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 .
Priority
This application is a 371 of PCT/GB2021/053191, filed 12/07/2021. This application claims benefit to foreign application UNITED KINGDOM 2019286.0, filed 12/08/2020. Claims 41-60 are pending and have been examined on the merits.
Information Disclosure Statement
The information disclosure statement submitted on 9/6/2023 has been considered by the examiner.
Drawings
The drawings are objected to for informalities detailed below.
37 C.F.R. 1.84 sets forth the standards for drawings in patent applications and 37 C.F.R. 1.84(u)(1) drawn to the numbering of views states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheets. Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.” Figs. 1-21 are labeled as “Figure 1” through “Figure 21” rather than the required “FIG.”.
37 C.F.R. 1.84(t) drawn to the numbering of sheets of drawings states “Numbering of sheets of drawings. The sheets of drawings should be numbered in consecutive Arabic numerals, starting with 1, within the sight as defined in paragraph (g) of this section. These numbers, if present, must be placed in the middle of the top of the sheet, but not in the margin. The numbers can be placed on the right-hand side if the drawing extends too close to the middle of the top edge of the usable surface. The drawing sheet numbering must be clear and larger than the numbers used as reference characters to avoid confusion. The number of each sheet should be shown by two Arabic numerals placed on either side of an oblique line, with the first being the sheet number and the second being the total number of sheets of drawings, with no other marking.” The numbering of sheets of drawings received 6/6/2023 recites “1 of 20” through “20 of 20” rather than being shown by two Arabic numerals placed on either side of an oblique line, i.e., 1/20 through 20/20.
37 C.F.R. 1.84(i) drawn to the arrangement of views states “One view must not be placed upon another or within the outline of another. All views on the same sheet should stand in the same direction and, if possible, stand so that they can be read with the sheet held in an upright position. If views wider than the width of the sheet are necessary for the clearest illustration of the invention, the sheet may be turned on its side so that the top of the sheet, with the appropriate top margin to be used as the heading space, is on the right-hand side. Words must appear in a horizontal, left-to-right fashion when the page is either upright or turned so that the top becomes the right side, except for graphs utilizing standard scientific convention to denote the axis of abscissas (of X) and the axis of ordinates (of Y).” and 37 C.F.R. 1.84(p)(i) drawn to the arrangement of reference characters states “Reference characters (numerals are preferred), sheet numbers, and view numbers must be plain and legible, and must not be used in association with brackets or inverted commas, or enclosed within outlines, e.g., encircled. They must be oriented in the same direction as the view so as to avoid having to rotate the sheet. Reference characters should be arranged to follow the profile of the object depicted.” Figs. 10A, 11A, 13 and 17 have the figure label in a different orientation than the graphs and text in the figures.
Text in Figs. 13 and 17 is illegible and should be replaced with larger, less pixelated, legible text.
Fig. 20 says Fig. 1 in legend which is incorrect.
Appropriate correction of the above deficiencies is required.
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 Objections
Claim 43 is objected to because of the following informalities:
Claim 43 recites “the composition does not comprise a vector, which encodes aromatic amino acid decarboxylase (AADC)” which should be “the composition does not comprise a vector[[,]] which encodes aromatic amino acid decarboxylase (AADC)”, i.e., without the comma between “vector” and “which encodes aromatic amino acid decarboxylase (AADC)” for clarity.
Appropriate correction is required.
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 44-52, 55-57 and 60 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 44 recites the broad recitation “wherein: ... (ii) the coding sequence encoding TH comprises a nucleotide sequence encoding truncated TH lacking the regulatory domain of TH”, and the claim also recites “optionally wherein the coding sequence encoding TH comprises a nucleotide sequence substantially as set out in SEQ ID No: 3 or 23, or a fragment or variant thereof, or wherein the coding sequence encoding TH comprises a nucleotide sequence encoding an amino acid sequence substantially as set out in SEQ ID No: 4 or 24, or a fragment or variant thereof” which is the narrower statement of the range/limitation.
Claim 45 recites the broad recitation “(ii) the promoter in the first and/or second expression vector is the CBh promoter, or a fragment or variant thereof”, and the claim also recites “optionally wherein the promoter in the first and second vectors comprises the CBh promoter” and “optionally wherein the promoter sequence in the first and/or second expression vector comprises a nucleotide sequence substantially as set out in SEQ ID No: 8, or a fragment or variant thereof” which are the narrower statements of the range/limitation.
