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 .
Applicants' arguments, filed October 13, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112 – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 5, 6, 8, 10, 12 and 14 – 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The specification as originally filed and the claims referred to the disclosed composition as having a “first mixed part” and a “second mixed part”, and while only a single ingredient was positively recited for each of these two parts, the disclosure indicates that 40% by weight or less of the total sodium bicarbonate is present in the first mixed part, so the first part can contain a mixture of omeprazole/enantiomer/pharmaceutically acceptable salt thereof and sodium bicarbonate. The example formulations prepared contain many ingredients in the portion containing the omeprazole (first mixed part) and the second mixed part containing the sodium bicarbonate (see Example 1 beginning at ¶ [0069] of the PGPub of the instant application). No definition of “mixed” was given in the disclosure as originally filed but a relevant definition would be “made of two different kinds of things mixed together or combined” (see definition of “mixed” from britannica.com that accompanies this office action). Therefore a reasonable interpretation of “first mixed part” and “second mixed part” as set forth in the disclosure as originally filed was that the first and second parts each contained at least two ingredients even if only one was positively recited for each part.
The amendments to the claims have deleted the word “mixed” from what was “first mixed part” and “second mixed part” so they now recite “a first part comprising omeprazole, an enantiomer thereof or a pharmaceutically acceptable salt thereof”, a phrase which can be met by this part only containing omeprazole/enantiomer/pharmaceutically acceptable salt thereof as 0% sodium bicarbonate also satisfies the limitation of less than 40% of the total sodium bicarbonate. Similarly, the claim limitation “a second part comprising sodium bicarbonate” is met by this portion only containing sodium bicarbonate.
Therefore claim 1 as currently presented constitutes new matter as compositions that only comprise omeprazole/enantiomer/pharmaceutically acceptable salt thereof in one part and sodium bicarbonate as the second part fall within the scope of claim 1 but such compositions were not clearly disclosed in the disclosure as originally filed which through the examples and use of the phrasing “first mixed part” and “second mixed part” indicated that more than 1 ingredient was required for each part.
The dependent claims fall therewith.
If Applicant is in disagreement with the Examiner regarding support for the amended claim, Applicant is respectfully requested to point to specific sections such as by page and line number wherein support may be found for the instant invention.
Claim Rejections - 35 USC § 112 – Written Description
Claims 1, 2, 5, 6, 8, 10, 12 and 14 – 18 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This written description rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed May 14, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that amended claim 1 clearly specifies the structure of the tablet of the present invention and is designed such that, irrespective of solution pH, the sodium bicarbonate is released first, followed by omeprazole release, due to the structural characteristics of the formulation. The specification discloses 9 preparations that are all immediate release tablets that correspond to the amended claims. While some claims were canceled, claim 5, 6, 10, 12, 14, and 15 are supported by various portions of the specification as listed in a table spanning pages 9 and 10 of the remarks filed October 13, 2025.
These arguments are unpersuasive. This is a written description and not a new matter rejection so the question is not whether there is support for the claim limitations in the disclosure as filed. The question is for the functional limitations set forth in the claims, was there possession at the time of filing of a representative number of species within the claimed genus to support claims drawn to the genus of formulations with such functions. As discussed in greater detail on p 8 – 9 of the Office Action mailed May 14, 2025, the example preparations are similar in structure and in composition to one another. The dosage form structure shown on p 6 of the Remarks filed October 13, 2025 that was not present in the disclosure as originally filed is one possible arrangement but is not the only structural arrangement that falls within the structural limitations of the claims. The first parts need not be uniform in size, need not be spaced in a relatively uniform pattern as shown on p 6 and need not be only present on the interior of the dosage form. The broadest reasonable interpretation of the claims in view of specification is that sodium bicarbonate dissolution, even a very small amount, prior to omeprazole/enantiomer/pharmaceutically acceptable salt thereof dissolution is sufficient to meet the functional limitations of claim 1. That formulations that meet the functional limitations of claim 1 and the further functional limitations in dependent claims may be obvious to one of ordinary skill in the art is insufficient to meet the written description requirement. The claim amendments and arguments have not demonstrated the possession of a representative number of species within the claimed genus that have functions as required by the claims and therefore the written description requirement is not fully met.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 1, 2, 5, 6, 8, 10, 12 and 14 – 18 were 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.
