DETAILED ACTION
Applicant's response, filed 3/23/2026, has been fully considered.
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 filed 11/16/2023 is a Continuation of 15777234, filed 05/18/2018, now U.S. Patent # 11823799, which is a National Stage entry of PCT/EP2016/078353 with an International Filing Date of 11/21/2016, and further claims priority from Provisional Application 62257938, filed 11/20/2015, and foreign priority to European Application 15306845.7, filed 11/20/2015. The claims are therefore examined as filed on 11/20/2015, the effective filing date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further review of the priority application(s).
Claim Status
Claims 1-17 are pending.
Claims 4, 6-13, and 15-17 are withdrawn.
Claims 1-3, 5 and 14 are directed to the elected invention.
Claims 1-3, 5 and 14 are examined.
Claims 1-3, 5 and 14 are rejected.
Withdrawn Rejections
The rejection of claims 1-3 and 14 under 35 U.S.C. §103 over Al-EJEH and ROBERTS, in the Office action mailed 10/21/2025 is withdrawn in view of the amendments filed 03-23-2026, and persuasive argument that the cited prior art does not teach the limitation of using a set of genes comprising specifically between 20-1000 genes selected from the listed markers of tumor status, angiogenic and lymphangiogenic status, tumor microenvironment and markers of cell migration activity, and calculating and ranking their global variation amplitude to select a therapeutically targetable dominant signaling pathway for treatment (remarks pg 15-16).
The rejection of claim 5 over Al-EJEH, ROBERTS, and DREW in the Office action mailed 10/21/2025 is withdrawn in view of the amendments filed 03-23-2026, and withdrawal of the rejection of claims 1-3 and 14 above.
Drawings
Color photographs and color drawings (see Figs 6B - 14F, and 18) are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Response to Arguments – Drawings
In the reply filed 3/23/2026, the Applicant indicated that “drawings-only black and while line drawings” was selected as the document description when the application was filed and later changed when entered to “Drawings-other than black and white drawings”, and further asserts that color drawings are not required and will not be filed in the application (pg 13). The document description was changed because the drawings, specifically Figures 6B - 14F, and 18, contain color. Because these drawings contain color, and no petition to use color images has been filed, the objection to the drawings must be upheld.
As the Applicant indicates that the color drawings are not required, the Examiner recommends submitting black and white replacement drawings for the colored figures to resolve the objection.
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 1-3, 5 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, and 13 of U.S. Patent No. 11823799. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the claimed invention:
Claim 1 of the patent anticipates claims 1 and 2 of the invention.
Claim 2 of the patent anticipates claim 3 of the invention.
Claim 4 of the patent anticipates claim 5 of the invention.
Claim 13 of the patent anticipates claim 14 of the invention.
Response to Arguments- Double Patenting
In the reply filed 3/23/2026, Applicant asserts that the amended claims are not obvious over the claims of the cited patent (remarks pg 19). However, this is not persuasive, as the patent claims encompass the limitations of the present claims, and the amendment to the present claims does not sufficiently differentiate them from the limitations of the patent claims.
The Examiner acknowledges the Applicant’s consideration of filing a terminal disclaimer when allowable subject matter is indicated. At present, the double patenting rejection is the only rejection remaining.
Conclusion
All claims are rejected.
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.
/M.C.L./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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