DETAILED ACTION
Claims 1-30 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a CON of 17/898,558 (08/30/2022) which is a CON of 16/297125 (03/08/2019) which is a CON of 15/828,858 (12/01/2017) which is a CON of 15/048,416 (02/19/2016) as reflected in the filing receipt issued on September 11 2023.
Drawings
The drawings are objected to for the following reasons: 37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."” In the current case, the view numbers for Figures 1A-1D are preceded by the word "Figure" instead of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8, 11-14, 17-22 and 25-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification discloses chemicals, such as propylene glycol which meet the written description and enablement provisions of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. However, claim(s) 1-8, 11-14, 17-22 and 25-29 is(are) directed to encompass any non-aqueous solvent which allows for the composition to be stable after storage (i.e. at least 90% of the initial dosage concentration of pemetrexed after storage at a temperature of 2°C to 8°C) which only correspond in some undefined way to specifically instantly disclosed chemicals. The scope of the solvents claims fail meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. More specifically, the specification fails to describe what structure associated with the solvent allows for the claimed stability at the concentrations claimed. The specification provides insufficient written description to support the genus encompassed by the claim. Note: MPEP 2163.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, (Fed. Cir. 1991), makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004), further supports this by stating that:
The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. A description of an anti-inflammatory steroid, i.e., a steroid (a generic structural term) described even in terms of its functioning of lessening inflammation of tissues fails to distinguish any steroid from others having the same activity or function. A description of what a material does, rather than of what it is, usually does not suffice…. The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. (Emphasis added).
With the exception of the above specifically disclosed chemical structures, the skilled artisan cannot envision the detailed chemical structure of the encompassed solvents, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The chemical structure itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Circ. 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016, (Fed. Cir. 1991). In Fiddes v. Baird, 30 USPQ2d 1481, 1483, (Bd. Pat. App. & Int. 1993), claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence. Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 (Fed. Cir. 1997) held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing “sufficiently detailed, relevant identifying characteristics,” including “functional characteristics when coupled with a known or disclosed correlation between function and structure.” Univ. of Rochester v. G.D. Searle, 68 USPQ2d 1424, 1432 (DC WNY 2003).
While one skilled in the art would understand the scope of the recitation of non-aqueous solvent and while one skilled in the art would recognize various different species which fall within the scope, the claims do not just require the non-aqueous solvent but require that when the non-aqueous solvent present at a particular concentration with pemetrexed that upon dilution possess a stable composition. However, the specification only ever shows the stability associated with propylene glycol and never indicates what specific structure is required to achieve any of the claimed stability parameters.
The specification clearly shows the effect with propylene glycol with contains two OH groups. However, other solvents taught include hydrocarbons which would not contain any other functional groups other than carbon and hydrogen. Therefore, these solvents have vastly different properties and there is no evidence in the instant specification that these solvents would achieve the claimed stability. While the specification suggests a variety of other solvent which include OH groups such as polyethylene glycol and alcohols, the specification does not describe that these solvents can achieve the claimed stability. Especially in light of polyethylene glycol possessing a variety of different molecular weights from low molecular weight like PEG400 but could include PEG with molecule weights of 20,000 g/mol+.
The specification teaches that stable, ready to use formulations of pemetrexed are known but they require stabilizers or high levels of non-aqueous solvents (page 2 of the specification). The instant specification, however, never describes how the claimed stability can be achieved at the claimed concentration of solvent with solvents other than propylene glycol.
Therefore, only the above chemically structurally defined chemicals, but not the full breadth of the claim(s) meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. The species specifically disclosed are not representative of the genus because the genus is highly variant. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 USC § 112 is severable from its enablement provision. (See page 1115.)
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claim(s) 1-9, 12, 14, 17-23, 26 and 28 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Zaludek (WO 2015193517).
The instant application claims a pharmaceutical composition comprising a) pemetrexed and b) a non-aqueous solvent present at less than 0.30 mL/mL; wherein upon dilution with a pharmaceutically acceptable diluent to an initial dosage concentration of pemetrexed, the composition comprises at least 90% of the initial dosage concentration of pemetrexed after storage at a temperature of 2°C to 8°C for at least 12 hours.
Zaludek is directed to liquid pharmaceutical composition comprising pemetrexed. Exemplified composition comprise pemetrexed in 50 mg/ml (page 10) or 25 mg/ml (page 16) and propylene glycol in 0.2 ml/ml (page 10) or 0.05 or 0.1 ml/ml (page 16). The exemplified compositions were shown to be stable. The pemetrexed is the diacid (page 4, line 16). The compounds of the compositions are mixed and the volume is made up with water (for injection) (claim 13). Exemplified compositions comprise from 0.15 to 5 mg/ml antioxidant (page 20).
