DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Species C (Figs. 14-15 and 18-30), Subspecies 1 in the reply filed on January 26, 2026 is acknowledged. Currently, claims 1-19 are found by the Examiner to be readable on the elected Species and Subspecies. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species A-B and D-G and/or Subspecies 2-3 , there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 26, 2026.
The following is a complete response to the January 26, 2026 response.
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on the following Chinese applications: CN202110177082.7 (February 9, 2021), CN202110638975.7 (June 8, 2021) and CN202111510577.3 (December 10, 2021). It is noted, however, that applicant has not filed a certified copy of any of the listed priority documents as required by 37 CFR 1.55.
In light of the lack of filing of the certified copies of the priority documents, the Examiner has searched and located each of the documents listed in the foreign priority section of the continuity data in the application data sheet. It is well established that a later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The Examiner is of the position, upon brief review of each of CN202110177082.7 (February 9, 2021), CN202110638975.7 (June 8, 2021) and CN202111510577.3 (December 10, 2021), that each of the prior-filed applications fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application commensurate with the elected embodiment . In particular, the Examiner has failed to find support of the elected Species C (Figs. 14-15 and 18-30), Subspecies 1 in any of the priority documents. The Examiner further requests for Applicant to supply both the certified copy of each of the priority documents as well as an English translation of each priority document as provided for by 35 CFR 1.55(g)(3)(ii). As such, the Examiner has taken the instant priority date for elected claims 1-19 to be the February 9, 2022 date which is the filing date of parent application PCT/CN22/75719.
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 requirement in claim 16 for a) the ring structure to be “formed by a proximal conductive portion of the first conductive portion and the second conductive portion”, b) a ring structure formed by “a distal conductive portion of the first conductive portion and the second conductive portion” and c) for the radial dimension of the ring of a) to be greater than the radial dimension of the ring in b) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. In particular, the Examiner has failed to find any showing in the drawings for a ring structure to be defined as a combination of a portion of each of the first and second conductive portions. At most, figure 35 appears to show that a radial dimension of a ring structure formed by the second conductive portion 3332 to be greater than the radial dimension of a ring structure formed by the first conductive portion 3331. But this fails to contemplate that each ring is formed by a portion of each of the first and second conductive portion.
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.
Claim Rejections - 35 USC § 112
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 16 is 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 16, the claim currently recites “wherein in a natural state, a radial dimension of a ring structure formed by a proximal conductive portion of the first conductive portion and the second conductive portion is greater than that a radial dimension of a ring structure formed by a distal conductive portion of the first conductive portion and the second conductive portion”. Parent claim 12 provides that “the first conductive portion and the second conductive portion respectively arranged on opposite side of the accommodating space” and parent claim 1 (in light of the elected species and subspecies) provides that each of the first and second conductive portions are provided on the support. The Examiner is of the position that the scope of claim 16 is indefinite given that the required structural relationship between each of the first and second conductive portions is rendered indefinite by claim 16 defining that the proximal conductive portion having the respective ring structure is formed by both the first conductive portion and the second conductive portion. Similar indefiniteness exists with the distal conductive portion having its respective ring structure being formed by both the first conductive portion and the second conductive portion. It would appear, from reviewing the structure set forth in each of parent claims 15, 12, 11 and 1 that the first conductive portion and second conductive portion are spaced apart from one another and cannot be reasonably described in the claims a having a structural relationship that would form any manner of proximal or distal ring structure. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (CN 212165884) further in view of Eyster et al. (US Pat. Pub. 2021/0393327 A1).
*** The Examiner notes that all references to the Tang disclosure are made to the machine translation in the attached NPL document ***
Regarding claim 1, Tang provides for an ablation system (see figure 4) comprising:
a support (see figure 4, 10), and
an ablation element (see figure 4, 30), comprising a first conductive portion (32 with 321) and a second conductive portion (33 with 331), the first conductive portion provided on the support (see figure 4 with 32 on 10), the second conductive portion provided on the support or the delivery device or independently from the support and the delivery device (see figure 4 with 33 on the structure of 20), both the first conductive portion and the second conductive portion electrically connected to an external pulse ablation source (the disclosure throughout provides for the connection of the electrode to a pulse source; see at least page 5, lines 26-30), and the first conductive portion and the second conductive portion are configured to transmit pulse ablation energy with different polarities to the target tissue to achieve tissue ablation (the disclosure provides that “the pulse source … is connected with the first electrode 32, the other electrode of the pulse source is connected with the second electrode 33; when energized, the first electrode 32 and the second electrode 33 generate high voltage pulse energy” in page 5, lines 26-30). While the support and ablation element of Tang requires delivery within the body, Tang fails to specifically recite a delivery device, wherein a distal end of the delivery device is connected to the support, and the delivery device is configured to deliver the support to a target tissue.
