SYNTHON B.V.

Patent Trials and Appeals Board

Jan 13, 2022

2021004427 (P.T.A.B. Jan. 13, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 16/322,571 02/01/2019 Sonia GARCIA JIMENEZ P1709US00/PF-333 8555 38427 7590 01/13/2022 Buscher Patent PLLC 7371 Atlas Walk Way #136 Gainesville, VA 20155 EXAMINER NEAGU, IRINA ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 01/13/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): jls@buscherpatent.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte SONIA GARCIA JIMENEZ, LUIS NOGUEIRAS NIETO, LISARDO ALVAREZ FERNANDEZ, and JOSE VELADA CALZADA Appeal 2021-004427 Application 16/322,571 Technology Center 1600 ____________ Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and ULRIKE W. JENKS, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM IN PART. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Synthon BV. Appeal Br.1. Appeal 2021-004427 Application 16/322,571 2 STATEMENT OF THE CASE Pomalidomide is an anti-angiogenic compound that also acts as an immunomodulator in the treatment of multiple myeloma. Spec. 1:8-9. According to the Specification, pomalidomide is practically insoluble in water. Spec. 1, 13. The Specification explains that there is a need to formulate pomalidomide to “exhibit excellent long term stability and which are suitable for production on commercial scale by applying techniques and equipment commonly used in industry.” Id. at 2:16-18. The pharmaceutical composition described in the Specification contains pomalidomide, maltodextrin, and a filler. Id. at 5:2. Claims 1-9, 11, 14-17, and 20 are on appeal, and can be found in the Claims Appendix of the Appeal Brief.2 Claim 1, the sole independent claim,3 is representative of the claims on appeal, and reads as follows: 1. A pharmaceutical composition comprising pomalidomide, maltodextrin and a filler, wherein the weight ratio of 2 Herein we refer to the Final Office Action mailed April 6, 2020 (“Final Act.”), Appeal Brief submitted January 19, 2021 (“Appeal Br.”), Examiner’s Answer mailed May 3, 2021 (“Ans.”), and Reply Brief submitted July 6, 2021 (“Reply Br.”). 3 During oral argument held on December 15, 2021, Appellant directed our attention to a species election made during prosecution. Tr. 5:14-17, 17:14- 16. In the response to the election in the restriction requirement made by Examiner, Appellant elected the species microcrystalline cellulose as the filler, sodium stearyl fumarate as the lubricant, and croscarmellose sodium as the disintegrant. See Response filed December 6, 2019. We note that a species election is a tool to focus initial examination on a species of the applicant’s choosing. A species election, however, does not limit the claims to the elected species when the language of the claim encompasses a broader scope. In this case, claim 1 is not limited to microcrystalline cellulose as the filler and therefore encompasses other fillers. See, e.g., Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). Appeal 2021-004427 Application 16/322,571 3 maltodextrin to filler ranges from 1:1 to 1:2, said composition is in the form of a capsule, and said composition exhibits a dissolution rate of at least 65% in 15 minutes and at least 90% in 45 minutes when tested in aqueous hydrochloric acid 0.1 N in a USP apparatus II at 50-100 rpm, 37°C. Appeal Br. 30 (Claims Appendix). REJECTIONS Appellant requests review of the following grounds of rejection made by Examiner: 1) Claims 1-9, 11, 14-17, and 20 under 35 U.S.C. §103 over Tutino4 in view of Stahly;5 and 2) Claims 1-9, 11, 14-17, and 20 under 35 U.S.C. §103 over Tutino in view of Stahly and further in view of Guajardo- Flores6 and Nazzal.7 I. Obviousness over Tutino and Stahly The issue is whether the preponderance of evidence of record supports Examiner’s conclusion that the combination of Tutino and Stahly renders the claims directed to a pharmaceutical composition comprising pomalidomide, maltodextrin, and a filler in the recited weight ratio obvious? 4 Tutino et al., US 2011/0045064 A1, published Feb. 24, 2011 (“Tutino”). 5 Stahly et al., US 2016/0039785 A1, published Feb. 11, 2016 (“Stahly”). 