DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant previously canceled claims 1-74. Applicant newly adds Claims 75-94. Claims 75-94 are currently pending and under examination.
Any objection or rejection of record in the previous Office Action, which is not addressed in this action has been withdrawn in light of Applicant’s amendments and/or arguments. This action is Final.
Priority
It is acknowledged that a translation of the certified copy of CN 2020/10376936 was received.
Claim Objections
Claims 75 and 83 are objected to because of the following informalities:
In claim 75, lines 19-20, “the plant cell is configured to be associated with” should read “ the plant cell is associated with”.
In claim 83, lines 1-2, “geminivirus Rep and RepA protein” should read “ geminivirus Rep/RepA protein”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 75-94 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. These are new rejections as necessitated by amendments.
Claim 75 is considered vague and indefinite for the following reasons:
In claim 75, the terms “the geminivirus replicon comprises all elements required for the geminivirus replication are unclear and confusing. It is unclear as what elements are to be considered all elements? Are there specific sets or types of elements that must be included or is this considered to be any element as long as replication occurs?
Claim 75 recites the limitation "the genetic elements" in lines 7 and 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the vector" in lines 8 and 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the Rep/RepA protein" in line 13. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the resultant population of transformed plant cells" in lines 17 and 18. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the replication level" in line 19. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the desired function" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 75 recites the limitation "the genetic element mutant" in line 20. There is insufficient antecedent basis for this limitation in the claim.
Claims 76-94 depend from claim 75 and are therefore included in this rejection.
Claim 76 is considered vague and indefinite for the following reasons:
Claim 76 recites the limitation "the genetic elements" in line 1.There is insufficient antecedent basis for this limitation in the claim.
Claim 90 depends from claim 76 and is therefore included in this rejection.
Claim 77 is considered vague and indefinite for the following reasons:
Claim 77 recites the limitation "the genetic elements" in line 1.There is insufficient antecedent basis for this limitation in the claim.
Claim 78 is considered vague and indefinite for the following reasons:
Claim 78 recites the limitation "the vector" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 91 depends from claim 78 and is therefore included in this rejection.
Claim 79 is considered vague and indefinite for the following reasons:
Claim 79 recites the limitation "the vector" in lines 1, 2 and 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 79 recites the limitation "the inserted mutant" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 92 depends from claim 79 and is therefore included in this rejection.
Claim 80 is considered vague and indefinite for the following reasons:
Claim 80 recites the limitation "the vector" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 81 is considered vague and indefinite for the following reasons:
Claim 81 recites the limitation "the amino acid" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 82 is considered vague and indefinite for the following reasons:
Claim 82 recites the limitation "the number" in lines 1, 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 82 recites the limitation "the mutants" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 83 is considered vague and indefinite for the following reasons:
Claim 83 recites the limitation "the geminivirus Rep and RepA protein " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 83 recites the limitation "the desired function" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 93 depends from claim 83 and is therefore included in this rejection.
Claim 84 is considered vague and indefinite for the following reasons:
Claim 84 recites the limitation "the genetic element" in lines 3, 7, 12, 18 and 24. There is insufficient antecedent basis for this limitation in the claim.
Claim 84 recites the limitation "the open reading frame" in line 26. There is insufficient antecedent basis for this limitation in the claim.
Claim 94 depends from claim 84 and is therefore included in this rejection
Claim 85 is considered vague and indefinite for the following reasons:
Claim 85 recites the limitation "the desired function" in lines 1, 4 and 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 86 depends from claim 85 and is therefore included in this rejection.
Claim 86 is considered vague and indefinite for the following reasons:
Claim 86 recites the limitation "the genetic element" in lines 1, 3, 8, 14, 20 and 24. There is insufficient antecedent basis for this limitation in the claim.
Claim 87 is considered vague and indefinite for the following reasons:
Claim 87 recites the limitation "the desired function" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 88 is considered vague and indefinite for the following reasons:
Claim 88 recites the limitation "the enriched genetic element mutant" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 93 is considered vague and indefinite for the following reasons:
Claim 93 recites the limitation "the another vector" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 94 is considered vague and indefinite for the following reasons:
Claim 94 recites the limitation "the amino acid" twice in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 75-94 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions (i.e., product of nature, a law of nature, a natural phenomenon, or an abstract idea) without significantly more. This is a new rejection as necessitated by amendments.
