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 .
DETAILED ACTION
Status of Claims
Claims 1, 68-69, and 72-100 are pending.
Election/Restrictions
Applicants’ election of Group II and dexamethasone as a second active agent, in the reply filed on 9/8/2026 is acknowledged. The election was made without traverse.
Claims 1 and 69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Claims 68 and 72-100 are under examination in the instant office action.
Claim Objections
Claim 75 is objected to because of the following informalities: typographical errors. The claim appears to be dependent from incorrect claim due to typographical error because XRPD pattern is for a crystalline compound. Applicants are advised to amend claim 75 as follows: “The method of claim [[73]]74, wherein the crystalline free base of Compound 1 is characterized by an XRPD pattern comprising peaks at approximately 14.6, 18.2, and 18.30◦ 2θ”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 68 and 93-100 are rejected under 35 U.S.C. 102(a)(2) as being anticipated over US 2019/0008852 (hereafter Alexander et al.; cited in the IDS filed on 1/16/2025).
Alexander et al. teach a method of treating multiple myeloma comprising administering a therapeutically effective amount of (S)-4-(4-(4-(((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-4-yl)oxy)methyl)benzyl)piperazin-1-yl)-3-fluorobenzonitrile:
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to a patient in need thereof (Compound 2) and a pharmaceutical composition comprising the compound, which further comprises a pharmaceutical carrier, diluent or excipient (abstract, [0011], [0286], and claims 1-2, 7 and 10-11).
Alexander et al. disclose that dosage forms or compositions contain active ingredient in the range of 0.005% to 100% with the balance made up from non-toxic carrier; and for oral administration, a pharmaceutically acceptable non-toxic composition is formed by the incorporation of any of the normally employed excipients, such as, for example pharmaceutical grades of mannitol, lactose, starch (diluent), magnesium stearate, talcum (lubricant), cellulose derivatives, sodium crosscarmellose, glucose, sucrose, magnesium carbonate or sodium saccharin ([0297]). Alexander et al. further disclose that such compositions include solutions, suspensions, tablets, capsules, powders and sustained release formulations and methods for preparation of these compositions are known to those skilled in the art ([0297]).
Alexander et al. disclose that the multiple myeloma is newly diagnosed or relapsed, refractory to standard treatments and the multiple myeloma is high risk multiple myeloma, that is relapsed or refractory to one, two or three previous treatments ([0197], [0198], claims 15 and 20)
Alexander et al. also disclose a method of treating, preventing, or managing multiple myeloma, comprising administering to a patient the Compound 1 or an enantiomer, mixture of enantiomers, tautomer, isotopolog, or pharmaceutically acceptable salt thereof, in combination with one or more second active agents, and optionally in combination with radiation therapy, blood transfusions, or surgery ([0224], [0225], and [0230]). Alexander et al. further disclose that the method further comprises administering a second active agent such as dexamethasone and bortezomib (claims 24-26).
As such, the instant claims are anticipated by Alexander et al.
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 of this title, 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.
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.
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 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 68, 72-89, and 91-100 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0008852 (hereafter Alexander et al.) in view of US 2004/0229930 (hereafter, Gatti; cited in the IDS filed on 1/16/2025) and US2015/0099745 (hereafter, Parikh et al.; cited in the IDS filed on 1/16/2025).
Alexander et al. teach a method of treating multiple myeloma comprising administering a therapeutically effective amount of (S)-4-(4-(4-(((2-(2,6-dioxopiperidin-3-yl)-1-oxoisoindolin-4-yl)oxy)methyl)benzyl)piperazin-1-yl)-3-fluorobenzonitrile:
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to a patient in need thereof (Compound 2) and a pharmaceutical composition comprising the compound, which further comprises a pharmaceutical carrier, diluent or excipient (abstract, [0011], [0286], and claims 1-2, 7 and 10-11).
Alexander et al. disclose that dosage forms or compositions contain active ingredient in the range of 0.005% to 100% with the balance made up from non-toxic carrier; and for oral administration, a pharmaceutically acceptable non-toxic composition is formed by the incorporation of any of the normally employed excipients, such as, for example pharmaceutical grades of mannitol, lactose, starch (diluent), magnesium stearate, talcum (lubricant), cellulose derivatives, sodium crosscarmellose, glucose, sucrose, magnesium carbonate or sodium saccharin ([0297]). Alexander et al. further disclose that such compositions include solutions, suspensions, tablets, capsules, powders and sustained release formulations and methods for preparation of these compositions are known to those skilled in the art ([0297]).
