DETAILEDA 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 .
Election/Restrictions
Applicant’s election without traverse of group I in the reply filed on July 23, 2026 is acknowledged.
The election groups are clarified to include claims 48-51 and 55 in group I instead in group II, such that claims under examination include claims 2, 4, 7, 10-11, 13-22, 48-51, 55-56, 59-60, 63, 65, 67-68, and 71.
The restriction is deemed proper and thereby made FINAL.
Claims 23-24, 26-28, 30, 32, 35-47, and 69-70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Duplicate Claim Warning
Applicant is advised that should claims 4 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification makes no mention of the limitations of claims 51 and 55 which recite a perceived bitter flavor being reduced by at least 50% compared to maribavir when assessed according to the Flavor Profile Method or of perceived oral bitterness being reduced by at least 90% compared to maribavir when assessed according to the Flavor Profile Method.
Means-Plus-Function Interpretation
Claim 50 recites a “pharmaceutical composition comprising:(a) maribavir; (b) a pharmaceutically acceptable carrier or excipient; and (c) means for masking a perceived bitter flavor of maribavir”. Claims 51 and 55 further limit the degree of perceived bitter flavor stating “perceived bitter flavor is reduced by at least 50% compared to maribavir when assessed according to the Flavor Profile Method” in claim 51 and “perceived oral bitterness is reduced by at least 90% compared to maribavir when assessed according to the Flavor Profile Method” in claim 55.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claims 50-51 and 55 invoke means-plus-function interpretation.
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 51 and 55 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.
Claim 50 invokes means-plus-function interpretation due to the “means for” recitation followed by functional language and no structural recitation. The instant specification then states “[t]o successfully achieve taste masking of the bitter maribavir flavor, provided formulations employ both polymer coated maribavir granules and other agents (e.g., sweetener and flavorant)” (see paragraph 48). Various embodiments are discussed with varying degrees of specificity concerning the polymer coating and “other agents” that are located in the maribavir granules or outside (extragranular) the maribavir granules (see paragraphs 50-64 and 67). Claims 51 and 55 depend from claim 50 and recite perceived bitter flavor or perceived oral bitterness is reduced by particular amounts when assessed according to the Flavor Profile Method. While this method for assessing flavor is mentioned in paragraph 66, there is no discussion of any particular level of bitterness as assessed by this method nor any structure to achieve any particular level of bitterness reduction as assessed by this method. Thus the disclosure fails to provide adequate written description of the structure required to achieve the claimed function and the artisan of ordinary skill would not have deemed the application to be in possession of the invention as instantly claimed at the time of filing.
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 15, 48-49, 51, 55, and 68 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.
Claims 15 and 68 recite the trademark/trade names Eudragit® EPO as a limitation or parenthetically. 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 Eudragit® EPO is used to identify/describe a copolymer of butyl methacrylate dimethylaminoethyl methacrylate and methyl methacrylate. Accordingly, the identifications/descriptions are indefinite.
Claim 48 recites a composition for oral administration of maribavir but the body of the claim does not recite maribavir as a component. Thus it is unclear if the claim recites an intended use for a set of excipients that can also include maribavir if the claim requires the presence of maribavir.
Claims 51 and 55 recite perceived bitter flavor or oral bitterness reduction as assessed by the Flavor Profile Method. However, there are multiple times at which this method assesses bitterness such as an initial assessment upon placement in the mouth and at various times after oral administration/swallowing (see Pereira et al. US PGPub No. 2017/0224664; paragraphs 186-194). The claims are not specific about which times are to be considered and which can be compared to one another. Thus it is unclear which comparison is to made in the stated assessment. In addition, while coatings, sweeteners, and flavors are known to be able to reduce bitterness, the scope of coatings, excipient components, and their arrangement that achieve the claimed degree of bitter flavor or bitterness reduction is unclear because the components and configurations of a composition that achieves this function has been disclosed. Thus the structure required to fulfill the function of the means-plus-function claims is also unclear.
Claims that are rejected but are not explicitly elaborated upon are also indefinite because they depend from an indefinite clam and do not add clarity.
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.
Claim 14 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. The claim recites dissolution properties of the enteric polymer of its parent claim, but it is not clear that any enteric polymer would fail to be soluble at an acidic pH and insoluble a neutral pH such that the scope of the claim is narrower than that of the parent claim. 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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Coquerel et al. (US PGPub No. 2012/0178709) in view of Trofe et al. (Annals of Pharmacotherapy 2008 42:1447-1457), and Jain et al. (WO 2008122993) as evidenced by Appel et al. (US PGPub No. 2017/0266115).
Coquerel et al. teach maribavir as an antiviral medicinal compound envisioned along with a carrier in various forms that include tablets and suspensions (see abstract, paragraphs 2-3 and claims 1 and 4-5).
