DETIALED 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 .
Status of Claims
Claims 1-10 are pending in the instant application.
Priority
This application claims priority to foreign application No. TW113121393, filed June 7th, 2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed October 2nd, 2024 was considered by the Examiner.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. Claim recites “for losing weight and improving gut microbiota” which is intended use and the claim limitation is presumed met by a compound of formula (I).
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 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claim(s) recite(s) a naturally occurring product. This judicial exception is not integrated into a practical application because the claims do not require more than the natural product itself. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims embrace compositions that are identical to what occurs in nature.
Applicant is directed to MPEP 2106 regarding criteria for subject matter eligibility.
Step 1
Step 1 in the analysis is “Is the claim to a process, machine, manufacture or composition of matter?” In this situation, the claims are directed to compositions of matter (Step 1: YES).
Step 2A: Prong One
The next step (2A) is a two-prong inquiry where prong one is “Does the claim recite an abstract idea, law of nature, or natural phenomenon?” In this situation, the claims embrace a naturally occurring material, i.e., marine shellfish-associated fungus Monascus ruber BB5.
Ran (Mar. Drugs 2020, 18, 100) teaches that the following compound is isolated from marine shellfish-associated fungus Monascus ruber BB5 (Abstract, Figure 1):
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This compound is embraced by instant formula (I), wherein R1 is hydroxyalkyl, R2 is O, R3 is H and R4 is H. The claims are either directed to compositions comprising the naturally occurring compound as well.
There is no indication or requirement of the instant claims that the compositions are different structurally from the composition as found in its natural environment relative to the composition claims
For the reasons above, the instant claims are directed to a nature-based product. As noted in MPEP 2106.04(b)(II):
When 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 and determine the answer to Step 2A. […]
Furthermore, MPEP 2106.04(c)(II) sets forth the process for performing the markedly different characteristic analysis including the steps of “selecting the appropriate counterpart(s),” “identifying appropriate characteristics for analysis,” and “evaluating characteristics to determine whether they are ‘markedly different’”.
Since the instant claims embrace materials, such as a natural isolate, the appropriate counterpart is the composition as it occurs naturally.
MPEP 2106.04(c)(II)(B) outlines identifying appropriate characteristics that can include “Biological or pharmacological functions or activities;” “Chemical and physical properties;” and “Structure and form, whether chemical, genetic or physical.” In the instant situation, the specification discloses the property of abietane as being an inhibitor of glioblastoma cells (paragraph [0144]).
As noted in MPEP 2112.01: ‘"Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.’ Since the structure of the naturally occurring compound is identical, the properties observed by Applicant are inherent to the compound as it occurs in nature.
MPEP 2106.04(c)(II)(C) outlines evaluating characteristics and notes:
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.
In this situation since there are no required changes relative to the naturally occurring counterpart, the instant claims lack markedly different characteristics.
For the reasons above, the instantly claimed compositions do not possess markedly different characteristics relative to the naturally occurring counterpart since they have the same structures and properties of the materials that occur in nature. (STEP 2A, Prong One: YES).
Step 2A: Prong Two
The second prong of step 2A is (MPEP 2106.04(d)) to determine whether the claim as a whole integrates (or does not integrate) the judicial exception into a practical application. In the instant situation, the claims are generally only compositions that do not require application to any particular condition or any specific type of formulation.
Step 2B
The final step (MPEP 2106.05(II)) is “Does the claim recite additional elements that amount to significantly more than the judicial exception?” The same section instructs:
Examiners should answer this question by first identifying whether there are any additional elements (features/limitations/steps) recited in the claim beyond the judicial exception(s), and then evaluating those additional elements individually and in combination to determine whether they contribute an inventive concept (i.e., amount to significantly more than the judicial exception(s)).
None of the composition claims require anything beyond the naturally occurring components.
For this reason, the claims do not require significantly more than the exception itself. (STEP 2B: NO).
Based on the analysis above, the instant claims are deemed to be drawn to subject matter that is ineligible under 35 USC 101.
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) 1-10 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Chen et al (WO 2021/129166 A1, published July 1st, 2021).
Chen teaches the following compound (page 6):
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Regarding claim 1, this compound is embraced by instant formula (I), wherein R1 is hydroxyalkyl, R2 is O, R3 is H and R4 is H. The claims are either directed to compositions comprising the naturally occurring compound as well.
Regarding claim 2, the claim places limitations of the alkyl of R3 and R4, however, the compound above has R3 and R4 as hydrogen. As such, the compound above reads on the claim as the limitations are to the alkyl and not hydrogen.
Regarding claim 3, the claim places limitations of the alkylcarbonyl of R1, however, the compound above has R1 as hydroxyalkyl. As such, the compound above reads on the claim as the limitations are to the alkylcarbonyl and not the hydroxyalkyl.
Regarding claim 4, R1 is hydroxypentyl.
Regarding claim 5, the compound is of formula (I-C).
Regarding claim 6, the claim recites “for losing weight and improving gut microbiota”, which is intended use and the claim limitation is presumed met by a compound of instant formula (I). However, Chen teaches that the compound above is for use in a fat-reducing medication (Claims).
Regarding claims 7-8, the prior art is silent regarding "capable of enhancing bacterial abundance of Bacteroidales, and lowering ratio of Firmicutes to Bacteroidetes and capable of enhancing abundance of beneficial intestinal flora and changing gut microbiota composition". However: "capable of enhancing bacterial abundance of Bacteroidales, and lowering ratio of Firmicutes to Bacteroidetes and capable of enhancing abundance of beneficial intestinal flora and changing gut microbiota composition" will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (a compound of instant formula (I)) is being taught in the prior art. In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding "capable of enhancing bacterial abundance of Bacteroidales, and lowering ratio of Firmicutes to Bacteroidetes and capable of enhancing abundance of beneficial intestinal flora and changing gut microbiota composition", by having a compound of instant formula (I) be anticpated by the art, one will also be “capable of enhancing bacterial abundance of Bacteroidales, and lowering ratio of Firmicutes to Bacteroidetes and capable of enhancing abundance of beneficial intestinal flora and changing gut microbiota composition” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("promoting sensory hair cell regeneration") of the method taught by the prior art ("the administration of Compound 346, a compound of structure (I) to a patient suffering from hearing loss").
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Regarding claims 9-10, Chen teaches that the compound is formulated as a function food or a fat-reducing drug (abstract) in a dose of 50-200 mg (claims).
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/900,610 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because: the compound application claims the following compounds (claim 5):
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The copending application also claims a composition with the above compounds, such as a food composition (claim 14).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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