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 .
Detailed Action
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-4, 7, 9-10, 12, 14, 33-35) in the reply filed on 05/23/2025 is acknowledged. Species election a) zebrafish and b) G-protein coupled receptor in the reply filed on 05/23/2025 is acknowledged. Election of AHR in the response filed is acknowledged.
Claim 7 is rejoined because it is generic but species election is still in place.
Claims 15-19, 21-22, and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/23/2025.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2020/066461, filed 12/21/2020.
Applicant' s claim for the benefit of a prior-filed parent provisional application 62952218, filed on 12/21/2019, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is 12/21/2019.
Claims Status
Claim 7 is rejoined due to withdrawal of the relevant species election, claims 5-8, 11, 13, 20, 23-32, 36-37 and 39-42 were previously canceled, claims 15-19, 21-22 and 38 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-4, 7, 9-10, 12, 14, and 33-35 have been considered on the merits. All arguments have been considered.
Withdrawn Objections & Rejections
Applicant's response filed 01/08/2026 has been considered. Rejections and/or objections not reiterated from the previous Office action mailed 07/08/2025 are hereby withdrawn.
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application.
Claim Rejections - 35 USC § 112 (new)
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.
The term “optimized” in claim 1 is a relative term which renders the claim indefinite. The term “optimized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 101 (New)
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 9, 10, 12 and 14 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a judicial exception (specifically a mental step) without significantly more.
Regarding claim 9: Claim 9 recites a method for screening the interaction between a human therapeutic agent and a therapeutic target, providing a non-human organism, contacting the organism with a therapeutic agent, performing phenotype assays, and recording a change in a phenotype whereby agents are assessed and selected.
Step 1: Is the claim directed to a statutory category of invention?
Yes, the claim is drawn to a method which is a statutory category of invention (Step 1: YES).
Step 2A, Prong 1: Does the claim recite an abstract idea judicial exception (JE)?
MPEP 2106.04(III) states “the ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions”.
The limitation of “screening” is considered a mental process because it can be performed mentally and is therefore drawn to the judicial exception of an abstract idea.
With Respect to Step 2A, prong one, the judicial exception, the claim is directed to a “recording a change in phenotype” “whereby human therapeutic agents are selected”. The steps of recording and selecting are abstract ideas or mental thought performed by the artisan, and thus directed to a judicial exception (Step 2A, prong 1: Yes)
Step 2A, Prong 2: Does the claim recite additional elements that integrate the JE into a practical application?
The claim recites the additional element of “providing a non-human organism, contacting the organism with a therapeutic agent, performing phenotype assays, and recording a change” However, this not considered to integrate the judicial exception into a practical application.
Additionally, regarding implementation of a “practical application”, MPEP 2106.04(d)(2) states:
“A claim reciting a judicial exception is not directed to the judicial exception if it also recites additional element(s) demonstrating that the claim as a whole integrates the exception into a practical application. One way to demonstrate such integration is when the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition. …in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used… The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s).”
In the instant application, the “selected based on their change in the modified phenotype” limitation is recited at a high level of generality and is not considered to be particular (Step 2A Prong 2: No).
Step 2B: Are there additional elements that add significantly more to the ‘product of nature judicial exception’?
The claim does not recite additional elements that amount to significantly more than the judicial exception itself, as described above (Step 2B: No).
Claims 10, 12 and 14 are also rejected because of their dependency on claim 9 and their failure to correct the deficiencies of claim 9.
The claims are patent ineligible.
Claim Rejections - 35 USC § 102 (new)
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.
Claims 1-3, 9-10, 12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al (US 2020/0179333; priority 16/340352 filed 04/08/2019; previously cited).
Regarding claims 1 and 2: MPEP 2111.01 reads “Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification”.
MPEP 2111.02 states “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim”.
The intended use statement in claim 1 “for screening a human therapeutic agent and a therapeutic target” does not impose or imply a structure for the claimed invention and is therefore not considered limiting for examination purposes in the following analysis.
The claim recites “optimized for expression in the non-human organism”. The instant specification is silent on an explicit definition of the term “optimized for expression”. One of ordinary skill in the art would understand that optimizing expression of a gene means that the expression of the optimized gene product is greater when compared to an unoptimized condition.