Every claimed invention must be examined to determine whether the claimed invention complies with 35 U.S.C. 101, particularly whether the claimed invention falls within a 35 U.S.C. 101 judicial exception of non-patentable subject matter (e.g., an abstract idea, law of nature, natural phenomenon, natural product etc.). Phenomena of nature, though just discovered, natural products, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. See MPEP 2106. As per the “2019 Revised Subject Matter Eligibility Guidance” (Federal Register Vol. 84, No. 4, available 01-07-2019), claims drawn to a process, machine, manufacture or composition of matter are further analyzed according to a two-part process to determine if A) the claim(s) is/are “directed to” a judicial exception because the claims(s) recite(s) a judicial exception (i.e. prong one) that is not integrated into a practical application (i.e. prong two) and, if so, if B) the claim(s) provide(s) an inventive concept, i.e. recite(s) additional elements that amount to significantly more than the judicial exception.
Subject Matter Eligibility Test for Products and Processes
Step 1 - Is the Claim to a Process, Machine, Manufacture or Composition of Matter? YES
Claims 75-94 are directed to one of the statutory classes. Claims 75-94 are directed to a method for directed evolution of a genetic element (Process).
Step 2A, Prong One — Does the Claim Recite an Abstract Idea, Law of Nature, or Natural Phenomenon? YES
Claims 75-94 recite the abstract ideas of receiving and processing data using mental steps. Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection (see MPEP 2106.04). Abstract ideas include certain methods of organizing human activity, and mental processes (including procedures for collecting, observing, determining, evaluating, and organizing information (See MPEP 2106.04(a)(2)). In particular, these abstract ideas include:
• Detecting and selecting from the resultant population of transformed plant cells (mental process, human mind is capable of receiving, observing and organizing data as well as evaluating information).
• The replication level of the geminivirus replicon in the plant cells is configured to be associated with the desired function of the genetic element mutant. (mental process of observing, receiving and organizing data as well as evaluating/comparing information).
• The activity or expression level of the geminivirus Rep and/or RepA protein in the plant cell is associated with the desired function of the genetic element mutant (mental process of observing, receiving and evaluating/comparing information).
Step 2A, Prong Two — Does the Claim Recite an Additional Elements that Integrate the Judicial Exception into a Practical Application? NO.
The Supreme Court has long distinguished between principles themselves, which are not patent eligible, and the integration of those principles into practical applications, which are patent eligible. However, absent are any additional elements recited in the claim beyond the judicial exceptions which integrate the exception into a practical application of the exception. The “integration into a practical application” requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception.
The claim analysis continues with identifying additional elements beyond the judicial exceptions that might evidence integration of the judicial exceptions into a practical application. The steps or elements in addition to the judicial exceptions are: "providing a library", “the mutant is inserted into the geminivirus replicon so that while the geminivirus replicon is replicated, the mutant is amplified”, “transforming a population of plant cells with the library”, and “culturing the population of plant cells", which is not indicative of integration into practical application. These steps, recited at a high level of generality, comprise routine data gathering, which is considered an insignificant extra-solution activity. This data gathering is required for using the judicial exceptions. (See MPEP 2106.05(g)). There are no further/additional steps which applies either the identified judicial exception into practical application. Thus, a careful evaluation of the claim as a whole fails to reveal the practical application of the judicial exception to, e.g., effect an improvement to the functioning of a computer or other technology/technical field, effect a particular treatment or prophylaxis for a disease or medical treatment, implement a particular machine that is integral to the claim, or effect a transformation or reduction of a particular article to a different state or thing, or to apply the judicial exception in another meaningful way beyond generally linking its use to a particular technological environment. Accordingly, the claims do not integrate the judicial exception(s) into a practical application and is therefore directed to a judicial exception.
Step 2B - Does the Claim Recite Additional Elements that Amount to Significantly More than the Judicial Exception? NO.
The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to “significantly more” than the judicial exception(s) itself. The claims as a whole are analyzed to determine whether any additional element/step, or combination of additional elements/steps, in addition to the identified judicial exception(s) is sufficient to ensure that the claim amounts to “significantly more” than the exception(s).
