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 .
Priority
This application was filed 10/27/2023 and is a 371 of PCT/US2022802633 (04/26/2022). Claims 1, 4-5, 34, 36 and 44 are before the Examiner.
Election/Restriction
Applicant elected group 1 during a telephone election on 04/06/2026. In the responds dated 07/15/2026, all non-elected claims have been deleted, confirming the election.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The rejection of claims 1, 34, 36 and 44 under 35 U.S.C. 102(a)(1) as being anticipated by WO2014/168941, as stated in paper dated 04/21/2026, is upheld. As previously stated, WO teaches LB-100 (page 1 line 28, page 28 line 25 as two or more ingredients and page 34 line 1) in combination with another active anti-cancer agent. WO names several known anti-cancer agents, one of which is gemcitabine (page 42 line 29, which lists the anti-cancer agents in alphabetical order). The abstract and page 1 line 26 has a PP2A inhibitor to treat cancer. Cancer treatment is listed on page 1 line 21, page 30 line 1 and page 36 line 5. This anticipates claim 1. Pancreatic cancer is listed on pages 30 line 8, page 34 line 5 and page 36 line 12 which anticipates claim 44. Wo teaches sealed packages of LB-100 with other active ingredients on pages 3 line 10 and lines 15-20 with saline solutions. This anticipates claims 34 and 36. A second anti-cancer agent is taught (page 30 lines 18-19). Claim 27 is anticipated by WO page 30 line20 docetaxel being the second active agent; paclitaxel page 42 last line and doxorubicin on page 4 line 14, among others. Claim 43 is anticipated by page 42 line29 with gemcitabine. Pancreatic cancer is taught on page 36 line 12 anticipates claim 4445 is anticipated b page 1 line 25 teaching of LB-100. ). Claim 1 has language that “comprises LB-100” and “comprises gemcitabine”. This is open language. Thus, other active ingredients such as docetaxel and paclitaxel can be in this composition and not exclusively LB-100 and gemcitabine.
Applicant argues in paper dated 07/15/2026 that Kovach (WO) does not specifically call for the combination of LB-100 and gemcitabine and that gemcitabine is not specifically called out. However, the instant claims are not specific to the combination of LB-100 and gemcitabine only by the use of “comprises”. Further, Kovach (WO) does not limit the pharmaceutical composition to only LB-100 and one other ingredient. Kovach lists several well-known anti-cancer agents and teaches that any of the can be combined with LB-100 to treat cancer in a composition. This gives the ordinary artisan the ability to immediately envision the combination of LB-100 and gemcitabine. Kovach teaches that any of the listed drugs can be combined with LB-100 and create an advantage in the pharmaceutical composition (page 63 line 1). The rejection of claims 1, 34, 36 and 44 over WO 2014/168941 is upheld.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The rejection of claims 4-5 under 35 U.S.C. 103 as being unpatentable over WO2014168941, D’Arcy and Gilad, as stated in paper dated 04/21/2026, is upheld. As previously stated, WO teaches the treatment of cancer with LB-100 which is a PP2A inhibitor (pg. 1 l 25-26) with other active ingredients (pg. 1 l 26 , pg30 l18-19, pg42 l29) such as cisplatin (pg30 l 20) and gemcitabine (pg42 l29) and such a combination gives an advantage (page 63 line 1). Gilad teaches drug combination in cancer treatment and careful optimization of administration scheduling (page 10 or 25). D’Arcy teaches the treatment of cancer with LB-100 which is a PP2A inhibitor with other active ingredients (pg557 second paragraph). The cited art does not specifically teach the administration of the drugs either simultaneously or sequentially. WO does teach how to administer the composition and that the ordinary artisan can use any of the delivery systems well known in the art (page 43 line 34 – page 45 line 27). The use of combination drug treatment is well known in the art and the ability to give the drugs either simultaneously or sequentially is well known in the art. The ordinary skilled artisan can use any technique known in the art to most effectively treat cancer (as is taught by WO on page 43 line 34 – page 45 line 27). Further the use of a kit containing two known cancer drugs in their pharmaceutical compositions (such as saline as taught by WO page 43 lines 26-32) is well within the skills of the ordinary artisan to optimize the treatment of cancer. WO teaches that the combination of LB-100 with other known anti-cancer agents (with gemcitabine being specifically named in the WO) gives an advantage (page 63 line 1 of WO).
Applicant argues in paper dated 07/15/2026 that the combination of LB-100 and gemcitabine gives a synergistic effect. First, WO teaches the combination of LB-100 and another agent from the listed agents (including gemcitabine) gives an advantage to the combination (page 63 line 1). Second, the claims are not limited to the combination of LB-100 and gemcitabine due to the use of “comprises” in the claims such that other ingredients can or are in the composition. Third, the claims are not limited to the synergistic combination of LB-100 and gemcitabine. The above rejection of claim under 35 USC 103 is upheld.
Conclusion
No claim is allowed.
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 D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
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