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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus a date of 6/21/2022 has been used for priority.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 03/16/2024 and 07/15/2025 are being considered by the examiner.
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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. Claim 1 recites:
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The remaining claims do not add significantly more because they only further limit by which formula, adding asymmetric carbons, or specifying a large range of wt% of the compound in an agent.
In accordance with the 2019 Revised Patent Subject Mater Eligibility Guidance (aka 2019 PEG), the following revised flowchart found in MPEP §2106(III), is used when considering whether or not a claimed invention recites eligible subject matter:
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The invention recited in claims 1-15 are drawn to a composition of matter, in this case a composition comprising a compound of formula 1-4. Step 1 is satisfied.
Step 2 has now been broken out into a two-prong analysis:
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Step 2A first asks whether or not the claimed invention is directed to a judicial exception such as a natural phenomenon (e.g., product of nature). Here, the answer is yes, since the only compositional requirement set forth in the composition comprises a composition comprising a compound of formula 1-4. The reference Matsuda et al., The Journal of Antibiotics (2024) 77:228–237 provides evidence that “hazimycins A (1) and B (2), isocyanide-containing dityrosine analogs that were originally isolated from actinobacteria in 1982 [27, 28] and 2015 [29] (Fig. 2a, Fig. S1). 1 was obtained as a mixture of interconvertible isomers, which is consistent with previously reported interconvertibility of stereoisomers with the same stereochemistry (i.e., R, R or S, S) or different stereochemistries (R, S) [27, 28]”(page 230) and the following structure of hazimycins A (1) and B (2) (fig 2) are natural products that fall under the instantly claimed formula 1-2a. The instant specification also provides evidence that claimed formula 1-4a are all natural products[0003] see also IDS document (Acta Pharmaceutica Sinica B 2015;5(6):564–568).
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The second leg of the analysis evaluates whether the claim recites additional elements that integrate the established judicial exception into a practical application of the exception. Based on the recitations provided in claims 1-15, the answer is no. There is not a practical application of the law of nature. These claims do not recite further ingredients or steps.
Lastly, step 2B asks if the claim recites additional elements that amount to “significantly more” than the judicial exception. Asked another way, do the claims recite anything additional demonstrating that the recited composition provides an inventive concept? Here, again, the answer is no because the claims simply do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from a natural product. Reciting the intended use of a natural product (i.e., a copper chelating agent, anticancer agent) does not amount to significantly more than the judicial exception. The composition contains naturally occurring ingredients that do not have markedly different characteristics from what occurs in nature. Even though the claimed subject matter recites specific amounts or ratios, the claims are still patent ineligible because each naturally occurring product would still be structurally identical to what exists in nature. The recitation of the (wt%) amounts of ingredients do not arrive at any change in the characteristics (structural or functional) of the naturally occurring ingredients. In the instant case, the claim encompass ingredients that exist in nature thus the composition is formed of naturally occurring ingredients. It does not have markedly different characteristics from any naturally occurring counterpart(s) in their natural state. For example, gunpowder comprising a finely ground mixture of 75 % potassium nitrate, 15 % charcoal and 10 % sulfur. The three counterparts occur naturally in nature. None of them are explosive in nature. When the substances are finely ground and intimately nixed in the claimed ratio, the claimed combination is explosive upon ignition. The explosive property of the claimed combination is markedly different from the non-explosive properties of the substances by themselves in nature and thus the claimed combination has markedly different characteristics. In the instant case, there is no evidence that the combination has any markedly different characteristics. There is no indication that the claimed ingredients has any characteristics (structure, functional or otherwise) that are different from the naturally occurring ingredients. As such, the claims fail to recite subject matter that is patent eligible, and thus the claims do not amount to significantly more than the judicial exception.
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) 1-4, 6-9, 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Wright ( Wright, et al., X-Ray Crystal Structure Determination and Synthesis of the New Isonitrile-containing Antibiotics, Hazimycin Factors 5 and 6, J. CHEM. SOC., CHEM. COMMUN., 1982).
The reference Wright teaches “X-Ray Crystal Structure Determination and Synthesis of the New Isonitrile-containing Antibiotics, Hazimycin Factors 5 and 6”(title) and the structures of Hazimycin Factors 5 and 6 (figure 1).
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Hazimycin strcuture is the same as formula (1) of the instant invention and because “Products of identical chemical composition cannot have mutually exclusive properties”, therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F. 2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This anticipates claims 1-4, 6-9, 11-14.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright ( Wright, et al., X-Ray Crystal Structure Determination and Synthesis of the New Isonitrile-containing Antibiotics, Hazimycin Factors 5 and 6, J. CHEM. SOC., CHEM. COMMUN., 1982).
The reference Wright has been discussed supra and does not disclose wherein a content of the at least one compound is 0.0001 wt% to 90 wt% (claims 5, 10, 15).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Wright to get the specific wt% of the instant claims because "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.). One would be motivated to try new compositions with new wt% as potential antibiotic solutions and one would have a reasonable expectation of success because 0.0001 wt% to 90 wt% is a very large range and so is easy to fall within.
Conclusion
Claims 1-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR SALAMATIAN whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627