DETAILED ACTION
Claims 48-66 were pending, Applicant has amended claims 48 and 60 and canceled claims 52 and 61 per the reply of 3/13/2026. The amendment simply moves the limitation of 52 an 61 into the independent claims.
Claims 48-51, 53-60, and 62-66 are pending and are the Subject of the Office Action below.
Priority
The instant application, filed 8/17/2022 and claims priority from Provisional Application 63/234773, filed 8/19/2021.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 3/13/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
Claim Rejections - 35 USC § 103
(Maintained)
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 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 48-51, 53-60, and 62-66 are rejected under 35 U.S.C. 103 as being unpatentable over Raz WO 2016/145193 A1 Published September 15, 2016; am Ende et al. “Improving the Content Uniformity of a Low-Dose Tablet Formulation Through Roller Compaction Optimization,” Pharmaceutical Development and Technology, 12:391–404, 2007; and ; Ullah et al. “Moisture-Activated Dry Granulation-Part I: A Guide to Excipient and Equipment Selection and Formulation Development,” Pharmaceutical Technology-11-02-2009, Volume 33, Issue 11 as applied to claims 48-51 above in further view of Sharma et al. “Review on Moisture activated Dry Granulation Process,” PharmaTutor; 2017; 5(12); 58-67; Takasaki et al. “Importance of excipient wettability on tablet characteristics prepared by moisture activated dry granulation (MADG),” International Journal of Pharmaceutics 456 (2013) 58– 64; and Moravkar et al. “Application of moisture activated dry granulation (MADG) process to develop high dose immediate release (IR) formulations,” Advanced Powder Technology 28 (2017) 1270–1280.
Independent claim 48 is directed to an immediate release capsule dosage form, wherein the capsule contains a granulation powder which comprises:
i. LSD in an amount of less than 1 weight %, or a salt thereof;
ii. mannitol;
iii. hypromellose; and
iv. water in an amount of 1-5 weight %.
Independent claim 60 is directed towards an immediate release capsule dosage form, wherein the capsule contains a granulation powder which comprises:
i. d-LSD-tartrate (less than 1% wt )
ii. mannitol; (10-90% wt instant claim 53 and 62)
iii. hypromellose; (1-5% wt instant claim 56 and 63)
iv. partially pregelled starch;
v. mesoporous silicon dioxide; (<2% wt instant claim 58 and 65)
vi. croscarmellose sodium; and (1-25% wt instant claim 59 and 66)
vii. water in an amount 1-5% wt,
These claims are directed towards the composition in a capsule, wherein said composition includes 10-90 weight % mannitol, 1-5 weight % hydoxypropyl methylcellulose, 1-5 weight % purified water, 25-50 weight % partially pregelled starch, less than 2 weight % mesoporous silica, 1-25 weight % croscarmellos sodium and wherein said composition is formulated with a granulation liquid stock solution of LSD and water, blending mannitol and hydroxypropyl methylcellulose, spraying the granulation liquid onto a dry mixture and blending to form an agglomeration, adding an absorbent of starch and blending, and adding disintegrants, glidants, and lubricants and blending to form a granulation powder (this is not claimed).
The claims do not have limitations to particle size, flow characteristics, or other physical/structural limitations. As such these claims do not require the Moisture Activated Dry Granulation (MADG) process. Regardless of this being the case, MADG will be discussed in the following rejection as representing an obvious and/or optimal design choice for obtaining the instantly claimed LSD formulation. MADG is conventional.
Raz teaches using LSD for the treatment of Alzheimer's disease. Raz makes immediate release capsules to perform the treatment. The capsules contain a solid mixture of LSD tartrate and a filler (diluent) e.g., talc, silica, lactose. See Example 1 page 13. The unit dose of the capsules is 5 μg, 10 μg, 15 μg, and 20 μg D-lysergic acid diethylamide tartrate (meeting the limitations of instant claims 48 and 50). Raz notes the filler/excipient could include lactose, which is a known equivalent to mannitol (both are sugars). Their equivalence will be discussed below.
