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 .
Priority
The instant application claims foreign priority to GB2200539.1 filed 01/18/2022. The instant application is a 371 of PCT/IB2023/050355 filed 01/16/2023.
Information Disclosure Statement
The information disclosure statement (IDS) dated 07/17/2024 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Claim Objections
Claims 2 and 3 are objected to because of the following informalities: improper capitalization. Appropriate correction is required.
Claim Rejections - 35 USC § 112b Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-8 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.
With regards to claim 1, claim 1 recites “wherein the formulation is free of buffer”, the term buffer is to the best of Examiner’s understanding not defined in the specification. The claims and specification do not recite “buffering agents” to the best of the Examiner’s understanding but the term “buffer”. It is presently unclear what constitutes “buffer”. Is a buffer anything that changes or alters the pH of the composition, is it a specific list of salts, is it any compound with a pH outside of a specific range, is it any acid or base. In some cases, even water can be considered a buffer or a pH adjuster as it can be added to change a composition to a neutral pH. Claims 2-7 depend on claim 1 and are therefore also indefinite. Presently, for the purpose of compact prosecution and to provide applicable prior art the Examiner is interpreting “buffer” to be any compound labeled as a “buffer” or “buffering agent” within the individual prior art. As an example, one prior art may use sodium chloride specifically as a buffering agent while another uses sodium chloride specifically as a flavor enhancer; the prior art where it is labeled as a buffer will consider it a buffer and the prior art where the same compound is used specifically for flavor would consider it not a buffer.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation “triglycerides”, and the claim also recites “triolein, trilaurin, tricaprin, tricaprylin” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 (i.e., changing from AIA to pre-AIA ) 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
A) Claims 1, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Mehta et al (US Patent Application Publication 20190015389A1 as provided in the Applicant’s IDS filed 07/17/2024).
Mehta recites a liquid formulation with clonidine hydrochloride, propylparaben, methylparaben, citric acid, and sucrose in water. See Table at paragraph [0102] below;
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B) Claims 1, 4 and 6-7 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
Liu Hongfei (Hongfei, 2021 as provided in Applicant’s IDS filed 07/17/2024) recites a liquid formulation with clonidine hydrochloride, polyparaben, and sucrose in water. See Table 2 reproduced below;
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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 (i.e., changing from AIA to pre-AIA ) 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.
a) Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Mehta et al (US Patent Application Publication 20190015389A1 as provided in the Applicant’s IDS filed 07/17/2024).
Mehta recites a liquid formulation with clonidine hydrochloride, propylparaben and sucrose in water. See Table at paragraph [0102] below;
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Mehta teaches that useful preservatives include, but are not limited to, sodium benzoate, benzoic acid, potassium sorbate, salts of edetate (also known as salts of ethylenediaminetetraacetic acid, or EDTA, such as disodium EDTA), parabens (e.g., methyl, ethyl, propyl or butyl-hydroxybenzoates, etc.), and sorbic acid. Amongst useful preservatives include chelating agents some of which are listed above and other chelating agents, e.g., nitrilotriacetic acid (NTA); ethylenediaminetetracetic acid (EDTA), hydroxyethylethylenediaminetriacetic acid (HEDTA), diethylenetriaminepentaacetic acid (DPTA), 1,2-Diaminopropanetetraacetic acid (1,2-PDTA); 1,3-Diaminopropanetetraacetic acid (1,3-PDTA); 2,2-ethylenedioxybis[ethyliminodi(acetic acid)] (EGTA); 1,10-bis(2-pyridylmethyl)-1,4,7,10-tetraazadecane (BPTETA); ethylenediamine (EDAMINE); Trans-1,2-diaminocyclohexane-N,N,N′,N′-tetraacetic acid (CDTA); ethylenediamine-N,N′-diacetate (EDDA); phenazine methosulphate (PMS); 2,6-Dichloro-indophenol (DCPIP); Bis(carboxymethyl)diaza-18-crown-6 (CROWN); porphine; chlorophyll; dimercaprol (2,3-Dimercapto-1-propanol); citric acid; tartaric acid; fumaric acid; malic acid; and salts thereof (Mehta at [0072]). Mehta teaches that the artificial sweeteners [e.g., sucralose, acesulfame K, and dipeptide based sweeteners] are used in amounts of about 