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
2. Claims 1, 3, 8, 10, 14, 17, 19, 28 – 31, 35 – 37, 39, 43 – 45, and 47 – 48 are pending in this application. Applicant’s preliminary amendment, filed April 4, 2023, is entered, wherein claims 3, 8, 10, 14, 17, 19, 28 – 29, 31, 35 – 36, 39, 43, and 47 are amended and claims 2, 4 – 7, 9, 11 – 13, 15 – 16, 18, 20 – 27, 32 – 34, 38, 40 – 42, 46, and 49 – 102 are canceled.
Priority
3. This application is a national stage application of PCT/US2021/053559, filed October 5, 2021, which claims benefit of domestic applications 63/087,415 and 63/157,268, filed October 5, 2020 and March 5, 2021, respectively.
Election/Restrictions
4. Applicant’s election without traverse of group I, claims 1, 3, 8, 10, 14, 17, 19, and 28, drawn to compounds of Formula III, filed November 24, 2025, is acknowledged. The following species was elected by Applicant without traverse in the reply, filed November 24, 2025, with claims 1, 3, 8, 10, 17, 19, and 28 reading on the elected species:
(i) A specific compound of Formula III with its corresponding substituents R20, R21, and R22 recited in claims 1, 3, 8, 10, 14, 17, and 19:
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Claim 14 is noted in the Response to Election / Restriction Filed by Applicant as a claim reading on the elected species. Upon careful consideration, claim 14 should be withdrawn because none of the claims defines Z2 as hydrogen that is shown in the elected species. Claims 14, 29 – 31, 35 – 37, 39, 43 – 45, and 47 – 48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to non-elected invention, there being no allowable generic or linking claim.
Therefore, claims 1, 3, 8, 10, 17, 19, and 28 are examined on the merits herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/04/2023 and 10/24/2023 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in line 11 of page 79. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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, 3, 8, 10, 17, 19, and 28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (e.g. a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claims recite a compound of Formula III, wherein the compound is clorobiocin, which is a natural product.
Step 1: Claims 1, 3, 8, 10, 17, 19, and 28 recite composition of matter, thus, the claims fall into a statutory category of invention under 35 U.S.C. 101.
Step 2A1: The claimed compound comprises clorobiocin, which is a naturally occurring compound that are known in the art. When, as here, a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation.
The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed in terms of structure, function, and/or other properties, and are evaluated on what is recited in the claim. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception. MPEP 2106.04(c)(II).
Claiming a natural product that is merely separated from elements found in its natural environment, where the structure of the natural product is not otherwise altered, does not support a conclusion that the isolated product is patent eligible. Ass’n for Molecular Pathology v. Myriad, 569 U.S. 576 at 593-5 (2013) (contrasting cDNA, which is exons-only molecule that is not naturally occurring, from isolated DNA segments because the isolated DNA segments do not contain altered genetic information compared to the gene from which isolated, notwithstanding that the isolated DNA segment was obtained by breaking chemical bonds).
The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. 576 at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the Applicant must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
The first step in the analysis requires selecting the appropriate natural counterparts to the claimed nature-based products. The appropriate natural counterpart to the claimed compound is clorobiocin as found in their natural state. The second step in the analysis requires identifying appropriate characteristics to compare. In this case, the appropriate characteristics pertain to the chemical nature of the compound, which ultimately determine their bioactivity.
The analysis requires determining if the claimed compound results in structural, functional, or other properties that are different from the claimed compound as found in the natural setting. While the specification stating that the claimed compound possesses certain bioactivity (page 74, lines 28 – 32; page 75, lines 6 – 34; page 76, lines 1 – 7), this activity is based on the chemical structure . No actual evidence or data is provided to asserted that combining it with a carrier or excipient changes the intrinsic bioactivity of the claimed compound.
Claim 28 requires the pharmaceutical composition comprising clorobiocin and a pharmaceutically acceptable carrier or excipient. Where a claim is directed to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts (MPEP 2106.04(c)(I)(A), unless the combination cannot be found in nature, in which case the closest counterpart may be the individual nature-based components of the combination. (MPEP 2106.04(c)(II)(A). For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence). Id. In this case, there is again no evidence presented indicating that the inclusion of this carrier or excipient alters the chemical nature or intrinsic bioactivity of clorobiocin.
