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 .
Restriction/Election
Applicant’s election of Group I, claims 32-53 in the reply filed on 01/12/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Warning
Applicant is advised that should claim 32 be found allowable, claim 53 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 32-53 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. the purpose of the written description requirement is the MPEP states t the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"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 Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). ("The 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." Regents of the University of California V. Eli Lilly & Co., 43 USPQ2d 1398. Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of Califormia V. Eli Lilly & Co. the court stated "A written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or sub combinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus "( Regents of the University of Califormia V. Eli Lilly & Co., 43 USPQ2d 1398).
The MPEP states that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. The Guidelines for Examination of Patent Applications Under 35 USC 112, first, "Written Description" Requirement (Federal Register, Vol. 66, No. 4, pg. 1105, column 3), in accordance with MPEP § 2163, specifically state that for each claim drawn to a genus the written description requirement may be satisfied through sufficient description of a representative number of species by a) actual reduction to practice; b) reduction to drawings or structural chemical formulas; c) disclosure of relevant, identifying characteristics (i.e. structure) by functional characteristics coupled with a known or disclosed correlation between function and structure. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention (Federal Register, Vol.66, No. 4, p. 1105, 3rd column, 3rdparagraph).
Scope of claims: In the instant case the claimed scope is extremely broad with a variety of distinct variables encompass essentially countless compounds. The claims are draw to a fatty acid, an organic compound that can form a keto-enol tautomer, a charged phospholipid, a charged protein, a ribonucleic acid, a poly saccharide, a prodrug with a lipid moiety, with straight or branched aliphatic moiety, with 2 mer to 30 mer peptide moiety and. with a pegylated moiety. Furthermore, the cleavable covalent bond of claim prodrug comprises one of: an ester bond, a hydrazone bond, an imine bond, a disulfide bond, a thioester bond, a thioether bond, a phosphate ester bond, a phosphonate ester bond, a boronated ester bond, an amide bond, a carbamate ester bond, a carboxylate ester bond, and a carbonate ester bond.
Scope of disclosure and reduction to practice: the instant specification discloses Arg-Gln-Ile-Arg-Arg-Ile-Ile-Gln-Arg-NH₂ as a positively charged protein within the scope of positively charged protein. The instant specification discloses One example of how a prodrug may be incorporated into a multiphasic colloidal suspension which is from among the class of mitochondria-targeted tetrapeptides (MTT), which can be used to form a prodrug that is a product of a condensation or esterification reaction, of formula, (II):
[00061] H-d-Arg-DMT-Lys-Phe(-O)-R, designated as EY005-R. Here, the specification does not provide reasonably representative disclosure of an organic compound that can form a keto-enol tautomer, a charged protein, a ribonucleic acid, a poly saccharide, a prodrug with a lipid moiety, with straight or branched aliphatic moiety, with 2 mer to 30 mer peptide moiety and with a pegylated moiety and The compounds that are active as inactive prodrug is metabolized in the body. Furthermore, the cleavable covalent bond of a prodrug is claimed to be one of: an ester bond, a hydrazone bond, an imine bond, a disulfide bond, a thioester bond, a thioether bond, a phosphate ester bond, a phosphonate ester bond, a boronated ester bond, an amide bond, a carbamate ester bond, a carboxylate ester bond, and a carbonate ester bond creating, a potentially huge genus inclusive of many different compounds having widely divergent structure and function. A correlation between structure and function, for instantly claimed genus of compounds, is neither known in the art nor disclosed in the specification. It is the examiner's position that substantial structural variation exists in the genus/subgenus embraced by the instant claims and the disclosure of species supporting genus is limited to compounds reduced to practice, which their scope is not commensurate in scope with the genus/subgenus as claimed herein. Furthermore, common structural attributes of the claimed genus/subgenus, combined with a correlation between structure and function, is neither disclosed in the instant application nor commonly known in the art. Thus, the specification fails to provide adequate written description for the genus of compounds claimed and does not reasonably convey to one skilled in the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
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 32, 35, and 53 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 32 and 53 is indefinite as to the “an organic compound that can form a keto enol tautomer”. The claims are indefinite since they relate to a compound by its function of being able to form another compound.
Claim 35 is indefinite as to the expression “Dlin-MC3-DMA”. Such expression fails to set forth the intended meaning.
Claims 33, 34, and 36-39 are rejected as being dependent on rejected claims, considering that such claims have all the limitations of the rejected claims.
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.
The factual inquiries 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.
Claim(s) 32-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swanick et al. (US 20100233232 submitted by the applicant) in view of Sullivan et al. Submitted by the applicant) and further in view of Voigt et al. (US 20170252301 submitted by the applicant) Phippen et al. (submitted by the applicant) and Szeto et al. ( US 20170035899 submitted by the applicant).
The claims are drawn to A composition of a multiphasic colloidal suspension comprising a drug substance and one or more complexation agents, admixed in a dispersal medium having a release profile of one or more phases of drug release, wherein the one or more complexation agents is formulated as an irregular-shaped particulate that forms drug substance- complex particulates by noncovalent, reversible binding to the drug substance, and is one of: a fatty acid, an organic compound that can form a keto-enol tautomer, a charged phospholipid, a charged protein, a ribonucleic acid, and a polysaccharide; further wherein the dispersal medium is a hydrophobic liquid oil comprising at least one of: saturated fatty acid methyl esters, unsaturated fatty acid methyl esters, saturated fatty acid ethyl esters, unsaturated fatty acid ethyl esters.
