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 .
DETAIL ACTION
This office action is a response to Applicant’s amendments/remarks after final rejection filed 11/14/2025 and 11/20/2025.
As filed, claims 1, 10, and 25-27 are pending; claims 15, 19-24, and 28-31 are withdrawn; and claims 2-9, 11-14, 16-18, and 32-36 are cancelled.
After an updated search, the Examiner finds that there are additional 102(a)(2) prior arts and additional ODPs (see rejections below). Since the pending claims were not amended for prior art purpose, and the previous 102(a)(2) rejections were removed under 102(b)(2)(C) exception (see details below), the Examiner, after a discussion with the Applicant’s representative and per guidance under MPEP 706.07(a), has decided to withdraw the finality of the previous office action, which is mailed on 8/12/2025, in order to introduce the abovementioned 102(a)(2) prior arts and ODPs. Accordingly, the prior arts and ODPs are considered as a new ground of rejection and thus, this office action is non-final.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 11/14/2025 and 11/20/2025, with respect to claims 1, 10, and 25-27, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 102(a)(2) rejection of claims 1, 10, and 25-27 by Wang1 and its English equivalent (i.e. US Patent Application Publication No. 2022/0211693) is withdrawn per disqualification of Wang1 and its English equivalent as prior arts under 102(b)(2)(C) exception. The Applicants submitted a statement on 11/14/2025, which stated that the instant application and Wang1 or the instant application and the abovementioned English equivalent of Wang1 were, no later than the effective filing date of the claim invention, both subject to an obligation of assignment to Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The § 103(a) rejection of claims 1, 10 and 25-27 by Wang1 and its English equivalent (i.e. US Patent Application Publication No. 2022/0211693) is withdrawn per disqualification of Wang as prior art under 102(b)(2)(C) exception, as stated above in #4.
The § 103(a) rejection of claims 1, 10 and 25-27 by Wu and its English equivalent (i.e. US Patent Application Publication No. 2022/0313685) is withdrawn per disqualification of Wu and its English equivalent as prior arts under 102(b)(2)(C) exception. The Applicants submitted a statement on 11/14/2025, which stated that the instant application and Wu or the instant application and the abovementioned English equivalent of Wu were, no later than the effective filing date of the claim invention, both subject to an obligation of assignment to Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The § 103(a) rejection of claims 1, 10 and 25-27 by Zhan and its English equivalent (i.e. US Patent Application Publication No. 2022/01963067) is withdrawn per disqualification of Wu and its English equivalent as prior arts under 102(b)(2)(C) exception. The Applicants submitted a statement on 11/14/2025, which stated that the instant application and Zhan or the instant application and the abovementioned English equivalent of Zhan were, no later than the effective filing date of the claim invention, both subject to an obligation of assignment to Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
The claim objection of claim 25 is withdrawn per amendments.
Claim Rejections - 35 USC § 102
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)(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.
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent No. 11,419,862, hereinafter Wang2.
The applied references have a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1 and 10, Wang2, for instance teaches a combined pharmaceutical composition comprising a compound of formula I and at least one second therapeutic agent, such as etoposide, irinotecan, etc. for treating nasopharyngeal carcinoma.
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(abstract)
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(column 2, lines 15-30)
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(column 5, lines 34-40)
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(Eng. Equivalent, ‘862 patent, column 10, lines 8-34)
According to the guidance in MPEP 2131.02(III), the Examiner finds that a person of skill in the art would read the abovementioned Wang2 publication and “at once envisage” the claimed arrangement or combination in the abovementioned claims, which led to the abovementioned anticipation.
Claims 1, 10, and 25-27 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Foreign Patent Application Publication No. WO2020/015703, as well as its English equivalent, which are U.S. Patent No. 12,390,458, hereinafter Tian.
The applied references have a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 1, 10, and 25-27, Tian, for instance teaches a combined pharmaceutical composition comprising a compound of formula I and at least one second therapeutic agent, such as sintilimab, etc. for treating lung and liver tumors. In addition, Tian teaches the components of the abovementioned composition can be formulated separately into a suitable pharmaceutical composition, or be in a non-fixed combination wherein each components can be packaged, sold or administered as a fully independent pharmaceutical composition.
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(Eng. Equivalent, ‘458 patent, abstract)
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(Eng. Equivalent, ‘458 patent, column 2, lines 1-15)
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(Eng. Equivalent, ‘458 patent, column 5, lines 60-65)
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(Eng. Equivalent, ‘458 patent, column 8, lines 32-41)
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(Eng. Equivalent, ‘458 patent, column 8, lines 49-61)
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(Eng. Equivalent, ‘458 patent, column 9, lines 32-39)
According to the guidance in MPEP 2131.02(III), the Examiner finds that a person of skill in the art would read the abovementioned Tian publication and “at once envisage” the claimed arrangement or combination in the abovementioned claims, which led to the abovementioned anticipation.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to a combined pharmaceutical composition comprising instant compound I and a second therapeutic agent depicted in claim 1.
Claims 1 and 10 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
12,390,458
1-3
No
In this instance, the analysis employed for the abovementioned nonstatutory obviousness-type double patenting rejection parallels the analysis for anticipation, wherein the instant combination is anticipated by the combination encompassed by the abovementioned conflicting claims of the abovementioned U.S. patent.
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(claim 1 of the ‘458 patent)
Claims 1 and 10 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
11,419,862
15-22
No
12,390,458
4-14
No
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned U.S. patents are drawn to a method of treatment using the instant pharmaceutical composition.
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned U.S. patents described the instant pharmaceutical composition in a method of treatment-type claim.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness – none.
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other. As recited above, the pharmaceutical composition in the conflicting claims of abovementioned U.S. patents is the instant pharmaceutical composition.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that pharmaceutical composition of the abovementioned U.S. patents is excluded as the instant pharmaceutical composition of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant pharmaceutical composition and that of the conflicting claims of the abovementioned U.S. patents to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy 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.
Conclusion
Claims 1, 10, and 25-27 are rejected.
Claims 15, 19-24, and 28-31 are withdrawn
Claims 2-9, 11-14, 16-18, and 32-36 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621