Raz teaches solid dosage forms, see Page 8, “Solid dosage forms for oral use.”
“Formulations for oral use include tablets containing the lysergic acid diethylamide, or a pharmaceutically acceptable salt thereof, in a mixture with non-toxic pharmaceutically acceptable excipients. These excipients may be, for example, inert diluents or fillers (e.g., sucrose, sorbitol, sugar, mannitol, microcrystalline cellulose, starches including potato starch, calcium carbonate, sodium chloride, lactose, calcium phosphate, calcium sulfate, or sodium phosphate); granulating and disintegrating agents (e.g., cellulose derivatives including microcrystalline cellulose, starches including potato starch, croscarmellose sodium, alginates, or alginic acid); binding agents (e.g., sucrose, glucose, sorbitol, acacia, alginic acid, sodium alginate, gelatin, starch, pregelatinized starch, microcrystalline cellulose, magnesium aluminum silicate, carboxymethylcellulose sodium, methylcellulose, hydroxypropyl methylcellulose, ethylcellulose, polyvinylpyrrolidone, or polyethylene glycol); and lubricating agents, glidants, and antiadhesives (e.g., magnesium stearate, zinc stearate, stearic acid, silicas, hydrogenated vegetable oils, or talc). Other pharmaceutically acceptable excipients can be colorants, flavoring agents, plasticizers, humectants, buffering agents, and the like.”
Raz states on Page 7, “[t]he pharmaceutical compositions may be formulated according to conventional pharmaceutical practice.”
To be clear, Raz teaches all the requirements of the instant claims 48-50 (except Raz doesn’t teach the moisture/water in the formulation). Raz notes i, D-LSD, Tartrate; ii. mannitol; and iii. Hypromellose.
Raz teaches Example 1 page 13:
“Example 1. Immediate Release Capsules (capsules are required by claim 48).
D-lysergic acid diethylamide tartrate (a solid, see evidence from Stoll) is mixed with pharmaceutically suitable diluents (e.g., talc, silica, lactose) and placed into gelatin capsules. Formulated for immediate release, LSD's effects can typically last from 6-12 hours depending on dosage, tolerance, body weight and age. Immediate release LSD dosed at 1 μg/kg can have an apparent plasma half-life of 5.1 hours, with a peak plasma concentration of 5 ng/mL at 3 hours post-dose.
Raz teaches capsules containing 5 μg, 10 μg, 15 μg, and 20 μg D-lysergic acid diethylamide tartrate can be useful in the methods of the invention.”
Talc, silica, and lactose are solids/powders.
D-lysergic acid diethylamide tartrate is a solids/powders. See Stoll, “By dissolving one equivalent of the base with one equivalent of d-tartaric acid in a small quantity of methanol the neutral tartrate of d-lysergic acid diethylamide crystallizes out in form of bundles of needles. The salt is very easily soluble in water and melts indistinctly and under decomposition at 200 degrees C. (corr.).”
Instant claim 50 requires LSD is a tartrate salt. LSD is present in an amount of 0.01-1 mg. Raz teaches 0.02 mg dose of the tartrate.
Instant claim 60 requires LSD is the D enantiomer and tartrate salt, Raz teaches D-lysergic acid diethylamide tartrate as noted above.
While Raz outlines most of the components and alludes to the conventional formulation practice in the art. Raz is not specific enough to render obvious all the limitations of claims. To this end, the am Ende reference is brought in to show how highly potent, low dose active pharmaceutical ingredients (APIs) are formulated to reach a uniform and optimized tablet. Raz doesn’t specifically make an example containing ii. mannitol; iii. hypromellose; and iv. water in the granulation powder; even though all those things are noted, and water is understood to be present unless the material never is exposed to the ambient conditions. Regardless, the following references will provide more context.
am Ende teaches improving content uniformity of a low-dose tablet formulation by optimization of the dry granulation process (am Ende teaches an immediate-release tablet containing a model, potent drug candidate with a target potency of 0.5 mg in a 100-mg tablet (< 1% drug loading).