Alexander et al. disclose a method of treating, preventing, or managing multiple myeloma, comprising administering to a patient the Compound 1 or an enantiomer, mixture of enantiomers, tautomer, isotopolog, or pharmaceutically acceptable salt thereof, in combination with one or more second active agents, and optionally in combination with radiation therapy, blood transfusions, or surgery ([0224], [0225], and [0230]). Alexander et al. disclose that the method further comprises administering a second active agent such as dexamethasone and bortezomib (claims 24-26).
Alexander et al. disclose a free base of the Compound 2 and purified solid compound (crystalline) ([0339] and Example 4). While Alexander et al. is silent about XRPD pattern, Alexander et al. disclose a crystalline free base of the same compound which is prepared by the same method, thus the product of the prior art necessarily encompasses the crystalline free base of the same compound characterized by an XRPD pattern as claimed in the absence of evidence to the contrary. Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
Alexander et al. also disclose a method of treating, preventing, or managing multiple myeloma, comprising administering to a patient the Compound 1 or an enantiomer, mixture of enantiomers, tautomer, isotopolog, or pharmaceutically acceptable salt thereof, in combination with one or more second active agents, and optionally in combination with radiation therapy, blood transfusions, or surgery ([0224], [0225], and [0230]). Alexander et al. further disclose that the method further comprises administering a second active agent such as dexamethasone and bortezomib (claims 24-26).
Alexander et al.do not specifically disclose the combination of specific diluent, glidant, acidifier, lubricant and disintegrant and their concentrations in the composition.
However, those excipients including diluent, glidant, acidifier, lubricant and disintegrant are well known and commonly used for preparing oral solid dosage forms such as tablets and capsules as evidenced by Alexander et al. This is further evidenced by Gatti and Parikh et al.
Gatti discloses a formulation suitable for oral administration, wherein the formulation comprises an indolinone, and a pharmaceutically acceptable carrier (abstract). Gatti teaches that a pharmaceutically acceptable carrier comprises 10-86% w/w of one or more pharmaceutically acceptable diluents, 2-20% w/w of one or more pharmaceutically acceptable binders, 2-20% w/w of one or more pharmaceutically acceptable disintegrants, and 1-10% w/w of one or more pharmaceutically acceptable lubricants ([0028]). Gatti further teaches that suitable pharmaceutically acceptable diluents include pregelatinized starch, lactose, monohydrate or lactose anhydrous, mannitol, microcrystalline cellulose, and the like, and suitable combinations of two or more thereof ([0351]).
Gatti further teaches that suitable pharmaceutically acceptable lubricants include magnesium stearate, stearic acid, and sodium stearyl fumarate ([0354]). Gatti further teaches that suitable pharmaceutically acceptable disintegrants include sodium starch glycolate, croscarmellose, crospovidone, sodium carboxymethylcellulose, calcium carboxymethylcellulose, starch and the like, and suitable combinations of two or more thereof ([0353]). Also, Gatti teaches that the carrier further includes pharmaceutically acceptable flow enhancers (glidant) such as colloidal silicon dioxide and talc ([0355]).
In addition, Gatti teaches that the indolinone is solubilized by combining it with a molar equivalent of an acid solution and acid solution is typically one which has a pH lower than 7 and is capable of reacting with a basic solution (acidifier) and is selected from the group consisting of hydrochloric acid, sulfuric acid, formic acid, lactic acid, malic acid, maleic acid, succinic acid, acetic acid, methane sulfonic acid, benzene sulfonic acid, phosphoric acid, malonic acid ([0360]).
Parikh et al. disclose pharmaceutical compositions and single unit dosage forms suitable for oral administration comprising (benzyloxy-1-oxoisoindolin-2-yl)piperidin-2,6-dione derivative,
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, which shares the same core structure as the claimed Compound 1, and a pharmaceutically acceptable excipient (abstract, [0005], and [0036]). Parikh et al. further teach that the active ingredient comprises from about 0.1 to about 5 weight percent or from about 0.1 to about 3 weight percent of total weight of the composition and the active ingredient and carrier, diluent, binder, or filler are directly blended and ([0042] and [0043]).
Parikh et al. further teach that the dosage form comprises a lubricant such as stearic acid which comprise from about 0.01 to about 5 weight percent of total weight of the composition ([0047], [0048], and [0049]).
Parikh et al. further teach that the carrier, diluent, binder, or filler comprises lactose and/or starch, or the mixture thereof wherein the lactose is anhydrous lactose and the starch is pregelatinized starch wherein lactose and starch comprise from about 85 to about 99 weight percent of total weight of the composition ([0043] and [0045]).
Parikh et al. discloses that the ratio of starch to lactose in the dosage form is from about 1:1 to about 1:5 or about 1:3 ([0046]), which falls within the claimed ratio in claims 45-46.
