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 .
Priority
The instant application, filed 04/18/2022, is a CON of PCT/US2020/027678, filed 04/10/2020, which claims domestic priority to CON of 17/498,617, filed 10/11/2021, and claims domestic priority to provisional U.S. application no. 67/833,107 filed 04/12/2019.
Information Disclosure Statement
The Information Disclosure Statements, both filed on 08/11/2025 as well as the previously submitted IDS, filed 05/12/2022 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statements are considered.
Claim Status
The amendment filed on 08/11/2025 is acknowledged and entered.
Claims 1, 6, and 15 are amended;
Claims 1-27 are pending and are under prosecution.
Response to Arguments
Regarding the office action of 04/10/2025:
Claims 1-27 was rejected under 35 U.S.C. § 112 (b) as being indefinite for as being indefinite for failing to particularly point out and distinctly claim the subject matter which a joint inventor regards as the invention. In view of Applicant’s to amendments claim 1 and Applicant’s remarks filed on 08/11/2025, the rejection is withdrawn.
Claims 1-20 and 24 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1 of copending Application No. 18/106,893 (US 20230190760 A1) in view of Bjorklund et al. (Blood Cancer Journal (2015) Volume 5, e354, published October 2, 20
Claims 1, 17, and 18 of copending Application No. 18/797,261 (US 20240391912 A1) in view of Bjorklund.
Claims 1, 117, and 118 of copending Application No. 18/683,619 (US 20240360150 A1)
In view of Applicant’s remarks filed on 08/11/2025 and according to MPEP § 804 (I)(B)(1)(b)(i), the previous double patenting rejections are maintained, as these provisional double patenting rejections are not the only rejections remaining in view of the new double patenting rejection and the new rejection under 35 USC 112 (a) detailed below. This action is Non-Final.
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.
Claim Rejections - 35 U.S.C. § 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 1-27 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. subject matter. More specifically, the specification does not describe methods to treat a human with multiple myeloma comprising the administration of an effective amount of a compound of claim one.
The following factors are considered in determining whether undue experimentation is required to practice the invention:
(1) Nature of the invention;
(2) Breadth of the claims;
(3) State of prior art;
(4) Level of ordinary skill in the art;
(5) Level of predictability in the art;
(6) Amount of direction provided;
(7) Presence of working examples; and
(8) Quantity of experimentation required to make or use the invention.
In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Nature of the invention: Independent claim 1 recites a method of treating a human with multiple myeloma comprising administering a therapeutically effective amount of the instantly claimed compounds to a human in need thereof. The claims encompass the use of at least one compound claimed in treating a human with multiple myeloma.
Breadth of the claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The rejected claims are extremely broad. Applicant claims that all of the claimed compounds can be used to treat a human with multiple myeloma. Thus the cited claims are deemed very broad since these claims read the common treatment of multiple myeloma by a range of compounds characterized by substituents with much variability (e.g., R7) i.e. large Markush group/genus scope. Furthermore, the claims are deemed very broad with respect to patient group (i.e., newly diagnosed or remission, cytogenetic risk, transplant eligibility), biomarker status, disease stage, routes of administration, duration of treatment, and dosing schedules of a compound of claim 1.
State of the Prior Art: The current state of the art recognizes that cereblon-dependent degradation of the transcription factors Ikaros and Aiolos is central to the anti-myeloma activity of immunomodulatory drugs (e.g. lenalidomide and pomalidomide) (Abstract, Bjorklund et al. Blood Cancer Journal, Volume 5 e354, published October 2, 2015, hereinafter Bjorklund). In multiple myeloma cells, immunomodulatory drugs alter cereblon substrate specificity, and drive ubiquitination and proteosomal degradation of Ikaros and Aiolos (page 8). This, in turn, causes sequential down-regulation of accessory protein functions, culminating in growth inhibition and apoptosis (pages 1, 2, 4, Figure 3) . Most critically, sustained target downregulation is required, and it is the rate of Ikaros and Aiolos degradation which correlates with efficacy of treatment (pages 5, 7, Figure 5).
More contemporary reviews likewise explain that immunomodulatory drugs activate the cereblon E3 ligase to degrade Ikaros and Aiolos; that these transcription factors are overexpressed and required for multiple myeloma cell survival; and that genetic silencing of either protein is sufficient to inhibit proliferation and induce cell death (page 3, Cippitelli et al., Int J Mol Sci, Volume 22, Issue 1103, published January 22, 2021, hereinafter Cippitelli). Most importantly, the reference teaches that tumor-intrinsic activity is only part of the therapeutic effect. Immunomodulatory drug-induced Ikaros and Aiolos degradation reprograms the tumor immune interface (page 3). These teachings suggest immune-context mechanisms materially affect clinical activity and are not predictable from a simple cytotoxic readout (pages 7 and 8). The art further teaches that anti-myeloma efficacy via cereblon-E3 ligase Ikaros and Aiolos degradation depends on achieving the right target engagement, the rate and durability of degradation, and context-dependent immune mechanisms (pages 8 and 9).
