DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-10 are pending.
Priority
This application is filed 09/11/2024, and claims the benefit of domestic priority as below:
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Information Disclosure Statements
One IDS(s) received on 12/04/2024 has been considered unless marked with a strikethrough.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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.
Regarding claim 5, the phrase "a content of the component (D) is from 1 to 70 wt.%." renders the claim indefinite because it is unclear whether the percentage is based on the total weight of the additive composition, the combined weight of components (A) through (D), or the total tablet composition including the active pharmaceutical ingredient and any additional components. The specification does not define the total weight of the additive composition for the component (D).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, and 3-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by applicants. (see MPEP 2163.02)
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. (Emphasis added)
Further, the MPEP states that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. (see MPEP 2161.01)
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171, the court stated as follows:
We held that a sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can “visualize or recognize” the members of the genus. Id. At 1568-69. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. Id. At 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genus and showing that one has invented a genus and not just a species.
With respect to claim 1, the claim is drawn to an additive composition for an orally disintegrating tablet comprising components (A)-(D), wherein component (D) broadly encompasses (D1) a (meth)acrylic polymer and/or (D2) a specified cellulosic polymer. Since Claim 1 uses the open-ended term “comprising,” it does not exclude additional formulation components, such as APIs or other excipients. Thus, the formulations encompassed by claim 1 are not limited to formulations consisting only of components (A)-(D). However, the written description concern for claim 1 is the breadth and material diversity of the recited D1 genus.
The specification supports for several materials within component (D1) including selected copolymers and commercially available methacrylic polymers (i.e., Eudragit L100-55, and Eudragit EPO). However, the concern is mainly with the breadth of D1 as “a (meth)acrylic polymer”. The specification states that “the copolymer of the (meth)acrylic polymer is not particularly limited” (paragraph [0030]) and describes multiple types of D1 polymers (paragraphs [0029]-[0050]), whereas the working examples use only a limited number of D1 species. Under MPEP 2163, where a claimed genus encompasses substantial variation, the disclosed species must be sufficiently representative of that variation, or the disclosure must provide relevant identifying characteristics showing possession of the genus. (see AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300-01 (Fed. Cir. 2014))
According to the following reference, tablet disintegration characteristics are materially dependent on formulation components and formulation condition. Desal et al. (Functionality of disintegrants and their mixtures in enabling fast disintegration of tablets by a quality by design approach., AAPS PharmSciTech., 15(5), 1093-104, pub’d 05/22/2014) shows the examination of tablet formulations containing APIs with different physicochemical properties (discussion section). Desal’s study is also used the same disintegrants as instant component (C) including croscamellose sodium and crospovidone (experimental design section). Thus, Desal shows that tablet disintegration is affected by factors including API identity, disintegrant identity and concentration and compression conditions (discussion section).
Moreover, Ghourichay et al. (Formulation and Quality Control of Orally Disintegrating Tablets (ODTs): Recent Advances and Perspectives., Biomed. Res. Int., 2021, 6618934, pub’d 12/24/2021) identifies physicochemical characteristics of drugs and excipients, including solubility, crystal morphology, particle size, hygroscopicity, and compressibility, as factors associated with differences in final ODT characteristics (Features of APIs and Excipients and Conclusion sections). Ghourichay explains that excipient section, including the amount and type of superdisintegrant, can affect ODT disintegration behavior (Features of APIs and Excipients and Formulation Methods: Merits and Demerits sections). Thus, Ghourichay supports the view that ODT performance depends on the physicochemical and formulation characteristics of the selected ingredients, and that fundamentally different materials cannot necessarily be considered functionally interchangeable.
Similarly, Tomas et al. (Probing the early stages of tablet disintegration by stress relaxation measurement., Eur. J. Pharm. Sci., 124, 145-152, pub’d 08/24/2018) shows that the examination of tablet formulations having varying API content and tableting pressures and describes tablet disintegration as involving wetting, liquid ingress into the tablet pore structure, pH, and loosening of interparticle bonds (abstract). Thus, Tomas presents additional evidence that tablet composition, the resulting tablet structure, and process conditions are related to differences in disintegration behavior.
Accordingly, Desal, Ghourichay and Tomas evidence that differences in formulation components and conditions affect the functionality of tablets. Furthermore, this supports the importance of material variability. However, the specific embodiments disclosed in the specification do not represent the broader genera recited in the claims. Here, the specification discloses and exemplifies a limited subset of D1 species and does not identify common structural, physicochemical, or other relevant characteristics demonstrating that those species representative of the full scope of the claimed D1 genus. Thus, the deficiency is not merely that unexemplified D1 polymers exist, but that the claimed genus encompasses materially varied polymer species, without providing a sufficient variety of representative species or identifying common characteristics showing possession of the full genus. Claims 3-10 share the deficiency because they directly or indirectly depend from claim 1. Claims 9 and 10 likewise recite the broad scope of limitations.
