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 and 22-31 and 33-38 are pending and examined. Claims 1-15, 17-21 and 32 have been cancelled.
The objections to claims 26 and 27 are withdrawn in light of the amendments.
Examiner’s Comment
Applicant’s request for interview is currently premature and improper. Applicant is reminded that for interviews, use of the USPTO’s Automated Interview Request (AIR) Form available at www.uspto.gov/InterviewPractice is encouraged, but in the alternative, the examiner may be contacted by letter, facsimile, electronic mail, telephone or the "Applicant Initiated Interview Request" form (PTOL-413A) to schedule the interview.
The AIR form or the PTOL-413A form may be submitted to the examiner prior to the interview in order to permit the examiner to prepare in advance and to focus on the issues to be discussed.
These forms should identify the participants of the interview, the proposed date of the interview, the communication mode (e.g., telephonic, video conference, or in-person), and should include a brief description of the issues to be discussed. See MPEP 713.01(IV).
Here, Applicant has not complied with any of the aforementioned requirements and has not provided any description of issues to be discussed that would advance prosecution.
Specification
The disclosure REMAINS 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.
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 and 22-31 REMAIN 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 mutating a gene from which an mRNA is transcribed and wherein the mRNA comprises a TLS and the mutating modifies the TLS. Thus, the claim encompasses mutations anywhere in the gene, for example, introns and exons of the gene.
The metes and bounds of the claim are indefinite because it is not clear if it is the gene that is mutated which indirectly modifies the TLS, or if the mutation in the gene corresponds to a mutation in the TLS that modifies the TLS. In other words, there is no nexus between the mutation/structure of the gene and the corresponding change in structure of the TLS.
For example, the mutation may be in a region of the gene that does not correspond to the TLS. In this scenario, it unclear how this mutation would modify the TLS. Similarly, the claim encompasses mutations to the introns of the gene: it is not clear how this mutation would modify the TLS.
Claim 22-31 are rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
Response to Arguments
Applicant traverses the rejection of claim 16 because the amendments clarify any ambiguity in so far as the gene’s transcribed sequence encodes the TLS so that the mutating the gene is the means by which the TLS carried in the mRNA is modified (Applicant reply dated 05 August 2026, p. 17, ¶ 1).
This argument is not persuasive for the reasons as set forth above. Namely, it is not clear if it is the gene that is mutated indirectly modifies the TLS, or if the mutation in the gene corresponds to the mutation in the TLS that modifies the TLS.
Claims 16, 22-31 and 33-38 are rejected under 35 U.S.C. 112, 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(s), at the time the application was filed, had possession of the claimed invention. THIS IS A NEW MATTER REJECTION.
37 CFR 1.118 (a) provides that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application".
In the instant case, the claims have been amended to include limitations that were not previously claimed, and adequate support for the newly claimed limitations are not found in the disclosure.
For instance, claim 16 has been amended to encompass a method for altering mobility of an mRNA of a gene in a eukaryotic “cell”.
Additionally, claim 32 as presented encompasses an mRNA that comprises two separate features/elements: a TLS and an RNA-guided endonuclease.
Here, the specification provides limited support for changing the intercellular mobility of mRNA (see also claim 16 as originally presented; see also p. 5, ¶ 1 and 2) or for an endonuclease comprising a TLS (e.g., see p. 17, ¶ and 2), and does not provide support for (1) altering the mobility of mRNA within the cell or (2) making an mRNA that comprises both a TLS and an RNA-guided endonuclease the latter of which does not comprise the TLS.
Furthermore, the specification has been thoroughly searched and support for (1) altering mobility of an mRNA of a gene in a eukaryotic “cell” and (2) making an mRNA that comprises both a TLS and an RNA-guided endonuclease cannot be found.
Applicant is invited to point to the specification where support can be found. THIS IS A NEW MATTER REJECTION.
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 and 21-31 REMAIN rejected, and claims 33-38 are NOW 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 mobility of an mRNA of a gene in any conceivable eukaryote comprising modifying a TLS by mutating the gene from which it is transcribed where the mutating modifies the TLS or where the TLS is included 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, and an mRNA comprising a TLS and coding for an RNA-guided endonuclease.
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 eukaryotic cell.
