Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Reissue Applications
For reissue applications filed on or after September 16, 2012, all references to 35 U.S.C. 251 and 37 CFR 1.172, 1.175, and 3.73 are to the current provisions. This reissue application, filed October 23, 2023, is a reissue continuation of U.S. application Serial No. 17/177,550, filed Feb 17, 2021, now U.S. patent RE49,742, which is a reissue continuation of U.S. application Serial No. 16/899,848, filed June 12, 2020, now U.S. patent RE49,741, which is a reissue of U.S. Patent 9,993,438 (hereafter the '438 patent), which issued from U.S. application Serial No. 14/633,177 (the ‘177 application) with claims 1-5 on June 12, 2018.
Assignment of the ‘438 Patent
As noted in MPEP 1450.II, the original patent is surrendered when at least one reissue patent has been granted and there are no pending applications for reissue of the original patent. Accordingly, the ‘438 patent has not yet been surrendered because Applicant filed the instant reissue continuation application. Thus, the assignment for the ‘438 patent should be changed to Vivesto AB so as to align with the instant reissue application. Currently, the ‘438 patent is assigned to Oasmia Pharmaceuticals AB rather than Vivesto AB.
Certificate of Corrections
Since 16/899,848 and 17/177,550 have issued as reissue patents, it is requested that Applicant file a Certificate of Correction in each reissue patent to provide the cross reference to all the reissue applications of the ‘438 patent. As per MPEP 1451(I), it is suggested that the following language be used:
“Notice: More than one reissue application has been filed for the reissue of Patent No. 9,993,438. The reissue application numbers are 18/382,817, 17/177,550, 17/177,544 and 16/899,848.”
Rejections Overcome
The 35 USC 251 new matter rejection, the 35 USC 112(b) rejection, and the 35 USC 112(d) rejection have been overcome by Applicant’s amendment.
Reissue Declaration
The substitute statement for inventor Julian Aleksov filed 07/21/2026 is defective (see 37 CFR 1.175 and MPEP § 1414) because of the following:
The error statement in the substitute statement is incomplete as it ends in the middle of a sentence. Please provide a new substitute statement with a complete error statement.
Claims 6-35 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251 as set forth above. See 37 CFR 1.175.
The nature of the defect(s) in the reissue declaration is set forth in the discussion above in this Office action.
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 6-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-23 of U.S. Patent RE49,741 (hereinafter the ‘741 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the method in instant claims 6, 7, 17-21 and 29-35 teaches the limitations of, and thus, anticipates the method in claims 19-23 of the ‘741 patent.
With respect to the method in instant claims 8-16 and 22-28, the drug delivery system in claims 5-18 of the ‘741 patent teaches the limitations of instant claims 8-16 and 22-28, the difference being that claims 5-18 of the ‘741 patent do not set forth a method of treating a tumor disease with the drug delivery system. However, according to the ‘741 patent specification, the intended use of the drug delivery system is for treating a tumor disease (see, e.g., col. 2, line 52 through col. 3, line 4, and col. 9, lines 42-54).
It would have been obvious to one of ordinary skill in the art to have used the drug delivery system in claims 5-18 of the ‘741 patent for treatment of a tumor disease because such is taught in the ‘741 patent specification as a use of the drug delivery system. Accordingly, instant claims 8-16 and 22-28 are rendered obvious by the claims of the ‘741 patent.
Claims 6-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-29 of U.S. Patent RE49,742 (the ‘742 patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the drug delivery system in claims 6-29 of the ‘742 patent teaches the limitations of instant claims 6-35, the difference being that claims 6-29 of the ‘742 reference patent do not set forth a method of treating a tumor disease with the drug delivery system. However, according to the ‘742 patent specification, the intended use of the drug delivery system is for treating a tumor disease (see, e.g., col. 2, line 53 through col. 3, line 5, and col. 9, lines 42-54).
It would have been obvious to one of ordinary skill in the art to have used the drug delivery system in claims 6-29 of the ‘742 patent for treatment of a tumor disease because such is taught in the ‘742 patent specification as a use of the drug delivery system. Accordingly, instant claims 6-35 are rendered obvious by the claims of the ‘742 patent.
Response to Arguments
Applicant's arguments filed July 21, 2026 have been fully considered but they are not persuasive.
With respect to the non-statutory double patenting rejection, Applicant states that e-terminal disclaimers were filed with their response (Remarks p. 13). However, no terminal disclaimers accompanied Applicant’s response, and thus, the non-statutory double patenting rejections are maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceed-ing in which Patent No. 9,993,438 is or was involved. These proceedings would include interferences, reissues, reexaminations, and litigation. Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is mate-rial to patentability of the claims under consideration in this reissue appli-cation. These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN D DIAMOND whose telephone number is (571)272-1338. The examiner can normally be reached Monday through Thursday 5:30 am to 3:00 pm, and Fridays from 5:30 am to 9:30 am.
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, Patricia Engle can be reached at 571-272-6660. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/ALAN D DIAMOND/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991
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