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 without traverse of the method of Claims 5 and 6 in the reply filed on 12 January 2026 is acknowledged.
Priority
The instant application is a National Stage entry of International application PCT/JP2022/030484 filed 9 August 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 relating to Japanese national application JP2021-134883 filed 20 August 2021.
Status of the Claims
Claims 1-11 are pending.
Claims 1-4 and 7-11 are withdrawn from consideration as directed to nonelected inventions.
Claims 5 and 6 are presented for examination and rejected as set forth in greater detail below.
Claim Interpretation
Applicants Claims are directed to methods of producing magnesium oxide tablets by first combining particles of magnesium oxide with a cellulose to prepare a mixture, granulating the mixture to provide granules, then combining these granules with a cellulose and tableting the resulting mixture, where the amount of cellulose in the granules is present in relation to the cellulose of the combined mixture fall within a weight ratio of 3:1 to 1:9. As no particular process parameters have been recited, any means by which the magnesium oxide and a cellulose are combined to form a composition for granulation will be considered sufficient to address the “mixing” step recited. Claim 6 narrows the identity of the cellulose to be present in each of the granule and external to the granule in the tablet formulation.
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 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.
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Eto (JP2015048316)(of record, and machine translation provided; all references are to the machine translation).
Eto describes methods of providing magnesium oxide tablets. [0009]. Per Eto, a liquid binder is combined with magnesium oxide to coat and granulate the magnesium oxide and binder. [0021-22]. This granulate is then combined with a “tablet raw material” to provide a mixture, which is then tableted. [0009; 0013]. Eto indicates that each of the hydroxypropyl methylcellulose, hydroxypropyl cellulose, and methyl celluloses recited by applicants instant Claim 6 are suitable binders to be combined with magnesium oxide to form the granules. [0009; 0017]. Eto indicates that either powdered or fine particular magnesium oxide may be used. [0015]. Eto indicates that magnesium oxide may represent 90% or more of the mass of the granulate, with the binder representing at least 1% by mass or more of the granulate material. [0029]. Eto indicates that crystalline cellulose and cellulose derivatives such as hydroxypropyl cellulose and hydroxypropyl methylcellulose may serve as the tablet raw material, the amount of which is not particularly limited. [0040]. Because each of the cellulosic binder of the magnesium oxide core and the tablet raw material binder celluloses are described by Eto as contributing essential properties to the resultant mixture prior to tableting, Eto establishes that the amounts of each are result-effective variables suitable for optimization through little more than the routine experimentation of the skilled artisan. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.). As such, while Eto does not specifically advocate the ratio of cellulose in the granulate material to cellulose as the external additive recited by the claims, the weight ratio of 3:1 to 1:9 appears, given what the art teaches, little more than the result of routine experimentation of the skilled artisan.
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have combined magnesium oxide with either hydroxypropyl methylcellulose or hydroxypropyl cellulose, granulated such a mixture, combined that granulate with either of hydroxypropyl methylcellulose or hydroxypropyl cellulose so that the mass of cellulose in the granulate and exterior to the granulate are present in a weight ratio within the range of 3:1 to 1:9, then tableting the resultant mixture to reflect a method “yielding no more than one would expect from such an arrangement.”
Claims 5 & 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hattori (TW1724629)(machine translation attached; all references are to the machine translation).
Hattori describes lozenges containing magnesium oxide as the active ingredient. (Abs.). Hattori indicates these lozenges are to be made by a process whereby magnesium oxide particles are combined with crystalline cellulose recited by Claim 6 as a binder, mixing and then granulating such a mixture, combining these granulates with additional crystalline cellulose, and then tableting the resulting mixture. (pg.4, “Manufacturing method (A)”). Hattori indicates that the content of the binding agent in the tablet is to be within the range of 3-15% by weight. (Pg.5, “Binding agent”). Because each of the crystalline cellulose binder of the magnesium oxide granule and the additional crystalline cellulose binder are described by Hattori as contributing essential properties to the resultant mixture prior to tableting, Hattori establishes that the amounts of each are result-effective variables suitable for optimization through little more than the routine experimentation of the skilled artisan. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.). As such, while Hattori does not specifically advocate the ratio of crystalline cellulose in the granulate material to crystalline cellulose as the external additive recited by the claims, the weight ratio of 3:1 to 1:9 appears, given what the art teaches, little more than the result of routine experimentation of the skilled artisan.
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have combined magnesium oxide with crystalline cellulose as a binder, granulated such a mixture, combined that granulate with additional crystalline cellulose binder so that the mass of crystalline cellulose in the granulate and exterior to the granulate are present in a weight ratio within the range of 3:1 to 1:9, then tableting the resultant mixture to reflect a method “yielding no more than one would expect from such an arrangement.”
Conclusion
No Claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614