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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 23, 2026 has been entered.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1-3, 5-9, 11-14
Withdrawn claims:
None
Previously canceled claims:
4
Newly canceled claims:
10
Amended claims:
1
New claims:
None
Claims currently under consideration:
1-3, 5-9, 11-14
Currently rejected claims:
1-3, 5-9, 11-14
Allowed claims:
None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5-9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Seminara (US PGPub 2019/0167706 A1) in view of O’Connor (US PGPub 2014/0294990 A1).
Regarding claim 1, Seminara teaches a pharmaceutical composition that can be in the form of an effervescent tablet ([0055]) and Example 3 ([0849], Table) comprising:
Sofosbuvir (i.e., an active ingredient) in an amount of 400 mg, corresponding to 29.9% of the total composition, which falls within the claimed range of “1-40 weight-%”;
Mannitol (a diluent, [0064]) in an amount of 360 mg, corresponding to 26.96% of the composition, which falls within the claimed range of “20-95 weight-%”;
Croscarmellose sodium and colloidal silicon dioxide (both disintegrants, [0068]) in a total amount of 120 mg, corresponding to 8.99% of the total composition, which falls within the claimed range of “2-50 wt-%”; and
The example does not comprise any carbonates, which falls within the claimed range of “below 0.5 wt-%”.
Seminar does not teach wherein the at least one active ingredient is selected from the group consisting of vitamins, prebiotics, probiotics, carotenoids, minerals, and any other dietary ingredient.
However, in the same field of endeavor, O’Connor teaches an anhydrous composition that may be a tablet configured to dissolve in water comprising vitamins and minerals (Abstract).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the tablet of Seminara with the use of vitamins and minerals taught by O’Connor as the active ingredient in the tablet. One would be motivated to make this modification because, as taught by O’Connor, the composition of O’Connor can be used to treat a sore throat ([0025]). One of ordinary skill would thus consult O’Connor to determine a composition that could be used in the tablet of Seminara to treat a sore throat.
Although Seminara and O’Connor do not explicitly teach that a tablet without carbonate is an effervescent tablet, the tablet of Seminara in view of O’Connor has the same composition of the claimed effervescent tablet. Additionally, MPEP §2112.01 states where the claimed and prior art 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). Thus, the tablet of Seminara in view of O’Connor renders the claimed invention obvious.
The recitation “wherein the tablet is dissolved or dispersed in water or a water-based liquid before it is consumed” is interpreted as the intended use of the invention. MPEP §2111.02(II) states if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). Furthermore, O’Connor teaches an anhydrous composition that may be a tablet configured to dissolve in water (Abstract).
Regarding claim 2, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara teaches that the composition may be in the form of a tablet ([0055]). However, Seminara is silent as to the shape of the tablet. MPEP §2143(E) states “The rationale to support a conclusion that the claim would have been obvious is that ‘a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.’” KSR, 550 U.S. at 421, 82 USPQ2d at 1397. Because there are a finite number of shapes known in the art for tableting, one of ordinary skill in the art would have found it obvious to try a disc shape for the dissolving tablet to determine the tablet shape that facilitates administration of the tablet. One of ordinary skill would have a reasonable expectation of success using a disc-like shape for the tablet because the shape is well known in the art for dissolving tablets.
Furthermore, MPEP §2144.04(IV)(B) states “The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.” In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Therefore, one of ordinary skill in the art would have found it obvious to make the product of Seminara into a disc-like shape.
Regarding claim 3, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara also teaches Sofosbuvir (i.e., an active ingredient) in an amount of 400 mg ([0849], Table), corresponding to 29.9% of the total composition, which falls within the claimed range of “5-30 weight-%”
Regarding claim 5, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara also teaches Mannitol (a diluent, [0064]) in an amount of 360 mg ([0849], Table), corresponding to 26.96% of the composition, which falls within the claimed range of “25-90 weight-%”.
Regarding claim 6, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara also teaches wherein the diluent can be mannitol or sorbitol (i.e., sugar alcohols) and sucrose or lactose (i.e., disaccharides) ([0064]).
Regarding claim 7, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara also teaches a disintegrant in an amount of 22 to 36 weight-% ([0070]), which falls within the claimed range of “10-45 wt-%”.
Regarding claim 8, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara also teaches wherein the disintegrant can be starches, crospovidone, and sodium starch glycolate ([0068]).
Regarding claim 9, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara also teaches wherein the tablet can further comprise flavors, colorants, and sweeteners ([0085]).
Regarding claim 11, Seminara in view of O’Connor teaches all elements of claim 1 as described above. Seminara also teaches an example of the composition that does not comprise any carbonates ([0840]-[0843]), where no carbonate falls within the claimed range of “essentially free of any carbonate.”
Regarding claim 12, Seminara in view of O’Connor teaches all elements of claim 1 as described above.
Seminara does not teach the tablet having a hardness of about 5 to 20 kp.
