DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Election/Restriction
Applicant’s election of Group I, claims 1-13, and the species mannitol, sodium starch glycolate, and sodium stearyl fumarate in the reply filed on 1 July 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of Claims
Claims 1-16 are pending in the instant Office Action.
Claims 14-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election has been treated as being made without traverse in the reply filed on 1 July 2026.
Claims 1-13 are under consideration in the instant Office Action, to the extent of the following elected species:
the specific diluent mannitol;
the specific disintegrant sodium starch glycolate; and
the specific lubricant sodium stearyl fumarate.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of parent India Application No. IN 202241012175, filed on 7 April 2022, has been received from the International Bureau.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 November 2024, was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2-9 are objected to for the following informalities:
Claims 2-9 should recite a comma after the phrase “claim 1” in each of claims 2-9 (e.g., “composition of claim 1,”).
Claim 6 recites the composition of claim 1 to be in the form of “a tablet, capsules, granules, powder, pellets, and sachets” (bold added for emphasis). The word “and” is believed to have been erroneously put into the end of the list as one composition cannot be all 6 forms simultaneously, and the bolded word should be replaced with “or”.
Claim 7 recites “wherein one or more pharmaceutically acceptable excipients”. The claim should recite “wherein the one or more pharmaceutically acceptable excipients” (bold added for emphasis).
Claim 9 recites “in the form a tablet” in line 2. The word “of” should be inserted so the resulting phrase reads “in the form of a tablet” (bold added for emphasis).
Appropriate correction is required.
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.
Claims 9-12 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 9 recites a weight ratio of erdafitinib to “the uncoated core tablet”. There is insufficient basis for this limitation in the claims because neither claim 9 nor claim 1, from which claim 9 depends, recite an uncoated core tablet. Applicant may overcome this rejection by amending claim 9 to clarify the components comprising “the uncoated core tablet”. Instant spec. discloses in Examples 2 and 4 compositions that comprise 5 mg erdafitinib and core table weights of 125 mg, which is a weight ratio of erdafitinib to the total weight of the uncoated core tablet of 1:25. If this is the intended meaning of the limitation in claim 9, Applicant should amend the claim accordingly – however, Applicant is notified that this is equivalent to erdafitinib being 4% w/w of the total weight of the uncoated core tablet.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 10 and 11 recite a range followed by “preferably” a smaller range and “more preferably” a still smaller range in parts a.-e. and a.-d., respectively. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by the narrower language of preferably and more preferably is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 12 depends from claim 11, incorporates all of its limitations, and is therefore also indefinite. Applicant may overcome this rejection by amending each claim to only recite one range for each species and/or genre.
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.
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 1-8 are rejected under 35 U.S.C. 103 as being obvious over Teva Pharmaceuticals International GMBH (WIPO International Publication No. WO 2022/040111 A2, published on 24 February 2022, provided by Applicant in the IDS filed on 18 November 2024, hereafter referred to as Teva).
Teva teaches solid forms of erdafitinib and pharmaceutical compositions comprising the drug (Abstract). Erdafitinib is taught to be a “fibroblast growth factor receptor inhibitor” with potential in treating cancer and genetic alternations (para. [0003]). Teva teaches that erdafitinib may be in a solid pharmaceutical composition in the form of a tablet and comprise excipients such as diluents, disintegrants, and lubricants (para. [00116-00120] and claims 14 and 119). In some embodiments, the diluent may be mannitol (para. [00116]), the disintegrant may be sodium starch glycolate (para. [00118]), and the lubricant may be sodium stearyl fumarate (para. [00120]). Finally, Teva does not teach the composition to comprise a formaldehyde scavenger.
Teva is silent regarding the change in erdafitinib content of their pharmaceutical composition during storage. However, the storage properties of the pharmaceutical composition recited in claims 2-5 arise from the composition of the pharmaceutical composition. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP § 2112.01. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
"[I]nherency may supply a missing claim limitation in an obviousness analysis." PAR, 773 F.3d at 1194-1195; see also Endo Pharms. Sols., Inc. v. Custopharm Inc., 894 F.3d 1374, 1381, 127 U.S.P.Q.2D (BNA) 1409 (Fed. Cir. 2018). It is long settled that in the context of obviousness, the "mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not distinguish a claim drawn to those things from the prior art." In re Oelrich, 666 F.2d 578, 581 (C.C.P.A. 1981). The Supreme Court explained long ago that "[i]t is not invention to perceive that the product which others had discovered had qualities they failed to detect." Gen. Elec. Co. v. Jewel Incandescent Lamp Co., 326 U.S. 242, 249, 66 S. Ct. 81, 90 L. Ed. 43, 1946 Dec. Comm'r Pat. 611 (1945).
Inherency, however, is a "high standard," that is "carefully circumscribed in the context of obviousness." PAR, 773 F.3d at 1195. Inherency "may not be established by probabilities or possibilities," and "[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient." Oelrich, 666 F.2d at 581 (emphasis added) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214, 26 C.C.P.A. 937, 1939 Dec. Comm'r Pat. 327 (C.C.P.A. 1939); see also In re Rijckaert, 9 F.3d 1531, 1533-1534 (Fed. Cir. 1993). Rather, inherency renders a claimed limitation obvious only if the limitation is "necessarily present," or is "the natural result of the combination of elements explicitly disclosed by the prior art." PAR, 773 F.3d at 119511-96; see also Alcon Research, Ltd. v. Apotex Inc., 687 F.3d 1362, 1369 (Fed. Cir. 2012). Because Teva teaches the pharmaceutical composition comprising erdafitinib and the elected excipients mannitol, sodium starch glycolate, and sodium stearyl fumarate as recited in instant claims 1-7, the claimed storage stability is necessarily present.
