Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since t1his application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/22/26 has been entered.
Claim Status
Claims 1-17 are cancelled.
Claims 18-38 are pending.
Information Disclosure Statement
The information disclosure statement filed 5/22/26 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.1
Withdrawn rejections
Applicant's amendments and arguments filed 5/22/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 18-38 are rejected under 35 U.S.C. 103(a) as being unpatentable over Thompson et al. (US20050186267) and Ma et al. (International Journal of Pharmaceutics 1999; 189:227-234) and Stella et al. (Toxicologic Pathology, 36:30-42, 2008).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims, for example
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmaceutical formulation, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 18, 25, 26, 28, 29 and 37, Thompson et al. teach compositions comprising a sulfoalkyl ether cyclodextrin and one or more active agents (Abstract; claims 1, 15, 18, 20, 23), where the sulfoalkyl ether cyclodextrin is SBE7-β-CD, known as Captisol®, with a degree of substitution between 6-7.1 [0016-0017, 0143], which falls within the range of n = 1-10 and renders obvious the claimed range. The active agent comprises antineoplastics [0196] such as the nitrogen mustards cyclophosphamide [0208] and melphalan [0243] and their salt forms [0195]. Please note Merck & Co., Inc. v. Biocraft Laboratories, Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) where the prior art patent disclosed a genus of 1200 effective combinations of compounds, including the claimed combination, it was held that “[d]isclos[ure of] a multitude of effective combinations does not render any particular formulation less obvious." Thompson et al. teach (Examiner added emphasis): “the CD will generally be, but need not be, present in excess of the active agent. The amount of excess will be determined by the intrinsic solubility of the agent, the expected dose of the agent, and the binding constant for inclusion complexation between the specific drug (agent) and the specific CD derivative used. It should be noted that the cyclodextrin derivative can be present in uncomplexed form and therefore in amounts substantially in excess of the amount of active agent present. The weight ratio or molar ratio of derivatized cyclodextrin to active agent can exceed 100, 1000 or even more.” [0145] Thompson et al. even suggest that: “the ratio of derivatized cyclodextrin to active agent may need to be varied from the ratios set forth herein in order to compensate for the abovementioned variables.” [0147] Thus, Thompson et al. teach and suggest a weight ratio with an excess CD in amounts that can exceed 100:1 as well as optimization of the ratio. Thompson et al. teach solid fill compositions [0035, 0037, 0071] and that it is known to have a solid physical mixture of an SAE-CD and an active agent [0022-0023]. Thompson et al. also teach placing the SAE-CD and solid active drug in vial containers in amounts of 3, 5, 25, 50 and 60 mg of active ingredient [0257]. Thompson et al. teach that (Examiner added emphasis): “complexation of drugs with the CAPTISOL® cyclodextrin generally allows for increased solubility and stability of drugs in aqueous solutions.” [0018]
Regarding claims 18, 25-33, 35 and 37, Ma et al. teach freeze dried solid powder, hence a lyophilized powder, composition consisting of (SBE)7m-β-cyclodextrin (SBE = sulfobutyl ether and the subscript 7 indicates the degree of substitution) and melphalan in a simplified one-vial delivery system (Abstract) where 100 ml solution of 0.1 M (SBE)7m-β-cyclodextrin containing 0.5 g melphalan was prepared (page 229-230, 2.5). The MW of the (SBE)7m-β-cyclodextrin is 2248.64 (page 228, 2.1). The 100 ml of a 0.1M solution will have 22.4864 g of (SBE)7m-β-cyclodextrin in it. Therefore, the weight ratio of cyclodextrin to melphalan is 22.4864:0.5 or 44.9:1, which rounds to 45:1. Ma et al. teach that the melphalan comes as the hydrochloride (page 228, left column second paragraph). Ma et al. teach taking 0.5 ml of the stock solution (0.5 grams melphalan in 100 ml solution = 5 mg/ml) and placing into 2 ml vials prior to freeze drying would provide 0.5 ml X 5 mg/ml = 2.5 mg of melphalan per vial and similarly one calculates ~112 mg of SBE (Page 229, 2.5. through page 230 top left column). In Table 1 (Page 230), Ma et al. teaches that 100 mM (SBE)7m-β-CD had a time to 10% loss of 5.01 ± 0.1 hours and the reference co-solvent was 1.69 ± 0.05 hours for about a 3-fold (5.01/1.69 = 2.96) improvement in stability. Ma et al. teach that the commercial product Alkeran® contains in a single vial 50 mg melphalan (Page 228, left column).
