DETAILED ACTION
The following is a Final Office Action on the merits.
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 .
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 10/28/2025.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Applicant has not addressed any of the drawings objections nor 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the double patenting rejections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 103 rejections set forth in the previous office action.
Response to Arguments
Applicant failed to address the 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “216”, “218’ (Fig. 11A).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
The drawings are objected to because:
Fig. 9 contains 5 figures
Fig. 12 contains 5 figures
Fig. 12 contains text
Fig. 13 contains 3 figures
Fig. 14 contains 5 figures
Fig. 14 contains text
Fig. 15 contains 3 figures
Fig. 15 contains text
Fig. 16 contains 5 figures
Fig. 16 contains text
Fig. 18 contains text
Fig. 18 is shaded
Fig. 19 is a photograph
Fig. 20A-B contain text
Fig. 20A is a photograph
Fig. 21A-E contain multiple photographs and multiple figures
Fig. 21A-E contain text
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 Objections
Claim 14 is objected to because of the following informalities: amend “a fluid” to -a first fluid- in ll. 3 to correspond to the recitation of “a first fluid” in claim 24. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: amend “conduct energy” to -conduct the energy- in ll. 6 as “energy” is previously recited in claim 1. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: amend “an end” to -a proximal end- in ll. 1 to provide proper antecedent basis for “proximal end” in ll. 2. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: amend “2cm” to -2 cm- in ll. 2 (twice). Appropriate correction is required.
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.
Claims 2-3, 5-6, 8, 11, 14-17, 19, 21-22, 24 & 26-27 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.
Claim 2 recites the limitation “the outer balloon has an ellipsoid shape”; however, claim 1, upon which claim 2 depends, recites the limitation “the outer balloon has a non-spherical shape”. It is unclear how many shapes the outer balloon has. For purposes of examination, claim 2 will be interpreted as -the non-spherical shape comprises an ellipsoid shape-.
Claim 3 is dependent on claim 2 and is thus also rejected.
Claim 3 recites the limitation “the outer balloon has a prolate ellipsoid shape or an oblate ellipsoid shape”; however, claim 2, upon which claim 3 depends, recites the limitation “the outer balloon has an ellipsoid shape” and claim 1, upon which claim 3 depends, recites the limitation “the outer balloon has a non-spherical shape”. It is unclear how many shapes the outer balloon has. For purposes of examination, claim 3 will be interpreted as -the ellipsoid shape comprises a prolate ellipsoid shape or an oblate ellipsoid shape-.
Claim 27 is dependent on claim 3 and is thus also rejected.
Claim 5 recites the limitation “the outer balloon has a cylindrical shape”; however, claim 1, upon which claim 5 depends, recites the limitation “the outer balloon has a non-spherical shape”. It is unclear how many shapes the outer balloon has. For purposes of examination, claim 5 will be interpreted as -the non-spherical shape comprises a cylindrical shape-.
Claim 6 is dependent on claim 5 and is thus also rejected.
Claim 6 recites the limitation “the outer balloon has a right cylindrical shape or an oblique cylindrical shape”; however, claim 5, upon which claim 6 depends, recites the limitation “the outer balloon has a cylindrical shape” and claim 1, upon which claim 6 depends, recites the limitation “the outer balloon has a non-spherical shape”. It is unclear how many shapes the outer balloon has. For purposes of examination, claim 6 will be interpreted as -the cylindrical shape comprises a right cylindrical shape or an oblique cylindrical shape-.
Claim 8 recites the limitation “the outer balloon has a conical shape, a pyramidal shape, or a polyhedron shape”; however, claim 1, upon which claim 8 depends, recites the limitation “the outer balloon has a non-spherical shape”. It is unclear how many shapes the outer balloon has. For purposes of examination, claim 8 will be interpreted as -the non-spherical shape comprises a conical shape, a pyramidal shape, or a polyhedron shape-.
Claim 11 is dependent on claim 8 and is thus also rejected.
Claim 11 recites the limitation “the outer balloon has a shape”; however, claim 8, upon which claim 11 depends, recites the limitation “the outer balloon has a conical shape, a pyramidal shape, or a polyhedron shape” and claim 1, upon which claim 11 depends, recites the limitation “the outer balloon has a non-spherical shape”. It is unclear how many shapes the outer balloon has. For purposes of examination, claim 11 will be interpreted as -wherein the outer balloon has the polyhedron shape and said polyhedron shape…-.