A non-human transgenic host organism does express human genes unless a gene is specifically introduced into the non-human organism. Thus any non-human transgenic host organism which expresses a human gene product can be considered “optimized” for expression of the human gene product if the human gene product is expressed at any level because the host organism comprising the human gene will express more of the human gene product than a host organism in it’s more natural state which does not comprise the human gene. Thus any level of gene expression of a human transgene in a non-human host organism is considered to read on the claim limitation “optimized for expression in the non-human organism”.
Turning to the art, Kumar teach a non-human transgenic organism (zebrafish) that comprises a human heterologous gene (human clarin-1 (hCLRN1)) (p9 para 0096). The transgene is operably linked to a heterologous promoter (the zebrafish promoter pvalb9, also known as pvalb3b) (p14 para 0111). This reads on a heterologous promoter selected for expression in the host organism cells, as the zebrafish promoter is heterologous to the human gene to which it is operably linked.
Kumar teach the transgene is inserted into a non-native locus (the transgene is randomly inserted using Tol2). Kumar also teach the transgene is a therapeutic target (hCLRN1N48K causes deaf-blindness) (p1 para 0004). Kumar teach the expression of a human gene in a non-human organism, which reads “optimized for expression in the non-human organism” as the zebrafish taught by Kumar expresses more of the gene product than a zebrafish which does not comprise the human transgene.
The claim recites “induces a modified phenotype”. Expression of a non-native gene product (human gene) is considered a modified phenotype because the proteomic expression profile of the host organism is modified.
Regarding claim 3: Kumar teaches the expression of a human transgene in a non-human organism. Because neither protein is not normally expressed in the non-human organism, the target is also not normally expressed in the non-human organism. Thus any level of expression the reads on “over expressed in non-orthologous tissue”.
Regarding claims 9, 10, 12: The claims are drawn to a method of use of the product (non-human transgenic organism) of claim 1.
Kumar teach the active steps of the claimed method. As discussed supra, Kumar teach the non-human transgenic organism comprising a human gene encoding a protein sequence for a therapeutic target operable linked to a heterologous promoter selected for expression in the host organism. This reads on a) providing a non-human organism of claim 1. Table 1 teach arthemisinin is capable of rescuing the survival phenotype, demonstrating the agent was selected (Table 1 p 12). Improving the survival rate from 0% to 100% reads on a statistically significant measurable difference (Table 1; p11/12).
Kumar teach b) contacting the non-human transgenic organism of step a) with one or more human therapeutic agent during and incubation period; Kumar teach contacting the genetically modified organism with the human therapeutic agent arthemisinin (p12 [0107]). Table 3 teach the incubation period ranged from 1-10 hours (p13).
Kumar teach c) performing a phenotype assay during or after the incubation period; Table 1 teach arthemisinin is capable of rescuing the survival phenotype, demonstrating the agent was selected (Table 1 p 12).
Kumar teach d) recording a change in the modified phenotype following the phenotype assay; the publication of these data disclosed by Kumar required recording a change in the phenotype and selection of the therapeutic agent was based. Kumar identify the arthemisinin as capable of rescuing the survival phenotype, demonstrating the agent was, in fact, selected (Table 1 p 12).
Regarding claim 14: As discussed supra, anti-correlated phenotype is understood to be a phenotype that is negatively correlated with exposure to the therapeutic agent- increasing concentration of therapeutic agent reduces the phenotype.
Kumar teach that hCLRN1N48K zebrafish have a 95% death (5% survival) at 27 dpf in the absence of ART, and in the presence of 0.4 uM of ART (increased concentration) have a 55% death (Table 1 p11/12). Because the deathrate decreases as the drug concentration increases, the phenotype (death percentage) is anticorrelated with exposure to the therapeutic agent (ART).
Support for the above teachings of Kumar is found in the 16/340352 filed 04/08/2019.
Thus the teachings of Kumar anticipate the invention as claimed.
Claim Rejections - 35 USC § 103 (new)
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al (US 2020/0179333; previously cited) as applied to claims 1-3, 9-10, 12 and 14 above, and further in view of Greenwald et al (Gene There.(2013)20(4)1-22; previously cited).
Claims 1-3, 9-10, 12 and 14 are anticipated by Kumar, and thus are also rendered obvious (see above).
Regarding claim 4: The teachings of Kumar are discussed above. Kumar do not teach the therapeutic target comprises a G-protein coupled receptor associated with disease in humans.
Greenwald teach a G-protein coupled receptor associated with disease in humans (rhodopsin (p2/3 para 5/1)).
It would have been prima facie obvious to one of ordinary skill in the art to modify the non-human zebrafish disease model taught by Kumar with the G-protein coupled receptor taught by Greenwald.
