DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The amendment filed 10 November 2025 is acknowledged and has been entered.
Status of the Claims
Claims 1-122 have been cancelled.
Claim 126 has been withdrawn
Claims 123-125 and 127-139 are presented for examination on the merits.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 123-125 and 127-139 stand rejected under 35 U.S.C. 103(a) as being unpatentable over Kiliaan et al. (US 7208180) in view of McCaddon (US 2004/0157783) in further view of Alpert et al (1997) and Puri et al. (2004).
Killiaan et al. beneficially teach a method for the prevention and/or treatment of vascular disorders and/or secondary disorders associated therewith, such as neuropsychatric conditions such as depression. The method comprises administration of compositions containing, inter alia, long chain fatty acids such as omega-3 like EPA and DHA as well as compounds which are a factor in methionine metabolism, such as folate (or is physiological equivalents, i.e. methyl folate) and SAMe (see entire document, including e.g., abstract, Column 4, lines 10 – Column 5, line 2; Col. 5, ln 60 – Col. 6, ln. 24)
McCaddon et al. beneficially teach a method and medical composition for the treatment and/or prevention of Vitamin B12 deficiency which may present as dementia or other neuropsychiatric abnormality. The composition may be administered with compounds such as methyl-folate and SAMe to assist in their therapeutic action against neuropsychiatric disease (see entire document, including e.g., paragraph [0022]).
Alpert et al. beneficially disclose that addition of the folate derivative methylfolate to the medication of depressed patients improved clinical outcome at 3-6 months better than placebo. Additionally, treatment of elderly patients with depressive disorders with methylfolate at 50 mg/d alone was associated with an impressive 81% response rate over a 6-week period. It was additionally reported that methylfolate was selected because it is actively transported into the CNS and concentrated in synaptic regions where it is involved in essential metabolic pathways (see entire document, including, e.g., page 146-147).
Puri beneficially reports that supplementation with EPA resulted in improvement in patients suffering from chronic fatigue syndrome, which is characterized by the feeling of fatigue, musculoskeletal pain and many neuropsychiatric symptoms (see entire document).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to further include methyl folate within the composition and method taught by Kiliaan et al. based upon the beneficial teachings provided by McCaddon as well as Alpert. As discussed above, Kiliaan et al. may not explicitly disclose the addition of methyl folate in the administered composition, however it is disclosed that physiological equivalents of folate and folic acid would be acceptable. Methyl folate is widely recognized as the biologically active form of folate and the skilled artisan would find this an obvious substitute. Furthermore, McCaddon does actually explicitly disclose methyl folate as a compound administered for treating/preventing neuropsychatric disorders, which would necessarily promote happiness. In addition, would be well within the purview of the skilled artisan to optimize the amount of EPA in the fatty acids administered for the beneficial effects taught by Puri et al. The instant claims appear to be merely applying a combination of components known in the field. (See KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1742 (2007) “Such a combination according to known methods is likely to be obvious when it does no more that yield predictable results.”) In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that when a patent 'simply arranges old elements with each performing the same function it had been known to perform' and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
Applicant’s invention is predicated on an unexpected result, which typically involves synergism - an unpredictable phenomenon, highly dependent upon specific proportions and/or amounts of particular ingredients. Accordingly, the instant claims, in the range of proportions where no unexpected results are provided, would have been obvious to one of ordinary skill having the above cited references before him/her.
Administration of the known components are all well known in the promotion of wellness/energy (i.e., vitamin B and omega-3 supplementation) and as taught by the cited references. Adjustment of appropriate dosages depending upon the subject is considered adjustment of particular conventional working conditions and is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Furthermore, merely listing the multitude of potential subjects with alternative forms of neuropsychiatric more or less associated with depression, who are likely to be diagnosed as such and treated medically, also does not make the claims nonobvious. A person of ordinary skill in the art would certainly find it within his/her purview to treat the variety of subjects claimed for the numerous neurological problems.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of skill in the art at the time the invention was made, as evidence by the references, especially in the absence of evidence to the contrary, such as surprising or unexpected results provided by Applicant.
Furthermore, The adjustment of particular conventional working conditions (e.g., determining the daily dosage of the administered composition(s) depending upon various factors such as age, size, sex, overall health, etc. of the subject, or administering the constituent component together in a single composition or in separate compositions, for as long as they are administered at roughly the same time they will be digested together and thus present in the bloodstream together) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan, particularly given the very broad ranges of constituent components recited in the claimed composition.
