DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election (11/10/25) without traverse of SEQ ID NO: 55; Specific Active Ingredient: claim 31, protein; claim 34, antibody; and Specific Contrast Agent claim 35 superparamagnetic contrast agent.
Claims 28-47 are examined as they read on the elected invention.
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 28-47 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 specification teaches that the hTERT CPCP are useful for the delivery of
drugs for delivery into mitochondria for the treatment of mitochondrial related diseases and disorders - see [0032], [0078]. At page 22, [0081], a list of mitochondrial related diseases are stated to include: Huntington's disease, amyotriophic lateral sclerosis, MELAS (Mitochondrial Encephalomyopathy with Lactic Acidemia and Stroke-like episodes); MERRF(Myoclonus, epilepsy, and myopathy with ragged red fibers,; NARP/MILS (Neurogenic muscular weakness, ataxia, retinitis pigmentosa/Maternally inherited leigh syndrome); LHON (Lebers hereditary optic neuropathy); KSS (Kearns-Sayre Syndrome); PMPS(Pearson Marrow-Pancreas Syndrome); CPEO (Chronic progressive external opthalnoplegia); Reye's syndrome; Alper's syndrome; Multiple mtDNA deletion syndrome; mtDNA depletion syndrome; Complex I deficiency; Complex II (SDH)deficiency; Complex III deficiency; Cytochrome c oxidase (COX, Complex IV)
deficiency; Complex V deficiency; Adenine nucleotide translocator (ANT) deficiency;
Pyruvate dehydrogenase (PDH) deficiency; Ethyl malonic acid aciduria having lactic
acid acidemia; 3-methyl glutaconic acid aciduria having lactic acid acidemia;
refractoriness epilepsy representing a decline during infection; Asperger's syndrome
representing a decline during infection; Autism representing a decline during infection;
Attention deficit hyperactivity disorder (ADHD); Cerebral palsy representing a decline
during infection; Alexia representing a decline during infection; Maternal hereditary
thrombocytopenia; Leukemia; MNGIE (Mitochondrial myopathy, peripheral and
autonomic neuropathy, gastrointestinal dysfunction, and epilepsy); MARIAHS syndrome
(Mitochondrial ataxia, recrudescent infection, aphasia, hypouricemia/hypomyelination,
seizure and dicarboxylic acid aciduria); ND6 dystonia; Cyclic vomiting syndrome
representing a decline during infection; 3-hydroxyisobutyric acid aciduria having lactic acid acidemia; Diabetes having lactic acid acidemia; Uridine reactive neural syndrome (URNS); Familial bilateral striatum necrosis (FBSN); Hearing loss related with aminoglycoside; Relaxed myocardiopathy; Spleen lymphoma; Wolframs syndrome;
Multiple mitochondria DNA deletions syndrome; and Renal tubular acidosis/diabetes/ataxia syndrome, but not limited to those. Yet, not a single active ingredient is proposed to be fused to the CPCP for the treatment of any disease. There are no examples of 80% homologs of cell penetrating peptides and treating subjects having mitochondrial-related diseases or disorders by administering a conjugate of CPCP and an active ingredient. At paragraph [0042], the specification teaches that amino acids maybe be changed for use of chemical crosslinkers for the formation of peptide conjugates. Yet, no discussion of how the amino acids would be changed, which portions of the claimed SEQ ID NO:’s must be conserved to retain the claimed functions, and how that CPCP would be conjugated to the active ingredients which are not disclosed.
Therefore, the specification does not 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.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claims 28-32, 35-36 & 38-45 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Cech et al. US 616178.
Regarding claims 28 and 41, the elected species, SEQ ID NO: 55 is identical to the Cech SEQ ID NO 606.
Regarding claims 28-32 & 39-40, the patent indicates that the construct contains an insert derived from nucleotides 782 to 1636 of the hTRT insert in the plasmid pGRN121. The vector directs expression in E coli of high levels of a fusion protein composed of glutathione-S-transferase, thrombin cleavage sequence recognition sequence for heart muscle protein kinase residues introduced by cloning in brackets and hTRT protein fragment. Cech SEQ ID NO: 600 is a fusion protein, wherein the GST and hTRT fragment are linked via a thrombin cleavage site or recognition sequence.
