DETAILED ACTION
Claims16-33 and 36-38 from the claim set filed February 11, 2026 are pending. Claims 1-15 and 34-35 are cancelled. Claims 37-38 are newly added. Claims 21-22, 24-29, 32-33 and 37-38 are withdrawn. Thus, claims 16-20, 23, 30-31 and 36 are being examined on the merits herein.
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 .
Election/Restrictions
Applicant's election of Group I, claims 16-31 and 36 (and newly added claims 37-38) in the reply filed on February 11, 2026 is acknowledged. Additionally, Applicant’s species election of claim 23 as the species of second target is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
In regards to newly added claims 37 and 38, Examiner notes said claims, if previously presented, would have been incorporated into the election of species requirement previously set forth in the OA dated December 11, 2025. Examiner respectfully notes newly added claims 37 and 38 are drawn to the second target, and specifically to the second target comprising a virus and thus do not read on the species of second target (i.e., claim 23) of which Applicant elected which does not require the second target comprising a virus. As such, claims 37 and 38 are withdrawn as being drawn to a nonelected invention.
Thus, non-elected without traverse Group II (i.e., claims 32-33) and non-elected without traverse species (i.e., claims 21-22, 24-29, and 37-38) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 16-20, 23, 30-31 and 36 will be examined on the merits herein.
Priority
A claim for benefit of a prior-filed application under 35 U.S.C. 119(a)-(f) or under 35
U.S.C. 120, 121, 365(a)-(c), 386 (a) or 386(c) has been made. The effective filing date of the
present application is November 20, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/11/2023 and 11/19/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
(1) Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. MPEP 2422.02 requires, "that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the Sequence Listing and the sequence identifier ("SEQ ID NO:X') must be used, either in the drawing or in the Brief Description of the Drawings." See MPEP § 2421-2422.
Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
See Fig T2 which has amino acid or nucleic acid sequences that are not accompanied by SEQ ID NO in the figure or in the specification.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Drawings
The drawings of May 19, 2023, and specifically Fig T2, are objected to because the drawings contain nucleotide and amino acid sequences that are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). All sequences longer than ten nucleotides or four amino acids referenced in the specification must include a SEQ ID NO and must be included in the Sequence Listing. MPEP 2422.02 requires, "that when a sequence is presented in a drawing, regardless of the format or the manner of presentation of that sequence in the drawing, the sequence must still be included in the Sequence Listing and the sequence identifier ("SEQ ID NO:X') must be used, either in the drawing or in the Brief Description of the Drawings." See MPEP § 2421-2422.
It is noted that this office action comprises both an objection to the Nucleotide and/or Amino Acid Disclosure AND the objection to the Drawings. Applicant need only either amend the specification at the Brief Description of the Drawings section OR provide amended drawings to overcome both objections. Applicant does not need to do both.
The drawings are objected to because the drawings are not numbered in consecutive Arabic numerals, as required by 37 C.F.R § 1.84 (u)(1). The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). 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. View numbers must be preceded by the abbreviation “FIG.” Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation “FIG.” must not appear.
In the instant case, the drawings are numbered as Fig. 1-6, Fig. S1-S14 and Fig. T1-T2. Examiner respectfully notes the Figure should be labeled consecutively as Fig. 1-22, for example.
Appropriate correction is required.
The drawings are objected to because p20/38-22/38 of the drawings are not labeled as any particular figure. Examiner believes p20/38-22/38 are unlabeled duplicates of Fig. S14 found on p23/38-25/38.
Appropriate correction is required.
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 Interpretation
&
Claim Rejections - 35 USC § 112(b)
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.
Claims 16-20, 23, 30-31 and 36 are rejected under 35 U.S.C. 112(b), 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. Dependent claims 17-20, 23, 30-31 and 36 are rejected by virtue of their dependency on claim 16 and for not remedying the issue at hand.
Claim 16 is drawn to a kit of parts having biological activity, the kit of parts comprising:
-a first target comprising a first protein, and
-a second target comprising a second protein,
wherein the first protein and the second protein are suitable to form a heterodimer upon irradiation with UV, visible or infrared light in a first wavelength range or in the dark,
wherein the biological activity consists of triggering both the uptake of DNA, RNA, proteins, or small molecules into a cell and biological effects, and
wherein at least one of the first and the second target itself has reduced biological activity as compared with the heterodimer.
