DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 1
Status of the Claims
Claims 41, 45, 46, 48-50 and 81-90 is/are pending in this application.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted June 4, 2026 (total of five) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant did not provide arguments to rebut the obviousness type double patenting rejections (ODP) rejection over 19075423. This rejection is maintained.
With regard to the balance of the ODPs, starting at page 2 of June 4, 2026 Applicant’s response, Applicant argues the ODP’s are improper because of previous restriction requirements made in the prosecution of the parent applications.
During the prosecution of App. 15257674, in the July 3, 2017 Restriction Requirement, the Attorney response argues Groups I and II were restricted due to a finding of distinct inventions between a related product and process of use, necessitating the restriction, i.e. the product can be used for the treatment of diarrhea in patients with or without mastocytic enterocolitis, (two distinct patient populations). See also Application 16513342, where in the April 28, 2020 Restriction Requirement, it was determined the claimed combination product could be used for patentably distinct methods of treatment of diarrhea and in vitro toxicity testing.
The Attorney response also argues materially different processes are claimed in 17916535 (treatment of acute respiratory distress syndrome) and Application No. 18693500 (treatment of interstitial cystitis).
Applicant argues the above identified methods are distinct from each other as they are not obvious over each other (see MPEP 806.05(h)) and requests withdrawal of the obviousness-type double patenting rejections.
In response, these restrictions requirements were made before consideration of evidence now present before the Examiner. Over time, earlier findings of distinctness evolve with the consideration of new evidence during the prosecution of later filed applications. Presently, the pending product claims are examined years after the initial findings of the earlier restrictions, and now rejected for ODP.
Applicant’s arguments dated June 4, 2026, with respect to the rejection of claim(s) 41, 45, 46, 48, 50 and 81-90 for obviousness type double patenting over US Pats. 9,717,726; 10,034,875; 11,058,681 and 11,419,868, and Application Nos. 17916535, and 18693500 have been fully considered but do not overcome the maintained rejections.
The Attorney response states the pending ODP rejections over U.S, Pat Nos. 9717726 issued Aug 1 2017; 10034875 issued July 31 2018; 11,058,681 issued July 13, 2021; US 11,058,681 and 11,419,868 issued August 23 2022 based on request to change the status of the pending application from a continuation (CON) to a divisional (DIV) of the parent application and issued patent. See page 2 Application Data Sheet dated June 4, 2026 reproduced below.
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It is noted, MPEP 211.02(a) “Correcting or Adding a Benefit Claim After Filing” allows for a request for corrected filing receipt for applications the pending application, filed after September 16 2012, via a corrected ADS as reproduced above.
However, Applicant’s request for a change in application status to a DIV from a CON, is not recognized at this time, where MPEP 211.02(a)(I.) notes “[A]pplicants are advised that only the benefit claims that are listed on the filing receipt have been recognized by the Office.”
At this time, a corrected filing receipt has not been issued by the Office recognizing the divisional status. Therefore, the ODP rejection of claims 41, 45, 46, 48, 50 and 81-90 over the cited patents and applications remain maintained.
Further, even if the application is recognized as a DIV, with regard to U.S, Pat Nos. 9717726 issued Aug 1 2017; and US 10034875 issued July 31 2018, they would not be eligible as detailed below.
Per MPEP 802 citing to 35 USC 121
A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as a reference either in the Patent and Trademark Office or in the courts against a divisional application or against the original application or any patent issued on either of them, if the divisional application is filed before the issuance of the patent on the other application. The validity of a patent shall not be questioned for failure of the Director to require the application to be restricted to one invention.
So not only must an Application be a DIV of the conflict parent, it must have been filed prior to the issuance of said patent.
The conflict ODP patents and their issue dates are:
US Pat No. 9,717,726 issued Aug 1, 2017;
US Pat No. 10034875 issued July 31 2018.
The pending Application was filed on May 28 2021, after the issuance dates of the ‘726 and ‘875 patents, so it does not qualify for Safe Harbor protection.
Further, the Attorney arguments regarding US 11419868 issued August 23 2022, do not overcome the obviousness type double patenting rejection, despite any potential change in status of the pending application from a continuation to a divisional. US 11419868 is not in the domestic priority chain of the pending application, where the pending application can claim status as a divisional thereof. See US Application data of the US 114198682 and therefore cannot receive safe harbor protection. Further, arguments of distinct invention between products and processes made for this application’s family are not applicable here.
