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 .
Status of Claims
Claims 16-32 are pending and examined. Claims 1-15 have been cancelled.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (e.g., see p. 39, lines 7 and 10). Applicant is required to delete all embedded hyperlinks and/or other forms of browser-executable code. See MPEP § 608.01.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 26 recites the limitation “a” tRNA-like structure and should therefore use the definitive article when referring back to a previous claim. The limitation “a” should be replaced with the limitation --the--.
Claim 27 is objected to for failing to italicize the limitation “in vitro”.
Appropriate action 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 16-32 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 16 is drawn to modifying a TLS present in mRNA by mutating the gene from with the mRNA is transcribed. The metes and bounds of the claim are indefinite because it is not clear how the tRNA-like structure is modified when the method requires mutating “the gene” from which the mRNA is transcribed as opposed to mutating the tRNA-like structure itself.
Claim 16 also recites the limitation including the sequence of a tRNA-like structure in “the transcribed part of the gene”. The metes and bounds of the claim are indefinite because it is not clear if the transcribed part of the gene refers to the gene in which the tRNA-like structure is present, or if the claim refers to a gene of interest that differs from that in which the tRNA-like structure is found.
Claim 23 recites the limitation deleting part of the “transcribed” sequence of mRNA and therefore presents the same issue as claim 16: it is not clear how the tRNA-like structure is being modified when the claim requires deleting part of the transcribed sequence as opposed to deleting a part of the tRNA-like structure itself.
Claim 23 also refers to “the tRNA”. The metes and bounds of the claim are indefinite because it is not clear if the method is directed to mutating “tRNA” or if the method is directed to mutating a tRNA-like structure.
Claims 17-22 and 24-32 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
The following is a quotation 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.
Claims 16-32 are rejected under 35 U.S.C. 112(a), first paragraph, because the specification, while being enabling for making a construct comprising a nucleic acid sequence encoding GUS and SEQ ID NO: 101, does not reasonably provide enablement for making and using the method as broadly claimed by modifying a t-RNA-like structure (TLS) in an mRNA or including a TLS in the transcribed part of a gene. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)), the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation". These factors include: (a) the quantity of experimentation; (b) the amount of guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the predictability of the prior art; (g) the breadth of the claims; and (h) the relative skill in the art. The factors are analyzed in turn for the instant case as follows:
Here, the methods are broadly drawn to methods for changing the intercellular mobility of an mRNA of a gene in any conceivable organism comprising modifying a TLS by mutating the gene from which it is transcribed or including the sequence of the TLS in the transcribed part of the gene, wherein the modification induces loss of mobility of the transcript or the transcript changes destinations or the loss of mobility results in loss of function of the gene or the change in mobility results in ectopic production of the gene.
It is initially noted that the specification broadly defines a TLS: they comprise not only intact tRNA structures that are present in the mRNA transcript of a gene but also incomplete tRNA structures that lack one or more stem loop structures that still retain and enable the intercellular mobility of the mRNA transcript of the gene (p. 8, last ¶).
It is further noted that the claims encompass either changing the inherent mobility of an mRNA, or conferring upon a non-mobile mRNA the ability to change locations within an organism.
Meanwhile, the specification teaches that fusing immobile DMC1 mRNA to plant BEL5 transcripts which are known to be mobile resulted in DMC1 becoming mobile (p. 32). Similar results were obtained when tRNAmet was fused to the DMC1 gene (p. 32).
When the GUS gene was fused to tRNAMet or tRNAGly GUS protein mobility was observed in planta, while the GUS gene fused to tRNAIle demonstrated no GUS activity (p. 36, Example 2; p. 40). tRNAMet, tRNAGly and tRNAIle correspond to TAIR accession no. AT5G57885, AT1G71700 and AT3G05835, respectively (p. 32, par. 3; see also p. 36, ¶ 2).
To determine the structures within tRNAMet required for mobility, deletion constructs lacking various structures of the TLS were made and fused to the GUS gene. TLS with D, DT, and DA-arm/loop structures removed were sufficient to mediate/mobilize GUS expression in plants while AT-arm/loop tRNAMet deletions failed to mobilize GUS protein (p. 40).