These teachings show that successful multiple myeloma therapy via the cereblon E3 ligase pathway depends on a multitude of factors including: drug, target, and time-dependent biology, rather than mere administration of a compound. As such, the art would not have expected a generic cereblon-binding compound to predictably treat multiple myeloma absent guidance sufficient to achieve sustained Ikaros and Aiolos degradation, and downstream transcriptional effects, required for successful treatment, according to the state of the art. Thus the state of the art fails to support the claimed invention of treating multiple myeloma comprising the administration of a compound as claimed in claim 1.
Predictability/Unpredictability in the Art: The level of ordinary skill in producing a medicinal dose from a bioactive compound requires sufficient experience in pharmaceutical formulations and is considered to be sophisticated. Regardless, the level of skill cannot overcome the extreme unpredictability in the field of multiple myeloma therapy.
With regard to the relationship of predictability of the art and the enablement requirement, the MPEP § 2164.03 states,
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938).
In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). A need for greater disclosure derives from the fact it is not obvious from the disclosure of one species, what other species will work.
Generally speaking, then, the Courts recognize that predictability in chemical related arts is low enough to require a highly detailed disclosure. Unpredictability arises in chemical related arts because subtle changes in molecular structure may greatly impact a compound's structure-activity relationship, pharmacologic activity, and/or biologic profile. In drug development, the skilled artisan would not be able to easily extrapolate treatment for a medical use from a single example or limited disclosure without more instruction. These considerations support a requirement for a disclosure with a high level of detail. Predictability with regard to the claimed method of producing a medicinal dose from a raw plant is considered to be extremely low due to the lack of specificity regarding the type of plant, type of medicinal dose, and type of medical use. Considered in light of the general unpredictability of pharmacology, the predictability of practicing the claimed methods of is extremely low.
Guidance of the Specification/Working Examples: According to the instant specification, the instantly claimed compounds are targeted cereblon binders for the degradation of Ikaros or Aiolos proteins (page 1, lines 10-13), both known to be part of the Ikaros family of zinc finger proteins, which are lymphoid-specific transcription factor and punitive mediator for T cell commitment (page 2, lines 1-6). Furthermore, according to the instant specification, the binding of immunomodulatory drugs (e.g. lenalidomide and pomalidomide) to the celebron E3 ubiquitin ligase facilitates the subsequent binding of Ikaros and Aiolos, leading to their ubiquitination and proteosomal degradation (page 3, lines 4-29). In support of the claimed method, the specification provides no examples of a medicinal dose of the instantly claimed compounds in treating a human with multiple myeloma. Rather, the specification provides evidence, by way of existing scientific literature, that established immunomodulatory drugs (e.g., lenalidomide and pomalidomide) exert anti-myeloma effects by cereblon-dependent ubiquitination and proteosomal degradation of Ikaros and Aiolos, leading to growth inhibition and apoptosis. Unlike the prior art, however, the specification does not provide any data showing that any compound of Formula (I) engages cereblon or produces the required, sustained degradation of Ikaros and Aiolos in multiple myeloma cells, nor any in vivo, or clinical evidence demonstrating treatment of multiple myeloma in humans. Contemporary reviews likewise emphasize that immunomodulatory activity in multiple myeloma depends on depleting Ikaros and Aiolos in malignant plasma cells, underscoring that mechanistic and genetic guidance is necessary to achieve therapeutic outcome, and cannot be presumed from a generic administration of cereblon-binding agents.
The instant specification discloses that the instantly claimed compounds are cereblon-binding degraders intended to reduce Ikaros and Aiolos (pages 1-3). For experimental support, the specification provides only an in vitro cell viability screen (example 1732, pages 704-756, Table 2), with IC50 values for representative compounds. Importantly, a cell viability assay in one cell line does not demonstrate that a medicinal dose will treat a human with multiple myeloma, nor does it correlate with the claimed compounds effect on the Ikaros/Aiolos pathway that the art identifies as a determinative of efficacy. The specification provides no teaching that the instantly claimed compounds degrade Ikaros and Aiolos, so efficacy cannot be presumed from cereblon blinding alone. Furthermore, absent in vivo data, dose/range, regimen, or guidance to achieve the sustained target suppression of the art requires, a person of ordinary skill in the art would have to conduct extensive, iterative experimentation to practice the full scope of “treating a human with multiple myeloma” using the claimed compounds.
