DETAILED ACTION
Receipt of Arguments/Remarks filed on July 31 2026 is acknowledged. Claims 10, 12, 14, 16, 18-19, 21-23, 25-27, 29-30, 32-40 and 42-59 were/stand cancelled. Claims 20 and 28 were amended. Claims 1-9, 11, 13, 15, 17, 20, 24, 28, 31, 41 and 60 are pending. Claims 1-9, 11, 13, 15, 17, 31, 41 and 60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 25 2025. Claims 20, 24 and 28 are directed to the elected invention.
Applicants are reminded that pursuant to 37 CFR 1.121 (See also MPEP 714) indicates that the stats of every claim must be indicated after is claim number. Only claims having the status of “currently amended” or “withdrawn” shall include markings. Claim 20 has claim markings but includes the status identifier of “previously presented”. This claim should have the status identifier of “currently amended”.
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 .
Withdrawn Objections/Rejections
The amendment filed July 31 2026 are partially persuasive to overcome the objection of the drawings. While the Figures have corrected and removed the word Figure and replaced with FIG. However, Fig. 4A still includes “continued” following the word Fig.4A instead of another letter, same with Fig. 12.
The amendment to the specification filed July 31 2026 are sufficient to overcome the objection of the specification. The specification clarifies the sequences are referenced in Figure 4D.
The arguments filed July 31 2026 are sufficient to overcome the rejection of claims 20, 24 and 28 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. The remarks clarify the scope of the claims.
New/Modified/Maintained Rejections Necessitated by the Amendments filed July 31 2026
Drawings
The drawings are objected to for the following reasons:
CFR 1.84 (u)(1) states “Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter.” In the current case, the view numbers for the partial views for Figures 4 and 12 that appear on several sheets are followed by "Continued" instead of a capital letter such as FIG. 4A, FIG. 4B, etc.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 28 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 28 recites the limitation "the DNA cargo" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 28 depends from claim 24 which recites an RNA polynucleotide comprising… a cargo sequence. Therefore, the claim from which claim 28 depends on recites neither a DNA polynucleotide nor a DNA cargo.
Claim Rejections - 35 USC § 112-New Matter
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 of carrying out his invention.
Claims 20, 24 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 20 introduces new matter as the claims recite the limitation: "an RNA polynucleotide comprising…iv) a cargo sequence”. There is no support in the specification for this limitation. The limitation of: "RNA cargo sequence" was not described in the specification as filed, and person skilled in the art would not recognize in the applicant’s disclosure a description of the invention as presently claimed. The specification discloses DNA cargo in numerous sections of the specification and previously presented claim 24 but does not describe the instantly claimed limitation. Since the claim as currently amended clearly recites that the cargo sequence is part of the RNA polynucleotide it must be RNA. There is no guidance in the specification to select an RNA polynucleotide comprising a cargo sequence (i.e. an RNA cargo) and from MPEP 2163.06: “Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Applicant has not directed the Examiner to the support in the specification for the amendments. Therefore, it is the Examiner’s position that the disclosure does not reasonably convey that the inventor had possession of the subject matter of the amendment at the time of filing of the instant application.
Claim Rejections - 35 USC § 112-Enablement
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 20, 24 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for modifying a genetic target in prokaryotic cells, does not reasonably provide enablement for modifying a genetic target in eukaryotic cells. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Formal, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The breadth of the claims and Nature of the Invention
The instant claims are directed to a system for modifying a genetic target in cells the system comprising a first set of transposon genes encoding type I-F3 CRISPR-Cas proteins wherein said genes are tnsA, tnsB, tnsC and tniQ and Cas genes cas8f, cas5f, cas7f and cas6f and an RNA polynucleotide comprising the sequence of SEQ ID NO: 5774.
The instant claims are also directed to a method comprising introducing the system above into cells.
Therefore, the instant claims are broad and encompass the modification or the introduction in any cell which is inclusive of both prokaryotic and eukaryotic cells.
It is noted that while the recitation for modifying a genetic target in cells is an intended use, the enablement of compositions limited by a particular use must be considered. See In re Vaeck, 947 F.2d 488, 20 USPQ2d 1438 (Fed. Cir. 1991) and In re Gardner, 427 F.2d 786, 166 USPQ 138 (C.C.P.A. 1970). Note: MPEP 2164.01(c).