With respect to claims 6-10, claims 6-10 involve an orally disintegrating tablet composition comprising the additive composition for an orally disintegrating tablet described in claim 1 and (E) an active pharmaceutical ingredient (API). These claims encompass a broad range of APIs and claims 7 and 10 additionally encompass broad API loading and tableting pressure range, respectively.
The claim encompassing broad APIs, broad API loadings, and broad tableting conditions. The specification states that the API “is not particularly limited,” (paragraph [0080]) permits APIs from numerous therapeutic classes and in different physical forms, and permits their use alone or in combination. Therefore, while the limitations regarding APIs are distinct and encompass a broad and substantially diverse range of active ingredients, the embodiments disclose only a limited subset of formulations containing APIs.
In view of Desal, Ghourichay and Tomas as discussed above, they provide evidence of material variation including APIs within the formulation relevant to whether the limited disclosed species are representative of the breadth of the claimed genera. Therefore, regarding the written description requirement, the significance of these reference documents lies not in the fact that a person skilled in the art cannot manufacture the claimed formulation, but rather in the fact that the specification, which discloses only a limited number of examples while the claimed genera of D1 and the API encompass substantially different species, fails to demonstrate possession of the full scope of that diversity.
The specification does not disclose a representative number of species reflecting the material variation across the claimed D1 and API genera. Absent a representative species reflecting the material variations across the claimed scope, or a correlation between identifiable common structural, physicochemical, or other relevant properties (i.e., formulation characteristics), the broad D1 and non-limiting APIs discussed earlier are insufficient to reasonably substantiate coverage of the claimed genera while reflecting the material variations across the claimed scope.
As set forth in the en banc decision in Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010), to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention at the time of filing. Specifically, the specification must describe the claimed invention in a manner understandable to a person of ordinary skill in the art in a way that shows that the inventor actually invented the claimed invention at the time of filing. Id.; Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172. (see MPEP 2161.01).
Accordingly, as discussed above, in view of the breadth of the claimed component (D1) and APIs, the material variation among the species encompassed by those genera, the limited number and range of species actually disclosed, and the absence of identified common structural, physicochemical, or other relevant characteristics showing possession of the genera as a whole, the specification does not reasonably convey to those skilled in the art that the inventors are in possession of the full scope of claimed additive composition at the time of filing.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Kurasawa et al. (WO 2009/113703 A2, pub'd 09/17/2009, IDS cited as JP 2011-513204).
Kurasawa teaches the an orally disintegrating solid preparation. Kurasawa further teaches production Examples (PE) 1-4 are sequential steps for preparing the coated fine granules. The PE 5 separately prepares the out-layer granulated powder. The products of PE 4 and 5 are then combined to prepare the Example 1. The PE 1-5 and Example 1 describe an orally disintegrating solid preparation which is obtained by tableting at a tableting pressure of 20 kN/cm2 using 565.5 mg of a mixed powder (corresponding to the "additive composition (E)") comprising: 30 mg of compound X (corresponding to the "active pharmaceutical ingredient"); polymer coated fine granules containing 7 mg of mannitol (corresponding to the component (A)), 77 mg of a methyl methacrylate/methacrylic acid copolymer (corresponding to the component (D)), 24.09 mg of a methacrylic acid/methyl acrylate/methyl methacrylate copolymer; and an outer layer ingredient granulated powder containing 211 mg of mannitol, 31 mg of crystalline cellulose (corresponding to the component (B)), and 15 mg of crospovidone (corresponding to the component (C)) (specification pages 60-64). The calculation below is based on all components are recovered in the same portion.