I.e., said kit is for the use of importing DNA, RNA and/or proteins into cells.
Examiner notes the phrase “which can be optionally be reversed upon irradiating the heterodimer with UV, visible, or infrared light in a second wavelength or in the dark, wherein the second wavelength range is different from the first wavelength range” is read, as indicated by the claim language, as an optional limitation and thus not a requirement of claim 16.
Examiner respectfully notes the claim language “a first target comprising a first protein” and “a second target comprising a second protein” is unclear and indefinite. It is unclear what structural element is required by the “first target” and the “second target”. It is not clear if the first target comprising a first protein reads on ONE protein being both the first target and the first protein or if the first target is a different structure from the first protein. The same indefiniteness applies to the second target comprising a second protein.
The terms “first target” and the “second target” are not defined by the claims, the specification does not provide a standard for ascertaining what structure is required for said targets, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the metes and bounds of the claim cannot be determined and the claim is indefinite.
Additionally, Examiner notes the “first target comprising a first protein” and the “second target comprising a second protein” may be interchangeable, per the teachings of the specification (p17). This lends to the lack of clarity/indefiniteness when trying to understand the scope of the claims.
In the interest of compact prosecution, Examiner is interpreting “the first target comprising a first protein” to be two different structures. The same interpretation is being applied to the “second target comprising a second protein”. Further, and in regards to the phrase “first target comprising a first protein”, Examiner is interpreting the “first protein” to be, for example, an optogenetic protein, for example, a phytochrome, per claim 30. In regards to “first target”, Examiner is interpreting said target to be, for example, any molecule which is suitable to bind a lipid or a protein, per claim 18. In regards to the “second protein”, Examiner is interpreting said phrase to be, for example, an optogenetic binding partner, for example a phytochrome interacting partner, per claim 30. In regards to the “second target”, Examiner is interpreting said phrase to be, for example, a virus, per claim 37.
However, despite the above interpretation, such treatment does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
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 16-20, 23, 30-31 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
The rationale set forth below conforms to current Office practice for examination of claims under § 101.
These claims are analyzed for eligibility in accordance with their broadest reasonable interpretation. All of the claims are directed to a statutory category, e.g., a composition (Step 1: YES).
The next part of the analysis involves whether the claimed invention recites or is directed to one or more judicial exceptions (Step 2A, prong one).
Claim 16: Claim 16 is directed to a biological composition comprising:
-a first target comprising a first protein, and
-a second target comprising a second protein,
wherein the first protein and the second protein are suitable to form a heterodimer upon irradiation with UV, visible or infrared light in a first wavelength range or in the dark,
wherein the biological activity consists of triggering both the uptake of DNA, RNA, proteins, or small molecules into a cell and biological effects, and
wherein at least one of the first and the second target itself has reduced biological activity as compared with the heterodimer.
Claim 16 is recited in a generic and open-ended manner and given its broadest reasonable interpretation, would encompass a composition comprising an optogenetic protein binding partner pair such as PhyB and PIF6, thus reciting a combination of natural products. Examiner respectfully notes a first target comprising a first protein would encompass, for example, PhyB and a second target comprising a second protein would encompass, for example, PIF6. Examiner additionally notes PhyB and PIF6 form a heterodimer upon irradiation with UV, visible or infrared light.
In regards to the limitation directed to biological activity, the claim language as currently written is not narrowed to the proteins disclosed as having said biological activity. The claim language as currently written does not exclude other naturally occurring elements providing said biological activity.
Thus, the claim, as a whole recites a combination of natural products.
