DETAILED ACTION
Applicant’s preliminary amendment, filed September 6, 2024, is fully acknowledged by the Examiner. Currently, claims 2-20 are pending with claim 1 cancelled and claims 2-20 newly added. The following is a complete response to the September 6, 2024 communication.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the subject matter set forth in the instant claims 2-20 based on the requirements in claim 2 including the treatment of endometrial tissue utilizing a linear antenna delivered into the uterine cavity to treat endometrial tissue must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The Examiner respectfully points to the rejections of the claims under 35 U.S.C. 112, 1st paragraph below for additional information regarding the deficiencies in the instant disclosure.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The Examiner notes the instant specification filed in the application includes many features related to microwave antennas including a linear antenna, and for an antenna to include one or more electrodes. The Examiner further notes the instant Specification only sets forth endometrial tissue via an antenna in [0280] and makes note that such is contemplated with an antenna having arms 102 as in figure 4C.
Accordingly, the Examiner has failed to find that the instant Specification provides proper antecedent basis for the subject matter set forth in claim 2 including the specific method steps of a) “delivering a linear antenna into the uterine cavity”, b) “positioning the linear antenna adjacent to the endometrial tissue, wherein the linear antenna comprises a proximal end, a distal end, and an antenna axis, wherein at least one electrode is positioned along the antenna and is connected to a conductive wire, wherein the conductive wire is electrically isolated from the linear antenna, wherein the conductive wire is linear and parallel to the antenna axis”, c) “delivering microwave energy to the endometrial tissue through the linear antenna to generate a microwave field where the position of the conductive wire reduces a distortion of the microwave field otherwise resulting from the electrode and to create a first lesion” and d) “applying energy through the electrode to diagnose or treat the endometrial tissue while maintaining a position of the antenna in the uterine cavity”
Said differently, the specification is deficient in contemplating the specific manner of treating endometrial tissue in the uterine cavity with a linear antenna as currently claimed. The Examiner respectfully notes that the Examiner has attempted to find support in the large number of non-provisional and provisional patent applications in the priority information. Applicant’s attention is drawn to the rejection of the claims under 35 U.S.C. 112(a) below that provides a review of the subject matter of each of these applications. Any additional features in dependent claims 3-20 that do not appear in the instant specification should be added as well. Appropriate correction is required.
The disclosure is objected to because of the following informalities: The Examiner respectfully suggests Applicant amend the status of each of the applications set forth in paragraph [0001] of the filed Specification.
Appropriate correction is required.
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 2-20 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 2, the claim currently recites a method for delivering microwave energy to endometrial tissue of a patient and then specifically requires the steps of:
a) delivering a linear antenna into the uterine cavity;
b) positioning the linear antenna adjacent to the endometrial tissue, wherein the linear antenna comprises a proximal end, a distal end, and an antenna axis, wherein at least one electrode is positioned along the antenna and is connected to a conductive wire, wherein the conductive wire is electrically isolated from the linear antenna, wherein the conductive wire is linear and parallel to the antenna axis;
c) delivering microwave energy to the endometrial tissue through the linear antenna to generate a microwave field where the position of the conductive wire reduces a distortion of the microwave field otherwise resulting from the electrode and to create a first lesion; and
d) applying energy through the electrode to diagnose or treat the endometrial tissue while maintaining a position of the antenna in the uterine cavity.
As a preliminary matter, the Examiner notes that the instant application has substantial priority documents associated with its disclosure including numerous non-provisional and provisional applications. The Examiner has reviewed each of the priority documents as completely as possible during review of the instant application. Applicant is respectfully invited to review such as well as identify the specific location, if available, of support for the above-noted features of claim 2.
Turning to the instant Specification, the Examiner notes that disclosure includes minimal disclosure and detail relating to the treatment of the uterine cavity including endometrial tissue. Paragraphs [0250], [0280] and [0309] include the only instances of either “uterus” or “uterine” in the instant Specification. [0250] and [0309] are generic mentions that the uterus can be an area of treatment. [0280] notes that the system 100 can be introduced into the uterus to treat endometrial tissue with the active region 142 being “positioned inside the uterus and oriented perpendicular to the path of insertion of arms 102”. This disclosure in made within the arrangement shown in figure 4C and specifically contemplates “one or more arms 102”. [0280] makes no mention that the antenna contemplated is a linear antenna as claimed and figure 4C shows a non-linear device as reproduced below.
