Election/Restrictions
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 of Group I and the species of Valeriana officinalis for claim 3, hydroalcoholic dry extract for claim 4, Passiflora incarnata for claim 5, mixture of monohydrate lactose, microcrystalline cellulose and mannitol for claim 11, hydroxypropylcellulose for claim 13, mixture of aluminum and magnesium metasilicate for claim 15, mixture of silicon dioxide, talc, PEG or Macrogol) 8000 and magnesium sterate for claim 17, mixture of vanilla flavoring and bacon flavoring for claim 19, and pork liver hydrosylate (Palasurance ®) for claim 21, in the reply filed on 07/02/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 27-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/02/2026.
Claims 1-5, 8-9, 11, 13, 15, 17, 19 and 21 are being examined on the merits.
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.
Claims 1-5, 8-9, 11, 13, 15, 17, 19 and 21 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.
Claim 1 recites the term “enhancer” and it is unclear to the metes and bounds of this limitation. What function does the enhancer perform to be considered an enhancer and exactly what is being enhanced?
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim 21 contains the trademark/trade name Palasurance®, D Tech® 8P and Prosaf®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe pork liver hydrolysate, pork hydrolysate and yeast extract, and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-5, 8-9, 11, 13, 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Makoto Ozeki et. al. (EP1743633B1), James Wukjae Lee (US10517322B1), Jean-Noël Tilman and Benoît Wery (BE1026487B1) hereinafter Tilman, and Tomáš Bílik et. al. (Exploration of Neusilin® US2 as an Acceptable Filler in HPMC Matrix Systems—Comparison of Pharmacopoeial and Dynamic Biorelevant Dissolution Study, Pharmaceutics, 2022, 14, 127).
Ozeki teaches a sleep improvement composition comprising: (a) theanine; and (b) at least one component selected from the group consisting of chamomile, lavender, Saint John's wort, kawakawa, valerian, passionflower, tryptophan, (see abstract).
“Tryptophan is a type of amino acid and is a source of serotonin, which is an endogenous sleep chemical, and melatonin, which is called a sleep hormone. The dosage of tryptophan at one time is 0.0005mg/kg body weight to 10000mg/kg body weight, preferably 0.01 mg/kg body weight to 1600mg/kg body weight, and more preferably 1 mg/kg body weight to 100mg/kg body weight. When theanine and tryptophan are used in combination, the mass ratio of tryptophan to theanine is in the range of 0.05 to 100, preferably in the range of 0.1 to 20, and more preferably in the range of 1 to 2” (see 0024).
“Valerian is a plant of the family Valerian aceae that originates in Europe and contains valeranone, valerenic acid, etc. The dosage of valerian at one time is 0.002mg/kg body weight to 4000mg/kg body weight, preferably 0.4mg/kg body weight to 1600mg/kg body weight, and more preferably 2mg/kg body weight to 500mg/kg body weight. When theanine and valerian are used in combination, the mass ratio of valerian to theanine is in the range of 0.2 to 40, preferably in the range of 2 to 20, and more preferably in the range of 4 to 10” (see 0022).
“Passionflower is a perennial vine of the family Passi floraceae that originates in the southwestern part of North America and is an herb that has been used traditionally by native North Americans as a natural tranquilizer for relaxing tension and deepening sleep. The dosage of passionflower at one time is 0.002mg/kg body weight to 8000mg/kg body weight, preferably 0.5mg/kg body weight to 1040mg/kg body weight, and more preferably 5mg/kg body weight to 500mg/kg body weight. When theanine and passionflower are used in combination, the mass ratio of passionflower to theanine is in the range of 0.2 to 80, preferably in the range of 5 to 13, and more preferably in the range of 5 to 10” (see 0023).
Lee is relied upon to show additional tablet formulations for sleep aids comprising of the same plant extracts as being claimed.
Lee teaches a composition which comprises L-theanine (see claim 1, part b, see also table 2) and teaches the agent to promote or encourage healthy sleep can include melatonin or a salt thereof, valerian root extract (see column 6, 42-45, see also table 2), and teaches passionflower extract (see table 2, column 74), and teaches a tablet formation containing binders, diluents, lubricants (see column 68, lines 63-67), and flavoring agent (see columns 67, line 60 or column 70, line 3).
