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
This Office action is responsive to Applicant's Response to Election/Restriction, filed September 09, 2025. As filed, claims 1-6 are pending in the instant application.
Priority
This application filed 10/12/2022 is a Continuation of PCT/KR2021/004725 , filed 04/14/2021 claims foreign priority to 10-2020-0045314, filed 04/14/2020.
Information Disclosure Statement
Applicants' information disclosure statements (IDS) filed on 10/12/2022 have been considered except where lined through. Please refer to Applicants' copy of the 1449 submitted herewith.
Election/Restrictions
Applicant's election without traverse of Group I, claims 1-5, drawn to compounds of general formula 1 and 2 and compositions thereof as recited in the claims in the reply filed on 09/09/2025 is acknowledged.
Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-5 will be examined on the merits herein.
Claim Objections
Claim1 is objected to because of the following informalities: the chemdraw structures of Formula 1 and 2 are unclear and should be replaced.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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--5 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.
1.The recitation “heterocycloalkyl group having at least one hetero atom and consisting of 3-7 atoms” in claims 1, 5 renders the claims herein indefinite. It is unclear how a heterocycloalkyl moiety can consist of 3 (or 4) atoms and meet their full valency. For instance, an epoxide heterocycloalkyl has a total of 6 atoms (2 carbons, one oxygen, 3 hydrogen – one being substituted to connect to the core structure).
2.Claim 2 recites “ the heteroatoms is” which renders said claim indefinite because it is unclear which hetero atom is being referenced. Claim 2 depends from claim 1. Claim 1 recites several instances of "at least one heteroatom" including for R1, R2, R8, and R9 for a heteroallyl group or a heterocycloalkyl group. See MPEP 2173.05(e).
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.
(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.
1.Claims 1, 3-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sogawa, J. Med. Chem. 1993, 36, 3904-3909 (cited in PTO-892 attached herewith).
The article by Sogawa teach compounds for inflammatory and allergic diseases. Compound 16 disclosed in table 1 page 3905 which corresponds to the compound of claimed formula (1) in which R1 is OH and OMe, R2 is OH (two instances) and the species of claim 3 namely (E)-3-(3, 4-dihydroxyphenyl)-1-( 4-hydroxy-2-methoxyphenyl)prop-2-en-1-one; (CAS 94344-54-4 aka Sappanchalcone).
The compounds 1-4 in table 1 page 3905 corresponds to the claimed formula (1) in which variable R1 is OH (1- 3 instances) and R2 is H.
Compounds 5-13, 17-19 disclosed in Table 1 of the cited reference fall within claimed formula (1) in which variable R1 is OH halogen, R2 is OH or O-CH3. Disclosed on the experimental on page 3908 and Table IV of the article by Sogawa are the compositions of compounds in buffer, water, solvents which were tested for biological activity (instant claim 1, 3, 5).
With respect to the limitations drawn to the “ for treatment, prevention, or amelioration of lymphedema”, as it pertains to instant claims 4 and 5 these limitations are drafted as an “intended use.” MPEP 2111.02(II) provides the following instruction for interpreting the preamble of a claim:
“During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.”
See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir.1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”) and Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where the claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim). If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
In the instant case, the intended use limitations do not carry any patentable weight because the limitations do not further limit the structure of the claimed composition. Furthermore, according to the prior art composition is clearly capable of performing the claimed intended use. Since the teach all the limitations of the claimed composition, the instant claims are properly anticipated thereby.
2. Claims 1, 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keane et al. J. Org. Chem. 1970, 55, 2287 (cited in PTO-892 attached herewith).
The article by Keane teach compounds of formula 1, wherein R is H or OCH3 on Scheme on page 2287 which corresponds to the compounds of claimed formula (2) in which R8 and R9 are each hydrogen, or in formula (2) R8 is OCH3 and R9 is hydrogen .
With respect to the limitations drawn to the “ for treatment, prevention, or amelioration of lymphedema”, as it pertains to instant claim 4 these limitations are drafted as an “intended use.” MPEP 2111.02(II) provides the following instruction for interpreting the preamble of a claim:
“During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim.”
See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir.1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”) and Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where the claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim). If a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997).
In the instant case, the intended use limitations do not carry any patentable weight because the limitations do not further limit the structure of the claimed composition. Furthermore, according to the prior art composition is clearly capable of performing the claimed intended use. Since the teach all the limitations of the claimed composition, the instant claims are properly anticipated thereby.
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 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, product of nature or an abstract idea) without significantly more.
