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 .
The Amendment filed 4/21/26 has been received, entered into the record, and carefully considered. The following information provided in the amendment affects the instant application by:
Claims 15-16, and 18-23 have been amended.
No claims have been added.
Claims 1-14 have been canceled.
Remarks drawn to rejections of Office Action mailed include:
Claim objections: which have been overcome by applicant’s amendments and have been withdrawn.
101 rejections: which have been maintained for reasons of record.
112 1st paragraph written description rejections: which have been overcome by applicant’s amendments and have been withdrawn.
112 1st paragraph enablement rejections: which have been overcome by applicant’s amendments and have been withdrawn.
102(a)(1) rejections: which have been overcome by applicant’s amendments and arguments and have been withdrawn. It is noted the claims are no longer drawn to “metabolites” removing US 3,531,374 as art; and Sun differs from the present compounds in at least the stereochemistry of the -OH group.
103(a) rejections: which have been overcome by applicant’s arguments and have been withdrawn.
An action on the merits of claims 15-23 is contained herein below. The text of those sections of Title 35, US Code which are not included in this action can be found in a prior Office action.
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.
The rejection of claims 15-17 under 35 U.S.C. 101 because the claimed invention is directed to a naturally occurring product without significantly more, is maintained for reasons of record. The claim(s) recite(s) naturally occurring cerebrosides from Cordyceps sinensis which are not markedly different than they would occur in nature. This judicial exception is not integrated into a practical application because the combinations of agents (such as in the compositions claimed) would amount to nothing more than a combination of naturally occurring compounds. Naturally occurring saponins would read on the adjuvant in the composition of claims 16 and naturally occurring curcumin is a known anti-inflammatory. Thus, the combination of naturally occurring agents is also not seen to be markedly different than they would occur in nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements when considered separately, or in combination, that would add significantly more to the exception.
Applicant’s arguments filed 4/21/26 have been considered but are not persuasive. Applicants argue that claims 15-17 are patent eligible under step 2A, Prong One, because they do not recite a judicial exception. Applicants state that since the compounds claimed herein were isolated as white powders, this is distinctly different than any raw, unpurified Cordyceps sinensis preparations. Applicants then state that these compounds demonstrated good immunosuppressive activity wherein the unpurified Cordyceps sinensis preparations would not have been suitable for this purpose. Thus, applicants contend their isolated and purified compounds exhibit markedly different characteristics – both structural and functional – from their natural counterparts and thus do not recite a natural product and therefore are patent eligible. The examiner respectfully disagrees. Applicants do not argue that the claims are not drawn to compounds which are isolated from natural products, but rather that isolating them makes them patent eligible since they are not isolated in the natural product. However, the question at hand is whether the compound as it exists in nature would have a different structure than that claimed herein, and the answer is no. The compounds claimed herein would be identical to that in the natural product. Because the products were isolated, and the compositions containing the isolated compounds was a white powder, this does not negate the fact that the compounds present in the white powder would have the identical structure to those as they did in the natural products they were isolated from. Compounds isolated from natural products, which have the same structure as they do in nature, are deemed to be a judicial exception as these purified forms are structurally and functionally identical to the compounds in nature. If there is no difference in function, structure, or other properties, there are no markedly different characteristics and the claims are a product of nature exception.
Applicants then note, for arguments sake, the claims would also eligible under Step 2A, Prong Two because any alleged judicial exception is integrated into practical application. Applicants state their isolated and purified compounds reflect an improvement to the technical field related to treating immune-related diseases and thus since the claimed method improves the technical field to the treatment of immune-related diseases. It is noted that the examiner has not rejected the method claims, as these claims are integrated into practical application. However, the compounds claimed and the combinations of naturally occurring products do not meet this test, and the rejected claims are not eligible under Step 2A, Prong Two.
Applicants then argue the compounds also would be patent eligible under step 2B because the claims recite significantly more than any alleged judicial exception. Applicants state that since their compounds can be used in treating immune-related disease, which was not known prior, they would be found eligible under step 2B. However, the examiner notes the art need not recognize the activity of the present compounds as the compounds would have had these properties in their natural state also.
Allowable Subject Matter
Claims 18-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRAVISS C MCINTOSH III whose telephone number is (571)272-0657. The examiner can normally be reached Monday-Friday 9AM-5:30PM EST.
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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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/TRAVISS C MCINTOSH III/Primary Examiner, Art Unit 1693
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