DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, 17870607, Pre-Grant Publication 20220396801, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2,4,6,11-12,14-15,19,24-26,31-33,35,45-46, 58 and 60 are pending.
Claims 14-15,19,24-26,31-33,35,45-46 and 58 are withdrawn from consideration.
Claims 1, 2, 4, 6, 11, 12 and 60 are examined.
Election/Restrictions
Applicant’s election of Group I, Claims 1, 2, 4, 6, 11, and 12, in the reply filed on 10/28/2025 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)). Applicant’s election of the species of SEQ ID NO: 44 is acknowledged.
Priority
The filing receipt, mailed 8/31/2022, states that this application, filed 7/21/3033, claims benefit of domestic priority benefit as a CON of PCT/IL2021/050075, filed 01/24/2021, which claims benefit of US 62/964,821, 01/23/2020.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. Figures 1E and 1G appear to contain nucleotide sequences that fall within the sequence rules, but do not appear to be identified by SEQ ID NOs in the figures themselves or in the Brief Description of the Drawings in the specification.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Figure 18 appears to contain nucleotide sequences that fall within the sequence rules, but do not appear to be identified by SEQ ID NOs in the figures themselves or in the Brief Description of the Drawings in the specification.
Claim Objections
Claim 6 is objected to because of the following informalities:
In Claim 6, claimed SEQ ID NOs: 44-53 cannot be given their customary interpretation in the claims because these particular SEQ ID, SEQ ID NOs: 44-53, have not been entered into the computer readable form index, except to the extent that they are all null, with the entries “000”. Appropriate correction is required.
SEQ ID NOs: 44-53 cannot be entered into the computer readable form index because the current ST.26 rules prohibit inclusion of short sequence. The relevant part in Standard ST.26 paragraph 8, is stated below:
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The term “specifically defined” means any nucleotide other than those represented by the symbol “n” and any amino acid other than those represented by the symbol “X”, listed in Annex I (see Section 1, Table 1, and Section 3, Table 3, respectively).
There are sequences in this application that do not meet the minimum length requirement. Therefore, they must not be included in the ST.26 sequence listing. For example, SEQ ID NO 66 (“nnnnttttt”) only has 5 “specifically defined” nucleotides. When this sequence in the ST.25 format was converted to ST.26 in WIPO sequence, it is automatically converted to a skipped sequence.
The ST.26 sequence listing in this application is compliant, as the computer readable form version 2.1, received 8-19-22 and loaded 8-19-2022, is designated as good (“CRFE”). See, instant Figure 1 below.
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Figure 1.
The values currently assigned to SEQ ID NOs: 44-53, are each “000”. As an example, SEQ ID NO: 44, has the value “000”, (see, instant Figure 2 below).
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Figure 2.
Claim 6 is objected to because the claim elements SEQ ID NOs: 44-53 have not been provided definitions because they are currently place-holders and are described as “null”, and so are internally inconsistent with a further limitation to an actual sequence, (e.g., “TTTT”), as found in claim 6.
Applicant Traversal of Claim Objections
Applicant, in the Response filed 2/19/2026, argues that the SEQ ID numbers were identified in the specification and therefore the “computer readable index” was not needed for a skilled artisan to be able to understand their meaning. Applicants assert that “this claim was interpretable,” and that “the claim is amended with the full sequences and therefore there is no doubt as to the meaning of the claim.”
Applicant’s argument have been carefully considered but are not persuasive. Firstly, applicant should point out where in the specification, as originally filed, the full sequences of SEQ ID NOs: 44-53 are described. As can be seen in instant Figure 1, above, Applicant has provided several different versions of the SEQ ID Listing. Although the particular nucleotide sequences may not have changed, the contents of the SEQ ID NOs: 44-53, have been changed to conform with nucleotide sequence rules.
Secondly, claim 6 links nucleic acid sequences with particular SEQ ID NOs, but as explained above, these sequences are not found within the corresponding SEQ ID NOs. The claim must be considered in its totality. Thus the objection to claim 6 is maintained because claim 6 is self-contradictory and therefore improper as to form.
Claim Interpretation
In Claim 6, claimed SEQ ID NOs: 44-53 cannot be given their customary interpretation as nucleotide sequences, but are instead skipped sequences, because these sequences are NOT within the nucleotide/amino acid sequence rules.
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.
Claim 6 is 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “SEQ ID NO: 44-53” in claim 6 is used by the claim to mean “a nucleotide sequence,” while the accepted meaning is “null.” The term is indefinite because the specification does not clearly redefine the term.