Accordingly, claims 1, 3, 8, 10, 17, 19, and 28 recite judicial exceptions, i.e., products of nature.
Step 2A2: This part of the eligibility analysis evaluates whether a claim as a whole integrates the recited judicial exception into a practical application. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional element(s) demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. The application or use of the judicial exception in this manner meaningfully limits the claim by going beyond generally linking the use of the judicial exception to a particular technological environment, and thus transforms a claim into patent-eligible subject matter. In order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. (MPEP 2106.04(d)(2)).
Each of claims 1, 3, 8, 10, 17, 19, and 28 are drawn to composition which do not include limitations imposing any particular use of or application of the claimed judicial exceptions, such as a particular treatment or prophylaxis. Accordingly, the compositions of claims 1, 3, 8, 10, 17, 19, and 28 do not contain additional elements that result in a practical application of the claimed nutritional supplement, because these claims are drawn to compositions rather than applications of the compositions.
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim.
The search for an “inventive concept” as required by the Supreme Court in Alice is not the search for a “patentable invention” (which includes satisfying §§ 102, 103 and 112, in addition to 101). An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 573 U.S. at 21-18, 110 USPQ2d at 1981. Instead, an "inventive concept" is furnished by an element or combination of elements recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 573 U.S. at 27-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).
In this case, the claimed judicial exceptions occur within the compound of Formula III (claims 1, 3, 8, 10, 17, and 19) and pharmaceutical composition (claim 28). Formulating clorobiocin into such composition represents well-understood, routine, and conventional practice. For example, Heide (WO03/014352, Reference included with PTO-892) teaches clorobiocin is aminocoumarin antibiotic (page 1, para. 2) and a pharmaceutical composition containing the aminocoumarin compound in a pharmaceutically effective amount in combination with a pharmaceutically acceptable carrier and/or diluent (page 7, para. 1). Heide teaches that the composition is commonly used in the treatment of infections with gram-positive bacteria and of malignant diseases (page 7, para. 2).
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.
Claims 1, 3, 8, 10, 17, 19, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heide (WO03/014352A2).
a. Independent claim 1 is directed to a compound of Formula III:
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wherein R20 is R20c, wherein R20c is
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wherein R32 is -C(=O)(5-membered monocyclic heteroaryl substituted with one Z1 groups, wherein Z1 is methyl; R21 is a halogen; and R22 is R22a, wherein R22a is
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wherein R40 is -ORb1, wherein Rb1 is hydrogen, and R41 is C2-C6 alkenyl. Dependent claim 17 is directed to the compound, wherein R21 is chloro. Dependent claim 19 is directed to the compound, wherein the R22 is
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Independent claim 28 is directed to a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier or excipient.
Heide teaches clorobiocin that is an aminocoumarin antibiotic with the structure of (page 1, para. 2; Figure 5):
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Heide also teaches a pharmaceutical composition containing the aminocoumarin compound in a pharmaceutical effective amount in combination with a pharmaceutically acceptable carrier and/or diluent (page 7, para. 1).
Regarding claims 3, 8, and 10, these claims depend from claim 1. Claim 1 recites that substituent R20 is selected from R20a, R20b, and R20c. Claims 3, 8, and 10 further recite “R20a”, “R20b” and “Y1” are selected from substituents with different structures, which are limiting the R20a and R20b. Claims 3, 8, and 10 do not limit R20 to be R20a or R20b. The language limits the structures of R20a, R20b, and Y1 only in embodiments in which R20 is R20a or R20b, and it does not exclude embodiments when R20 is R20c because claim 1 recites that R20 may be R20c. Therefore, claim 3, 8, and 10 encompass embodiments wherein R20 is R20c.
For these reasons above, Heide teaches clorobiocin, which anticipates claims 1, 3, 8, 10, 17, 19, and 28, wherein R20 is R20c, wherein R20c is
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wherein R32 is -C(=O)(5-membered monocyclic heteroaryl substituted with one Z1 groups, wherein Z1 is methyl; R21 is a chloro; and R22 is
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Conclusion
No claim is found to be allowable.
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/H.Y.L./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693