DETAILED CORRESPONDENCE
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The claim set filed on 10/25/2024 is acknowledged.
Claims 4-9, 13, 15, 17, 19, 20, 23-25, 27-60, and 68-69 are cancelled.
Claims 1-3, 10-12, 14, 16, 18, 21, 22, 26, 61-67, and 70 are pending.
Claim Interpretation
The claims are drawn to composition that comprises optional ingredients, which examiner is interpreting with the broadest reasonable interpretation of the optional ingredients such that the limitations of claimed composition can also satisfied without the presence the optional ingredients. Further, the claims as written recite “one or both of a surfactant and a solubilizer” and examiner is interpreting this language with the broadest reasonable interpretation such that the limitations of claimed composition can also be satisfied with the presence of just one of either surfactant or solubilizer.
Regarding the oral liquid pharmaceutical composition, the specification discloses “[0087] The compositions described herein may be provided in any dosage form suitable for an oral liquid pharmaceutical composition, including a bulk dosage form or unit dosage form. … Alternatively, for a unit dosage form, a volume of composition providing a single dose or sub-dose thereof may be filled into one or more capsules.” Examiner interprets liquid filled capsules can satisfy the oral liquid pharmaceutical composition as claimed using the broadest reasonable interpretation.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 10-12, 14, 16, 18, 21, 22, 26, 61-67, and 70 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 1(iii), 1(iv), 2(iii), 2(iv), 70O(iii), 70O(iv), 70P(iii), and 70P(iv) are indefinite for reciting lauroyl polyoxylglyceride and lauroyl macrogoglyceride surfactants in each section (iii) which is a list of surfactants and then reciting lauroyl macrogolglyceride and lauroyl polyoxylglyceride surfactants in each section (iv) which is a list of co-surfactants, which is unclear because examiner is unable to determine if the “co-surfactant” is must be different or if the composition can comprise more of the same surfactant.
Claims 12, 62, and 70 are indefinite because the claims contain the trademarks “CAPMUL®, LABRAFIL®, LABRASOL®, ACCONON®, SOLUPLUS®, TRANSCUTOL®, and KOLLIPHOR®”. Generally, trademarks are not appropriate claim language because the mark identifies the product but not its composition. The components of trademarked products can change with no notice.
Claims 3, 10-11, 14, 16, 18, 21, 22, 26, 61, and 63-67 are included in the rejection because they do not correct for the defect of the claim from which they depend.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 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.
Claims 1-3, 10-12, 14, 16, 18, 21, 22, 26, 61-67, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Mika et al. (WO2015022349A1) hereinafter Mika in view of Venugopal et al. (WO2019030691A1) hereinafter Venugopal.
Regarding claims 1-3, 10-12, 14, 16, 18, 21, 22, 26, 61-67, and 70, Mika is drawn to dosage forms comprising enzalutamide, wherein the enzalutamide is present in a dissolved form (abstract).
Mika discloses due to the increased bioavailability the dosage form of the
present invention can be prepared with a superior drug load and thus can be provided in a form being easy to swallow such that an excellent patient compliance
can be achieved. Further, the dosage form of the present invention has an improved
dissolution profile and can be very stable over a long period (pg. 3, ln 13-17).
Mika discloses 1 to 20 wt. % enzalutamide (pg. 3, ln 8). Mika discloses examples of preferred compounds are sorbitan esters (Span), especially from saturated or unsaturated fatty acids, polyethoxylated sorbitan esters (Tween), especially from saturated or unsaturated fatty acids, polyethoxylated glycerides (Labrasol), Lauroyl macrogol-32 glycerides (Gelucire 44/14), stearoyl macrogol- 32 glycerides (Gelucire 50/13), especially from saturated or unsaturated fatty acids, polyethoxylated and/or hydroginated castor oils such as PEG-40 hydrogenated castor oil (Cremophor RH 40® ), PEG-60 hydrogenated castor oil (Cremophor RH 60® ), PEG-35 castor oil or polyoxyl 35 castor oil (Cremophor EL), Macrogol (25) cetostearyl ether (Cremophor A25), polyethoxylated ethers, especially from saturated or unsaturated fatty alcohols, polyethylene glycol such as PEG 200, poloxamer (Lutrol F 127), alpha tocopherol, polyoxyethylene lauryl ether (Brji 30, Brji 35), polyvinyl caprolactam-polyvinylacetate- polyethyleneglycol graft copolymer (e.g. Soluplus® ) and mixtures thereof (p. 8, ln 20-32).
Mika discloses the dosage form can preferably contain one or more antioxidants. Antioxidants are compounds for the protection of the used components from oxidation, preferably the first solvent and the oily component, especially the first solvent. Examples for suitable antioxidants comprise ascorbyl palmitate, butylated hydroxytoluene, butylated hdroxyanisole, propyl gallate and mixtures thereof. Antioxidants are used in an amount up to 2.0 wt.%, preferably10 0.1 to 1.8 wt.%, in particular 0.2 to 1.6 wt.% (pg. 15, ln 4-15).
Mike discloses the composition comprising PEG (80) sorbitan monooleate (Tween 80), diethylene glycol monoethylether 10 (Transcutol HP) and polyvinyl caprolactam-polyvinylacetate-polyethyleneglycol graft copolymer (Soluplus®) were mixed together and subsequently enzalutamide was added to the mixture (pg. 23, Example 7)
Mika discloses examples of cancers to be treated with an anti-tumoral compound comprise prostate cancer. Enzalutamide is a preferred embodiment of said anti-tumoral compound (pg. 18, ln 30 – pg. 19, ln 2).
Mika does not explicitly disclose the presence of propylene glycol caprylate surfactant.
However, Venugopal is drawn to pharmaceutical compositions of enzalutamide (abstract). Venugopal discloses suitable surfactants as component can be selected from preferably propylene glycol caprylates such as Capmul PG-8, Capryol 90; esters of glycerol and fatty acids, preferably glycerol oleates and caprylates (Capmul MCM) (pg. 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Mika, wherein the surfactant can also comprise, as previously disclosed by Venugopal, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Mika and Venugopal are in the field of enzalutamide compositions, and Venugopal discloses the pharmaceutical composition is particularly useful in medical treatments, specifically in the treatment of prostate cancer and breast cancer, benign prostate hyperplasia and ovarian cancer and in particular in the treatment of male patients with metastatic castration-resistant prostate cancer (pg. 14). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615