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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-10, in the reply filed on 5/11/2026 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Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/11/2026.
Information Disclosure Statement
The information disclosure statement filed 1/23/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 recites “O.2 to O.8” instead of “0.2 to 0.8”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US 2016/0228391). Smith is cited on the 6/6/2024 IDS.
Example 5 of Smith teaches coated particles (reading on tablet) comprising 2-hydroxy-4-methylthiobutanic acid (HMTBa), reading on hygroscopic raw material and a coating made up of 2 layers comprising calcium carbonate, stearic acid and an oligomer (i.e. a polymer).
Regarding claim 3: Smith teaches the coating to comprise both hydrophobic ingredients (i.e. ethyl cellulose) and hydrophilic ones (i.e. calcium carbonate), as such the coating is considered to be partially hydrophobic.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2016/0228391), as evidenced by Gottstein (WO 2019/034698).
Regarding claims 1 and 4: Smith teaches matrix and layer compositions (Abs) which can be administered in the form of a tablet [0121] to humans and animals [0122]. A suitable active agent includes 2-hydroxy-4-methylthiobutanic acid (HMTBa) ([0022] and working examples), reading on hygroscopic raw material. Smith teaches the core to comprise the bioactive agent and teaches a layer comprising a polymer formed over the core [0031-0032]. The layer comprising the polymer can further comprise one more additional agents including stearic acid and flow agents such as calcium carbonate [0055]. The working examples, in particular tables 1 and 2, exemplify stearic acid and calcium carbonate in the coating, thus directing a skilled artisan specifically to stearic acid (i.e. moisture barrier) and calcium carbonate, thus it would be prima facie obvious to use both of these agents in the coating along with the polymers.
Regarding claim 4: Smith teaches that calcium stearate can be included in the coating, as evidenced by Gottstein, this is a plasticizer (Gottstein – claim 4).
Regarding claims 2 and 5: Smith teaches that the layer ranges from 1-50% by weight of the total composition [0059], therefore as 1-50% of the total tablet can be the layer, the uncoated tablet can be calculated to make up 50-99% by weight of the total tablet. Smith teaches that the layer comprises 5-50% of the polymer and 50-95% of the one or more additional agents and when two or more agents are used, each agent may be provided in any ratio without limitation. Assuming the tablet as a whole weights 100g, the total amount of additional agents based on the weight of the layer is .5-47.5g ( .5*1=0.5; .5*50=25; .95*1=.95 and .95*50=47.5) and the total amount of polymer in the layer is .05-25g ( .05*1=0.05; .05*50=2.5; .5*1=.5 and .5*50=25), as such the total additional agents can be calculated to make up .47-95% by weight of the uncoated tablet (i.e. (.5-47.5)/(50-99))*100) and the polymer can be calculated to be present in amounts of .05-25% by weight of the uncoated tablet (i.e. ((.05-25)/(50-99))*100). Smith teaches amounts of polymer that overlap with the claimed ranges and while the references doesn’t teach the amounts of plasticizer, stearic acid and calcium carbonate as claimed, as discussed above, Smith teaches that when two or more agents are used, each agent may be provided in any ratio without limitation, this results in amounts of plasticizer, stearic acid and calcium carbonate that overlap with the claimed ranges. Smith also teaches that the layer can comprise 100% polymer, as such it would have been prima facie obvious to optimize the amounts of polymer and additional actives used. MPEP 2144.05 II: "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%.)"
Regarding claim 3: Smith teaches the coating to comprise both hydrophobic ingredients (i.e. ethyl cellulose) and hydrophilic ones (i.e. calcium carbonate), as such the coating is considered to be partially hydrophobic.
Regarding claim 9: Smith teaches that coloring agents can be added [0086].
Claim(s) 1-5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martino (US 2003/0180357) and CN102295788.
Martino teaches tablets comprising a core and a coating (Abs). The coating is an excipient coating, meaning it comprises no drug [0064]. Additional excipients such as plasticizers, dispersing agents, buffers, etc., can be added to the coating [0067]. A suitable active for use includes S-adenosylmethionine (Martino – claim 17).
Martino teaches that the coating is present in amounts that represents a 0.1-5% weight gain (Martino – claim 27), as such the uncoated tablet can be calculated to make up 95-99.9% of the total weight of the tablets plus the coating.
However, Martino does not teach the coating to comprise a polymer, stearic acid and plasticizer as recited by instant claim 1 and 4.
CN’788 teaches a calcium carbonate film coating formula containing 2-80% of a polymer such as hydroxypropyl methyl cellulose (HPMC); 2-70% of calcium carbonate; 1-50% of plasticizers such as triethyl citrate; 1-5% of a lubricant preferably stearic acid; 0.005-2% of a colorant. CN’788 exemplified a coating comprising HPMC, calcium carbonate and stearic acid (pg. 19). CN’788 teaches the coating to have a short production cycle, it uses less materials and has a strong moisture resistance (pg. 1). CN’788 teaches that the coating can be used in cosmetics, health products and pharmaceuticals, the coating is stable and economical (pg. 21).