Claim 45 also recites the broad recitation “(iii) the promoter in the first and/or second expression vector is a human synapsin promoter, or the chicken beta actin promoter with a cytomegalovirus enhancer (CB7), or a Tetracycline-responsive element (TRE) promoter”, and the claim also recites “optionally is not the CMV promoter, or the CMV enhancer/promoter,” and “optionally wherein the promoter comprises a nucleotide sequence substantially as set out in SEQ ID No: 9, 10, 11, or 25, or a fragment or variant thereof.” which are the narrower statements of the range/limitation.
Claim 46 recites the broad recitation “wherein the first expression vector and/or the second expression vector comprises an intron disposed between its promoter and the nucleotide encoding TH1 or GCH1, respectively”, and the claim also recites “optionally wherein (i) the intron is at least 25, 50, 75, or 100 nucleotides in length; (ii) the intron is at least 125, 150, 175, or 200 nucleotides in length; or (iii) the intron is at least 225, 250, 275, or 300 nucleotides in length” which is the narrower statement of the range/limitation.
Claim 47 recites the broad recitation “wherein the intron is selected from a group of introns consisting of: the human growth hormone (hGH) intron; the beta-actin intron; the minute virus of mouse (MVM) intron; the SV40 intron; and the EF-1 alpha intron”, and the claim also recites “optionally wherein the intron is the MVM intron, preferably wherein the intron comprises a nucleotide sequence substantially as set out in SEQ ID No: 27, or a fragment or variant thereof.” which is the narrower statement of the range/limitation.
Claim 48 recites the broad recitation “the MVM intron”, and the claim also recites “(SEQ ID No: 27)” which is the narrower statement of the range/limitation.
Claim 48 also recites the broad recitation “the human growth hormone (hGH) intron”, and the claim also recites “(SEQ ID No: 26)” which is the narrower statement of the range/limitation.
Claim 49 recites the broad recitation “wherein second expression vector further comprises a nucleotide sequence encoding Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE)”, and the claim also recites “optionally wherein the WPRE coding sequence is disposed 3' of GCH1 coding sequence, and/ or wherein the WPRE comprises a nucleic acid sequence substantially as set out in SEQ ID No: 12 or 13, or a fragment or variant thereof.” which is the narrower statement of the range/limitation.
Claim 50 recites the broad recitation “wherein: (i) the polyA tail comprises the simian virus SV40 polyA tail”, and the claim also recites “optionally comprising a nucleic acid sequence substantially as set out in SEQ ID No: 14, or a fragment or variant thereof” which is the narrower statement of the range/limitation.
Claim 50 also recites the broad recitation “(ii) the polyA tail comprises the bovine growth hormone (BGH) polyA tail”, and the claim also recites “optionally comprising a nucleic acid sequence substantially as set out in SEQ ID No: 15, or a fragment or variant thereof.” which is the narrower statement of the range/limitation.
Claim 51 recites the broad recitation “(i) the first expression vector and/ or the second expression vector comprises a nucleotide sequence encoding a 3' untranslated region (3' UTR)”, and the claim also recites “optionally wherein the first expression vector comprises a 3' UTR coding sequence comprising a nucleic acid sequence substantially as set out in SEQ ID No: 28, or a fragment or variant thereof;” which is the narrower statement of the range/limitation.
Claim 51 also recites the broad recitation “(ii) the first and/or second expression vector comprises a left and/or a right Inverted Terminal Repeat sequences (ITRs)”, and the claim also recites “optionally wherein the first and/ or second expression vector comprises one Inverted Terminal Repeat (ITR) sequence and one modified ITR sequence in which the terminal resolution site is deleted” and “optionally comprising an ITR comprising a nucleic acid sequence substantially as set out in SEQ ID No: 16, or a fragment or variant thereof;” which are the narrower statements of the range/limitation.
Claim 52 recites the broad recitation “(i) a first self-complementary adeno-associated virus (scAAV) vector comprising a promoter operably linked to a coding sequence, which encodes tyrosine hydroxylase (TH)”, and the claim also recites “optionally truncated TH lacking the regulatory domain;” which is the narrower statement of the range/limitation.