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 into a gene not comprising 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 by mutating a gene from which the mRNA is transcribed or including a TLS in the gene to change mobility of said mRNA in the vast genus of cells 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 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.
Response to Arguments
Applicant traverses the rejection of the claims based on the prosecution history of similarly issued patents and in light of the amendments to the claims (Applicant reply dated 05 August 2026, p. 9, ¶ 1; see also p. 11, ¶ 1 and 2; see also p. 16).
Applicant’s arguments are unpersuasive because they are not commensurate in scope with what is claimed. Here, the instant claims remain broadly drawn to any eukaryotic organism and fail to recite the structure of any particular TLS that is mutated in a mRNA comprising said TLS or introduced into a mRNA lacking a TLS.
Applicant argues the Office fails to account for totality of the teachings of the cited references and provides an analysis of each of said references (Applicant reply dated 05 August 2026, p. 12-15).
Applicant’s arguments are not persuasive because as noted above, they are not commensurate in scope with what is claimed. Namely, by arguing what is or is not taught by the references does not address the fact the claims remain drawn to a method to be practiced in an infinite genus of eukaryotic cells, and that the specification has failed to teach one how to predictably make, and more importantly use, the claimed method in this genus of cells.
With regard to Zhang 2016, Applicant’s arguments are not persuasive because the fact the mRNA has alleged bidirectional mobility does provide guidance to the skilled artisan for using the method as claimed in other eukaryotic cells. For example, the fact that mRNA may go from shoot to root or root to shoot provides no information whatsoever on how mobility of mRNA would be altered in a human or mouse, let alone other species of plant.
With regard to Zhang 2009 there have been no conflated “experimental paradigms”. Zhang 2009 is cited for what it teaches: 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. Applicant’s own specification reinforces this result.
Regarding Calderwood, the art need not directly refute the exact results as provided by the instant specification. Calderwood is cited for what it teaches: one of skill in the art would not know how to predictably use the instantly claimed methods as it remains unclear to what extent mRNA mobility is biologically meaningful, and that the structures of TLS that confer mobility are unclear because mRNA abundance is sufficient to explain the observed mobility of mRNA and because mobile mRNA is non-sequence specific.
Regarding Xia, the fact that the reference explains unpredictability does not mean that the instant claims are enabled for their full scope, and does not mean that the reference provides guidance for overcoming the unpredictability in the art.
Regarding Goodenbour, Applicant’s argument is not persuasive and does not address the fact TLS as claimed encompassed an infinite number of structures, and that the specification has failed to teach which of these structures confers predictable mobility.
Regarding Paajanen, Applicant’s arguments are not persuasive as they are not commensurate in scope with what is claimed. The citation to Zhang reaffirms that while one may arguably know what to expect when practicing the instant methods in a plant, one would have no idea whatsoever how the claimed method is applied and used in other eukaryotic cells.
Applicant argues the specification provides positive and negative teachings (Applicant reply dated 05 August 2026, p. 15). This argument is not persuasive and reinforces the position of the Office: the claims encompass embodiments that are not enabled.
Applicant argues tRNA structure is conserved across all eukaryotes (Applicant reply dated 05 August 2026, p. 16). This argument is not persuasive because it is not commensurate in scope with what is claimed as there are no conserved structural features recited in the claims that confer function.
Claims 16 and 21-31 REMAIN rejected, and claims 33-38 are NOW 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, 21-31 and 33-38 are broadly drawn to methods for changing the mobility of an mRNA of a gene in any conceivable eukaryotic cell comprising modifying a TLS by mutating the gene from which it is transcribed and modifies the TLS structure or including the sequence of the TLS in 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, and an mRNA comprising both a TLS and an RNA-guided endonuclease.
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 eukaryotic cell.
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 cells as broadly claimed for the skilled practitioner to be of the opinion that Applicant possess the instant invention.
Moreover, the specification fails to describe, in fact, that any region of a gene from which mRNA is transcribed and whose mobility is to be changed may be mutated to modify the structure of a TLS in the mRNA.
For example, the specification fails to describe that mutations in regions that do not correspond to the TLS, in fact, modify the structure of the TLS. Similarly, the specification fails to describe that mutations to the introns of the gene, in fact, modify the structure of TLS in mRNA transcribed from said gene.
