DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims contain the abbreviation “API” without first providing a definition. It is not clear the meaning of abbreviation, therefore the claims are indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-9, 12, 13, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryoo et al. (US Patent Pub. 2010/0112050, disclosed by applicant).
Ryoo et al. disclose oral dosage forms as a biodegradable, water soluble film for delivering pharmaceutically active agents, particularly antimigraine agents to patients through insertion into the mouth of the patient (ABSTRACT). Ryoo et al. disclose a method of treating migraine headaches with triptans, which include sumatripan, zolmitriptan, and naratriptan ({0011]). Ryoo et al. disclose the film comprises sodium alginate at a concentration from about 5% to about 95% and water ([0022], Examples). Ryoo et al. disclose treating symptoms of migraines which include nausea and vomiting ([0018]). Ryoo et al. disclose treatment with chemotherapeutics, which would meet the limitation of treatment for cancer of instant claim 17 ([0049). Ryoo et al. disclose the film is formed by mixing the active agent with a solution of non-toxic acid such as phosphoric acid ([0019]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryoo et al. (US Patent Pub. 2010/0112050) in view of Huebinette et al. (WO 2007073346, disclosed by applicant).
Ryoo et al. is discussed above and differs from the instant claims insofar as they do not disclose the alginate salts of instant claims 5 and 6.
Huebinette et al. disclose a film comprising alginate salt of monovalent cation comprising from 25 to 35% by weight of β–D mannuronate and 65 to 75% by weight of α–D guluronate with a molecular weight of from 30,000 g/mol to 90,000 g/mol (reference claims 3-5).
It is prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, MPEP 2144.07. Therefore, it would have been obvious to have used the claimed alginate salt, since they are known for film formulations.
Claims 8-11, 14, 15 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ryoo et al. (US Patent Pub. 2010/0112050, disclosed by applicant) in view of Myers et al. (US Patent Pub. 2014/0271788, disclosed by applicant).
Ryoo et al. disclose oral dosage forms as a biodegradable, water soluble film for delivering pharmaceutically active agents, particularly antimigraine agents to patients through insertion into the mouth of the patient (ABSTRACT). Ryoo et al. disclose a method of treating migraine headaches with triptans, which include sumatripan, zolmitriptan, and naratriptan ({0011]). Ryoo et al. disclose the film comprises sodium alginate at a concentration from about 5% to about 95% and water ([0022], Examples). Ryoo et al. disclose treating symptoms of migraines which include nausea and vomiting ([0018]). Ryoo et al. disclose treatment with chemotherapeutics, which would meet the limitation of treatment for cancer of instant claim 22 ([0049). Ryoo et al. disclose the film is formed by mixing the active agent with a solution of non-toxic acid such as phosphoric acid ([0019]). Ryoo et al. disclose forming an aqueous solution comprising mixing sodium alginate, active ingredient, plasticizers and pharmaceutically acceptable additives, flavoring agents, adjuvants. The mixture is then cast into films by coating and drying generally using a coating and casting machine. Generally drying can take place at from about 60° to 80° C. The oral usage dosage film has a thickness of from about 0.1 mm to about 5 mm ([0042])
Ryoo et al is discussed above and differs from the instant claims insofar as they do not disclose the buffering component and acidifying agent of instant claim 10.
Myers et al. disclose film dosage compositions for treating pain (Abstract and [0006]). Myers et al. disclose the polymer included in the films include sodium alginate ([0033]). Myers et al. disclose the compositions comprise plasticizers such as glycerol and sorbitol at a concentration of about 0.5 to about 30% ([0056]). Myers et al. disclose the composition includes at least one buffer so as to control the local pH of the film to a pH of about 2 to about 4, including disodium phosphate, phosphoric acid and combinations thereof ([0087]).
It is prima facie obviousness to select a known material based on its suitability for its intended use. Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function. See, MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art to have used the buffering agent, sodium dihydrogen phosphate and phosphoric acid and plasticizers sorbitol of glycerol, since they are known for oral film formulations.
In regard to the amount of buffering component, i.e. sodium dihydrogen phosphate, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05. Myers et al. disclose the amount of buffering component as a “result effective” variable, since they control the local pH of the film ([0087]). Therefore, it would be obvious to have varied the amount of buffering agent within the composition motivated by the desire to achieve the desired effect, i.e. control the local pH of the film.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,007,144. Although the claims at issue are not identical, they are not patentably distinct from each other because in both instances the claims are directed to a film suitable for administration to an oral cavity comprising; (i) an alginate salt of a monovalent cation or a mixture of alginate salts containing at least one alginate salt of a monovalent cation; and (ii) a triptan or a pharmaceutically acceptable salt thereof.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,285,521. Although the claims at issue are not identical, they are not patentably distinct from each other because in both instances the claims are directed to a film suitable for administration to an oral cavity comprising; (i) an alginate salt of a monovalent cation or a mixture of alginate salts containing at least one alginate salt of a monovalent cation; and (ii) a triptan or a pharmaceutically acceptable salt thereof.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NANNETTE HOLLOMAN whose telephone number is (571)270-5231. The examiner can normally be reached Monday-Friday 9am-6pm.
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, Sahana S. Kaup can be reached at 571-272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NANNETTE HOLLOMAN/Primary Examiner, Art Unit 1612
Prosecution Insights