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 .
Status of Claims
A new claim set was filed on 6/8/26 with the following:
Amended claims
12-17
Newly canceled claims
Newly added claims
18-20
Previously canceled claims
Previously withdrawn claims
1-11
Claims under instant examination
12-20
Withdrawn Claim Rejections
The rejections of claims 12-17 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention are hereby partially withdrawn in view of the claim amendments filed on 6/8/26.
The rejection of:
claims 12-16 under 35 U.S.C. 102(a)(1) as being anticipated by Tekenaka et al. (Chem Pharm Bull, 19(6), 1234-1244, 1/1/71; in IDS dated 1/15/24)
is hereby withdrawn in view of the claim amendments filed on 6/8/26.
Duplicate Claims – CAUTION
Applicant' s claim amendments have necessitated the following new grounds of objection.
Applicant is advised that should claims 19-20 be found allowable, claims 19-20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). In the instant case, both claims recite identical dependency and limitations. Therefore, there does not appear to be any difference in scope between the two claims.
Partially Maintained Claim Rejections - 35 USC § 112(b)
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.
Claim 14 remains rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 14 is unclear. The claims recite “preferably” and “more preferably” in lines 9-10 (part c). The species recited after such phrases render the claims indefinite because it is unclear whether the limitation(s) after “preferably” are part of the claimed invention. See MPEP § 2173.05(d).
New Claim Rejections - 35 USC § 112(d)
Applicant' s claim amendments have necessitated the following new grounds of rejection.
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.
Claim 14 fails to further limit the subject matter of the claim upon which they depend. Claim 14 depends from claim 12 and claim 12 requires “the BET specific surface area in the range from 30 to 80 m2/g, measured using nitrogen and the BET method according to ISO 9277:2010”. However, due to the “and/or” iterations in claim 14, one interpretation is that claim 14 requires a BET specific surface area with a broader range (10 to 100 m2/g) than the range required in its independent claim (30 to 80 m2/g). Thus, claim 14 fail(s) to further limit claim 12 because it broadens the subject matter of the claim from which it depends. 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.
Modified and New Claim Rejections - 35 USC § 103
Applicant' s claim amendments have necessitated the following modified and new grounds of rejection.
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 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.
Claims 12-17 remain rejected and claims 18-20 are newly rejected under 35 U.S.C. 103 as being unpatentable over Takenaka et al. (Chem Pharm Bull, 19(6), 1234-1244, 1/1/71; in IDS dated 1/15/24), in view of Budde et al. (CA3085130; published: 08/01/19; of record).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
With regards to instant claims 12-14 and 18, Takenaka teaches a granule composition comprising magnesium carbonate granules, wherein the bulk density is 0.121- 0.220g/cm³ (overlaps with the claimed range) [p. 1234-1235, 1240, table IV]. As indicated in MPEP §2144.05(I): “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.” Takenaka teaches wherein the magnesium carbonate-containing granules were fairly uniform spherical particles [¶ after Fig. on p. 1236]. Takenaka teaches wherein the magnesium carbonate-containing granules have a specific surface area by the BET method ranging from 13.7-28.9 g/cm3, which do not overlap but are merely close with the claimed range; for example, 28.9 g/cm3 is very close to 30 g/cm3 [Table IV]. As indicated in MPEP §2144.05(I): a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). In view of the “and/or” iterated throughout the list on instant claim 14 and at the end of the list recited in claim 13, the BET specific surface area teachings and the spherical shape read on the claims.
With regards to instant claim 15, Takenaka teaches the following method: preparing an aqueous solution of binders, gum Arabic, gelatin, polyvinyl alcohol, carboxymethylcellulose, methylcellulose, and polyvinylpyrrolidone, slowly adding magnesium carbonate to the aqueous solution, using a homogenizer for stirring, until uniform, smooth slurries were obtained, the slurry was fed to the atomizing wheel of the spray dryer and the cyclone collector collected the agglomerated powder [p. 1234-1235].
With regards to instant claim 16, Takenaka teaches a process of forming a tablet (e.g., for a medicine) from the abovementioned agglomerated powders via compressing easily using a Korsch machine employing 8mm flat bevel-edge punches at the rate of thirty tablets per minute [p. 1235, last full ¶].
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Takenaka is silent with regards to an intra-particle intruded specific pore volume and specifically in the range of 0.9-2.3 cm3/g, as required by instant claim 17. However, this deficiency is cured by Budde
Budde is directed to carrier material for the release of one or more active agents in a home care formulation, specifically, wherein the delivery system if in the form of a tablet [Abstract and p. 21]. Budde teaches a delivery system comprising a carrier material consisting of magnesium carbonate having:
a specific surface area (BET method) in the range of 25-150 m2/g [claim 2];
an intra-particle intruded specific pore volume in the range from 0.9-2.3 cm3/g [claim 3];
a d50 (vol) in the range of 1-75 gm [claim 4];
a d98 (vol) in the range of 2-150 gm [claim 5]; and
wherein the delivery system is in the form of a tablet [claims 7 and 11].
Budde teaches that it has been surprisingly found out that due to the specific surface area in combination with intra-pore structure of the magnesium carbonate, it is a superior carrier material for active agents to be loaded and the be released over time relative to common magnesium carbonates having lower specific surface areas and/or lower intra-particle pore volume [¶ bridging p. 11-12]. Furthermore, the specific surface area in combination with the intra-pore structure of the magnesium carbonate allows the loading of the carrier material with liquid active agent(s) such that the obtained delivery system is suitable for dry formulations [p. 12].
Takenaka do not specifically teach the volume particle size d90, d50 and d10 ranging from 15-500, 5-300 and 1-100 µm as required by instant claims 19-20a, 19-20b and 19-20c, respectively.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Takenaka and Budde are both directed to magnesium carbonate containing particles used to form tablets. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the particles of Takenaka with an intra-particle intruded specific pore volume in the range of 0.9-2.3 cm3/g to achieve the predictable result of obtaining a composition suitable for tablet formation. One of ordinary skill in the art would have been motivated to do so because Budde teaches that it is advantageous for loading active agents [p. 12].
The granule volume particle size (d90, d50 and d10) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal particle size in order to best achieve the desired results as such would provide advantageous flowability. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Takenaka teaches that the particle size distribution of almost all the agglomerated products was found to have log normal distributions [Fig. 3] and the geometric mean diameter of the particles is affected mainly by the kind of binder used and the binder concentration [Table II and Abstract]. Furthermore, Takenaka teaches that the products will be free flowing if the particle diameter is large and specific surface area is low [p. 1241]. The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the particle size would impact the flowability of the product and therefore be an optimizable variable.
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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Response to Arguments
Applicants’ arguments with regard to the previous rejections are moot in view of the withdrawn claim rejections. To the extent that Applicants’ arguments are pertinent to the newly applied rejections, they are addressed as follows:
Applicants argue that the specific surface area of claim 1 refers to the specific surface area of the magnesium carbonate particles themselves, not the carrier material as claim 1 of Budde recites “the carrier material consisting of magnesium carbonate having a specific surface area…” [Remarks: p. 9-10].
This is not found persuasive. In response, due to the “consisting of” language in the claim of Budde recited above, the carrier material and magnesium carbonate particles are identical because the carrier material only has magnesium carbonate particles due to the close-ended nature of “consisting of”.
Conclusion
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 GENEVIEVE S ALLEY whose telephone number is (571)270-1111. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/GENEVIEVE S ALLEY/ Primary Examiner, Art Unit 1617
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