It would have been prima facie obvious to modify the teachings of Martino with those of CN’788, one of skill in the art would have been motivated to use the coating formulation of CN’788 and include the gellan gum of Martino, as CN’788 teaches that the coating formulation to be stable and economical with strong moisture resistance. One of skill in the art would have a reasonable expectation of success as CN’788 teaches that the coating can be used in pharmaceuticals and Martino teaches that in addition to the gellan gum the coating can comprise additional excipient including plasticizers, and dispersing agents, thus its prima facie obvious to select a material (i.e. a coating) for its recognized suitable for its intended purpose.
Regarding claims 2 and 5: As discussed above, 95-99.9% of the tablet is uncoated, assuming the tablet as a whole weighs 100g, the stearic acid is present in an amounts of 1-5% of the coating layer and can be calculated to be .005-.25g (i.e. .01*.1=.001, .01*5=.05, .05*0.1=.005, .05*5=.25) and thus makes up .005-.26% of the uncoated tablet (i.e. (.005-.25)/(95-99.9)*100). While this doesn’t overlap with the claimed 0.6-2.4, CN’788 teaches stearic acid to be a lubricant which has a good lubricating effect and strong hydrophobicity, so it would have been prima facie obvious to optimize the amounts used. In the alternative 0.6% and 0.25% are sufficiently close and are reasonable expected to result in similar properties.
Regarding the calcium carbonate, this is taught to make up 2-70% of the coating and can be calculated to be .0002-3.9g (i.e. .02*.01=.0002, .7*.01=.007, .02*5=.1, .7*5=3.9) and thus makes up .0002-4.11% of the uncoated tablet (i.e. (.0002-3.9)/(95-99.9)*100) which overlaps with the claimed ranges.
Regarding the amount of polymer (i.e. HPMC), this is taught to make up 2-80% of the coating and can be calculated to be .0002-4g (i.e. .02*.01=.0002, .8*.01=.008, .02*5=.1, .8*5=4) and thus makes up .0002-4.21% of the uncoated tablet (i.e. (.0002-4)/(95-99.9)*100) which overlaps with the claimed ranges.
Regarding the amount of plasticizer (i.e. triethyl citrate), this is taught to make up 1-50% of the coating and can be calculated to be .0001-2g (i.e. .01*.01=.0001, .5*.01=.005, .01*5=.05, .5*5=2) and thus makes up .0001-2.002% of the uncoated tablet (i.e. (.0001-2)/(95-99.9)*100) which overlaps with the claimed ranges.
Regarding claim 3: The above references make obvious a coating comprising both hydrophobic ingredients (i.e. HPMC) and hydrophilic ones (i.e. calcium carbonate), as such the coating is considered to be partially hydrophobic.
Regarding claim 9: The above references make obvious a coating comprising a coloring agent.
Claim(s) 1-5, 6-8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martino (US 2003/0180357) and CN102295788, as applied to claims 1-5 and 9 above, and further in view of Gardner (US 5,980,951).
As discussed above, the prior art makes obvious the limitations of claims 1-5 and 9, but does not teach the use of purified stearic acid.
Regarding claim 6: Gardner teaches pharmaceutical compositions and teaches a commercially available coating to comprise purified stearic acid (col. 5, lines 1-5).
It would have been prima facie obvious to modify the teachings of the above references with those of Gardner and use purified stearic acid in the coating formulation made obvious above, as its prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended purpose.
Regarding claim 7: As discussed above, the coating comprises HPMC, purified stearic acid and triethyl citrate.
Regarding claim 8: Martino teaches that excipients such as lecithin can also be included in the coating [0067].
Claim(s) 1-9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martino (US 2003/0180357), CN102295788 and Gardner (US 5,980,951), as applied to claims 1-7 and 9 above, and further in view of Okamoto (US 4,168,321).
As discussed above, the prior art makes obvious the limitations of claims 1-9, but does not teach the colorant to be caramel.
Okamoto teaches tablets (abs) and teaches that coloring agents including caramel can be used (col. 2, line 5).
It would have been prima facie obvious to modify the teachings of the above references with those of Okamoto and use caramel as a coloring agent in the coating formulation made obvious above, as its prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended purpose.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer A Berrios whose telephone number is (571)270-7679. The examiner can normally be reached Monday-Thursday from 9am-4pm and Friday 9am-3:30pm.
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/JENNIFER A BERRIOS/Primary Examiner, Art Unit 1613
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