One would have been motivated to modify the zebrafish model taught by Kumar to express the G-protein coupled receptor taught by Greenwald because Greenwald teach mutations in the G-protein coupled receptor is associated with disease in humans (p2/3 para 5/1).
One would have had a reasonable expectation of success because Kumar teach zebrafish disease models to express disease causative human transgenes and Greenwald teach that rhodopsin is a disease causative human transgene.
Claims 33-35 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al (US 2020/0179333; previously cited) as applied to claims 1-3, 9-10, 12 and 14 above, and further in view of Newman et al (Frontiers in Genetics (2014)5(189)1-10; previously cited).
Claims 1-3, 9-10, 12 and 14 are anticipated by Kumar, and thus are also rendered obvious (see above).
Regarding claims 33, 34, and 35: Claim 35 recites optional components; “the reporter sequence is operably linked to a tissue-specific promoter”. Optional components are considered required.
The teachings of Kumar are discussed supra. Kumar teach a zebrafish model for diseases associated with glycosylation-defective proteins by expression of a human transgene in zebrafish. Kumar do not teach a zebrafish model comprising a coding sequence for a genetic variant associated with Alzheimer’s Disease.
Newman teach a transgenic zebrafish model for Alzheimer’s Disease in which a human transgene (MAPT) is expressed in zebrafish neurons (p7 col1 para 3).
It would have been obvious for one of ordinary skill in the art to modify the zebrafish which expresses a human transgene (CLRN1 driven by the pvalb3b promoter) to model disease associated with glycosylation-defective proteins as taught by Kumar, with the teachings of Newman, to use a zebrafish which expresses a human transgene (MAPT driven by the enolase 2 promoter) to model Alzheimer’s disease as taught by Newman.
One of ordinary skill in the art would have been motivated to modify the zebrafish model as taught by Kumar with the teachings of Newman, to express human MAPT in zebrafish as a model for AD because Newman teach transgenic zebrafish expressing human MAPT provide a useful system to investigate whether chemical inhibitors can modulate the observed AD phenotype (tauopathy-associated changes) in the fish (p7 col1 ¶3). Newman also teach zebrafish are an ideal model for drug testing prior to clinical testing in rodents (p1 col2 ¶2 ; p7 col2 ¶2).
One would have had a reasonable expectation of success because both Kumar and Newman are drawn to zebrafish models of specific diseases which are can be modeled by the expression of human transgenes in the zebrafish.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al (US 2020/0179333; previously cited) as applied to claims 1-3, 9-10, 12 and 14 above, and further in view of Frokjaer-Jensen et al (Cell (2016) 166;343-357).
Claims 1-3, 9-10, 12 and 14 are anticipated by Kumar, and thus are also rendered obvious (see above).
Regarding claim 7: Claim 7 is rejoined due to the amendment to the claim. The teachings of Kumar are discussed supra. Kumar do not teach that the human heterologous gene is a chimeric sequence comprising heterologous exon coding sequences interspersed with artificial host organism intron sequence optimized for expression in the host.
Frokjaer-Jensen teach introns interspersed with artificial host organism intron sequences improve the expression of transgene expression in C. elegans; PATC-rich introns significantly reduced stochastic transgene silencing (p350 col2 ¶1).
It would have been prima facie obvious to one of ordinary skill in the art to modify the non-human zebrafish disease model taught by Kumar by expressing the transgene with host intron sequences as taught by Frokjaer-Jensen.
One would have been motivated to modify the zebrafish model taught by Kumar by Kumar by expressing the transgene with host intron sequences as taught by Frokjaer-Jensen because Frokjaer-Jensen teach using interspersed host intron sequences improves transgene expression.
One would have had a reasonable expectation of success because both inventions are drawn to expression of transgenes in host model organisms.
Thus the combined teachings of Kumar, Greenwald, Newman and Frokjaer-Jensen render obvious the invention as claimed.
Double Patenting (New)
Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
The nonstatutory double patenting rejection is based on a judicially created 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Regarding Claims 1 and 2: Co-pending claim 1 teaches a non-human transgenic system wherein a first heterologous peptide is integrated into the host genome and at least one of the first heterologous polypeptide coding sequence or the second heterologous polypeptide coding sequence is a chimeric heterologous polypeptide coding sequence comprising heterologous exon coding sequences interspersed with artificial host intron sequences optimized for expression in the host. Co-pending claim recites a host nematode, which is considered a species of the genus “non-human transgenic organism”.