Trofe et al. teach that maribavir is known for oral administration and to elicit a strong bitter adverse response (see page 1450 first column first full paragraph, page 1452 second column last partial paragraph, page 1454 second column last partial paragraph and table 3).
Jain et al. teach of the benefit of oral reconstitutable pharmaceutical suspension formulations that avoid grittiness and the bad taste from the drug by providing the drug as a core coated with pH dependent, water insoluble polymer and dispersing the coated particles in a suspending medium (see page 3 lines 4-24, page 4 lines 34-38, page 5 line 33-page 6 line 3 and page 8 line 31-page 9 line 12; instant claim 50). The water insoluble polymers are envisioned as the polymer sold under the name Eudragit® EPO, a copolymer of butyl methacrylate dimethylaminoethyl methacrylate and methyl methacrylate (see page 8 line 31-page 9 line 12; Appel et al. paragraph 10). This coating polymer is insoluble at neutral pH, but soluble at acidic pH, making it an enteric polymer (see Appel et al paragraph 13; instant claim 14). Envisioned drugs include antiviral compounds (see page 6 lines 23-25 and 34). Jain et al. exemplify a reconstitutable suspension composed of drug granulate with the drug, copovidone, and microcrystalline cellulose as intragranular components that are coated with Eudragit® EPO (see example 1; instant claims 2, 4, 7, and 13). The coated granules are then included with extragranular components that include sucrose (sweetener), sucrose (diluent), and alginate (suspending/gelling agent) as a powder preparation that is reconstituted with water prior to use (see example 1, page 9 lines 32-34, page 10 lines19-26, and page 11 lines 31-33; instant claims 21-22 and 71). Flavoring agents are also taught in the composition (see page 10 lines 9-12; instant claims 2, 4, 7, and 13). Jain et al. further teach mannitol as an envisioned diluent along with microcrystalline cellulose (see page 10 lines 19-26; instant claims 7, 11, and 17). Viscosifying agents such as carboxymethyl cellulose sodium and alginic acid (alginate) are also envisioned components (see page 10 lines 35-38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a reconstitutable suspension composition to facilitate the preparation of an oral suspension of the maribavir of Coquerel et al. based on the coating configuration, excipient mixture, and assembly as exemplified by Jain et al. This modification would have been obvious so as to ameliorate the known bitter taste of maribavir when orally administered as detailed by Trofe et al. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. The maribavir qualifies as an antiviral drug agent for the composition of Jain et al. The addition of flavorant to the suspending excipients or intragranular excipients would follow, as suggested by Jain et al. The substitution of mannitol or microcrystalline cellulose for sucrose extragranular diluent would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome. Therefore claims 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71 are obvious over Coquerel et al. in view of Trofe et al. and Jain et al. as evidenced by Appel et al.
Claims 2, 4, 7, 10-11, 13-18, 21-22, 50, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Coquerel et al. in view of Trofe et al. and Jain et al. as evidenced by Appel et al. as applied to claims 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71 above, and further in view of Mate et al. (US PGPub No. 2012/0164216).
Coquerel et al. in view of Trofe et al. and Jain et al. as evidenced by Appel et al. render obvious the limitations of instant claims 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71, where the extragranular material includes sweetener, flavoring, thickener, and diluent material. The specific instantly claimed combination of extragranular excipients is not detailed.
Mate et al. teach a reconstitutable suspension with a taste masked drug particle that includes Eudragit® EPO in combination with an extragranular component that has several excipients (see paragraphs 1-2, 56-67 and examples 2 and 4). Here the combination of microcrystalline cellulose, sodium carboxymethyl cellulose, fruit flavor, and sucralose is described as well as the combination of mannitol and sucralose in an extragranular material as sweeteners (see paragraphs 64 and examples 2 and 4; instant claims 10, 16, and 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the reconstitutable suspension of Coquerel et al. in view of Trofe et al. and Jain et al. as evidenced by Appel et al. where the extragranular excipients are chosen in light of the teachings of Mate et al. such that diluent, filler, sweetener, flavoring and sweetener are provided by microcrystalline cellulose, sodium carboxymethyl cellulose, fruit flavor, and sucralose along with mannitol as an additional sweetener. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome for each of the categories of components. Therefore claims 2, 4, 7, 10-11, 13-18, 21-22, 50, and 71 are obvious over Coquerel et al. in view of Trofe et al., Jain et al., and Mate et al. as evidenced by Appel et al.
Claims 2, 4, 7, 11, 13-18, 21-22, 50-51, 55, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Coquerel et al. in view of Trofe et al. and Jain et al. as evidenced by Appel et al. as applied to claims 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71 above, and further in view of Pereira et al.
