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 .
DETAILED ACTION
Claims 1–34 are pending and under examination.
Priority
The instant application is a continuation of 18/047,960 filed on 10/19/2022.
Information Disclosure Statement
The information disclosure statements filed on 4/11/2024 and 10/23/2024 have been considered by the examiner.
Claim Objections
Claim 6 is objected to for not having “further” before “comprises rice bran”.
Claim 17 is objected to for being a repeat claim of claim 7. Applicant may delete claim 7 or claim 17.
Claim 19 is objected to for not having “further” before “includes a sugar, an edible oil, and rice bran”.
Claims 30-34 is objected to for being repeat claims of claims 10-14. Applicant may delete claims 10-14 or delete claims 30-34.
Appropriate corrections are required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 22-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition of products of nature without significantly more. The claim(s) recite(s) a base material for a tablet (composition with intended use for making tablets, but not yet a tablet) that has carnauba wax and oil (can include natural plant oil), which are both naturally found in plants. In claim 24, pharmaceutical ingredients or nutritional supplements can be found in plants as vitamins, minerals or natural bioactive compounds. This judicial exception is not integrated into a practical application because the components are not provided in a manner that provides markedly different characteristics from the natural carnauba wax, the natural oil or the natural nutrients or bioactive compounds. Concentrations of carnauba wax are only to amounts of the naturally occurring product. Although the composition can be used to make a tablet, it is not in the form of a tablet or in a manner that provides markedly different characteristics. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because each of the components only provides the activities that each are found to have individually in nature.
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.
Claims 1-34 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.
Claim 1 is indefinite for the recitation of “carnauba wax constitutes more than 50% of the base material, and is between 50 and 80% by weight of the base material” as “more than 50%” suggests that 50% is not included while “between 50 and 80%” (the further limitation of this range) can allow for 50% to be part of the range. For the purpose of compact prosecution, the examiner will consider the range as including 50%, however, it is suggested that applicant delete the recitation of “constitutes more than 50% of the base material, and” in the claim.
Claims 2-17 and 30-34 are rejected as being dependent on an indefinite claim.
Claims 1-4, 22-23, and 25 are indefinite for reciting %’s without indicating what the %’s refer to (e.g. by weight, molar, etc.). The specification does not particularly define percentages as being weight percents. Applicant may amend these to indicate “% by weight” if this is what they mean. The problematic recitations are “more than 50% of the base material”, “greater than 60% of the base material”, “greater than 70% of the base material”, “greater than 80% of the base material”, and “greater than 50% of the base material”. For the purpose of compact prosecution, they will be read as “% by weight”. Applicant can add “by weight” after the %.
Claims 5-17, 24 and 30-34 are rejected as being dependent on an indefinite claim.
Claims 1, 18, and 26 recite the limitation "the active agent" in the claims without a first recitation of “an active agent”. The prior recitation of “an active pharmaceutical ingredient” appears to be a narrower recitation of “active agent” but not the equivalent of it, so applicant would either have to introduce this with “an active agent is an active pharmaceutical ingredient” or change the recitation of “the active agent” to be “the active pharmaceutical ingredient” to agree with what was first introduced. Otherwise, there is insufficient antecedent basis for this limitation in the claim.
Claims 2-17, 19-21, and 27-34 are rejected as being dependent on an indefinite claim.
Claim 9 contains the trademark/trade name Aleve. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe Naproxen and, accordingly, the identification/description is indefinite.
Claim 20 is indefinite for the recitation of “the mixture is a flavoring agent” where claim 18, on which it depends, has already indicated that the base material and the active pharmaceutical ingredient are parts of the mixture. Thus, claim 20 might be defining the mixture to be a flavoring agent with “the mixture is a flavoring agent”, but it is unclear if applicant means to have the mixture further comprise a flavoring agent. Applicant may correct this to “the mixture further comprises a flavoring agent.” if this is what is meant.
Claim 24 recites the limitation "the active ingredient" in the claim with dependence to claim 22 where there is no prior recitation of “an active ingredient”. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 is indefinite for the recitation of “comprising essentially” as it is unclear how “comprising essentially” would limit the claim. It is unclear if applicant means to say “consisting essentially of” or “comprising”, which may both have different effects on the claimed formulation (see MPEP 2111.03). Applicant may delete “essentially” from the claim or change the recitation to “consisting essentially of” if appropriate.
