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 .
DETAILED ACTION
Status of claims
Claims 1-6 are pending and under examination in this office action
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed 1/6/25. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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 1-6 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1 - 13 of U.S. Patent No. 11419842; US 10780172 (claims 1-12) and US Patent 10500285 (claims 1-19). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to a composition and method of treating cancers with the composition comprising docetaxel and human serum albumin, wherein the composition is a solid formulation, wherein the molar ratio of Docetaxel and the human serum albumin in the composition is from about 0.1:1 to about 5:1, wherein the pH of the composition is from 5.8 or wherein the docetaxel and the HAS is 1:60 -1:1300; 1:1000 as in the claims. The ratios overlap in scope and therefore it is within the purview of the skilled artisan to modify and used in the treatment of cancer with a reasonable expectation of success
· Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims and methods are obvious variation of each other. Therefore one of ordinary skill in the art would have been motivated to use the patented claims in practicing the instant claimed invention.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-6 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11510895 and US patent no. 10980792 (claims 1-16) in view of Teng et al. (CN-105012251). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to a composition and method of treating cancers with the composition comprising docetaxel and human serum albumin, wherein the composition is a solid formulation, wherein the molar ratio of cabazitaxel and the human serum albumin in the composition is from about 0.1:1 to about 5:1, wherein the pH of the composition is from 5.8 or wherein the docetaxel and the HAS is 1:50 -1:100 as in the claims. The only difference is that the instant claims recites a solid which is dissolved in an aqueous solution and the patent claims recites a clear solution.
Keng teaches a composition comprising taxane wherein the taxane is cabazitaxel, wherein the taxane is from 10-20% taxane and 20-70 wt% and the albumin maybe human serum and such concentration will result in or overlap in the range recited in the claims. Therefore it would have been obvious to one of ordinary skill in the art to substitute docetaxel with cabazitaxel with a reasonable expectation of success because docetaxel and cabazitaxel are in the same class of taxanes and would expect success in doing so.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 1-6 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11413265 in view of Teng et al. (CN-105012251). Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to a composition and method of treating cancers with the composition comprising docetaxel and human serum albumin, wherein the composition is a solid formulation, wherein the molar ratio of cabazitaxel and the human serum albumin in the composition is from about 0.1:1 to about 5:1, wherein the pH of the composition is from 5.8 or wherein the docetaxel and the HAS is 1:50 -1:100 as in the claims. The only difference is that the instant claims recites a solid which is dissolved in an aqueous solution and the patent claims recites a clear solution.
Keng teaches a composition comprising taxane wherein the taxane is cabazitaxel, wherein the taxane is from 1020% taxane and 20-70 wt% and the albumin maybe human serum and such concentration will result in or overlap in the range recited in the claims. Therefore it would have been obvious to one of ordinary skill in the art to substitute docetaxel with cabazitaxel with a reasonable expectation of success because docetaxel and cabazitaxel are in the same class of taxanes and would expect success in doing so.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
Claims 21-31 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12090135. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· Both sets of claims refer to a composition and method of treating cancers with the composition comprising docetaxel and human serum albumin, wherein the composition is a solid formulation, wherein the molar ratio of Docetaxel and the human serum albumin in the composition is from about 0.1:1 to about 5:1, wherein the pH of the composition is from 5-8. Wherein obtaining the pharmaceutical composition steps are almost identical with the patented claims. And therefore the pharmaceutical composition of the patented claims would have been used to treat cancer as recited by the instant claim.
· Both applications recite using the same compositions and/or derivatives thereof. The compositions recited in the claims and methods are obvious variation of each other. Therefore one of ordinary skill in the art would have been motivated to use the patented claims in practicing the instant claimed invention.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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, Robert A. Wax can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 6/18/26
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