Instant claims recites compound of formula (1) namely (E)-3-(3, 4-dihydroxyphenyl)-1-( 4-hydroxy-2-methoxyphenyl)prop-2-en-1-one CAS 94344-54-4 aka Sappanchalcone which is a natural product https://pubchem.ncbi.nlm.nih.gov/compound/Sappanchalcone). Instant claims recites compound of formula (2) wherein when R8 and R9 are both hydrogen corresponds to namely 2-Phenyl-4cromatone aka flavone which is a natural product https://pubchem.ncbi.nlm.nih.gov/compound/Flavanone#section=DSSTox-Substance-ID.
The recited compounds in the claims, are not markedly different from its naturally occurring form because both naturally occurring and recited in the instant claims has the same structure. This judicial exception is not integrated into a practical application because additional element, fails to integrate the judicial exception into a practical application. This is because merely composition of the product of nature in water does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the product of nature to a particular technological environment.
Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___, 132 S. Ct. 1289 (2012), the Supreme Court set forth a two-step framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts. The first step looks to determine whether claims are directed to a patent-ineligible concept. Mayo, 132 S. Ct. at 1297. If they are, the second step is to consider whether the additional elements recited in the claim “transform the nature of the claim” into a patent eligible application by reciting an “inventive concept” that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the ineligible concept itself.” Id. at 1294.
Claim 1 of U. S. Patent No. 6,355,623 in the Mayo dispute is reproduced here for applicant’s convenience:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8.times.10.sup.8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8.times.10.sup.8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
In addition, the court in Arisosa Diagnostics, Inc v. Sequenom, Inc., No. 2014-1139, Fed. Cir. June 12, 2015 found ineligible claims drawn to a method of detecting paternally inherited cell free fetal DNA (cffDNA) in serum or blood. It is determined that the natural phenomenon in the claims is the cffDNA found in serum or blood.
The PTO guidance for determining subject matter eligibility under 35 U.S.C. 101 may be found in the Federal Register notice/ Subject Matter Eligibility update,” hereafter referred to as the “Guidance.” The Guidance supersedes the factor-based analysis of the “Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, and/Or Natural Products” from March of 2014.
The Guidance provides a test for determining subject matter eligibility under 35 U.S.C. 101 that comprises the following steps:
1) Is the claim to a process, machine, manufacture, or composition of matter? If the answer to this question is “no,” then the claim is not eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the analysis proceeds to the second step.
2) Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? If the answer to this question is “no,” then the claim is eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the analysis proceeds to the third step.
3) Does the claim recite additional elements that amount to significantly more than the judicial exception? If the answer to this question is “no,” then the claim is not eligible subject matter under 35 U.S.C. 101. If the answer to this question is “yes,” then the claim is eligible subject matter under 35 U.S.C. 101. Applicant is also directed to Section III of the Guidance (“Sample Analyses”), in particular, Example 5, Mayo v. Prometheus (U.S. Patent No. 6,355,623).
In the instant case, the claims are drawn to one of the statutory categories, i.e., a composition of matter, so the analysis proceeds to the second step. With respect to the second step, the claims are deemed to be directed to a judicially recognized exception, i.e., a product of nature, because, claims 1-5 are drawn to a natural product, Sappanchalcone and flavone which are a natural product https://pubchem.ncbi.nlm.nih.gov/compound/Sappanchalcone). This discovery does not, by itself, render the instant claims as patent eligible. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013) (“Myriad”). As a result, the answer to the second question is deemed to be “yes,” and the analysis proceeds to the third step. As indicated above, the third step asks whether the claim recites elements or steps in addition to the claimed judicial exception that amount to significantly more than the judicial exception. As indicated above, the instant claims are drawn to a compound which naturally occurs. Thus, the claims recites a nature-based product. Because there is no indication in the record that (E)-3-(3, 4-dihydroxyphenyl)-1-( 4-hydroxy-2-methoxyphenyl)prop-2-en-1-one has resulted in a marked difference in structure, function or other properties as compared to its naturally occurring counterpart, (E)-3-(3, 4-dihydroxyphenyl)-1-( 4-hydroxy-2-methoxyphenyl)prop-2-en-1-one aka Sappanchalcone is a product of nature exception. Similarly rational is applicable for fulvic acid.
As a result, it is the Examiner’s position that the instant claims inform a relevant audience about a naturally existing compound. Even though Applicant may be claiming a narrow law with limited application, the claims do not amount to significantly more than the product of nature, and accordingly, the claimed invention is not directed to patent eligible subject matter under 35 U.S.C. 101.
Conclusion
Claims 1-5 are rejected. Claim 6 is withdrawn from further consideration.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANA MURESAN whose telephone number is (571)-270-7587. The examiner can normally be reached on Monday through Friday, 8:30 am to 5:30 pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANA Z MURESAN/Primary Examiner, Art Unit 1692