The amount of direction or guidance provided and the presence or absence of working examples
The specification fails to include an explanation or example of how the CRISPR/Cas type I-F system is capable of being successful in eukaryotic cells. While the specification contemplates use in vitro or in vivo such as in a prokaryotic or eukaryotic cell (see page 4, 17, 25, 30, 70, 72-74, 80-81 and 85 ). The specification that’s that modifications of the system may include adapting the expression system to allow expression in eukaryotic hosts (page 30). The specification provides working examples in E. Coli (BL21) (see pages 99-100) but never actually shows how the system is to be used in eukaryotic cells. No specific guidance for using the system in eukaryotes is provided and no working examples that demonstrate the efficacy of the system in eukaryotes are provided.
The Relative Skill Level, the State of the Prior Art and The Level of
Predictability in the Art
The relative skill of those in the art is high, that of an MD or PHD with experience in molecular biology. However, the art, with regards to the use of CRISPR/Cas type I-F systems in eukaryotic cells establishes unpredictability.
Zheng et al (Nucleic Acids Research, 2019) provide a discussion of the capabilities of the CRISPR/Cas Type I-F system in prokaryotes vs eukaryotes. Zheng teaches that CRISPR/Cas Type I-F is a class I system, which is a multicomponent system (Page 11461, right column), whereas Class 2 systems, such as CRISPR-Cas9 and CRISPR-Cas12a are simpler systems widely developed for gene editing in eukaryotes and prokaryotes (Page 11462, left column, 1st paragraph). Zheng teaches that the CRISPR-Cas I-F system has not been developed yet for non-model industrial micro-organisms, providing that it has not been tested or deemed capable of another organism besides Z. mobilis at the time of the published literature (Page 11462; bridging columns 1 and 2). Based on these teachings one skilled in the art would have recognized the underdeveloped state of the art with regard to the use of CRSIPR Type I-F systems in eukaryotic cells.
Zetsche et al (Cell. 2015) and Chen et al (Nat Commun, 2017) teaches that the Cas9 system was the first to be found successful in eukaryotic cells with the later use of a Cpf-1 family protein (Abstract). Zetsche teaches the identification of eight different Cpf1-family proteins and their guide RNAs and demonstrates the effectiveness of each Cpf1-family protein in cleaving DNA in vitro (Page 764, bridging columns 1 and 2). However, only two out of the eight proteins provided a successful result when tested in cultured human cells after codon optimization and the addition of a nuclear localization signal (NLS), demonstrating how variable in success the systems can be for mammalian cells (Page 764, bridging columns 1 and 2). Chen et al (Nat Commun 8, 14958 (2017) teaches that many CRISPR-CAS systems have been explored for mammalian gene editing and were found inactive in the cells even though they were active in bacteria or on purified DNA substrates (Page 2; Column 1). Given the unpredictability with simpler Class 2 CRISPR Cas systems, one skilled in the art would have recognized the unpredictability in adapting a Class 1 from use in a prokaryote to a eukaryote.
In the instant case, the claims encompass the use of the CRISPR/Cas type I-F system in both prokaryotes and eukaryotes and the specification fails to show how the claimed system can be used to modify a target gene in any cell or practice the claimed methods in any cell. Neither the claims nor the specification provide the steps or function of how the system is used in eukaryotic cells due to no evidence of the type I-F system being capable of successful use within eukaryotic cells.
The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used to modify a target in any cell as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
Response to Arguments/Declaration under Rule 132
Applicants’ arguments filed July 31 2026 have been fully considered but they are not persuasive.
Applicants argue that the declaration under Rule 132 establishes, via experiments conducted, the system functions in eukaryotic cells. The argument repeat the details in the declaration of Panels A-D presented in the declaration. It is argued that Penel D shows that using the claimed system results in at least two orders of magnitude greater transposition than control. It is argued that this is consistent with the instant specification pointing to page 32 which states transposition efficiency is greater than a control value.
The declaration under 37 CFR 1.132 filed July 31 2026 is insufficient to overcome the rejection of claims 20, 24 and 28 based upon lack of enablement under 35 USC 121(a) as set forth in the last Office action.