am Ende teaches tablets, but it is important to note that before compression the granulated powder will meet the limitations of the instant claims, as such this reference is relevant to the instant invention. One can simply fill a capsule with the powder, as noted by Raz. No compression required. Also this is standard to test the powder in studies inside a capsule.
am Ende teaches formulation with the composition/ingredients (Table 1):
API 0.5% (less than 1% as required by the independent claims)
Microcrystalline cellulose 62.92% (filler, binder, diluent, and absorbent)
Dibasic calcium phosphate anhydrous 33.33% (binder and filler)
Croscarmellose sodium 2.00% (absorbent and disintegrant)
Colloidal silicon dioxide 0.50% (anti-caking agent, adsorbent, disintegrant, and glidant)
Magnesium stearate 0.75% (lubricant and glidant)
am Ende teaches us the basic components of a granulation powder. The components are known in the art to be substituted with a variety of equivalents that have been shown to predictably lead to similar results in the art.
am Ende teaches improved content uniformity of the tablets made from this process, see the Conclusion. Note here, it is understood that product formulations must meet standards for content uniformity, as the dose of drug must be consistent when manufacturing is done. One would always be checking to make sure that the process meets the required uniformity from one capsule to the next to assure the dose on the label is in the capsule, plus or minus 5-15%.
While the instant invention calls for mannitol as the excipient, and am Ende is using microcrystalline cellulose. One should note these are equivalents in the art and will be discussed more below. Moreover, note Applicant shows this fact in TABLE 5 (Specification) of the instant application, showing using microcrystalline cellulose, mannitol, and lactose as the excipient and showing similar results. Indicating their ability to be predictably substituted.
Now, going back to Raz “solid dosage forms”, see Page 8, we see that lactose and mannitol are considered equivalent fillers. To bolster these common equivalents, Ullah is brought in. Ullah also indicated the known fact that formulations contain water.
Ullah states, “In what is arguably the seminal paper on the moisture-activated dry-granulation (MADG) process, the authors proposed a simple, economical, and novel granulation process that uses a small amount (1-4%) of water to cause agglomeration without subsequently requiring a drying step.” What is important to note, this implies common knowledge that granulation requires water, and if you use a lot of water you are required to remove it via drying. MADG allows one to use less water, and thereby no drying and the water content remains low, 1-4%.
Ullah teaches about using different fillers. When Ullah discussing fillers the reference notes that “MADG process uses nonabsorbent, easy-to-wet fillers such as lactose monohydrate and mannitol.”
Ullah notes that, “Microcrystalline cellulose or starch products can help avoid over wetting and over granulation of the product even when little moisture is used.”
Ullah notes that, “Previous studies indicate that low viscosity polyvinylpyrrolidones (PVPs) such as PVP K-12 are ideal for this purpose. If PVP is not an acceptable choice because of formulation concerns such as chemical compatibility, binders such as hydroxypropyl cellulose effects or address specific concerns.”
Ullah also discusses the use of many different moisture absorbents in the MADG process. Lastly, Ullah makes it clear that one can mix and match multiple materials and end up with a viable and predictable result of a granulation powder ready for capsules or for compression to tablets. The obviousness is based on equivalence in the art. See MPEP 2144.06 Art Recognized Equivalence for the Same Purpose.
Mannitol, MCC, and Lactose are known equivalents as fillers/excipients.
HMP and PVP and known equivalent binders.
Claims 48-51 are obvious as they are directed to conventional formulations. This is illustrated by Raz teaching immediate release solid capsule formulations of D-LSD-Tartrate with lactose filler, and explaining that a person of ordinary skill in the art would use conventional means to arrive at these formulations. When one goes to the art, looking for formulations of high potency (and therefore low dose) compounds they see an example of dry granulation/dry blending/MADG (conventional methods) one finds plenty of routine and obvious ways to combine the active drug in an excipient/filler and their equivalents in the art. A person of skill is aware of needing fillers (lactose/mannitol), binders (HMPC), absorbents (croscarmellose sodium) disintegrants, glidants, and lubricants. This is common practice in the art as noted by both Raz, am Ende, and Ullah. Therefore, the instantly claimed formulations were obvious at the time of filing given the conventional nature of the instant claims.
