 U.S.C. 112(a) is improper because para [0054] of the specification supports the language of both claims 4 and 5 (see Remarks, pg. 10). However, para [0054] of the specification makes no mention of the subject matter of claims 4 and 5, specifically that a containment device is advanced from a collapsed position to a deployed position and positioned around the target tissue to be treated, and administering devascularizing material through a nozzle of the treatment end to the target tissue.
It appears that Applicant's arguments cited para [0054] of the published application. Since Applicant's submitted specification and published specification both contain paragraph numbers, Applicant should specify, for clarity of record, whether citations to Applicant's own application are directed to its submitted specification or its published specification.
Even so, Applicant's published application at para [0054] also fails to provide support for the subject matter of claims 4 and 5, as it makes no mention, whatsoever, of the subject matter of claims 4 and 5.
For this reason, the rejection is maintained.
The Rejection of Claims Under § 103
Applicant's arguments in this section appear to attack both references of Bagwan and Basu individually, but the rejection was made based on the combination of references. “[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA].” In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
Applicant also argued that modifying Bagwan, as proposed in the Office action, "would render Bagwan inoperable for its intended purpose of mixing fluids at the distal end of the device" (see Remarks, pg. 13, citing para [0038] of Bagwan).
However, Bagwan discloses mixing two fluids at the distal end of the device among numerous possible use of its device; importantly, Bagwan teaches another embodiment of the device where a fluid chamber 115 holds only a single fluid to be delivered (see para [0021]). Additionally, Bagwan's teaching of multiple fluid chambers appears to correspond to Fig. 2, whereas the Office action relied on the embodiment in Fig. 3a for teaching the features of Applicant's invention.
For at least this reason, proposing to modify Bagwan according to the teaching of Basu would not have destroyed the operation of the Bagwan reference, as alleged by Applicant.
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 and distally beyond the sharp end portion of the second treatment end (see Remarks, pgs. 16-18).
The ground of rejection relying on Van Oepen has been withdrawn. A new ground of rejection relying on Bagwan has been applied, rendering Applicant's argument over Van Oepen moot.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
06/22/2026
Prosecution Insights