Regarding claims 18, 28-29 and 37, Stella et al. teach: “A number of workers have attempted to identify, prepare, and evaluate various CD derivatives with superior inclusion complexation and maximal in vivo safety for various biomedical uses. A systematic study led to SBE-β-CD (Captisol), a polyanionic variably substituted sulfobutyl ether of β-CD, as a non-nephrotoxic derivative and HP-β-CD, a modified CD developed by Janssen. SBE-β-CD and HP-β-CD have undergone extensive safety studies and are currently used in six products approved by the Food and Drug Administration (four for Captisol and two for HP-β-CD). They are also in use in numerous clinical and preclinical studies.” (Abstract)
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Thompson et al. is that Thompson et al. do not expressly teach a solid lyophilized powder pharmaceutical composition comprising 25-125 mg melphalan hydrochloride salt, 2000-3000 mg SBE, in a vial container or the functional limitations “wherein when…” of claims 19-24. This deficiency in Thompson et al. is cured by the teachings of Ma et al. and Stella et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the composition of Thompson et al. comprising 25-125 mg melphalan hydrochloride and 2000-3000 mg sulfobutyl ether-β-cyclodextrin in a weight ratio of at least 50:1; 50:1 to 100:1; or about 54:1, as a lyophilized solid powder in a vial container, as suggested by Ma et al. and Stella et al., with the functional limitations “wherein when…”of claims 19-24 and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because for the following sound articulated reasoning with rational underpinning based upon the evidence. As noted above, Thompson et al. teach and suggest a solid embodiment with where the cyclodextrin can be Captisol®. Stella et al. teach that Captisol® was identified in systematic studies from other CD derivatives and has the desirable distinction as being approved by the Food and Drug Administration. Thus, it is desirable to select Captisol® for the sulfoalkyl ether-β-cyclodextrin. Ma et al. teach and suggest a lyophilized solid powder composition comprising melphalan, which is available as the hydrochloride salt, and the sulfobutyl ether-β-cyclodextrin in a weight ratio of 45:1 and Thompson et al. teach and suggest optimization of the weight ratio including in excess of 100:1. That reasonably provides a weight ratio range of 45:1 to greater than 100:1, which encompasses the claimed ranges of at least 50:1, 50:1 to 100:1 or about 54:1. See MPEP 2144.05(I): “A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case.” See also MPEP 2144.05(I): 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). Ma et al. further teaches the advantages of freeze-dried melphalan/cyclodextrin formulation: “A freeze-dried melphalan/(SBE)7m-b-CD formulation was successfully prepared and was found to be very stable over a period of 1 year. This formulation approach simplifies the two-vial delivery system to a one-vial system as well as having the other advantages noted in this work.” (Page 234, 4. Conclusions). Consequently, in view of the combined references the ordinary artisan would have a reasonable expectation of success in formulating a solid lyophilized powder composition comprising melphalan hydrochloride and sulfobutyl ether-β-cyclodextrin Captisol®, for its desirable non-nephrotoxicity and Food and Drug Administration approval, in the amounts and weight ratios claimed and placing it in a vial container. Furthermore, it is expected that the stability of the active agent is increased upon increasing CD concentration as taught by Ma et al. and Thompson et al.
Regarding the amounts of 25-125 mg melphalan and 2000-3000 mg sulfobutyl ether-β-cyclodextrin, it is merely routine optimization by the ordinary artisan to provide sufficient melphalan for therapeutic benefit and the amount of sulfoalkyl ether-beta-cyclodextrin to satisfy the range or 45:1 to an excess of 100:1 with a reasonable expectation of success. See MPEP 2144.05 (II) (A): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Especially when Thompson et al. teach and suggest 25, 50 and 60 mg of active ingredients [0257-0258]. In a hypothetical example, the Thompson et al. embodiment with a weight ratio of 100:1 with 25 mg active ingredient would have 2500 mg of sulfobutyl ether-β-cyclodextrin. Thus, the claimed amounts are readily derived from the teachings of Thompson et al.
Regarding the functional “wherein when” limitations and claims dependent therefrom, what one does with the solid pharmaceutical composition is an intended use of the composition and such intended use is inherent in the composition itself. An intended use will not limit the scope of the claim because it merely defines a context in which the invention operates. Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Thus, dilution with normal saline not including propylene glycol or ethanol at a pH between 4-6 and dilution to 0.45 mg/ml melphalan; the degradation of melphalan and AUC0-t, are naturally present in the composition consisting of the same two components taught by Thompson et al. and Ma et al. Especially when Thompson et al. guide the artisan to Captisol® for the sulfoalkyl ether-β-cyclodextrin to combine with melphalan. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963) ("From the standpoint of patent law, a compound and all of its properties are inseparable; they are one and the same thing."). Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Id.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 5/22/26 have been carefully considered but are not persuasive.
On page 5 of remarks, Applicant summarizes the rejection but left out the detail that the primary reference of Thompson guides the artisan to the sulfoalkyl ether-beta cyclodextrin Captisol® as well.
