DETAILED ACTION
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 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.
Information Disclosure Statement
The information disclosure statement filed 10/16/24 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the cited references lacked dates. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains less than 50 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Furthermore, the lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities: In claims 1 (line 12) and 20 (line 11), -fluid delivery- should be inserted before “conduit”; In claim 1, line 20, -airway- should be inserted before “wall”. 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 and 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 pre-AIA the applicant regards as the invention.
Claim 2 recites the limitation "one or more lesions" in line 3. The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “one or more lesions”. Appropriate correction is required.
Claim 20 is found to be indefinite because Examiner is unsure of what is meant by the limitation “so as to protect non tissue” (line 18), which renders the scope of the claim unclear. It appears as though “non” should be replaced with ‘non-target’.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 8,777,943. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 9,005,195. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,017,324. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 9,675,412. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the claims of the application. Accordingly, the application claims are not patentably distinct from the patent claims. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1-16, 19, and 20 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Edwards, U.S. 2009/0131928 (hereinafter Edwards).
Regarding claims 1 and 20, Edwards discloses (note figs. 24-27; paragraphs 84-85) an apparatus comprising: a shaft (see fig. 27); and an ablation assembly including an expandable member (16), a fluid delivery conduit (110), and an energy emitter (44); wherein the ablation assembly is movable in the claimed manner, configured for circulation of cooling fluid in the claimed manner, and capable of being used in the claimed manner.
Regarding claim 2, Edwards discloses (note figs. 24-27; paragraphs 84-85) an apparatus further comprising a source of energy (necessarily) and a cooling system (‘104’ and ‘106’).
Regarding claim 3, Edwards discloses (note figs. 24-27; paragraphs 84-85) an apparatus wherein the energy emitter comprises a single elongated electrode (‘44’ in fig. 27).
Regarding claims 4-8, Edwards discloses (see above) an apparatus having the claimed energy emitter configuration (note fig. 9C and paragraph 65). It should be noted that 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.
Regarding claims 9-11, Edwards discloses (see above) an apparatus having the claimed energy emitter configuration (note paragraph 64).
Regarding claim 12, Edwards discloses (note fig. 27) an apparatus wherein the energy emitter is necessarily movable in the claimed manner.
Regarding claim 13, Edwards discloses (note figs. 24-27; paragraphs 84-85) an apparatus capable of being used in the claimed manner.
Regarding claims 14 and 16, Edwards discloses (note fig. 27) an apparatus wherein the energy emitter includes an electrode coupled to the fluid delivery conduit, wherein this electrode could necessarily be described as a conductive ‘foil, film, or coating’ (on balloon ‘16’).
Regarding claim 15, Edwards discloses (see above) an apparatus wherein the electrode is ‘collapsible’ (necessarily collapsible for deflation of balloon to occur; also see figs. 9A-C).
Regarding claim 19, Edwards discloses (see above) an apparatus that is capable of being optically coupled to a viewing device (which has not been positively recited) in the claimed manner.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 17-18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards in view of Saab, U.S. 5,902,268 (hereinafter Saab).
Regarding claims 17-18, Edwards discloses (see above) an apparatus comprising an expandable ablation assembly (at the end of a shaft) having a cooled energy emitter thereon (see fig. 27). While the shaft would necessarily comprise an inflow and outflow lumen therein in order to circulate coolant through the energy emitter (via fluid delivery conduit ‘110’), Edwards fails to explicitly disclose that a proximal end of the fluid delivery conduit is directly coupled to the inflow lumen at a distal end of the shaft. Saab teaches (note figs. 4A & 5A) a similar system comprising a shaft that includes a first delivery lumen (portion of 242a that is proximal of 236a) in fluid communication with a coolant channel (distal portion of 242a) of an expandable member (236a) and a second delivery lumen (232a; col. 14, line 19 - col. 15, line 3) in fluid communication with a chamber (interior of 236a) of the expandable member, the coolant channel being fluidly connected to the chamber (via 243a and similar apertures) to allow the coolant to flow between them. It is well known in the art that these different cooling configurations (i.e., coolant flows from balloon to surface conduit vs. coolant flows from shaft to surface conduit) are widely considered to be interchangeable. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made, to have modified the apparatus of Edwards so that a proximal end of the fluid delivery conduit is directly coupled to the inflow lumen at a distal end of the shaft (in view of Saab). This is because this modification would have merely comprised a simple substitution of interchangeable cooling configurations in order to produce a predictable result (see MPEP 2143). It should be noted that this modified device would be capable of meeting the remaining functional limitations in the cited claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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, Joanne Rodden can be reached at 303-297-4276. 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.
/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
Prosecution Insights