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 Status
Claims 1-18 are pending.
Claims 1-18 have been examined.
Claims 1-18 are rejected.
Drawings
The drawings filed on 06/14/2024 are objected to because
The titles of the graphs are missing from Figures 1-7. Additionally, each figure must be presented on a separate sheet.
FIG. 4 – The font size should be increased to improve legibility. The plotted lines are nearly overlapping and difficult to distinguish. It is suggested that one of the lines be depicted as a dashed line or otherwise differentiated to improve visual distinction. The overall clarity should be improved using FIG. 2 as a reference.
FIG. 5 – The two plotted data series identified by circular symbols are difficult to distinguish in the grayscale reproduction. It is suggested that the figure adopt a style similar to that in FIG. 2 to improve clarity. The font size should also be increased to enhance legibility.
FIG. 6 – The overall font size should be increased to improve readability. The symbol used for the plotted data should be changed to different shapes rather than a filled circles, as the current symbols are difficult to distinguish in grayscale. FIG. 2 may be used as a reference for an acceptable presentation.
FIG. 7 – The plotted data symbols should be changed to different shapes rather than all filled circles to improve visual distinction and ease of interpretation. FIG. 2 may be used as a reference for an acceptable presentation.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Priority
Acknowledgment is made of Applicant's claim that the present application is a continuation of U.S. Application No.18/051,283, filed 10/31/2022, which claims the benefit of priority to U.S. Provisional Application No. 63/274,350, filed 11/01/2021.
Information Disclosure Statement
[1] The information disclosure statement (IDS) submitted on 12/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
[2] The information disclosure statement filed on 09/09/2024 (a) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the cited non-patent literature document, PCT/US2022/048482, is not of record in the application. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
[3] The information disclosure statement filed on 09/09/2024 (b) fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the cited non-patent literature documents identified as items (A)–(Z) have not been made of record. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claim 10 is objected to as follows:
The phrase “present in amount” should be amended to “present in an amount.”
Claim Rejections - 35 USC § 112(b)
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.
[4] Claim 5 is 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 claim recites the term “easy” in the limitation “wherein the formulation is packaged in an easy open container.” The term “easy” is a relative term that lacks a clear and objective boundary. The term is not defined in the claims, and the specification does not provide an objective standard for determining the scope of the limitation.
Accordingly, a person of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the claimed invention. The claim fails to specify what characteristics or criteria render a container “easy open,” thereby leaving unclear which packaging configurations fall within the scope of the claim. Therefore, the claim is indefinite.
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.
[5] Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Merello et al. (‘Merello”) (US9198897B2, published 12/01/2015), in view of Murrin (British Journal of Anaesthesia, Volume 45, Issue 5, Pages 475-480, published 05/01/1973), further in view of Mubaslat et al. (“Mubaslat”) (Psychopharmacology (2020) 237:2905–2915, published 09/02/2020), further in view of Lubrizol (Lubrizol Life Science, published 2020), and further in view of 21 CFR 101.80 (Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries, published 01/01/2021), as evidenced by Bausch & Lomb Incorporated (Atropine Sulfate Ophthalmic Ointment, 1% (Sterile), published 04/2020), as further evidenced by Om et al. (“Om”) (Inventi Rapid: Pharm Tech Vol. 2016, Issue 1, published 11/16/2015), and as further evidenced by FDA (High-Intensity Sweeteners, published 05/19/2014).
In regard to claims 1, 7, 9-10, 13 and 15-16, Merello teaches compositions and, importantly, methods for decreasing saliva production in individuals. In particular, Merello teaches compositions useful for the treatment of sialorrhea and a method for decreasing saliva production in an individual in need thereof by intra-orally administering to the individual an effective amount of a composition comprising tropicamide as an active ingredient and, optionally, an excipient, whereby saliva production in the individual is decreased (see, Title; Field of the Invention; claims 1, 9, and 19). Merello further teaches that tropicamide is an anti-cholinergic agent and identifies preferred anti-cholinergic agents useful in the disclosed methods and compositions as tertiary and quaternary amine anti-cholinergic agents, including atropine, salts thereof, and combinations thereof (see, column 5, paragraph 3). Merello additionally teaches that suitable excipients include anionic polymer, including Carbopol® (see, column 5, paragraph 3; claims 2 and 14; columns 17-18). Merello further teaches a method wherein the active ingredient is present in the composition in an amount ranging from 0.01 to 200 milligrams, inclusive (see, claim 16). Merello further teaches that the composition may be provided in a dosage form selected from the group consisting of an oral spray, oral drop solution, film, candy composition, gum, buccal patch, lingual tablet, sublingual tablet, and fast-dissolving tablet (see, claims 4). However, Merello does not explicitly teach atropine sulfate monohydrate in an amount of 0.01-1 wt.%, Carbopol® 974P (carbomer) in an amount of 0.5-5 wt.%, or a gel formulation.
