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 .
Power of Attorney
Applicant filed a Power of Attorney on 9/19/2025, which was accepted on 9/24/2025.
Claim Amendments
Claim 1 has been amended to add the phrase “in need thereof, thereby treating cancer or recurrent cancer in the subject (lines 4-5) and incorporate the limitation of claim 6, which has been canceled. Moreover, claims 2 and 4 have been amended to obviate claim objections.
Claims 1-5 and 7 remain pending and have been examined on the merits.
Claim Objections
RE: Objection to the claims
The corrections on claims 2 and 4 are sufficient to overcome the claim objections. However, the amendment on claim 4 necessitates a new objection and is set forth below.
New objection
Claim 4 is objected to because of the following informality: lack of space before the open parenthesis symbols. To rectify this issue, applicant must amend lines 3-4 to “Programmed Death-Ligand 1 (PD-1L1) inhibitor, a Programmed Death-1 (PD-1) inhibitor, and a Cytotoxic T-Lymphocyte-Associated protein 4 (CTLA-4) inhibitor”.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
RE: Rejection of claims 1-6 under 35 U.S.C. 102(a)(2) as being anticipated by Coffin
Traversal of rejections is based on the cited prior art failing to teach every element of the claimed subject matter. Applicant points out that Coffin merely mentions reovirus as an oncolytic virus and oral administration as one of various administration routes. It is asserted that experiments were only performed on Herpes Simplex Virus (HSV) and administering it via intra-tumoral injection.
Applicant’s traversal has been fully considered and is found unpersuasive. According to MPEP § 2123, “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments”. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). So even though HSV is the preferred oncolytic virus and the only oncolytic virus evaluated experimentally, it does not negate Coffin’s teaching that other oncolytic viruses like reovirus are suitable for treatment of cancer. Furthermore, MPEP § 2131.02(II) states that a prior art that names the claimed species anticipates the claim regardless of the number of other named species. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught). Thus, oral administration is as applicable as the other listed administration routes.
The claimed method is therefore considered anticipated by the cited prior art. But to address the claim amendments, the rejections of record have been withdrawn. Modified prior art rejections are presented below.
Modified rejections
Claims 1-5 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Coffin (Pub. No. WO 2019/243847 A1).
Coffin discloses improved oncolytic viruses having improved direct oncolytic effects that can improve therapeutic effects in patients (lines 22-26, page 5), as well as a pharmaceutical composition comprising the oncolytic virus and a pharmaceutically acceptable carrier or diluent (lines 21-32, page 42). The composition can be formulated for any suitable route and means of administration (lines 6-7, page 43) including through oral administration (line 26, line 48).
The oncolytic virus has the following properties:
(a) is, or derived from, a clinical isolate which has been selected by comparing the abilities of a panel of three or more clinical isolates of the same viral species to kill tumor cells of two or more tumor cell lines in vitro and selecting a clinical isolate which is capable of killing cells of two or more tumor cell lines more rapidly and/or at a lower dose in vitro than one or more of the other clinical isolates in the panel;
(b) comprises (i) a fusogenic protein-encoding gene and (ii) an immune stimulatory molecule-encoding gene;
(c) comprises (i) a GM-CSF-encoding gene and (ii) an immune co-stimulatory pathway activating molecule or immune co-stimulatory pathway activating molecule-encoding gene; and/or
(d) comprises a gene encoding a CTLA-4 inhibitor (lines 10-21, page 10).
The oncolytic virus can be utilized in a method of treating or preventing cancer such as triple negative breast cancer, small cell lung cancer, advanced recurrent head and neck cancer, colorectal cancer, and recurrent melanoma after surgery (lines 4-5, page 1; lines 29-32, page 9; line 19, page 10; lines 4-13, page 44). The cancer is in a mammal, preferably in a human (lines 16-18, page 43).
The disclosed oncolytic virus can be administered in combination with other therapeutic agents including immunomodulators such as agents designed to block immune checkpoints (lines 28-30, page 44), preferably a PD-L1 inhibitor, a PD-1 inhibitor, and a CTLA-4 inhibitor (lines 1-3, page 46).