Claim 14 recites the limitations “the inner balloon is configured to transition from a collapsed configuration to an expanded configuration” and “the outer balloon is configured to correspondingly transition from a collapsed configuration to an expanded configuration”; however, claim 1, upon which claim 14 depends recites the limitation “said inner balloon and outer balloon are configured to transition from a collapsed configuration into an expanded configuration”. It is unclear how many “collapsed” configurations and “expanded” configurations are being claimed. For purposes of examination, the claims will be interpreted as the inner balloon having an inner balloon collapsed and expanded configuration and the outer balloon having an outer balloon collapsed and expanded configuration such that claim 1 is interpreted as: -said inner ballon is configured to transition from a collapsed configuration into an expanded configuration and said outer balloon is configured to transition from a collapsed configuration into an expanded configuration- and claim 14 is interpreted as: -the inner balloon is configured to transition from the collapsed configuration to the expanded configuration- and -the outer balloon is configured to correspondingly transition from the collapsed configuration to the expanded configuration-.
Claims 24 & 26 are dependent on claim 14 and are thus also rejected.
Claim 15 recites the limitation “an expanded configuration”; however, claim 1, upon which claim 14 depends recites the limitation “said inner balloon and outer balloon are configured to transition from a collapsed configuration into an expanded configuration”. It is unclear how many “expanded” configurations are being claimed. For purposes of examination, claim 15 will be interpreted as: -wherein, when the inner and outer balloons are in the expanded configurations”.
Claims 16-17 & 19 are dependent on claim 15 and are thus also rejected.
Claim 19 recites the limitation “plurality of conductive wires” and “one or more sets of a combination of conductive elements”. It is unclear if the “conductive elements” are the same as or different from the “conductive wires”. For purposes of examination, they will be interpreted as being the same.
Claim 21 recites the limitation “of claim 20” and thus is dependent on a cancelled claim and indefinite. For purposes of examination, claim 21 will be interpreted as being dependent on 1.
Claim 21 recites the limitation “each of the plurality of conductive elements”; however, claim 1, upon which claim 21 depends per the interpretation above, recites the limitation “a plurality of conductive wires”. It is unclear if the “conductive elements” are the same as or different from the “conductive wires”. For purposes of examination, they will be interpreted as being the same.
Claim 21 recites the limitation “each of the plurality of conductive elements is substantially aligned with one of the plurality of perforations”. It is unclear if each of the conductive elements is aligned with a single one of the perforations (e.g., all of the conductive elements align with the same perforation) or if each conductive element aligns with a respective one perforation). For purposes of examination, the claim will be interpreted as each respective wire being aligned with one respective perforation.
Claim 22 recites the limitation “of claim 18” and thus is dependent on a cancelled claim and indefinite. For purposes of examination, claim 22 will be interpreted as being dependent on 1.
Claim 24 recites the limitation "the lumen" in ll. 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, claim 24 will be interpreted as : -a lumen- in ll. 1
Claim 26 is dependent on claim 24 and is thus also rejected.
Allowable Subject Matter
Claims 1, 13 & 28 are allowed.
Claims 2-3, 5-6, 8, 11, 14-17, 19, 21-22, 24 & 26-27 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art, neither alone nor in combination teaches a medical device comprising expandable inner and outer balloons and “a plurality of conductive wires disposed within the interior chamber and configured to conduct energy to be carried by a conductive fluid passing through one or more of the plurality of perforations, wherein each of the plurality of conductive wires having a substantially constant cross-section along its length from a proximal end to a distal end thereof, wherein the distal end of each conductive wire comprises a hook-shaped bend and is covered by a heat shrink sleeve, and wherein each of the plurality of conductive wires is covered by an outer heat shrink sleeve, each outer heat shrink sleeve comprising a cutout portion to thereby expose a corresponding portion of the respective conductive wire.”
The closest prior art is regarded as: Rioux et al. (2016/0317221, previously cited) teaches a medical device comprising inner and outer balloons and a plurality of conductive wires disposed in an interior chamber between the inner and outer balloons, but fail to specifically disclose “wherein the distal end of each conductive wire comprises a hook-shaped bend and is covered by a heat shrink sleeve, and wherein each of the plurality of conductive wires is covered by an outer heat shrink sleeve, each outer heat shrink sleeve comprising a cutout portion to thereby expose a corresponding portion of the respective conductive wire.” Matsukuma et al. (2012/0046647) teach using heat shrinkable tubing to affix a conductive wire to a tube body, but fail to disclose “wherein the distal end of each conductive wire comprises a hook-shaped bend and is covered by a heat shrink sleeve, and wherein each of the plurality of conductive wires is covered by an outer heat shrink sleeve”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794