While the amendments to the claims have resolved some the issues previously identified, below is a complete list of issues with claim 1 as currently presented that render the claims indefinite.
Claim 1 recites the limitation "the pellets or granules" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the preparation" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 now recites “the pellets or granules are mixed with the second part in the single tablet” (emphasis added) which appears to be an active method step and not a product by process limitation that would be proper in a product claim. Claims that recite method step(s) of are indefinite (see MPEP 2173.05(p)(II)).
The dependent claims fall therewith.
Please clarify.
Claim 1 was previously rejected as being indefinite for the wherein clause at the end of the claim relating to dissolution in solution.
In response, Applicants present a picture of the claimed dosage form and state that sodium bicarbonate is first released, followed by omeprazole release.
The arguments and amendments are unpersuasive regarding the wherein clause at the end of claim 1. As discussed above, the structure in the remarks represents an embodiment within the scope of the claims but is not the only embodiment within the scope of the claims. All of the granule/pellets shown in the drawing in the remarks are not exposed to the surface of the dosage form shown. It remains unclear if this wherein clause requires a tablet dosage form in which the sodium bicarbonate completely encases a dosage form as potentially the dissolution of any sodium bicarbonate, even a very small amount, prior to omeprazole/enantiomer/pharmaceutically acceptable salt thereof dissolution is sufficient to meet the functional limitations of claim 1.
For all of the reasons above, claim 1 and all the claims that depend from claim 1 are indefinite.
Claims 8 and 12 were 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.
As set forth in the Office Action mailed April 14, 2025, each of the claims recites includes the phrase “the single administration of the preparation” which lacks antecedent basis and product claims which recite a method step are indefinite.
Applicants argue that claims 7 – 14 do not fall under the examples of indefiniteness cited in the MPEP and that MPEP § 2173.05(p)(II) states that limitations which focus on the capabilities of the system, not the specific actions or functions performed by the user may be definite and the limitations in claims 8, 10, 12, 14 are not specific actions or functions performed by the user but are characteristics of the tablet itself.
These arguments are unpersuasive. The examples in the MPEP are not an exhaustive list of all issues that can lead to claims being indefinite so that they do not fall under an example does not indicate that the instant claims must be definite. The decision cited in the last paragraph in 2173.05(p)(II) is a software case and not a pharmaceutical formulation with a claim limitation requiring single or repeated administration and Applicants have not laid out how the fact pattern of that case is sufficiently similar to the present claims that each claim is definite. These arguments do not address the lack of antecedent basis for an administration step, so how can it be determined who or what is carrying out the action? Phrasing such as in claim 6, that was not rejected as indefinite, is more in line with a characteristic of the tablet itself. Claims 8, 10, 12 and 14 relate to physiological effects (e.g., alteration in stomach pH) that must occur when a dosage form is administered to a subject and such limitations can be definite. But given the phrasing of “after the single/repeated administration”, even if the antecedent basis issue was addressed, the claims read as requiring administration which results in an indefinite claim.
Claims 10 and 14 were 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.
As set forth in the Office Action mailed April 14, 2025, each of the claims recites includes the phrase “the repeated administration of the preparation” which lacks antecedent basis and product claims which recite a method step are indefinite. Please see above for the response to arguments regarding these claims.
Claim 15 was 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. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed May 14, 2025 and those set forth herein.
Claim 15 has been amended but still remains indefinite as discussed below.
Applicants argue that “the administration of the preparation” is not a method step and as amended the comparator has been clearly specified.
