DETAILED ACTION
The present application is a national stage entry of PCT/MY2021/050126, filed 23 December 2021, which claims foreign priority to MYPI2020007106, filed 28 December 2020.
The preliminary amendment filed 13 January 2026 is acknowledged. Claims 1, 2, 6 and 7 are pending in the current application and are examined on the merits herein.
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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-7 in the reply filed on 13 January 2026 is acknowledged. The traversal is on the ground(s) that searching all claims in the application should not be an undue burden on the Examiner to consider. This is not found persuasive because burden of examination is not a criterion for restriction in a national stage entry application.
The requirement is still deemed proper and is therefore made FINAL.
Previously presented claims 8-20 (now canceled) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 13 January 2026.
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, 2, 6 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature with intended use without significantly more. The claim(s) recite(s) a compound, FGS03, which is found in Fusarium. This judicial exception is not integrated into a practical application because the claims are solely directed to a compound with an intended use. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception:
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter.
Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claims recite a compound, FGS03, wherein the compound inhibits prolyl oligopeptidase. FGS03 is naturally occurring, as evidenced by Applicant’s own specification which states isolating FGS03 from Fusarium sp. Strain F274 (see p.4:14 to p.5:4). Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “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.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “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 as the product’s structure, function, and/or other properties…”.
In this case, FGS03 naturally occur in Fusarium sp. Strain F274. Thus, there is not considered to be a marked distinction between the claimed product and naturally occurring Fusarium sp. Strain F274. Thus, the claimed composition as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use of inhibiting prolyl oligopeptidase; or for treating neurodegenerative diseases by inhibiting prolyl oligopeptidase. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the claims do not recite additional elements. Thus, the answer to Step 2B is No.
Consequently, the claims are not directed to patent eligible subject matter.
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, 2, 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tze (Thesis, “The submerged aerobic culture of Fusarium sp. IMI397470 isolated in Sarawak, for the production of Prolyl Oligopeptidase Inhibitor, 2013, cited in PTO-892).
Tze discloses crude extracts from the liquid culture of Fusarium sp. Isolated in 2007 in the Malaysian state of Sarawak exhibited high inhibitory activity against prolyl oligopeptidase (POP), (abstract). Tze found obtaining a 17-fold improvement in POP inhibitor yield from using a shake flask culture using a semi-defined mineral salts medium with glucose as the carbon source (Parker Broth), (abstract). The basal composition of Parker Medium used for Fusarium is described in Table 3.1 (see p.49), reproduced below:
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664
566
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.
From the Fusarium fermentate, butanol was used to produce a crude extract, having POP inhibitory activity (p.57). Tze describes re-suspending the extract in DMSO (p.57, last para).
The fungal extract disclosed by Tze is the same fungal species as described in the Specification for obtaining the compound of claim 2 (see p. 10, present Specification, Fermenting step). Additionally, the fermenting medium/step and extracting step disclosed by Tze are the same as described in the Specification for obtaining the compound of claim 2 (see p. 10, present Specification, Fermenting step and Extracting step). Finally, the extract of Tze has POP inhibitory activity, like the compound of claim 2 (per present claims 6 and 7). Thus, while Tze does not expressly disclose obtaining the claimed compound, an extract was prepared in the same way, and from the same fungal species as Tze, and having the same chemical property as the claimed compound. Thus, the fungal species of Tze inherently comprises the compound presently claimed.
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.
Since the Office does not have the facilities for preparing the claimed materials and comparing them with prior art inventions, the burden is shifted to Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art.
See MPEP 2112, and In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Thus, the disclosure of Tze anticipates claims 1, 2, 6 and 7 of the present application.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAHAR A CRAIGO whose telephone number is (571)270-1326. The examiner can normally be reached M-F: Noon-8pm ET.
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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699