Instant claim 8 is interpreted as a product-by-process claim. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP § 2113. Therefore, because Teva teaches the product recited in claim 1, instant claim 8 is unpatentable and Teva anticipates instant claims 1-8.
Although “picking, choosing, and combining various disclosures not directly related to each other by the teachings of the cited reference...has no place in...a 102, anticipation rejection,” picking and choosing may be entirely proper in an obviousness rejection. In re Arkley, 455 F.2d 586, 587 (CCPA 1972). Addressing the issue of obviousness, the Supreme Court noted that analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007)). The Court further emphasized that “[a] person of ordinary skill is…a person of ordinary creativity, not an automaton” (Id. at 1742).
The only difference between Teva and instant claims 1-8 is that Teva does not teach the specific combination of components as claimed in a single embodiment (e.g., one composition comprising erdafitinib, the specific diluent mannitol, the specific disintegrant sodium starch glycolate, and the specific lubricant sodium stearyl fumarate), or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Teva, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Where, as here, the reference does not provide any explicit motivation to select this specific combination of variables, anticipation cannot be found. However, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” See MPEP § 2141.I. Consistent with this reasoning, it would have been prima facie obvious to a person having ordinary skill in the art, prior to the effective filing date of the instant application, to have selected various combinations of the various disclosed ingredients from within the teachings of Teva, to arrive at an invention such as the one being sought.
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Teva (WIPO International Publication No. WO 2022/040111 A2, published on 24 February 2022, provided by Applicant in the IDS filed on 18 November 2024) in view of Broggini (U.S. Patent No. 10,898,482 B2, cited by Applicant in the IDS filed on 18 November 2024).
Teva has been described above.
Teva does not teach the quantity of erdafitinib, mannitol, sodium starch glycolate, or sodium stearyl fumarate in their solid tablet composition. These deficiencies are offset by the teachings of Broggini.
Broggini teaches pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine, commonly known as erdafitinib (Abstract). When the composition is in the form of a tablet, erdafitinib is taught to be present in an amount from 0.5-20 mg (col. 6, line 60 - col. 7, line 12). Broggini teaches tablets that have weights of 150, 200, or 250 mg, which would result in erdafitinib being present in amounts from 0.2-13% w/w (Composition Tablets 1, 2, and 3). In Composition Tablets 1, 2, and 3, Broggini teaches erdafitinib to be present in amounts of 3, 4, and 5 mg, respectively, which account for 2% w/w of the total weight of the uncoated tablets.
The tablets are further taught to comprise diluents in amounts from 85-95% w/w and in one embodiment the diluent may be mannitol (col. 8, line 62 - col. 9, line 9). In specific examples, Broggini teaches tablets comprising 20-95% w/w mannitol, which would be 50-142.5 mg, based on the total mass of the tablets (Composition Tablets 1, 2, and 3). Disintegrants are taught to be present in an amount from 2.5-15% w/w, which would be 6.25-22.5 mg, based on the total mass of the tablets (col. 8, lines 49-61 and Composition Tablets 1, 2, and 3). Finally, Broggini teaches lubricants to be present in their compositions in an amount from 0.2-7.0% w/w, which would be 0.5-10.5 mg, based on the total mass of the tablets (col. 9, lines 24-26 and Composition Tablets 1, 2, and 3).
It would have been prima facie obvious to a person of ordinary skill in the art, prior to the filing of the instant application, to combine the teachings of Teva and Broggini to arrive at the invention of instant claims 9-13 because combining prior art elements from similar inventions to provide missing information produces predictable results. Teva anticipated a pharmaceutical composition in the form of a solid tablet comprising erdafitinib, mannitol, sodium starch glycolate, and sodium stearyl fumarate, but did not teach quantities of any component. An ordinary artisan would be motivated by the teachings of Broggini to use the quantities cited above in the composition of Teva because Teva did not teach any quantities and the ordinary artisan would desire the teachings of Broggini to complete their invention. Broggini teaches their quantities to be suitable for solid tablet compositions comprising erdafitinib and one of ordinary skill would have a reasonable expectation of success in using the quantity ranges in another solid table pharmaceutical composition comprising erdafitinib and many of the same excipients. As a result, there is a reasonable expectation of success in arriving at the invention of claims 9-13 in view of the teachings of Teva and Broggini.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure includes:
the FDA prescribing information for Balversa® (approved for sale in 2019, document last revised April 2020), which comprises 3, 4, and 5 mg erdafitinib, mannitol as a diluent, croscarmellose sodium as a disintegrant, magnesium stearate as a lubricant, and microcrystalline cellulose as a filler/binder (pg. 12, 11. Description); and
U.S. Patent No. 10,786,489 B2 (priority to 10 October 2018) which teaches solid tablet pharmaceutical compositions (col. 4, lines 10-17) comprising selpercatinib, mannitol as a diluent (col. 2, lines 57-67), sodium starch glycolate as a disintegrant (col. 3, lines 39-60), sodium stearyl fumarate as a dispersing agent (col. 21, lines 33-56), and erdafitinib as a fibroblast growth factor receptor (FGFR) inhibitor (col. 202, lines 1-12).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sean J. Steinke, Ph.D., whose telephone number is (571) 272-3396. The examiner can normally be reached Mon. - Fri., 09:00 - 17:00 ET.
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/S.J.S./
Examiner, Art Unit 1619
/TIGABU KASSA/ Primary Examiner, Art Unit 1619
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