6 Guajardo-Flores et al., Influence of excipients and spray drying on the physical and chemical properties of nutraceutical capsules containing phytochemicals from black bean extract, 20 MOLECULES 21626-35 (2015) (“Guajardo-Flores”). 7 Nazzal et al., Effect of extracellular microcrystalline cellulose on compaction, surface roughness, and in vitro dissolution of a self- nanoemulsified solid dosage form of ubiquinone, PHARMACEUTICAL TECHNOLOGY 86-98 (2002) (“Nazzal”). Appeal 2021-004427 Application 16/322,571 4 A. Findings of Fact (FF) FF1. Tutino teaches pharmaceutical compositions containing 0.5-5 mg strength pomolidomide dosage capsules. Tutino ¶¶ 135-146 (Examples 1-6). “Pomolidomide [(4-amino-2-(2,6-dioxopiperidine-3- yl)isoindoline-1,3-dione)] is an immunomodulatory compound that inhibits, for example, LPS induced monocyte TNFα, IL-1β, IL-12, IL- 6, MIP-1, MCP-1, GMCSF, G-CSF, and COX-2 production. The compound is also known to co-stimulate the activation of T-cells.” Tutino ¶ 4. Table 1 of Tutino is reproduced below: Table 1, reproduced above, shows a formulation of pomolidomide, starch 1500, sodium sterile fumarate, and spray dried mannitol. Tutino ¶ 135. Tables 2-6 corresponding to examples 2 to 6 of Tutino, show capsules having formulations from 1-5 mg pomolidomide. Tutino ¶¶ 135-146. FF2. Stahly teaches pomalidomide (4-amino-2-(2,6-dioxopiperidine-3- yl)isoindoline-1,3-dione) in pharmaceutical compositions. See Stahly, Abstract, ¶ 8. Specifically, Stahly teaches using “solid forms (e.g., Appeal 2021-004427 Application 16/322,571 5 crystal forms, amorphous forms, or mixtures thereof) comprising (a) a free base of pomalidomide, or a solvate, hydrate, stereoisomer, prodrug, or clathrate thereof; and (b) a coformer.” Stahly ¶ 57. Cocrystals are crystalline molecular complexes of two or more non-volatile compounds bound together in a crystal lattice by non-ionic interactions. Pharmaceutical cocrystals are cocrystals of a therapeutic compound, e.g., an active pharmaceutical ingredient (API), and one or more nonvolatile compound(s) (referred to herein as coformer). A coformer in a pharmaceutical cocrystal is typically a nontoxic pharmaceutically acceptable molecule, such as, for example, food additives, preservatives, pharmaceutical excipients, or other APIs. In recent years, pharmaceutical cocrystals have emerged as a possible alternative approach to enhance physicochemical properties of drug products. Id. ¶ 6 FF3. Stahly teaches formulating oral dosage forms as tablets or capsules. Stahly ¶ 265, see also id. ¶ 280 (“The hard gelatin capsule, also known as the dry-filled capsule (DFC), consists of two sections, one slipping over the other, thus completely enclosing the active ingredient”). “[T]he total amount of pomalidomide in the capsule is about 1 mg, about 2 mg, about 3 mg, about 4 mg, or about 5 mg. . . . Each capsule can contain pomalidomide as the active ingredient and one or more of the following inactive ingredients: mannitol, pregelatinized starch and sodium stearyl fumarate.” Id. “[T]he capsule composition may additionally include polymers, colorings, flavorings and opacifiers as required. In certain embodiments, the capsule comprises HPMC.” Id. FF4. Stahly teaches the use of a binding agent “in an amount of from Appeal 2021-004427 Application 16/322,571 6 about 50% to about 99% w/w.” Stahly ¶ 269. “Binders may be used, e.g., to impart cohesive qualities to a tablet or a capsule, and thus ensure that the formulation remains intact after compression.” Stahly provides a list of suitable binders that includes but is not limited to the following: starch (including potato starch, com starch, and pregelatinized starch), microcrystalline cellulose, maltodextrin, and maltose among others. Id. FF5. Stahly teaches the use of a diluent to achieve the desired volume for a tablet or capsule. “Diluents may be used in amounts calculated to obtain a desired volume for a tablet or capsule.” Stahly ¶ 272. Stahly provides a list of suitable diluents that includes but is not limited to the following: pregelatinized starch, mannitol, and maltodextrin among others. Id. FF6. Stahly