Note, US Pat 11,058,681 (‘681 patent) was issued July 13, 2021, where the pending Application was filed on May 28, 2021, prior to the issuance of ‘681 patent. Upon recognition of Divisional status by a corrected filing receipt for this Application, a determination will be made if Safe Harbor protection form the ‘681 patent is warranted.
The Attorney response argues per MPEP 804(I)(B)(1)(b)(i), any remaining provisional obviousness type double patent rejections (18693500 and 17916535) should be withdrawn if they are only remaining rejections.
Initially, it is pointed out the provisional ODP rejections are not the sole remaining rejections, as the ODP rejections recited below are maintained. Further, Applicant did not address the ODP rejection over App. No.19075423, and therefore the rejection is maintained.
Non-Statutory Double Patenting Rejections
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 41, 45, 46, 48-50 and 81-90 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 9-20 of US Patent 9717726 B2 (reference patent aka 726 patent), in view of PEPCID® 2001, Prescribing Information, Merck & Co. and US 5096894 (894 patent). All references were previously cited by the Examiner
Claim 41 is directed to an oral dosage (comprising at least a capsule or tablet), pharmaceutical composition, with the intended use to treat diarrhea, comprising cetirizine, levocetirizine or mixtures thereof, and famotidine,
The reference 726 patent generally claims a method of treating diarrhea in a patient, comprising administering an H1 receptor antagonist, cetirizine, and an H2 receptor antagonist, famotidine, to the patient suffering from chemotherapy induced diarrhea. See claim 9.
Regarding the limitation of a capsule or a tablet, and a unit dosage form, the reference patent discloses the combination of the cetirizine and famotidine are administered together as a unit dosage form. See claims 16-17.
While the reference patent does not claim a tablet or capsule, comprising famotidine, these formulations are known in the art. See page 1 of PEPCID® 2001. See also the 894 patent disclosing species of oral dosage forms as oral rehydration solutions comprising sodium and glucose.
It would have been prima facie obvious to a PHOSITA following the teachings of the reference patent in view of the secondary references treat with a H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation of success to the PHOSITA
Regarding claim 45, the reference patent teaches cetirizine. See above.
Regarding claim 46 (an oral unit dosage form, the reference patent teaches “cetirizine, levocetirizine or mixtures thereof and the famotidine are administered together as a unit dosage form.” See claims 16-17.
Regarding claim 48, the reference patent’s claims do not recite an oral dosage form further comprising sodium and glucose.
However based on art teachings, oral rehydration solutions, as unit dosage forms, that comprise sodium and glucose are known.
Accordingly, a PHOSTA would have a rationale to look towards such a solution with a reasonable expectation of success as rehydration solutions are standard of care to treat diarrhea in patients, with disaccharide glucose polymers (rice and corn dextrins). See column 5 lines 3-12; and claim 1. Such standard of care is taught by the art, where the 894 patent teaches oral formulations used for the treatment of diarrheal disease, see column 1, lines 11-29.
As required by claim 50 limited to a plurality of unit dosage forms, the reference patent discloses a unit dosage form, as noted above. While not reciting a plurality, it would obvious to one of ordinary skill in the art to look toward multiple unit dosage forms to be used to treat a patient has irritable bowel syndrome diarrhea.
Regarding claim 81 (cetirizine is in an amount of 5 to 20 mg), this limitation is taught by reference claim 14.
Claim 82 claims a pharmaceutical composition comprising:
cetirizine in an amount of in an amount of 5 to 20 mg, and
famotidine is present in an amount of 10 to 40 mg
wherein the pharmaceutical composition is an oral dosage form, and
the composition is a unit dosage form.
With regard to claim 82, the reference patent teaches treatment of chemotherapy induced diarrhea with a combination of cetirizine and famotidine. See claim 9.
The amounts of cetirizine and famotidine are recited in claims 14-15 and 19-20. The unit dosage form is taught in claims 16-17. While the reference patent does not claim an oral unit dosage form per se, such as a tablet or capsule, tablets, solutions or suspensions (powder for rehydration) and orally disintegrating tablets (ODTs), comprising famotidine, these formulations are known in the art. See page 1 of PEPCID® 2001. See also the 894 patent disclosing species of oral dosage forms as oral rehydration solutions comprising sodium and glucose. A PHOSITA would have a reasonable expectation of success in arriving at oral unit dosage forms, based on the teachings of the art as unit doses are single, ready to administer doses of medicine packaged for one administration.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference to treat form H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral unit dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a PHOSITA a reasonable expectation of success.