These arguments are unpersuasive. As above, the antecedent basis issue has not been addressed in the claim amendments or arguments. As amended, the quantities being compared are “the time to maintain the pH in the stomach of 4 or less for 24 hours” which is not clear. Is the pH of 4 or less maintained for a time period of 24 hours? But then the comparator uses the exact same language but must somehow be reduced by 30% or more even though both recite 24 hours. This claim might be attempting to quantify how after administration of the proton pump inhibitor containing composition, the pH of the stomach spends less time at pH 4 or less and/or more quickly rises to a pH of 4 or less. But “time to maintain” that now is somehow tied to a 24 hour time frame so the metes and bounds of the claims still cannot be determined.
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.
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) 1, 2, 5, 6, 8, 10, 12 and 14 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over Odidi et al. (WO 2004/112756) in view of Hall et al. (US 2014/0271853).
Odidi et al. discloses oral pharmaceutical compositions comprising multiple populations of at least one of beads, pellets, tablets and granules provided in a capsule comprising two populations of a pharmaceutical active substance and a population of a basic substance (whole document, e.g., abstract). The pharmaceutically active substance can be a proton pump inhibitor compound (PPI) that is rapidly released beginning in the stomach due to the presence of an optional excipient and by the stable environment created by the elevated pH of the stomach caused by the rapid disintegration and dissolution of the population of basic substance (p 8, ln 24 – p 9, ln 2). The pH of the stomach can be more than about 4.0 and less than about 7.0 and achieved in less than about 1 hour (p 8, ln 31 – p 9, ln 2). Either or both populations can be formulated with suitable excipients as understood by one of skill in the art (p 9, ln 12 – 22). The PPI can be in a neutral form or alkaline salt such as more typically the Mg2+ salt (p 12, ln 1 onward). Amongst the disclosed PPIs are omeprazole (p 12, ln 16) and the enantiomerically pure S or (-) enantiomer of omeprazole known as esomeprazole (p 12, ln 31 – p 13, ln 2). Hydrate forms can also be used (p 13, ln 7 – 8). The basic substance can be sodium bicarbonate (claim 21).
An exemplary formulation with a population of esomeprazole containing particles and a population of sodium bicarbonate containing particles is not disclosed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use esomeprazole as the PPI in one population within the pharmaceutical composition of Odidi et al. and to select sodium bicarbonate as the basic population of particles in the same composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Odidi et al. generally discloses compositions comprising multiple populations with one population being a PPI, which can be omeprazole or esomeprazole including salts such as magnesium or hydrates thereof, and a second population with a basic substance such as sodium bicarbonate. Various formulations are disclosed but none specifically disclose the PPI and basic material used but one of ordinary skill in the art can select from the specific materials disclosed as suitable for use in the PPI are basic substance containing particles by Odidi et al.
Odidi et al. discloses that the rapid dissolution of the basic substance raises the pH of the stomach within an hour allowing for delivery of the acid labile PPI in the stomach with an elevated pH level. While specific time frames for release or more specific times for the time frame of pH change are not given, the dosage forms of Odidi et al. fall within the scope of the instant claims. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 Even if the compositions do not fall within the claimed functional parameters, one of ordinary skill in the art would routinely optimize the release rate of the ingredient that elevates the pH of the stomach to deliver the acid labile PPI to the stomach in a rapid release fashion. There is no evidence of record as to the criticality of the claimed time frames and/or pharmacokinetic parameters.
A formulation that is a single tablet and not multiple tablets of different composition inside a capsule is not disclosed.