See e.g., MPEP 2144.05
II. ROUTINE OPTIMIZATION
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A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
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B. There is a Motivation to Optimize Result-Effective Variables
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In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. In KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of skill in the art at the time the invention was made, as evidence by the references, especially in the absence of evidence to the contrary.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 123-125 and 127-139 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,372,451 and claims 1-11 of U.S. Patent No. 9,662,359.
Although the claims at issue are not identical, they are not patentably distinct from each other because both are drawn to a method of treatment by administering compositions containing SAMe, methyl folate and omega-3 fatty acids. In addition, please note that the instant claims encompass and/or are encompassed by the "451 and/or ‘359 claims.
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 103 rejection have been fully considered but they are not persuasive.
The claims have been amended to recited ranges of constituent components of the medicament administered in the claimed method. However, as stated previously finding the optimal dosage of active ingredients is deemed routine optimization and well within the purview of the skilled practitioner.
As previously stated, the claims amount to supplementation with a supplement the components of which (i.e, SAM, folate and omega 3s) are well-known supplement ingredient known to individually provide benefits. As stated previously, combining them together is well within the purview of the skilled practitioner. In KSR, the Supreme Court indicated that the obviousness analysis should consider the “background knowledge possessed by a person having ordinary skill in the art.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Under KSR, information deemed within PHOSITA’s general knowledge is more powerful than that found buried in a prior art reference because we assume that PHOSITA would consider using their general knowledge in combination with the prior art — even absent any express motivation to do so. Under 35 U.S.C. § 103, the obviousness inquiry turns not only on the prior art, but whether “the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious . . . to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. § 103. Regardless of the tribunal, the inquiry into whether any “differences” between the invention and the prior art would have rendered the invention obvious to a skilled artisan necessarily depends on such artisan’s knowledge.
Applicant cited later published reports as evidence of patentability. It is unclear what relevance this has regarding the question of whether at the time of filing a person of ordinary skill in the art would be motivated to combine SAM, folate and omega 3s in a supplement. The later studies confirm that such a person of ordinary skill in the art as well as Applicant was correct in combining them. The literature is replete with such evidence that supplementation of SAM, folate and omega-3 fatty acids is beneficial myriad reasons, including cognitive function (see e.g., attached literature documents).
Presumably Appendix A is submitted as evidence that there is some sort of synergy between the components.
However this appears to be a proposal for a treatment, rather than actual evidence of synergistic effects. Furthermore, the proposal is for a specific combination of the three components in a specific proportion: That is -- Gentelon will be 400mg of SAMe, 3.75 mg of L-methylfolate, and 450 mg of EPA.
With respect to such unexpected results, please note that in KSR, the Court also reaffirmed that evidence of unexpected results may overcome an examiner's prima facie case of obviousness. KSR, 550 U.S. at 416 ("The fact that the elements worked together in an unexpected and fruitful manner supported the conclusion that Adams' design was not obvious to those skilled in the art" - discussing United States v. Adams, 383 U.S. 39). However, "any superior property must be unexpected to be considered as evidence of non-obviousness." Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1371 (Fed. Cir. 2007). Thus, "[m]ere improvement in properties does not always suffice to show unexpected results ....[W]hen an applicant demonstrates substantially improved results.., and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995). Moreover, in order to establish unexpected results for claimed invention, objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978). Please also note that "the discovery of an optimum value of a variable in a known process is usually obvious." Pfizer v. Apotex, 480 F.3d at 1368. The rationale for determining the optimal parameters for prior art result effective variables "flows from the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Id. (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).
In order to accord substantial weight to secondary considerations in an obviousness analysis, “the evidence of secondary considerations must have a ‘nexus’ to the claims, i.e., there must be ‘a legally and factually sufficient connection’ between the evidence and the patented invention.” Henny Penny Corp. v. Frymaster LLC, 938 F.3d 1324, 1332 (Fed. Cir. 2019) (quoting Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988)). “The patentee bears the burden of showing that a nexus exists.” WMS Gaming Inc. v. Int’l Game Tech., 184 F.3d 1339, 1359 (Fed. Cir. 1999). “To determine whether the patentee has met that burden, we consider the correspondence between the objective evidence and the claim scope.” Henny Penny, 938 F.3d at 1332.
There has been no evidence presented of any criticality (i.e., not simply routine optimization) in the specified ranges in producing some unexpected results (e.g., synergy). Absence such objective evidence the claims are deemed to be obvious to one of ordinary skill in the art at the time of the filing date of the instant Application.
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.
Conclusion
No claims are allowed.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655