Here, and aside from these limited number of examples from Arabidopsis, the specification fails to provide the appropriate guidance for practicing the methods as broadly claimed. While the specification teaches that a gene including a specific TLS changes mobility such that it is present in phloem associated cells (e.g., see p. 38, ¶ 3), the specification fails to teach the structures of a TLS as broadly claimed that confers functional activity, and further fails to teach how mRNA mobility of other genes is provided or abolished in any other organism, eukaryotic or not.
In other words, in order to teach the methods as claimed the specification must provide guidance for determining which genes are mobile (i.e., where transcription is initiated and where the resulting mRNA is transported) and are found in the exhaustive genus of organisms as broadly claimed for the skilled practitioner to predictably modify a TLS in the mRNA of the gene.
Instead, the specification merely identifies that tRNAMet or tRNAGly can induce systemic movement of GUS throughout the plant. The specification fails to teach whether any of the TLS as encompassed by claim 16 comprise the structures necessary to mobilize mRNA or abolish its movement, and fails to teach where the TLS mobilizes the mRNA to.
Moreover, the art teaches that tRNAMet is only responsible for systematic movement from shoots to roots (Zhang et al, 2016, The Plant Cell, 28:1237-1249; p. 1241, col. 1, last ¶ bridging col. 2). Or see Zhang et al, which teaches that Ile-tRNA and Thr-tRNA is not detected in phloem and thus does not appear to be a TLS that can impart or abolish mRNA mobility, and that fragments of tRNA contribute to translational inhibition (2009, Plant Physiology, 150:378-387; see p. 380, col. 2, penultimate ¶; p. 382, col. 2, last ¶).
In fact, the specification teaches that the tRNAIle is incapable of mobilizing mRNA. The specification fails to teach whether the structures of the immobile tRNAIle are shared with those TLS encompassed by claim 16 and would therefore also be immobile.
Furthermore, aside from identifying arm/loop structures that aid in mobility, the specification fails to teach other structures that can be modified that enable the TLS to retain functional activity. Thus, the skilled practitioner would be unable to predictably practice the method as claimed because they would be unable to identify a mobile gene comprising a TLS and/or be unable to mutate said gene to abolish TLS function and mRNA mobility.
The deficiencies of the specification as discussed above are compounded by state of the art: Calderwood et al teach that it remains unclear to what extent mRNA mobility is biologically meaningful, and that mRNA abundance is sufficient to explain the observed mobility of mRNA (2016, The Plant Cell, 28:610-615; see p. 610, col. 1, last ¶ and col. 2, ¶ 1). Moreover, Calderwood et al teach that mobile mRNA is non-sequence specific (p. 613, col. 2, last par).
Or see Xia et al which teaches that TLS motifs do not necessarily lead to mobility: out of the top 100 most abundant mRNAs in leaves of tobacco/tomato heterograft system 18 harbored the TLS motif but none were mobile and among the top 2000 most abundant mRNAs 174 harbored the TLS motif but only 11 were mobile (2018, Plant Physiology, 177:745-758; see p. 752, col. 1, last ¶ bridging col. 2).
This guidance is also critical because the claims encompass a large genus of tRNA structures: tRNA structures range in size from 75-95 nucleotides and vary in sequence structure between different organisms (Goodenbour et al, 2006, Nucleic Acids Research, 34:6137-6146; see Abstract; see p. 6137, col. 1; p. 6138, col. 1; p. 6139, col. 2; see p. 6144, col. 2).
Finally, Paajanen et al, which includes coauthor and inventor of the instant invention Friedrich Kragler, teaches that taking technological noise, biological variation, potential contamination and incomplete genome assemblies into account show that a high percentage of annotated graft mobile transcripts are left without statistical support from available data challenging the finding of previous studies and current views of mRNA communication (2025, Nature Plants, 11:977-984; see Abstract; see also p. 981, col. 1, penultimate ¶).
In short, the specification has failed to provide guidance for predictably identifying and mutating or introducing a TLS as broadly encompassed by the claims, for identifying mobile genes comprising sequences corresponding to TLS as broadly claimed, and for identifying the particular functions of TLS as broadly claimed (i.e., changing the mobility of an mRNA as broadly claimed) for use in the vast array of organisms, cell types and organs.