Claims 27-29 are rejected for being dependent on an indefinite claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2-4 allow for open ended ranges of greater than 60%, greater than 70% and greater than 80% for carnauba wax in the base material while claim 1, on which they depend, provides a limitation for carnauba wax concentration of “between 50 and 80%”. Thus, these ranges of claims 2-4 allow one to extend beyond the range presented in claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 is defining the active agent as an active pharmaceutical ingredient in dependence to claim 1, which already has an active pharmaceutical ingredient. Thus, this claim does not further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 24 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 24 provides for a limitation to another material (active ingredients, supplement) in “the tablet” and is dependent on claim 22 which is to the base material. As the active ingredients in the tablet are not part of the base material, this does not further limit the base material, which is what the claim is towards. See paragraph 15 of applicant’s specification where “the tablet features a formulation of active ingredients integrated into a carnauba wax base material”, indicating the active ingredient and base material would be separate entities until put together in the tablet. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 18, and 21-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Riva US3459850.
Riva teaches “A sustained-release tablet having ephedrine hydrochloride as the drug ingredient intimately mixed with hydrogenated castor oil as the digestible fat and carnauba wax or white wax as the indigestible wax” (column 1). Riva teaches Tablet FC/2 with hydrogenated castor oil to carnauba wax at ratio of 1:3 (column 5). This ratio teaching means 25% by weight oil and 75% by weight carnauba wax. In the table in column 5, there is also ephedrine HCl as the active agent of FC/2. Thus, Riva anticipates a base that is hydrogenated castor oil and carnauba wax and the amounts/ratios of carnauba wax of applicant’s claims. Riva teaches “In the preferred embodiment the drug component is intimately mixed with the digestible fat and indigestible wax forming granules with the granules uniformly dispersed throughout the solid polymer which forms a sparingly water soluble carrier for the granules” (abstract). Riva teaches mixing the fat and wax with the active substance and any other secondary substances, granulating the resulting mixture, mixing the granulate with the polymer and any other tableting agents, and compressing the resulting mixture.” (column 3). Due to the granulation, the active ingredient will be granulated. In column 3, the process is taught with the compressing of the resulting mixture to make the tablet. Thus, Riva provides the teachings of the composition claim and the method for making a tablet of applicant’s claims.
Claim(s) 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douglas US 5635200A.
Douglas teaches lipid coated particles of ranitidine in a non-aqueous vehicle (abstract). Douglas teaches granulating the lipid coated particles (column 6). Douglas teaches making tablets by compressing the granules (bottom of column 6). Douglas teaches using carnauba wax that was melted and mixed with milled ranitidine HCl (bottom of column 7, preparation 2). Douglas teaches combining glyceryl tripalmitate (an oil) to the ranitidine HCl-carnauba wax particles (example 2, column 8). Example A in column 9 provides for use of the ranitidine HCl-carnauba wax core overcoated with glyceryl palmitate that is mixed with xylitol, flavour and granulating fluid to make granules, combined with magnesium stearate, and then the example A composition is compressed into chewable tablets in example B in column 10 (also see column 7 with various preparations with flavouring agents). Thus, through example A and example B with teachings of column 6, a carnauba wax/granulated ranitidine HCl material is made combined in a mixture and then compressed into a tablet. As a flavor is added in example A, this would be a flavoring agent. Douglas teaches suitable lipids for an outer coating including oils (bottom of column 2).
Claim Rejections - 35 USC § 103
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.
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 1-4, 7-13, 15-18, and 20-33 are rejected under 35 U.S.C. 103 as being unpatentable Luber US 20030068373A1.
