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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 12-15-2025 has been entered.
Response to Arguments
Applicant’s cancelation of claim 49 and statements regarding claim 85 has have overcome their rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite. The rejection of claims 49 and 85 are withdrawn.
Applicant’s arguments, with respect to the rejection of claim(s) 41, 45, 46, 48-50 and 81-85 for obviousness type double patenting over US Pats. 9,717,726; 10,034,875; 11,058,681; and 11,419,868, and Application Nos. 18/693,500 and 17/916,535 have been fully considered, necessitating new rejections as detailed below. New ground(s) of rejection is/are made over now pending claims 41, 45, 46, 48, 50 and 81-90 below.
The Attorney response argues that the pending obviousness type double patent rejections are prohibited under the safe harbor provisions of 35 U.S.C. 121 because the claims of the present application were filed after a Restriction Requirement made between the claimed product and methods of treatment of diarrhea inpatients without mastocytic enterocolitis (US Pats. 9,717,726; 10,034,875; 11,058,681) and after Restriction Requirement of claimed product and methods of treating diarrhea for US 11,419,868. The Attorney response argues that product claims were canceled in 15257674 and 16513342, and later filed in the present application.
The Attorney response since the present product claims were subject to Restriction previously, canceled for examination and allowance of method claims, and under examination here, a double patenting rejections of the product claims are prohibited.
The Attorney response states per MPEP 804(I)(B)(1)(b)(i), any remaining provisional obviousness type double patent rejections should be withdrawn if they are only remaining rejections.
In response, 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.
With regard to the Attorney response to rebut the double patenting rejections under the safe-harbor provisions, it is pointed the examined claims are a continuation and NOT a divisional of the conflict reference patents, as confirmed by the claim to Domestic Priority on the Filing Receipt dated Nov 8 2021.
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Note that US 11,419,868 is not in the domestic priority chain of the examined application, where the pending application can claim status as a divisional thereof. See US Application data of the US 11419868.2
The pending application is not a divisional of any of the conflict patents that are the basis of the ODP rejections detailed below, and therefore the safe-harbor provisions of 35 USC 121 do not apply here.
Information Disclosure Statements
At this time, an IDS has not been filed by applicant.
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 are 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 a pharmaceutical composition, with the intended use to treat diarrhea, comprising cetirizine, levocetirizine or mixtures thereof, and famotidine, wherein the pharmaceutical composition is an oral dosage form, and the oral dosage form comprises at least one tablet or capsule.
Regarding the examined claims, 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, and the patient has chemotherapy induced diarrhea. See claim 9.
Regarding the limitation of a capsule or a tablet and the limitation 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 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 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. The reference patent teaches “cetirizine, levocetirizine or mixtures thereof and the famotidine are administered together as a unit dosage form.” See claim 16. See also claim 17 teaching a unit dosage form.
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, that comprise sodium and glucose are known in the art.
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, this limitation is taught by 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 claimed amounts of cetirizine and famotidine are recited in claims 14-15 and 19-20. The claimed limitation of an 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.
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.
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, 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, oral rehydration solutions are known in the art as per the ‘894 patent, and where oral liquid formulations of famotidine are known, PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; an amount of cetirizine 5 to 20 mg, 10 to 40 mg amount of famotidine; tablet or capsules or packets; further comprising glucose. Tablets, ODTs, and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching powders to be reconstituted into oral suspensions (powder constituted with 46 mL of purified water). 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.
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 1-17 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 limitation of a capsule or a tablet and the limitation 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.
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. 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, that comprise sodium and glucose are known in the art.
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, 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.
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.
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 well known in the art. See column 1, lines 11-29 of the 894 patent.
Per claim 85, oral rehydration solutions are known in the art as per the ‘894 patent, and where oral liquid formulations of famotidine are known, PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; an amount of cetirizine 5 to 20 mg, 10 to 40 mg amount of famotidine; tablet or capsules or packets; further comprising glucose. Tablets, ODTs, and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching powders to be reconstituted into oral suspensions (powder constituted with 46 mL of purified water). 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.
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; an amount of cetirizine 5 to 20 mg, 10 to 40 mg amount of famotidine; tablet or capsules or packets; further comprising glucose. Tablets, ODTs, and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching powders to be reconstituted into oral suspensions (powder constituted with 46 mL of purified water). 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. See also where the reference patent discloses this oral rehydration solution. See claim 12.
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 1-15 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 well 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 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.
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. 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 in the art.
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.
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.
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, 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, oral rehydration solutions are known in the art as per the ‘894 patent, and where oral liquid formulations of famotidine are known, PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; an amount of cetirizine 5 to 20 mg, 10 to 40 mg amount of famotidine; tablet or capsules or packets; further comprising glucose. Tablets, ODTs, and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching powders to be reconstituted into oral suspensions (powder constituted with 46 mL of purified water). 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.
Claims 41, 45, 46, 50 and 81-83 is/are 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 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 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 and the limitation of 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 are 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.
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 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, oral rehydration solutions are known in the art as per the ‘894 patent, and where oral liquid formulations of famotidine are known, PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; an amount of cetirizine 5 to 20 mg, 10 to 40 mg amount of famotidine; tablet or capsules or packets; further comprising glucose. Tablets, ODTs, and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching powders to be reconstituted into oral suspensions (powder constituted with 46 mL of purified water). 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. This is a provisional nonstatutory double patenting rejection.
Claims 41, 45, 46, 50 and 81-83 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).
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.
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 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, oral rehydration solutions are known in the art as per the ‘894 patent, and where oral liquid formulations of famotidine are known, PEPCID® 2001. See above.
Claims 86-90 are directed to oral dosage forms of packets, suspensions; an amount of cetirizine 5 to 20 mg, 10 to 40 mg amount of famotidine; tablet or capsules or packets; further comprising glucose. Tablets, ODTs, and oral suspensions are taught by PEPCID® 2001, page 1. See also page 9 of PEPCID® 2001 teaching powders to be reconstituted into oral suspensions (powder constituted with 46 mL of purified water). 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. This is a provisional nonstatutory double patenting rejection.
Claims 41, 45, 46, 50 and 81-90 are 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.
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.
This is a provisional double patenting rejection.
Conclusion and Correspondence
In summary, no claims are allowed. 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 be reached M-F.
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, 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
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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.”).