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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/14/2026 has been entered.
Status of the Claims
2. Claims 1-65 are the original claims filed 3/8/2023. IN the Preliminary Amendment of 10/2/2023, claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33-38, 45-50, and 64-65 are amended, claims 4-11, 13-14, 16, 18- 19, 21-22, 24-25, 27-28, 30-32, 39-44 and 51-63 are canceled, and new claims 66-67 are added. In the Response of 4/13/2026, claims 1-3, 17, 20, 23, 26, 33-38, 45-46, and 66-67 are amended and claim 64 is canceled. In the Response of 8/14/2026, claims 1-3, 33-38, 45, 46, 66, and 67 are amended and claim 65 is canceled.
Claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33-38, 45-50, and 66-67 are pending.
The Office Action contains new grounds for rejection.
Priority
3. USAN 18/025 203, filed 03/08/2023, and having 1 RCE-type filing therein, is a National Stage entry of PCT/EP2021/075016, International Filing Date: 09/10/2021, PCT/EP2021/ 075016 Claims Priority from Provisional Application 63/076,797, filed 09/10/2020. The contents of the provisional application are similar to that of the instant application. The contents are hypothetical in both cases for the method dose regimen for treating DLBCL. Written description support and enablement for the claimed invention is provided in ClinicalTrials.gov ID NCT05578976.
Information Disclosure Statement
4. As of 9/21/2026, a total of eight (8) IDS is filed: 9/14/2023; 9/14/2023; 9/14/2023; 9/14/2023; 9/14/2023; 4/13/2026; 4/13/2026; and 8/14/2026. The corresponding initialed and dated 1449 form is considered and of record. The submissions follow the provisions of 37 CFR 1.97.
Withdrawal of Rejections
Double Patenting
5. The rejection of Claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33-38, 45-50, and 65-67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11845805 is moot for the canceled claim(s) (Claim 65) and withdrawn for the pending claims.
The terminal disclaimer filed on 8/14/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11845805 has been reviewed and is accepted. The terminal disclaimer has been recorded.
6. The provisional rejection of Claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33-38, 45-50, and 64-67 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 12, 15, 17, 20, 23, 26, 29, 33-38, 46-50, 64-67 of copending Application No. 18/500,799 (US 20240301078) is moot for the canceled claim(s) (Claim 65) and withdrawn for the pending claims.
The terminal disclaimer filed on 8/14/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of Application No. 18/500,799 has been reviewed and is accepted. The terminal disclaimer has been recorded.
New Grounds for Objection
Claim Objections
7. Claims 1 and 29 are objected to because of the following informalities:
a) Amend claim 1 for proper punctuation, i.e., insert a colon (:) at “wherein: (a)”; and insert a semi-colon (;) between (a)(iii) and (b).
b) Amend claim 29 to comport with claims 17, 20, 23, and 26 to recite “wherein the administration of prednisone once every 21-day cycle is performed for six or eight 21-day cycles.”
Appropriate correction is required.
New Grounds for Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claims 33-38 and 66-67 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 33-38 and 66-67 recite “cycle” or “cycles”, and that in depending from claim 1, is a broadening limitation. Claim 1 is drawn to the combination being administered in 21-day cycles. Claim 33-38 and 66-67 do not depart in scope from the combination. Accordingly, where the limitation corresponds to one of the combinations of claim 1, the cycle is proscribed to be of a 21-day cycle.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Written Description
9. Claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33-38, 45-50, and 66-67 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.
Claims 1-3, 12, 15, 17, 20, 23, 26, 29, 33-38, 45-50, and 66-67 are drawn to the dosage regimen in the DLBCL subject at least until “an unacceptable toxicity occurs” in claim 1.
“unacceptable toxicity”: the specification does not define the per se meaning of the phrase. The POSA cannot readily ascertain what metrics or parameters are evaluated to identify any stage of toxicity much less that nearing an unacceptable level(s) for the combination therapy.
The specification refers to examples for monitoring some biological functions for adverse dose effects:
hematological drug toxicity for cyclophosphamide or doxorubicin at [0141]
“In one embodiment, the dose of cyclophosphamide or doxorubicin is reduced when a subject presents with cyclophosphamide- or doxorubicin-related hematological toxicities during a treatment cycle in accordance with standard of care guidelines, for example, as specified in the product label. See, for example, Table 8 for dose modification criteria or cyclophosphamide and doxorubicin (see also Table 9).”
impaired hepatic function for vincristine at [0142]
[0142] In one embodiment, the dose of vincristine is reduced when a subject presents with impaired hepatic function, e.g., using serum bilirubin levels as a marker. For example, if a subject has serum bilirubin levels of 2-3 mg/dL, then the dose of vincristine is reduced to 75% of the normal dose. If a subject has serum bilirubin levels of >3.0 mg/dL, then the dose of vincristine is reduced to 50% of the normal dose. Vincristine can be re-escalated when hyperalbuminemia improves.
a general adverse event for prednisone at [0143]
In one embodiment, the dose of prednisone (or equivalent) is reduced according to local prescribing information. For example, when a subject develops an adverse event related to corticosteroid and cannot tolerate the 100 mg/day dose (or equivalent), then the dose may be reduced to no less than 80 mg/day. In some embodiments, the dose reduction of prednisone (or equivalent) is performed in a tapering regimen.
The specification even alerts the POSA in using the combination therapy towards potential adverse events at [0633]
Treatment-emergent adverse events of R-CHOP combination therapy predominantly comprise hematologic toxicities (such as neutropenia, leucopenia, thrombocytopenia, and anemia). Nonhematologic disorders such as asthenia, sensory disturbance, mucositis, alopecia, sepsis, dyspnea, back pain, hyperglycemia, hypersensitivity, and cardiac disorders have all also been observed when treatment with R-CHOP has been administered. It is not always easy to assess the role of any 1 agent in these events; therefore, it is at the investigator's discretion to decide if 1 or more agents are causal.
The POSA cannot ascertain what critical indicia preceed the most extreme concern of the method invention, namely, unacceptable toxicity. The examiner’s search of the specification for the limitation does not identify literal support. (MPEP 706.03(m) states in part "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.”)
Conclusion
10. No claims are allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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