Hall et al. discloses compositions with a combination of a PPI and at least one buffering agent that have been found to possess improved bioavailability, chemical stability, physical stability, dissolution profiles, disintegration times, as well as other improved pharmacokinetic, pharmacodynamic, chemical and/or physical properties (whole document, e.g., abstract). One general embodiment comprises a therapeutically effective amount of at least one acid labile proton pump inhibiting agent and at least one antacid (¶ [0008]). The PPI can be esomeprazole, a free base, free acid, salt, hydrate, polymorph, enantiomer, isomer, tautomer or prodrug thereof (¶ [0018]). The antacid can comprise at least 400 mg of sodium bicarbonate (¶ [0020]). Exemplified solid dosage forms include tablets and capsules (¶ [0021]) and the tablet can be a multi-layer tablet (¶ [0033]). In example 9A (beginning at ¶ [0385]), micronized omeprazole, which reads on pellets or granules; and bicarbonate were mixed with the later addition of additional excipients to prepare an immediate release tablet layer.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare a multi-layer tablet rather than using multiple tablets placed inside a capsule dosage form as disclosed by Odidi et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Hall et al. discloses a variety of dosage forms for a formulation comprising a PPI and an antacid such as sodium bicarbonate including capsules as in Odidi et al. and a multilayer tablet in which at least some of the materials used to prepare the final dosage form are present as pellets or granules. Different types of dosages forms are preferred by different people so a multilayer tablet as in Hall et al. could be preferred over a capsule as in Odidi et al. by some users. There is no evidence of record as to the criticality of the type of dosage form. Given the greater solubility of sodium bicarbonate in water (about 9.3 g/100 mL at 20°C; see “sodium bicarbonate” sheet from inchem.org, accessed May 9, 2025) compared to omeprazole (0.5 mg/mL in water; see sigma product information sheet, accessed May 9, 2025), at least some bicarbonate would dissolve before the omeprazole, meeting the wherein clause at the end of instant claim 1, when the dosage form rendered obvious by the combination of Odidi et al. and Hall et al. is brought into contact with a solution.
A new ground of rejection is set forth above to address the new limitation in claim 1 of a single tablet that uses the same Odidi et al. reference that was previously applied and the new reference Hall et al. to address the new claim limitation. Therefore the arguments regarding the failure of Odidi et al. to teach a single tablet are moot in light of this new rejection.
Applicants also argue that the increase in gastric pH within one hour relates to the basic substance population and cannot be regarded as disclosing the effect for the capsule as a whole with no concrete experimental data nor does it specify the PPI (proton pump inhibitor) or basic substance in the formulation. If omeprazole dissolves prior to sodium bicarbonate, the pharmacological effect would be reduced and a skilled person would understand that the formulation of Odidi et al. may fail to achieve stable omeprazole release. Test example 1 of the instant application shows an effect of higher omeprazole concentrations for first parts containing less than 40% of the total sodium bicarbonate compared with those that had more sodium bicarbonate in the first part. Test Examples 2 – 4 demonstrate rapid and superior pharmacological activity.
These arguments are unpersuasive. Arguments without factual support are mere allegations and are not found persuasive. Applicants bear the burden of explaining evidence offered in support of alleged unexpected results. The reasoning leading to the conclusion of the expectation of unstable omeprazole release if sodium bicarbonate dissolves later has not been spelled out or supported by evidence of record. A comparison with the closest prior art is not set forth which is not necessarily a commercially available formulation. No clear explanation as to the expected results has been given. Odidi et al. discussed the stable environment created by the elevated pH of the stomach caused by the rapid disintegration and dissolution of the population of basic substance (p 8, ln 24 – p 9, ln 2). ¶ [0033] of the newly applied Hall et al. reference which states “antacid in an amount sufficient to increase gastric fluid pH to a pH that prevents acid degradation of at least some of the proton pump inhibitor in the gastric fluid”. These statements suggest that the dissolution of sodium bicarbonate in amounts sufficient to raise the pH of the stomach would result in increased amounts of the proton pump inhibitor being pharmacologically available and the results observed are not in fact unexpected. Such evidence must also be reasonably commensurate in scope with the claims. The claims permit any amount of sodium bicarbonate to dissolve before omeprazole dissolution. The exemplary formulations are formulated in such a way that a relatively large amount of sodium bicarbonate is present outside the omeprazole containing part that was coated prior to addition to the second part with most of the bicarbonate. Even if such coated materials were present on the surface of the dosage, the present of that coating would act to delay even slightly omeprazole dissolution compared to the sodium bicarbonate portion. Therefore even if the results were in fact unexpected, the evidence of record is not reasonably commensurate in scope with the claims and does not outweigh the prima facie case of obviousness set forth above.