Raz, am Ende, and Ullah render obvious an immediate release capsule of LSD tartrate. They do not however note using the known MADG process. These combined references would allow one to arrive at a blended/mixed granulation powder having 0.5% LSD tartrate with all the excipients required in claims 48-51. The granulation powder would then be compressed to tablets, or loaded into capsules.
The claims require
10-90 weight % mannitol,
1-5 weight % hydoxypropyl methylcellulose
1-5 weight % purified water
25-50 weight % partially pregelled starch,
less than 2 weight % mesoporous silica,
1-25 weight % croscarmellos sodium.
The 3 previous references, rejecting claims 48-51 arrived at a blended granulation powder with the following composition of matter based on am Ende:
API (LSD Tartrate) 0.5%
Microcrystalline cellulose 62.92% (filler, binder, diluent, and absorbent)
Dibasic calcium phosphate anhydrous 33.33% (binder and filler)
Croscarmellose sodium 2.00% (absorbent and disintegrant)
Colloidal silicon dioxide 0.50% (anti-caking agent, adsorbent, disintegrant, and glidant)
Magnesium stearate 0.75% (lubricant and glidant).
Given the knowledge in the art, one would be motivated however to use the known MADG technique for LSD tartrate in place of blending. Looking to Sharma we see why one would use MADG. Sharma notes that Dry Granulation tends to create dust and increases the potential for contamination (page 60, column 2, last para), given that LSD tartrate is highly potent one would want to limit exposure of workers preparing the tablets, and one would be motivated to avoid dry blending. Sharma also notes the MADG process has advantages and is quick, cost effective, and requires a single machine (high shear granulator) (see page 65, last para). Sharma explains the MADG process:
“MADG has two stages: agglomeration and moisture distribution. Success depends on the selection and order in which the formulation ingredients are added, as well as how the process is carried out. During agglomeration, a major portion of the formulation containing the drug is agglomerated. The drug is blended with filler and binder in the powder form, and this blend constitutes approximately 50–80% of the formula weight. In the second stage, a small amount (0%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, and 5%) of water is sprayed as small droplets onto the blend (while blending). (Devender et al., 2017) Water moistens the blend and causes the binder to become tacky, which causes particles, particularly fines, to form moist agglomerates. The process does not create large granules, which would need milling, and because very little water is used in the process, the endpoint is not sensitive to blending.”
Sharma concludes with the following:
“The moisture activated dry granulation method was found to be simple, reproducible, easily controllable, economical, and continues process. Additionally, the excipients used for the formulation of tablets were cheap and easily available. Other drugs for the use in moisture activated dry granulation method can be incorporated in the formulation of tablets. Therefore, these types of moisture activated dry granulation method for tablets can be commercially processed easily and potentially better other than wet granulation method for formulation of tablets.”
Sharma is clearly providing a rationale to use the MADG process (a conventional and known process as called for by Raz) when formulating compounds for human use. Sharma doesn’t however provide a specific formulation mixture.
Takasaki is brought in to further provide motivation to use MADG, and to provide an example of the excipients used in the process. Takasaki outlines the advantages of MADG in the Introduction, and states, “[f]inally, as transfer steps are the main source of unintended exposure, MADG is the ideal granulation process for the manufacture of solid dosage forms from highly potent compounds.”
Takasaki teaches the process, two different stages: the agglomeration stage and the moisture absorption stage. Initially API, water soluble fillers and binders are pre-mixed in the granulator and the binder is activated by a small amount of water to form the granules. MADG typically requires a significantly reduced amount of granulation liquid compared to a conventional high shear granulation (HSG) process (1–4% (m/m)) of the mass to-be-granulated. During the absorption stage, the moisture within the granules is reduced and distributed to the whole blend by subsequently adding a water insoluble filler-component as an absorbent powder.