teaches the use of a disintegrants such as croscarmellose among others. Stahly ¶ 274. FF7. Stahly teaches capsules made up of “one or more solid forms comprising pomalidomide and a conformer.” Stahly ¶ 277. The oral dosage from also can include one or more excipients such as microcrystalline cellulose as well as one or more “inactive ingredients: mannitol, pregelatinized starch, sodium stearyl fumarate, gelatin, titanium dioxide, FD&C blue 2, yellow iron oxide, white ink, black ink, FD&C red 3, and a combination thereof.” Id. B. Analysis Examiner finds that Tutino teaches “a pharmaceutical composition comprising pomalidomide 2%, pregelatinized starch 56%, mannitol (filler) Appeal 2021-004427 Application 16/322,571 7 41.7%, sodium stearyl fumarate (lubricant) 0.3%.” Ans. 3 (citing Tutino Example 6); FF1. Examiner finds that Tutino’s pharmaceutical composition contains pomalidomide “in an amount of 2% by weight of the composition.” Ans. 3. Examiner finds that Tutino also teaches the use of the lubricant sodium stearyl fumarate. Id. Examiner acknowledges that Tutino does not disclose the use of maltodextrin in the pharmaceutical formulation containing pomalidomide, or the weight ratio of maltodextrin to filler in a range from 1:1 to 1:2 as claimed. Ans. 4. Examiner looks to Stahly for teaching pomalidomide in an oral dosage from that includes capsules that contain excipients such as binders, fillers, diluents, disintegrated, and lubricants. Ans. 4 (citing Stahly ¶¶ 265, 277); see FF2-FF7. Based on the combined teachings of Tutino and Stahly, Examiner concludes that a person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated: to replace pregelatinized starch and mannitol from a pharmaceutical composition compromising pomalidomide taught by Tutino, with microcrystalline cellulose and maltodextrin, because Stahly teaches that pregelatinized starch, microcrystalline cellulose and maltodextrin can be used interchangeably as binders, and Stahly also teaches that microcrystalline cellulose, mannitol, pregelatinized starch can be used to replace pregelatinized starch and mannitol interchangeably as fillers, and Stahly further teaches that microcrystalline cellulose, pregelatinized starch, maltodextrin and mannitol can be used interchangeably as diluents in pharmaceutical compositions of pomalidomide. Ans. 5-6; FF1-FF7. Appellant contends that Examiner’s rejection does not provide (a) an adequate motivation to modify Tutino, (b) a reasonable expectation of success, and (c) an adequate response to Appellant’s showing of unexpected Appeal 2021-004427 Application 16/322,571 8 results using the pharmaceutical formulation containing pomalidomide, maltodextrin, and microcrystalline cellulose filler. We address Appellant’s contentions below: 1. Motivation to combine Appellant contends that the rejection does not provide adequate motivation to modify to Tutino because to Tutino already teaches a successfully stabilized pomalidomide composition, and therefore, there is no motivation to change the excipients. Appeal Br. 17. Appellant further contends that “when it comes to capsule compositions, specifically, Stahly does not include or suggest maltodextrin as being appropriate.” Id. at 15. We are not persuaded by Appellant’s contention that the combination as articulated by Examiner is insufficient. Here, Examiner is relying substituting Stahly’s fillers and diluents for the fillers and diluents disclosed in Tutino. See Ans. 6 (“Stahly further teaches that microcrystalline cellulose, pregelatinized starch, maltodextrin and mannitol can be used interchangeably as diluents in pharmaceutical compositions of pomalidomide.”); FF5. “[W]hen a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007), citing United States v. Adams, 383 U.S. 39, 50-51 (1966). “Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious.” In re Fout, 675 F.2d 297, 301, (CCPA 1982); see also In re Mayne, 104 F.3d 1339, 1340 (Fed. Cir. 1997) (“Because the applicants Appeal 2021-004427 Application 16/322,571 9 merely substituted one element known in the art for a known equivalent, this court affirms [the rejection