With regard to claim 83 (tablets and capsules), see PEPCID® 2001, page 1, disclosing tablets and ODTs.
Regarding claims 84-85 where the oral dosage form further comprises an oral rehydration solution and the limitations of an oral dosage form further comprises sodium and glucose, respectively, the reference patent does not recite oral rehydration solution in its claims. Per claim 84, oral rehydration solutions, comprising electrolytes such as sodium and carbohydrates such as glucose, are well known in the art. See column 1, lines 11-29 of the 894 patent.
Per claim 85, directed to oral rehydration solutions, these are taught by ‘894 patent and PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; 5-20 mg cetirizine, 10 to 40 mg famotidine; tablet, capsules or packets; further comprising glucose. Tablets, ODTs (orally disintegrating tablets), and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching oral suspensions from powder reconstituted with 46 mL purified H2). Oral rehydration solutions, comprising sodium electrolytes and glucose carbohydrates are known, col. 1, lines 11-29 (‘894 patent).
Claims 41, 45, 46, 48-50 and 81-90 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-17 of US Patent 10034875 B2 (reference patent, 875 patent), in view of PEPCID® 2001, Prescribing Information, Merck & Co. and US 5096894 (894 patent). All references were previously cited by the Examiner.
Discussion of claim 41 and its claimed oral dosage unit (capsule or tablet) combination of cetirizine/levocetirizine and famotidine with intended use to treat diarrhea is discussed above and incorporated herein.
Regarding the examined claims, US Patent 10034875 (reference patent) generally claims a method of treating diarrhea in a patient, comprising administering an H1 receptor antagonist and an H2 receptor antagonist to the patient, wherein the patient does not have mastocytic enterocolitis, the patient has [irritable bowel syndrome diarrhea] IBS-D, the H1 receptor antagonist is cetirizine, levocetirizine, or mixtures thereof, and the H2 receptor antagonist is famotidine. See claim 1.
Regarding the limitations of a capsule or a tablet and of a unit dosage form, the reference patent discloses the combination of the cetirizine and famotidine are administered together as a unit dosage form. See claims 9, 10 and 14.
While the reference patent does not claim a tablet or capsule, or orally disintegrating tablets (ODTs), comprising famotidine, these formulations are known in the art. See page 1 of PEPCID® 2001. See also the 894 patent disclosing species of oral dosage forms as oral rehydration solutions comprising sodium and glucose.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference to treat form H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation to the PHOSITA.
Regarding claim 45 (cetirizine), the reference patent teaches cetirizine. See above.
Examined claim 46 is directed to an oral unit dosage form. The reference patent teaches “cetirizine, levocetirizine or mixtures thereof and the famotidine are administered together as a unit dosage form.” See claims 9, 10 and 14.
Regarding claim 48, the reference patent’s claims do not recite an oral dosage form further comprising sodium and glucose.
However based on the teachings of what is known in the art, oral rehydration solutions, as unit dosage forms, comprising sodium and glucose are known.
Accordingly, one of ordinary skill in the art would have a rationale to look towards such a solution with a reasonable expectation of success as rehydration solutions are standard of care to treat diarrhea in patients, with disaccharide glucose polymers (rice and corn dextrins). See column 5 lines 3-12; and claim 1. Such standard of care is taught by the art, where the 894 patent teaches oral formulations used for the treatment of diarrheal disease, see column 1, lines 11-29.
As required by claim 50 where the oral dosage form comprises a plurality of unit dosage forms, the reference patent discloses a unit dosage form, as noted above. While not reciting a plurality, such plurality would be obvious to one of ordinary skill in the art to look toward multiple unit dosage forms to be used to treat a patient has irritable bowel syndrome diarrhea.
Regarding claim 81 reciting the cetirizine is in an amount of 5 to 20 mg, this limitation is taught by claim 6.
With regard to claim 82 and its claimed combination, the reference patent teaches treatment of IBS-D with a combination of cetirizine and famotidine. See claims 1 and 11. The claimed amounts of cetirizine (5 to 20 mg) and famotidine (10 to 40 mg)are recited in claims 5, 6, 8 and 15-17. The claimed limitation of an unit dosage form is taught in claims 9, 10 and 14.