Eyster discloses a similar ablation system as that of Tang for treatment of cardiac tissue via pulsed ablation energy and with expandable element (see figure 36). Eyster further provides for the expandable element (122; with such being used for ablation) to be at the distal end of a delivery element (120). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a delivery device as in Eyster with the system of Tang including the expandable support element and ablation element to provide for a combined system that can be inserted to a target location within the body. Eyster readily teaches that such a delivery device is known in the art and provides for an exemplary manner of delivering such pulsed energy ablation devices to the same location in the body as contemplated by Tang.
Regarding claims 2 and 3, while Tang contemplates ablation via pulsed energy application, and for such to include irreversible electroporation, Tang fails to specifically provides that an intensity of an electric field generated by the ablation element at a distance of 2 mm from a surface of the ablation element is greater than 400 V/cm (as in claim 2) or an intensity of an electric field generated by the ablation element at a distance of 3 mm from a surface of the ablation element is greater than 400 V/cm (as in claim 3).
Eyster provides for an exemplary system of treating tissues of the heart including the LAA, and further contemplates the use of a device that includes an expandable energy delivery element (as in at least figure 36). Eyster further discloses the use of pulse ablation energy with different polarities to the target tissue to achieve tissue ablation with such being via IRE as disclosed in Tang (see [0363]). Eyster then teaches in [0394] with respect to closely spaced bipolar conductive portions (as in Tang) that such electric fields would be generated in a distance range of 1 mm to 1 cm and with such involving an intensity of up to 3000 V/cm (see [0394]).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to provide the pulse generator associated with the treatment element of Tang to include the energy parameters and algorithms contemplated in Eyster for the bipolar application of IRE to target tissue so as to provide the control and application of the pulse energy ablation to the tissue surrounding the ablation element. Eyster readily contemplates that such functionality of the generator would then result in the capability to create a) an intensity of an electric field at a distance of 2 mm from a surface of the ablation element is greater than 400 V/cm or b) for an intensity of an electric field generated by the ablation element at a distance of 3 mm from a surface of the ablation element is greater than 400 V/cm.
Tang, itself, already establishes the general parameters of treatment and readily contemplates that the parameters of the pulse ablation energy source are to be adjusted to treat tissue with different thicknesses (“[i]n the actual use process, the voltage of the pulse source can be selected, pulse width and other parameters, so as to adapt to the ablation of tissue with different thickness” in page 5, lines 26-30) with Eyster readily providing known examples of such parameters to generate desired IRE electric field intensities within the tissue so as to provide for the treatment of the varying different thickness of tissue. The Examiner is further of the position, in view of the direction in both of Tang and Eyster, that the selection of the claimed electric field intensities at the claimed distances would have been further obvious since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 7, Tang further provides that a zone where an intensity of an electric field generated around the first conductive portion greater than a field intensity threshold of the target tissue is a first ablation zone (ablation zone around 32), a zone where an intensity of an electric field generated around the second conductive portion greater than the field intensity threshold of the target tissue is a second ablation zone (ablation zone around 33), and the first ablation zone and the second ablation zone are partially overlapped with each other (via the forming of the zone of ablation via the IRE of the tissue being located between 32/33).
Regarding claim 8, Tang provides that the first ablation zone and the second ablation zone are formed at different axial positions of the ablation system (via the axial separation of 32 and 33 as in figure 4).
Regarding claim 9, Tang provides that the first conductive portion is provided on a peripheral edge area of the support (see figure 4 with 32 on a peripheral edge of the support).
Regarding claim 10, Tang provides that the first conductive portion is at least provided at a portion with the maximum radial dimension on the peripheral edge area of the support (see again, figure 4 providing that 32 is at a portion with a maximum radial dimension at the peripheral edge of the respective portion of the support 10).
Regarding claim 11, Tang provides that the shortest line between any point on the first conductive portion and any point on the second conductive portion is the shortest electric field line and at least one shortest electric field line passes through an area outside the support (via each of 32 and 33 being on an outer peripheral edge of the respective connective structure and with the shortest line between respective ones of 321/331 being outside of the support 10; see figure 4).