The lack of evidentiary support tends to lead to a conclusion of lack of enablement. (See, e.g., In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689, claim drawn to “The method of treating a malignant condition selected from the group consisting of leukemias, sarcomas, adenocarcinomas, lymphosarcomas, melanomas, myelomas, and ascitic tumors” administering a small genus of compounds. The Court decided that human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed.”; Ex parte Stevens, 16 USPQ2d 1379 a claim to “A method for therapeutic or prophylactic treatment of cancer in mammalian hosts” was refused because there was “no actual evidence of the effectiveness of the claimed composition and process in achieving that utility.”).
The MPEP at § 2164.02 states that a single working example in the specification for a claimed invention is enough to preclude a rejection stating nothing is enabled, since at least that embodiment would be enabled. However, in these cases a rejection stating that enablement is limited to a particular scope may continue to be appropriate. The Court in In re Brana is instructive with regard to working examples in the pharmaceutical setting. In essence, the Court found a pharmaceutical invention enabled where the animal model (in vitro or in vivo) correlates to the claimed use and the claimed compounds compared favorably with compounds known to have the same therapeutic effect. In re Brana, 51 F.3d 1560, 1566; 34 USPQ2d 1436, 1441 (Fed. Cir. 1995).
The MPEP at § 2164.02 is instructive regarding animal models and states that an in vitro or in vivo animal model example in the specification constitutes a "working example" if that example "correlates" with a disclosed or claimed method invention. If there is no correlation, then the examples do not constitute "working examples." In this regard, the issue of "correlation" is also dependent on the state of the prior art. If the art is such that a particular model is recognized as correlating to a specific condition, it should be accepted as correlating unless the examiner has evidence that the model does not correlate. In re Brana at 51 F.3d 1566; 34 USPQ2d 1441 (Fed. Cir. 1995).
Patent applications claiming new methods of treatment usually find support in test results, however, human trials cannot be required for a therapeutic invention to be patentable. Janssen Pharmaceutica N.V. v. Teva Pharms. USA, Inc., 583 F.3d 1317, 1324 [92 USPQ2d 1385] (Fed. Cir. 2009). Results from animal tests or in vitro experiments may suffice to satisfy the utility requirement. Id. Under the appropriate circumstances, in vitro testing alone may establish a practical utility for the compound in question. For example, in Janssen Pharmaceutica, the Federal Circuit noted its own previous findings with regard to in vitro test results,
We noted in Cross v. Iizuka that “[w]e perceive no insurmountable difficulty, under appropriate circumstances, in finding that the first link in the screening chain, in vitro testing, may establish a practical utility for the [pharmaceutical] compound in question” in order for a patent to issue. 753 F.2d 1040, 1051 [224 USPQ 739] (Fed. Cir. 1985). We concluded that in vitro test results for a claimed pharmaceutical compound, combined with animal test results for a structurally similar compound, showed “a reasonable correlation between the disclosed in vitro utility and an in vivo activity. Id. at 1327.
In this case, no working examples are presented demonstrating the claimed process. Thus, the specification fails to provide sufficient evidence in support of the broad treatment of multiple myeloma in a human subject using a compound of claim 1 as recited in the instant claims.
The Quantitation of Experimentation Required: A great deal of experimentation is necessary to take molecule from the bench to the clinic. For example, Hörig and Pullman, (J. Translational Med. Volume 2, Article Number 44, published December 20, 2004) note that the path to successfully utilizing a compound as treatment: “requires satisfying a matrix of domains from relevance to the disease and the drug-ability of the target through feasibility and convenience of drug delivery, demonstration of favorable benefit-risk profile in order to achieve a drug label that reflects physician and patient acceptance” (page 44). Hörig and Pullman further suggest that the complexity of determining whether a molecule may be used as treatment of diseases requires collaborative research, where success is determined by: “identification and validation of novel drug targets, development of robust and validated assays to screen drug leads for safety and potential efficacy in humans, and the identification of suitable patients for expedited but informative trials (page 45).
Each step involved in determining whether a compound may be used to treat a disease presents a need for rigorous experimentation. Years of research may be required in determining whether a compound may be used to treat a disease. Therefore, in order to practice the claimed invention, the amount of experimentation required would be considered undue and burdensome.