for obviousness].”). Tutino teaches formulating pomalidomide with a starch, a lubricant, and a filler. FF1. Stahly similarly teaches formulating a pomalidomide containing compositions in conjunction with fillers and diluents. See FF2- FF7. Based on the combined teachings of Tutino and Stahly we are not persuaded by Appellant’s contention that the teachings are insufficient to support a conclusion that it would have been obvious to substitute any of the diluents and fillers disclosed in Stahly for those taught in Tutino. Especially, Stahly like Tutino already discloses capsules containing pomalidomide as the active ingredient and one or more of the following inactive ingredients: mannitol, pregelatinized starch and sodium stearyl fumarate. Compare FF3 with FF1. Stahly, however, does not exemplify any capsule formulations and therefore consultation with Tutino for guidance in formulating the same active ingredient in a capsule is reasonable. We are also not persuaded by Appellant’s contention that Stahly teaches a different solid form of pomalidomide as claimed. Appeal Br. 14; Reply Br. 4. We agree with Examiner, “the fact that Stahly formulates solid forms of pomalidomide and a conformer does not diminish in any way the general teaching by Stahly that pharmaceutical compositions of pomalidomide as the active ingredient contain one or more inactive ingredients/excipients such as binders, fillers, or diluents.” Ans. 13 (emphasis added). We further note that claim 1 recites a composition “comprising” pomalidomide. “‘Comprising’ is a term of art used in claim language which means that the named elements are essential, but other elements may be Appeal 2021-004427 Application 16/322,571 10 added and still form a construct within the scope of the claim.” Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501 (Fed. Cir. 1997). Here, Stahly teaches pomalidomide in a solid form that contains a freebase of pomalidomide as the active pharmaceutical ingredient in conjunction with a coformer. Cocrystals are crystalline molecular complexes of two or more non-volatile compounds bound together in a crystal lattice by non-ionic interactions. Pharmaceutical cocrystals are cocrystals of a therapeutic compound, e.g., an active pharmaceutical ingredient (API), and one or more nonvolatile compound(s) (referred to herein as coformer). A coformer in a pharmaceutical cocrystal is typically a nontoxic pharmaceutically acceptable molecule, such as, for example, food additives, preservatives, pharmaceutical excipients, or other APIs. In recent years, pharmaceutical cocrystals have emerged as a possible alternative approach to enhance physicochemical properties of drug products. FF2. The solid form disclosed in Stahly still contains pomalidomide as the active pharmaceutical ingredient even if it is bound to a coformer for the purpose of formulating the pharmaceutical composition. Based on the comprising language as recited in the claims, the claims can reasonably include coformer crystals. After all the interaction between the coformer and the pomalidomide is based on non-ionic interactions indicating that the active ingredient remains the same. Furthermore, we note that the Specification also does not limited the active ingredient to a particular form of pomalidomide. We are also not persuaded by Appellant’s contention that “examiner impermissibly plucked maltodextrin out of a long list of excipients.” Id. at 16. In this case, “the fact that Stahly formulates solid forms of pomalidomide and a coformer does not diminish in any way the general Appeal 2021-004427 Application 16/322,571 11 teaching by Stahly that pharmaceutical compositions of pomalidomide as the active ingredient contain one or more inactive ingredients/excipients such as binders, fillers, or diluents.” Ans. 13. Stahly just like Tutino discloses capsules comprising pomalidomide, mannitol, pregelatinized starch and sodium stearyl fumarate. Compare FF3 with FF1. Stahly does not exemplify formulations using the inactive ingredients mannitol, pregelatinized starch and sodium stearyl fumarate, but Tutino exemplifies pomalidomide formulations using the same inactive ingredients. Therefore, we find no error with Examiner’s use of Tutino as a starting point for formulating pomalidomide containing capsules. Picking from a list is obvious. Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (A “strong case of obviousness based on the prior art references of record. [The claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known . . . agent for another.”). Here, Stahly teaches a finite number of identified binding agents and diluents that could be substituted for those disclosed in the pomalidomide containing capsules taught by both Tutino and Stahly (see FF1, FF3-FF5), this is the “product not of innovation but of ordinary skill and common sense.” See Wrigley, 683 F.3d at 1364-65 (citing KSR, 550 U.S. at 421); see also Ans. 14 (“These are well known and most commonly used ingredients/excipients in pharmaceutical compositions, and have been taught by Stahly to be compatible with pomalidomide. Choosing any of these well-known pharmaceutical ingredients to formulate pomalidomide as a capsule is well within the skill of the artisan.”). Specifically, Stahly teaches a list of art recognized binding agents that include microcrystalline cellulose, Appeal 2021-004427 Application 16/322,571 12 maltodextrin, and pregelatinized starch. See FF4. Stahly, therefore, teaches that these binding agents are equivalents. See FF4; Ans. 5-6. Stahly also teaches that pregelatinized starch and maltodextrin could be substituted for mannitol based on their art recognized status as diluents. FF4; Ans. 5-6. Based on the disclosures of Tutino and Stahly, we conclude that the evidence cited by Examiner supports a prima facie case of obviousness with respect to claim 1. 2. Reasonable expectation of success Appellant contends that given the difficulty of formulating pomalidomide there would have been no reasonable expectation of success. Specifically, “[t]he EPAR tells the difficulties in obtaining a final successful and stable pomalidomide formulation and identifies some formulations/excipients that had failed” and were unstable after only a few weeks of storage. Appeal Br. 18. We are not persuaded by Appellant’s contention that the combination lacks a reasonable expectation of success based on the combination of Tutino and Stahly as proposed by Examiner. See Ans. 3-7. “Obviousness does not require absolute predictability of success . . . For obviousness under § 103, all that is required is a reasonable expectation of success.” In re O’Farrell, 853 F.2d 894, 903-904 (Fed. Cir. 1988). Examiner explains that the “prior art clearly teaches formulations of pomalidomide in the form of capsules; the fact that not all formulations of pomalidomide have the same stability does not mean that pomalidomide cannot be formulated using well-known excipients, with reasonable expectation of success.” Ans. 18. We agree with Examiner and further note that the claim does not recite a particular stability all that is recited in the Appeal 2021-004427 Application 16/322,571 13 claim is a combination of pomalidomide, maltodextrin, and filler at particular weight ratios having the specified dissolution profile. In formulating the rejection, Examiner recognizes that Tutino does not recite maltodextrin and looks to Stahly for providing the maltodextrin limitation. As Examiner explains, “Stahly teaches [formulating capsules] with microcrystalline cellulose and maltodextrin, because Stahly teaches that pregelatinized starch, microcrystalline cellulose and maltodextrin can be used interchangeably as binders, and Stahly also teaches that microcrystalline cellulose, mannitol, pregelatinized starch can be used interchangeably as filler.” Ans. 5-6. We agree with Examiner, that “the in vitro release rate of a drug from a matrix is an inherent property of the composition.[8]Since Tutino in view of Stahly render the claimed composition obvious, the property of such a composition is inherent, absent unexpected results, since the properties (in this case in vitro drug release rate) are inseparable from the composition.” Ans. 19. Based on the disclosures of Tutino and Stahly, we agree with Examiner that the substitution of equivalents as set out in Stahly would reasonably provide a formulation of a pomalidomide containing maltodextrin and filler. 