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 .
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.
Claims 1-6 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Sabin (US 2021/0282964).
Regarding claim 1, Sabin discloses a method for treating esophageal cancer in situ with a flow of heated air that can be inhaled through a mask (fig.8-11, face mask 800) and mouthpiece (fig.11), comprising the steps of: providing and directing the flow of the heated air from a heat source to be inspired/inhaled through the mouth and into the trachea/windpipe (fig.8-11; see also [0135]), at an elevated temperature less than sauna air temperatures into the trachea of the patient at a sufficient constant positive pressure [0134] and temperature to uniformly heat the patient's tracheoesophageal party wall sheath membrane extending between the esophagus and the respiratory trachea in the patient [0105]; monitoring and allowing the heated air to heat the patient's tracheoesophageal party wall sheath membrane at a predetermined temperature and constant positive air pressure through the tracheoesophageal party wall sheath membrane to conductively heat the esophageal cancer tumor adjacent to the heated trachea [0061] and the tracheoesophageal party wall sheath membrane [0065]; whereby the heat provided at a predetermined temperature and at constant positive pressure from the heater air is inspired by the patient through the trachea migrates/transmits/disperses conductively across the tracheoesophageal party wall sheath membrane separating the patient trachea from the esophagus to contact the esophageal tumor at the predetermined heat and positive pressure sufficient to cause apoptosis programmed cell death thereat [0102].
Regarding claim 2, Sabin discloses the method of claim 1, wherein said heat source has an outlet nozzle which is sufficiently large and shaped to deliver heat to the esophageal cancer through the tracheoesophageal party wall sheath membrane, separating the trachea from the esophagus.
Regarding claim 3, Sabin discloses the method of claim 1, wherein said heat source has a display comprising an LCD screen showing both of said temperatures, including said set programmed temperature and said current temperature within the trachea and esophagus of the patient (fig.1 and fig.1A, see also [0121]).
Regarding claim 4, Sabin discloses the method of claim 3 in which the set programmed temperature is displayed on the screen of the heat source (fig.2, see also [0141]).
Regarding claim 5, Sabin discloses the method of claim 4, wherein said efficacious internally applied heated air is delivered to said esophageal cancer located adjacent to the tracheoesophageal party wall sheath membrane, separating the trachea from the esophagus at a range of about 107 to 113 degrees F [0145].
Regarding claim 6, Sabin discloses the method of claim 5, further comprising the step of inserting a subcutaneous needle probe temperature monitor into the in situ site of the esophageal tumor being treated and measuring the temperature of the tumor being treated [0189].
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.
Claim 1-6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 of U.S. Patent No. US 12,233,213. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent No. US 12,233,213 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.
19/041,841
US 12,233,213
1. A method for treating esophageal cancer in situ with a flow of heated air that can be inhaled through a mask and mouthpiece, comprising the steps of: providing and directing the flow of the heated air from a heat source to be inspired/inhaled through the mouth and into the trachea/windpipe, at an elevated temperature less than sauna air temperatures into the trachea of the patient at a sufficient constant positive pressure and temperature to uniformly heat the patient's tracheoesophageal party wall sheath membrane extending between the esophagus and the respiratory trachea in the patient; monitoring and allowing the heated air to heat the patient's tracheoesophageal party wall sheath membrane at a predetermined temperature and constant positive air pressure through the tracheoesophageal party wall sheath membrane to conductively heat the esophageal cancer tumor adjacent to the heated trachea and the tracheoesophageal party wall sheath membrane; whereby the heat provided at a predetermined temperature and at constant positive pressure from the heater air is inspired by the patient through the trachea migrates/transmits/disperses conductively across the tracheoesophageal party wall sheath membrane separating the patient trachea from the esophagus to contact the esophageal tumor at the predetermined heat and positive pressure sufficient to cause apoptosis programmed cell death thereat.
1. A method for treating esophageal cancer in situ with a flow of heated air that can be inhaled through a mask and mouthpiece, comprising the steps of: providing and directing the flow of the heated air from a heat source to be inspired/inhaled through a mouth and into a trachea/windpipe, at an elevated temperature less than sauna air temperatures into the trachea of a patient at a sufficient constant positive pressure and temperature to uniformly heat the patient's tracheoesophageal party wall sheath membrane extending between an esophagus and a respiratory trachea in the patient; monitoring and allowing the heated air to heat the patient's tracheoesophageal party wall sheath membrane at a predetermined temperature and constant positive air pressure through the tracheoesophageal party wall sheath membrane to conductively heat the esophageal cancer adjacent to the heated trachea and the tracheoesophageal party wall sheath membrane; whereby the heat provided at the predetermined temperature and at the constant positive pressure from the heated air is inspired by the patient through the trachea migrates/transmits/disperses conductively across the tracheoesophageal party wall sheath membrane separating the patient trachea from the esophagus to contact the esophageal cancer at the predetermined heat and positive pressure sufficient to cause apoptosis programmed cell death thereat, further comprising the steps of: a) providing a heat gun as said heat source; b) installing a correct outlet nozzle on the heat gun; c) determining and adjusting the temperature of the flow of heated air; d) programing and providing the flow of heated air at said constant positive pressure and at a threshold temperature of the esophageal cancer sufficient to remove the esophageal cancer; e) adjusting the output nozzle of said heat gun and supplying said flow of heated air through the patient's mouth and trachea to a location of the tracheoesophageal party wall sheath membrane separating the trachea from the esophagus in the vicinity of the esophageal cancer f) activating said temperature-controlled heat gun with locks and interlocks for a predetermined time, at which time the entire tumor will be conductively heated across the tracheoesophageal party wall sheath membrane from the trachea into the esophagus with heat derived from said flow of heated air at controlled threshold temperatures; and, g) monitoring the cancer temperature for ensuring that the heated air does not exceed a safe temperature threshold within the trachea and esophagus of the patient.
2. The method of claim 1, wherein said heat source has an outlet nozzle which is sufficiently large and shaped to deliver heat to the esophageal cancer through the tracheoesophageal party wall sheath membrane, separating the trachea from the esophagus.
2. The method of claim 1, wherein said outlet nozzle is sufficiently large and shaped to deliver heat to the esophageal cancer through the tracheoesophageal party wall sheath membrane, separating the trachea from the esophagus.
3. The method of claim 1, wherein said heat source has a display comprising an LCD screen showing both of said temperatures, including said set programmed temperature and said current temperature within the trachea and esophagus of the patient.
3. The method of claim 2, wherein a display comprises an LCD screen showing both of said temperatures, including said set programmed temperature and a current temperature within the trachea and esophagus of the patient.
4. The method of claim 3 in which the set programmed temperature is displayed on the screen of the heat source.
4. The method of claim 3, in which the set programmed temperature is displayed on the screen of the heat gun.
5. The method of claim 4, wherein said efficacious internally applied heated air is delivered to said esophageal cancer located adjacent to the tracheoesophageal party wall sheath membrane, separating the trachea from the esophagus at a range of about 107 to 113 degrees F.
5. The method of claim 3, wherein an efficacious internally applied heated air being delivered to said esophageal cancer located adjacent to the tracheoesophageal party wall sheath membrane, separating the trachea from the esophagus at a range of about 107 to 113 degrees F.
6. The method of claim 5, further comprising the step of inserting a subcutaneous needle probe temperature monitor into the in situ site of the esophageal tumor being treated and measuring the temperature of the tumor being treated.
6. The method of claim 5, further comprising the step of inserting a subcutaneous needle probe temperature monitor into the in situ site of the esophageal cancer being treated and measuring the temperature of the cancer being treated.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
