DETAILED ACTION
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 .
Specification
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 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 1-18 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 1 recites the limitations “the tissue” and “the resection cavity wall”. There is insufficient antecedent basis for these limitations in the claim.
Claims 7-9 each recite the limitation “the one or more temperature sensors”. There is insufficient antecedent basis for this limitation in each claim.
Claim 12 recites “a radiation source” while parent claim 11 recites “a radiation source”. It is unclear whether applicant intends to reference the same radiation source.
Claim 13 recites “the radiation source” while parent claims 11 and 12 each recite “a radiation source”. It is unclear which previously recited radiation source applicant intends to reference.
Claim 15 recites the limitations “the tissue” and “the resection cavity wall”. There is insufficient antecedent basis for these limitations in the claim.
Claim 15 recites the limitation “a tissue” in line 15 yet previously recites “the tissue” in line 11. It is unclear whether applicant intends to reference the same tissue in each limitation.
Claim 17 recites the limitations “the tissue surrounding a resection cavity”. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation “a substantially non-ablative temperature distribution of about 40-45°C”. It is unclear whether applicant intends to reference the same temperature distribution of parent claim 17.
Claim 18 recites the limitation “a tissue surrounding the resection cavity” while parent claim 17 recites “the tissue…cavity”. It is unclear whether applicant intends to reference the same tissue in each limitation.
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 1-12 and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,911,631 in view of U.S. Patent Application Publication No. 2017/0065324 (Attaluri et al.).
Regarding instant claim 1, claim 1 of the ‘631 patent recites all the limitations of instant claim 1, except “wherein the treatment system is configured to deliver a therapeutic agent to the resection cavity”.
However, Attaluri teaches a multimodality treatment system for treating a patient (abstract), comprising: a biocompatible expandable balloon (28) configured to fill a resection cavity, the balloon including magnetic material (29) ([0025]; Figures 7 and 8); a non-contacting induction coil (52) configured to apply a magnetic field surrounding the biocompatible balloon ([0030]; Figure 7); wherein the treatment system is configured to deliver a therapeutic agent to the resection cavity ([0029]); and wherein the magnetic field is adapted to be inductively coupled to and thereby heat the magnetic material to produce a temperature distribution of about 40-45°C for up to 24 hours in the tissue ([0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of claim 1 of the ‘631 patent to be configured to deliver a therapeutic agent to the resection cavity as taught by Attaluri in order to improve the therapeutic benefit of the delivered treatment (Attaluri: [0029]).
Regarding instant claim 2, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of claim 1. Claim 2 of the ‘631 patent recites all the limitations of instant claim 2.
Regarding instant claim 3, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of claim 3.
Regarding instant claim 4, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 1. Claim 2 of the ‘631 patent recites all the limitations of instant claim 4.
Regarding instant claim 5, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 4. Claim 3 of the ‘631 patent recites all the limitations of instant claim 5.
Regarding instant claim 6, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 1. Claim 4 of the ‘631 patent recites all the limitations of instant claim 6.
Regarding instant claims 7 and 8, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 1. Claim 5 of the ‘631 patent recites all the limitations of instant claims 7 and 8.
Regarding instant claim 9, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 1. Claim 6 of the ‘631 patent recites all the limitations of instant claim 9.
Regarding instant claim 10, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 1. Claim 7 of the ‘631 patent recites all the limitations of instant claim 10.
Regarding instant claims 11 and 12, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 1. Claim 8 recites all the limitations of instant claims 11 and 12.
Regarding instant claim 15, claim 1 of the ‘631 patent recites all the limitations of instant claim 15, except “wherein the treatment system is configured to deliver a therapeutic agent to the resection cavity”.
However, Attaluri teaches a multimodality treatment system for treating a patient (abstract), comprising: a biocompatible expandable balloon (28) configured to fill a resection cavity, the balloon including magnetic material (29) ([0025]; Figures 7 and 8); a non-contacting induction coil (52) configured to apply a magnetic field surrounding the biocompatible balloon ([0030]; Figure 7); wherein the treatment system is configured to deliver a therapeutic agent to the resection cavity ([0029]); and wherein the magnetic field is adapted to be inductively coupled to and thereby heat the magnetic material to produce a temperature distribution of about 40-45°C for up to 24 hours in the tissue ([0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of claim 1 of the ‘631 patent to be configured to deliver a therapeutic agent to the resection cavity as taught by Attaluri in order to improve the therapeutic benefit of the delivered treatment (Attaluri: [0029]).
Regarding instant claim 16, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 16.
Regarding instant claim 17, claim 17 of the ‘631 patent recites all the limitations of instant claim 17, except “wherein the system is configured to deliver a therapeutic agent to the resection cavity”.
However, Attaluri teaches a multimodality treatment system for treating a patient (abstract), comprising: a biocompatible expandable balloon (28) configured to fill a resection cavity, the balloon including magnetic material (29) ([0025]; Figures 7 and 8); a non-contacting induction coil (52) configured to apply a magnetic field surrounding the biocompatible balloon ([0030]; Figure 7); wherein the treatment system is configured to deliver a therapeutic agent to the resection cavity ([0029]); and wherein the magnetic field is adapted to be inductively coupled to and thereby heat the magnetic material to produce a temperature distribution of about 40-45°C for up to 24 hours in the tissue ([0034]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of claim 17 of the ‘631 patent to be configured to deliver a therapeutic agent to the resection cavity as taught by Attaluri in order to improve the therapeutic benefit of the delivered treatment (Attaluri: [0029]).
Regarding instant claim 18, claim 17 of the ‘631 patent recites all the limitations of instant claim 18.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,911,631 in view of U.S. Patent Application Publication No. 2017/0065324 (Attaluri et al.) and U.S. Patent Application Publication No. 2010/0228074 (Drobnik et al.).
Regarding instant claim 13, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of instant claim 12. Claim 1 of the ‘631 patent as modified does not recite “the system is configured for slow release of the therapeutic agent after administration of radiation treatment with the radiation source” of instant claim 13.
However, Drobnik teaches a multimodality treatment system (abstract; [0048]), wherein the system is configured for slow release of a therapeutic agent after administration of radiation treatment with a radiation source ([0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of claim 1 of the ‘631 patent and Attaluri such that the system is configured for slow release of the agent after administration of radiation treatment with a radiation source as taught by Drobnik in order to increase the therapeutic effectiveness of the treatment (Drobnik: [0049]).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,911,631 in view of U.S. Patent Application Publication No. 2017/0065324 (Attaluri et al.) and U.S. Patent Application Publication No. 2009/0054721 (Martin).
Regarding claim 14, claim 1 of the ‘631 patent in view of Attaluri recites all the limitations of claim 1. Claim 1 of the ‘631 patent as modified does not recite the location of the cavity.
However, Martin teaches a radiotherapy treatment system (abstract), comprising an expandable balloon (112) for insertion in a resection cavity for delivering treatment to the tissue surrounding the cavity ([0029]; [0032]; [0040]). Martin recognizes resection cavities may be in a breast ([0004]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of claim 1 of the ‘631 patent as modified such that the cavity is in a breast as taught by Martin in order to deliver radiotherapy to tissue surrounding a breast resection cavity (Martin: [0004]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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, Alexander Valvis can be reached at 571-272-4233. 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.
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
Prosecution Insights