Parikh et al. further teach that tablets, caplets, and capsules typically contain from about 50 mg to about 500 mg of the pharmaceutical composition (i.e., active ingredient and excipient(s)) ([0038]). Also, Parikh et al. disclose that the total weight of the dosage form is 125 mg or 150 mg and the dosage form is suitable for administration in a size #3 or larger capsule ([0060] and [0070]). In addition, Parikh et al. disclose that suitable organic acids include maleic, fumaric, benzoic, ascorbic, succinic, acetic, formic, oxalic, propionic, tartaric, salicylic acid ([0021]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add commonly employed excipients including a diluent (e.g., lactose and starch), a glidant (colloidal silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. for preparing a pharmaceutical composition suitable for oral administration because Alexander et al. already disclose that for oral administration, a pharmaceutically acceptable non-toxic composition is formed by the incorporation of any of the normally employed excipients such as mannitol, lactose, starch (diluent), magnesium stearate, talcum (lubricant), and other excipients. It is a routine procedure in making pharmaceutical formulations in the art of pharmaceutics. The skilled artisan would have reasonably expected that such addition of excipients would provide a pharmaceutical composition suitable for oral administration. As to fumaric acid as acidifier, Gatti teaches that the indolinone compound is solubilized by combining it with a molar equivalent of an acidifier (acid solution) comprising known organic acids and fumaric acid is well known organic acid along with formic acid, lactic acid, malic acid, maleic acid, and succinic acid as evidenced by Parikh et al. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use fumaric acid as an acidifier for solubilizing the claimed isoindolinone compound. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07.
Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been prima facie obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of such excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
Claims 82 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0008852 (hereafter Alexander et al.) in view of US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.) in further view of US 2015/0224039 (cited in the IDS filed on 1/16/2025).
Alexander et al., Gatti, and Parikh et al. as applied supra are herein applied for the same teachings in their entirety.
They do not specifically disclose silica dimethyl silylate as glidant recited in claims 82 and 90. However, it was well known in the art that silica dimethyl silylate as a flow aid (glidant) assists the flow of the powder into the formulation as evidenced by US 2015/0224039 ([0062]). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use silica dimethyl silylate as glidant for improving flowability of the claimed compound in formulating a composition. Generally, it is prima facie obvious to select a known material for incorporation into a composition based on its recognized suitability for its intended use. See MPEP 2144.07.
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
1. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-23 of US Patent 12,064,427 as evidenced by US2015/0099745 (hereafter, Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of a pharmaceutical composition to a patient having multiple myeloma, wherein the pharmaceutical composition comprises the same compound or a crystalline free base thereof and similar excipients such as diluent/filler (mannitol), a glidant (Colloidal Silicone dioxide or silica dimethyl silylate), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate). While the claims of the patent do not specifically recite the mixture of starch and lactose as diluent/filler, starch and lactose are well known diluent/filler as evidenced by Parikh et al. Parikh et al. as applied supra is herein applied for the same teachings in their entirety. Thus, it would have been prima facie obvious to use starch and lactose as diluent/filler in place of mannitol because they were known to provide the same function. The skilled artisan would have been motivated to do so on the reasonable expectation that the mixture of starch and lactose would provide similar intended function as diluent/filler as mannitol in preparing a pharmaceutical composition. As such, the instant claims would have been obvious over the claims of the patent.
2. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 11-26 of US Patent 10,357,489 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating multiple myeloma comprising administering a therapeutically effective amount of a pharmaceutical composition comprising the same compound as claimed in combination with a second active agent such as dexamethasone. While the claims are silent about adding specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
3. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent 11,185,543 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are drawn to a method of treating multiple myeloma comprising administering a therapeutically effective amount of a pharmaceutical composition comprising the same compound as claimed in combination with a second active agent such as dexamethasone. While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
4. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of US Patent 11,439,637 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with a second active agent such as a bispecific antibody.
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
5. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent 12,053,466 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with second active agents such as a bispecific antibody and dexamethasone.
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
6. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of US Patent 10,969,381 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with a second active agent. While the method of the patent comprises additional steps, the claimed method recites open-ended language “comprising”, thus does not exclude additional unrecited elements or steps (see MPEP 2111.03).
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
7. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of US Patent 11,726,080 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with a second active agent. While the method of the patent comprises additional steps, the claimed method recites open-ended language “comprising”, thus does not exclude additional unrecited elements or steps (see MPEP 2111.03).
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
8. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-18 of US Patent 12,510,533 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with a second active agent. While the method of the patent comprises additional steps, the claimed method recites open-ended language “comprising”, thus does not exclude additional unrecited elements or steps (see MPEP 2111.03).