The eligibility analysis proceeds with identifying any additional elements or limitations, separate from the judicial exceptions, that might potentially render the claims directed to a judicial exception patent eligible. To render the claims patent- eligible, these elements must comprise meaningful limitations that add to or transform the judicial exception to the effect that it amounts to significantly more than the natural correlation or abstract idea itself - i.e. provide an “inventive concept’. The elements that are in addition to the judicial exception comprise: providing a library, inserting the mutant into the geminivirus replicon so that while the geminivirus replicon is replicated, the mutant is amplified, transforming a population of plant cells with the library and culturing the population of plant cells. When considered separately and in combination, these elements do not add significantly more to the judicial exception. These steps are well-understood, routine and conventional activities in the field. For example, Castle et al. (WIPO International Application Publication WO 01/38513 A2, published May 31, 2001), discloses providing a library, inserting the mutant into the geminivirus replicon so that while the geminivirus replicon is replicated, the mutant is amplified, transforming a population of plant cells with the library and culturing the population of plant cells. The claims recite an abstract idea with additional elements. Because these elements are not inventive concepts, the claims do not integrate the abstract idea into a practical application. The judicial exception alone cannot provide that inventive concept or practical application (MPEP 2106.05). The claims therefore do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Accordingly, the claims do not qualify as patent-eligible subject matter.
For further information, please see the latest revision of MPEP 2104-2106 {Patent Subject Matter Eligibility Under 35 U.S.C. 101}, including MPEP 2106.04 {Eligibility Step 2A: Whether a Claim is Directed to a Judicial Exception} and 2106.05 {Eligibility Step 2B: Whether a Claim Amounts to Significantly More}, as well as the guidance on Subject Matter Eligibility, including the 2019 Guidance issued Jan. 7, 2019, and the October 2019 Update, provided on the USPTO website at https:/Awww.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter- eligibility.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 75-91 and 93 are rejected under 35 U.S.C. 102 (a)(1) and (a)(2) as being anticipated by Castle et al. (WIPO International Application Publication WO 01/38513 A2, published May 31, 2001), previously cited in the November 20, 2025 Office Action. This is a new rejection as necessitated by amendments.
Regarding claim 75, Castle teaches a method for directed evolution of a desired genetic element (Page 13, Third Paragraph and Page 27, First Paragraph). Castle teaches constructing or synthesizing a library comprising different mutated forms of the desired genetic element (Page 6, First-Last Paragraph, Page 13, Third Paragraph—Page 14, Last Paragraph, Page 35, Second Paragraph—Page 36, Second Paragraph and Page 40, Last Paragraph—Page 41, Second Paragraph). Castle teaches the library contains a plurality of mutated forms of the desired genetic element which are respectively inserted into different vectors each containing a geminivirus replicon and each of the mutated forms of the genetic elements is inserted into the geminivirus replicon contained in the vector whereby when the geminivirus replicon in the vector replicates (Page 21, First Paragraph—Page 22, Third Paragraph, Page 29, First—Last Paragraph—Page 31, First Paragraph, Page 53, Fourth and Fifth Paragraph and Figs. 1-6). Castle teaches the mutated form of the genetic element is amplified (Page 4, First Paragraph, Page 12, Fourth Paragraph, Page 45, First Paragraph and 48, Third Paragraph). Castle teaches the geminivirus replicon comprises all elements required for the geminivirus replication, except a full length Rep/RepA gene (Page 6, Last Paragraph—Page 7, First Paragraph, Page 29, Last Paragraph—Page 30, First Paragraph and Figs. 5-6). Castle teaches transforming a population of plant cells with the library (Page 7, First Paragraph—Page 8, Second Paragraph). Castle teaches the plant cells comprise an expression construct encoding the Rep/RepA protein and expression of the Rep/RepA gene is dependent on a function of the desired genetic element (Page 56, Fourth Paragraph—Page 57, Last Paragraph). Castle teaches the plant cells are suitable plant cells for the geminivirus replicon replication (Page 21, First Paragraph—Page 22, Third Paragraph, Page 29, First—Last Paragraph—Page 31, First Paragraph, Page 53, Fourth and Fifth Paragraph and Figs. 1-6). Castle teaches culturing the resultant population of transformed plant cells (Page 24, First Paragraph). Castle teaches detecting and selecting from the resultant population of transformed plant cells, and the replication level of the geminivirus replicon in the plant cells is configured to be associated with the desired function of the genetic element mutant (Page 10, Third Paragraph, Page 22, Second Paragraph—Page 23, First Paragraph Page 30, Last Paragraph—Page 31, First Paragraph and Page 58, First Paragraph).