Murrin teaches administration of atropine sulfate intramuscularly and orally in nine healthy adult subjects to evaluate salivary secretion suppression. For oral administration, atropine sulfate is provided as an aqueous solution prepared by diluting an injectable ampoules formulation with distilled water to a concentration of approximately 0.1 mg/mL (approximately 0.1 wt.%). Murrin reports salivary suppression five hours post oral dosing ranging from approximately 3% to 21%, depending on dosage, as summarized in Table V. Thus, Murrin teaches oral administration of approximately 0.1 wt.% atropine sulfate for reducing salivary secretion.
Mubaslat teaches the sublingual administration of commercially available atropine sulfate 1% ophthalmic drops for the treatment of clozapine-induced hypersalivation (CIH), identifying the product as Bausch & Lomb Australia Pty Ltd. atropine sulfate 1% eye drops. The Bausch & Lomb product insert identifies atropine sulfate monohydrate as the active ingredient in the disclosed formulation. Accordingly, the evidence of record establishes that the atropine sulfate 1% ophthalmic formulation used in Mubaslat contains atropine sulfate monohydrate. Mubaslat further acknowledges, based on a review of the literature, that atropine has shown promise for the treatment of sialorrhea in additional patient populations, including palliative care and Parkinson’s disease patients. This is consistent with Merello, which teaches that prior investigators utilized commercially available drug products intended for unrelated indications for the treatment of sialorrhea. Merello therefore evidences that existing pharmaceutical formulations developed for different therapeutic applications were nonetheless considered relevant and applicable in the context of treating sialorrhea (see, Background of the Invention).
Lubrizol teaches that Carbopol® polymers are a product brand name of the Lubrizol Corporation, while “carbomer” is the generic pharmacopeial name for a class of high-molecular-weight crosslinked acrylic acid polymers. Lubrizol further teaches that Carbopol® polymers have been successfully formulated into a variety of commercial oral dosage forms, including swallowable (peroral), chewable, buccal, and sublingual tablets. Lubrizol teaches that Carbopol® polymers provide formulation flexibility and controlled-release properties and may be used with a variety of active pharmaceutical ingredients and excipients. Lubrizol further teaches that selection of a particular Carbopol® grade and concentration is formulation dependent and may be based on factors such as drug properties, co-excipients, processing parameters, manufacturing considerations, and desired formulation performance. Lubrizol teaches that Carbopol® 974P is one suitable member of the Carbopol® polymer family and identifies typical polymer levels for Carbopol® 974P of about 3% to 25%. Om evidences that Carbopol® 974P polymer can be used to formulate lotions, creams, gels, bioadhesives, and oral liquids/semisolids (see, Table 4). Om further evidences representative usage levels for Carbopol® 974P in pharmaceutical formulations including 0.1 - 1.0 wt.%.
Accordingly, the evidence demonstrates that Carbopol® 974P is a known, commercially available member of the broader carbomer polymer class and that selection of a particular carbomer grade and concentration was recognized in the art, prior to the instant effective filing date, as formulation dependent. Therefore, to the extent Merello teaches the use of a carbomer or Carbopol® polymer in an oral pharmaceutical composition, selection of Carbopol® 974P and an appropriate concentration within the ranges taught by the art would have been a routine matter of formulation choice and optimization for a person of ordinary skill in the art prior to the instant effective filing date (see, MPEP §2144.04 and §2144.05).
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to modify the anti-sialorrhea composition and method of Merello with the atropine sulfate teaching of Murrin and Mubaslat and the Carbopol® 974P of Lubrizol and Om to arrive at the claimed composition.
Merello teaches oral compositions and methods for reducing saliva production using anti-cholinergic agents, including atropine and salts thereof, and further teaches the use of Carbopol® polymers as excipients. Murrin teaches that orally administered atropine sulfate at approximately 0.1 wt.% suppresses salivary secretion, while Mubaslat teaches the use of atropine sulfate monohydrate containing ophthalmic drops for treating hypersalivation, evidencing that known atropine sulfate formulations were suitable for reducing salivary secretion.
Lubrizol teaches that Carbopol® 974P is a commercially available member of the Carbopol® family suitable for oral dosage forms and that selection of a particular carbomer grade and concentration depends on formulation requirements. Om further teaches the use of Carbopol® 974P in gels and oral semisolid formulations.
Accordingly, one of ordinary skill in the art, prior to the instant effective filing date, would have been motivated to select atropine sulfate monohydrate as a known atropine sulfate effective for reducing salivary secretion and to select Carbopol® 974P at an appropriate concentration to formulate a gel dosage form, with such selections representing routine formulation optimization yielding predictable results (see, MPEP §2144.04 and 2144.05).
