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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/3/25 was filed in a timely manner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 15 recites the limitation "the sodium wt% of each tablet " in line 1. There is insufficient antecedent basis for this limitation in the claim. There is no sodium recited in claim 1
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 5, 7-9, 12, 16-20, 22 and 23 is/are rejected under 35 U.S.C. 102a1,2 as being anticipated by Tritthart et al (US 6,242,002 hereafter Tritthart).
Tritthart discloses a solid effervescent dosage comprising a plurality of minitablets where the minitablets comprise at least one active agent, at least one acid, at least one alkaline agent and at least a binder/ excipients where the minitablets dissolve in an aqueous including saliva solution forming a solution [abstract, col. 3, lin. 59-65, col. 4, lin. 30-37). The active agent can be a mineral or vitamin (col. 3, lin. 44-47). The plurality of minitablets further comprise a second plurality of minitablet comprising an additional complimentary active agents for combination dosage forms (col. 3, lin. 65-col. 4, lin. 24). The acids include tartaric, malic citric acid or maleic acid (col. 2, lin. 57-65). The alkaline agents include sodium carbonate and bicarbonate (col. 3, lin. 4-8). The ratio of the acid to the alkaline agent can range from 0.97 to about 1.4 (Examples 1-11). The dosage forms comprise a colorant (Examples). The plurality of minitablets further comprise sugar alcohols including mannitol or sorbitol (col. 5, lin. 3-6). The dosage can be packaged as sachets (col. 4, lin. 53-56). The dosage have a size about 411 or 493 mg (Example 8 and 8). These disclosures render the claims anticipated.
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.
Claim(s) 1-14 and 16-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Tritthart et al (US 6,242,002 B1 hereafter Tritthart) in view of Gerardi et al (US 2021/0378948 A1 hereafter Gerardi).
As discussed above Tritthart discloses an effervescent dosage for comprising minitablets that comprises one or more active agents, acids, alkaline agents, binders and excipients, that dissolves in an aqueous material and forms a solution. While the reference discloses a minitablet formulation, the reference is silent to the specific active agent of claim 3. The use of such compounds in small tablet formulation is known in the art as seen in the Gerardi patent.
Gerardi discloses a tablet formulation comprising an acid, a base and at least one active agent along with excipients [abstract]. The acid include citric, maleic, and tartaric and the alkaline is a bicarbonate including sodium [0007, 0006, 0024, 0096-0098]. The acid is present in a ratio to the base in a ratio of 1:1 [0010]. The formulation comprises sugar alcohols like mannitol and sorbitol [0014, 0120]. The active agents can include at least vitamins, proteins, amino acids and botanical agents [0138, 0136]. Specific compounds include beta-hydroxy-beta-methyl butyrate [0155]. The formulation further comprises flavors like mint [0157]. The minitablets have a diameter of at least 3 mm [0201]. The minitablets can weight from 50-100 mg [0212]. The minitablets will dissolve in the mouth or an aqueous compound forming a solution for easier swallowing, in less than 1 minute [0204]. The formulation can comprise more than one active agents with the vitamin being present up to 15%, the botanical being present up to 15% and stimulants being present up to 15% meaning the active agent can be present at least 45% of the formulation. It would have been obvious to modify the tablets of Tritthart as they solve the same problem.
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable effervescent formulation. It would have been obvious to optimize the ranges and concentrations of the components through routine experimentation as the general conditions of the claims have been met by the prior art. One of ordinary skill int eh art would have been motivated to combine the active agents of Gerardi into the formulation Tritthart as they solve the same problem. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable dosage form useful in treating patients that have difficulty swallowing tablets.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
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