Regarding claim 76, Castle teaches the genetic element is selected from a protein coding sequence, a functional RNA coding sequence, or an expression regulatory sequence such (Page 10, Second-Third Paragraphs, Page 15, Last Paragraph, Page 17, Last Paragraph, Page 22, Last Paragraph, Page 23, Frist Paragraph, Page 31, Second Paragraph and Claim 129).
Regarding claim 77, Castle teaches the geminivirus is a wheat dwarf virus (WDV) or a bean yellow dwarf virus (BeYDV) (Page 53, Last Paragraph).
Regarding claim 78, Castle teaches the vector containing the geminivirus replicon is a circular DNA (Page 53, Last Two Paragraphs, Page 57, First Paragraph, Page 54, Second Paragraph and Claim 12).
Regarding claim 79, Castle teaches the vector containing the geminivirus replicon contains at least one large intergenic region (LIR) (Page 17, Last Paragraph, Page 22, Last Paragraph, Page 53, Lat Paragraph—Page 54, First Paragraph, Page and Figure 1-6).
Regarding claim 80, Castle teaches the vector containing the geminivirus replicon contains at least one small intergenic region (SIR) (Page 17, Last Paragraph, Page 22, Last Paragraph, Page 53, Lat Paragraph—Page 54, First Paragraph, Page and Figure 1-6).
Regarding claim 83, Castle teaches the activity or expression level of the geminivirus Rep and RepA protein in the plant cell is associated with the desired function elicited by the mutated form of the desired genetic element and results in the directed evolution of the genetic element (Page 12, Last Paragraph, Page 54, Second Paragraph, Page 32, Second Paragraph, Page 45, Second Paragraph and Page 57, First Paragraph—Page 58, First Paragraph).
Regarding claim 84, Castle teaches the genetic element is a promoter (Page 25, Third Paragraph). Castle teaches the genetic element is a cauliflower mosaic virus (CaMV) 35S promoter (Page 4, Third Paragraph and Page 8, First Paragraph). Castle teaches the genetic element is a sequence encoding a transcription activator (Page 54, Third Paragraph and Page 57, First Paragraph).
Regarding claim 85, Castle teaches the desired function elicited by the mutated form of the desired genetic element in the plant cells is associated with the expression of a specific nuclease (Page 59, First Paragraph). Castle teaches the genetic element without the desired function cannot allow the nuclease to cut its recognition site to achieve the enrichment, thereby the directed evolution of the genetic element is achieved (Page 57, First and Second Paragraphs).
Regarding claim 86, Castle teaches the genetic element is a DNA binding domain (Page 57, First Paragraph).
Regarding claim 87, Castle teaches the detecting and selecting of the genetic element mutant which elicits the desired function and which enriched in the population of plant cells is performed by high-throughput sequencing (Page 28, Last Paragraph—Page 29, First Paragraph, Page 57, Second Paragraph, Page 14, First Paragraph and Page 16, First Paragraph).
Regarding claim 88, Castle teaches identifying the function of the enriched genetic element mutant (Page 4, Last Paragraph, Page 10, Second—Third Paragraph, Page 11, Last Paragraph—Page 12, First Paragraph, Page 57, First Paragraph, Page 41, Second Paragraph, Page 43, Fourth Paragraph, Page 46, Third Paragraph and Page 58, Last Paragraph—Page 59, Last Paragraph).
Regarding claim 89, Castle teaches the plant is a monocotyledon or a dicotyledon or corn, wheat, rice, barley, sorghum, kidney bean, beet, tomato, cassava, cucumber, Arabidopsis or tobacco (Page 24, Second Paragraph—Page 25, Second Paragraph and Page 27, Second Paragraph).
Regarding claim 90, Castle teaches the functional RNA coding sequence, is as tRNA and siRNA coding sequences and an expression regulatory sequence is as a promoter sequence, an enhancer sequence, and a terminator sequence (Page 10, Second-Third Paragraphs, Page 15, Last Paragraph, Page 17, Last Paragraph, Page 22, Last Paragraph, Page 23, Frist Paragraph, Page 31, Second Paragraph and Claim 129).
Regarding claim 91, Castle teaches the circular DNA, is as a plasmid or a minicircle DNA (Page 53, Last Two Paragraphs, Page 57, First Paragraph, Page 54, Second Paragraph and Claim 12).
Regarding claim 93, Castle teaches co-transforming the population of plant cells with the another vector which provides for the expression of geminivirus Rep and/or RepA protein by the population of plant cells comprised in the library (Page 54, Second Paragraph—Page 55, Last Paragraph).