Lee teaches including microcrystalline cellulose as a diluent (see column 68, line 25 or column 67, line 49, line 53) and teaches bentonite (see column 68, line 59) and calcium carbonate (see column 67, lines 45-46 and column 68, lines 25-26).
Lee teaches using lactose binders (see column 56, lines 56-57, column 46, line 66, column 68 lines, 39) and mannitol (see column 68 lines, 39), and PEG and silicon dioxide (see table 1) and teaches including vanilla (see column 7, line 21), which would act as flavoring.
Lee teaches magnesium stearate is used as a lubricant and is added at 0.2 % of the total weight of the granules (see column 71, lines 28-30).
Ozeki and Lee do not specifically teach the binder and adsorbent as aluminum and magnesium silicate being in a ratio of 1:2. Lee teaches both valerian and passionflower extract however is silent on the valerian being Valerian officinalis and passion flower being Passiflora incarnata hydroalcoholic dry extracts.
Tilman teaches compositions comprising at least one plant extract and anhydrous colloidal silica as an excipient (see claim 1) and teaches both Valeriana officinalis and Passiflora incarnata as plant extracts (see claim 2) and further teaches composition characterized in that said at least one plant extract is a dry extract, in particular an aqueous dry extract, hydroalcoholic, ethanolic, methanolic or acetonic (see claim 4).
Tilman teaches “unfortunately, the conservation of formulations comprising plant extracts constitutes a real problem since these are hygroscopic substances which tend to absorb moisture from the air (by absorption or by adsorption), a presence of moisture within the formulations. drastically reducing storage times” (see page 2, 2nd para.).
To solve this problem, there is provided, according to the invention, a composition comprising at least one plant extract and anhydrous colloidal silica as an excipient (see page 2, para. 3).
Bílik teaches that magnesium aluminometasilicate Neusilin ® US2 (NEU) is a commonly used inert filler with unique properties that are usable in various pharmaceutical fields (see abstract).
Magnesium aluminosilicates (MAS) (Neuslin®, Pharmsorb®, Veegum®) are an exceptional group of pharmaceutical excipients with excellent potential for the matrix tablets technology. They are available in numerous types as neutral or alkaline substances, and they become more and more perspective in modern drug delivery systems [11]. In the silicate family, Neusilin® is an entirely synthetic MAS, insoluble in water, and available in 11 different grades as an amorphous white powder or granules with the empirical formula Al2O3·MgO·1.7SiO2·xH2O. It is prepared using the spray drying process, resulting in an extensive specific surface area (100–300 m2/g) [12], high absorption capacity (up to 3.4 mL/g), high porosity [13], and good flow [14] and compression properties [15,16]. In an aqueous medium, it does not form a gel [12]. In modern pharmaceutical development, Neusilin® is used mainly in the technology of liquisolid systems [17], self-emulsifying systems [18–20], enzyme immobilization [21], solid dispersions [22], and others” (see page 2, para. 3).
Bílik teaches that magnesium aluminometasilicate when used in combination with other fillers in varying concentrations can have different pharmacokinetic and dissolution properties (see abstract and top of page 2, 2.6, page 5, 3.1, page 7, table 3, page 8, etc.) and teaches Further study is planned to investigate the different NEU/MCC (microcrystalline cellulose) ratios to eventually find the boundaries of the observed synergy with the eventual involvement of the in vivo study to correlate with dissolution analysis” (see last line of Conclusions, page 15).