While the reference patent does not claim an oral unit dosage form per se, such as a tablet or capsule, tablets, solutions or suspensions (powder for rehydration) and orally disintegrating tablets (ODTs), comprising famotidine, these formulations are known in the art. See page 1 of PEPCID® 2001. See also the 894 patent disclosing species of oral dosage forms as oral rehydration solutions comprising sodium and glucose. A PHOSITA would have a reasonable expectation of success in arriving at oral unit dosage forms, based on the teachings of the art as unit doses are single, ready to administer doses of medicine packaged for one administration.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference to treat form H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral unit dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation of success. With regard to the limitation of tablets and capsules of claim 83, see PEPCID® 2001, page 1, disclosing tablets and ODTs.
With regard to the limitation of tablets and capsules of claim 83, see PEPCID® 2001, page 1.
Per claim 84, oral rehydration solutions, comprising electrolytes such as sodium and carbohydrates such as glucose are known. See column 1, lines 11-29 of the 894 patent.
Per claim 85, directed to oral rehydration solutions, these are taught by ‘894 patent and PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; 5-20 mg cetirizine, 10 to 40 mg famotidine; tablet, capsules or packets; further comprising glucose. Tablets, ODTs (orally disintegrating tablets), and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching oral suspensions from powder reconstituted with 46 mL purified H2). Oral rehydration solutions, comprising sodium electrolytes and glucose carbohydrates are known, col. 1, lines 11-29 (‘894 patent).
Claims 41, 45, 46, 48-50 and 81-90 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-12 of US Patent 11058681 B2 (reference patent, aka 681 patent), in view of PEPCID® 2001, Prescribing Information, Merck & Co. and US 5096894 (894 patent). All references were previously cited by the Examiner.
Discussion of claim 41 and its claimed oral dosage unit (capsule or tablet) combination of cetirizine/levocetirizine and famotidine with intended use to treat diarrhea is discussed above and incorporated herein.
Regarding the examined claims, US Patent 11058681 (reference patent) generally claims a method of treating diarrhea in patients, comprising administering an H1 receptor antagonist and an H2 receptor antagonist to the patients,
wherein the patients have chronic idiopathic diarrhea,
the H1 receptor antagonist comprises cetirizine, levocetirizine or mixtures thereof,
the H2 receptor antagonist comprises famotidine, ranitidine or mixtures thereof, and the patients do not have mastocytic enterocolitis. See main claim.
With regard to the limitation of tablets and capsules, while not expressly in claim 1, and the limitation of a unit (oral) dosage form, the reference patent discloses the combination of the cetirizine and famotidine are administered together as a unit dosage form, an oral dosage form and a form that comprises at least one tablet or capsule. See claims 8-10 respectively. See also the 894 patent disclosing species of oral dosage forms as oral rehydration solutions comprising sodium and glucose.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference to treat form H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral dosage forms such as tablets, ODT and/or powders/suspensions are known in the art.
The PHOSITA would have a reasonable expectation of success because such cetirizine and famotidine oral dosage forms (tablets and capsules) are known in the art.
Regarding claim 45 and cetirizine as the compound, the reference patent teaches cetirizine. See above.
Examined claim 46 is directed to an oral dosage form as a unit dosage form, these limitations are taught in claims 8 and 9. See also claim 10 that discloses at least one tablet or capsule.
Regarding claim 48 and the limitation of wherein the oral dosage form further comprises sodium and glucose, this limitation is taught by claim 11 of the reference patent.
Regarding claim 50 where the oral dosage form comprises a plurality of unit dosage forms, the reference patent discloses a unit dosage form, as noted above. While not reciting a plurality, such plurality would be obvious to one of ordinary skill in the art to look toward multiple unit dosage forms to be used to treat a patient has irritable bowel syndrome diarrhea. See claims 8-10.
Regarding claim 81 and the limitation of wherein the cetirizine is in an amount of 5 to 20 mg, this limitation is taught by claim 6.
With regard to claim 82, the reference patent teaches treatment of chronic idiopathic diarrhea with the claimed combination of cetirizine and famotidine. See claim 1. The claimed amounts of cetirizine (5 to 20 mg) and famotidine (10 to 40 mg) are recited in claims 6-7. The claimed limitations of an unit dosage form and oral dosage form are taught in claims 8 and 9, respectively.