However, in the same field of endeavor, O’Conner teaches an anhydrous composition that may be a tablet configured to dissolve in water (Abstract) with a hardness of from about 5 Kp to about 10 Kp ([0060]), which falls within the claimed range of “about 5 to 20 kp”.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the tablet of Seminara with the hardness taught by O’Connor. Because Seminara is silent to the hardness of the effervescent tablet, one of ordinary skill would be motivated to consult O’Connor to determine the hardness of a similar tablet configured to dissolve in water.
Regarding claim 13, Seminara in view of O’Connor teaches all elements of claim 6 as described above. Seminara also teaches wherein the diluent can be mannitol or sorbitol ([0064]).
Regarding claim 14, Seminara in view of O’Connor teaches all elements of claim 6 as described above. Seminara also teaches wherein the diluent can be sucrose or lactose ([0064]).
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1-3, 5-9, 11-14 over Seminara and O’Connor: Applicant’s arguments filed February 23, 2026 have been fully considered but they are not persuasive.
Applicant argued that Seminara does not describe an effervescent tablet in example 3, and that the tablet of example 3 is made by hot-melt extrusion. Applicant further argued that hot-melt extrusion is known to lead to very dense delivery forms (Remarks, p. 5, ¶ 3-4).
This argument has been considered. However, it is known in the art that tablets made using hot-melt extrusion are still capable of effervescing as demonstrated by Lima (Lima, Ana, et al. “Hot-Melt Extrusion as an Advantageous Technology to Obtain Effervescent Drug Products”, Pharmaceutics, Vol. 12(8), published August 17, 2020). Lima teaches that hot-melt extrusion can bring great benefits to the production of effervescing drug products by simplifying the production process (p. 16, ¶ 5). Therefore, the tablet of Seminara made using hot-melt extrusion would still be capable of being an effervescent tablet. Additionally, the claims do not recite the method upon which the effervescing tablet was produced. Therefore, asserting that a tablet made by a different process would be different is improperly reading limitations into the claims that are not currently recited.
Applicant further argued that O’Connor does not provide guidance to overcome the distinction (Remarks, p. 5, ¶ 4-5).
This argument has been considered. However, O’Connor is not relied upon to teach the limitation of an effervescent tablet. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that O’Connor is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant further argued that the Lima reference used to demonstrate that hot-melt extrusion can result in an effervescent tablet was (1) published after the effective filing date of the instant application and (2) the authors of Lima state that as far as they know they are the first work involving effervescent drug products by hot-melt extrusion. Applicant further argued that Lima describes effervescent tablets with carbonates (Remarks, p. 6, ¶ 1- p. 7, ¶ 3).
This argument has been considered. However, Lima is not relied upon for an obvious rejection. Lima is relied upon to provide evidence that tablets produced by hot-melt extrusion would still be capable of effervescing. Although Lima states that they believe to be the first to use hot-melt extrusion for effervescing tablets, MPEP §2112(II) states “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003) (rejecting the contention that inherent anticipation requires recognition by a person of ordinary skill in the art before the critical date and allowing expert testimony with respect to post-critical date clinical trials to show inherency)”. Thus, Lima is sufficient for use as evidence that tablets made by hot-melt extrusion can be effervescent tablets.
Although the tablets in the reference of Lima also have carbonate present, Lima is not relied upon for the teaching of the tablets of the claimed invention. Lima is merely relied upon to demonstrate that production of tablets by hot melt extrusion does not preclude a tablet from being effervescent. The Examiner maintains that although Seminara and O’Connor do not explicitly teach that a tablet without carbonate is an effervescent tablet, the tablet of Seminara in view of O’Connor has the same composition of the claimed effervescent tablet. Additionally, MPEP §2112.01 states where the claimed and prior art 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). Thus, the tablet of Seminara in view of O’Connor renders the claimed invention obvious.
Applicant further argued that the present application concerns a beverage tablet, whereas Lima is a drug formulation (Remarks, p. 7, ¶ 4).
This argument has been considered. However, Lima is not relied upon to teach the claimed invention. Lima is merely relied upon to demonstrate that a tablet made using hot-melt extrusion is capable of being an effervescent tablet. Absent evidence to the contrary, the active ingredient of the tablet does not have an impact on the ability of the tablet to serve as an effervescent tablet.
Applicant argued that O’Connor is directed to a topical liquid formation, thus one of ordinary skill would not have modified Seminara with the addition of vitamins or minerals as taught by O’Connor (Remarks, p. 7, ¶ 5- p. 8, ¶ 2).
This argument has been considered. However, the composition of O’Connor is a tablet configured to dissolve in water (Abstract). O’Connor also states that the composition can be easily swallowed ([0045]). Thus, one of ordinary skill would have recognized that the vitamins and minerals of O’Connor could be added to the tablet of Seminara and still make an edible beverage tablet.
Double Patenting: the nonstatutory double patenting rejection of claims 1-12 over claims 1-3 and 5-13 of Application No. 18/250,617 has been withdrawn following abandonment of Application No. 18/250,617.
The rejections of claims 1-3, 5-9, and 11-14 have been maintained herein.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached Generally available M-Th 8:00a-5:00p, F 8:00-2:00.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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