Luber teaches an immediate release tablet with at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90 degrees C (abstract). This range includes values over 90% as it is overlapping. Luber teaches tablet was made by direct compression (abstract). Luber teaches suitable powdered waxes including carnauba wax (paragraphs 15 and 30). Luber teaches fats such as hydrogenated vegetable oil such as sunflower oil as an edible material that is a tableting ingredient (paragraphs 29-30). Luber teaches acetaminophen for a tablet (examples 1-2). Example 1 teaches mixing acetaminophen and a wax powder to produce a granulation and then compressing it into tablets (paragraph 32). Note that carnauba wax is an alternative to microcrystalline wax as a powdered wax (paragraph 15). Luber teaches flavors for tablets (paragraph 18). Luther teaches sugar (paragraph 30). Luber teaches other conventional ingredients such as fillers, including water soluble compressible carbohydrates such as sucrose (paragraph 18). Sucrose is a sugar. Luber teaches active ingredients such as expectorants, acetaminophen, ibuprofen, naproxen, aspirin, diphenhydramine, loratadine, pseudoephedrine and dextromethorphan (paragraph 11). The amount of acetaminophen in example 1 is 180.5 g in 206.28 g total ingredients which is 87.5% by weight of acetaminophen (paragraph 32). Luther teaches tablet hardness of 1 to 30kp/cm2 (9.8 to 294 N) and also provides for 4 to 20 kp/cm2 (39.2 to 196 N) (paragraphs 22-23). Luther allows for outer coatings of the tablet (paragraph 25). Luther teaches up to 20 wt% of the total tablet being wax (paragraph 16). Luber teaches directly compacting a blend of the active ingredient, the powdered wax, and any other appropriate optional ingredients (paragraph 20), and thus, allows for the tablets being just active ingredient and the powdered wax (one option being carnauba wax). This means that up to 100% of the base composition, which does not include the active ingredient, can be a wax such as carnauba wax. Luber teaches sugars and oils as thermal setting polymers (paragraph 30).
One of ordinary skill in the art before the time of filing would have provided tablets with high amounts of active ingredients along with a base material having carnauba wax as the material as the prior art teaches these are used to make tablets by direct compression. Luber sees a variety of active ingredients including those of applicant’s claims as suitable for the formulations. Luber teaches overlapping ranges and examples with near values to those in applicant’s claims (MPEP 2144.05 – obviousness of ranges). Thus, there is a reasonable expectation of success in combining the teachings provided in Luber in regards to making a tablet, compositions for tablet bases and methods of making tablets and producing the compositions and method of making a tablet as in applicant’s claims to make formulations with excellent disintegration properties with more rapid onset of therapeutic effect (see paragraph 9 of Luber).
Claims 5-6, and 19 in addition to Claims 1-4, 7-13, 15-18, and 20-33 are rejected under 35 U.S.C. 103 as being unpatentable Luber US 20030068373A1 and Becker US 20180092379.
Luber teaches the claims as discussed above. Note in teachings above that Luber teaches the use of sugars and oils in its tablet formulations.
Luber does not teach edible oil coatings or rice bran in the tablet mixture.
Becker teaches stable, durable granules with active agents (abstract). Becker teaches the granules suitable for tableting (abstract). Becker teaches rice bran as a diluent for the composition with active agents(paragraphs 20 and 88). Becker teaches sucrose in formulations (table 2). Becker teaches oil coatings for protective moisture barrier coatings including oils such as canola oil (paragraphs 110-111 and 115).
One of ordinary skill in the art before the time of filing would have additionally used rice bran it its tablet formulations as it is seen as an acceptable diluent for making tablets by teachings of Becker and used edible oils like canola oil to provide a protective moisture barrier coating over the tablet by teachings of Becker when making tablets of Luber to obtain new formulations that are more stable and durable based on teachings of Becker. There would be a reasonable expectation of success in combining the teachings of the references and producing more stable and durable tablet compositions.
Claims 14 and 34 in addition to Claims 1-4, 7-13, 15-18, and 20-33 are rejected under 35 U.S.C. 103 as being unpatentable Luber US 20030068373A1 and Jones US20100152173.
Luber teaches the claim as discussed above with including expectorants as an active agent for its formulations.
Luber does not teach guaifenesin.
Jones teaches tablets with improved stability having active agents (abstract). Jones teaches guaifenesin as an expectorant for its formulations (paragraph 21). Jones also teaches NSAIDs (paragraphs 23-30).
One of ordinary skill in the art before the time of filing would have included guaifenesin as a known expectorant for tableted formulations made by teachings of Luber with the reasonable expectation of a tablet with function as an expectorant.
Non-Statutory 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.
Claims 1 – 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of copending US Application No.18/057,119 to Spielberg et. al. (reference application, herein after Spielberg US Application No. ‘119) in view of Luber US 20030068373A1 and Jones US20100152173. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications direct to the scope of a tablet formulation.
Spielberg’119 renders obvious the instant application, as the instant application recites a broad genus of a tablet formulation comprising: an active material, and a base material comprising carnauba wax, wherein the carnauba wax is greater than 50% of the base material. The instant application recites that the base material can include rice bran, an active ingredient that is a nutritional supplement and/or an active agent that is a pharmaceutical ingredient, which encompasses the species of acetaminophen in claims 11, 18, and 22) formed by direct compression.