Instead, the specification merely describes that specific structures such as 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 eukaryotic cells comprising TLS, that when used in the instant method change mRNA mobility as broadly claimed, and has further failed to describe, in fact, an mRNA comprising both a TLS and the codes for an RNA-guided endonuclease.
Therefore, without a further description of a representative number of structures of TLS that confer functional activity and cells comprising them as broadly claimed, Applicant has failed to sufficiently describe methods for changing the 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.
Response to Arguments
Applicant traverses the rejection of the claims for the same reasons are provided for traversing the rejection of the claims for failing to comply with the scope of enablement requirement (Applicant reply dated 05 August 2026, p. 16, penultimate ¶).
This argument is not persuasive for the reasons as set forth above. Namely, Applicant’s arguments that the claims have been narrowed and the art has not been considered as a whole are not commensurate is scope with the instant claims which are directed to methods that encompass a vast genus of eukaryotic cells for which the specification fails to describe may be predictably have mRNA mobility altered.
Moreover, the fact that previous patents have been issued with similar claim language has no bearing on the instant matter and whether the current claims comply with the written description requirement. In any event, the instant claims are broader in scope in comparison to the issued patent claims which are not directed to any conceivable eukaryotic cell.
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 and 22-31 REMAIN rejected, and claims 33-38 are NOW 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, 22-31 and 33-38 are drawn to methods for changing the mobility of an mRNA of a gene in any conceivable eukaryotic cell comprising modifying a TLS by mutating the gene from which it is transcribed and the mutating modifies the TLS or including the sequence of the TLS in 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, and an mRNA comprising a TLS and coding for an RNA-guided endonuclease.
‘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 eukaryotic cells).
Moreover, if it is obvious to practice a method of modifying altering the mobility of an mRNA then it is obvious to arrive at the product used to practice the method as encompassed by instant claim 33.
Applicant asserts claims 16 and 22-31 do not involve endonucleases (Applicant reply dated 05 August 2026, p. 18, last ¶). However, this argument is not persuasive as “gene” in ‘865 is understood to encompass both endogenous and non-endogenous genes, for example, endonucleases (e.g., see col. 12 beginning at line 54 bridging col. 55). Thus, if it is obvious to practice a method of modifying altering the mobility of an mRNA then it is obvious to arrive at the product used to practice the method as encompassed by instant claim 33.
Claims 16 and 22-31 REMAIN rejected, and 33-38 are NOW 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, 22-31 and 33-38 are drawn to methods for changing the mobility of an mRNA of a gene in any conceivable eukaryotic cell comprising modifying a TLS by mutating the gene or including the sequence of the TLS in 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, and a mRNA comprising a TLS and coding for an RNA-guided endonuclease.
‘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).
Moreover, if it is obvious to practice a method of modifying altering the mobility of an mRNA then it is obvious to arrive at the product used to practice the method as encompassed by instant claim 33.
Applicant asserts claims 16 and 22-31 do not involve endonucleases (Applicant reply dated 05 August 2026, p. 18, last ¶). However, this argument is not persuasive as “gene” in ‘771 is understood to encompass both endogenous and non-endogenous genes, for example, endonucleases (e.g., see col. 13 beginning at line 8). Thus, if it is obvious to practice a method of modifying altering the mobility of an mRNA then it is obvious to arrive at the product used to practice the method.
Claims 16 and 22-31 REMAIN rejected, and 33-38 are NOW 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, 22-31 and 33-38 are drawn to methods for changing the mobility of an mRNA of a gene in any conceivable eukaryotic cell 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, and an mRNA comprising a TLS and coding for an RNA-guided endonuclease.
‘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 as opposed to the instantly claimed genus of mRNAs and genus of TLS), and because the instant specification indicates that gene encompasses a Cas9 endonuclease an mRNA of a gene.
Applicant argues the ‘901 patent claims do not suggest present claims 16 and 22-31 (Applicant reply dated 05 August 2026, p. 18, last ¶). However, this argument is not persuasive because a gene as encompassed by instant claim 1 encompasses an endonuclease as recited in claim 1 of ‘901. In other words, ‘901 claims a species that is encompassed by the genus of genes of the instant claims.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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