8 EPAR describes a hard gelatin capsule containing 1 to 4 mg of pomalidomide as the active substance in combined with mannitol, pregelatinized starch, and sodium stearyl fumarate. The capsule shells are made of gelatin and contain different pomalidomide depending on the strength. Id. at 10. Thus, EPAR describes same capsules disclosed in Tutino. Compare EPAR 10 with FF1. Example 4 of the Specification, shows that the commercial product described in EPAR and Tutino as meeting the dissolution profile recited in the claim at time zero. Spec. 11. Appeal 2021-004427 Application 16/322,571 14 3. Unexpected results Appellant contends that Examiner dismissed the evidence of unexpected result as not being commensurate in scope. Appeal Br. 25; Reply Br. 11; Tr. 11:5-23, 12:21-14:23. Appellant contends that the “present invention is not only stable, a surprising result, but also shows less moisture sensitivity than the commercial formulation, which corresponds to Tutino.” Appeal Br. 22. Appellant contends that the commercial products of pomalidomide require expensive packaging while the formulation of the present invention show stability using cheaper packaging, which is unexpected. Appeal Br. 23 (referencing the Specification Example 4, (tables 4 and 6)). Appellant contends that Examiner dismisses the evidence of unexpected results as not being commensurate in scope of the claims because only one embodiment was tested. Appeal Br. 25. We agree with Appellant that the art recognized that pomalidomide is unstable. Appeal Br. 22-26; Tr. 4:14-21. EPAR discloses a pomalidomide formulation in the form of a capsule containing anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. EPAR, 13. The disclosure in EPAR acknowledges that some instability has been detected with this particular formulation. Id. EPAR describes another formulation containing pomalidomide, anhydrous dibasic calcium phosphate, pregelatinized starch, croscarmellose sodium, and sodium stearyl fumarate. Id. This formulation also exhibited some instability. Id. Thus, EPAR suggests that different formulations of pomalidomide can affect the stability of the product. Appellant directs our attention to Tables 4-6 of the Specification to show that the combination of maltodextrin and microcrystalline cellulose as Appeal 2021-004427 Application 16/322,571 15 a filler, as specifically recited in claims 4 and 17, produces unexpected results. Tr. 12:21-14:23. Table 4 of the Specification shows that the commercially available pomalidomide product as disclosed in EPAR and Tutino has the recited dissolution profile at time zero, as well as after 3 and 6 months provided the product is stored either in and HDPE bottle/PP cap or an Al/Al blister. See Spec. 11. Tables 5 and 6 of the Specification shows that, when pomalidomide is formulated with maltodextrin and microcrystalline cellulose, the product maintains the requisite dissolution profile for up to 6 months regardless of the packaging. Spec. 12-13. Appellant explains that “[t]he pharmaceutical composition of the present invention is not only stable, a surprising result, but also shows less moisture sensitivity than the commercial formulation.” Appeal Br. 22; Reply Br. 7-12; see Tr. 12:21-14:23. “The stability is measured by the change, if any, in dissolution of pomalidomide from the capsule composition. The dissolution profile itself is designed to correlate with bioequivalency. If the dissolution profile of a composition significantly changed during storage, then a stored composition may no longer be bioequivalent, which is commercially unacceptable.” Appeal Br. 23. On this record, we find that Appellant has sufficiently shown that the Specification establishes that the combination of pomalidomide in combination with maltodextrin and microcrystalline cellulose within the recited ratios maintains the recited dissolution profile over an extended period of time. See Appeal Br. 25; Reply Br. 11; Tr. 11:5-23, 