Once the examiner has established a prima facie case of lack of enablement, the burden falls on the applicant to present persuasive arguments, supported by suitable proofs where necessary, that one skilled in the art would have been able to make and use the claimed invention using the disclosure as a guide. In re Brandstadter, 484 F.2d 1395, 179 USPQ 286 (CCPA 1973). Evidence to supplement a specification which on its face appears deficient under 35 U.S.C. 112 must establish that the information which must be read into the specification to make it complete would have been known to those of ordinary skill in the art. In re Howarth, 654 F.2d 103, 210 USPQ 689 (CCPA 1981) (copies of patent specifications which had been opened for inspection in Rhodesia, Panama, and Luxembourg prior to the U.S. filing date of the applicant were not sufficient to overcome a rejection for lack of enablement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph).MPEP 716.09. "[A]pplicants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). MPEP 716.02(b)
Looking to the declaration under Rule 132, #3 states that using the systems described in the ‘134 application experiments were conducted. The Declaration points to the exhibit which includes Panel A-D. However, the declaration fails to provide a description of what was precisely done and how these test conditions/materials utilized are the same in the instant specification. The declaration in panel A states the components of a plasmid used in the experiments. However, claim 20 never refers to a plasmid and the cargo is expressly claimed as being part of an RNA polynucleotide which also contains SEQ ID NO: 5744. It is not clear from the declaration that this is the structure utilized in the testing. Panel D which is purported to refer to transposition frequency. This panel refers to Tn6900 which the instant specification teaches is an element derived from A. salmonicida S44. However, none of the other Tn are mentioned in the instant specification nor does the declaration explain what these are structurally. Looking at panel C the Cargo is located between Tn6900 RE and Tn6900 LE. However, the claims recite an RNA polynucleotide comprising contiguously in a 5’ to 3’ direction and recites the cargo sequence last. It is not clear that this polynucleotide includes the RNA polynucleotide with the structural requirement recited in the instant claims. Therefore, the declaration is insufficient as it does not establish supported by suitable proofs where necessary, that one skilled in the art would have been able to make and use the claimed invention using the disclosure as a guide as it is not clear that the same structure as claimed is actually tested.
Furthermore, even if the data were commensurate in scope with the claims and specification, the examiner cannot agree that the data establishes over the full scope of the claims that the claims are enabled. The comparison shown in Panel D is in isolated HEK293T cells. However, the claims encompass cells both in vivo and in vitro. The data utilizes evoCast as control and shows transposition significantly less than evoCAST (specifically while Tn6900 was 1000x higher than the negative control it was also 10,000x lower than evoCAST). Looking to the art, Witte et al. (Science, 2025) discusses evoCAST and as shown in Fig. 1 requires specific engineering to work, see for example 1B which discusses phage-assisted continuous evolution. Witte et al. teaches that Type I-F CASTs despite their robust efficiency in bacteria, natural Type I-F CASTs are minimally active in human cells. Witte et al. states that low activity of PseCAST in human cells could arise from many potential explanations (page 3, last paragraph). The evoCAST system supports 10-25% insertion efficiencies in HEK293T cells (page 4, first paragraph). However, when evoCAST was used in additional human cells lines (HeLa and K562) the editing activity was significantly less (page 13; Fig. 51). Therefore, the declaration fails to make clear the engineering required to enable the claimed system to effectively work in any eukaryotic cell (including those both in vitro and in vivo), especially in light of the unpredictability in the art.
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.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The claims recite laws of nature and natural phenomena. These judicial exceptions are not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception as explained below:
Subject Matter Eligibility Guidance
A three-step inquiry has been established to determine subject matter eligibility under 35 U.S.C. 101, in accordance with MPEP § 2106:
Step (1). Is the claim directed to a process, machine, manufacture, or composition of matter?
Step (2A). Is the claim directed to a law of nature, natural phenomenon (product of nature), or an abstract idea?
Prong 1 – Does the claim recite a law of nature, natural phenomenon, or an
abstract idea?
Prong 2 – If the claim recites a judicial exception, does it recite additional elements that integrate the judicial exception into a practical application?
Limitations that are indicative of integration into a practical application include:
Improvements to the functioning of a computer, or to any other technology or technical field. See MPEP § 2106.05(a)
Applying the judicial exception with, or by use of, a particular machine. See MPEP § 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing. See MPEP § 2106.05(c)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. See MPEP § 2106.05(d)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(e)
Step (2B). If the recited judicial exception is not integrated into a practical application, does the claim recite additional elements that amount to significantly different than the judicial exception such that they provide an inventive concept? This step includes evaluation of the same considerations under Step (2A), Prong 2, as well as two additional considerations:
Adding a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; and
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Analysis
Step (1): The answer to this step is yes since claim 20 is directed to a system (composition of matter), which is a statutory category.