Claim 60 recites the broad recitation “A kit of parts comprising the first and second expression vectors as defined in claim 41”, and the claim also recites “optionally, instructions for use”, “optionally wherein the kit comprises a first container in which the first expression vector is contained, and a second container in which the second expression vector is contained” and “optionally wherein the first and/or second container is a vial, syringe, Eppendorf, or the like.” which are the narrower statements of the range/limitation.
The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The term “substantially” in claim 44, lines 2, 4, 8, 11-12 and 14; claim 45, lines 10 and 16; claim 47, line 5; claim 49, line 5; claim 50, lines 4 and 7; and claim 51, lines 5, 10-11 and 13 is a relative term which renders the claim indefinite. The term “substantially” 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. Hence, claims 44-45, 47 and 49-51 are rejected under 35 U.S.C. §112(b) as being indefinite.
Claims 44-47, 50-51, 55-57 and 60 have antecedent basis issues, detailed below, mainly due to limitations in the claims preceded by the word “the” which, in patent claims, indicates that the limitation has been previously set forth, i.e., has an antecedent. Many of the antecedent basis rejections below can be resolved by rewording the claims to avoid the antecedence issue.
Claim 44 recites the limitation "the regulatory domain of TH" in line 7. There is insufficient antecedent basis for this limitation in the claim. Claim 44 depends from claim 41 and neither claim 44 nor 41 disclose a regulatory domain of TH; hence, there is no antecedent basis for the limitation; therefore, claim 44 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 45 recites the limitations "the CBh promoter" in line 6, “the chicken beta actin promoter” in line 13, “the CMV promoter” in line 14 and “the CMV enhancer/promoter” in line 15. There is insufficient antecedent basis for these limitations in the claim. Claim 45 depends from claim 41 and neither claim 45 nor 41 disclose a CBh promoter, a chicken beta actin promoter, a CMV promoter nor a CMV enhancer/promoter; hence, there is no antecedent basis for these limitations; therefore, claim 44 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 46 recites the limitation "the nucleotide encoding TH1 or GCH1" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 46 depends from claim 41 and neither claim 46 nor 41 disclose a nucleotide encoding TH1 or GCH1; hence, there is no antecedent basis for this limitation; therefore, claim 46 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 47 recites the limitations " the human growth hormone (hGH) intron" in line 2, “the beta-actin intron” in line 2, “the minute virus of mouse (MVM) intron” in lines 2-3, “the SV40 intron” in line 3 and “the EF-1 alpha intron” in line 3. There is insufficient antecedent basis for these limitations in the claim. Claim 47 depends from claim 46 which depends from claim 41 and neither claim 47, 46 nor 41 discloses a human growth hormone (hGH) intron, a beta-actin intron, a minute virus of mouse (MVM) intron, a SV40 intron nor an EF-1 alpha intron; hence, there is no antecedent basis for these limitations; therefore, claim 47 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 50 recites the limitations "the simian virus SV40 poly A tail" in line 3 and “the bovine growth hormone (BGH) poly A tail” in line 6. There is insufficient antecedent basis for these limitations in the claim. Claim 50 depends from claim 41 and neither claim 50 nor 41 discloses a simian virus SV40 poly A tail nor a bovine growth hormone (BGH) poly A tail; hence, there is no antecedent basis for these limitations; therefore, claim 50 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 51 recites the limitation "the terminal resolution site" in line 9. There is insufficient antecedent basis for this limitation in the claim. Claim 51 depends from claim 41 and neither claim 51 nor 41 discloses a terminal resolution site; hence, there is no antecedent basis for these limitations; therefore, claim 51 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 55 recites the limitations "the blood stream" in line 2, “the cerebrospinal fluid” in line 2, “the brain” in line 2, “the striatum” in line 3, “the putamen” in line 4, “the pars compacta region” in line 4 and “the substantia nigra” in lines 4-5. There is insufficient antecedent basis for these limitations in the claim. Claim 55 depends from claim 54 and neither claim 55 nor 54 discloses a blood stream, a cerebrospinal fluid, a brain, a striatum, a putamen nor a substantia nigra; hence, there is no antecedent basis for these limitations; therefore, claim 55 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 56 recites the limitation "the dose of the composition" in line 1 and “the titre of each AAV” in line 5. There is insufficient antecedent basis for these limitations in the claim. Claim 56 depends from claim 54 and neither claim 56 nor 54 discloses a dose of the composition nor a titre of each AAV; hence, there is no antecedent basis for these limitations; therefore, claim 56 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 57 recites the limitation "the dose of each DNA plasmid vector" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 57 depends from claim 54 and neither claim 57 nor 54 discloses a dose of each DNA plasmid vector; hence, there is no antecedent basis for this limitation; therefore, claim 57 is rejected under 35 U.S.C. 112(b) as being indefinite.
