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 .
DETAILED ACTION
Claims 1-14, 17 and 20-24 are currently pending and amendments to the claims filed on 03/05/2026 are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 03/05/2026 was filed before the mailing date of the instant action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Allowable Subject Matter
Claim 10 is 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. Specifically, there is no motivation to combine all the ingredients and amounts thereof to achieve the claimed invention, and accordingly, it would be hindsight to derive the instantly claimed subject matter from the combined references.”
Withdrawn rejections:
Applicant's amendments and arguments filed 03/05/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below are herein withdrawn.
The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
New Grounds of Rejections --- as necessitated by amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1, 2, 17, 23 and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Each of claims 1, 2, 17, 23 and 24 recites the unclear term “if present”. Base claim 1 requires “at least a humidity sensitive vitamin” as an essential element. However, “if present” suggests uncertainty, possibility, or a rare occurrence— even one vitamin might or might not be there. Thus, those claims are indefinite.
Meanwhile, "When present" suggests certainty, inevitability, or a regular/expected occurrence—it is expected to be there. Since the capsule filling must have at least one humidity sensitive vitamin, then that is an expected certainty. It is not a rare occurrence that at least one vitamin can be present. Therefore, the Examiner suggest amending the term to “when present” if applicant agrees.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 8 recites “the choline glycerophosphate is at least 8wt% of the total weight of the soft gelatin capsule”. Base claim 1 recites “between 50 and 1000 mg of choline glycerophosphate”. It appears that “at least 8wt” may exceed the scope of claim 1. It may not be said that claim 8 further defines claim 1 in a proper manner.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-3, 5, 8, 14, 20 and 24 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Bredesen et al. (WO2014/151364A1, IDS of 07/17/2023, citation is obtained from its corresponding US2016/0038552A1).
Applicant claims the below claim 1 filed on 03/05/2026:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a soft gelatin capsule research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from capsule medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Bredesen teaches improved cognitive supplements or formulations in the form of soft gel made of gelatin which reads on the claimed soft gel shell (instant claims – soft gel shell) and the formulation comprises vitamins (e.g., vitamins A, B1, B5, D, etc. which reads on the claimed humidity sensitive vitamin as supported by the instant publication at [0198], fatty acids (e.g., omega-3 fatty acids including DHA and EPA which reads on the claimed essential unsaturated fatty acid), lipids or phospholipids (e.g., L-alpha glycerylphosphorylcholine (Alpha-GPC) which reads on the claimed choline glycerophosphate), etc. (e.g., [0068], [0183], [0237], and claims 1-6 & 17-20 of prior art); in one embodiment, the formulation comprises vitamin D3 (=cholecalciferol) in an amount of between 500IU and 5000IU (= 12.25 mcg to 120.25mcg) that overlaps the instant range of between 0.5mcg and 50 mcg or between 1mcg and 30 mcg), vitamin B1 (=thiamine) in an amount of about 2.5mg to about 25mg that overlaps the instant range of between 0.05mg and 3 mg, B5 (=pantothenic acid=pantothenate), B9 (=folic acid=folate) in an amount of about 0.4-about 10mg that overlaps the instant range of between 0.01 and 1.00mg or between 0.05mg and 0.7mg, and B12, DHA and EPA, L-alpha glycerylphosphorylcholine, etc. ([0109], [0118], [0227]: Table 2 and [0237]) wherein the alpha-GPC is used in an amount of 250-1500mg or 400-1000mg (Table 2) which overlaps the instant range of between 50 and 1000mg or between 70 and 700mg; one or more DHA and EPA are preferably used in an amount of about 100 to about 2000mg or about 250 mg to about 1500mg or about 250 to 1000mg which overlaps the instant range of between 100 and 1500mg and since DHA and EPA are present together (e.g., claims 14-15 of prior art) and the claimed ratio of between 1:50 and 1:1.2 would be optimized. MPEP 2144.05: “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).” The formulation contains zinc oxide ([0232]) and although Bredesen does not teach copper or iron, it would be obvious variation from zinc minerals; and the formulation contains minerals such as magnesium ([0167]), and zinc oxide ([0232]), and chelating agent ([0253]). Further, the composition contains plasticizer such as glycerol or sorbitol ([0246]) which reads on the claimed plasticizer (instant claims 1-3, 8, 14, 20 and 24); the formulation contains vitamin B1 in an amount of 2.5-25mg or 10-25mg, B5 in an amount of 100-250mg or 150-250mg, B9 in an amount of 0.4mg to 10mg or 0.8mg to 10mg, vitamin D3 in an amount of 500-500IU or 1000 to 5000 IU (Table 2).
Although Bredesen does not expressly teach at least 8% of soft gelatin capsule of instant claim 8, Bredesen teaches overlapping amount of 250-1500mg or 400-1000mg and thus one of the ordinary artisan would optimize the prior art amount with the claimed amount (%) (instant claim 5).
In light of the foregoing, instant claims 1-3, 5-8, 14, 20 and 24 are rejected by Bredesen.