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The Examiner notes that the balance of the disclosure includes disclosure regarding the provision and use of a linear antenna (See figure 1A and paragraphs [0103], [0107], [0111] and [0113]) and for such a linear antenna to have electrodes thereon (as in [0131] providing for 118 on the antenna 112). Neither these, nor any other portion of the instant disclosure, specifically provides that a linear antenna with at least one electrode thereon was ever contemplated as being used in the method set forth in claim 2 to deliver microwave energy to endometrial tissue of the patient via the delivering of the energy to the endometrial tissue through the linear antenna to generate a microwave field … to create the first lesion.
Again, the disclosure only contemplates in [0280] for treatment of the endometrial tissue of the uterus via an antenna, but that antenna such as in figure 4C cannot be considered as a linear antenna as claimed. To this end, the Examiner has further failed to find any support for the manner in which at least one electrode on the linear antenna would then function to apply energy through the electrode to diagnose or treat the endometrial tissue while maintaining a position of the antenna in the uterine cavity. The general lack of disclosure in the instant Specification regarding the use of the linear antenna for treating the endometrial tissue of the uterine cavity then brings question as to whether Application, at the time the invention was made, had contemplated the further diagnosis or treatment of such tissue via the electrode on the linear antenna.
For the sake of completeness, the Examiner has reviewed the various priority documents associated with the instant application. Parent applications 17/652718, 16/038921, 14/462434 and 12/603134 recite substantially the same subject matter as the instant specification and, as such, include the same deficiencies in the disclosure as the instant Specification.
Parent application 12/603349 is relevant in its disclosure in figures 8A-8C of the antenna within the uterus. Paragraphs [0121] and [0122] of the filed Specification in the ‘349 application provide the relevant disclosure with respect to figures 8A-8C. [0121] specifically sets forth with respect to figure 8B that the antenna 104 “is moved to a different location in the uterus and antenna 104 is used to ablate a region of the uterine endometrium”. This is followed with discussion of similar movement to a different location in figure 8C and that such movement is accomplished by steering the antenna 104 by various mechanisms. There is no disclosure in [0121] or [0122] that the antenna is a linear antenna in the arrangements in figures 8B or 8C and, rather, it appears that these figures provide for the antenna 104 with element 112 to be bent/curved along its length.
The Examiner has failed to find anything in the balance of the disclosure to suggest that Applicant has specifically contemplated the use of a linear arrangement for the antenna when treating the endometrial tissue discussed in [0121] or [0122]. The Examiner further notes that the disclosure of the ‘349 application is devoid of any disclosure relating to the inclusion of at least one electrode on the linear antenna or for such to be used as set forth in claim 2 to provide diagnosis or treatment.
Turning to parent applications 12/829222, 13/854673 and 12/603077, the Examiner finds that each application is deficient in disclosing that Applicant has possession of the specific combination of limitations noted above at the time of each application’s filing. While various portions of each application contemplate features such as treatment of endometrial tissue of the uterus, a linear antenna, and one or more electrodes on the linear antenna, the Examiner has failed to find the specific provision of the treatment of endometrial tissue of the uterus via microwaves applied from a linear antenna wherein the antenna has one or more electrodes thereon and where the electrode is used to apply energy for diagnostic or therapeutic purposes.
Lastly, the Examiner notes that provisional applications 61/113192, 61/113194, 61/180133, 61/107252, 61/113189 and 61/686125 fail to provide any manner of disclosure the fairly discloses or supports the combination of limitations set forth in the claim 2 above at their time of their respective filing. With respect to the remaining provisional applications 61/222409, 61/162241, 61/162244 and 61/752351, the Examiner finds that each application is deficient in disclosing that Applicant has possession of the specific combination of limitations noted above at the time of each application’s filing. While various portions of each application contemplate features such as treatment of endometrial tissue of the uterus, a linear antenna, and one or more electrodes on the linear antenna, the Examiner has failed to find the specific provision of the treatment of endometrial tissue of the uterus via microwaves applied from a linear antenna wherein the antenna has one or more electrodes thereon and where the electrode is used to apply energy for diagnostic or therapeutic purposes.
Thus, it is for at least the reasoning set forth above that the Examiner finds that the specific combination of limitations set forth in the method of claim 2 were 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. Claims 3-20 are rejected due to their dependency on claim 2. Appropriate correction is required.
Regarding each of claims 3-20, the Examiner further finds that each claim similarly fails to comply with the written description requirement because each contains additional subject matter that 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. Appropriate correction is required.
