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 .
Claims 104-126 are pending in this application.
Claim interpretation
(1) “coherent”
All claims recite or read on the “core constituting a coherent uncooked mass.” Regarding the term “coherent,” the instant specification discloses the following at lines 15-18 of page 16:
In the present context, “cohesiveness” or “coherent” is intended to mean the way the mass of the core behaves when it is for instance pulled apart. A high “cohesiveness” requires a higher force to pull the core apart.
Therefore, the term “coherent” shall be interpreted to describe the core as a mass that can be pulled apart with some force, wherein for example highly coherent means greater force is required to pull the core apart.
(2) “uncooked”
The instant specification discloses heating to a temperature below 60 °C is within the meaning of “uncooked” (page 13, lines 25-28).
35 U.S.C. 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.
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 104-126 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (WO 02/01962; hereinafter, King) in view of Puglia et al. (US 4,327,076; hereinafter, Puglia) and Ehrenhauser et al. (hereinafter, Ehrenhauser).
King (WO 02/01962) discloses an uncooked, unspun intimately mixed confectionary delivery system for actives having sufficient internal cohesiveness to be handled without losing its integrity as a mass, said composition being substantially free of unbound water comprising:
(i) about 16-75 wt% of a saccharide based component, which include for example maltodextrins having dextrose equivalence (DE) of less than 20 (page 16, lines 12-19) or polydextrose (page 16, lines 20-24).
(ii) about 20-45 wt% of a hydrated hydrobinding component having a water activity substantially less than about 75% ERH, in combination with a humectant such as glycerin;
(iii) about 2-18 wt% of a fat component having a melting point in the range of about 28 to 45 °C for providing a soft chew texture, including vegetable oil
See claims 1-10, 25-40; see also page 1, lines 19-23 and page 8, line 16 to page 9, line 6. King further discloses, “In the present invention, the water activity is not greater than about 60% ERH” (page 7, lines 30-31), which is equivalent to water activity that is not greater than about 0.6.1 Further incorporation of pharmaceuticals, food ingredients, nutraceuticals, soluble fiber, insoluble fiber, protein, vitamin, mineral, or herbs is disclosed (claims 6-7). 10-40% calcium carbonate can be present in the composition (claims 8-10; page 9, lines 19-23). Antacids or other active ingredients can be incorporated in amounts ranging from 0.1 to 50 wt% (page 19, line 7 to page 22, line 19). The hydrated hydrobinding agent (ii) includes a carbohydrate syrup such as hydrogenated glucose syrup, which is a semi-liquid syrup (page 6, lines 11-14; page 13, lines 21-26; claim 2). Example 3 discloses 28.75 wt% calcium carbonate in combination with 30-40 wt% powdered sugar (page 40); Example 5 discloses 23.7 wt% calcium carbonate, 18.1-27.1 wt% corn syrup solids (King discloses, “[c]orn syrup solids are commonly known as maltodextrins”)2, 26.6-35.6 wt% 6X powdered sugar, 0.35 wt% lecithin, 3 wt% glycerin, and 1.5-1.8 wt% gelatin. Example 10 discloses 11-12 wt% maltodextrin, 18 wt% corn syrup solids, 0.7 wt% lecithin, 43 wt% confectioners sugar 6X powder, 3-4 wt% glycerin, 2 wt% gelatin, and 1 wt% medium chain triglyceride (MCT) oil (pages 50-51). Up to 20 wt% of other materials such as flavors, sweeteners, colorants, surfactants, emulsifiers, fats, or oils can be incorporated to enhance appearance, taste, and texture (page 17, line 16 to page 19, line 6).
Puglia (US 4,327,076) discloses that soft chewable antacid tablets can be spray coated or otherwise coated with chocolate or other standard confections coating to prevent breakage during shipment. In addition, a confections glaze may be applied over the coating to prevent premature melting during handling. See column 6, lines 54-62 in view of column 2, last paragraph and column 3, lines 29-35.
Ehrenhauser is cited to establish that powdered sugar products can have mean size of 9.8 to 23.5 microns (Table 1).
King does not explicitly disclose every single feature of the claimed invention of the instant application or explicitly discloses such features in the same exact language. However, for the reasons set forth below, the ordinary skilled artisan would have found the claimed invention obvious.
Coated soft chew tablet
King discloses a chewy “nougat” which is obtained without cooking (page 1, lines 19-23), which is soft and retains its softness over time (page 9, lines 17-18; page 10, lines 13-15). The nougat is processed by cutting into dosage size pieces (page 29, lines 21-23). Thus, a composition within the broad ambit of “tablet” is adequately disclosed or suggested by King.
Core constitutes a coherent uncooked mass
King discloses an uncooked, unspun intimately mixed confectionary delivery system for actives having sufficient internal cohesiveness to be handled without losing its integrity as a mass (see e.g., page 8, line 16 to page 9, line 5). As discussed previously in this Office action, Applicant’s specification defines “cohesiveness” and “coherent” as similar terms that mean the way the mass of the core behaves when it is for instance pulled apart. Thus, a core constituting a coherent uncooked mass is taught by King.