Regarding claim 12, Tang provides that the support comprises an accommodating part which is adjacent to an axis of the support relative to the first conductive portion and/or the second conductive portion (portion of 10 that curves inwardly toward the section at 40 as in figure 4), an accommodating space for accommodating a tissue to be ablated defined outside an outer peripheral wall of the accommodating part (via the recessed portion providing a space to have a tissue therein, and with such outside the peripheral wall of this part; see figure 4 again), the first conductive portion and the second conductive portion respectively arranged on opposite sides of the accommodating space (via the placement of 32/33 relative to the space defined above), and during ablation, at least one shortest electric field line passes through the accommodating space (via the shortest line between 321/331 extending through this space as defined above).
Regarding claim 13, Tang provides that at least part of an outer wall of the accommodating part is configured to contact the tissue to be ablated (via the accommodating part as defined above being capable of contacting tissue to be ablated as claimed).
Regarding claim 14, Tang provides that the accommodating part is arranged in a circumferential direction of the support (via the above defined portion of 10 that curves inwardly toward the section at 40 as in figure 4 being in a circumferential direction of the remainder of the structure of 10) , and the first conductive portion and the second conductive portion are axially spaced apart from each other (with 32 and 33 being spaced along the longitudinal axis of the device as in figure 4).
Regarding claim 15, Tang provides that at least one shortest electric field line passing through the accommodating space is inclined relative to an axis of the support (via the shortest line defined between 32/33 and 321/331 being inclined relative to the longitudinal axis defined through the center of the device in figure 4).
Regarding claim 17, Tang provides that the target tissue is myocardial tissue (via the device of Tang being capable of treating myocardial tissue; see further the disclosure of IRE in the myocardium). The Examiner notes that this recitation in the claim is directed to a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the system of Tang is readily capable of treating myocardial tissue as claimed.
Regarding claim 18, Tang further provides, in view of the rejection in claim 17, that the target tissue is left atrial appendage, and the ablation system is configured to occlude and ablate the left atrial appendage (via the LAA being disclosed throughout the Tang reference; see at least the Abstract), and wherein the support comprises a sealing part (part at 10) and an anchoring part (part at 20) connected to each other, the sealing part is configured to cover an ostium of the left atrial appendage, and the anchoring part is configured to be fixed to a tissue wall of the left atrial appendage (see Tang providing that “the sealing part 10 located at the proximal end of the operator for sealing the left atrial appendage, anchoring part 20 located at the distal end of the operator for occluding the ablation device is anchored in the left atrial appendage”; see page 5, 31-34).
Regarding claim 19, Tang provides that the first conductive portion is provided on a peripheral edge area of the sealing part (see figure 4 with 32 on the sealing part at 10), and wherein the second conductive portion is provided on the support (see figure 4 with 33 on the anchor part 20), and the first conductive portion is provided on a proximal side of the second conductive portion (via the relative locations of 32and 33 as in figure 4).
Allowable Subject Matter
Claims 4-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: During the search of the prior art, the Examiner has identified the above cited Tang and Eyster references as the most relevant prior art to the instant claims. The Examiner has failed, however, to find any disclosure in either of Tang or Eyster that reasonably provides for the combination of the various parameters for a) the pulse voltage, b) the discharge area of the first conductive portion, c) the discharge area of the second conductive portion, d) and the distance between the two closest points on surfaces of the first conductive portion and the second conductive portion.
Tang is silent with respect to any parameters of the applied pulse voltage, or for structural dimensions of its ablation element including the first and the second conductive portions. Eyster, while teaching a pulse voltage in the claimed range (as in at least [0393]) but fails to provide an details regarding the discharge area(s) or distances of surfaces of the expandable ablation element arrangement such as that in figures 36-40A. Thus, the Examiner cannot find that either Tang or Eyster disclose, fairly suggest or render obvious each and every limitation set forth in any of claims 4-6 when take alone or in combination. The Examiner has further failed to find any other reference or combination of references that would disclose, fairly suggest or render obvious each and every limitation set forth in any of claims 4-6.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tang et al. (CN 209203392) provides for a similar device as set forth in claim 1 and including a first conductive portion 122a and a second conductive portion 122b forming an ablation element 122 as in figure 7;
Waldestreicher (US Pat. Pub. 2019/0201089) provides for an expandable ablation element (See figure 17) with a first (108) and a second (108’) conductive portion.
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
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