0.005 to about 5.0% and most preferably about 0.01 to about 2.5% by weight per volume of the final liquid composition (Mehta at [0074]). Mehta teaches the use of sorbitol, xylitol and mannitol (Mehta at [0073]). Mehta teaches the use of water (Mehta at [0071]). Mehta teaches a 0.2mg dose of clonidine (Mehta at [0107], [0011], [0017], Figure 2]). Mehta teaches that the amount of clonidine that can be loaded onto a resin will typically range from about 0.5% to about 50% by weight of the clonidine-ion exchange resin particles, or about 0.75% to about 1% by weight of the clonidine-ion exchange resin particles. A skilled artisan with limited experimentation can determine the optimum loading for any drug resin complex. In one embodiment, loading of about 10% to about 40% by weight, more desirably, about 15% to about 30% by weight, of the drug-ion exchange resin particles can be employed. Typical loadings of about 25% by weight of the drug-ion exchange resin particles can be advantageously employed (Mehta at [0043]).
Mehta is discussed in the Anticipation Rejection supra. The teachings of Mehta differ from the instant claims in this rejection insofar as it does not teach the combination of the of the instantly recited components with sufficient specificity for anticipation. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Mehta to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1, Mehta recites a liquid formulation with clonidine hydrochloride, propylparaben and sucrose in water (Mehta at [0102]).
Regarding instant claim 2, Mehta teaches that useful preservatives include, but are not limited to, sodium benzoate, benzoic acid, potassium sorbate, salts of edetate (also known as salts of ethylenediaminetetraacetic acid, or EDTA, such as disodium EDTA), parabens (e.g., methyl, ethyl, propyl or butyl-hydroxybenzoates, etc.), and sorbic acid (Mehta at [0072]).
Regarding instant claim 3, Mehta teaches that the artificial sweeteners [e.g., sucralose, acesulfame K, and dipeptide based sweeteners] are used in amounts of about 0.005 to about 5.0% and most preferably about 0.01 to about 2.5% by weight per volume of the final liquid composition (Mehta at [0074]).
Regarding instant claim 4, Mehta teaches the use of sorbitol, xylitol and mannitol (Mehta at [0073]). Mehta teaches the use of water (Mehta at [0071]).
Regarding instant claim 5, Mehta teaches that the amount of clonidine that can be loaded onto a resin will typically range from about 0.5% to about 50% by weight of the clonidine-ion exchange resin particles, or about 0.75% to about 1% by weight of the clonidine-ion exchange resin particles. A skilled artisan with limited experimentation can determine the optimum loading for any drug resin complex. In one embodiment, loading of about 10% to about 40% by weight, more desirably, about 15% to about 30% by weight, of the drug-ion exchange resin particles can be employed. Typical loadings of about 25% by weight of the drug-ion exchange resin particles can be advantageously employed (Mehta at [0043]). Mehta further teaches a 0.2mg dose of clonidine (Mehta at [0107], [0011], [0017], Figure 2]), which overlaps the instantly claimed range of 1 to 100 mg /5mL. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 6, Mehta recites a liquid formulation with clonidine hydrochloride, propylparaben, methylparaben, citric acid and sucrose in water (Mehta at [0102]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 7, Mehta teaches that the artificial sweeteners [e.g., sucralose, acesulfame K, and dipeptide based sweeteners] are used in amounts of about 0.005 to about 5.0% and most preferably about 0.01 to about 2.5% by weight per volume of the final liquid composition (Mehta at [0074]), which overlaps with the instantly claimed range of 1 to 100mg/5mL. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 8, Mehta teaches the use of mixing, heating, and diluting with water to produce an oral suspension (Mehta at [0103]). Mehta further teaches the use of clonidine hydrochloride (Metha at whole document), parabens (e.g., methyl, ethyl, propyl or butyl-hydroxybenzoates, etc.) (Mehta at [0072]), sucralose (Mehta at [0074]) and water (Mehta at [0103]). It would have been prima facie obvious to one of ordinary skill in the art to have used the materials of Mehta and the method of Mehta to produce the reasonable outcome of a clonidine oral suspension. There would be a reasonable expectation of success because Mehta teaches the materials and methods of creating a clonidine oral suspension. See MPEP 2144.07. See MPEP 2144.06.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
I) Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/865,731 in view of Mehta et al (US Patent Application Publication 20190015389A1 as provided in the Applicant’s IDS filed 07/17/2024).
