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
Applicants’ election of Group II (claims 12-16) drawn to granules comprising magnesium ion-comprising material, is acknowledged. The election was made with traverse.
Applicants have indicated that new claim 17 reads on the elected subject matter. The Examiner agrees.
The grounds for traversal as indicated by Applicants, is that the Examiner has not shown that searching the subject matter of the 2 groups of claims would be an undue burden. he Examiner respectfully points out that MPEP 1893.03(b) clearly states that unity of invention is applicable to national stage applications and as such "Undue search burden” is not a requirement for unity of invention determination in a 371/national stage application.
As the requirement for restriction is deemed proper, it is maintained and hereby made FINAL.
Claims 1-11 are hereby withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. The instant claims have been examined commensurate with the scope of the elected invention. Applicants timely responded to the restriction requirement in the reply filed 2/17/26.
Accordingly, claims 12-17 are under current examination.
Status of Claims
A new claim set was filed on 2/17/26 with the following:
Amended claims
Newly canceled claims
Newly added claims
17
Previously canceled claims
Instantly withdrawn claims
1-11
Claims under instant examination
12-17
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 12-17 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.
Claims 12-14 and 16 are unclear. The claims recite “preferably”, “more preferably”, “even more preferably” and/or “most preferably”. 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).
Claim 13 is unclear. Claim 13 recites a list of granule characteristics. It essentially states “wherein the granules have a)…and b)…and c)…and/or d)…and/or e)”. Due to the combination of and’s and and/or’s, it is unclear what is absolutely required. Does the last “and/or” in the claim, mean that prior art teaching only e) reads on the claim? Or with the first two and’s, does a), b) and c) have to be present in addition to either d) only, e) only or d) and e)? These multiple interpretations make
Claims 15 and 17 are unclear. The claims recite "... a magnesium ion-comprising material...". This language renders the claim indefinite because claims 15 and 17 depend from claim 12 and claim 12 contains this exact limitation; therefore, it is unclear if the “magnesium ion-comprising material” recited in claim 15 is the same or different than the one recited in claim 12. Amending the claim to recite "the magnesium ion-comprising material" would obviate the rejection.
Claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefinite concerns outlined above.
Claim Rejections - 35 USC § 102
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.
Claims 12-16 are rejected 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).
With regards to instant claim 12, Tekenaka teaches a granule composition comprising magnesium carbonate granules, wherein the bulk density is 0.121- 0.220g/cm³ [p. 1234-1235, 1240, table IV].
With regards to instant claim 13, Tekenaka teaches wherein the magnesium carbonate-containing granules were fairly uniform spherical particles [¶ after Fig. on p. 1236]. See the multiple interpretations for instant claim 13 in the 112b rejection above.
With regards to instant claims 13-14, Tekenaka 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 overlaps with the claimed range; for example, 28.9 g/cm3 [Table IV]. In view of the “and/or” iterated throughout the list on instant claim 14, the BET specific surface area teachings read on the claim.
With regards to instant claim 15, Tekenaka 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, Tekenaka 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 ¶].
Therefore, by teaching all the limitations of claims 12-16, Tekenaka anticipates the instant invention as claimed.
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 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 are rejected under 35 U.S.C. 103 as being unpatentable over Tekenaka 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).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
As noted in the anticipation rejection above Tekenaka anticipates claims 12-16 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103 over Tekenaka for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Tekenaka 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].
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Tekenaka 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 Tekenaka 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].
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.
Conclusion
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