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 Application
Receipt of the Preliminary Amendment filed on October 15, 2023 is acknowledged.
Claim 1-20 are pending in this application.
Claim 4 has been amended.
All pending claims are under examination in this application.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on December 4, 2024 is acknowledged. A signed copy is attached to this office action.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 2, the claim recites “wherein the sugar is a powdered sugar”, it is unclear if the claim is attempting to limit the sugar recited in claim 1 to “powder sugar” which additionally comprises corn starch or if the sugar recited in claim 1 is just in a powder form.
Regarding claim 10, the claim recites the limitation "the edible acid" in line 1. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 9, which does not recite an “edible acid”.
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.
Claims 1, 3-5, 9-10, 14-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ramtoola et al. (US 2010/0074948) in view of Wang et al. (CN101134024) and further in view of Food and Gear Guide (Freeze Dried Food 101: What is it? How it’s made? And more, July 9, 2021).
Ramtoola discloses fast dissolving tablets comprising:
At least 80-85% sugar alcohol, for example lactose, dextrose, sucrose (paragraph 0007);
5-15% an osmotic agent, such as citric acid (paragraph 0064); and
0.5-5% flavoring agent including synthetic, natural or plant extracts, such as raspberry, strawberry, lemon and orange (paragraph 0066)
Regarding claims 3-4, as noted above, the sugar can be dextrose.
Regarding claims 5, as noted above, the flavoring agent including synthetic, natural or plant extracts, such as raspberry, strawberry, lemon and orange.
Regarding claims 9-10, as noted above, an osmotic agent, such as citric acid, can be include.
Regarding claim 14, the claim recites functional property. Applicant’s attention is directed to MPEP 2112.01 which discloses “products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 15, the claim recites intended use of the composition. Since the prior art discloses the same composition as recited in the instant claims, it would necessarily be suitable for its intended use. Applicant’s attention is directed to MPEP 2144.07.
Regarding claim 16, as noted above, the composition comprising:
At least 80-85% sugar alcohol, for example lactose, dextrose, sucrose (paragraph 0007);
5-15% an osmotic agent, such as citric acid (paragraph 0064); and
0.5-5% flavoring agent including synthetic, natural or plant extracts, such as raspberry, strawberry, lemon and orange (paragraph 0066). Applicant is directed to MPEP 2111.03 (III) which discloses “the transitional phrase "consisting essentially of" limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976)”. Ramtoola does not discloses any additional materials have may materially affect the basic and novel characteristics of their recited composition.
Ramtoola does not disclose the tablet composition is freeze dried.
Wang discloses orally disintegrating freeze drying tablets (Novelty).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have freeze dried the tablets of Ramtoola in order to obtain orally disintegrating and rapidly absorbed in the oral cavity for 30 seconds only medicine which does not require water to administer. The skilled artisan would have a reasonable expectation of success since Wang discloses freeze drying medical tablets is a known technique.
Ramtoola and Wang do not disclose the water content of the freeze dried tablets is 0.5-5%.
Food and Gear discloses the freeze drying process works by quickly freezing the material (flash freezing) and can remove up to 99% of the water content.
Regarding claim 17, as noted above, the combination of Ramtoola, Wang, and Food and Gear Guide render the method of preparation obvious.
Regarding claim 20, as noted above, freeze drying process can remove up to 99% of the water content.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have freeze dried the tablets of Ramtoola in view of Wang to the water content disclosed by Food and Gear to preserve the texture, flavor and nutritional content in order to obtain a tablet that tends to rehydrate more quickly and effectively.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ramtoola et al. (US 2010/0074948) in view of Wang et al. (CN101134024) and further in view of Food and Gear Guide (Freeze Dried Food 101: What is it? How it’s made? And more, July 9, 2021) as applied to claims 1, 3-5, 9-10, 14-17, and 20 above, and further in view of Reiss et al. (US 2009/0155446).
The teachings of Ramtoola, Wang, and Food and Gear Guide are discussed above.
The combination does not disclose the flavoring is a puree or concentrate.
Reiss discloses a process of preparing a flavoring concentrate (abstract).
Regarding claim 6, the flavoring concentrate can be a fruit or vegetable concentrate (paragraph 0085).
Regarding claim 7, examples of fruit concentrates include strawberry, raspberry, apple, orange, grapefruit, cherry and peach (paragraph 0085).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have utilized he flavor concentrates disclosed by Reiss in the compositions of Ramtoola, Wang, and Food and Gear Guide since they are disclosed
flavoring and/or aromatic substances which convey a positive sensory impression (paragraph 0004).