Regarding claims 32 and 53, Swanick teaches a method of forming therapeutic fatty acid particles comprising: (a) combining a cross-linked, fatty acid-derived biomaterial (e.g., a cross-linked fish oil) and a therapeutic agent to form a first composition; (b) submerging, surrounding, or suspending the composition in a cryogenic liquid (c) fragmenting the composition; and (d) optionally removing the dispersing media. In one embodiment, the dispersing media comprises a solvent that will not dissolve the therapeutic agent or the cross-linked, fatty acid-derived biomaterial. See Para [0012]. Swanick teaches that the mean particle size of the particles produced by the methods described herein is in the range of about 1 micron to about 50 microns, e.g., 1 micron to about 10 microns. Swanick teaches that the particles have a distribution of size of about 1-20 .mu.m (v,0.1), 21-40 .mu.m (v,0.5), and 41-150 .mu.m (v,0.9). See Para [0013]. Swanick teaches the fatty acid-based particles (with or without a therapeutic agent) can also be loaded into fatty acid-based liquids (e.g., fish oil) or gels (e.g., partially cured fish oil) to create an emulsion or suspension. See Para [0035].
Swanick does not specifically teach the use of methyl ester or ethyl ester in the fatty acid. However, Sullivan teaches that fish oil has above 1.5% ethyl ester. See the abstract. Therefore, the use of fish oil taught by Swanick, comprises ethyl ester as taught by Sullivan et al.
Regarding claim 33, Swanick does not teach the use of magnesium palmitate, or magnesium stearate or calcium palmitate or calcium stearate as a complexing agent. However, Voigt et al. teach biocompatible composite nanoparticles comprising magnesium stearate nanoparticles and at least one oil. See Para [0002]. Voigt teaches that at least one oil is mixed with magnesium stearate to create a paste-like composition. In at least one embodiment the paste-like composition is low in water and oil fractions. The paste-like composition is added to a plant oil and the system is stirred to achieve a special particle size distribution. In at least one embodiment, the hydrophobic system is supportive and prevents excessive phase separation. See para [0010]. Voigt teaches that the oil(s) may be any of a wide variety of agents, which are known to those skilled in the art. Suitable oils may include, but are not limited to, tocopherol, castor oil, plant oil, and any suitable oil accepted in biomedicine or cosmetics. See Para [0025]. Voigt teaches the sustained release nature of the nanoparticles in Para [0026]. Voigt et al. teach Stearate may be mixed with one or more ingredients (one ingredient is essentially an oil, for example, tocopherol or castor oil). See Para [0029] and claim 14. It would have been obvious to a person skilled in the art to use magnesium stearate as a fatty acid ester in the composition of Swanick, motivated by the teachings of Voigt, which teaches the use of magnesium stearate in combination with a drug and an oil for forming nanoparticles in a drug delivery composition as old and well known.
Regarding claim 34, Voigt teaches Suitable oils may include, but are not limited to, tocopherol, castor oil, plant oil, and any suitable oil accepted in biomedicine or cosmetics. See Para [0025].
Regarding claim 35, Voigt teaches stearate/tocopherol/magnetite nanoparticles dispersed with medium-intensity stirring in a lecithin-stabilized aqueous system. See Para [0041].
Regarding claim 36 Swanick teaches a complexing agent, such as functional protein and collagen. See Para [0079] and table 1.
Regarding claim 37, Voigt teaches the use of a ribonucleic acid (RNA), as an active agent. See claim 7.
Regarding claim 38, Voigt teaches the use of carbohydrates as an active ingredient in combination with an oil and magnesium stearate. See claim 6.
Regarding claim 39, Voigt teaches that at least one active ingredient is selected from the group consisting of one or more proteins, peptides, nucleic acids, lipids, amino acids, carbohydrates and derivatives of these aforementioned ingredients, magnetite, fluorescent markers, and any combination thereof. See claim 6.
Regarding claim 40, Voigt et al. teach biocompatible composite nanoparticles comprising magnesium stearate nanoparticles and at least one oil. See Para [0002]. Voigt teaches that at least one oil is mixed with magnesium stearate to create a paste-like composition. See Para [0002]. Such teachings read on R being C4-C30 lipid moiety (fatty acid). The addition of a drug to magnesium stearate is taught in claim 7. Regarding claim 41, Voigt et al. teach biocompatible composite nanoparticles comprising magnesium stearate nanoparticles and at least one oil. See Para [0002]. Such teachings reads on the cleavable covalent bond being an ester.
Regarding claim 42, Swanick teaches the cross-linked, fatty acid-derived biomaterial degrades (e.g., by hydrolysis) into fatty acid, short and long chain alcohol, and glyceride molecules. See Para [0060]. The determination of fatty alcohols within the scope of Swanick would have been obvious to a person skilled in the art in the absence of evidence to the contrary.