The instant invention recites “A liquid pharmaceutical formulation of clonidine hydrochloride comprising clonidine hydrochloride, preservative, sweetener and a vehicle, wherein the formulation is free of buffer”. The reference application is not a case of statutory double patenting because it requires the composition to be in the form of a solid in the independent claim.
The reference application recites a solid pharmaceutical composition suitable for sublingual administration comprising clonidine or pharmaceutically acceptable salts thereof, at least one disintegrant, and at least one diluent (‘731 at claim 1). The reference application recites wherein clonidine or pharmaceutically acceptable salts thereof are present in the range from about 0.005 %w/w to about 0.2 %w/w, preferably in the range from about 0.001%w/w to about 0.15 %w/w (‘731 at claim 2). The reference application recites wherein the disintegrant is selected from alginic acid, carbon dioxide, carboxymethylcellulose calcium, carboxymethylcellulose Sodium, croscarmellose sodium, guar gum, methylcellulose, polacrilin potassium, poloxamer, Sodium alginate and sodium starch glycolate or combination thereof (‘731 at claim 3). The reference application recites wherein the disintegrant is sodium starch glycolate present in the range of about 0.5 %w/w to about 10 %w/w,preferably in the range from about 1 %w/w to about 7.5 %w/w (‘731 at claim 4). The reference application recites wherein the diluent is selected from microcrystalline cellulose, dextrates, dextrose, fructose, mannitol, Sorbitol, starch, pregelatinized starch, Sucrose, Xylitol, maltose, maltodextrin, maltitol and combinations thereof (‘731 at claim 5). The reference application recites wherein the diluent is mannitol present in the range from about 30 %w/w to about 99 %w/w, preferably from about 75 %w/w to about 95 %w/w (‘731 at claim 6). The reference application recites further comprising at least one pharmaceutically acceptable excipient selected from sweetener, flavouring agent,binder, glidants, and lubricants (‘731 at claim 7). The reference application recites further comprising povidone K30, orange flavor, acesulfame potassium, talc, and magnesium stearate (‘731 at claim 8). The reference application recites the solid pharmaceutical composition according to claim 1 is for treatment of all grades of essential and secondary hypertension, prophylactic management of migraine or recurrent vascular headache, and management of vasomotor conditions associated with menopause and characterised by flushing (‘731 at claim 9).
The reference application differs from the instant application insofar as it does not teach a liquid composition. The teachings of Mehta cure this deficit.
The teachings of Mehta are discussed above. Mehta further teaches solid compositions. Mehta teaches a common clonidine hydrochloride dosage that is produced in both liquid and solid forms in order to provide different dosage releases overtime to the patient.
One of ordinary skill in the art with the teachings of Mehta would be able to provide solid and liquid formulations of clonidine to optimize the dosage treatment overtime for the patients’ specific needs. See MPEP 2144 (II). One would be motivated to provide a liquid version of a pharmaceutical for patients who have swallowing difficulties or are unable to take pills.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are presently allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA MICHELLE PETRITSCH whose telephone number is (571)272-6812. The examiner can normally be reached M-F 08:30-17:00 EST ALT Fridays.
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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.
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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