DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
2. Applicant’s election without traverse of Group I (claims 1-9, & 24-32) in the reply filed on 04/06/2026 is acknowledged. Claims 10-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
3. Claims 1-9 & 24-32 have been examined on the merits.
Specification
4. The disclosure is objected to because of the following informalities:
The paragraph beginning at pg. 1, line 5 of the as-filed Specification, entitled “Related Applications,” should be amended to include the Patent Number (U.S. 11,497,554) of the Parent Application (U.S. 15/831,615).
Appropriate correction is required.
Claim Objections
5. Claim 5 is objected to because of the following informalities:
In claim 5, line 5, the recitation of “increases microwave of electromagnetic heating” should instead recite --increases microwave or electromagnetic heating--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
6. 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.
7. Claims 1-9 & 24-32 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
8. Claim 1 recites the limitation “the temperature” in line 10. There is insufficient antecedent basis for this recitation in the claim.
9. Claim 1 recites the limitation “the therapy drug agent” in line 12. There is insufficient antecedent basis for this recitation in the claim.
10. Claims 2-9 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
11. Claim 5 recites the limitation “the temperature of the heat substrate agent” in line 4. There is insufficient antecedent basis for this recitation in the claim.
12. Claim 6 is rejected as ultimately depending from a claim (claim 5) rejected under 35 U.S.C. 112(b).
13. Claim 6 recites the limitation “the reverse change polymer” in lines 1-2. There is insufficient antecedent basis for this recitation in the claim.
14. Claim 9 recites the limitation “the temperature of the second combination therapy formulation” in lines 13-14. There is insufficient antecedent basis for this recitation in the claim.
15. Claim 9 recites the limitation “the second therapy drug agent” in line 15. There is insufficient antecedent basis for this recitation in the claim.
16. Claim 24 recites the limitation “the temperature” in line 3. There is insufficient antecedent basis for this recitation in the claim.
17. Claim 24 recites the limitation “the therapy drug” in lines 6-7. There is insufficient antecedent basis for this recitation in the claim.
18. Claim 24 recites the limitation “the temperature of the therapy drug” in line 11. There is insufficient antecedent basis for this recitation in the claim.
19. Claims 25-32 are rejected as ultimately depending from a claim (claim 24) rejected under 35 U.S.C. 112(b).
Double Patenting
20. 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 1.321I 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 §§ 706.02(l)(1) – 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
21. Claims 1, 2, 4, 7, 24, 27-29, & 32 are rejected on the ground of non-statutory double patenting as being unpatentable over claim 11 of U.S. Patent No. 11,497,554 (the “’554 Patent”).
22. Although the claims at issue are not identical, they are not patentably distinct from
each other because any matters of differing claim scope between the instant claims and the issued claims would be resolved and obvious to one of ordinary skill in the art in view of the various references of record. Further, while the subject matter may differ in language or slightly in scope, each of the instant claims listed below are not considered distinct from the associated claim(s) of the ‘554 Patent. At least the following relationships are noted by the Examiner:
Instant claim 1 to claim 11 of the ‘554 Patent;
Instant claim 2 to claim 11 of the ‘554 Patent;
Instant claim 4 to claim 11 of the ‘554 Patent;
Instant claim 7 to claim 11 of the ‘554 Patent;
Instant claim 24 to claim 11 of the ‘554 Patent;
Instant claim 27 to claim 11 of the ‘554 Patent;
Instant claim 28 to claim 11 of the ‘554 Patent;
Instant claim 29 to claim 11 of the ‘554 Patent; and
Instant claim 32 to claim 11 of the ‘554 Patent.
Allowable Subject Matter
23. Claims 1-9 & 24-32 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(b) set forth in this Office action, and upon submission and approval of a Terminal Disclaimer to obviate the non-statutory double-patenting rejection set forth above.
24. Independent Claim 1
Independent claim 1 is directed to a localized therapy drug delivery method comprising:
“administering to a patient a combination therapy formulation, the combination therapy formulation comprising: a therapy drug; a heat substrate agent; and a polymer, the combination therapy formulation formulated for direct delivery to a target tissue at a target site; and fixing the heat substrate agent by hardening the polymer at the target site” (emphasis added).
Claim 1 further requires:
wherein:
hardening the polymer at the target site comprises heating the heat substrate agent with an external energy source to increase the temperature of the combination therapy formulation substantially uniformly beyond a given temperature; and
hardening the polymer expels the therapy drug agent at the target site to deliver the therapy drug over an extended time.
Emphasis added.
While the administration/delivery of formulations to a target site for the purpose of enhancing microwave therapies for treating cells and tissues was generally known [see, e.g., U.S. 2013/0336897 to Wolf et al. (of record), and U.S. 2011/0034916 to Te et al. (of record)], none of the references of record, either alone or in combination, fairly teach or suggest fixing a heat substrate agent (of a combination therapy formulation) at a target site by hardening the polymer (also of the combination therapy formulation) at the target site by heating the heat substrate agent with an external energy source to increase the temperature of the combination therapy formulation in order to expel the therapy drug (of the combination therapy formulation). As such, independent claim 1 is allowable over the references of record.
25. Independent Claim 24
Independent claim 21 is directed to a therapy formulation, and includes limitations similar to those addressed above in the discussion of independent claim 1. Accordingly, independent claim 24 is allowable for the same reasons.
Conclusion
26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794
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