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Ramtoola et al. (US 2010/0074948) in view of Wang et al. (CN101134024) and further in view of Food and Gear Guide (Freeze Dried Food 101: What is it? How it’s made? And more, July 9, 2021) as applied to claims 1, 3-5, 9-10, 14-17, and 20 above, and further in view of Chen et al. (US 2001/0007679).
The teachings of Ramtoola, Wang, and Food and Gear Guide are discussed above.
The combination does not disclose the flavoring is a puree or concentrate.
Chen discloses powder compositions containing fruit and vegetable concentrates which can be incorporated into tablets (abstract).
Regarding claim 6, as noted above, flavoring concentrates include fruit and vegetable concentrates.
Regarding claim 8, examples of flavoring concentrates include carrot (paragraph 0070; 0076).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have incorporated any of the flavoring components disclosed by Chen in order to provide flavor to the tablets, as well as additionally vitamin components.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ramtoola et al. (US 2010/0074948) in view of Wang et al. (CN101134024) and further in view of Food and Gear Guide (Freeze Dried Food 101: What is it? How it’s made? And more, July 9, 2021) as applied to claims 1, 3-5, 9-10, 14-17, and 20 above, and further in view of Parikh et al. (US 20030180367).
The teachings of Ramtoola, Wang, and Food and Gear Guide are discussed above.
The combination does not disclose the use of a tonicity agent or those specifically recited in claim 12.
Parikh discloses tablet compositions (abstract).
Regarding claims 11-12, the dried powder, which can be compressed into tablets with the addition of binders and other excipients. Mannitol and other agents can be added to adjust the final formulation to isotonicity (paragraph 0030).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have added an isotonicity agent to the composition of Ramtoola, Wang, and Food and Gear Guide in order to act as a stabilizing aid during drying.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ramtoola et al. (US 2010/0074948) in view of Wang et al. (CN101134024) and further in view of Food and Gear Guide (Freeze Dried Food 101: What is it? How it’s made? And more, July 9, 2021) as applied to claims 1, 3-5, 9-10, 14-17, and 20 above, and further in view of Faour (US 2002/0099361).
The teachings of Ramtoola, Wang, and Food and Gear Guide are discussed above.
As noted above, Ramtoola discloses the sugar alcohol discloses dextrose and the osmotic agent includes citric acid.
The combination does not disclose the extracts include cherry and pineapple puree or the osmotic agent include malic acid.
Faour discloses a tablet formulation comprising:
flavoring agents including cherry and pineapple (paragraph 0092), additionally disclosed include raspberry, strawberry, lemon, and orange, which are also recited in Ramtoola; and
osmotic agents including malic acid (paragraph 0130), additionally disclosed include citric acid, which is also recited in Ramtoola.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date to have used any of the art recognized suitable equivalents in the composition of Ramtoola. Applicant’s attention is directed to MPEP 2144.06 II which discloses art recognized equivalence for the same purpose. The prior art discloses the flavoring agents and osmotic agents utilized in the instant claims are regarded as functional equivalents in the preparation of tablets.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ramtoola et al. (US 2010/0074948) in view of Wang et al. (CN101134024) and further in view of Food and Gear Guide (Freeze Dried Food 101: What is it? How it’s made? And more, July 9, 2021) as applied to claims 1, 3-5, 9-10, 14-17, and 20 above, and further in view of How to freeze dry faster, March 15, 2016.
The teachings of Ramtoola, Wang, and Food and Gear Guide are discussed above.
The combination does not disclose cutting the frozen mixture into pellets prior to freeze drying.
How to freeze dry faster discloses Spreading the sample out to increase the surface area as well as forming a thin layer of ice will speed the sublimation process. Pre-freezing in a thin layer covering the flask is called shell freezing. Commercial shell freezers are available to freeze samples in flasks. By increasing the surface area, more sample is in contact with the flask resulting in better heat transfer to the sample (Perfect your pre-freeze step).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have cut the frozen mixture into smaller particles in order to increase the surface area of the frozen mixture to provide a more evenly dried final product.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ramtoola et al. (US 2010/0074948) in view of Wang et al. (CN101134024) and further in view of Food and Gear Guide (Freeze Dried Food 101: What is it? How it’s made? And more, July 9, 2021) as applied to claims 1, 3-5, 9-10, 14-17, and 20 above, and further in view of The VacMaster Team (Top 15 Advantages to Vacuum Sealing Your Food, October 3, 2017).
The teachings of Ramtoola, Wang, and Food and Gear Guide are discussed above.
The combination does not disclose cutting the frozen mixture into pellets prior to freeze drying.
The VacMaster Team discloses advantages of vacuum sealing. Examples include vacuum sealing preserves and protects foods and extends shelf life.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have vacuum sealed the final product of the freeze dried composition in order to obtain the advantages disclosed by VacMaster.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615