DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 09/14/2024, are acknowledged. Claims 59-78 are pending in this action. Claims 1-58 have been cancelled. Claims 59-78 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application is a 371 of PCT/EP2023/056506, filed March 14, 2023, which is a continuation-in-part of PCT/EP2022/058180, filed March 28, 2022, which claims benefit of provisional U.S. Application No. 63/269,330, filed March 14, 2022; and also is a continuation-in-part of U.S. Patent Application No. 17/656,702, filed March 28, 2022 and now issued as U.S. Patent No. 12,678,502, which claims benefit of provisional U.S. Application No. 63/166,995, filed March 27, 2021.
Inventorship
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.
Specification
The lengthy specification (189 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification comprises multiple acronyms without proper definition, e.g., PXRD, UHPLC (Para. 0013-0016, 0269-0271); LDL, ROS (Para. 0025, 0176); GPCR (Para. 0029); ACE, PPAR (Para. 0044); HLB (Para. 0094); SP, CGRP (Para. 0184); BBB (Para. 0185); MAPK, ROCK (Para. 0197-0217); RTK, ACK, ABL, FES, ABL, CSK, FAK, SYK (Para. 0261); MEBF (Para. 0284-0288); BRCA (Para. 0289); OLPF (Para. 0294-0299). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed. Appropriate correction is required.
The use of the trademarks/trade names has been noted in this application (e.g., Para. 0013, 0079, 0264-0266, 0268, 0271, 0275, 0281-0282, 0290-0292, 0302-0304). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The specification comprises references on publications (e.g., Para. 0038). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The specification comprises typographic errors, e.g., “solubility(i.e., water solubility of the ionized form)” (Para. 0041) that need to be corrected to “solubility (i.e., water solubility of the ionized form)”. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statements, filed 04/17/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
Claim Objections
Claims 59-64, 66-67, 69-71, 73 are objected to because of the following informalities:
Claim 59 comprises acronym “PARP”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed.
Claim 60 recites the limitation “inhibitor is a tyrosine protein kinase inhibitor, a serine-threonine protein kinase inhibitor, or” that needs to be corrected to “inhibitor is a tyrosine protein kinase inhibitor, or a serine-threonine protein kinase inhibitor, or” or clarified. Similar is applied to claims 64, 67, 73.
Claim 61 comprises the typographic error “in an amount of about 0.1% to” that needs to be corrected to “in an amount of from about 0.1% to”. Similar is applied to other constituents recited in claim 61 as well as to claims 62, 63, 66, 69.
Claim 70 comprises the typographic error “ratio of about 5:1 to” that needs to be corrected to “ratio of from about 5:1 to”. Similar is applied to other constituents recited in claim 71.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 59-78 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.
Independent claim 59 refers to compositions, wherein several elements are characterized by their assumed function (e.g., “digestion enhancers”, “therapeutic compounds”) and not by the chemical structure essential for said compositions. This claim is unclear and indefinite, because it is well known in the field that the function of a particular compound may change and/or depend on conditions. Claiming a result/function without reciting what materials produce that result/function is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. Further, it is noted that the invention should be explained in such a way as to describe what the invention is, not what the invention does. Given that there is no clear cut indication of the scope of the subject matter covered by the claim, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. MPEP 2173.05(g). Similar is applied to claim 72. Clarification is required.
Claim 59 recites the limitation “one or more therapeutic compounds comprise a protein kinase inhibitor or a PARP inhibitor” that is not reasonably clear. Does this limitation impy that “therapeutic compounds” is a mixture that may include other components/compounds even in large amounts (i.e., comprise). Similar is applied to claims 64, 68 regarding the limitation “glycerolipid comprises”, to claims 65, 67 regarding the limitation “fats include”, to claim 73 regarding the limitation “digestion enhancers include”, to claim 74 regarding the limitation “bile acids include”. Clarification is required.
Claim 61 is unclear and indefinite, because the claim recites a broad range/limitation (e.g., about 0.1% to about 50%) together with a narrow range/limitation (e.g., about 0.1 to about 1%) that falls within the broad range/limitation in the same claim. Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05(c). Similar is applied to claims 62-63, 66, 69-72, 75-77. Clarification is required.