Furthermore, SEQ ID NOs: 44-53 are listed in the latest Sequence Listing, entered 8/19/2022, as skipped sequences and without values. But the earlier Sequence Listing, entered 7/27/2022, and which is now superseded by the Sequence Listing, entered 8/19/2022, shows sequences for these SEQ ID NOs: 44-53. Thus SEQ ID NOs: 44-53 have more than one meaning in the specification, as so are indefinite.
Applicant Traversal of Claim Rejections - 35 USC § 112
Applicant, in the Response filed 2/19/2026, argues that “[t]he specification clearly spells out the meaning of each sequence of SEQ ID NO: 44-53 even if the computer readable sequence listing does not,” (emphasis added). Applicant argues that because “the full sequences being claimed are now explicitly written in claim 6,” the claim is definite and the rejection is rendered moot.
Applicant’s argument have been carefully considered but are not persuasive. There are evidently three different sources for the meaning of SEQ ID NO: 44-53, namely the specification as filed, the current SEQ ID Listing, and the currently amended claims. Thus, claim 6 is vague and indefinite, as this claim is capable of disparate meanings and definitions.
Firstly, applicant should point out where in the specification, as originally filed, the full sequences of SEQ ID NOs: 44-53 are described. As can be seen in instant Figure 1, above, Applicant has provided several different versions of the SEQ ID Listing. Although the particular nucleotide sequences may not have changed, the contents of the SEQ ID NOs: 44-53, have been changed to conform with nucleotide sequence rules.
Secondly, claim 6 links nucleic acid sequences with particular SEQ ID NOs, but as explained above, these sequences are not found within the corresponding SEQ ID NOs. The claim must be considered in its totality. Thus the objection to claim 6 is maintained because claim 6 is self-contradictory and therefore improper as to form.
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.
1. (Original) A method for producing a nucleic acid molecule optimized for expression of a second protein encoded by a second sequence comprising a translational start site (TSS) not more than 100 nucleotides away from a first stop codon of a first sequence encoding a first protein, the method comprising: introducing a mutation into a region from 7 to 75 nucleotides downstream of said first stop codon; wherein said mutation increases folding energy of said region or of RNA encoded by said region.
Claim(s) 1, 2, 4, 6, 11, 12, and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Hunt, US 20180010136, 15314709; Wu, 2018, Cell Systems Vol. 6, pages 1-20, (of record, IDS); Kudla, Science 2009, Vol. 324,(5924), pages 1 to 9, (of record, IDS); and Tuller 2010 PNAS Sci USA, Vol 107, Number 8, pages 3645 to 5650, (of record, IDS).
Hunt, US 20180010136, 15314709, throughout the publication and abstract, and at para [0006], describes a method of “providing a nucleic acid sequence comprising a coding sequence encoding the polypeptide and a 5′ UTR comprising a ribosome binding site and wherein the 5′ UTR is functionally linked to said coding sequence, and (a) introducing one or more substitutions, (reading on mutations), in the 5′UTR or one or more synonymous nucleic acid substitutions in a head sequence consisting essentially of the first 48 nucleic acids of the coding sequence, wherein the one or more substitutions in the 5′UTR and the one or more synonymous nucleic acid substitutions increase the predicted free energy of folding of the RNA sequence corresponding to the head sequence and the 5′ UTR functionally linked to said coding sequence (i.e., decrease the stability of its folding). Hunt teaches a RNA sequence.
Hunt, at para [0164] and Figures 41A-41D, show the effect of gene optimization on physiological expression, wherein genes cloned in a plasmid are expressed by the native E. coli's RNA polymerase with an arabinose inducible promoter, reading on instant claim 12. Hunt, at para [0258], states “[o]ne skilled in the art will readily be able to generate or identify a suitable expression vector that contains a promoter to direct expression of the recombinant polypeptide in the desired expression system.” The instant Specification at para [0154], discloses that “[i]n some embodiments, the regulatory element is a promoter.”
Hunt does not teach a first protein comprising a first stop codon and a second sequence comprising a translational start site from the first stop codon.
Wu, 2018, Cell Systems Vol. 6, pages 1-20, throughout the publication and abstract, and at p. 1, para 2, Figure 1A, B, C, D, teach synthetic polycistronic mRNA. Wu, at p. 9, para 2-3, teaches that the context dependency of gene expression is not just limited to the ribosome binding sites (RBS) region but also includes characteristics of the whole operon. The quantitative relationship between adjacent transcriptional regions and gene expression regulation in polycistronic circuits helps to evaluate each gene’s relative expression levels in a circuit and predict circuit outputs in order to help predict and control translation initiation and protein expression. With the increasing complexity of integrated multi-layer circuits, organization of specific bio-components and circuitry structure design become extremely important for functionality.
