Notice of Pre–AIA or AIA Status
1. 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
Priority
2. The instant application is a National Stage Entry under 35 U.S.C 371 of International Patent Application No. PCT/EP2021/085935 filed on 12/15/2021, which claims priority to European Patent Application No. 20216253 filed on 12/21/2020.
Status of Claims
3. The cancellation of claims 5 – 10, 12, 14, 16, 17, 20, 21, 25, 27 – 35, 39, 42, and 43 and claim 2 pursuant to the amendments on 06/04/2024 and 10/06/2025, respectively, is acknowledged by the Examiner.
4. Applicant's election with traverse of group I and the species of avibirnavirus and solid cancer in the reply filed on 10/06/2025 is acknowledged. The traversal is on the ground(s) that the method claims of group II, corresponding to claims 23, 24, and 26, as amended read on the elected claims of group I, corresponding to claims 1, 3, 4, 11, 13, 15, 18, 19, 22, 40, and 41. The restriction requirement between groups I and II is withdrawn in response to applicant’s arguments and amendments. Applicant further argues that Coffey, M. C. and Thompson, B. G. (US 2016/0271193 A1; Published 09/22/2016; Cited in Applicant’s IDS on 06/20/2023, US Patent Application Publications, Cite No. 2), hereby Coffey ‘16, discussed in the Office Action mailed on 08/26/2025 is not applicable and that the restriction requirement should be withdrawn in its entirety. However, this is not found persuasive because the technical feature Coffey ‘16 teaches the usage of an oncolytic virus from the birnaviridae family (page 2, paragraph 0011, lines 1 – 15), whereas Bakács, T., et. al. (US 8398969 B2; Published 03/19/2013), hereby Bakács, teaches that infectious bursal disease virus (IBDV) belongs to the avibirnavirus genus and is a member of the birnaviridae family (column 3, lines 5 – 8). The restriction requirement between the method and kit claims is still deemed proper and is therefore made FINAL.
Claims 36 – 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species and there being no allowable generic or linking claim. Claims 1, 3, 4, 11, 13, 15, 18, 19, 22 – 24, 26, 40, and 41 are pending in this application and are under examination. Applicant timely traversed the restriction/election requirement in the reply filed on 10/06/2025.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 06/20/2023 has been considered by the examiner. However, the IDS fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non–patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All references have been considered except where lined through.
Specification
6. The disclosure contains an embedded hyperlink and/or other form of browser–executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser–executable code; references to websites should be limited to the top–level domain name without any prefix such as http:// or other browser–executable code. See MPEP § 608.01.
7. The use of the terms GoTaq®, Imlygic®, Avastin®, Erbitux®, Vectibix®, and possibly others in the specification, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM, or ® following the terms. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
8. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
9. The drawings are objected to under 37 CFR 1.84(u)(1), which states "view numbers must be preceded by the abbreviation "FIG.". In the instant case, the view numbers of Figures 1 and 2 is/are preceded by the word FIGURE instead of the abbreviation “FIG.”.
Corrected 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
10. Claims 1, 13, 15, 26, and 41 are objected to because of the following informalities:
In claim 1, line 3, the “a” is grammatically incorrect. It is recommended that the sentence read “an avibirnavirus”;
In claim 13(i), line 5, the comma after “carcinoma” should be a semicolon;
In claim 1, line 2, the comma after “RACK1” should be a semicolon;
In claim 1, line 1, the comma after “mutation” should be a semicolon;
In claim 41, line 3, the acronym “ORAOV1” has previously been defined in claim 15. An acronym should only be defined the first time it appears in the claims;
In claim 41, line 4, the acronym “VDAC2” has previously been defined in claim 15. An acronym should only be defined the first time it appears in the claims;
In claim 41, line 4, the acronym “RACK1” has previously been defined in claim 15. An acronym should only be defined the first time it appears in the claims;
In claim 41, line 4, the comma after “RACK1” should be a semicolon;
In claim 41, line 5, the comma after “mutation” should be a semicolon.
Appropriate correction is required.