Regarding claims 35-38, Cech teaches a contrast agent including using the elected superparamagnetic beads. Cech indicates The term "label" also refers to covalently bound or otherwise associated molecules (e.g., a biomolecule such as an enzyme) that act on a substrate to produce a detectable atom, molecule or complex. Detectable labels suitable for use in the present invention include any composition detectable by spectroscopic, photochemical, biochemical, immunochemical, electrical, optical or chemical means. Labels useful in the present invention include biotin for staining with labeled magnetic beads (e.g., Dynabeads.TM.), fluorescent dyes (e.g., fluorescein, Texas red, rhodamine, green fluorescent protein, enhanced green fluorescent protein, lissamine, phycoerythrin, Cy2, Cy3, Cy3.5, Cy5, Cy5.5, Cy7, FluorX [Amersham], SyBR Green I & II [Molecular Probes], and the like), radiolabels (e.g., .sup.3 H, .sup.125 I, .sup.35 S, .sup.14 C, or .sup.32 P), enzymes (e.g., hydrolases, particularly phosphatases such as alkaline phosphatase, esterases and glycosidases, or oxidoreductases, particularly peroxidases such as horse radish peroxidase, and others commonly used in ELISAs), substrates, cofactors, inhibitors, chemiluminescent groups, chromogenic agents, and colorimetric labels such as colloidal gold or colored glass or plastic (e.g., polystyrene, polypropylene, latex, etc.) beads.
Regarding claims 42-45, Ceh teaches polynucleotides, vectors [III. Nucleic Acids] and transformed cells [Col 46-50] as well as treatments of mitochondrial-related disorders.
The reference anticipates the claim subject matter.
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 (i.e., changing from AIA to pre-AIA ) 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 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 28-47 are rejected under 35 U.S.C. 103 as being unpatentable over Cech et al 616178 and Armstrong (2007; Mitochondrial medicine: Pharmacological targeting of mitochondria in disease. British Journal of Pharmacology. 151: 1154-1165).
mitochondria in disease. British Journal of Pharmacology. 151: 1154-1165).
The elected species, SEQ ID NO 55 is identical to the Cech SEQ ID NO 606 (claim 41). Ceh teaches polynucleotides, vectors [III. Nucleic Acids] and transformed cells [Col 46-50] as well as treatments of mitochondrial- related disorders (claims 42-47).
Regarding claims 28-32 & 39-40, the patent indicates that the construct contains an insert derived from nucleotides 782 to 1636 of the hTRT insert in the plasmid pGRN121. The vector directs expression in E coli of high levels of a fusion protein composed of glutathione-S-transferase, thrombin cleavage sequence recognition sequence for heart muscle protein kinase residues introduced by cloning in brackets and hTRT protein fragment. Cech SEQ ID NO: 600 is a fusion protein, wherein the GST and hTRT fragment are linked via a thrombin cleavage site or recognition sequence.
Regarding claims 35-38, Cech teaches a contrast agent including using the elected superparamagnetic beads. Cech indicates The term "label" also refers to covalently bound or otherwise associated molecules (e.g., a biomolecule such as an enzyme) that act on a substrate to produce a detectable atom, molecule or complex. Detectable labels suitable for use in the present invention include any composition detectable by spectroscopic, photochemical, biochemical, immunochemical, electrical, optical or chemical means. Labels useful in the present invention include biotin for staining with labeled magnetic beads (e.g., Dynabeads.TM.), fluorescent dyes (e.g., fluorescein, Texas red, rhodamine, green fluorescent protein, enhanced green fluorescent protein, lissamine, phycoerythrin, Cy2, Cy3, Cy3.5, Cy5, Cy5.5, Cy7, FluorX [Amersham], SyBR Green I & II [Molecular Probes], and the like), radiolabels (e.g., .sup.3 H, .sup.125 I, .sup.35 S, .sup.14 C, or .sup.32 P), enzymes (e.g., hydrolases, particularly phosphatases such as alkaline phosphatase, esterases and glycosidases, or oxidoreductases, particularly peroxidases such as horse radish peroxidase, and others commonly used in ELISAs), substrates, cofactors, inhibitors, chemiluminescent groups, chromogenic agents, and colorimetric labels such as colloidal gold or colored glass or plastic (e.g., polystyrene, polypropylene, latex, etc.) beads.
Where Cech may not be sufficiently specific to anticipate all of the claimed embodiments of applicant’s invention, particularly the conjugation of the peptide with active ingredients, it would have been obvious at the time the invention was made to use the peptide of Cech (same as applicant’s elected SEQ ID NO 55) as a conjugate for active ingredients because Armstrong teaches (1157-1158, Fig. 1d) that mitochondrial proteins (akin to Cech’s peptides including SEQ ID No 606) can be linked to other non-mitochondrial proteins to create chimeric proteins that is taken up into the mictochondrial matrix via the protein import pathway. The MLS are useful for targeting drugs, proteins, antibodies and DNA to the mitochondria (Fig. 1) to treat disease.
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was filed especially in the absence of evidence
to the contrary.
.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657