Takasaki teaches several specific formulations, see Table 1. Here we see in the agglomeration stage is done with lactose (Granulac 200) as a filler, and PVP as the binder. These materials are granulated by spraying them with water. Then the moisture absorbent was added, in this case various forms of cellulose/starch/crospovidone/carmellose calcium. Lastly the lubricant was added, PVP and magnesium stearate.
Takasaki teaches that the MADG process results in a faster disintegrating tablets that the HSG process and that MADG offers a simple and cost-saving process in addition to producing fast-disintegrating tablets.
Comparing Takasaki to the instant:
INSTANT Takasaki
10-90 weight % mannitol, 64-85% lactose,
1-5 weight % hydoxypropyl methylcellulose 5% povidone,
1-5 weight % purified water water to wet,
25-50 weight % partially pregelled starch, 12% starch, 26% cellulose, (other)
less than 2 weight % mesoporous silica,
1-25 weight % croscarmellos sodium, and 2.5% crospovidone
less than 2 weight % sodium stearyl fumarate, 1% mag stearate
The compositions are generically similar, using a filler/binder with water, then a moisture absorbent, followed by lubricant. Therefore obviousness requires mannitol and lactose to be equivalents fillers and are the following subtitutions obvious, povidone with hydoxypropyl methylcellulose, or crospovidone with croscarmellos sodium/sodium starch glycollate.
Going back to Raz “solid dosage forms”, see Page 8, we see that lactose and mannitol are considered equivalent fillers. To bolster these common equivalents, Ullah is brought in.
Ullah teaches about the MADG process. When discussing fillers the reference notes that “MADG process uses nonabsorbent, easy-to-wet fillers such as lactose monohydrate and
mannitol.”
Ullah notes that, “Microcrystalline cellulose or starch products can help avoid overwetting and overgranulation of the product even when little moisture is used.”
Ullah notes that, “Previous studies indicate that low viscosity polyvinylpyrrolidones (PVPs) such as PVP K-12 are ideal for this purpose. If PVP is not an acceptable choice because of formulation concerns such as chemical compatibility, binders such as hydroxypropyl cellulose effects or address specific concerns.”
Ullah also discusses the use of many different moisture absorbents in the MADG process. Lastly, Ullah makes it clear that one can mix and match multiple materials and end up with a viable and predictable result of a granulation powder ready for capsules or for compression to tablets.
Moravkar is brought in to show that MADG is known to be used for immediate release formulations. Moravkar teaches that (MADG) was developed by Ullah. MADG is a simple and innovative process where granules are created with water and a granulating binder, as in wet granulation, but are not heat dried or milled. This process helps to minimize endpoint sensitivity. The whole process can ideally be performed within a conventional high shear granulator, hence this process is called as ‘‘one-pot process”. Moravkar concludes that with MADG, it is possible to produce high drug loaded granules for drugs with significantly varying properties and attributes. MADG is found to be a simple cost-effective process yielding formulation with desirable pharmaceutical quality parameters. The study can conclude that the compatibility and dissolution profiles of product made by this method are satisfactory. Moravkar also states MADG can be easily explored as a granulation technique for drugs with different properties. It minimizes the total number of excipients thus decreasing the complexity of the formulation and increasing the scalability of the formulation. Moravkar shows the application of MADG to immediate release profiles.
Given that the Applicant’s invention is directed towards a known drug product, LSD tartrate, formulated with the known technique of MADG, the instant invention is obvious based on the fact that using the known technique on a known product ready for improvement is predictable as taught by the combination of references. Ullah also makes clear that formulate concentrations will vary to some degree as they are result effective in getting proper particle size an flowability for processing. Given that the references clearly teach adding all the ingredients in the general range claimed a prima facie case of obviousness is found for the vlaims to amounts and ranges. "[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). As such the instant claims are obvious.