With regard to the limitation of tablets and capsules of claim 83, such limitation is taught by the reference patent. See claim 10.
Regarding claims 84-85 where the oral dosage form further comprises an oral rehydration solution and the limitations of an oral dosage form further comprises sodium and glucose, these limitations are taught in claims 11-12.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; 5-20 mg cetirizine, 10 to 40 mg famotidine; tablet, capsules or packets; further comprising glucose. Tablets, ODTs (orally disintegrating tablets), and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching oral suspensions from powder reconstituted with 46 mL purified H2). Oral rehydration solutions, comprising sodium electrolytes and glucose carbohydrates are known, col. 1, lines 11-29 (‘894 patent).
Claims 41, 45, 46, 48-50 and 81-90 remain rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of US 11419868 Patent B2 (reference patent, aka 868 patent), previously cited, in view of ZYRTEC® Prescribing Information 2002 (cited on the PTO-892 form) and PEPCID® 2001, Prescribing Information, Merck & Co. and US 5096894 (894 patent), cited on the PTO-892 form. All references were previously cited by the Examiner
Discussion of claim 41 and its claimed oral dosage unit (capsule or tablet) combination of cetirizine/levocetirizine and famotidine with intended use to treat diarrhea is discussed above and incorporated herein.
Regarding the examined claims, US Patent 11419868 generally claims a method of treating diarrhea in a patient, comprising: administering cetirizine and famotidine, wherein the cetirizine is administered in a dose of 6.0-7.0 mg per day and the famotidine is administered in a dose of 12.0-15.0 mg per day. See claim 1.
While the reference patent discloses the combination of the cetirizine and famotidine are administered together to treat diarrhea, it does not recite the limitation of oral doses such as tablets. However, one of ordinary skill in the art would predictably arrive at the claimed invention with a reasonable expectation of success as orally dosed tablets of cetirizine and famotidine are known.
Regarding the limitation of an oral unit dose form of cetirizine tablet, ZYRTEC® 2002 teaches tablets of cetirizine. See page 1.
Regarding the limitation of an oral unit dose form of famotidine tablet, PEPCID® 2001 teaches tablets of famotidine. See page 1.
While the reference patent does not claim species of a tablet or capsule, or orally disintegrating tablets (ODTs), comprising famotidine, these formulations are known in the art. See page 1 of PEPCID® 2001. See also the 894 patent disclosing species of oral dosage forms as oral rehydration solutions comprising sodium and glucose.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference patent to treat form H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation of success.
Regarding claim 45 and cetirizine as the compound, the reference patent teaches cetirizine. See above.
Examined claim 46 is directed to an oral dosage form as a unit dosage form. As noted above, PEPCID® 2001 and ZYRTEC® 2002 teach oral dosage forms such as tablets.
Regarding claim 48, the reference patent’s claims do not recite an oral dosage form further comprising sodium and glucose. Nor does the reference patent teach oral rehydration solutions as unit dosage forms as per claim 49.
However based on the teachings of what is known in the art, oral rehydration solutions, as unit dosage forms, that comprise sodium and glucose are known.
Accordingly, one of ordinary skill in the art would have a rationale to look towards such a solution with a reasonable expectation of success as rehydration solutions are standard of care to treat diarrhea in patients, with disaccharide glucose polymers (rice and corn dextrins). See column 5 lines 3-12; and claim 1. Such standard of care is taught by the art, where the 894 patent teaches oral formulations used for the treatment of diarrheal disease, see column 1, lines 11-29.
As required by claim 50 where the oral dosage form comprises a plurality of unit dosage forms, the reference patent discloses a unit dosage form, as noted above. While not reciting a plurality, such plurality would be obvious to one of ordinary skill in the art to look toward multiple unit dosage forms to be used to treat a patient has irritable bowel syndrome diarrhea.
Regarding claim 81 and the limitation of wherein the cetirizine is in an amount of 5 to 20 mg, ZYRTEC® 2002 teaches 5 and 10 mg tablets of cetirizine. See page 1.
With regard to claim 82, the reference patent teaches treatment of diarrhea and IBS-D with the claimed combination of cetirizine and famotidine. See claims 1 and 9.
Regarding the limitations of famotidine is present in an amount of 10 to 40 mg, PEPCID® Prescribing Information teaches once daily dosing of famotidine (either 20 to 40 mg), see page 10, under Dosage and Administration.