Coffin reads on the instant application’s method as follows:
Regarding claim 1: administering a therapeutically effective amount of the oncolytic virus to an individual in need thereof, wherein said oncolytic virus can be reovirus (lines 25-26, page 22) and provided as a pharmaceutical composition (lines 21-32, page 42), is the same as “administering a composition comprising a reovirus; or a reovirus-treated biological sample as an active ingredient into a subject”.
Using the oncolytic virus or its composition to treat cancer such as advanced recurrent head and neck cancer, colorectal cancer, and recurrent melanoma after surgery (lines 4-5, page 1; lines 28-32, page 9; line 19, page 10; lines 4-13, page 44) during stage I, II, III, or IV cancer or following recurrence (lines 4-9, page 49) satisfies the intended function “treating cancer or recurrent cancer” and the effect “thereby treating cancer or recurrent cancer in the subject”.
Orally administering the pharmaceutical composition containing the oncolytic virus (line 26, line 48) is identical to “wherein the reovirus or the reovirus-treated biological sample is orally administered”.
Hence, claim 1 is anticipated by Coffin.
Regarding claim 2: the cancer being treated includes cervical cancer, pancreatic cancer, small cell lung cancer, non-small cell lung cancer, liver cancer, colon cancer, colorectal cancer, melanoma or other skin cancer, head and neck cancer, ovarian cancer, breast cancer, endometrial cancer, esophageal cancer, prostate cancer, bladder cancer, and kidney cancer (lines 30-32, page 43; lines 1-18, page 44) meets the limitation “wherein the cancer is one or more selected from the group consisting of cervical cancer, lung cancer, pancreatic cancer, non-small cell lung cancer, liver cancer, colon cancer, colorectal cancer, bone cancer, skin cancer, head and neck cancer, skin melanoma, intraocular melanoma, uterine cancer, ovarian cancer, rectal cancer, brain cancer, blood cancer, stomach cancer, perianal cancer, breast cancer, fallopian tube carcinoma, endometrial carcinoma, vaginal cancer, vulvar carcinoma, Hodgkin's disease, esophageal cancer, small intestine cancer, endocrine gland cancer, thyroid cancer, parathyroid cancer, adrenal cancer, soft tissue sarcoma, urethral cancer, penile cancer, prostate cancer, bladder cancer, kidney cancer, urinary tract cancer, renal cell carcinoma, renal pelvic carcinoma, CNS central nervous system (CNS) tumors, primary CNS lymphoma, spinal cord tumors, brainstem glioma, and pituitary adenoma”.
Regarding claim 3: the oncolytic virus being used in combination with other therapeutic agents such as agents designed to block immune checkpoint (lines 26-30, page 45; lines 17-23, page 46) is equivalent to “further comprising an immune checkpoint inhibitor.”
Regarding claim 4: applicable immune checkpoint blockers include a PD-L1 inhibitor, a PD-1 inhibitor, and a CTLA-4 inhibitor (lines 1-3, page 46), which fulfills “wherein the immune checkpoint inhibitor is one or more selected from the group consisting of a PD- L1 inhibitor, a PD-1 inhibitor, and a CTLA-4 inhibitor”.
Regarding claim 5: administering the oncolytic virus before, together, or after a therapeutic agent such as an immune checkpoint inhibitor is analogous to “wherein the reovirus or the reovirus-treated biological sample; and the immune checkpoint inhibitor are simultaneously, separately or sequentially administered”.
Regarding claim 7: the pharmaceutical composition is further specified to result in “increases infiltration of CD8+ T cells into a tumor”.
The prior art does not explicitly teach this limitation.
Nonetheless, this can be considered an inherent property. As such, it does not need to be recognized at the relevant time. Furthermore, MPEP § 2112(I) states that “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
RE: Rejection of claim 1-7 under 35 U.S.C. 103 as being obvious over Coffin in view of Conner
In addition to the arguments discussed above, Applicant contends that Conner focuses on oncolytic Herpes Simplex Virus, specifically HSV1716. It is also argued that Conner does not teach oral administration of a reovirus.