Regarding claim 43, Swanick teaches the use of fish oil, which reads on Panathenaic acid and hexadecanoic acid.
Regarding claim 44, Voigt teaches the active ingredients and functional ingredients may be any of a wide variety of agents, which are known to those skilled in the art. Examples of active ingredients and functional ingredients that can be used include, but are not limited to, proteins, peptides, nucleic acids, lipids, amino acids, carbohydrates and derivatives. See Para [0022]. Voigt does not teach the amino acids encompassed in a peptide. However, Szeto teach Szeto teaches a carrier complex comprising a molecule conjugated to an aromatic cationic peptide, wherein the aromatic cationic peptide is selected from the group consisting of: Tyr-D-Arg-Phe-Lys-NH.sub.2 (DALDA), 2′,6′-Dmt-D-Arg-Phe-Lys-NH.sub.2 (Dmt.sup.1-DALDA), Phe-D-Arg-Phe-Lys-NH.sub.2 (Phe.sup.1-DALDA), D-Arg-2′,6′Dmt-Lys-Phe-NH.sub.2, and 2′,6′-Dmp-D-Arg-Phe-Lys-NH.sub.2 (Dmp.sup.1-DALDA). See Claim 1.
Regarding claim 45, Voigt teaches the use of peptides in general. See Para [0022]. Szeto teaches a carrier complex comprising a molecule conjugated to an aromatic cationic peptide, wherein the aromatic cationic peptide is selected from the group consisting of: Tyr-D-Arg-Phe-Lys-NH.sub.2 (DALDA), 2′,6′-Dmt-D-Arg-Phe-Lys-NH.sub.2 (Dmt.sup.1-DALDA), Phe-D-Arg-Phe-Lys-NH.sub.2 (Phe.sup.1-DALDA), D-Arg-2′,6′Dmt-Lys-Phe-NH.sub.2, and 2′,6′-Dmp-D-Arg-Phe-Lys-NH.sub.2 (Dmp.sup.1-DALDA), and wherein the molecule is a lipid, an enzyme, an antibody, or a neurotrophic growth factor. See claim 1. It would have been obvious to a person skilled in the art to use compounds attached to a peptide, motivated by the teachings of Szeto, which teaches peptides can be a carrier complex for delivering a molecule to the cell.
Regarding claim 46, Voigt teaches carbohydrates and derivatives as active ingredients. See Para [0022].
Regarding claim 47, Voigt teaches the active ingredient being peptides. See Para [0022].
Regarding claim 48, Swanick teaches the use of fish oil as a dispersing agent. Swanick does not specifically teach the use of methyl ester or ethyl ester in the fatty acid. However, Sullivan teaches that fish oil has above 1.5% ethyl ester. See the abstract. Therefore, the use of fish oil taught by Swanick, comprises ethyl ester as taught by Sullivan et al.
Regarding Claim 49, Swanick teaches the use of Fish oil, squid oil, omega 3 fatty acids, vegetable oils as dispersing agents See table 1. Voigt teaches suitable oils may include, but are not limited to, tocopherol, castor oil, plant oil, and any suitable oil accepted in biomedicine or cosmetics. See Para [0025]. Swanick and Voigt do not teach the use of a fatty acid methyl ester. However, Phippen et al. teach the presence of fatty acid methyl esters, such as methyl laurate (methyl dodecanoate) and methyl caprate (methyldecanoate) in a plant seed oil. The presence of methyl ester as a dispersal medium is the inherent property of vegetable/plant seed oil taught by Swanick and Voigt as a dispersal medium.
Regarding claim 50, Swanick teaches the use of fish oil, , squid oil, omega 3 fatty acids, vegetable oils as dispersing agents See table 1. Voigt teaches suitable oils may include, but are not limited to, tocopherol, castor oil, plant oil, and any suitable oil accepted in biomedicine or cosmetics. See Para [0025]. Swanick and Voigt do not teach the presence of the claimed fatty acid methyl ester. However, Phippen et al. teach the presence of fatty acid methyl ester, such as methyl laurate (methyl dodecanoate) in a plant seed oil. The presence of methyl dodecanoate as a dispersal medium is the inherent property of vegetable/plant seed oil taught by Swanick and Voigt as a dispersal medium.
Regarding claim 51, Swanick teaches the use of Fish oil, squid oil, omega 3 fatty acids, vegetable oils as dispersing agents See table 1. Swanick does not teach the use components, such as ethyl hexadecanoate. However, Sullivan teaches that fish oil has above 1.5% ethyl ester. See the abstract. Therefore, the use of fish oil taught by Swanick, comprises ethyl ester, such as ethyl hexadecanoate as taught by Sullivan et al.
Regarding claim 52, Swanick teaches the use of Fish oil, squid oil, omega 3 fatty acids, vegetable oils as dispersing agents See table 1. Swanick does not teach the use components, such as ethyl hexadecanoate. However, Sullivan teaches that fish oil has above 1.5% ethyl ester. See the abstract. Therefore, the use of fish oil taught by Swanick, comprises ethyl ester, such as ethyl pentadecanoate as taught by Sullivan et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617
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