Regarding the limitations of 5 to 20 mg cetirizine, ZYRTEC® 2002 teaches 5 and 10 mg tablets of cetirizine. See page 1.
Regarding claims 82-83 and the limitation of an oral unit dose form of cetirizine tablet, ZYRTEC® 2002 teaches tablets of cetirizine. See page 1. Regarding claims 82-83 and the limitation of an oral unit dose form of famotidine tablet, PEPCID® 2001 teaches tablets of famotidine. See page 1.
While the reference patent does not claim an oral unit dosage form per se, such as a tablet or capsule, tablets, solutions or suspensions (powder for rehydration) and orally disintegrating tablets (ODTs), comprising famotidine, these formulations are known in the art. See page 1 of PEPCID® 2001. See also the 894 patent disclosing species of oral dosage forms as oral rehydration solutions comprising sodium and glucose. A PHOSITA would have a reasonable expectation of success in arriving at oral unit dosage forms, based on the teachings of the art as unit doses are single, ready to administer doses of medicine packaged for one administration.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference to treat form H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral unit dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation of success.
With regard to the limitation of tablets and capsules of claim 83, see PEPCID® 2001, page 1, disclosing tablets and ODTs.
Regarding claims 84-85 where the oral dosage form further comprises an oral rehydration solution and the limitations of an oral dosage form further comprises sodium and glucose, the reference patent doesn’t claim an oral rehydration solution.
Per claim 84, oral rehydration solutions, comprising electrolytes such as sodium and carbohydrates such as glucose are known. See column 1, lines 11-29 of the 894 patent.
Per claim 85, directed to oral rehydration solutions, these are taught by ‘894 patent and PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; 5-20 mg cetirizine, 10 to 40 mg famotidine; tablet, capsules or packets; further comprising glucose. Tablets, ODTs (orally disintegrating tablets), and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching oral suspensions from powder reconstituted with 46 mL purified H2). Oral rehydration solutions, comprising sodium electrolytes and glucose carbohydrates are known, col. 1, lines 11-29 (‘894 patent).
Claims 41, 45, 46, 50 and 81-83 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6, 7, 14, 15 and 18-21 of copending Application No. 18693500.
Discussion of claim 41 and its claimed oral dosage unit (capsule or tablet) combination of cetirizine/levocetirizine and famotidine with intended use to treat diarrhea is discussed above and incorporated herein.
Regarding claim 41, the reference application discloses a combination of an H1 and H2 receptor antagonist to a patient. See claim 1. Claims 6 and 7 disclose the H1 antagonists, cetirizine and levocetirizine, and the H2 antagonist, famotidine, as claimed. See claims 6 and 7. As claimed by Applicant, the reference application discloses an oral dosage form, where such form comprises a unit dosage form such as at least one tablet or one capsule. See claims 18, 19 and 20, respectively.
While the reference discloses a subject in need suffering from interstitial cystitis and the claimed application’s composition is directed to the intended use of treating diarrhea, the reference application nonetheless discloses the claimed composition, comprising a combination of cetirizine/levocetirizine and famotidine, as claimed, as unit dosage form, such as an oral dosage form like tablets and capsules. A chemical composition and its properties are inseparable. See MPEP 2112.01 II.3 Setting aside the intended use of treating diarrhea being different from the reference method of treating interstitial cystitis, the reference application nonetheless teaches the same composition.
Regarding claims 45-46, the reference application teaches cetirizine and unit dosage forms as oral dosage forms such as tablets and capsules. See above.
As required by claim 50, the reference application discloses wherein the oral dosage form comprises a plurality of unit dosage forms. See claim 21.
Regarding claim 81 wherein the cetirizine is in an amount of 5 to 20 mg, this limitation is taught by claim 14.
With regard to claim 82, the reference application discloses the claimed combination of cetirizine and famotidine as a pharmaceutical composition in an oral dosage form as a unit dosage form. See above. With regard to the claimed amount of cetirizine, the reference application discloses the amount of 5 to 20 mg. See claim 14. With regard to the claimed amount of famotidine, the reference application discloses the amount of 10 to 40 mg. See claim 15.
With regard to the limitation of tablets and capsules of claim 83, such limitation is taught by the reference patent as detailed above. This is a provisional nonstatutory double patenting rejection.
