Detailed Action
The present office action is in response to the response filed on 12 Nov 2025.
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 .
Status
Claims 1-8 and 11-18 of the pending application have been examined on the merits. Claims 9-10 and 19-20 are withdrawn (see “Response to Applicant Election” below). Acknowledgement is made of the amendments filed 12 Nov 2025.
Priority
Applicants identify the instant application, Serial #: 18/012,999 filed 27 Dec 2022, as a National Stage Entry of International Patent Application #: PCT/CN2020/124755, filed 29 Oct 2020, which claims foreign priority from Foreign Application #: CN201911306631.5, filed 17 Dec 2019.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10 Jan 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant's election with traverse of Group I, claims 1-8 and 11-18, and the species of Compound 7 (below) in the reply filed on 12 Nov 2025 is acknowledged.
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The traversal is on the ground(s) that Groups I and II are linked as to form a single general inventive concept and have unity of invention under 37 CFR 1.475(a)-(b). Applicant argues that the role as an antitumor drug sensitizer is a special technical feature of the independent claim and makes a contribution over the prior art. Specifically, applicant argues that WO 2012/170442 (provided in the office action mailed 18 Sep 2025), hereinafter ‘442, does not teach the special technical feature of a compound of generic Formula (I) being an antitumor drug sensitizer. Applicant further argues that the species of the invention are all connected to each other in operation and that examiner has not shown the species to be independent or distinct. Applicant argues that examiner has not established a serious search burden to examine all the claims.
This is not found persuasive. Examiner respectfully notes that '442 teaches Compound 1, which has the same core structure as the compounds of instant formula (I), and that Compound 1 enhances the anti-tumor effect of GM-CSF in a melanoma model. See the restriction requirement mailed 18 Sep 2025. The reference relied on therefore teaches all the technical features of the generic claim and Unity of Invention is broken between Groups I and II. Furthermore, the instant application is subject to the “Unity of Invention” restriction standard and not the “Independent and Distinct/Undue Search Burden” restriction standard. Examiner respectfully reminds applicant that, as set forth in Rule 13.1 of the Patent Cooperation Treaty (PCT), "the international application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept.” Moreover, as stated in PCT Rule 13.2, "where a group of inventions is claimed in one and the same international application, the requirement of unity of invention referred to in Rule 13.1 shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features." Furthermore, Rule 13.2 defines "special technical features" as "those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art." Under the Unity of Invention standard the examiner does not need to show the species of the invention to be independent or distinct or establish a serious search burden for the claims. The requirement is still deemed proper and is therefore made FINAL.
Claims 9-10 and 19-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12 Nov 2025.
Claim Objections
Applicant is advised that should claim 6 be found allowable, claim 11 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Further, should claim 8 be found allowable, claim 15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 1 and 3-4 are objected to because of the following informalities: claims 1 and 3-4 contain “the” in front of each substituent. Applicant may overcome this objection by removing the word “the” from in front of the substituents. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-8 and 11-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because claim 1 recites a “method of an application of N-(3-hydroxypyridine-2-carbonyl)glycine and derivatives of the N-(3-hydroxypyridine-2-carbonyl)glycine in a preparation of an antitumor drug sensitizer.” Claim 1, therefore, is a use claim without any active, positive steps delimiting how this use is practiced. Claims 2-8 and 11-18 are rejected as they do not remedy the deficiencies of claim 1.
Applicant may overcome this rejection by amending claim 1 to recite a claim directed to one of the four statutory categories having active, positive steps delimiting how the application of an N-(3-hydroxypyridine-2-carbonyl)glycine and derivatives of the N-(3-hydroxypyridine-2-carbonyl)glycine is practiced. In the interest of compact prosecution, prior art will be applied against claims 1-8 and 11-18 that are directed a method of using N-(3-hydroxypyridine-2-carbonyl)glycine and derivatives of the N-(3-hydroxypyridine-2-carbonyl)glycine as an antitumor drug sensitizer.
Claim Rejections - 35 USC § 112(b)
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 1-8 and 11-18 are 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 1 is not directed towards one of the four statutory categories (see above) and is therefore indefinite for not reciting any active, positive steps related to the application of N-(3-hydroxypyridine-2-carbonyl)glycine and derivatives of the N-(3-hydroxypyridine-2-carbonyl)glycine as an antitumor drug sensitizer. Claims 2-8 and 11-18 do not remedy the deficiencies of claim 1 and are also rejected. Applicant may overcome this rejection by amending the claims to recite one of the four statutory categories.
Claim Rejections - 35 USC § 112(d)
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.
Claim 2 is 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. Claim 1 limits the N-(3-hydroxypyridine-2-carbonyl)glycine and derivatives of the N-(3-hydroxypyridine-2-carbonyl)glycine to compounds of formula (I):
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Wherein ring A is phenyl or absent. Claim 2 limits the compounds of formula (I) to being selected from formula (IA) and formula (IB):
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By limiting compounds of formula (I) to either formula (IA) or formula (IB), ring A is still either phenyl or absent. Therefore, claim 2 fails to further limit claim 1.
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.
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.
Claim(s) 1-8, and 11-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 110721185, hereinafter ‘185.
Applicant elected group I, claims 1-8 and 11-18. Applicant further elected Compound 7 (below) as the species of formula (I) and doxorubicin as an antitumor drug. These species read on claims 1-8 and 11-18. The claims further limit the mass ratio of antitumor drug sensitizer to antitumor drug to (0.1-20):1 (claim 7).
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‘185 teaches using roxadustat to treat doxorubicin cardiomyopathy (pg. 3). ‘185 teaches that roxadustat has the following molecular formula (pg. 2):
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‘185 teaches treatment of two cancer cell lines (HepG2 cells and MCF7 cells) with 5 µM of roxadustat and 1-2 µM of doxorubicin (pg. 5). ‘185 teaches treating mice with 10 mg/kg/day of roxadustat and 12.5 mg/kg/day of doxorubicin dissolved in normal saline, a pharmaceutically acceptable carrier (pg. 3; pg. 4). By teaching the same steps of applying roxadustat and doxorubicin to cancer cells as found in the instant claims, ‘185 necessarily teaches the same outcomes and roxadustat would necessarily act as a sensitizer for an anticancer compound. See MPEP § 2112(I). Thus, ‘185 anticipates the instant claims.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Claim(s) 1-6, 8, and 11-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2007/0292433, hereinafter ‘433.
‘433 teaches Compound D is used to treat chemotherapy induced anemia (paragraph [0235]; paragraph [0312]). Compound D is the IUPAC name of the instantly elected Compound 7 (see below).
Compound D
[(4-Hydroxy-1-methyl-7-phenoxy-isoquino line-3-carbonyl)-amino]-acetic acid
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‘433 teaches doxorubicin as one of the possible chemotherapeutics that cause anemia which can be treated with roxadustat (paragraph [0007]; paragraph [0036]; claim 7). ‘433 also teaches suitable carriers for the administration of the reference compounds (paragraph [0300]). By teaching the same steps of applying roxadustat and doxorubicin to cancer cells as found in the instant claims, ‘433 necessarily teaches the same outcomes and roxadustat would necessarily act as a sensitizer for an anticancer compound. See MPEP § 2112(I). Therefore, ‘433 anticipates the instant claims.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625