Claims 4, 9, 11-12 and 23 remain/are rejected under 35 U.S.C. 103 as being unpatentable over Bredesen et al. (WO2014/151364A1, IDS of 07/17/2023, citation is obtained from its corresponding US2016/0038552A1) in view of McCleary (US2004/0043013A1, IDS of 03/17/2013).
However, Bredesen dose not expressly teach other ingredients of instant claim 4 (selenium), claim 9 (copper, iodine, calcium or combination thereof), claim 11 (vitamin B3 & B8), claim 12 (vitamin E), and claim 23 (vitamin C and B12). The deficiencies are cured by McCleary.
McCleary discloses a composition of agents for metabolic uncoupling therapy wherein the therapy is effective to treat e.g., neuronal and/or cognitive dysfunction, dementia, attention and attention/hyperactivity disorders, mood disorders, etc. ([0002], [0018], [0085]-[0086], [0096]-[0097], etc.); the composition comprises e.g., EPA, glyceryl phosphorylcholine ([0083]) and vitamins such as vitamin A in an amount of 2500 IU; vitamin B group including B2 in an amount of 25 mg, B3 (=niacinamide) in 25 mg that is within the instant range of between 5 and 50mg, B5 in an amount of 25 mg, B6 in an amount of 25mg or 1 mg to 400 mg ([0054] and [0068]), B8 (=inositol) in an amount of 10mg-10g or 100mg to 2g ([0054]), B9 (=folate=folic acid) in an amount of 100 mcg to 20 mg or 400 mcg to 10mg ([0054]), and B12 in an amount of 1mg ([0068]); vitamin C (50mg) ([0131]) that is within the claimed range of between 10 and 300mg; vitamin D in an amount of 400 IU; and vitamin E (100 IU) ([0105]); selenium in an amount of 100 mcg; and calcium in an amount of 1000mg); and the composition contains taurine (e.g., [0134] and claim 26 of prior art). MPEP 2144.05 noted above (instant claims 4, 9, 11-12 and 23).
Although the applied art does not expressly the claimed amounts of ingredients such as vitamin B8 and E, the claimed amounts would be optimized depending on the intended purpose, type of formulation, severity of disease/disorder, sex, body weight, mode of administration, etc., in the absence of criticality of the claimed ranges.
It would have been obvious to modify the composition of Bredesen with addition of various different vitamins B3, B8, C and E and minerals of McCleary in order to enhance the synergistic properties of the soft gelatin capsule composition as taught/suggested by McCleary.
Further, where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of elements in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "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". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 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." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the disclosed elements and embodiments of the cited reference to prepare the instantly claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed invention is within the purview of the ordinary skilled artisan upon reading the cited reference and would yield predictable results.
In light of the foregoing, instant claims 4, 9, 11-12, and 23 are obvious over Bredesen in view of McCleary.
Claim 13 remains rejected under 35 U.S.C. 103 as being unpatentable over Bredesen et al. (WO2014/151364A1, IDS of 07/17/2023, citation is obtained from its corresponding US2016/0038552A1) in view of Spleiss (US2015/0297529A1).
However, Bredesen does not expressly teach gelatin type of instant claim 13. The deficiency is curd by Spleiss.
Spleiss discloses a pharmaceutical composition in the form of soft gelatin capsule comprising a soft gelatin shell encapsulating the composition comprising EPA, DPA, DHA, etc. (abstract and claims 1, 19 and 20 of prior art); and the gelatin shell is made up of porcine type A gelatin or bovine type B gelatin ([0011] and [0016]-[0018]) and here type A gelatin improves the shelf life of the capsules ([0011]).
It would have been obvious to modify the soft gelatin capsule of Bredesen with gelatin type A or B in order to protect the capsule or improve shelf life of the capsule as taught by Spleiss.
In light of the foregoing, instant claim 13 is obvious over Bredesen in view of Spleiss.
From the combined 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 ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments have been fully considered, but are not persuasive.
Applicant argues that the inclusion of certain amount of each of the humidity sensitive vitamins and GPB of between 50 and 1000mg and a specific mixtures of fatty acids in a single soft gelatin capsule would not be obvious; Bredesen discloses higher amounts of B5 and B12; and therefore the claimed specific combination of GPC, vitamins and fatty acids in 1:50 to 1:1.2 is not obvious over the applied art; and McCleary does not mention about GPC, fatty acid mixtures and ratio thereof, and vitamins such as B2, B6 and B12 are outside of the ranges of claim 1.
The Examiner responds that the claimed vitamin is at least one vitamin and Bredesen reads on the claimed vitamins (e.g., vitamin B1, B9 or D3), and Bredesen teaches GPC and such at least one vitamin, EPA/DHA combination and their overlapping amounts, and McCleary discloses vitamin B3, calcium, selenium, etc. as noted in the body of Action, and the combination of the applied art would achieve the claimed invention, unless criticality of the claimed ranges are given. Please note that the current rejection is the 103 rejection not the 102 rejection and for the same purpose of providing single soft gelatin capsule for treating various diseases/disorders, both references would be combinable to achieve the claimed invention. In addition, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In reKeller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In reMerck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). MPEP 2145.
Conclusion
The instant case is not in condition for allowance.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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