Claims 41, 45, 46, 50 and 81-90 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 6, 7, 14, 15 and 18-21 of copending Application No. 18693500 in view of in view of PEPCID® 2001, Prescribing Information, Merck & Co. and US 5096894 (894 patent). All references were previously cited by the Examiner.
As discussed above, the subject matter of claims 41, 45, 46, 50 and 81-83 are rejected as being provisionally rejected on the ground of double patenting over the 18693500 reference application. It is noted that that the reference application does not teach the species of claims 84-90.
However it would have been prima facie obvious to a PHOSITA following the teachings of the reference application to treat subjects in need with H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral dosage forms such as tablets, ODT and/or powders/suspensions are known in the art.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference to treat subjects in need with H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral unit dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation of success.
Regarding claims 84-85 where the oral dosage form further comprises an oral rehydration solution and the limitations of an oral dosage form further comprises sodium and glucose, the reference patent doesn’t claim an oral rehydration solution.
Per claim 84, oral rehydration solutions, comprising electrolytes such as sodium and carbohydrates such as glucose are known. See column 1, lines 11-29 of the 894 patent.
Per claim 85, directed to oral rehydration solutions, these are taught by ‘894 patent and PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; 5-20 mg cetirizine, 10 to 40 mg famotidine; tablet, capsules or packets; further comprising glucose. Tablets, ODTs (orally disintegrating tablets), and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching oral suspensions from powder reconstituted with 46 mL purified H2). Oral rehydration solutions, comprising sodium electrolytes and glucose carbohydrates are known, col. 1, lines 11-29 (‘894 patent). This is a provisional nonstatutory double patenting rejection.
Claims 41, 45, 46, 50 and 81-83 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of copending Application No. 17916535, in view of ZYRTEC® Prescribing Information 2002 (cited on the PTO-892 form) and PEPCID®2001 Prescribing Information, MERCK & Co., Inc., published 2001 (previously cited).
Discussion of claim 41 and its claimed oral dosage unit (capsule or tablet) combination of cetirizine/levocetirizine and famotidine with intended use to treat diarrhea is discussed above and incorporated herein.
Regarding claim 41, the reference application discloses a combination of an H1 and H2 receptor antagonist to a patient. See claim 1. Claim 12 discloses the H1 antagonists, cetirizine (5-20 mg), and the H2 antagonist, famotidine (10-40 mg), as claimed. Regarding claim 41, the reference application discloses oral administration of the combination. See claims 19-21.
While the reference patent discloses the combination of the cetirizine and famotidine are administered orally together in the claimed amounts of the dependent claims, it does not disclose unit dosage, oral dosage form such as tablets as claimed.
However, one of ordinary skill in the art would predictably arrive at these limitations with a reasonable expectation of success as such unit/oral dosage forms such as tablets are known in the art.
Regarding the limitation of an oral unit dose form of cetirizine tablet, ZYRTEC® 2002 teaches tablets of cetirizine. See page 1.
Regarding the limitation of an oral unit dose form of famotidine tablet, PEPCID® 2001 teaches tablets of famotidine. See page 1.
While the reference discloses a subject in need suffering from an acute respiratory distress syndrome or pulmonary distress, and the claimed application’s composition is directed to the intended use of treating diarrhea, the reference application nonetheless discloses the claimed composition, comprising a combination of cetirizine/levocetirizine and famotidine, as claimed, as unit dosage form, such as an oral dosage form like tablets and capsules. A chemical composition and its properties are inseparable. See MPEP 2112.01 II. See footnote 6. Setting aside the intended use of treating diarrhea being different from the reference method of treating respiratory or pulmonary distress, the reference application nonetheless teaches the same composition.
Regarding claim 45 where cetirizine is the compound, claim 46 and the limitation of unit dosage form as an oral dosage form, the reference application teaches cetirizine. See above. Further ZYRTEC® teaches unit dosage forms as an oral dosage form of cetirizine, as tablets. See above.
As required by claim 50 where the oral dosage form comprises a plurality of unit dosage forms, the reference application and ZYRTEC® disclose a unit dosage form as noted above. While not reciting a plurality, such plurality would be obvious to one of ordinary skill in the art to look toward multiple unit dosage forms to be used to treat a patient has irritable bowel syndrome diarrhea.
Regarding claim 81, the reference application discloses cetirizine in the claimed amount, 5-20 mg. See claim 12.