In regard to claims 2 and 3, Merello teaches various intra-orally administrable dosage forms, including candy compositions designed to facilitate administration of therapeutic agents to children and other individuals who may experience difficulties with other forms of drug delivery. The candy compositions comprise an anticholinergic agent and may optionally include one or more excipients, including a sweetener (see, column 13). While Merello does not explicitly teach xylitol, erythritol, sorbitol, mannitol or maltitol as the sweetener, Merello recognizes the optional inclusion of sweeteners in the claimed candy dosage forms.
21 CFR § 101.80 teaches that eligible noncariogenic carbohydrate sweeteners include sugar alcohols such as xylitol, sorbitol, mannitol, maltitol, isomalt, lactitol, hydrogenated starch hydrolysates, hydrogenated glucose syrups, and erythritol, and combination thereof (see, section 2 (ii)). The FDA further teaches that sugar alcohols, including sorbitol, xylitol, lactitol, mannitol, erythritol, and maltitol are commonly used as sugar substitutes and do not promote tooth decay.
It would have been obvious to one of ordinary skill in the art, prior to the instant effective filing date, to select one or more of the known noncariogenic sweeteners taught by 21 CFR § 101.80 and FDA guidance for use in Merello’s composition. The motivation for incorporating such known noncariogenic sweeteners into Merello’s compositions would have been to provide sweetness while reducing the cariogenic effects associated with conventional sugars, thereby improving the suitability of the dosage form for oral administration.
The substitution of a known sweetener with another known sweetener performing the same function constitutes no more than the predictable use of prior art elements according to their established functions (see, MPEP §2143 (I)(B)). Furthermore, where the prior art provides a finite number of identified, predictable solutions, the selection of one such known noncariogenic sweetener from among the recognized sugar alcohol sweeteners would have been a matter of routine optimization and ordinary skill in the art (see, MPEP §2143).
In regard to claims 4, 11, and 17, Merello also teaches dissolution rates and a dissolution time of up to approximately two hours (e.g., about 7,200 seconds) (see, column 15).
In regard to claim 5, Merello teaches packaging and container systems for the disclosed intra-orally administrable anti-cholinergic compositions, including blister packages, pouches, individual foil wrappers, and similar packaging formats. The reference emphasizes packaging that is easy to open, particularly for elderly or disabled individuals who may have limited hand strength or coordination, as well as packaging that is discreet, thereby allowing use of the medicament in social settings without drawing attention to treatment for drooling (see, columns 19-20).
In regard to claim 6, Merello teaches that compositions comprising an anti-cholinergic agent may optionally include one or more excipients to provide desirable features to the compositions (see, column 5, paragraph 3). Suitable excipients include pharmaceutically acceptable buffering agent, a plasticizing agent, a muco-adhesive agent, a stabilizing agent, a taste-masking agent, a flavoring agent, a breath freshening agent, a coloring agent, an antiseptic agent, an inert filler agent, a preserving agent, nonionic polymer, anionic polymer, softening agent, swelling agent, chelating agent, foaming agent, and combinations thereof (see, column 5, paragraph 3; claims 2 and 14).
In regard to claims 8 and 14, Merello further teaches a method wherein the individual is a patient suffering from a condition selected from Parkinson's Disease, cerebral palsy, stroke, motor neuron disease, and other disorders associated with excessive drooling (see, claim 20).
In regard to claim 12 and 18, Merello teaches that control over the onset and duration of the saliva-decreasing effect is an important consideration for patients seeking treatment for drooling. Merello further teaches that the method may administered on a regular schedule once, twice, three times, or more per day, including between and after meals, or alternatively on an as needed basis (see, column 12). An administration schedule of every six hours corresponds to four administration per day and therefore falls within Merello’s disclosure of administration “three times, or more per day.” Moreover, Merello recognizes that administration frequency affects the desired therapeutic outcome by explicitly teaching the importance of controlling the onset and duration of the saliva decreasing effect. Accordingly, selection of a particular administration interval, including administration every six hours, would have been no more than routine optimization of a known result-effective variable and would have been within the ordinary skill in the art (see, MPEP §2144.05).
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.
[6] Claims 1, 4, and 6-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 7-10, and 14-16 of U.S. Patent No. US12048763B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Claims 1-3 of the reference application, when considered in combination, are not patentably distinct from instant claim 1. Claim 5 is not patentably distinct from instant claim 4. Claim 7 is not patentably distinct from instant claim 6. Claim 8 is not patentably distinct from instant claims 7 and 9, when considered in combination. Claim 10 is not patentably distinct from instant claims 8 or 14. Claim 14 is not patentably distinct from instant claims 9-10 or 15-16, when considered in combination. Claim 15 is not patentably distinct from instant claims 11 or 17. Claim 16 is not patentably distinct from instant claims 12 or 18. Claim 9 is not patentably distinct from instant claim 13.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALI M ALAOUIE whose telephone number is 571-272-0844. The examiner can normally be reached Flextime: (M-TH) 7:30 am 6:30 pm.
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/ALI M. ALAOUIE/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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