The claims encompass a broad method of treating multiple myeloma using the instantly claimed compounds. While the art recognizes that established immunomodulatory drugs (e.g., lenalidomide and pomalidomide) are capable of treating multiple myeloma by way of cereblon-dependent ubiquitination and proteosomal degradation of Ikaros and Aiolos—leading to apoptosis—clinical activity depends on achieving sustained Ikaros and Aiolos suppression, and the rate of degradation (Bjorklund, Abstract). The specification, however, provides no evidence that any claimed compound: i) engages cereblon; ii) produces sustained Ikaros and Aiolos degradation; or iii) drives the required transcriptional cascade in multiple myeloma cells, or in a human subject. The specification discloses only a 96-hour cell viability screen in a single multiple myeloma cell line, which is not establish treatment of a human with multiple myeloma, or correlate to the foregoing mechanism. Moreover, contemporary reviews show that tumor-intrinsic and immune-context effects materially influence the outcome of treatment strategies (Cippitelli, pages 7-9). None of these critical factors are addressed by the instant specification. Given these art-recognized mechanistic and kinetic dependencies, and the absence of in vivo dosing/guidance or patient selection criteria in the instant specification, a person of ordinary skill in the art would have to undertake undue experimentation to practice the full scope of the instantly claimed method. In addition, while the level of skill in the art is high, it cannot overcome a lack of evidentiary support found in the art or the specification. Without such evidence, in light of the unpredictability found in the chemical and pharmaceutical arts, the amount of experimentation required to practice the invention is considered to be undue.
In conclusion, Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. A method of treating a human with multiple myeloma comprising administering a compound of claim 1 is not enabled by the instant specification.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/106,893 (US Publication No. 20230190760 A1) in view of Bjorklund et al. (Blood Cancer Journal (2015) Volume 5, e354, published October 2, 2015), hereinafter Bjorklund. Although the claims at issue are not identical, they are not patentably distinct from the claims of the reference application because the reference claims use of the instantly claimed compounds to treat a disorder mediated by Ikaros or Aiolos. The present invention is directed to a method of treating a human with multiple myeloma. The co-pending application is drawn to a method of treating a disorder mediated by Ikaros or Aiolos. According to Bjorklund, Ikaros and Aiolos degradation underlies differential activity of lenalidomide and pomalidomide in multiple myeloma (title). Furthermore, both the instant application and co-pending reference application recite the use of CAS Registry Number: RN 2504233-68-3 [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 2504233-68-3 Entered STN: 04 Nov 2020], (see Figure 1).
Figure 1. RN 2504233-68-3
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Figure 1. RN 2504233-68-3 as taught in the instant application, as well as co-pending application numbers 18/106,893, 18/797,261, and 18/683,619.
Thus, a person having ordinary skill in the art following the claims of the reference application would have found it prima facie obvious to administer a recited compound to a human having multiple myeloma because Bjorklund teaches multiple myeloma is mediated by Ikaros and Aiolos. Accordingly, the present claims are drawn to drawn to methods which are patentably indistinct from those recited in copending U.S. Patent Application No. 18/106,893
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17, and 18 of copending Application No. 18/797,261 (US Publication No. 20240391912 A1) in view of Bjorklund (citation above). Although the claims at issue are not identical, they are not patentably distinct from each other because they’re both drawn to the use of the same compounds to treat multiple myeloma, and the co-pending application is drawn to a method of treating a disorder mediated by IKZF1 (Ikaros) and/or IKZF3 (Aiolos). As stated above, according to Bjorklund, Ikaros and Aiolos degradation underlies differential activity of lenalidomide and pomalidomide in multiple myeloma (title). Furthermore, both the instant application and co-pending application teach the use of CAS Registry Number: RN 2504233-68-3, in the methods portions of their claims. Thus, the inventions are drawn to patentably indistinct methods, disorders (because multiple myeloma is mediated by (Ikaros and Aiolos), and patentably indistinct compounds used in the treatment of said conditions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 117, and 118 of copending Application No. 18/683,619 (US Publication No. 20240360150 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because they’re both drawn to the use of the same compounds to treat multiple myeloma. Specifically, both the instant application and co-pending application teach the use of CAS Registry Number: RN 2504233-68-3, in the methods portions of their claims. Thus, the inventions are drawn to patentably indistinct methods used to treat multiple myeloma, with patentably indistinct compounds used in the treatment of said conditions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11407732 B1 (cited on IDS dated 08/11/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to the same compounds as in the patented case, and thus, the compounds inherently are capable of the same use, i.e. a method of treating multiple myeloma in a human subject. Moreover, the pharmaceutical composition of the patented case (claims 25-30) dictates that the composition should be formulated for oral, parenteral, and intravenous administration, making it fully obvious over the oral, parenteral, and systemic administration of the instantly claimed method (instant claims 19-27). Furthermore, the patented case is filed as a continuation of the instant application and not a divisional application. “The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. § 121 (prohibition of double patenting rejection) does not extend to all types of continuing applications, stating that "the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications." Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008).” Finally, the prohibition of a double patenting rejection as guaranteed by 35 U.S.C. § 121 applies only where the Office has made requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant, and not in response to a requirement for restriction (see MPEP § 804.01). Accordingly, the instant claims stand rejected on the ground of nonstatutory double patenting over the patented case.
Correspondence
No claim is allowed.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623