Therefore it would have been obvious to persons having ordinary skill in the art before the effective filing date to use magnesium aluminometasilicate as a binder or adsorption agent in the composition taught by Ozeki and Lee and to optimize the amount of binder and adsorption agent to be in the 1:2 ratio as claimed because this is an optimization well within the purview of any skilled artisan especially since they are taught for having the same properties. Optimizing binders and adsorption agents (fillers) is common practice when formulating tablets and any person having ordinary skill in the art would arrive at the instant invention because they would have determined the best dissolution kinetics and other binding properties of the fillers being used to formulate stable tablets. Bílik teaches when combining magnesium aluminometasilicate with that of microcrystalline cellulose there was observed slowed controlled drug release. It would have also been obvious to use hydroalcoholic extracts of both Valeriana officinalis and Passiflora incarnata along with anhydrous excipients such as colloidal silica which can help form stable tablet formulations and fix the problem of the hygroscopic substances in the extracts. It would have been obvious to optimize the active and inactive ingredients to being within the instantly claimed ranges especially given the prior art.
There would have been a reasonable expectation of success in arriving at the instant invention because tablet formulations which comprise of the active plant extracts for improving sleep and the inactive fillers for controlling tablet formation are known.
Claim 19 and 21 is rejected under 35 U.S.C. 103 as being unpatentable over Makoto Ozeki et. al. (EP1743633B1), James Wukjae Lee (US10517322B1), Jean-Noël Tilman and Benoît Wery (BE1026487B1) hereinafter Tilman, and Tomáš Bílik et. al. (Exploration of Neusilin® US2 as an Acceptable Filler in HPMC Matrix Systems—Comparison of Pharmacopoeial and Dynamic Biorelevant Dissolution Study, Pharmaceutics, 2022, 14, 127) as applied to claims 1-5, 8-9, 11, 13, 15 and 17 above, and further in view of María López-Pedrouso (In Search of Antioxidant Peptides from Porcine Liver Hydrolysates Using Analytical and Peptidomic Approach, Antioxidants, MDPI, 2022, 11, 27).
The instant invention is taught from the above relied upon art however the limitations of claim 21 is not described
López-Pedrouso teaches “the search for antioxidant peptides as health-promoting agents is of great scientific interest for their biotechnological applications. Thus, the main goal of this study was to identify antioxidant peptides from pork liver using alcalase, bromelain, flavourzyme, and papain enzymes. All liver hydrolysates proved to be of adequate quality regarding the ratio EAA/NEAA, particularly flavourzyme hydrolysates. The peptidomic profiles were significantly different for each enzyme and their characterizations were performed, resulting in forty-four differentially abundant peptides among the four treatments. Porcine liver hydrolysates from alcalase and bromelain are demonstrated to have the most antioxidant capacity. On the other hand, hydrophobic amino acid residues (serine, threonine, histidine and aspartic acid) might be reducing the hydrolysates antioxidant capacity” (see abstract).
Therefore, it would have been obvious to persons having ordinary skill in the art before the effective filing date to include pork liver hydrolysates as a flavoring agent in the invention taught by Ozeki, Lee, Tilman and Bílik because as discussed by López-Pedrouso they also have antioxidant properties.
Response to Arguments
Applicant's arguments filed 07/02/2026 have been fully considered but they are not persuasive. The applicant argues that neither Lee of Taiyokagu (Ozeki), discloses individually or inherently the specific combination of active ingredients and the selected excipient as defined in claim 1. The applicant argues that the list of ingredients that Lee teaches are many and does not teach the composition to combine V. officinalis and P. incarnata and tryptophan with aluminum and magnesium metasilicate adsorbent in a 1:2 ratio to the binder. Lee indeed teaches each ingredient and Ozeki teaches the same and offers reasons to include them. The Office relies on Bílik to teach that magnesium aluminometasilicate Neusilin ® US2 (NEU) is a commonly used inert filler with unique properties that are usable in various pharmaceutical fields. It is obvious to determine functional parameters for binders and adsorbents and persons using them would indeed create sable tablet formulations based upon the relying art.
The applicant argues that they have found unexpected synergistic effects because when they combine the aluminum and magnesium metasilicate as the adsorbent with a binder in a critical ratio of 1:2 this configuration neutralizes negative effects of the high hygroscopisity of the active ingredients. Determining formulations to tablet plant extracts is common and conventionally done in the art and is well known. Tilman also teaches how to deal with such issues of incorporation of the same plant extracts into tablet formulation with the use of anhydrous colloidal silica as an excipient.
Conclusion
Currently no claims are allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655
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