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 .
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 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.
Previous Rejections
Applicants' arguments, filed February 11, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 8-9, 13-15, and 19 are cancelled.
Claims 1-7, 10-12, 16-18, and 20-23 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejections
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.
1) Claims 1-3, 5, 7, 10-12, 16-18, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Dettmer (US 6,610,667; of record).
Dettmer teaches pharmaceutical gel compositions comprising alginate, a pharmaceutically acceptable gum, calcium carbonate, and sodium bicarbonate (Abstract; col 2: 50-53; col 3: 63 to col 4: 17). Dettmer also teaches the composition may contain buffering agents, sweeteners, and flavorings (col 3: 57-62).
Dettmer teaches the pharmaceutical gel is preferably dosed in the form of sachets containing 1-25 mL of gel composition (col 6: 5-7). Dettmer teaches the pharmaceutical gel comprises sodium alginate in an amount of 0.1% to 11% by weight (col 6: 15-16); sodium carbonate in an amount of 0.1% by weight (col 4: 1-4); calcium carbonate in an amount of from 0.1% to 5% (col 4: 13-17). Given preferred amounts of each element as set forth by Dettmer (sodium alginate in 2.5-8%, claim 2; 0.1-8% of sodium bicarbonate; and 0.1-5% of calcium carbonate), the Examiner calculates an amount of sodium alginate of 250-800 mg; an amount of sodium bicarbonate of 1-80 mg; and an amount of calcium carbonate of 10-500 mg. Because, for each element, the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For claim 2, the amount of calcium carbonate present, calculated as 10-500 mg, overlaps with the claimed range.
For claim 3, Dettmer teaches the pharmaceutical gel comprises sodium alginate (col 5: table).
For claim 3, Dettmer teaches the pharmaceutical gel comprises sodium alginate (col 5: table).
For claim 5, Dettmer teaches the pharmaceutical gel may comprise a flavoring in an amount of 1% (col 4: 30-33), or 100 mg for a 10 gm or 10 mL sachet, within the claimed range.
For claim 7, Dettmer teaches the pharmaceutical gel may comprise a sweetener such as sodium saccharin (col 8, Example 2).
For claims 10, 11, and 16, Dettmer teaches the following (col 3: 44-56):
In a preferred embodiment of the present invention, the composition is also useful in treating and/or ameliorating the effects of gastric reflux by forming a raft which floats on the stomach contents of a consumer of the product, which raft prevents reflux of the gastric contents into the oesophagus or preceding the gastric contents into the oesophagus during reflux.
It will be appreciated that the composition preceding gastric content into the oesophagus during an episode of reflux may be beneficial in that the physical barrier of the composition adhering to or coating the oesophagus because of its Superior bioadhesive properties will be recharged during such an episode.
For claim 12, Dettmer teaches the pharmaceutical gel is provided in unit dosage form (col 5: 65); one of ordinary skill is able to determine the appropriate dosing schedule.
For claims 17 and 18, Dettmer teaches the following (col 6: 8-13):
According to a further aspect to the present invention, there is provided a method of treating and/or preventing reflux oesophagitis, gastritis, dyspepsia and/or disorders of the oesophagus associated with reflux
For claims 20 and 23, Dettmer teaches sodium alginate as the species of alginate in the pharmaceutical gel composition, the same polymer disclosed in the instant disclosure. Since the alginate species in each instance appears to be the same, the alginate polymer must have the same properties. See MPEP 2112 (I) and (II), and MPEP 2112.01(I): “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). ‘When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.’ In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
For claims 21 and 22, Dettmer teaches alginate, as well as locust bean gum, carrageenan, and xanthan gum (Abstract; col 5, table; Example 1).
The examiner acknowledges that some picking and choosing was used to arrive at the instantly claimed composition of Dettmer. However, the claimed combination of components, including the sodium alginate, sodium bicarbonate, and calcium carbonate, in the form of a gel, is taught as known and used for administration to a subject in need of treating and/or preventing reflux oesophagitis, gastritis, dyspepsia and/or disorders of the oesophagus associated with reflux. Further, Dettmer teaches administration with the same excipients of an orally administered gel composition. It would have therefore been prima facie obvious to a person having ordinary skill in the art to administer the claimed combination of ingredients to a subject with a reasonable expectation of success that the treatment would be efficacious, as taught by Dettmer.
2) Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Dettmer (cited above), in view of Phillips (US 2011/0097401 A1, of record).
The teachings of Dettmer are discussed above.
Dettmer does not teach alginate compositions comprising citrate.
Phillips teaches the missing element of the Dettmer.
Phillips teaches a composition in the form of a gel (pg 1, [0007]) comprising sodium alginate (pg 8, [0063]), calcium carbonate (pg 31, [0758]), and sodium bicarbonate (pgs 9-10, [0073]; [0758]) that may be useful for the treatment of reflux esophagitis (pg 31, [762]). Phillips teaches the composition may comprise sodium alginate (pg 8, [0063]) and sodium bicarbonate (pgs 9-10, [0073]). For claim 4, Phillips teaches that citric acid may be used as a buffering agent in the compositions (pg 9, 0073]), or an element to elicit effervescence in the presence of the alkaline metal carbonate ([0758]).
The skilled artisan would have expected success in adding citric acid to the gel composition of Dettmer because Dettmer teaches the addition of buffering agents, and the advantages of an effervescent composition (col 3: 63-66), and Phillips teaches the addition of citric acid to a gel composition that may comprise the combination of sodium alginate, calcium carbonate, and sodium bicarbonate. Regarding the amount of citric acid recited in claim 4, the person of ordinary skill would have had a reasonable expectation of success in selecting the claimed amount of citric acid since Dettmer teaches the addition of buffering agents to maintain the desired pH of the gel composition. The skilled artisan would have been motivated to select Phillip's citric acid because citric acid is a safe acidic buffering agent found in numerous fruits and is considered a safe additive.
3) Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Dettmer (cited above), in view of Richardson (US 2007/0087038 A1; of record).
The teachings of Dettmer are discussed above; of note is that Dettmer teaches the addition of a sweeteners and flavorants (col 3: 61-62).
Dettmer does not teach the addition of a stevia sweetener recited in claim 7.
Richardson teaches the missing elements of Dettmer.
Richardson teaches an antiulcer composition containing calcium carbonate (pg 5, [0049]), sodium bicarbonate (pg 6, [0060]), and alginates (pg 4, [0043]). See also Example 5, pg 10 and Example 12, pg 12. Richardson teaches addition of sweetening agents such as stevia derivatives, as well as sucrose (pg 7, [0064]).
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to include both a high-intensity sweetener and sucrose in the composition and method of Dettmar. A person of ordinary skill would have been motivated to choose each of the sweeteners in the method of treating acid reflux of Dettmar since Richardson teaches that optimal sweetening of the composition of the claimed method can be obtained using combinations of the claimed sweeteners.
Examiner’s Reply to Attorney Arguments dated 2/11/2026
1. Rejection of claims 1-3, 5, 10-12, 15-18 and 20-23 under 35 U.S.C. § 103 over Gaserod and Carbonaro.
Applicant' s arguments with respect to claims 1-3, 5, 7, 10-12, 15-18 and 20-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
2. Rejection of claim 4 is rejected under 35 U.S.C. § 103 over Gaserod, Carbonaro and Phillips.
The applicant argues that Phillips does not teach the claimed amounts of alginate, bicarbonate, or calcium carbonate. The applicant further argues that Phillips teaches several forms that include foams and gels.
Applicant's arguments have been fully considered but they are not persuasive.
The cited prior art of Dettmer teaches each of sodium alginate, sodium bicarbonate, and calcium carbonate in the claimed amounts, and in the form or a gel. As such, the amounts allegedly missing from Phillips are taught by the primary reference.
4. Rejection of claim 6 under 35 U.S.C. § 103 over Gaserod, Carbonaro and Richardson.
The applicant argues that Richardson does not teach the claimed amount of sodium bicarbonate or calcium carbonate. The applicant argues: “For sodium bicarbonate, Richardson teaches that the composition should not contain more than 0.5 wt% of the organic or inorganic acid as to minimize potential interference by this acid component.” The applicant further argues that Richardson does not teach a gel formulation.
Applicant's arguments have been fully considered but they are not persuasive. As discussed above, Dettmer teaches a gel composition comprising the claimed elements in the claimed amounts. It is further noted that sodium bicarbonate is a basic compound, known to neutralize acids with release of carbon dioxide (effervescence).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612