Applicant should note that where the specification discloses only a starting point for further iterative research in an unpredictable and poorly understood field and offers no guidance or predictions about particular substitutions to be made, and where there is a need to engage in a systematic screening process for each of the candidate compounds, experimentation is considered to be excessive. see Wyeth v. Abbott Laboratories, Nos 12-1223,-1224 (Fed. Cir. 2013).
Here, Applicant has merely provided two working examples of TLS that result in the non-specific movement of mRNA in Arabidopsis and has merely prophetically taught that TLS may be modified or used in any possible organism. As a result, the skilled practitioner would be required to engage in a systematic screening process to determine those TLS and structures thereof which retain functional activity and mobilize mRNAs to specific organs, tissues or cell types in the wide array of organisms as broadly claimed.
Thus, in light of the inadequate guidance in the specification, the lack of working examples, and the state of the art which teaches that mRNA abundance is sufficient to explain observed mobility of mRNA, the skilled practitioner would be unable to predictably practice the instant methods as broadly claimed.
Assuming arguendo the specification does teach TLS as broadly claimed, the specification fails to teach the skilled practitioner how to predictably use the instant methods. For example, the specification teaches that cells of a leaf may respond to a change in light and signal this to root cells (p. 7, par. 1). In this example, it is not clear how the skilled artisan would use the instant method to change the mobility of a gene responsible for sensing light.
The skilled practitioner would first turn to the instant specification for guidance in making and using a modified TLS in an mRNA or including a TLS in the gene to change intercellular mobility of said mRNA in the vast genus of organisms as broadly claimed. However, the specification does not provide sufficient guidance for making and/or using said TLS as broadly claimed. Moreover, the prior art is also lacking in examples of predictably utilizing a TLS or modified TLS to change the intercellular mobility of an mRNA.
Finally, said practitioner would turn to undue trial and error experimentation for making and using the TLS or modified TLS as broadly claimed. Therefore, in the absence of further guidance, undue experimentation becomes the burden of the practitioner.
Claims 16-32 are rejected under 35 U.S.C. 112(a), 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, at the time the application was filed, had possession of the claimed invention.
Claims 16-32 are broadly drawn to methods for changing the intercellular mobility of an mRNA of a gene in any conceivable organism comprising modifying a TLS by mutating the gene from which it is transcribed or including the sequence of the TLS in the transcribed part of the gene, wherein the modification induces loss of mobility of the transcript or the transcript changes destinations or the loss of mobility results in loss of function of the gene or the change in mobility results in ectopic production of the gene.
The specification describes that fusing immobile DMC1 mRNA to BEL5 transcripts, which are known to be mobile, resulted in DMC1 becoming mobile (p. 32). Similar results were obtained when tRNAmet was fused to the DMC1 gene (p. 32).
When the GUS gene was fused to tRNAMet or tRNAGly GUS protein mobility was observed, while the GUS gene fused to tRNAIle demonstrated no GUS activity (p. 36, Example 2; p. 40). tRNAMet, tRNAGly and tRNAIle correspond to TAIR accession no. AT5G57885, AT1G71700 and AT3G05835, respectively (p. 32, ¶ 3; see also p. 36, ¶ 2).
To determine the structures within tRNAMet required for mobility, deletion constructs lacking various structures of the TLS were made and fused to the GUS gene. TLS with D, DT, and DA-arm/loop structures removed were sufficient to mediate/mobilize GUS expression while AT-arm/loop tRNAMet deletions failed to mobilize GUS protein (p. 40).
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
It noted that the specification broadly defines a TLS: they comprise not only intact tRNA structures that are present in the mRNA transcript of a gene but also incomplete tRNA structures that lack one or more stem loop structures that still retain and enable the intercellular mobility of the mRNA transcript of the gene (p. 8, last ¶).
It is also noted that the claims encompass either changing the inherent mobility of an mRNA, or conferring upon a non-mobile mRNA the ability to change locations within an organism.
Here, the specification fails to adequately describe the methods as broadly claimed. While the specification describes that a gene including a specific TLS changes mobility such that it is present in phloem associated cells (e.g., see p. 38, ¶ 3), the specification fails to describe a representative number of species from the broad genus of structures of a TLS as broadly claimed that confers functional activity, and further fails to describe how mRNA mobility of other genes is changed in any other conceivable organism.