MPEP 2131.02 reads "’A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus.’ The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960)”.
Thus the disclosure of ‘221 reads on the instant claims 1 and 7; a non-human transgenic organism that comprises a heterologous gene wherein the
human heterologous gene is a chimeric sequence comprising heterologous exon coding sequences interspersed with artificial host organism intron sequences optimized for expression in the host.
Co-pending claim 1 does not teach the heterologous gene is a human transgene operably linked to a heterologous promoter or that the transgene is inserted in a non-native locus.
Kumar teach a non-human transgenic organism (zebrafish) that comprises a human heterologous gene (human clarin-1 (hCLRN1)) (p9 para 0096). The transgene is operably linked to a heterologous promoter (the zebrafish promoter pvalb9, also known as pvalb3b) (p14 para 0111).
Kumar teach the transgene is inserted into a non-native locus (the transgene is randomly inserted using Tol2)(p10 para 0102). Kumar also teach the transgene is a therapeutic target (hCLRN1N48K causes deaf-blindness) (p1 para 0004). Kumar teach the expression of a human gene in a non-human organism, which reads on expression in a non-orthologous time and/or tissue.
It would have been prima facie obvious to one of ordinary skill in the art to combine the teachings of co-pending claim 1 with the non-human zebrafish disease model taught by Kumar.
It would have been obvious to link the transgene to a heterologous promoter and express in non-orthologous tissue, as taught by Kumar, because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Combining expression of a human transgene in zebrafish as taught by the co-pending application, with the heterologous promoter driving expression in non-orthologous tissue as taught by Kumar would have led to predictable results with a reasonable expectation of success because both inventions are drawn to zebrafish models of human disease.
Response to Arguments
The responses are directed to the Arguments filed 01/08/2026, all arguments have been fully considered.
III. Regarding Arguments directed to the restriction:
Applicant's species election of “AHR” is acknowledged. Applicant is thanked for the election of the species which will expedite examination in the event of a rejoinder of the relevant claim.
IV. Regarding Arguments directed to 35 USC § 112(b):
Applicant's arguments directed to rejections over “heterologous promoter”, “therapeutic agent” and “phenotype revealing agent” have been fully considered and they are persuasive.
The claim amendments overcome the rejection over “non-orthologous time and/or non-orthologous tissue” because the amended claims do not cite the term. The rejections directed to claims 1, 9 and 14 are withdrawn.
V. Regarding Arguments directed to 35 USC § 101:
Applicant argues that the present claims do not recite a mental process or an abstract idea.
MPEP 2106.04(a)(2) reads “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674”.
The instant claims recite “screening”, “recording” and “selecting”, which are capable of being performed in the human mind and thus the claim limitations are considered to encompass mental processes, as discussed in greater detail supra in the instant rejection. Thus the Arguments are not persuasive.
In view of the claim amendments the rejection is withdrawn and a new rejection is entered to address the changed claim language, however the new rejection is essentially repeated from the previous action.
VI. Regarding Arguments directed to 35 USC § 102:
A. Regarding the rejection over Hopkins et al.:
Applicant’s statement disclosing the shared Applicant (NemaMetrix) overcomes the rejection and the rejection is withdrawn.
B. Regarding the rejection over Kumar et al.:
The amendments to the claims overcome the rejection. Specifically, claim 1 is amended to recite “optimized for expression in the non-human organism”, which is not addressed in the previous rejection.
The rejection is withdrawn.
VII. Regarding Arguments directed to 35 USC § 103:
Applicant asserts the cited art does not teach or reasonably suggest optimization of the trans gene prior to insertion in the host organism, as claim 1 has been amended to recite.
This is persuasive and the rejection is withdrawn.
In response to arguments relevant to the instant rejection:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., insertion sites to completely knock-out/replace a gene within the host organism; single copy insertion at a native locus or at a “safe harbor” site, direct interaction between a therapeutic test compound and a human expressed transgene) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
VIII./IX. Regarding Arguments directed to Double Patenting and Obviousness Double Patenting:
Applicant submits Claim 2 of the '221 application was previously
canceled and claim 1 amended to recite "nematode" in the claim set filed 07/08/2025.
The amendments to the claims of 17/433,221 filed 11/17/2025 overcome the rejection as written. The rejection is withdrawn.
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 ANDREA LYNNE MORRIS SPENCER whose telephone number is (571)272-3328. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/ANDREA LYNNE MORRIS SPENCER/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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