12:21-14:23. Appellant, however, has not sufficiently established that a pomalidomide formulation containing maltodextrin with any other filler maintains the recited dissolution profile over an extended period of time. See Ans. 19 Appeal 2021-004427 Application 16/322,571 16 (Examiner “notes that the data in the Specification tabulates dissolution rates corresponding [to] one specific formulation of pomalidomide (as in Table 2, last column 4 mg/capsule).”). Because we agree with Appellant that the composition containing the recited ratio of maltodextrin and microcrystalline cellulose in combination with pomalidomide shows a surprising stability we reverse the rejection of claims 4 and 17 that limit filler to microcrystalline cellulose. 4. Claim 5 Claim 5 depends from claim 1 and further recites: “composition according to claim 1, wherein pomalidomide is present in an amount of more than 2% by weight based on the total weight of the composition.” A claimed range overlaps with a prior art range if the two ranges share a common endpoint (e.g., claim range of 50-100 Å overlaps with prior art range of 100-600 Å). In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997). Examiner explains that “Tutino teaches (Example 6, Table) a pharmaceutical composition comprising pomalidomide 2%; the concentration of pomalidomide 2% wt. overlaps/is very close to the lower limit of the range in instant claim 5. A concentration of, for example, 2.01 % wt., or of 2.05% wt. pomalidomide, which reads on the instant limitation in claim 5, is rendered obvious by a 2% concentration of pomalidomide taught by Tutino.” Ans. 26; Final Act. 8 (“Tutino teaches pharmaceutical compositions of pomalidomide, wherein pomalidomide is present in an amount of 2% weight of the composition, with overlaps with the range in instant claim 5”). Accordingly, we are not persuaded by Appellant’s contention that Examiner Appeal 2021-004427 Application 16/322,571 17 has not provided an articulated basis for the “more than 2% by weight” limitation as recited in claim 5. C. Conclusion We conclude that the evidence cited by Examiner supports a prima facie case of obviousness with respect to claims 1 and 5. As Appellant does not argue the dependent claims 3, 6-9, 11, 14-16, and 20 separately, they fall with claims 1 and 5. 37 C.F.R. § 41.37 (c)(1)(iv). Because Appellant has sufficiently shown that the formulation of maltodextrin and microcrystalline cellulose produces an unexpected stability in the product we reverse the rejection of claims 4 and 17. II. Obviousness Examiner has rejected claim 1-9, 11, 14-17, and 20 as obvious based on the teachings of Tutino, Stahly, Guajardo-Flores, Nazzal. Ans. 7-12. Appellant’s only argument with respect to this rejection is that “these tertiary references do not overcome the deficiencies of the basic rejection.” Appeal Br. 27. Specifically, Appellant contends that “these tertiary references affirm that maltodextrin and MCC are known excipients, they are not concerned with the narrow world of pomalidomide and its unique formulation problems.” Appeal Br. 28. This argument is not persuasive because, as discussed above, we conclude that Tutino and Stahly would have made obvious the pharmaceutical composition comprising pomalidomide, maltodextrin and any filler as set out in claim 1. We, therefore, affirm the rejection of claim 1, and dependent claims 2, 3, 5-9, 11, 14-16, and 20 for the reasons discussed above (see I.B) and those presented the Examiner in the Answer and Final Office Action. Appeal 2021-004427 Application 16/322,571 18 For the reasons discussed above (see I.B.3) with respect to the unexpected results proffered by Appellants with regard to the combination of pomalidomide, maltodextrin, and microcrystalline cellulose filler we reverse the rejection of claims 4 and 17. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1-9, 11, 14- 17, 20 103 Tutino, Stahly 1-3, 5-9, 11, 14-16, 20 4, 17 1-9, 11, 14- 17, 20 103 Tutino, Stahly, Guajardo-Flores, Nazzal 1-3, 5-9, 11, 14-16, 20 4, 17 Overall Outcome 1-3, 5-9, 11, 14-16, 20 4, 17 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED IN PART