Claim 60 recites the limitation "or the like" in line 5. There is insufficient antecedent basis for this limitation in the claim. The phrase "or the like" renders the claim indefinite because the claim includes elements not actually disclosed (those encompassed by "or the like"), thereby rendering the scope of the claim unascertainable. See MPEP § 2173.05(d).
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 41-46, 49-56 and 58-60 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by McDonald, US 2019/032079 (US Patent Application Publication cite 2, IDS, 9/6/2023; herein “McDonald”).
McDonald teaches an expression system for enzyme replacement therapy with the aim of obtaining or maintaining a steady level of L-DOPA in the blood of an individual through systemic administration of the expression system for treating disorders such as Parkinson’s disease (Abst.) wherein the expression system can comprise a first expression vector comprising a self-complementary AAV comprising liver promoter/enhancer 1 (LP1 promoter) driving truncated tyrosine hydroxylase (tTH; SEQ ID NO: 24; thus comprising a self-complementary coding sequence for TH) followed by a woodchuck hepatitis virus posttranscriptional regulatory element (WPRE; SEQ ID NO: 28) and a second expression vector comprising a self-complementary AAV comprising the LP1 promoter driving GTP-cyclohydrolase 1 (GCH1) (Figs. 2B-C, 5; [0037], [0040-41], [0100-108], [0162-163], [0348-349], [0373], [0378], claim 145), i.e., a composition comprising first and second expression vectors, wherein the first expression vector comprises a promoter operably linked to a self-complementary coding sequence, which encodes tyrosine hydroxylase (TH), and the second expression vector comprises a promoter operably linked to a coding sequence, which encodes GTP cyclohydrolase 1 (GCH1), wherein the first expression vector and/or the second expression vector is an AAV vector, wherein the composition does not comprise a vector which encodes aromatic amino acid decarboxylase (AADC), wherein the coding sequence encoding TH comprises a nucleotide sequence encoding truncated TH lacking the regulatory domain of TH, anticipating claims 41-44 and 52.
McDonald teaches a pharmaceutical composition comprising the expression system and a pharmaceutically acceptable vehicle [0025] anticipating claim 53.
McDonald teaches methods to treat Parkinson’s disease by administering a therapeutically effective amount of the composition to a subject in need of such treatment (Abst.; [0002], [0020-21]) anticipating claims 54 and 58-59.
McDonald teaches that the expression system can be provided as a kit [0035] anticipating claim 60.
McDonald teaches that the promoters driving the expression of TH and GCH1 can comprise constitutive promoters [0205-216], i.e., the promoter in the first and/or second expression vector is one that permits high expression in a subject's neurons, or in the subject's glial cells, or in the subject's neurons and glial cells, or in the subject's neurons and ependymal cells lining the cerebral ventricles, or in the subject's neurons and glial cells and ependymal cells, anticipating claim 45.
McDonald teaches that the expression constructs can comprise an intron operably linked to the 5' end of the TH and/or GCH-1 transcript ([0221], claim 148), i.e., wherein the first expression vector and/or the second expression vector comprises an intron disposed between its promoter and the nucleotide encoding TH1 or GCH1, respectively, anticipating claim 46.
McDonald teaches that the expression constructs can comprise a WPRE element [0219-220], i.e., wherein second expression vector further comprises a nucleotide sequence encoding Woodchuck Hepatitis Virus Post-transcriptional Regulatory Element (WPRE), anticipating claim 49.
McDonald teaches that the expression constructs can comprise a 3’ untranslated region with an SV40 polyadenylation signal ([0052], [0218]), i.e., the first expression vector and/or the second expression vector comprises a nucleotide sequence encoding a 3' untranslated region (3' UTR) and a nucleotide sequence encoding a polyA tail, wherein the poly A tail comprises the simian virus SV40 poly A tail, anticipating claims 50-51.