Response to Applicant’s Arguments: Applicant states that PHOSITA in possession of Raz would have needed to make at least the following modifications:
1) Select the immediate release capsules of Raz Example 1 (the "Raz Formulation"),
rather than the sustained release pellets of Raz Example 2, or the liquid saline
formulations of Raz Example 3, for further development. This is not true, as one would be motivated to modify all 3 for further development, as such this required selection is not pertinent. The art also clearly shows that LSD has traditionally been administered directly to the patient for immediate adsorption in the mouth. So one would understand the immediate release to be more relevant to the traditional method of administration.
2) Specify the concentration of LSD (or salt thereof) to be less than 1 weight %, despite
no disclosure in Raz of any LSD concentration in any formulation. Response: This argument is misplaced by simple understanding of LSD. The drug is highly potent and the dosing of Raz shows dosing as low as 5 micrograms. A PHOSITA is aware that a typical gel capsules used in pharamacuetical research (Size 0 to Size 000) hold around 400 to 800 mg of filler, like mannitol. So adding 0.005 mg LSD to 400 mg mannitol is way less than 1% by weight. Again, this is just looking at Raz for what it teaches to a skilled artisan. The Examiner relied on other art, to show in more polished research with potent compounds of 0.5% AI, but if one were honestly looking at Raz alone the percent LSD would be below 1% as well. This argument in not persuasive.
3) Specifically select, from the nine categories of excipients identified by Raz, an inert
diluent/filler and a binding agent, and to blend these excipients with LSD in a granulation
powder. This argument is misplaced as the rejection simply relies on known equivalents in the art and is stating that it doesn’t matter what filler, binding agent, and blending method is used. Applicant has not shown any significance to the choices made. As such they are all the same in the art, and in the rejection. Therefore this is a misplaced argument. If Applicant shows that selecting mannitol is significant, rather than any other sugar or filler, then the claims would potentially be allowable. This is not the case. The Specification doesn’t teach significance, and Applicant has not shown any. Therefore this argument is not persuasive.
4) Specifically select mannitol from the list of twelve possible inert diluents or fillers,
none of which are called out by Raz as being preferred above any of the others. If Applicant shows that selecting mannitol is significant, rather than any other sugar or filler, then the claims would potentially be allowable. This is not the case. The Specification doesn’t teach significance, and Applicant has not shown any. Therefore this argument is not persuasive.
5) Specifically select hypromellose (i.e., hydroxypropyl methylcellulose) from the list of
seventeen possible binding agents, none of which are called out by Raz as being
preferred above any of the others. If Applicant shows that selecting hypromellose is significant, rather than any other binder, then the claims would potentially be allowable. This is not the case. The Specification doesn’t teach significance, and Applicant has not shown any. Therefore this argument is not persuasive.
6) further add water in an amount of 1-5 weight %. The amount of water is common from the process, and again no significance has been shown. Residual water in formulations is common. If Applicant shows that this amount of residual water is significant, then the claims would potentially be allowable. This is not the case. The Specification doesn’t teach significance, and Applicant has not shown any. Therefore this argument is not persuasive.
7) (for claim 60) further add partially pregelled starch, mesoporous silicon dioxide, and
croscarmellose sodium. This has the same problem. These are common additives and Applicant has not shown significance. Therefore this argument is not persuasive.
Next Applicant states that a low dose formulation is not motivated. This is not true, as the dose of Raz in between 5-20 micrograms. This is a low dose. Moreover the art teaches LSD has highly potent. Therefore the only dose is low dose. Therefore this argument is not persuasive.
Next Applicant states there is no motivation to select mannitol and Hypromellose. Again the rejection makes clear there are a number of choices, these are included, they all behave the same, and therefore are an obvious choice. If Applicant shows that selecting Hypromellose and mannitol is significant, rather than any other binder and filler, then the claims would potentially be allowable. This is not the case. The Specification doesn’t teach significance, and Applicant has not shown any. Therefore this argument is not persuasive.
Conclusion
No claims allowed.
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 MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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