In other words, the specification must provide a description of a representative number of genes that are mobile (i.e., where transcription is initiated and where the resulting mRNA is transported), must describe a representative number of TLS or structures that confer TLS functional activity, and must describe a representative number of species from the exhaustive genus of eukaryotic organisms as broadly claimed for the skilled practitioner to be of the opinion that Applicant possess the instant invention.
Instead, the specification merely describes that tRNAMet or tRNAGly can induce systemic movement of GUS throughout an Arabidopsis plant. The specification fails to describe whether any of the TLS as encompassed by claim 16 comprise the structures necessary to mobilize mRNA, and fails to describe where the TLS mobilizes the mRNA to.
Moreover, the art describes that tRNAMet is only responsible for systematic movement from shoots to roots (e.g., see Zhang et al; p. 1241, col. 1, last par. bridging col. 2). Or see Zhang et al from 2009 which describes that Ile-tRNA and Thr-tRNA is not detected in phloem and thus does not appear to be a TLS that can impart or abolish mRNA mobility, and that fragments of tRNA contribute to translational inhibition (see p. 380, col. 2, penultimate ¶; p. 382, col. 2, last ¶).
In fact, the specification describes that the tRNAIle is incapable of mobilizing mRNA. The specification fails to describe whether the structures of the immobile tRNAIle are shared with those TLS encompassed by claims 1 or 12 and would therefore also be immobile.
Furthermore, aside from identifying arm/loop structures that aid in mobility, the specification fails to describe other structures that can be modified that enable the TLS to retain functional activity. Thus, the skilled practitioner would not be led to believe that Applicant possesses the method as claimed because they would be unable to identify a gene comprising a TLS and/or be unable to mutate said gene to abolish TLS function and mRNA mobility or to include said TLS with a gene to confer mobility.
The deficiencies of the specification as discussed above are compounded by state of the art: Calderwood et al describe that it remains unclear to what extent mRNA mobility is biologically meaningful, and that mRNA abundance is sufficient to explain the observed mobility of mRNA (p. 610, col. 1, last ¶ and col. 2, ¶ 1). Moreover, Calderwood et al describes that mobile mRNA is non-sequence specific (p. 613, col. 2, last ¶).
Or see Xia et al which describes that TLS motifs do not necessarily lead to mobility: out of the top 100 most abundant mRNAs in leaves of tobacco/tomato heterograft system 18 harbored the TLS motif but none were mobile and among the top 2000 most abundant mRNAs 174 harbored the TLS motif but only 11 were mobile (see p. 752, col. 1, last ¶ bridging col. 2).
This description is also critical because the claims encompass a large genus of tRNA structures: tRNA structures range in size from 75-95 nucleotides and vary in sequence structure between different organisms (Goodenbour et al, see p. 6137, col. 1; p. 6138, col. 1; p. 6139, col. 2; see p. 6144, col. 2).
Finally, Paajanen et al, which includes coauthor and inventor of the instant invention Friedrich Kragler, describes that taking technological noise, biological variation, potential contamination and incomplete genome assemblies into account show that a high percentage of annotated graft mobile transcripts are left without statistical support from available data challenging the finding of previous studies and current views of mRNA communication (see Abstract; see also p. 981, col. 1, penultimate ¶).
In short, the specification has failed to describe a representative number of TLS that can be modified or included in a gene, the critical structures of TLS as broadly encompassed by the claims that can be modified or included in a gene, or a representative number of organisms, organs, tissues or cell types comprising TLS, that when applied in the instant method change the intercellular mobility as broadly claimed.
Therefore, without a further description of a representative number of structures of TLS that confer functional activity and organisms comprising them as broadly claimed, Applicant has failed to sufficiently describe methods for changing the intercellular mobility of an mRNA.
Given the lack of written description in the specification with regard to the method of modifying or including TLS as broadly claimed, it is not clear that Applicant was in possession of the invention at the time this application was filed.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially create doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-32 are rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,351,865 B2 (referred to herein as ‘865). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 16-32 are drawn to methods for changing the intercellular mobility of an mRNA of a gene in any conceivable organism comprising modifying a TLS by mutating the gene from which it is transcribed or including the sequence of the TLS in the transcribed part of the gene, wherein the modification induces loss of mobility of the transcript or the transcript changes destinations or the loss of mobility results in loss of function of the gene or the change in mobility results in ectopic production of the gene.