Regarding claims 14 and 28, amounts of antioxidant exemplified read on the substantially free recitation of the anti-oxidant.
Regarding the claimed “wherein upon dilution” recitation, this is how the composition performs in use and "the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002). Thus, this limitation is given little patentable weight. Furthermore, since the prior art teaches the same active and solvent in the same claimed amount, it would inherently have the same stability. Note MPEP 2112.02 (1I): "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claim(s) 1-30 is/are rejected under 35 U.S.C. 102(a)(1) and/or (a)(2) as being anticipated by Palepu et al. (USPGPUB No. 20130231357).
The instant claims are set forth above.
Palepu et al. is directed to pharmaceutical compositions containing pemetrexed having extended storage stability. Compositions comprising 25 mg/ml pemetrexed disodium salt and 10% (i.e. 0.1 ml/ml) of propylene glycol and .9 ml/ml water for injection (table 3). Other specifically taught amounts of propylene glycol include 25% (i.e. 0.25 ml/ml aka 250 µl/ml) and 75% water (i.e. 0.75 ml/ml) (claim 8). Claimed is pemetrexed or a pharmaceutically acceptable salt thereof (claim 1). Thus Palepu et al. expressly contemplates the use of the diacid. Amounts of antioxidant taught is from 1 mg/ml to 20 mg/ml (claim 10).
Regarding claims 14 and 28, amounts of antioxidant exemplified read on the substantially free recitation of the anti-oxidant.
Regarding the claimed “wherein upon dilution” recitation, this is how the composition performs in use and "the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801,809 (Fed. Cir. 2002). Thus, this limitation is given little patentable weight. Furthermore, since the prior art teaches the same active and solvent in the same claimed amount, it would inherently have the same stability. Note MPEP 2112.02 (1I): "Products of identical chemical composition cannot have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Regarding claims 29-30, the wherein clause merely states the results of the limitation in the claim and adds nothing to the patenting or substance of the claim. Since the prior art suggests the same claimed ingredient in the same or substantially similar amount, it is the position of the examiner that the compositions would possess the same storage stability. Thus, the burden is shifted to applicants to demonstrate that the property is not possessed by the prior art composition.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10-11, 15-16 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Zaludek as applied to claims 1-9, 12, 14, 17-23, 26 and 28 above.
Applicant Claims
The instant application claims the propylene glycol is present at 0.25 ml/ml and comprises at least 0.5 ml/ml water.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The teachings of Zaludek are set forth above.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Zaludek does not expressly teach 0.25 ml/ml or at least 0.5 ml/ml water.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the amount of propylene glycol and water. Since Zaludek expressly teaches the volume is made up from water for injection, depending on the amount of the ingredients, it would have been obvious to one of ordinary skill in the art to manipulate the amount of water. Note: MPEP 2144.05: A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. It is generally noted thatdifferences in concentrations do not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[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). Given that applicant did not point out the criticality of the propylene glycol or water concentration of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentrations.
Regarding claims 29-30, the wherein clause merely states the results of the limitation in the claim and adds nothing to the patenting or substance of the claim. Since the prior art suggests the same claimed ingredient in the same or substantially similar amount, it is the position of the examiner that the compositions would possess the same storage stability. Thus, the burden is shifted to applicants to demonstrate that the property is not possessed by the prior art composition.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9655898. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims a pharmaceutical composition comprising: a) pemetrexed and b) a non-aqueous solvent present at less than 0.30 mL/mL; wherein upon dilution with a pharmaceutically acceptable diluent to an initial dosage concentration of pemetrexed, the composition comprises at least 90% of the initial dosage concentration of pemetrexed after storage at a temperature of 2°C to 8°C for at least 12 hours.
The instant application claims a pharmaceutical composition comprising a) 25 mg/mL pemetrexed, and b) propylene glycol at 250 µL/mL) water wherein upon dilution with a pharmaceutically acceptable diluent to an initial dosage concentration of pemetrexed, the composition comprises at least 90% of the initial dosage concentration of pemetrexed after storage at a temperature of 2°C to 8°C for at least 24 hours.
The instant application claims a pharmaceutical composition comprising a) an initial pemetrexed concentration of 25 mg/mL, b) propylene glycol at 250 µL/mL, and c) water; wherein the composition comprises at least 90% of the initial pemetrexed concentration after storage at a temperature of 2°C to 8°C for at least 12 months.