Wu, at p. 3, para 2, teach calculation from the -70-nt to +38-nt region around the GFP’s RBS (GFP’s translation starting site is denoted as +1. Wu, at p.3, para 3, teaches the stop codon for the GFP.
Kudla, Science 2009, Vol. 324,(5924), pages 1 to 9, (of record, IDS), at p. 2, para 3, teaches codon adaptation near the 5’ terminus as particularly important for expression. At p.2, para 5, Kudla teaches that the strong correlation between mRNA folding and fluorescence suggests the simple mechanistic explanation that tightly folded messages obstruct translation initiation, thereby reducing protein synthesis. Predicted structures for high-expression GFP mRNAs characteristically contained many unpaired nucleotides near the start codon, whereas low- expression constructs featured long hairpin loops (Fig. 2B), consistent with known obstructions to initiation (19).
Kudla at p. 3, para 5, states:
Our findings lead to the following prediction: Adding a stretch of codons with weak mRNA structure to the 5’ end of a gene with originally strong structure should increase expression, even if the additional codons have low CAI. To test this prediction we fused a 28-codon tag to the 5’ terminus of 72 GFP constructs. The tagged constructs, which featured weak mRNA secondary structure and low CAI (see Methods), produced consistently high expression, including those GFPs poorly expressed in non-tagged form (Fig. 3). These results suggest that endogenous £. coli genes may have undergone selection for weak 5’ secondary structure. Consistent with this hypothesis, we found that the predicted secondary structures for the 4,294 F’. coli genes are significantly weaker near their start codons (nt —4 to +37) than immediately downstream (nt +38 to +79; Wilcoxon p<1E-15).
Kudla at p. 3, para 5.
Tuller, 2010 PNAS Sci USA, Vol 107, Number 8, pages 3645 to 5650, throughout publication and abstract, stating “folding energy does modulate the strength of association between codon bias and translation efficiency, which is maximized at very weak mRNA folding, (i.e., high folding energy) levels.”
It would have been prima facie obvious before the filing date of the instant application for one of ordinary skill in the art to have made and used a second protein encoded by a second sequence comprising a translational start site (TSS) not more than 100 nucleotides away from a first stop codon of a first sequence encoding a first protein, the method comprising: introducing a mutation into a region from 7 to 75 nucleotides downstream of said first stop codon, as taught by Wu, Kudla and Tuller with a method for producing a mutation that increases folding energy of the region, as taught by Hunt.
One of ordinary skill in the art would have motivated to have combined and used a second protein encoded by a second sequence comprising a translational start site (TSS) not more than 100 nucleotides away from a first stop codon of a first sequence encoding a first protein, the method comprising: introducing a mutation into a region from 7 to 75 nucleotides downstream of said first stop codon in the method of Hunt, because Wu teaches polycistronic systems for use in modulating gene expression, and the association of stop codons associated with an expressed gene. Wu teaches a region from 7 to 75 nucleotides from the end of a first gene, and Kudla teaches the introduction of mutations into a 5’UTR region in order to increase folding energy, so as to remove obstacles to translation initiation, as taught by Tuller and Kudla.
Applicant Traversal of Claim Rejections - 35 USC § 103
The Response filed 2/19/2026, at p. 13, para 1, argues that the prior art references of Hunt, Kudla and Tuller all relate to monocistronic mRNA translation. Applicant states:
Hunt, Kudla and Tuller all relate to monocistronic mRNA translation, that is translation when there is a single gene downstream of a promoter. All three teach that the region directly around the start codon of the one gene impacts translation. In particular, it is asserted by the Office Action that they teach that translation efficiency is increased by weak mRNA folding (i.e., high folding energy). However, instant claim 1 does not relate to a monocistronic mRNA, but rather to an mRNA that is at least bicistronic. The only art cited by the Office Action that relates to polycistronic mRNA translation is Wu. Applicants assert that Wu does not teach the subject matter of instant claim 1, but rather expressly teaches away from claim 1.
Response filed 2/19/2026, at p. 13, para 1.
In traversing Wu, applicant states:
Claim 1 states that translation is optimized. It is clear from the specification that optimization is increased translation as compared to the translation before the production of the mutation. For the purposes of absolute clarity, new claim 60 states this explicitly. Claim 1 states the translation is optimized by producing a mutation that "increases folding energy". Thus, claim 1 is stating that the relationship between translation and folding energy is proportional: increasing folding energy increases translation.
Response at p. 12.
The Response, filed 2/19/2026, argues that claim 1 states that increasing folding energy increases translation and argues that the prior art reference of Wu at p.3, para 2, teaches “exactly the opposite” by allegedly teaching “increasing folding energy decreases translation. Applicant finds that Figure 2A of Wu makes “readily apparent” that increasing free energy decreases translation, which is the “exact opposite of what is recited in instant claim 1!”, (Response at p. 12). To make this judgment applicant reproduces to the rightmost plot in Figure 2A of Wu, .