McDonald teaches administering the pharmaceutical composition by bolus intravenous injection [0355], i.e., wherein the composition or the pharmaceutical composition are administered into the blood stream, anticipating claim 55.
McDonald teaches that the titer of the first self-complementary adeno-associated virus (scAAV) encoding TH was 3.51 x 1010 and the titer of the second scAAV encoding GCH1 was 3.51 x 1010 (Example 2, [0353-367]), i.e., wherein if administered as a mixture of AAV vectors, the titer of each AAV is 1E8 to 5E14, anticipating claim 56.
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.
Claims 41-60 are rejected under 35 U.S.C. 103 as being unpatentable over McDonald in view of Kotin et al., US 2019/0358306 (cite A, attached PTO-892; herein “Kotin”).
The discussion of McDonald regarding claims 41-46, 49-56 and 58-60 set forth in the rejection above is incorporated herein.
McDonald teaches that a sample host can be transfected with the expression system vectors [0243] but does not specifically teach delivering the polynucleotides to brain hemispheres or teach a dose of each DNA plasmid vector to be delivered per brain hemisphere; however, a person of ordinary skill in the art at the time of filing would have found it obvious to deliver the polynucleotides to brain hemispheres in view of the disclosure of Kotin.
Kotin teaches treating Parkinson’s disease by delivering polynucleotides encoding aromatic L-amino acid decarboxylase (AADC) by infusion of the polynucleotides via stereotactic surgical delivery of the infusate to the subject’s brain wherein 3 x 1011 vector genomes of the polynucleotide are delivered (Example 5, [0334-341]).
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to practice the method made obvious by McDonald in view of Kotin wherein McDonald’s expression system consisting of polynucleotides of the two expression vectors, i.e., one expressing TH and the other expressing GCH1, are directly infused into subject’s brain hemispheres.
McDonald does not disclose the micrograms of each vector that would be required to effectively treat Parkinson’s disease with the two expression vectors; however, the number of micrograms of each polynucleotide (expression construct) delivered per brain hemisphere is a result effective variable and a person of ordinary skill in the art would expect the number of micrograms of each polynucleotide delivered per brain hemisphere to have an obvious effect on the recovery of the production of L-DOPA. Therefore, a person of ordinary skill in the art would find it obvious to vary this parameter to treat the Parkinson’s disease patient and would arrive at the range of micrograms recited in claim 57; therefore, claim 57 is prima facie obvious. See also MPEP 2144.05 II.A. “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature 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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)".
Regarding claims 47-48, McDonald clearly teaches that the expression constructs can comprise an intron operably linked to the 5' end of the TH and/or GCH-1 transcript ([0221], claim 148), i.e., wherein the first expression vector and/or the second expression vector comprises an intron disposed between its promoter and the nucleotide encoding TH1 or GCH1, respectively, but does not specifically teach that the intron is an MVM (minute virus of mouse) intron or that the promoter can be a synapsin (SYN1) promoter; however, a person of ordinary skill in the art at the time of filing would have found it obvious for the expression constructs to comprise an MVM intron between a SYN1 promoter and the nucleotides encoding TH1 or GCH1 in view of the disclosure of Kotin.
Kotin teaches treating Parkinson’s disease by delivering polynucleotides encoding aromatic L-amino acid decarboxylase (AADC, which catalyzes the conversion of L-DOPA to dopamine) (Abst.) wherein the polynucleotides can be self-complementary AAV expression vectors [0042], wherein the expression constructs drive the expression of AADC with a synapsin promoter wherein there is a MVM intron between the synapsin promoter and the gene of interest, i.e., AADC, because the promoter and intron increase the expression and target specificity of the expression construct [0051-54].
Hence, a person of ordinary skill in the art at the time of filing would have found it obvious to produce expression constructs made obvious by McDonald in view of Kotin wherein the expression constructs comprise a synapsin promoter followed by a MVM intron because Kotin teaches it enhances the expression and target specificity of the expression construct for their gene therapeutic (AADC) for Parkinson’s; therefore, claims 47-48 are prima facie obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Trent R Clarke whose telephone number is (571)272-2904. The examiner can normally be reached M-F 10-7 MST.
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/TRENT R CLARKE/ Examiner, Art Unit 1651
/DAVID W BERKE-SCHLESSEL/ Primary Examiner, Art Unit 1651