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 .
Drawings
The drawings are objected to because the drawings of record on 8/23/2023 are erroneously labeled as “REPLACEMENT SHEET U.S. Appl. No. 16/967,542…”. (The drawings appear to be otherwise correct.)
Correctly labeled drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
The objection to the drawings will not be held in abeyance.
Claim Objections Withdrawn
The objection to claim 73, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment corrects the claim text as appropriate.
112(b) Rejections Withdrawn
The rejection of claim 73 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate.
112(d) Rejections Withdrawn
The rejection of claim 79 under 35 USC 112(d) or 35 USC 112 (pre-AIA ), fourth paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment rewrites the claim such that it is now in proper dependent form.
Double Patenting, MAINTAINED
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, 18-20, 24, 26, 27, 31, 34, 35, 38, 48, 50-52, 57, 68, 73, 75, 76, 78, 79 and 91, and now also including new claim 95, remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8-11, 13-15, 18-21, 25, 30, 32-35, 38, 39, 41 and 45 of (parent) U.S. Patent No. 11,771,700 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Inventor teaches a liposomal composition comprising a pegylated liposome encapsulating a gamma polyglutamated lometrexol containing 4, 5, 6, 1-10, 4-6 or more than 5 glutamyl groups in the D-form (claim 1).
US 11,771,700 B2 teaches a liposomal composition comprising a gamma polyglutamated lometrexol encapsulated by a liposome wherein the liposome comprises a gamma polyglutamated lometrexol containing 4, 5, 2-10, 4-6, or more than 5 glutamyl groups (patented claim 5). Furthermore, US 11,771,700 B2 teaches a liposomal composition comprising a gamma polyglutamated lometrexol encapsulated by a liposome wherein the liposome is pegylated (patented claim 8).
As can be seen from the outline above, the instant method is essentially fully encompassed by the patented method - albeit with the patented limitations condensed into single claim in the instant application. The remaining dependent patented claims and those of the instant invention are essentially related as listed below:
Instant claims 18-20 correspond to patented claim 6;
Instant claims 24 and 26 correspond to patented claim 9;
Instant claim 27 corresponds to patented claim 10;
Instant claim 31 corresponds to patented claim 11;
Instant claim 34 corresponds to patented claim 13;
Instant claim 35 corresponds to patented claim 14;
Instant claim 38 corresponds to patented claim 15;
Instant claim 48 corresponds to patented claim 18;
Instant claim 50 corresponds to patented claim 19;
Instant claim 51 corresponds to patented claim 20;
Instant claim 52 corresponds to patented claim 21;
Instant claim 57 corresponds to patented claim 25;
Instant claim 68 corresponds to patented claim 30;
Instant claim 73 corresponds to patented claims 38 and 39;
Instant claim 75 corresponds to patented claim 32;
Instant claim 76 corresponds to patented claim 33;
Instant claim 78 corresponds to patented claim 34;
Instant claim 79 corresponds to patented claim 35;
Instant claim 91 corresponds to patented claim 41;
and instant claim 95 corresponds to patented claim 45.
In short, the patented claims and those of the instant invention are drawn essentially to the same method, but with the pertinent limitations grouped slightly differently. Nonetheless, the broader patented claims fully encompass the instant invention.
Inventor has not addressed the rejection other than to request abeyance.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EST.
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, Ali Soroush, can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN J DAVIS/Primary Examiner, Art Unit 1614 3/4/2026