Claim Rejections – 35 USC § 112
35 USC § 112(b)
11. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre–AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
12. Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre–AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre–AIA 35 U.S.C. 112, the applicant), regards as the invention.
13. The phrase “pancreatic ovarian carcinoma” in claim 13 renders the claim indefinite. Pancreatic carcinoma and ovarian carcinoma are two distinct types of cancer. Pancreatic ovarian carcinoma is not known in the art. In the interest of compact prosecution, it will be interpreted that the “pancreatic ovarian cancer” is a cancer of the pancreas, i.e., “pancreatic cancer”, as defined in the specifications, and since ovarian cancer has previously been listed in the claim. However, an appropriate amendment is required.
Claim Rejections – 35 USC § 103
14. 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.
15. Claims 1, 3, 4, 11, 13, 15, 18, 19, 22 – 24, 26, 40, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Coffey ‘16 in further view of Bakács; Coffey, M. C. and Thompson, B. G. (US 2007/0190032 A1; Published 08/16/2007), hereby Coffey ‘07; and Qin, Y., et. al., (2017). VP2 of Infectious Bursal Disease Virus Induces Apoptosis via Triggering Oral Cancer Overexpressed 1 (ORAOV1) Protein Degradation. Frontiers in Microbiology, 8, 1351, (Published 07/19/2017; Cited in Applicant’s IDS on 06/20/2023, Non–Patent Literature (NPL) Documents, Cite No. 9), hereby Qin.
Coffey ‘16 teaches a method of treating cancer in a subject that involves administering an oncolytic virus in combination with a chemotherapeutic agent (page 1, paragraph 0004, lines 1 – 5; page 58, claim 1), as recited in instant claim 1. It is taught that the cancer can be all types, including carcinomas, sarcomas, and melanomas, wherein the cancer is that of the lung, colon, head and neck, stomach, uterus, breast, cervix, ovary, pancreas, brain, and kidney (page 2, paragraph 0009, lines 1 – 13), as stated in instant claims 11 and 13. Coffey ‘16 goes on to teach that the cancer cells may have a mutation in which the ras gene is activated (page 2, paragraph 0012, lines 1 – 7; page 59, claim 34) and mutations or dysregulation of the double–stranded RNA activated protein kinase (PKR; page 2, paragraph 0012, lines 18 – 20), as defined in instant claims 15 and 41. Page 7, paragraph 0047, lines 4 – 6 further teach that the pharmaceutical composition used to treat the cancer includes one or more oncolytic virus and one or more chemotherapeutic agent, wherein the chemotherapeutic agent can be natural, semisynthetic, or synthetic to include monoclonal antibodies, alkylating agents, topoisomerase inhibitors, and anthracycline (page 1, paragraph 0006, lines 11 – 23; page 7, paragraph 0043, lines 1 –7), as defined in instant claims 23 and 24. Coffey ‘16 continues to teach that the virus can be administered in a variety of manners depending on the type of cancer, including orally, nasally, or by inhalation (page 8, paragraph 0055, lines 17 – 23), as recited in instant claim 40. It is further taught that the provided methods, i.e., the administration of the oncolytic virus with a chemotherapeutic agent, may be combined with other tumor therapies, including radiotherapy, surgery, hormone therapy and/or immunotherapy (page 9, paragraph 0062, lines 1 – 3), as required in instant claims 18 and 19.
While Coffey ‘16 does teach that the oncolytic virus can be from the birnaviridae family (page 2, paragraph 0011, lines 1 – 15), it fails to teach that the birnavirus employed is an avibirnavirus, as required in instant claim 1. Additionally, Coffey ‘16 fails to teach that the avibirnavirus is IBDV of strain 903/78, as recited in instant claims 1, 3 and 4. However, Bakács teaches that IBDV belongs to the avibirnavirus genus and is a member of the birnaviridae family (column 3, lines 5 – 8), as recited in instant claims 1 and 3. It is further taught that the IBDV designated as strain 903/78 is a viral replication inhibitory strain that does not have detrimental effects to the cells (column 1, lines 59 – 66), as stated in instant claim 4.