The claim as a whole, considering all claim elements both individually and in combination, does not amount to significantly more than the natural product of an optogenetic protein binding partner pair such as PhyB and PIF6. The combination of said optogenetic protein binding partner does not improve or change in any way each components natural functioning. Thus, the claimed composition does not have markedly different characteristic from what occurs in nature and is a "product of nature" exception. Accordingly, the claim is directed to an exception (Step 2A, prong one: YES). Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
Claim 17: Claim 17 depends from claim 16. Claim 16, as currently written, does not require a cell. Thus, claim 17 does not modify the original structure of the claimed proteins of claim 16. Thus, the combination of a cell to the naturally occurring proteins of claim 16 does not improve or change in any way each components natural functioning. Thus, the claimed composition does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Accordingly, the claim is directed to an exception (Step 2A, prong one: YES). Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
Claims 18-20: It is noted that these claims recite limitations that are considered only to be directed to intended use/functional limitations. Said limitations do not modify the original structure of the claimed proteins and the further the recited function of the claims doesn’t provide additional structure/doesn’t structurally modify the composition to provide a markedly different characteristic. Thus, the claimed composition does not have markedly different characteristics from what occurs in nature and is a "product of nature" exception. Accordingly, the claims are directed to an exception (Step 2A, prong one: YES). Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
Claims 23, 30, 31, 36: Said claims are related to naturally occurring products which do not modify the original structure of the claimed proteins in such a way that is markedly different from what occurs in nature. The combination does not improve or change in any way each components natural functioning. Thus, the claimed composition does not have markedly different characteristic from what occurs in nature and is a "product of nature" exception. Accordingly, the claims are directed to an exception (Step 2A, prong one: YES). Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101.
The next part of the analysis involves whether the claimed invention recites additional elements that integrate the judicial exception into a practical application (Step 2A, prong two).
Given the claims are directed to a composition, the claims do not recite additional steps that integrate the judicial exception into a practical application (Step 2A, prong two: No).
The final part of the analysis involves whether the claimed invention, as a whole, recite something “significantly more” than the judicial exceptions (Step 2B).
In view of the above and considered as a whole, the claimed composition does not have markedly different characteristics from what occurs in nature and such elements discussed above are not significantly more than the indicated judicial exceptions. Thus, the claims do not qualify as eligible subject matter, and are rejected under 35 U.S.C. 101 (Step 2B: NO).
Claim Rejections - 35 USC § 112(a)
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.
Claim 31 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regards to claim 31, the claim under rejection is directed to the kit of claim 16, wherein the phytochrome interacting partner is selected from the group comprising “PIF1, PIF2, PIF3, PIF4, PIF5, PIF6, PIF7, PIF8, FHY1, FHL, PpsR2, Q-PAS1 and engineered antibodies or fragments thereof.”
To satisfy the written description aspect of 35 U.S.C. 112, first paragraph, for a claimed genus of molecules, it must be clear that: (1) the identifying characteristics of the claimed molecules have been disclosed, e.g., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed cor-relation between function and structure, or by a com-bination of such identifying characteristics; and (2) a representative number of species within the genus must be disclosed. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
In giving the term fragments thereof [of PIF1, PIF2, PIF3, PIF4, PIF5, PIF6, PIF7, PIF8, FHY1, FHL, PpsR2, Q-PAS1 and engineered antibodies] its broadest reasonable interpretation, the number and types of compounds which can be considered a fragment thereof of these molecules is extraordinarily great. Applicants’ disclosure of such compounds is limited to, for example Figure 1 and PIF6, per se, there is no disclosure of acceptable fragments thereof of PIF1, PIF2, PIF3, PIF4, PIF5, PIF6, PIF7, PIF8, FHY1, FHL, PpsR2, Q-PAS1 and engineered antibodies.
Regarding disclosure of identifying characteristics of the claimed molecules a review of the specification fails to provide a definition of what structural characteristics of PIF1, PIF2, PIF3, PIF4, PIF5, PIF6, PIF7, PIF8, FHY1, FHL, PpsR2, Q-PAS1 and engineered antibodies the fragments thereof encompassed by the current claim must have; Applicants have not identified any particular core chemical structure or function (along with a correlation between function and a specific conserved structure) of these molecules which must be shared by all fragments thereof; and thus one of ordinary skill in the art would not immediately envisage all fragments thereof of PIF1, PIF2, PIF3, PIF4, PIF5, PIF6, PIF7, PIF8, FHY1, FHL, PpsR2, Q-PAS1 and engineered antibodies, as currently claimed. Therefore, Applicants have not disclosed the identifying characteristics of the claimed molecules.
Regarding disclosure of a representative number of species within the genus, a review of the specification shows that Applicants have not disclosed specific species of fragments thereof. Disclosure of a single species does not constitute a representative number for such a broad genus as is encompassed by the breadth of claim 31. Therefore, Applicants have not disclosed a representative number of species, as would be required to support description and to show possession of the entire genus.