Coquerel et al. in view of Trofe et al. and Jain et al. as evidenced by Appel et al. render obvious the limitations of instant claims 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71 in a taste masking composition to reduce the bitterness of maribavir. The impact of the composition excipients on maribavir bitterness is not detailed.
Pereira et al. teach a reconstitutable suspension for taste masking a bitter drug (see abstract and paragraph 98). They detail particularly effective combinations of taste masking sweeteners and flavors, namely sucrose with sucralose and a cherry or bubblegum flavor in an extragranular excipient mixture (see figures 1, 6A-7B, formulations 12 and 14, and paragraphs 24-27, 186-194, 196-197, and 199; instant claims 16 and 18). Here the control formulation scored an initial 3 for bitterness via the Flavor Profile Method that decayed to 1.25 over 30 minutes after swallowing, while the addition of the taste masking extragranular excipients of formulations 12 and 14 dropped the initial bitterness perception to a score of 0.5 which decayed to zero by 20 minutes after swallowing (see figures 1 vs figures 6A and 7A; instant claims 51 and 55). This meets the limitation of an at least 50% reduction in bitterness comparing the initial bitterness values and an at least 90% reduction comparing the bitterness at 20 minutes post-swallowing (see instant claims 51 and 55).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the reconstitutable suspension of Coquerel et al. in view of Trofe et al. and Jain et al. as evidenced by Appel et al. where the extragranular excipients are chosen in light of the teachings of Pereira et al. formulations 12 and 14 et al. such that the sweeteners, flavorant, and other extragranular components not already present in the Pereira et al. compositions are employed. These choices are obvious so as to further improve the bitterness reduction of the maribavir. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome as well as the application of the same technique to a similar product in order to yield the same improvement. According to MPEP 2145II, mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). In addition, the fact that an inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The composition rendered obvious has the claimed components in the claimed configuration as well as components explicitly linked in the prior art to achieve the claimed bitterness reduction function, thus the composition rendered obvious would achieve the claimed reduction in bitterness flavor as compared to maribavir, absent evidence to the contrary. Therefore claims 2, 4, 7, 11, 13-18, 21-22, 50-51, 55, and 71 are obvious over Coquerel et al. in view of Trofe et al., Jain et al., and Pereira et al. as evidenced by Appel et al.
Claims 2, 11, 13-15, 18, 21-22, 50, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Coquerel et al. in view of Trofe et al., and Javeri (US PGPub No. 2013/0115300) as evidenced by Appel et al.
Coquerel et al. teach maribavir as a medicinal compound envisioned along with a carrier in various forms that include tablets and suspensions (see abstract, paragraph 2 and claims 1 and 4-5).
Trofe et al. teach that maribavir is known for oral administration and to elicit a strong bitter adverse response (see page 1450 first column first full paragraph, page 1452 second column last partial paragraph, page 1454 second column last partial paragraph and table 3).
Javeri teaches the amelioration of bitter taste of a drug active in an oral drug suspension by providing the suspended granulated active with a taste masking coating composed of methacrylate copolymers that is included with an extragranular mixture of additional excipients and taste modulators in powder form (see abstract, paragraphs 11-12, 15, 25-29, and 93-95; instant claims 21-22 50, and 71). This composition may be combined with water prior to consumption (see abstract, paragraphs 11-12, 15, 25-29, and 93-95; instant claims 21 and 71). The extragranular material includes flavorants, sweetener, glidant, suspending agent, and diluent (see paragraphs 28 and 93-95). They teach the drug containing granulate to include microcrystalline cellulose (diluent) as well as starch (disintegrant) (see paragraphs 46 and 55; instant claim 2). The granulate coating includes the methacrylate copolymers sold under the name Eudragit® EPO, a copolymer of butyl methacrylate dimethylaminoethyl methacrylate and methyl methacrylate (see paragraphs 55-56 and 74-75; Appel et al. paragraph 10; instant claims 2 and 15). This coating polymer is insoluble at neutral pH but soluble at acidic pH making it an enteric polymer (see Appel et al. paragraph 13; instant claim 14). The flavors included are exemplified as fruit flavors (see paragraphs 67-95; instant claim 18). Suspending agents are envisioned as sodium carboxymethyl cellulose (see paragraph 47; instant claim 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a reconstitutable suspension to facilitate the preparation of an oral suspension of maribavir of Coquerel et al. based on the coating configuration, excipient mixture, and assembly as taught by Javeri. This modification would have been obvious so as to ameliorate the known bitter taste of maribavir when orally administered as detailed by Trofe et al. The modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. The inclusion of exemplary and envisioned excipients as arranged by Javeri would follow. Therefore claims 2, 11, 13-15, 18, 21-22, 50, and 71 are obvious over Coquerel et al. in view of Trofe et al. and Javeri as evidenced by Appel et al.