Whereas, Spielberg‘119 recites a subgenus of tablet formulation comprising: an active material (ref. claims 1, 8, and 12-13) and a base material comprising gum, rice bran, carnauba wax, maltodextrin (sugar) and a flavoring agent (ref. claims 1, 9, and 18 - 19). Spielberg‘119 teaches that the active material (i.e.; active ingredient and active agent) is a nutritional supplement (ref. claim 8) and/or an active agent that is a pharmaceutical ingredient (ref. claim 12). Spielberg‘119 teaches that the active pharmaceutical is acetaminophen (ref. claim 13 and 20) formed by direct compression (ref. claim 11).
‘119 does not provide for pharmaceutical actives of applicant’s dependent claims except for acetaminophen.
Luber teaches an immediate release tablet with at least 60 weight % of an active ingredient and powdered wax having a melting point greater than about 90 degrees C (abstract). This range includes values over 90% as it is overlapping. Luber teaches tablet was made by direct compression (abstract). Luber teaches suitable powdered waxes including carnauba wax (paragraphs 15 and 30). Luber teaches fats such as hydrogenated vegetable oil such as sunflower oil as an edible material that is a tableting ingredient (paragraphs 29-30). Luber teaches acetaminophen for a tablet (examples 1-2). Example 1 teaches mixing acetaminophen and a wax powder to produce a granulation and then compressing it into tablets (paragraph 32). Note that carnauba wax is an alternative to microcrystalline wax as a powdered wax (paragraph 15). Luber teaches flavors for tablets (paragraph 18). Luther teaches sugar (paragraph 30). Luber teaches other conventional ingredients such as fillers, including water soluble compressible carbohydrates such as sucrose (paragraph 18). Sucrose is a sugar. Luber teaches active ingredients such as expectorants, acetaminophen, ibuprofen, naproxen, aspirin, diphenhydramine, loratadine, pseudoephedrine and dextromethorphan (paragraph 11). The amount of acetaminophen in example 1 is 180.5 g in 206.28 g total ingredients which is 87.5% by weight of acetaminophen (paragraph 32). Luther teaches tablet hardness of 1 to 30kp/cm2 (9.8 to 294 N) and also provides for 4 to 20 kp/cm2 (39.2 to 196 N) (paragraphs 22-23). Luther allows for outer coatings of the tablet (paragraph 25). Luther teaches up to 20 wt% of the total tablet being wax (paragraph 16). Luber teaches directly compacting a blend of the active ingredient, the powdered wax, and any other appropriate optional ingredients (paragraph 20), and thus, allows for the tablets being just active ingredient and the powdered wax (one option being carnauba wax). This means that up to 100% of the base composition, which does not include the active ingredient, can be a wax such as carnauba wax. Luber teaches sugars and oils as thermal setting polymers (paragraph 30).
Jones teaches tablets with improved stability having active agents (abstract). Jones teaches guaifenesin as an expectorant for its formulations (paragraph 21). Jones also teaches NSAIDs (paragraphs 23-30).
Both applications contain tablet formulations with an overlap in base material elements; specifically, carnauba wax and rice bran. While Spielberg’119 recites additional base material elements (i.e., rum and carbonate) that are not recited in the instant application the instant application encompasses these elements. Mainly, since the instant application uses the term “comprising” (i.e., open and inclusive language) in the recitation, the instant claims encompasses unrecited elements. Thus, one of ordinary skill in the art would understand that the inclusion of additional elements to help in the tablet formulation are encompassed. Therefore, given the state of the pharmaceutical arts for the formulation of tablets, one of ordinary skill in the art would know how to modify the values of the carnauba wax, rice bran, and unrecited elements to get a tablet formulation within the recited ranges of the instant application. Additionally, given the state of the pharmaceutical arts one of ordinary skill in the art would be able to formulate a tablet with a hardness between 50N and 90N. Therefore, the copending Spielburg’119, which is encompassed by the instant application, renders obvious the instant application. One of ordinary skill in the art would use available pharmaceutical actives for tablet formulations taught in the teachings of Luber and Jones when making and providing tablets of ‘119. Thus, the instant application is obvious over the additional elements recited by Spielberg’119.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613