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
9. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of US Patent 11,370,777 as evidenced by as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound in a crystalline form characterized by an XRPD pattern comprising the same peaks as claimed and a pharmaceutical composition thereof. While the claims are silent about adding specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
10. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of US Patent 11,660,297 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with second active agents such as Bruton's tyrosine kinase (BTK) inhibitor and dexamethasone.
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
11. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of US Patent 12,186,311 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with second active agents such as EZH2 inhibitor and dexamethasone.
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
12. Claims 68 and 72-100 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-22 of US Patent 12,472,176 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of a pharmaceutical composition comprising 1) a hydrobromide salt of the same compound as claimed at an amount of from about 0.05 to about 3% w/w; 2) a carrier or diluent at an amount of from about 70 to about 98% w/w; 3) HPMC at an amount of from about 0.5 to about 10% w/w; 4) sodium starch glycolate (SSG) at an amount of from about 0.5 to about 10% w/w; and 5) stearic acid at an amount of from about 0.5 to about 8% w/w; and wherein the carrier or diluent is a mixture of mannitol and cellulose or a mixture of mannitol and starch.,
While the claims are silent about adding specific diluent such as a mixture of starch and lactose, glidant and acidifier as claimed, it would have been prima facie obvious to one of ordinary skill in the art to use well-known diluent/filler such as mannitol, lactose, starch, or their combination, a glidant such as colloidal silicone dioxide, and an acidifier (e.g., fumaric acid) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. Also, it would have been prima facie obvious to substitute the mixture of mannitol and starch with a mixture of starch and lactose as diluent/filler because they were known to provide the same function. The skilled artisan would have been motivated to do so on the reasonable expectation that the mixture of starch and lactose would provide similar intended function as diluent/filler as the mixture of starch and mannitol in preparing a pharmaceutical composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the patent.
12. Claims 68 and 72-100 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6 and 11-29 of co-pending application 18/563037 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with a second active agents such as dexamethasone and elotuzumab.
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the co-pending application.
13. Claims 68 and 72-100 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 43-55 and 58-61 of co-pending application 18/419894 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with a second active agents such as dexamethasone and bortezomib.
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the co-pending application.
14. Claims 68 and 72-100 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 23-42 of co-pending application 18/753467 as evidenced by US 2004/0229930 (hereafter, Gatti) and US2015/0099745 (hereafter Parikh et al.).
Although the conflicting claims are not identical, they are not patentably distinct from each other because they are directed to a method of treating multiple myeloma comprising administering a therapeutically effective amount of the same compound as claimed in combination with second active agents such as a bispecific antibody and additional active agent.
While the claims are silent about a pharmaceutical composition comprising specific excipients as claimed, it would have been prima facie obvious to one of ordinary skill in the art to add well-known pharmaceutical acceptable excipients including diluent (e.g., mannitol and mixture of lactose, starch), a glidant (Colloidal Silicone dioxide), an acidifier (e.g., fumaric acid), a lubricant (e.g., stearic acid), and disintegrant (e.g., sodium starch glycolate) disclosed in Gatti and Parikh et al. to arrive at the claimed pharmaceutical composition for making it suitable for oral administration. Gatti and Parikh et al. as applied supra is herein applied for the same teachings in their entirety. The result would have been predictable because the addition of at least one pharmaceutically acceptable carrier, excipient or diluent would provide a pharmaceutically suitable composition. Regarding the concentrations of the active compound and various known excipients recited in claims, the prior art references teach the ranges which fall within or overlapping with the claimed ranges. Thus, it is the position of the Examiner that it would have been obvious to one of ordinary skill in the art to determine suitable amounts of known excipients along with active ingredient for preparing oral formulations such as tablet and capsules through routine or manipulative experimentation to obtain the best possible results, as these are variable parameters attainable within the art based on the ranges disclosed in prior art. And in cases involving overlapping ranges, the courts have consistently held that even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of known excipients would have been obvious. Furthermore, the claimed ranges for a glidant, an acidifier, a lubricant, and disintegrant encompass “0” (see claim 72), thus do not require the presence of recited excipients when the amount is “0”. Thus, the recitations of the amount ranges of various known excipients do not make the claims non-obvious since the references in combination already disclose the claimed excipients and their suitable concentration ranges and teach that the pharmaceutical forms are prepared according to the known by pharmaceutical technique with excipients such as a diluent, a glidant, an acidifier, a lubricant and disintegrant suitable for the prescribed pharmaceutical forms.
As such, the instant claims would have been obvious over the claims of the co-pending application.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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