Regarding to claims 1-10, Kurasawa discloses:
1) an additive composition for an orally disintegrating tablet, and the additive composition of ((A)-(D)), as required in claim 1;
2) a methyl methacrylate (d11) and methacrylic acid copolymer (d12) of D1’s polymer, as required in claim 2;
3) applying Example 1 tablet, mannitol (A), is 438 g in 573 g of PE 5. Example 1 uses 58.8 g of PE 5, thus, (A) in PE 5 is 58.8 g x (438 g / 573 g) = 44.94 g. In addition, PE 4 contains 7 mg of (A) per 267.87 mg of granules, and Example 1 uses 54.0 g of the PE 4. Thus, the additional amount of (A) is 54.0 g x (7 mg / 267.87 mg)= 1.41 g. Accordingly, the total amount of (A) is 46.35 g. Crystalline cellulose (B) is 60 g in 573 mg in PE 5. Thus, the amount of (B) is 58.8 g x (60 g / 573 g)=6.16 g. (D), methacrylic polymers, is 77 mg from PE 3 and 24.09 mg from PE 4, thus, total amount is 101.09 mg in 267.87 mg of PE 4 granules. Thus, the amount of (D) in Example 1 is 54.0 g x (101.09 mg / 267.87 mg) = 20.38 g. Accordingly, (D)/((A)+(B)) = 20.38 g/(46.35 g+6.16 g) = ~0.39 part by weight, which falls within the claimed range of 0.01-5 parts by weight, as required in claim 3;
4) applying Example 1 tablet, crospovidone (C) is 30 g in 573 g of the outer layer granulated powder in the PE 5. Example 1 uses 58.8 g of the PE 5 powder, and the amount of (C) is 58.8 g x (30 g / 573 g) = 3.08 g. (D) is 101.09 mg in 267.87 mg of PE 4, and Example 1 uses 54.0 g of the PE 4. Thus, the amount of (D) is 54.0 g x (101.09 mg / 267.87 mg) = 20.38 g. Accordingly, (D)/(C)= 20.38 / 3.08 = 6.62 part by weight, which falls within the claimed range of 0.1-50 parts by weight, as required in claim 4;
5) as discussed the amount of (D) in 4), Example 1 contains 114 g of mixed powder, corresponding to a 565.5 mg tablet containing 30 mg of compound X. Thus, the amount of compound X in the 114g batch is 114g x (30 mg / 565.5 mg) = 6.05 g, and the total amount of the additive composition excluding compound x is 107.95 g. Accordingly, (D) is (20.38 g /107.95 g) x 100 = 18.88 wt. %, which falls within the claimed range of 1-70 wt. %, as required in claim 5;
6) PE 1-5 and Example 1 describes an orally disintegrating solid preparation PE 1 includes an active ingredient as compound X, as required in claim 6;
7) applying Example 1 tablet, (E), compound x, is 30 mg from PE 1 in a 565.5 mg tablet. Example 1 contains a total of 114 g of mixed powder. Thus, the amount of (E) in the Example 1 batch is 114 g x (30 mg / 565.5 mg) = 6.05 g. therefore, the amount of the additive composition, excluding (E) is 107.95 g. Accordingly, (E) per 100 parts by weight of the additive composition is (6.05 g / 107.95 g) x 100=5.60 part by weight, which falls within the claimed range of 0.5-233 parts by weight, as required in claim 7;
8) PE 1-5 and Example 1 describes an orally disintegrating solid preparation which is a tablet produced by tableting fine granules, as required in claim 8 (abstract and Production Examples 1-5 and Example 1);
9) applying PE 1-5 and Example 1, the ingredients and the process discussed above teaches that a method for producing an orally disintegrating tablet, as required by claim 9; and
10) applying Example 1, the mixed powder is tableted at a tableting pressure of 20 kN/cm2 using a 13 mm punch. Since 1 kN/cm2 = 10 MPa, 20 kN/cm2 corresponds to 200 MPa. Accordingly, the tableting pressure is 200 MPa, which falls within the claimed range of 20-600 MPa, as required in claim 10.
Claim(s) 1-6, and 8-10 is/are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Kano et al. (US 2018/0369194 A1, pub'd 12/27/2018, IDS cited).
Kano teaches a tablet preparation. Kano further teaches that Example 5 prepares a tablet by first mixing the maleate of Compound A with magnesium stearate, compression molding the resulting mixture using a dry granulating machine, and sizing the molded solid product. Example 5 than adds mannitol, ethyl cellulose, microcrystalline cellulose, crospovidone, and croscarmellose sodium to the obtained sized powder, followed by further addition of magnesium stearate. The resulting mixture powder is than tableted at a tableting pressure of approximately 9kN to prepare an uncoated tablet having a mass of 315 mg. Thus, Example 5 describes a tablet comprising: 2.61 g of the maleate of compound A (corresponding to X as the active pharmaceutical ingredient); 30.71 g of mannitol (corresponding to (A)); 3.74 g of macrocrystalline cellulose (corresponding to (B)); 3.76 g of crospovidone and 0.76 g of croscarmellose sodium (corresponding to (C)); and 3.0 g of ethyl cellulose (corresponding (D)), together with 0.9 g of magnesium stearate (paragraph [0171]). The calculation below is based on all components are recovered in the same portion.
