DETAILED ACTION
The following is a First Action, Non-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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 & 119(e) as follows:
The 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 disclosure of the prior-filed application, Application Nos. 16/853925, 14/828682 & 62/041773 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.
Accordingly, the claims are given the priority benefit date of 8/26/2014.
Claim Objections
Claim 26 is objected to because of the following informalities: amend “tissue” to -the tissue- in ll. 3. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: amend “the patient” to -a patient- in ll. 2. Appropriate correction is required.
Claim 28 is objected to because of the following informalities: amend “the target” to -the tissue- in ll. 3. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: amend “delivered” to -deliverable- in ll. 3. Appropriate correction is required.
Claim 36 is objected to because of the following informalities: amend “tissue” to -the tissue- in ll. 3. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: amend “the patient” to -a patient- in ll. 2. Appropriate correction is required.
Claim 38 is objected to because of the following informalities: amend “the target” to -the tissue- in ll. 3. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: amend “delivered” to -deliverable- in ll. 3. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21, 28, 32-33 & 38-40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tosoratti (WO 2006/084676, cited in IDS).
Concerning claim 21, as illustrated in Figs. 1-17, particularly Figs. 1-4 & 14, Tosoratti discloses a microwave ablation device assembly (Fig. 1-17), comprising:
a coaxial cable including: an inner conductor; an outer conductor separated from the inner conductor by a dielectric; (an internal conductor 2, surrounded by a layer of insulating material surrounded in turn by an external conductor 4, coaxial with the internal conductor 2, connectable to a source of microwave via connector 6; Pgs. 7-8, ll. 29-4) and
a distal radiating section coupled to a distal portion of the inner conductor and configured to deliver microwave energy to tissue (antenna emitting end portion 5; Pgs. 7-8, ll. 29-4); and
a catheter including an electrically conductive inner surface electrically shorted to the outer conductor of the coaxial cable, wherein the catheter is configured such that microwave energy conducted by the outer conductor of the coaxial cable is prevented from affecting tissue in proximity to the catheter (antenna 1 is inserted through hollow metal needle 7, taken to be a catheter, into the body of the patient and is selectively extended out the distal end to treat tissue, and comprises device 8 that is a quarter-wave impedance transformer terminating in a short circuit, commonly called a ‘choke’, comprising a layer 9 of dielectric material, a ring 10 fixed to said external conductor 4, and the metal walls of hollow needle 7 in sliding contact with the side surface of ring 10 to avoid indiscriminate heating of surrounding tissue for the length of the needle 7; Pg. 8, II. 5-25, PG. 12, II. 1-29).
Concerning claim 28, Tosoratti discloses the catheter (7) is configured to be received within airways of the patient for navigating the coaxial cable (2, 4) through the airways of the patient for placement of the distal radiating section (5) at the target as the eternal diameter can be a millimeter (Pg. 10, ll. 11-12).
Concerning claim 32, Tosoratti discloses a length of the electrically conductive inner surface of the catheter (7) is equal to a quarter-wavelength of a frequency of the microwave energy delivered by the distal radiating section (5) (Pg. 8, ll. 5-25).
Concerning claim 33, as illustrated in Figs. 1-17, particularly Figs. 1-4 & 14, Tosoratti discloses a microwave ablation device assembly (Fig. 1-17), comprising:
a microwave ablation antenna configured to deliver microwave energy to tissue (an internal conductor 2, surrounded by a layer of insulating material surrounded in turn by an external conductor 4, coaxial with the internal conductor 2, connectable to a source of microwave via connector 6 and has an antenna emitting end portion 5; Pgs. 7-8, ll. 29-4); and
a catheter including an electrically conductive inner surface electrically shorted to the microwave ablation antenna, wherein the catheter is configured such that microwave energy conducted by the microwave ablation antenna is prevented from affecting tissue in proximity to the catheter (antenna 1 is inserted through hollow metal needle 7, taken to be a catheter, into the body of the patient and is selectively extended out the distal end to treat tissue, and comprises device 8 that is a quarter-wave impedance transformer terminating in a short circuit, commonly called a ‘choke’, comprising a layer 9 of dielectric material, a ring 10 fixed to said external conductor 4, and the metal walls of hollow needle 7 in sliding contact with the side surface of ring 10 to avoid indiscriminate heating of surrounding tissue for the length of the needle 7; Pg. 8, II. 5-25, PG. 12, II. 1-29).
Claim 38 is rejected upon the same rationale as applied to claim 28.
Claim 39 is rejected upon the same rationale as applied to claim 28.
Concerning claim 40, as illustrated in Figs. 1-17, particularly Figs. 1-4 & 14, Tosoratti discloses a microwave ablation device assembly (Fig. 1-17), comprising:
a microwave ablation antenna configured to deliver microwave energy to tissue, the microwave ablation antenna including an outer conductor and an inner conductor disposed coaxially within the outer conductor (an internal conductor 2, surrounded by a layer of insulating material surrounded in turn by an external conductor 4, coaxial with the internal conductor 2, connectable to a source of microwave via connector 6 and has an antenna emitting end portion 5; Pgs. 7-8, ll. 29-4); and
a catheter including an electrically conductive inner surface electrically shorted to the outer conductor of the microwave ablation antenna (antenna 1 is inserted through hollow metal needle 7, taken to be a catheter, into the body of the patient and is selectively extended out the distal end to treat tissue, and comprises device 8 that is a quarter-wave impedance transformer terminating in a short circuit, commonly called a ‘choke’, comprising a layer 9 of dielectric material, a ring 10 fixed to said external conductor 4, and the metal walls of hollow needle 7 in sliding contact with the side surface of ring 10 to avoid indiscriminate heating of surrounding tissue for the length of the needle 7; Pg. 8, II. 5-25, PG. 12, II. 1-29).