On page 6 of remarks, Applicant asserts: “the Examiner's position requires comparison against a reconstructed formulation that exists only after the claimed invention is used as a roadmap.” Respectfully, the Examiner has a different perspective. As discussed above, Thompson expressly teaches commercialized Captisol® for the sulfoalkyl ether-beta cyclodextrin [0016-0018, 0137, 0279, 0282, 0293], melphalan as the active agent [0243], and that: “The weight ratio or molar ratio of derivatized cyclodextrin to active agent can exceed 100, 1000 or even more.” [0145] Thompson et al. even suggest that: “the ratio of derivatized cyclodextrin to active agent may need to be varied from the ratios set forth herein in order to compensate for the abovementioned variables.” [0147] Thus, Thompson et al. teach and suggest a weight ratio with an excess CD in amounts that can exceed 100:1 as well as optimization of the ratio.” Consequently, the only roadmap used by the Examiner is that provided by Thompson; not Applicant’s application. Furthermore, the combination of references provides for a reasonable expectation of success. All that has to happen is that the artisan mix a sulfoalkyl ether-beta cyclodextrin with melphalan in a weight ratio of at least 50:1 to produce a solid pharmaceutical composition and then place that composition in a container. Mixing together pharmaceutical components is the bread and butter of the pharmaceutical formulation scientist and such an artisan would have reasonable expectation of success in so doing. It requires no inventive effort to mix the claimed components together, measure functional parameters, and store the solid composition in a container such as a vial.
On page 6 of remarks, Applicant asserts that the rejection is based on impermissible hindsight. However, the facts speak otherwise. The instant claims are directed to a solid pharmaceutical composition comprising sulfoalkyl ether-beta-cyclodextrin and melphalan in a weight ratio of at least 50:1. Thompson et al. is directed to sulfoalkyl ether cyclodextrin-active agent compositions where the fill composition can be a solid [0037] and the active agent can be melphalan [0243] with a weight ratio of cyclodextrin to active agent exceeding 100 or more [0145], which is at least 50:1. Thompson et al. not only relates to aqueous fill compositions as alleged by Applicant but also Thompson et al. relate to solid fill compositions. Thompson et al. alone renders obvious the claimed subject matter. Ma et al. provides more specific guidance on which active agent (melphalan) to combine with the (SBE)7m-β-CD in a calculated weight ratio of 45:1. The combined references reasonable provides a weight ratio range of 45:1 to greater than 100:1, which encompasses the claimed ranges of at least 50:1, 50:1 to 100:1 or about 54:1. See MPEP 2144.05(I): “A range can be disclosed in multiple prior art references instead of in a single prior art reference depending on the specific facts of the case.” The Examiner is relying on Stella for extolling SBE-β-CD (Captisol) as desirable to select. Applicant also discloses Captisol. ([0065]; Example 1 [00159]; Example 2 [00162]; Example 8 [00173], Examples 10-15, for example). Those are the facts and no hindsight was employed by the Examiner.
On page 7 of remarks, Applicant states: “The issue is that the Examiner has not explained why Thompson's different, broad excess-cyclodextrin regime would have guided a POSA to further increase Ma's already-excess melphalan formulation, particularly when Stella identifies excess cyclodextrin as potentially problematic for drug formulations”. Respectfully, Applicant is twisting the rejection around. The primary references of Thompson has established that the weight ratio of derivatized cyclodextrin to active agent can exceed 100 or more [0145] and suggests melphalan as an active [0243]. Ma et al. is applied further guiding the artisan to select melphalan as the active agent and provide proven success in producing the combination in a ratio of 45:1. Applicant’s concerns regarding the reference of Stella citing Rajewski for a teaching that excess cyclodextrin can lower the free fraction of drug to render the drug ineffective has been noted by the Examiner but is not persuasive. As stated by the Examiner previously, Applicant’s concerns about insufficient free melphalan drug being present in the presence of excess CD is not persuasive due in part to melphalan’s known low binding affinity and to the fact that Ma et al. already teach and suggest a ratio of 45:1 and is unconcerned about insufficient free melphalan drug being present. In fact, the Rajewski reference teaches:
“If large excesses of cyclodextrin are present, they can lower the free fraction of drug and increase the fraction of drug in the complex form, thereby lowering the effectiveness of the agent (Scheme 3C) by pushing the equilibrium to the right, thus increasing the probability of greater nasolacrimal excretion of the complex.” (Page 1155, right column 2nd paragraph).
Ma et al. is not concerned with “greater nasolacrimal excretion of the complex” or ophthalmic drugs and neither would be the artisan employing the antineoplastic agent melphalan. Consequently, the Examiner can disregard the teachings of Stella and Applicant’s argument is not persuasive.