All arguments have been fully considered and are found unpersuasive. It is conceded that Conner only utilized reovirus as a control group in the working examples and only teaches administering intrathoracically or through intratumoral injection, intravenous infusion, or intraperitoneal injection. However, Conner was applied as a secondary reference to address the limitation of claim 7, i.e., to show that administering a reovirus is known to activate CD8+ cells. The primary reference discloses using an oncolytic virus to treat cancer and administering it orally.
It is therefore respectfully submitted that the claimed method is obvious over Coffin in view of Conner. The rejections of record have been modified to address claim amendments.
Modified rejections
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being obvious over Coffin (Pub. No. WO 2019/243847 A1) in view of Conner (Pub. No. US 2018/0207212 A1).
The teachings of Coffin are set forth above and applied herein. Coffin is found to anticipate claims 1-5 and 7.
Regarding claim 7: the pharmaceutical composition is further specified to result in “increases infiltration of CD8+ T cells into a tumor”.
Although Coffin does not explicitly teach the limitation of the instant claim, Conner demonstrates that administering an oncolytic virus like reovirus (“reo” in Figure 37) activates CD8+ cells (par. [0395]). Since this type of cells are known for directly killing tumor cells, there would be reasonable expectation that administering reovirus would activate CD8+ cells. Consequently, more CD8+ cells would infiltrate a tumor in order to kill the tumor cells present therein.
Thus, claim 7 is obvious over Coffin in view of Conner.
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.
RE: Nonstatutory double patenting rejections
Applicant traverses the rejections because co-pending application 18/258853 is directed to a method of using a modified reovirus for treating cancer, whereas the claimed method of treating cancer or recurrent cancer uses reovirus or a reovirus-treated biological sample. In addition, applicant submits that the co-ending application is a later-filed application and that the double patenting rejections will be addressed later through filing of a Terminal Disclaimer or applicant’s arguments.
The traversal has been fully considered and is found unpersuasive. First, the claims of the instant application do not recite a particular type of reovirus given that the term “a reovirus” is generic and encompasses both non-modified and modified reoviruses. Second, even if the claims specify using a non-modified reovirus, the co-pending application teaches an embodiment wherein the pharmaceutical composition is co-administered with a wild-type reovirus (claims 13-14). Lastly, none of the claims are in condition for allowance, and thus, the provisional double patenting rejections should be maintained in accordance with MPEP 804(I)(B)(1)(b)(i).
But since the claims of the instant application have been amended, the rejections have been modified as shown below.
Modified rejections
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of co-pending Application No. 18/258853 in view of Coffin (Pub. No. WO 2019/243847 A1); and claims 1-5 and 7 over co-pending Application No. 18/258853 in view of Conner (Pub. No. US 2018/0207212 A1).
The co-pending application is directed to a modified reovirus, a pharmaceutical composition comprising said modified reovirus, a kit comprising the pharmaceutical composition, and a method for preventing or treating cancer.
The method for preventing or treating cancer comprises administering the modified reovirus to a subject in need thereof. In some embodiments, the pharmaceutical composition is intended for preventing or treating cancer like cervical cancer and lung cancer. It can also further comprise an immune checkpoint inhibitor, wherein the immune checkpoint inhibitor is one or more selected from a group that includes PD-L1 inhibitor, PD-1 inhibitor, and CTLA-4 inhibitor. Alternatively, the modified reovirus-containing pharmaceutical composition and the immune checkpoint inhibitor can be co-administered simultaneously, separately, or sequentially.
The method disclosed by the co-pending application does not specify how the modified reovirus is administered. Despite this, oral administration of an oncolytic virus is a known technique in the art. Coffin, for example, teaches administering an oncolytic virus like reovirus to a subject through a variety of routes including oral administration (lines 17-26, page 48). A person with ordinary skill in the art before the effective filing date of the claimed invention would have thus orally administered the modified reovirus to a subject in need thereof and expect that it would facilitate treatment of cancer.
The co-pending application’s method also does not specify the effect of the pharmaceutical composition. But as discussed above (see 103 rejection), Conner shows that administering reovirus leads to activation of CD8+ cells (Figure 37; par. [0395]). Since the function of this type of cells is to kill tumor cells, it can be predicted that administering the modified reovirus would activate CD8+ cells, thereby increasing the infiltration of tumor cells.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651