1-40 wt% or 30-98 wt% outer coating; hard outer coating, film, soft, or chocolate coating; sub-coating
King does not explicitly disclose an outer coating or a sub-coat between the core
and the outercoating. However, King’s delivery system of actives is a confectionary-based delivery system, and it would have been obvious to provide the final composition with an outer coating that provides additional palatability, where needed, such as by providing a chocolate coating. The sub-coat and the outer coating is equivalent to dual coating, which would have been obvious for providing additional flavors or additional protection from breakage or premature melting (Puglia). As for the weight percentage of the coatings, the ordinary skilled artisan would have found it obvious to formulate many different types of coatings and a broad range of coating weight percentages, based on the target consumer or patient, who may require little or substantial taste enhancement of the active ingredients, which vary in taste, aftertaste, and mouthfeel characteristics.
Claims 109-110: the coherent uncooked mass has not been re-crystallized during formation of the core; said uncooked mass is characterized by preserved crystallinity of the one or more powdered monosaccharides and/or disaccharides during formation of the core
The instant specification discloses, “re-crystallized” is intended to mean that
crystalline ingredients applied in the process are not melted during the process and re-crystallized during or after cooling.” (page 10, lines 15-17). King teaches an uncooked cohesive mass without melting the crystalline sugars in his delivery system. Therefore, King teaches the claimed invention features.
Average particle size of powdered monosaccharides and/or disaccharides is less than 100 microns
King discloses incorporation of powdered sugar (page 40), which is available in sizes below 100 microns (Ehrenhauser). King further discloses his invention as providing “freedom from grit, and aftertaste” and thus enhanced palatability (page 8, lines 10-15). Because larger particle size would provide grittiness, it would have been obvious to the ordinary skilled artisan to utilize finer particle size such as less than 100 microns.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited references.
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 104-126 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-10, 18, 27-28, 33, 40, 43, 47, 53, 57, 68, 74, 80, 87, 96104-105, 111, and 130 of copending Application No. 19/216,992 (‘992 application) in view of King (WO 02/01962), Puglia (US 4,327,076), and Ehrenhauser.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons set forth below.
Claims of ‘992 application are directed to a soft chew tablet comprising (claim 1):
core constituting a coherent, uncooked and extruded-mass comprising:
10-45 wt%, based on weight of the core, of one or more indigestible water soluble fibers having a dextrose equivalent (DE) of 3 to 20 (claim 27), including polydextrose and indigestible maltodextrin (claim 28),
10-60 wt% of one or more powdered proteins, based on weight of the core,
0.1-25 wt% of texturizers such as lecithin, gelatine, carrageenan, acacia, glycerin, vegetable oil, based on the weight of the core (claims 96, 104),
sugar and/or sugar alcohol (claim 8),
0.1-30 wt% of semi-liquid sugar-based syrups, based on the weight of the core (claims 40, 43),
1-60 wt% of one or more active ingredients (claims 105, 111),
wherein the uncooked mass is formed at a temperature below 60 °C (claim 18).
Said mass is a coherent mass with remains of particles (claim 7) or remains of sugar particles (claim 9). The core can further comprise 5-20 wt% calcium carbonate (clam 87), and the tablet can comprise an outer coating comprising a chocolate coating (claim 130).
Teachings of King, Puglia and Ehrenhauser were discussed previously in this Office action, and the discussions there are incorporated herein by reference.
Claims of the ‘992 application discloses a similar soft chew tablet that contains
the same ingredients. Although the recrystallization feature of claims 109-110 of the instant application claims are not recited in the same exact language in the copending claims of the ‘992 application, said copending claims are directed to a coherent uncooked mass with remains of sugar particles, which would preclude recrystallization as defined in the instant specification. The instant specification discloses that “re-crystallized” is intended to mean that crystalline ingredients applied in the process are not melted during the process and re-crystallized during or after cooling.” (page 10, lines 15-17). It would have been obvious that uncooked mass with remains of sugar particles would also preserve crystallinity of powdered monosaccharides or disaccharides.
The average powdered monosaccharide or disaccharide particle size of less than 100 micron of instant claim 114 would have been obvious to the ordinary skilled artisan because larger particle size would provide undesirable characteristic of grittiness to the composition and size less than 100 micron would have been well known to the ordinary skilled artisan (Ehrenhauser).
The core having a water activity of less than 0.6 of instant claim 116 would have been obvious to the ordinary skilled artisan for reducing available water that can contribute to microbial growth. Further, King teaches such water activity (page 7, lines 30-31; see footnote 1 of this Office action).
The sub-coat and the outer coating is equivalent to dual coating, which would have been obvious for providing additional flavors or additional protection from breakage or premature melting (Puglia). As for the weight percentage of the coatings, the ordinary skilled artisan would have found it obvious to formulate many different types of coatings and a broad range of coating weight percentages, based on the target consumer or patient, who may require little or substantial taste enhancement of the active ingredients, which vary in taste, aftertaste, and mouthfeel characteristics.
For these reasons, the ordinary skilled artisan would have recognized the instant claimed invention as an obvious variation of the invention set forth in the claims of the ‘992 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
For the foregoing reasons, all claims are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699
1 Water activity = ERH/100.
2 Page 16, lines 13-14.