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.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tosoratti (WO 2006/084676, cited in IDS), as applied to claim 21, in further view of Ormsby et al. (2011/0130750).
Concerning claims 22-23, Tosoratti fails to disclose an electromagnetic (EM) location sensor disposed on at least one of the coaxial cable or the catheter. However, Ormsby et al. disclose a microwave ablation assembly (12) comprising a distal radiation section (18) and an electromagnetic (EM) location sensor (30). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Tosoratti to further comprise an electromagnetic (EM) location sensor in order to provide the benefit of calculating the position and orientation of the device in the patient’s body as taught by Ormsby et al. ([0022], [0025-0026]; Fig. 2). Tosoratti in view of Ormsby et al. fail to specifically disclose the EM location sensor disposed on at least one of the coaxial cable or the catheter. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Tosoratti such that the EM slocation sensor is disposed on at least one of the coaxial cable or the catheter, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Claim(s) 24-26, 29-31 & 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tosoratti (WO 2006/084676, cited in IDS), as applied to claims 21 & 33, in further view of Prakash et al. (2003/0088242).
Concerning claims 24 & 34, Tosoratti fails to disclose the catheter including an outer insulating layer and an inner insulating layer. However, Prakash et al. disclose a microwave ablation catheter comprising a coaxial cable (198, 200, 196) and an electrical choke (172), the electrical choke comprising an electrically conductive inner surface (224) that is disposed between an outer insulating layer (226) and an inner insulating layer (222), the electrically conductive inner surface (224) being electrically shorted to outer conductor (196). It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Tosoratti such that the catheter includes an outer insulating layer and an inner insulating layer, since Applicant has not disclosed that the outer insulating layer and an inner insulating layer solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the conductive hollow needle also comprising the outer insulating layer and the inner insulating layer of Prakash et al. in place of the conductive hollow needle, conductive ring, and dielectric of Tosoratti as Prakash et al. teach the configuration to be an equivalent in the art for the purposes of an electrical choke. ([0070-0071]; Fig. 9-13)
Concerning claims 25 & 35, Prakash et al. further disclose the electrically conductive inner surface (224) is disposed between at least a portion of the outer insulating layer (226) and the inner insulative layer (222) ([0070-0071]; Fig. 9-13).
Concerning claims 26 & 36, Prakash et al. further disclose the outer insulating layer (226) is configured to separate the electrically conductive inner surface (224) from tissue in proximity to the device ([0070-0071]; Fig. 9-13)
Concerning claims 29-31, Tosoratti fails to disclose the electrically conductive inner surface of the catheter is electrically shorted to the outer conductor of the coaxial cable adjacent to a proximal end of a layer of insulating material disposed on an outer surface of the outer conductor. However, Prakash et al. further disclose the electrically conductive inner surface (224) of the choke (172) is electrically shorted to the outer conductor (196) of the coaxial cable adjacent to a proximal end of a layer of polyethylene terephthalate (PET) insulating material (208 or 210) disposed on an outer surface of the outer conductor (196). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Tosoratti such that the electrically conductive inner surface of the catheter is electrically shorted to the outer conductor of the coaxial cable adjacent to a proximal end of a layer of insulating material disposed on an outer surface of the outer conductor in order to provide the benefit of a lubricious and sealant layer to facilitate insertion and prevent tissue sticking as taught by Prakash et al. ([0060], [0069]; Fig. 9-12)
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tosoratti (WO 2006/084676), as applied to claim 21, in further view of Flachman et al. (6,348,039).
Concerning claim 27, Tosoratti fails to disclose the electrically conductive inner surface of the catheter is braided. However, Flachman et al. disclose a catheter assembly comprising an extended working channel (80) configured to receive a catheter (16) that is formed of a braided metal material. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Tosoratti such that the conductive working surface of the working channel is made of a braided conductive working surface in order to provide the benefit of a material that provides the required column strength, while still permitting a degree of flexibility as taught by Flachman et al. (Col. 7-8, II. 31-7; Fig. 4)
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,624,697. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a microwave ablation device assembly, comprising: a coaxial cable including: an inner conductor; an outer conductor separated from the inner conductor by a dielectric; and a distal radiating section coupled to a distal portion of the inner conductor and configured to deliver microwave energy to tissue; and a catheter including an electrically conductive inner surface electrically shorted to the outer conductor of the coaxial cable, wherein the catheter is configured such that microwave energy conducted by the outer conductor of the coaxial cable is prevented from affecting tissue in proximity to the catheter.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,974,805. Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a microwave ablation device assembly, comprising: a coaxial cable including: an inner conductor; an outer conductor separated from the inner conductor by a dielectric; and a distal radiating section coupled to a distal portion of the inner conductor and configured to deliver microwave energy to tissue; and a catheter including an electrically conductive inner surface electrically shorted to the outer conductor of the coaxial cable, wherein the catheter is configured such that microwave energy conducted by the outer conductor of the coaxial cable is prevented from affecting tissue in proximity to the catheter.
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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