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
Election/Restrictions
Newly submitted claims 40-45 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Inventions I and claim 40-45 are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed effect of increasing bioavailable spermidine in invention 1 is a materially different effect than increasing Beclin-1 in a subject. This means that the inventions are mutually exclusive. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 40-45 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 19, 21, 23, and 36-39 are under examination herein.
Claim Objections
Claim 19 is objected to because of the following informalities: the claim recites the abbreviation BU without first defining the term in long form. Appropriate correction is required.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) the claims under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Graz.
Declaration Under 37 C.F.R. 1.132
Beclin-1 is a known marker of autophagy, and the cited combination of references (see 103 rejection, below) teach administration of the claimed ingredients to induce autophagy. As such, increased Beclin-1 levels would not have been unexpected. Applicant has not provided any evidence indicating that the particular dosage form/combination or amounts recited in the instant claims give a different result than what would be expected by one of ordinary skill in the arts.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 39 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 39, the claim requires administration for a duration sufficient to increase Beclin-1 levels in a human subject. The only mention of Beclin-1 in the specification is in reference to levels of Beclin-1 being monitored (instant specification 0023). There is no support for increasing Beclin-1 levels in a human subject by administering a composition as recited in the instant claims, only that the level of Beclin-1 can be monitored.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19, 21, 23, and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Beecham et al., (US 2020/0101029 A1, found in the IDS and previously cited) in view of Graz (NL1036427C2) and Kibe et al., 2014 (Upregulation of colonic luminal polyamines produced by intestinal microbiota delays senescence in mice, previously cited), as evidenced by Brito et al., 2017 (Bioactive amines and phenolic compounds in cocoa beans are affected by fermentation, found in the IDS and previously cited) and Jadhav et al., 2023 (Triglycerides of medium-chain fatty acids, previously cited)
Regarding claim 19, Beecham teaches methods for improving brain health in a user during aging comprising administering a food product comprising cocoa and spermidine at a concentration of approximately 4 mg (Examples 1 and 2). Beecham teaches that the method is for preventing deterioration during aging of human cognitive function (para. [0002]). Beecham teaches that the formulation of their invention can be configured as beverages, ice creams, or smoothies (Paragraph 0139), i.e., edible and therefore orally administered. Beecham teaches the method can be used to boost autophagy ([0008]).
Although cocoa is used as an nrf2 activator in the invention of Beecham, cocoa is also a spermidine-containing fruit, as evidenced by Brito (Abstract). Beecham also teaches that spermidine-rich foods comprise wheat germ, mushrooms, green peas, shellfish, chicken liver, potatoes, pears, and aged cheese (para. [0078]). Therefore, it would have been obvious to one of ordinary skill in the art that any of the spermidine-rich foods mentioned, which encompass spermidine-containing fruits, vegetables, legumes, and grains, may be used in the invention of Beecham. Beecham teaches that, in addition to cocoa and spermidine, the subject is also provided probiotics comprising Bifidobacterium, as it is a known spermidine-producing microbe (para. [0077]).
Beecham does not teach the concentration of the spermidine-producing bacteria, the administration of spermine, or administration of the spermidine precursor, arginine.
Graz teaches methods and compositions for the treatment of autophagy (abstract). Graz teaches that the method includes spermine (abstract). Graz teaches the spermine can be administered in a range of 5 mg-50 mg per serving (p98 2nd full paragraph). This overlaps the claimed range and therefore the claimed range is prima facia obvious. Graz teaches the composition can be administered as a food (p98 5th full paragraph). Graz teaches the composition can comprise probiotics (p107 line 26). Graz teaches the composition can comprise arginine (p116 last partial paragraph).
Although the concentration differs from that of the instant claim, section 2144.05 II of the MPEP states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")” The selection of specific spermine concentrations would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that spermine concentrations would affect the neuroprotective effects in subjects.
The combination of Beecham and Graz does not teach the concentration of arginine, or the concentration of the spermidine-producing bacteria.
However, Kibe teaches the administration of the spermidine precursor, arginine at concentrations ranging from 0-0.8 mg/g (Figure 2A) in combination with Bifidobacterium animalis (Abstract) at 108 CFU (Page 10, Column 1, Paragraph 3). Although the concentration of the probiotic differs from that of the instant claim, generally differences in concentration will not affect patentability as it is not inventive to discover the optimum or workable ranges by routine experimentation, as stated above.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have included spermine and arginine, as taught by Graz and Kibe, respectively, in the food product/probiotic combination taught by Beecham. One of ordinary skill in the art would have been motivated to do so because Graz teaches that spermine is useful for autophagy treatments (Abstract), while Kibe teaches that administration of arginine in combination with Bifidobacterium increased longevity in mice and protected mice from age-induced memory impairment by increasing polyamine concentrations (Abstract). Therefore, one of ordinary skill would be reasonably expected to understand that adding arginine/probiotic and spermine to the invention of Beecham would further increase polyamine content in the subject, which would protect said subject from neurocognitive pathologies associated with declining polyamine levels (para. [0051], para. [0075], para. [0077]).
Regarding claim 21, Beecham teaches the use of Bifodobacterium but does not teach strain LKM12. However, Kibe teaches that administration of the probiotic Bifidobacterium animalis subsp. lactis LKM512 in combination with the spermidine precursor, arginine, results in increased longevity in mice (Introduction, Paragraph 1). Therefore, one of ordinary skill in the art would have been reasonably expected to understand that the B. animalis subsp. lactic LKM12 strain taught by Kibe may be used as the Bifidobacterium probiotic taught by Beecham.
Regarding claim 23, Beecham teaches the use of aged cheddar cheese as a spermidine source (Example 2). Cheese is made from milk fat, and milk fat contains medium chain triglycerides, as evidenced by Jadav (Page 2145, Sources of medium chain triglycerides). Therefore, Beecham’s spermidine-containing food, cheese, inherently contains at least one medium chain triglyceride.
Regarding claim 36, Beecham teaches that the formulation of their invention can be configured as beverages, ice creams, or smoothies (Paragraph 0139).
Regarding claim 37, Beecham teaches that a key pathway by which nature enables partial autophagy in the brain is via spermidine (para. [007]). Therefore, increasing autophagy would be an inherent result of the method of Beecham.
Regarding claim 38, Beecham teaches that the food product comprises approximately 4g of spermidine (Examples 1 and 2). Graz teaches the spermine can be administered in a range of 5 mg-50 mg per serving (p98 2nd full paragraph), and Kibe teaches an arginine concentration of 0-0.8 mg/g (Figure 2A). Although the concentration of the probiotic differs from that of the instant claim, generally differences in concentration will not affect patentability as it is not inventive to discover the optimum or workable ranges by routine experimentation, as stated above. The selection of spermidine, spermine, and arginine concentrations would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that concentration would affect neuroprotective effects.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