‘865 claims a method for changing the intercellular mobility of an mRNA of a gene in a plant comprising mutating the sequence of the tRNA in the gene from which the mRNA is transcribed to abolish mobility or including the sequence of a tRNA in the transcribed part of the gene to confer mobility wherein the tRNA comprises an anticodon, wherein part of the tRNA is deleted, wherein the sequence is in a DNA construct, wherein the tRNA is introduced into the 3’ UTR or 5’UTR, wherein the construct is stably or transiently expressed and wherein the method comprises grafting a scion and rootstock.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to arrive at the methods as claimed because ‘865 claims a species of the instantly claimed methods (i.e., ‘865 claims a method of using specific tRNAs in plants as opposed to the instantly claimed genus of TLS in organisms).
Claims 16-32 are rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,142,771 B2 (referred to herein as ‘771). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 16-32 are drawn to methods for changing the intercellular mobility of an mRNA of a gene in any conceivable organism comprising modifying a TLS by mutating the gene from which it is transcribed or including the sequence of the TLS in the transcribed part of the gene, wherein the modification induces loss of mobility of the transcript or the transcript changes destinations or the loss of mobility results in loss of function of the gene or the change in mobility results in ectopic production of the gene.
‘771 claims a method for changing the intercellular mobility of an mRNA of a gene in a plant comprising mutating the sequence of the tRNA in the gene from which the mRNA is transcribed to abolish mobility or including the sequence of a tRNA in the transcribed part of the gene to confer mobility wherein the tRNA comprises an anticodon, wherein part of the tRNA is deleted, wherein the sequence is in a DNA construct, wherein the tRNA is introduced into the 3’ UTR or 5’UTR, wherein the construct is stably or transiently expressed and wherein the method comprises grafting a scion and rootstock.
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to arrive at the methods as claimed because the methods as claimed in ‘771 are a species of the instantly claimed methods (i.e., ‘771 claims a method of using specific tRNAs as opposed to the instantly claimed genus of TLS).
Claims 16-32 are rejected on the ground of nonstatutory double
patenting as being unpatentable over claims 1, 2, 3, 6 and 7 of U.S. Patent No. 11,981,901 B2 (referred to herein as ‘901). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claims 16-32 are drawn to methods for changing the intercellular mobility of an mRNA of a gene in any conceivable organism comprising modifying a TLS by mutating the gene from which it is transcribed or including the sequence of the TLS in the transcribed part of the gene, wherein the modification induces loss of mobility of the transcript or the transcript changes destinations or the loss of mobility results in loss of function of the gene or the change in mobility results in ectopic production of the gene.
‘901 claims a method for changing the intercellular mobility of an mRNA of a gene in a plant wherein the gene encodes an RNA-guided endonuclease and a TLS is included in said gene, wherein the gene is Cas9, and wherein the TLS is in the 5’, 3’ or coding sequence of the gene
Therefore, prior to the effective filing date of the instant invention it would have been prima facie obvious to arrive at the methods as claimed because the methods as claimed in ‘901 are a species of the instantly claimed methods (i.e., ‘901 claims a method of using specific tRNAs in the mRNA of a specific gene such as Cas9 and as opposed to the instantly claimed genus of mRNAs of gene and TLS), and because the instant specification includes a Cas9 endonuclease an mRNA of a gene.
Conclusion
No claim is allowed.
The claims appear to be free of the prior art, the closest of which is Li et al (2009, Journal of Virology, 83:3540-3548), which discloses nontranslatable FT sequence (i.e., a sequence of a TLS) imparts mobility upon viral and GFP protein mRNA (see Abstract; see also p. 3541, col. 2, last ¶). However, Li et al does not teach that mobile mRNA comprise TLS and thus does not reasonably teach, suggest or provide motivation for mutating a TLS or for including a TLS in the transcribed part of a gene.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The Examiner can normally be reached on 7:30am - 4pm.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662