On pages 7-8 of remarks, Applicant argues that the Examiner’s reliance on the Ma’s low binding constant is internally inconsistent. First of all, the Examiner only referenced Ma’s binding constant teaching in the arguments section and is not part of the rejection. Second of all, Applicant’s allegation that shifting from 45:1 to 50:1 or higher would have minimal effect on the stability because of the low binding constant is misplaced because Ma tested a specific sulfoalkyl ether-beta-cyclodextrin and the rejection is not over the sulfoalkyl ether-beta-cyclodextrin tested by Ma but over the sulfoalkyl ether-beta-cyclodextrin Captisol® suggested by Thompson. Applicant’s arguments are not persuasive.
On pages 8-9 of remarks, Applicant asserts that the Examiner’s inherency analysis is improper. The Examiner does not agree. Ma et al. tested one specific sulfoalkyl ether-beta-cyclodextrin and reported the experimental data for that particular sulfoalkyl ether-beta-cyclodextrin. However, the Examiner notes these details.
Independent claim 1 is open to any sulfoalkyl ether-beta-cyclodextrin and is not limited by any functional language.
The rejection is over the primary reference Thompson teaching Captisol®, which is the same sulfoalkyl ether-beta-cyclodextrin utilized by Applicant, and “complexation of drugs with the CAPTISOL® cyclodextrin generally allows for increased solubility and stability of drugs in aqueous solutions.” ([0018]; Examiner added emphasis).
“It is well known that the stabilization potential of cyclodextrins for drugs depends greatly on the cyclodextrin concentration, with greater cyclodextrin concentration leading to a longer drug shelf-life.” (Ma et al., page 233 left column).
All Applicant did was take a commercial product Captisol® (SBE6.5-β-CD, avg. M.W.=2163 g/mol) and compare the binding of melphalan HCl and free base to the SBE7-β-CD (avg. M.W.=2248 g/mol) utilized by Ma et al. ([00166]).
Applicant states that “Ma reports that its (SBE)7m-β-CD formulation had a time to 10% melphalan loss of about 5.01 ± 0.10 hours after reconstitution and dilution with normal saline. See Ma, Table 1, p. 230.” That is correct. However, the rejection is over Thompson expressly teaching Captisol® for the sulfoalkyl ether-beta-cyclodextrin and melphalan as the active agent. The fact that Ma et al. utilized a similar sulfoalkyl ether-beta-cyclodextrin and observed a time to 10% loss of about 5 hours and Applicant found a time to 10% loss of 11 hours for the 75 mM SBE6.5-β-CD and 18 hours for the 125 mM SBE6.5-β-CD (125 mM) is acknowledged but unavailing. That is just an improvement in an existing property and not a totally new, unexpected or qualitatively different property compared to the prior art. The trend observed by Applicant is increasing stability with increasing cyclodextrin concentration and that is what Ma et al. stated was well-known and predictable by the ordinary artisan. Furthermore, this is a difference in degree and not in kind from the data reported by Ma et al. “It is the general rule that while the change in the proportions of a combination shown to be old, such as is here involved, may be inventive, such change must be critical as compared with the proportions used in prior processes, producing a difference in kind rather than degree.” In re Dreyfus, 73 F.2d 931, 934 (C.C.P.A. 1934). In the present case, there is an expectation of a time to 10% loss to take hours and that is what Applicant has demonstrated. While Applicant may have produced better results in terms of time to 10% loss than the prior art, that is not enough to sustain a patent. “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” (In re Williams, 36 F.2d 436, 438, 17 C.C.P.A. (Patents) 718, 722). In the present case, the inventors merely used routine research methods to prove what was already believed to be the case. Scientific confirmation of what was already believed to be true may be a valuable contribution, but it does not give rise to a patentable invention. See Pharmastem v. Viacell, 491 F.3d 1342, 1364 (Fed. Cir. 2007): “Good science and useful contributions do not necessarily result in patentability.”
On pages 9-10, Applicant asserts that the unexpected results analysis is improperly constructed. However, the rejection is over Thompson teaching a weight ratio of cyclodextrin derivative Captisol® to active agent melphalan exceeding 100:1. Ma et al. provide evidence that formulations with excess cyclodextrin derivative to melphalan have a time to 10% loss on the scale of hours. It is the Examiner’s position that there are no unexpected results, the data observed is entirely predictable and at best represents merely better results that are different in degree and not in kind from the prior art. That is not enough to sustain a patent. Applicant’s arguments are not persuasive. The Examiner suggests proceeding to the Board of Appeals.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 For completeness of the record, the Examiner located the reference in question, reviewed the citations by Applicant and attached it with an PTO892.
Prosecution Insights