Coffey ‘16 also teaches that 103 – 1012 plaque forming units (PFU; page 10, paragraph 0070, lines 2 – 4; page 59, claim 27) or 108 – 1012 50% tissue culture infectious dose (TCID50; page 10, paragraph 0070, lines 6 – 8; page 59, claim 29) of the oncolytic virus is administered to the subject, as stated in instant claims 22 and 26. Moreover, Bakács teaches that each treatment dose of the IBDV 903/78 is 105 – 108 TCID50 (column 2, lines 13 – 16; column 5, lines 46 – 51; column 24, claim 7). The dosage of the avibirnavirus is clearly a result effective parameter that a person having ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient, i.e., the infectious units, needed to achieve the desired results. The principle of law states from MPEP §§ 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages," (see In re Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," (See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Furthermore, Coffey ‘16 teaches that the optimal dosages of viruses and therapeutic agents will depend on a variety of factors and an appropriate amount can be determine by one of ordinary skill in the art using routing experimentation (page 8, paragraph 0058, lines 1 – 11).
Both Coffey ‘16 and Bakács fail to teach where the sarcoma arises in the body, as recited in instant claim 13; and the overexpression of oral cancer overexpressed 1 (ORAOV1), voltage dependent anion channel 2 (VDAC2), and/or receptor of activated protein kinase C 1 (RACK 1 ) in the cancers, as defined in instant claims 15 and 41. While Coffey ‘16 does teach that the cancer can be a sarcoma (page 2, paragraph 0009, lines 1 – 13), it fails to teach that the sarcoma explicitly arises in the bone, muscle, fat, blood vessels, cartilage, and other soft or connective tissue of the subject, as required in instant claim 13. However, Coffey ’07 teaches that tumors originating from connective tissues, including muscle, fat, cartilage, and bone, are called sarcomas and can be treated by administering a combination of an oncolytic virus and immunosuppressive agent (page 1, paragraph 0006, lines 1 – 4; page 1, paragraph 0013, lines 2 – 11), as defined in instant claim 13. Furthermore, Qin teaches that ORAOV1 is a cellular protein that is commonly overexpressed in solid tumor cells, i.e., carcinomas (knockdown of ORAOV1 by RNAi induced apoptosis, page 8, line 1; discussion, page 16, left column, lines 16 – 20), wherein infection with IBDV causes a reduction in cellular ORAOV1 that could be developed as a cancer therapy (abstract, page 1, lines 4 – 7; discussion, page 17, right column, lines 19 – 24), as stated in instant claims 15 and 41.
Coffey ’16, Bakács, Coffey ’07, and Qin are considered to be analogous to the claimed invention because all are in the field of administering oncolytic viruses to treat a disease. Therefore, it would have been obvious to a person having ordinary skill in the art to have combined the method of treating cancer in a subject of Coffey ’16 with the IBDV 903/78 of Bakács, sarcomas of Coffey ’07, and ORAOV1 of Qin before the effective filing date of the claimed invention to provide a safe cancer therapeutic that is effective, inexpensive, easy to administer, and transport and storage stable (instant application; page 2, lines 21 – 23). All the claimed elements were known in the prior art. It would have been obvious to a person having ordinary skill in the art to have combined the elements as claimed by known methods with no change in their respective functions. The combination would have yielded nothing more than predictable results to one having ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415–421, 82 USPQ2d 1385, 1395–97 (2007) and MPEP §§ 2143A and 2143.02.
Conclusion
16. Claims 1, 3, 4, 11, 13, 15, 18, 19, 22 – 24, 26, 40, and 41 are rejected. No claims are allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Hallie N. Pennington, Ph.D. whose telephone number is (571)272–6781. The examiner can normally be reached M–Th 7:30–5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571)270–3497. The fax phone number for the organization where this application or proceeding is assigned is 571–273–8300.
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/HALLIE N. PENNINGTON, PH.D./Examiner, Art Unit 1671
/JANET L ANDRES/Supervisory Patent Examiner, Art Unit 1671