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 .
Claims 26 and 34-38 are presented for examination.
Claims 7, 11-13 and 19-25 are withdrawn from examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 26 and 34-38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, ij.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Application/Control Number: 17/634,980 Page 3 Art Unit: 1617
Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claims 26, and 34-38 are drawn to a solid food product, comprising:
90 mass% or more of a water-soluble ingredient, wherein the water-soluble ingredient contains 60 mass% or more of a sugar, when a mass of the solid food product is 100 mass%,
wherein the solid food product has a porosity of from 17% to 35%, both inclusive, and disintegrates in from 5 seconds to 65 seconds, both inclusive, in a disintegration test using an intra oral rapid disintegration measurement device, wherein the solid food product is a nutritional supplement, and wherein the solid food product has a surface roughness of from 20 µm to 400 µm, both inclusive.
Analysis of the flowchart:
Step 1, is the claim to a process, machine, manufacture or composition of matter?
Yes. The claim is drawn to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, Claims are drawn to a solid food product sugar and water soluble ingredients.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) 26 and 34-28 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception, as there is no indication that the volume, the thickness, the hardness and porosity of the food product causes the claimed compositions to have any characteristics that are different from the naturally occurring component of an natural compound.
For the reasons described above, the claimed product is not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
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) 26-38 are is/are rejected under 35 U.S.C. 103 as being unpatentable over Tatara et al. (US 6316026) in view of Perera (US 20160331014).
Regarding Tatara teaches a tablet capable of quick disintegration in the oral cavity that has a sufficiently large porosity and can be disintegrated in the oral cavity in a very short period of time, typically between 3 and 5 seconds. A tablet manufactured by means of such a method and such an apparatus also constitutes part of the present invention. The method for manufacturing a tablet capable of quickly disintegration in the oral cavity comprises steps of punching a tablet out of a pharmaceutical composition containing one or more than one medicinal agents and one or more than one water-soluble saccharides under pressure between 0.20 and 0.01 t/cm.sup.2 and shaping the tablet by moisturizing and drying it, See The abstract. Tatara teaches that The ratio of the water-soluble saccharides contained in a tablet according to the invention is not less than 30%, preferably not less than 50%, most preferably not less than 70%. While any water-soluble saccharides may be used for the purpose of the invention, the use of sugar alcohols is preferable from the viewpoint of the time required for the tablet to disintegrate in the oral cavity and the cool and fresh feeling they gives out when the tablet disintegrates in the oral cavity. The determination of surface roughness would have been obvious to a person skilled in the art in the absence of evidence to the contrary. The tablet taught by Tatara if used as a supplement, such as vitamins, minerals and other supplements reads on the solid food product of the instant invention. Tatara differs from the claimed invention in specifically teaching that the solid product is a food product. However, Perera teaches a solid food product including a D-allulose syrup and a native protein. Perera teaches that the use of this solid food product as a protein supplement for dietarians, athletes and bodybuilders. It also relates to use of D-allulose to reduce hardening of a protein food product, as an aid for quick hydration and as an aid for improving the cohesiveness of a dough. See the abstract. Perera teaches solid food product wherein the D-allulose syrup represents from 15 to 60 wt. % of the food product, based on the total weight of the food product. Perera makes clear that the use of sugar alcohols or saccharides at the claimed concentration in combination with a solid food is old and well known. It would have been obvious to use the composition of Tatara in a solid food product, motivated by the teachings of Perera, which teaches solid ingredients in combination with sugar alcohols have been previously used in a nutritional supplement.
Regarding claim 34, Tatara teaches that The ratio of the water-soluble saccharides contained in a tablet according to the invention is not less than 30%, preferably not less than 50%, most preferably not less than 70%. While any water-soluble saccharides may be used for the purpose of the invention, the use of sugar alcohols is preferable from the viewpoint of the time required for the tablet to disintegrate in the oral cavity and the cool and fresh feeling they gives out when the tablet. See column 4, lines 22-30.
Regarding claim 35, Tatara teaches Saccharides that can preferably be used for the purpose of the invention include erythritol, xylitol and mannitol. Any of these water-soluble saccharides may be combined to regulate the disintegration effect, the hardness and the agreeableness of the produced tablet. See column 3, lines 30-35. The porosity is taught to be between 20 and 40%. See the abstract. The use of erythritol is taught to be 160 wt. portions. See example 1.
Regarding claim 36, Tatara does not teach the volume and the thickness of the food product. However, the determination of volume and thickness is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claims 37 and 38, Tatara does not teach the hardness of the solid food product. However, the determination of hardness is considered to be within the skill of artisan in the absence of evidence to the contrary.
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 ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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/ZOHREH A FAY/ Primary Examiner, Art Unit 1617