Claim 63 recites the limitation “glycerolipids are in an amount of at least 20% by weight” that is unclear, because the recited amount of said constituent is not clearly delineated. Can it be 100%? Similar is applied to claims 66, 69, 72, 75-77. Clarification is required.
Claim 67 recites the limitation/term "partially hydrolyzed" that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim 70 recites the ratio limitations, e.g., “from about 5:1 to about 4:1” that are unclear and indefinite, because the recited relative amounts are not clearly delineated (e.g., a molar ratio, a weight ratio, a volume ratio, etc.), and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to claim 71. Clarification is required.
Claim 73 recites the limitations “free C14-24 fatty acids”, “free C14-24 fatty acid surfactants” that is not reasonably clear. To this point, it is noted that neither the claims nor the instant specification provides clear definitions for said terms/limitations. It is unclear what the term “free” does imply. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Similar is applied to claims 76, 77. Clarification is required.
Claim 78 is rejected as being dependent on rejected independent claim 59 and failing to cure the defect.
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, 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.
Claims 59-78 are rejected under 35 U.S.C. 103 as being unpatentable over Bannister et al., US 2014/0199296 A1 (hereinafter referred to as Bannister).
Bannister teaches pharmaceutical compositions comprising: (i) a cancer therapeutic, e.g., such protein kinase inhibitors as a phosphoglycerate kinase inhibitor (Claim 6; Abstract, Para. 0043 as applied to claim 59); (ii) glycerolipids, e.g., glycerides, monoglycerides, triglycerides (Para. 0102, 0106, 0122, 0126-127 as applied to claim 59, 64-65, 67-68); (iii) phospholipids, C4-24 fatty acids (Para. 0106, 0107, 0132 as applied to claims 59, 73) identified in the instant application as “digestion enhancers”.
Bannister teaches that said lipids can be an oil, an oil-based liquid, a fat, a fatty acid, a glyceride (mono-, di- or tri-glyceride), phospholipids, and/or a partially hydrolyzed triglyceride (Claims 16, 17; Para. 0106 as applied to claims 64-65, 67-68). Bannister also teaches that said compositions can be in a solid, a semi-solid, or liquid forms (Claim 8; Para. 0068-0071 as applied to claim 78).
Therefore, it is the examiner’s position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, because every element of the invention has been taught by the teaching of the reference cited. With regard to the concentrations and/or ratios as instantly claimed (Claims 61-63, 66, 69-72, 76), it is noted that differences in experimental parameters such as concentration of compounds in a composition/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components/compounds. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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. Claims 60, 74-75, 77 are rejected as been dependent on rejected base claim. Applicant is advised to clarify the claimed language and scope, the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2020/0368159 A1 (cited in IDS) - teaches one-phase liquid formulations for insoluble drugs, wherein said compositions are not emulsions and may include: (i) drugs selected from a group consisting of small molecules, peptides, proteins or a combination thereof; (ii) salt of bile acids such as cholic acid, glycocholic acid, taurocholic acid, deoxycholic acid, chenodeoxycholic acid (i.e., digestion enhancer); (iii) triglycerides/hard fat/glycerolipids (Claims 1-2, 8, 14-15; Abstract; Para. 0052, 0074, 0103, 0081, 0149)
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 59-78 are rejected on the ground of nonstatutory double patenting as being unpatentable over (1) claims 1-22 of U.S. Patent No. 12,226,484; (2) claims 1-21 U.S. Patent No. 12,678,502.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because prior patents also claim: A pharmaceutical composition comprising: (i) one or more therapeutic compounds; (ii) one or more glycerolipids, e.g., triglycerides, monoglycerides (iii) one or more free C14-22 fatty acids (identified in the instant application as digestion enhancers); and (iv) a one or more bile acids (identified in the instant application as digestion enhancers); wherein said compositions are not emulsions. Further, cited prior patents teach that said compositions include such therapeutic compounds as PARP inhibitor, kinase inhibitors. In the present case, the instant claims are merely broader than prior patent claims that include additional limitations (i.e., specific compounds present in specific amounts) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patent.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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