With regard to claim 82, the reference application, PEPCID® and ZYRTEC® disclose the claimed combination of cetirizine and famotidine as a pharmaceutical composition in an oral dosage form as a unit dosage form, in the claimed amounts. See above.
With regard to the limitation of tablets and capsules of claim 83, such limitation is taught by PEPCID® and ZYRTEC®. This is a provisional nonstatutory double patenting rejection.
Claims 41, 45, 46, 50 and 81-90 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of copending Application No. 17916535, in view of ZYRTEC® Prescribing Information 2002 (cited on the PTO-892 form) and PEPCID® 2001 Prescribing Information, MERCK & Co., Inc., published 2001 (previously cited) and US 5096894 (894 patent). All references were previously cited by the Examiner.
As discussed above, the subject matter of claims 41, 45, 46, 50 and 81-83 are rejected as being provisionally rejected on the ground of double patenting over the 17916535 reference application. It is noted that that the reference application does not teach the species of claims 84-90.
However it would have been prima facie obvious to a PHOSITA following the teachings of the reference application to treat subjects in need with H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral dosage forms such as tablets, ODT and/or powders/suspensions are known in the art.
It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference to treat subjects in need with H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral unit dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation of success.
Regarding claims 84-85 where the oral dosage form further comprises an oral rehydration solution and the limitations of an oral dosage form further comprises sodium and glucose, the reference patent doesn’t claim an oral rehydration solution.
Per claim 84, oral rehydration solutions, comprising electrolytes such as sodium and carbohydrates such as glucose are known. See column 1, lines 11-29 of the 894 patent.
Per claim 85, directed to oral rehydration solutions, these are taught by ‘894 patent and PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; 5-20 mg cetirizine, 10 to 40 mg famotidine; tablet, capsules or packets; further comprising glucose. Tablets, ODTs (orally disintegrating tablets), and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching oral suspensions from powder reconstituted with 46 mL purified H2). Oral rehydration solutions, comprising sodium electrolytes and glucose carbohydrates are known, col. 1, lines 11-29 (‘894 patent). This is a provisional nonstatutory double patenting rejection.
Claims 41, 45, 46, 50 and 81-90 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of copending Application No. 19075423.
Discussion of claim 41 and its claimed oral dosage unit (capsule or tablet) combination of cetirizine/levocetirizine and famotidine with intended use to treat diarrhea is discussed above and incorporated herein.
The reference application generally claims a method of treating diarrhea in a patient, comprising: administering cetirizine and famotidine, wherein the cetirizine is administered in a dose of, for example, 2.0-7.0 mg per day and the famotidine is administered in a dose of, for example, 3.0-15.0 mg per day. See claims 1-3 noting various dose ranges. Claims 4-7 and 21-22 indicated treatment of chronic, IBS and acute diarrhea. Claims 8-10 are directed to once daily dosing for at least 2, 7 days and where the patient does not have mastocytic enterocolitis. Claims 11-20 disclose a pharmaceutical composition comprising cetirizine and famotidine, in various doses, i.e. 2.0-7.0 mg cetirizine and 3.0-15.0 mg famotidine; oral and unit dosage forms; tablet or capsules; sodium, glucose and glucose containing saccharide; an oral rehydration solution; plurality of unit dosage forms.
While the conflict application does not teach a claimed composition comprising the various limitations of claims 41, 45, 46, 50 and 81-90, the various limitations of the examined claims are taught in reference application claims 1-22. It would have been prima facie obvious to a PHOSITA following the teachings of the primary reference patent to treat form H1 receptor antagonists and an H2 receptor antagonist, famotidine, as oral dosage forms such as tablets, ODT and/or powders/suspensions are known in the art, providing a reasonable expectation of success. This is a provisional double patenting rejection.
Conclusion and Correspondence
In summary, no claims are allowed. THIS ACTION IS MADE FINAL. 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 WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 This application is a continuation of USSN 16/029,384, filed 07/06/2018 issued as US PAT 11058681; USSN 16/029,384 is a continuation of USSN 15/257,674 filed on 09/06/2016, issued as US PAT 10034875; USSN 15/257,674 claims priority to App. No. 14209937, filed on 03/13/2014 which has issued as US Patent 9717726, which claims earliest priority to 61/782,608 filed 03/14/2013.
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3 MPEP 2112.01 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
“Products of identical chemical composition can not 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. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”).
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