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 .
Applicant’s amendment and response filed on 10/28/2025 has been received and entered into the case.
Claims 10-21, 29-32 and 37-66 have been canceled, claims 1-9 and 33-36 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 22-28 have been considered on the merits. All arguments have been considered.
Response to Amendment
The claim rejection under 35 USC 112(b) has been withdrawn due to the instant amendment.
The claim rejection under 35 USC 103 has been withdrawn due to the instant amendment and the declaration filed on 10/28/2025 that disqualified Chawla2019.
Priority
The earliest filing date of the claimed invention was previously determined as the filing date of PCT/US2020/027995, which is 4/13/2020.
Claim Objections
Claim 26 is objected to because of the following informalities: claim 26 was amended in the claim set filed 12/11/2024, however, the instant claim does not show the amendment. The term “any of” in line 1 should be deleted, and the “claims 22” should be “claim 22”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant amendment to claim 22 directed to the method for improving the survival of an individual with a metastatic tumor would be over 10 years and the therapeutically effective amount of CCNG1 inhibitor of greater than 1011 cfu to the individual with CCNG1 overexpression and/or Myc amplification.
The instant specification discloses an example (Example 1) showing the administration of 8x1011 cfu to 48x1011 cfu/6-week cycle of DeltaRex-G to 20 patients, and out of 20 patients, only 1 patient was alive after 10 years, and the 10-year-survival patient had bone metastases (paras. 43-46). According to Table 3, overall survival of 1 year was not even 100% to any of dose level. The listed dose levels except dose level I meet the claimed “greater than about 1011 cfu”. It is noted that the patients of the Example 1 were not disclosed to be identified to have CCNG1 overexpression or Myc amplification.
Example 2 of the instant specification summarized various studies for “long-term” data of patients with advanced chemotherapy-resistant malignancies treated with DeltaRex-G and DeltaVax, and the survival analysis showed 5% 10-year overall survival rate for DeltaRex-G alone and 18.8% for DeltaRex-G+DeltaVax (para. 50).
These disclosure does not support the claimed invention: none of these examples require a selection of the patients having overexpression of CCNG1 and/or Myc amplification as claimed. There is no indication that the 10-year survived patient shown in Example 1 was selected by the step of identifying the patient as required by the step (a) of claim 22. Example 2 as discussed above were from previously reported studies, and thus, the patients would not be screened for the overexpression of CCNG1 and/or Myc amplification. Furthermore, the studies listed in Example 2 do not disclose the dosages, and thus, the data shown in Example 2 merely indicate that DeltaRex-G would be somewhat effective in certain patients. However, this does not support that the claimed invention would be effectively improve the survival of the patients having metastatic tumor and overexpression of CCNG1 and/or Myc amplification as required by the claims.
Example 3 of the instant specification discloses that out of 451 patients, there are 33 patients having genetic mutations along the CCNG1 pathway, 2 patients having Myc amplification, and only 1 patient having CCNG1 overexpression. It is not known how many patients out of 33 that have genetic mutations along with CCNG1 pathway are metastatic as Table 5 shows not all of the patients have metastatic. While it appears that these limited number of patients were determined to have CCNG1 pathway mutation, Myc amplification or CCNG1 overexpression, however, the limited number of examples would not necessarily support the claimed invention as it requires a specific patient population having metastasis and CCNG1 overexpression/Myc amplification. As Furthermore, the studies in Example 3 do not disclose the dosage of the CCNG1 inhibitor, DeltaRex-G.
While DeltaRex-G treatment appears to produce or improve overall survival of the metastatic tumor patients, and some of these patients were determined to have claimed features of genetic mutation in CCNG1 pathway; Myc amplification; and/or CCNG1 overexpression based on the post-test analysis on the tumor, however, there is no showing that the identified metastatic patient group having these features would be necessarily improved in their survival over 10 years as claimed. In other words, while the improved patients by treating with DeltaRex-G or CCNG1 inhibitor contains a subpopulation of patients having the claimed features, however, all patients having these features are necessarily and sufficiently improved their survival upon the administration of DeltaRex-G as there is no evidence shown in the instant application.
Therefore, it is considered that the instant specification does not provide any support that the claimed improvement in survival rate over 10 years in the metastatic patients identified for overexpression of CCNG1 and/or myc amplification. Thus, the instant amendment introduces new matter to the instant application.
Claim 22 discloses the therapeutically effective amount of a CCNG1 inhibitor of greater than about 1011 cfu. Considering that there are several different CCNG1 inhibitors known in the art, and the instant specification as well as the claims specifically disclose “DeltaRex-G”, the scope of claim 22 with regard to the therapeutically effective amount to improve the survival over 10 years of the metastatic cancer patient as claimed is broader than the disclosure of the instant specification. Thus, the instant amendment introduces new matter to the instant application.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06 - § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
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.
Claims 22-28 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.
Claim 22 discloses the term “greater than about”. It is not clear what the lower limit of the number is referred by this term. As the term “greater than” requires a number for the lower end, i.e. at the minimum requirement, and the term “about” does not provide clear boundary of the range, one cannot determine what the minimum number of the claimed range, and thus, it is indefinite by using “greater than” and “about” together in defining the range in the claims. Applicant is advised to amend the term as “greater than”.
Response to Arguments
Applicant’s arguments with respect to claim(s) 22-28 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
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.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631