Claim(s) 1, 2, 5, 6, 8, 10, 12 and 14 – 18 are rejected under 35 U.S.C. 103 as being unpatentable over Odidi et al. and Hall et al. as applied to claims 1, 2, 5, 6, 8, 10, 12 and 14 – 17 above, and further in view of Marom et al. (Chirality, 2010).
Odidi et al. and Hall et al. are discussed above.
Magnesium salts and hydrates are generally disclosed by Odidi et al. but the trihydrate magnesium salt of esomeprazole is not specifically disclosed.
Marom et al. discloses that the active ingredient in NEXIUM® is esomeprazole magnesium trihydrate which launched in the US in 2001 and has been approved for treatment of Gastroesophageal Reflux Disease (GERD), risk reduction of NSAID-associated gastric ulcer, Heliobacter pylori eradication to reduce the risk of duodenal ulcer recurrence and pathological hypersecretory conditions including Zollinger-Ellison syndrome (p 798, col 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use esomeprazole magnesium trihydrate as the PPI in the compositions of Odidi et al. and Hall et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because that is the active ingredient used in the commercial product NEXIUM® that launched in the US in 2001 and has been approved to treat a number of indications such as GERD. Salts such as magnesium and hydrates of the PPI are generally disclosed by Odidi et al. and given the commercial availability and approvals for this particular salt/hydrate combination, one of ordinary skill in the art would be motivated to use esomeprazole magnesium trihydrate in the compositions of Odidi et al.
Applicants do not present arguments regarding Marom et al. for the Examiner to address herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Regarding the double patenting rejections, Applicants request that they be held in abeyance until the claims are otherwise in condition for allowance.
Applicants’ failure to argue the rejection on the grounds of non-statutory double patenting over US Patent Nos. 11,759,428; 11,813,285 and 12,251,375 is noncompliant with the regulations under 37 C.F.R. 1.111. The instant rejections are not provisional rejections as the claims of US Patent Nos. 11,759,428; 11,813,285 and 12,251,375 have been issued. In the interest of compact prosecution, the Examiner has examined the instant application. However, in order for the response to the instant Office Action to be fully responsive and in compliance with the regulations under 37 C.F.R. 1.111, the Applicant should either file a terminal disclosure or traverse the rejection based on US Patent Nos. 11,759,428; 11,813,285 and 12,251,375. Because applicant did not distinctly and specifically point out the supposed errors in the instant non-statutory double patenting rejection based on US Patent Nos. 11,759,428; 11,813,285 and 12,251,375 and no Terminal Disclaimer has been filed, the rejections are maintained for the reasons set forth below.
Claims 1, 2, 5, 6, 8, 10, 12 and 14 – 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 11 of copending Application No. 17/630,261 in view of Odidi et al. (WO 2004/112756) and Hall et al. (US 2014/0271853).
The claims of US’261 recite a pharmaceutical composition of 40 mg of esomeprazole and 800 mg of sodium bicarbonate that results in a maximal blood concentration within 1 hour after administration (claim 1). The esomeprazole can be the magnesium trihydrate form (claim 5). Claims requiring certain changes in gastric pH are also present (claims 8 – 11).
The localization of the sodium bicarbonate in the composition is not claimed.
Odidi et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to provide the ingredients claimed in US’261 as two populations of particles, one with esomeprazole and the other with sodium bicarbonate as disclosed by Odidi et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Odidi et al. generally discloses compositions comprising multiple populations with one population being a PPI, which can be omeprazole or esomeprazole, and a second population with sodium bicarbonate as the basic substance and one of ordinary skill in the art would reasonably expect that such a dosage form would be suitable for the compositions of US’261.
That the dosage form is a single tablet is not disclosed.