Castle teaches each and every claim limitation of claims 75-91 and 93, therefore Castle anticipates claims 75-91 and 93.
Claim Rejections - 35 USC § 103
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.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Castle et al. (WIPO International Application Publication WO 01/38513 A2, published May 31, 2001), as applied to claims 75-91 and 93, in view of Bendahmane et al. (“Identification and Characterization of Wheat Dwarf Virus from France Using a Rapid Method for Geminivirus DNA Preparation”, Molecular Plant Pathology, Vol. 85 No. 11, Pp 1449-1455, published June 26 1995), previously cited in the November 20, 2025 Office Action. This is a new rejection as necessitated by amendments.
Regarding claim 81, Castle teaches the geminivirus Rep protein as discussed above.
Castle does not teach or suggest the geminivirus Rep protein comprising specific sequence SEQ ID NO: 5.
Bendahmane teaches using wheat dwarf and using a method for geminivirus DNA preparation (Title). Bendahmane teaches wheat dwarf geminivirus with Rep protein C1-1, that is identical to SEQ ID NO:5.
It would have been prima facie obvious to one having ordinary skill in the art before the invention to modify the method of Castle by substituting SEQ ID NO: 5 as taught by Bendahmane because it has been held that the simple substitution of one known element for another to obtain predictable results is obvious. In re Fout, 213 USPQ 532 (CCPA 1982), In re O'Farrell, 7 USPQ2d 1673 (Fed. Cir. 1988). Simply substituting the wheat dwarf geminivirus Rep proteins of Castle with wheat dwarf geminivirus Rep proteins SEQ ID NO: 5 of Bendahmane would obtain predictable results because both Castle and Bendahmane teach methods for wheat dwarf geminivirus DNA preparation with Rep proteins.
Claim 82 is rejected under 35 U.S.C. 103 as being unpatentable over Castle et al. (WIPO International Application Publication WO 01/38513 A2, published May 31, 2001), as applied to claims 75-91 and 93 above. This is a new rejection as necessitated by amendments.
Regarding claim 82, Caste teaches the plant virus vectors used offer the advantage of high copy numbers of viral genomes per cell results in high expression levels of introduced genes (Page 21, Second Paragraph). Castle teaches that any number of vectors (with promoters) that direct transcription in plant cells can be suitable (Page 25, Last Paragraph—Page 26, Third Paragraph). Castle teaches high-level expression of the viral vectors (Page 29, First Paragraph) Castle teaches the methods of the invention are adapted to each application through the choice of substrates and the methods of screening or selection, as well as additional diversity can be introduced by mutagenic amplification (e.g., the method of Castle may be adapted to choose to amplify the mutant (viral) vector according the user’s specific needs, Page 48, Third Paragraph).
Castle does not explicitly teach or suggest the number of vector molecules containing the mutants in the library is 103 to 105 times of the number of the cells in the population of plant cells.
However, it would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to choose the number of vector molecules containing the mutant in the library to be 103 to 105 times of the number of the cells in the population of plant cells because Castle teaches high-level expression of the viral vectors, as well as the methods of the invention may be adapted to each application through the choice of substrates and the methods of screening or selection, as well as mutagenic amplification. Therefore it be obvious to adapt the method of Castle to choose to amplify the mutant (viral) vector according the user’s specific needs; such as using any number of viral vectors and using mutagenic amplification, to amplify the viral vector 103 to 105 times the number of cells in the population of plant cells, to create greater diversity as taught by Castle (Page 48, Third Paragraph).
Response to arguments
Applicant’s arguments and amendments, filed March 18, 2026 regarding the
rejections of claims 55-74 under 35 U.S.C. § 101, 102, 103 and 112(b) have been fully
considered and these rejections are rendered moot due to the cancellation of claims 55-74. Therefore, these rejections are withdrawn.
However, upon further consideration, new grounds of rejection under 35 U.S.C. § 112(b), 101, 102 and 103 are made in view of Applicant’s newly added claims.
As discussed above Castle discloses a method for directed evolution of a desired genetic element and therefore Castle as well as Castle in view Bendahmane are deemed to render the instant invention anticipated/obvious.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA DANIELLE PARISI whose telephone number is (571)272-8025. The examiner can normally be reached Mon - Friday 7:30-5:00 Eastern with alternate Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA D PARISI/ Examiner, Art Unit 1684
/HEATHER CALAMITA/ Supervisory Patent Examiner, Art Unit 1684
Prosecution Insights