Claims 2, 11, 13-16, 18-22, 48-50, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Coquerel et al. in view of Trofe et al. and Javeri as evidenced by Appel et al. as applied to claims 2, 11, 13-15, 18, 21-22, 50, and 71 above, and further in view of Chen (CN 101204375 – English translation referenced for citations).
Coquerel et al. in view of Trofe et al. and Javeri as evidenced by Appel et al. render obvious the limitations of instant claims 2, 11, 13-15, 18, 21-22, 50, and 71 where the extragranular material includes sucrose and aspartame as sweeteners, sucralose is not explicitly taught.
Chen teaches a dry suspension where the extragranular excipients include sucralose (see paragraph 2 and example 4; instant claim 16). They detail the sweeteners to be envisioned as sucralose as well as aspartame (see paragraph 16; instant claim 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to exchange sucralose for the aspartame in the extragranular mixture of Coquerel et al. in view of Trofe et al. and Javeri as evidenced by Appel et al. This modification would have been obvious in light of Chen as the simple substitution of one known element for another in order to yield predictable outcome. Therefore claims 2, 11, 13-16, 18-22, 48-50, and 71 are obvious over Coquerel et al. in view of Trofe et al., Javeri, and Chen and as evidenced by Appel et al.
Claims 2, 11, 13-15, 18-22, 48-50, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Coquerel et al. in view of Trofe et al. and Javeri as evidenced by Appel et al. as applied to claims 2, 11, 13-15, 18, 21-22, 50, and 71 above, and further in view of Jeong et al. (KR 20060092375 – English translation referenced for citations)
Coquerel et al. in view of Trofe et al. and Javeri as evidenced by Appel et al. render obvious the limitations of instant claims 2, 11, 13-15, 18, 21-22, 50, and 71 where an enteric coated intragranular powder is present as part of a dry suspension. The instantly claimed particle sizing is not detailed.
Jeong teach a dry suspension composed of coated drug cores to form the suspension where the coating is composed of enteric methacrylate polymers to overcome the bitter taste otherwise experienced from the drug active (see page 2 first full paragraph). The enteric polymers include methacrylic acid polymers (see page 3 first paragraph). They teach sizing the cores at 180 to 350 mm prior to coating and less than 400 mm after coating to easily disperse and avoid foreign body sensation during oral administration (see page 2 first full paragraph; instant claims 19-20 and 48-49).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the uncoated granulate and coated granules of maribavir in the product of Coquerel et al. in view of Trofe et al. and Javeri as evidenced by Appel et al. based on the sizes detailed by Jeong et al. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The sizing of the coated cores is greater than 180 mm to less than 400 mm which makes the median size of the particles also within this range. The possible median size range then embraces those instantly claimed, thereby rendering the claimed ranges obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). There is no evidence of criticality of the claimed sizing. Therefore claims 2, 11, 13-15, 18-22, 48-50, and 71 are obvious over Coquerel et al. in view of Trofe et al., Javeri, and Jeong et al. as evidenced by Appel et al.
Claims 2, 11, 13-15, 18-22, 48-50, 56, 59-60, 63, 65, 67-68, and 71 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Coquerel et al. in view of Trofe et al., Javeri, and Jeong et al. as evidenced by Appel et al. as applied to claims 2, 4, 7, 11, 13-15, 17, 21-22, 50, and 71 above, and further in view of Lu et al. (US PGPub No. 2019/006237).
Coquerel et al. in view of Trofe et al., Javeri, and Jeong et al. as evidenced by Appel et al. render obvious the limitation of instant claims 2, 11, 13-15, 18-22, 48-50, and 71. Amongst the limitations that are rendered obvious, the recitations of instant claims 59-60, 63, 65-67-68 and most of those of instant claim 56 are included. The coated granules are blended with the extragranular excipients and filled into packaging (see example 1; instant claim 56). Example 1 provides the extragranular material with sucrose (diluent), aspartame (sweetener), fruit powder flavor (flavorant) and other excipients. The size of the sucrose is not detailed.
Lu et al. teach a reconstitutable liquid oral suspension that includes sucrose as a component outside the drug particles (see paragraphs 4 and 11-12). They teach the sucrose to preferably have a D90 of 50 to 400 mm (see paragraph 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ sucrose sized as taught by Lu et al. in the extragranular portion of the suspension preparation of Coquerel et al. in view of Trofe et al., Javeri, and Jeong et al. as evidenced by Appel et al. This modification would have been obvious because it was known to be suitable for inclusion amongst the extragranular excipients in an oral suspension. The selection is also obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific sucrose vs generic sucrose). The result is a range of sizes that have a range of median overlaps or embraces that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 2, 11, 13-15, 18-22, 48-50, 56, 59-60, 63, 65, 67-68, and 71 are obvious over Coquerel et al. in view of Trofe et al., Javeri, Jeong et al., and Lu et al. as evidenced by Appel et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