Hall et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare a multi-layer tablet rather than using multiple tablets placed inside a capsule dosage form as disclosed by Odidi et al. for the compositions claimed us US’261. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Hall et al. discloses a variety of dosage forms for a formulation comprising a PPI and an antacid such as sodium bicarbonate including capsules as in Odidi et al. and a multilayer tablet in which at least some of the materials used to prepare the final dosage form are present as pellets or granules. Different types of dosages forms are preferred by different people so a multilayer tablet as in Hall et al. could be preferred over a capsule as in Odidi et al. by some users. There is no evidence of record as to the criticality of the type of dosage form. Given the greater solubility of sodium bicarbonate in water (about 9.3 g/100 mL at 20°C; see “sodium bicarbonate” sheet from inchem.org, accessed May 9, 2025) compared to omeprazole (0.5 mg/mL in water; see sigma product information sheet, accessed May 9, 2025), at least some bicarbonate would dissolve before the omeprazole, meeting the wherein clause at the end of instant claim 1, when the dosage form rendered obvious by the combination of Odidi et al. and Hall et al. is brought into contact with a solution.
The release profile or pharmacokinetic properties are not specifically claimed. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 Even if the compositions do not explicitly fall within the claimed functional parameters, one of ordinary skill in the art would routinely optimize the release rate of the ingredient that elevates the pH of the stomach to deliver the acid labile PPI to the stomach in a rapid release fashion. There is no evidence of record as to the criticality of the claimed time frames and/or pharmacokinetic parameters.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 5, 6, 8, 10, 12 and 14 – 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 1 - 7 of U.S. Patent No. 11,759,428. Although the claims at issue are not identical, they are not patentably distinct from each other because the dosage forms of US’428 do not require any sodium bicarbonate in the first layer that comprises the omeprazole and sodium bicarbonate is required to be present in the third layer (claim 1). The omeprazole can be esomeprazole magnesium trihydrate (claim 7). Based on the preparation process of claims 6 and 7, the product will be a single tablet as required by the instant claims.
The release profile or pharmacokinetic properties are not specifically claimed. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 Even if the compositions do not explicitly fall within the claimed functional parameters, one of ordinary skill in the art would routinely optimize the release rate of the ingredient that elevates the pH of the stomach to deliver the acid labile PPI to the stomach in a rapid release fashion. There is no evidence of record as to the criticality of the claimed time frames and/or pharmacokinetic parameters.
Claims 1, 2, 5, 6, 8, 10, 12 and 14 – 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 4 of U.S. Patent No. 11,813,285. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’285 recite a tablet dosage form comprising the magnesium salt of esomeprazole and sodium bicarbonate, with the bicarbonate not being in contact with the esomeprazole (claim 1) so therefore the omeprazole is not present in the same part as the omeprazole. The product will be a single tablet as required by the instant claims. The trihydrate form of the esomeprazole magnesium may be used (claim 2).
The release profile or pharmacokinetic properties are not specifically claimed. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 Even if the compositions do not explicitly fall within the claimed functional parameters, one of ordinary skill in the art would routinely optimize the release rate of the ingredient that elevates the pH of the stomach to deliver the acid labile PPI to the stomach in a rapid release fashion. There is no evidence of record as to the criticality of the claimed time frames and/or pharmacokinetic parameters.
Claims 1, 2, 5, 6, 8, 10, 12 and 14 – 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 7 of U.S. Patent No. 12,251,375 of U.S. Patent No. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’375 recite esomeprazole and sodium bicarbonate containing tablets (claim 1) and the pellet comprising the esomeprazole need not comprise sodium bicarbonate (claim 2). The product will be a single tablet as required by the instant claims. The esomeprazole can be the magnesium trihydrate form (claim 7).
The release profile or pharmacokinetic properties are not specifically claimed. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). “As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” MPEP 2113 Even if the compositions do not explicitly fall within the claimed functional parameters, one of ordinary skill in the art would routinely optimize the release rate of the ingredient that elevates the pH of the stomach to deliver the acid labile PPI to the stomach in a rapid release fashion. There is no evidence of record as to the criticality of the claimed time frames and/or pharmacokinetic parameters.
Conclusion
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618