Step (2A):
Product of Nature Definition
When a law of nature or natural phenomenon is claimed as a physical product, the courts have often referred to the exception as a "product of nature". See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580, 106 USPQ2d 1972, 1975 (2013); University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 758-59, 113 USPQ2d 1241, 1243 (Fed. Cir. 2014). As explained in those decisions, products of nature are considered to be an exception because they tie up the use of naturally occurring things, but they have been labeled as both laws of nature and natural phenomena. See Myriad Genetics, Inc., 569 U.S. at 590-91, 106 USPQ2d at 1979.
Claim Analysis
Prong 1
The markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions.
Claim 20 is directed to a system comprising a set of transposon genes encoding type I-F3 CRISPR-Cas proteins wherein said genes are tnsA, tnsB, tnsC and tniQ and Cas genes cas8f, cas5f, cas7f and cas6f and an RNA polynucleotide comprising the sequence of SEQ ID NO: 5744. While claim 20 was amended to recite a cargo sequence, as currently claimed, this is part of the RNA polynucleotide.
The appropriate counterpart to the currently claimed product of nature are: the naturally occurring type I-F3 CRISPR-Cas protein and guide RNA. As shown in Peters (Molecular Microbiology, 2019), figure 3, the major Tn7-like element families identified in sequence bacterial genomes include tnsA, tnsB, tnsC and tniQ and Cas genes cas8f, cas5f, cas7f and cas6. Figure 2 shows how target complexes are assembled at various preferred target sites with Tn7 and Tn-7 like which include gRNA-Cascade.
Petassi et al. (Cell, 2020) teaches in Figure 1, TN7-like Elements with I-F3 CRISPR-CAS systems found in Gammaproteobacteria which includes Aeromonas salmonicida S44. The instantly claimed SEQ ID NO: 5744 aligns with Aeromonas salmonicida S44 (GenBank: CP022176.1, 2017):
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746
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Thus, the broadest reasonable interpretation of claim 20 is that the instantly claimed system does not possess any markedly different characteristics from the naturally occurring I-F3 CRISPR-Cas system. The examiner notes that the instant claims does not limit the spacer sequence and thus the instantly claimed SEQ ID NO: 5744 does not distinguish between the sequence in Aeromonas salmonicida S44 which would include a cargo sequence as well.
Therefore, the answer to step 2A prong 1 is yes.
Prong 2:
The Prong Two analysis considers the claim as a whole. That is, the limitations containing the judicial exception as well as the additional elements in the claim besides the judicial exception need to be evaluated together to determine whether the claim integrates the judicial exception into a practical application.
The instant claim does not contain any additional elements.
Therefore, the answer to step 2A prong 2 is No.
Step (2B):
There are no additional elements.
Therefore, the answer to step (2B) is No.
Conclusion
Claim 20 is directed to a judicial exception and does not qualify as eligible subject matter under 35 U.S.C. § 101.
Claims 24 and 28 are NOT directed to a judicial exception and DO qualify as eligible subject matter under 35 U.S.C. § 101. The method claims practically apply the nature-based products recited in the claims. These claims are eligible under the streamlined analysis described in MPEP 2106.06.
Response to Arguments
Applicants’ arguments filed July 31 2026 have been fully considered but they are not persuasive.
Applicants argue that claim 20 as amended to include a cargo sequence, as in non-rejected claims 24 and 28. As such, it is believed the rejection has been overcome.
Regarding Applicants’ arguments, firstly as previously presented claims 24 and 28 recited “DNA cargo”. However, as amended claim 20 recites an RNA polynucleotide comprising a cargo sequence. Furthermore, the examiner clearly indicated on the record that previously presented claims 24 and 28 were not directed to judicial exception as they are directed to methods which practically apply the nature-based product.
Therefore, the rejection is maintained as the recitation cargo, especially as currently recited as being part of the RNA polynucleotide does not structurally distinguish the instantly claimed system from the naturally occurring I-F3 CRISPR-Cas system in light of the system being part of Aeromonas salmonicida S44. Even if the claim were amended to separately recite a DNA cargo, the examiner is not convinced this would necessarily result in an eligible product. Firstly, DNA sequences are known in nature. The recitation DNA cargo is so broad it would encompass a myriad of different DNA sequences. Since claim 20 is directed to a system, it is made up of separate parts all of which are naturally occurring. The system itself does not result in a marketed difference as the corresponding parts of the system do not possess any different structural or functional characteristic than its corresponding natural product.
Conclusion
Applicants’ 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 ABIGAIL VANHORN whose telephone number is (571)270-3502. The examiner can normally be reached M-Th 6 am-4 pm EST.
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, Neil Hammell can be reached at 571-270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636
Prosecution Insights