Applicant at p. 12, states:
Lest it be argued that Applicant is misinterpreting this figure, Wu explicitly states at the end of the results section describing the ATR effects "ATR GC content has a positive correlation with GFP expression while ATR size and local free energy are both negatively correlated." (page 3, right column, first full paragraph directly before the section entitled "Comprehensive Model of ATR Regulation"). A negative correlation means that increasing local free energy decreases translation. This is clearly teaching the exact opposite of instant claim 1.
Response at p. 12.
Applicant, at p. 13 of the Reply, argues that the prior art of Wu teaches away from the subject matter of claim 1 and states that Wu is the only art cited relating to polycistronic operons. Applicant argues that the method of Hunt is a method “to increase expression” of a protein skilled artisan would not have been motivated to make and use methods for “polycistronic operons”, Reply at p. 14. Applicant states that these sequences stop ribosome read through.
Applicant argues that the listed “specific sequences in which to make the mutation” in claim 5 are absent from the cited prior art.
Applicant, reply at p. 14, argues that claim 11 is drawn to mutation made from 7 to 50 nucleotides downstream of the stop codon and are not motivation by the prior art references of Hunt, Kudla or Tuller. Applicant argues, as stated above, that the reference of Wu teaches away from the claimed invention.
Applicant’s arguments have been carefully considered but are not found persuasive. It is noted that applicant argues the term “monocistronic”, stating that instant claim 1 does not relate to a monocistronic mRNA, but rather to an mRNA that is at least bicistronic. The only art cited by the Office Action that relates to polycistronic mRNA translation is Wu. Applicants assert that Wu does not teach the subject matter of instant claim 1, but rather expressly teaches away from claim 1.
Also, applicant argues that the prior art of Wu teaches “increasing” or maximizing gene expression, but claim 1 is drawn to “optimizing” expressing. The terms increasing or maximizing and optimizing are not the same.
Applicant argues that Wu teaches the opposite of the claimed invention. However, Wu teaches “free energy”, and not “folding energy”, as in claim 1. Applicant’s appears to argue that free energy and folding energy are the same, but do not provide objective evidence of such.
However, the limitations bicistronic, increasing, and free energy are terms not found in claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a superconducting magnet which generates a "uniform magnetic field" were not limited to the degree of magnetic field uniformity required for Nuclear Magnetic Resonance (NMR) imaging. Although the specification disclosed that the claimed magnet may be used in an NMR apparatus, the claims were not so limited.).
MPEP 2145
Furthermore, applicant offers a detailed and involved analysis of a figure of Wu, and provides an opinion that Wu teaches away from the claimed invention. However, applicant differing terminology does not establish the relevance of the teachings of Wu to the claimed invention. Mere attorney argument does not take the place of evidence. Thus applicant’s arguments are merely the opinions of counsel. See, MPEP 716.01(c) I, II, III.
Applicant argues that Wu teaches away so that the claimed invention is non-obvious. It is noted that the prior art rejection of Hunt teaches the effect of mutation on folding energy and gene expression.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
MPEP 2145, IV. Arguing against references individually, VI. Arguing Limitation which are not claimed.
Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993) (Claims to a superconducting magnet which generates a "uniform magnetic field" were not limited to the degree of magnetic field uniformity required for Nuclear Magnetic Resonance (NMR) imaging. Although the specification disclosed that the claimed magnet may be used in an NMR apparatus, the claims were not so limited.).
MPEP 2145
In regards to claim 6, there are evidently three different sources for the meaning of SEQ ID NO: 44-53, namely the specification as filed, the current SEQ ID Listing, and the currently amended claims. Thus, claim 6 is vague and indefinite, as this claim is capable of disparate meanings and definitions.
Secondly, claim 6 links nucleic acid sequences with particular SEQ ID NOs, but as explained above, these sequences are not found within the corresponding SEQ ID NOs. The claim must be considered in its totality. Thus the objection to claim 6 is maintained because claim 6 is self-contradictory and therefore improper as to form.
Applicant argues claim 11 is drawn to mutation made from 7 to 50 nucleotides downstream of the stop codon, which is narrower in scope that the range of nucleotides as in claim 1. This is not persuasive MPEP 2144.05 (I.) states in part: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark L Shibuya whose telephone number is (571)272-0806. The examiner can normally be reached M-F, 9AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Doug) Schultz, can be reached at (571) 272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MARK L. SHIBUYA
Primary Patent Examiner
Art Unit 1631
/MARK L SHIBUYA/Primary Patent Examiner, Art Unit 1631
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