Patent ‘898 claims a long term storage stable pemetrexed-containing aqueous liquid pharmaceutical composition, comprising: a) pemetrexed or a pharmaceutically acceptable salt thereof; b) 1 mg/ml to about 20 mg/ml L-methionine; and c) 0.005M to about 0.5M sodium citrate, tribasic; and d) an aqueous pharmaceutically acceptable fluid; and optionally e) propylene glycol; wherein the composition has a pH of from about 8.0 to about 9.5; and said pemetrexed-containing composition has less than about 5% total impurities, on a normalized peak area response (“PAR”) basis as determined by high performance liquid chromatography (“HPLC”) at a wavelength of 227 nm, after at least about 18 months of storage at a temperature of from about 5° C. to about 25° C. Up to about 50% propylene glycol is claimed. Both diacid and disodium are claimed. The same concentration of pemetrexed is claimed.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another as both are directed to compositions comprising pemetrexed and propylene glycol with the same or similar stability.
Regarding the concentration of propylene glycol, Patent ‘898 claims an overlapping range. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Claims 1-12, 14-26 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11793813. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims are set forth above.
Patent ‘813 claims a liquid pharmaceutical composition, consisting of: 20 mg/mL to 30 mg/mL of pemetrexed diacid; 200 mg/mL to 300 mg/mL of propylene glycol; 12 mg/mL to 24 mg/mL of tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6, wherein the composition is suitable for multi-dose administration, and wherein the composition remains stable when stored for about 14 months at a temperature of 2° C. to 8° C. in a container having a head-space oxygen content of about 20% v/v, such that the composition comprises no more than 3% w/w of total impurities after said storage.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another as both are directed to compositions comprising pemetrexed and propylene glycol with the same or similar stability.
Regarding the claimed concentration of propylene glycol, Patent ‘813 claims an overlapping range. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Claims 1-12, 14-26 and 28-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12115164. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
The instant application claims are set forth above.
Patent ‘164 claims a method of treating pleural mesothelioma or non-squamous, non-small cell lung cancer in a patient in need thereof comprising providing a liquid pharmaceutical composition consisting of: 20 mg/mL to 30 mg/mL of pemetrexed diacid; 200 mg/mL to 300 mg/mL of propylene glycol; 12 mg/mL to 24 mg/mL of tromethamine; optionally HCl; and water, wherein the pH of the composition is from about 7.4 to 7.6, wherein the composition is suitable for multi-dose administration, and wherein the composition remains stable when stored for about 14 months at a temperature of 2° ° C. to 8° C. in a container having a head-space oxygen content of about 20% v/v, such that the composition comprises no more than 3% w/w of total impurities after said storage; diluting the liquid composition with normal saline, water for injection, 5% dextrose in water, Ringer's Injection, or Lactated Ringer's Injection to form a diluted liquid composition; and intravenously administering the diluted liquid composition to the patient.
Therefore, the scopes of the patent claims and the instant application overlap and thus they are obvious variants of one another as both are directed to compositions comprising pemetrexed and propylene glycol with the same or similar stability.
Regarding the claimed concentration of propylene glycol, Patent ‘164 claims an overlapping range. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Claims 1-12, 14-26 and 28-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 31-50 of copending Application No. 18470621 (USPGPUB No. 20240009198). Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims overlap in scope.
This is a provisional nonstatutory double patenting rejection.
The instant claims are set forth above.
Copending ‘621 claims a diluted liquid pharmaceutical composition, consisting of:20 mg/mL to 30 mg/mL of pemetrexed diacid; 200 mg/mL to 300 mg/mL of propylene glycol; 12 mg/mL to 24 mg/mL of tromethamine; optionally HCl; water; and a dilution liquid selected from normal saline, water for injection, 5% dextrose in water, Ringer's Injection, or Lactated Ringer's Injection, wherein the pH of the liquid composition prior to dilution with the dilution liquid is from about 7.4 to 7.6, wherein the composition is suitable for multi-dose administration, and wherein the composition remains stable when stored for about 14 months at a temperature of 2 °C to 8 °C in a container having a head-space oxygen content of about 20 % v/v, such that the composition comprises no more than 3 % w/w of total impurities after said storage.
Therefore, the scopes of the copending claims and the instant application overlap and thus they are obvious variants of one another as both are directed to compositions comprising pemetrexed and propylene glycol with the same or similar stability.
Regarding the claimed concentration of propylene glycol, copending ‘621 claims an overlapping range. 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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached on 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL VANHORN/ Primary Examiner, Art Unit 1636
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