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.
Claims 2-20 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 2, the claim first recites “a linear antenna” in line 3 but then includes various recitations with respect to “the linear antenna” and “the antenna” therein. The Examiner is of the position that the use of “the linear antenna” and “the antenna” renders the scope of the claim as indefinite because it is unclear if the recitation of “the antenna” would encompass a shape for the antenna in the respective step to not be “linear” while performing the claimed step. The Examiner respectfully requests Applicant amend the claim to ensure consistency in the claim language and structure for each recitation of the “antenna” therein. Claims 3-20 are rejected due to their respective dependency on claim 2.
Regarding claims 3, 5-9, 11-12 and 15-17, each listed claim recites the limitation of “the antenna” therein. The Examiner is of the position that the scope of each claim is indefinite for substantially the same reasoning regarding “the antenna” recitation as listed in the rejection of claim 2 under 35 U.S.C. 112 2nd paragraph above. Appropriate correction is required.
Regarding claim 2, the claim recites “at least one electrode” in lines 5-6 and then further recites “the electrode” in each of lines 11 and 12. The Examiner is of the position that the use of “at least one electrode” and “the electrode” renders the scope of the claim as indefinite because it is unclear if the recitation of “the electrode” is determined to narrow the number of electrodes required in the claim to only be a single electrode. Such is further an issue when the “electrode” limitation is coupled with the requirement for the connection to a conductive wire. The Examiner respectfully requests Applicant amend the claim to ensure consistency in the claim language such as by using “the at least one electrode”. Claims 3-20 are rejected due to their respective dependency on claim 2. Appropriate correction is required.
Regarding claims 6, 14, 15 and 18-20, each listed claim recites one of “the at least one electrode” or “the electrode” therein. The Examiner is of the position that the scope of each claim is indefinite for substantially the same reasoning regarding the “electrode” recitation as listed in the rejection of claim 2 under 35 U.S.C. 112 2nd paragraph above. Appropriate correction is required.
Regarding claim 3, the claim recites the limitation of “the outer conductor” therein. This limitation fails to have proper antecedent basis in the claims as neither of claims 2 or 3 provide either an implicit or explicit basis of “an outer conductor” therein. Claim 4 is rejected due to its dependency on claim 3. Appropriate correction is required.
Regarding claim 5, the claim recites “a microwave field emitted by the antenna” therein. Parent claim 2 has previously set forth “delivering microwave energy … through the linear antenna to generate a microwave field …” therein. The Examiner is of the position that the recitation in claim 5 renders the scope of the claim as indefinite because it is unclear if the microwave field per claim 5 is the same as the microwave field in parent claim 2. The scope is further in question given that both microwave fields are related to interaction with the conductive wire. Appropriate correction is required.
Again, regarding claim 5, the claim recites therein that “every section of the first portion of the conductive wire is oriented non-parallel to the antenna axis”. Parent claim 2 has established that “the conductive wire is linear and parallel to the antenna axis”. Accordingly, the Examiner is of the position that the scope of claim 5 is indefinite because it is unclear how the first portion of the conductive wire can be both non-parallel to the antenna axis as required therein while also being parallel to the antenna axis as set forth in claim 2. Appropriate correction is required.
Regarding claim 7, the claim recites “the first portion of the conductive wire” therein. This limitation fails to have proper antecedent basis in the claims as neither claims 2 nor 7 provide an implicit or explicit basis for “a first portion” of the conductive wire. Appropriate correction is required.
Regarding claim 13, the claim recites the limitation of “the elongate microwave antenna” therein. This limitation fails to have proper antecedent basis in the claims as neither claims 2 nor 7 provide an implicit or explicit basis for “an elongated microwave antenna”. At most, parent claim 2 recites “a linear antenna” thereby leaving question if the elongate microwave antenna in claim 13 is the same structure as that set forth in claim 2, or is directed to different antenna. Appropriate correction is required.
Regarding claim 15, the claim recites the limitation of “the wire” therein. This limitation fails to have proper antecedent basis in the claims as neither claims 2 nor 15 provide an implicit or explicit basis for “a wire”. The Examiner notes that claim 2 recites a/the conductive wire therein. Appropriate correction is required.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Edwards (US Pat. No. 6,002,968) provides for the treatment of the uterus with a microwave emitting device;
vanHooydonk (US Pat. No. 5,902,251) provides for the treatment of the uterus with a microwave emitting device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794