Regarding to claims 1-6, and 8-10, Kano discloses:
an additive composition for an orally disintegrating tablet, and the additive composition of
((A)-(D)), as required in claim 1;
using an ethyl cellulose of D2’s polymer, as required in claim 2;
applying Example 5, the amount of (A), mannitol, is 30.71 g, (B), crystalline cellulose is 3.74
g, and (D), ethyl cellulose, is 3.00 g. Accordingly, (D)/((A)+(B))=3.00g/(30.71g+3.74g) = ~0.087 part by weight, which falls within the claimed range of 0.01-5 parts by weight, as required in claim 3;
applying Example 5, (C), crospovidone, is 3.76 g, and crosarmellose sodium is 0.76 g. Thus,
total amount of (C) is 4.52 g, and (D) is 3.00 g as discussed above. Accordingly, (D)/(C) = 3.00 / 4.52 = 0.664 part by weight, which falls within the claimed range of 0.1-50 parts by weight, as required in claim 4;
the sized powder is prepared from 467.39 g of compound A malate and 2.61 g of
magnesium stearate, total amount is 470.00 g. The amount of magnesium stearate in 107.14 g of the sized powder is 107.14 g x (2.61 g / 470 g) = ~0.595 g. The additive composition contains 30.71 g (A), 3.74 g (B), 4.52 g (C), 3.00 g (D), and 1.495 g (magnesium stearate, 0.595 g + 0.90 g). Thus, total additive composition is ~ 43.465 g. Accordingly, (D) wt. % is (3.00 g / 43.465 g) x 100= 6.90 wt. %, which falls within the claimed range of 1-70 wt. %, as required in claim 5;
Examples 5 describes prepares a tablet by first mixing the maleate of Compound A with
magnesium stearate. Compound A is 1-(3-(2-(1-Benzothiophen-5-yl)ethoxy )propyl)azetidin-3-ol as active ingredient and the specification states that “Compound A or a salt thereof is orally administered. Therefore, there is a need for a tablet comprising Compound A or a salt thereof.” (paragraph [0002]-[0003]) %, as required in claims 6 and 8;
applying Example 5, the ingredients and the process discussed above teaches that a method
for producing an orally disintegrating tablet, as required by claim 9; and
applying Example 5, the mixed powder is tableted at a tableting pressure of 9 kN using 8.5
mm double rounded punch. Thus, P = F/A=9kN/(π(d/2)2= 9kN/0.56745 Cm2=15.860 kN/Cm2. Since 1 kN/cm2 = 10 MPa, 15.860 kN/cm2 corresponds to 158.60 MPa. Accordingly, the tableting pressure is 158.60 MPa, which falls within the claimed range of 20-600 MPa, as required in claim 10.
Art of Record but not Applied
The current anticipation by Kurasawa and Kano sufficiently explains the claimed alternatives formulation components. In addition, the references below are also appropriately relied upon as evidence supporting the claimed alternatives formulation components.
JP 2016222651 A (IDS cited) discloses an orally disintegrating tablet containing miglitol as an active pharmaceutical ingredient and ethyl cellulose as a water insoluble polymer. The specification also identifies conventional tablet additive including mannitol, crospovidone, and other pharmaceutical excipient. Thus, the ‘651 supports the ethyl cellulose alternatives (i.e., component D2), as well as the use of alternative active pharmaceutical ingredients in orally disintegrating tablets.
US 2023/0087865 A1 (IDS cited) discloses pharmaceutical compositions for oral administration and teaches tablets containing active pharmaceutical ingredients. The specification identifies mannitol and microcrystalline cellulose as fillers, crospovidone and croscarmellose sodium as disintegrants, ethyl cellulose as a binder, and various methacrylic acid/methacrylate copolymer as enteric materials. Thus, the ‘237 demonstrates that the individual alternatives corresponding to components (A)-(D), as well as active pharmaceutical ingredients and tableting, are known pharmaceutical formulation choice.
US 2022/0233449 A1 (IDS cited) discloses solid dispersions containing an active pharmaceutical ingredient and a pharmaceutical polymer and further teaches formulation of such materials into solid pharmaceutical dosage forms. Thus, the ‘065 additionally supports that active pharmaceutical ingredients, pharmaceutical polymers, and their incorporation into solid oral dosage forms are known formulation alternatives.
Conclusion
Claims 1-10 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner
should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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