Thus, one of ordinary skill in the art, in looking to the instant specification, would not be able to determine that Applicants were in possession of the invention, as claimed, at the time the invention was made. Accordingly, claim 31 is considered to lack sufficient written description and is properly rejected.
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.
Claims 16-18, 20, 23, 30-31, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Ho (WO 2017/053629 A2, published March 30, 2017; cited in the Incoming Written Opinion of the International Searching Authority, filed 5/19/2023; IDS filed 12/11/2023).
In regards to claim 16, Ho teaches [0007] optogenetics offers a molecular toolbox of light-switchable proteins and among the photo-switchable proteins, phytochrome-family proteins are powerful because they can be activated by one wavelength and deactivated by a second wavelength, allowing control over the degree of activation in live cells in space and time. Ho teaches, for example, Phytochrome B (PhyB) has been used for light-switchable transcription, signal cascade activation, actin nucleation, autocatalytic protein splicing, and pseudopodia elongation. Ho teaches the apo form of PhyB from A. thaliana covalently binds to the tetrapyrrole chromophore phycocyanobilin (PCB) to form the holoprotein, after which PhyB rapidly associates with and dissociates from phytochrome interacting factor 6 (PIF6) upon absorption of red (R, Amax= 650nm) photons or far-red (FR, Amax=750nm) photons, respectively. Ho teaches the PhyB/PIF6 system dimerizes in seconds, is amenable to fusion proteins, and is non-toxic to mammalian cells [0007].
FIGURE 9A of Ho shows the expected mechanism for light-activable gene delivery using VNP-PIF6 in the presence of PhyB with a NLS fusion under deactivating (Far Red, left panel) light and activating (Red, right panel) light. Under activating conditions, the PhyB-NLS adopts a conformation capable of binding PIF6 and binds the VNP-PIF6 which enhances nuclear uptake of the virus through the NLS, while under deactivating conditions and/or ambient conditions, the PIF6 dissociates from and does not bind the PhyB-NLS, resulting in basal levels of nuclear uptake (Fig 9A, [0160]).
Thus, [0053] FIGURE 9A of Ho depicts a mechanism for decreasing or increasing nuclear uptake of a virus displaying an optogenetic binding partner (PIF6) on its surface into a target cell where an optogenetic protein (PhyB) and its associated chromophore are present to form the holoprotein (Pr and Pfr) in the cytoplasm, the optogenetic protein having a nuclear localization signal (NLS) on its surface and exposing the system to far-red (inactivating) light or red (activating light) to decrease or enhance nuclear uptake of the virus, respectively ([0053, Fig 9A).
Fig 9A, Ho
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Ho additionally teaches the virus can further include a nucleic acid molecule which can be a therapeutic nucleic acid molecule and said therapeutic molecule may be RNAi or a CRISPR/Cas genome editing tool [0121]. Examiner notes the instant specification (p7) teaches the biological effects of the claimed invention are caused by the DNA/RNAi, etc provided by the heterodimer (i.e., the therapeutic molecule comprised within the virus). Said therapeutic molecule may have biological effects on signal transduction, gene transcription, etc. Thus, the therapeutic molecule of Ho would inherently cause “biological effects” in the target cell.
Therefore, the invention of Ho teaches a method for delivering a nucleic acid molecule to the nucleus of a target cell, (i.e., the method of Ho teaches the uptake of a nucleic acid molecule into a cell) comprising obtaining a virus comprising a nucleic acid molecule and further comprising an optogenetic binding partner (i.e., PIF6), delivering the virus to a target cell containing an optogenetic protein (i.e., PhyB) which further comprises a nuclear localization signal and which is capable of binding the optogenetic binding partner (i.e., PIF6) present on the surface of the virus, exposing the target cell to light of a sufficient wavelength to induce conformational change in the optogenetic protein (i.e., PhyB) that allows the optogenetic protein (PhyB) to bind to the optogenetic binding partner (PIF6) on the surface of the virus, thereby enhancing nuclear delivery of the virus.
Thus, Ho teaches a first target (i.e., a nuclear localization signal) comprising a first protein (i.e., PhyB) and a second target (i.e., a virus) comprising a second protein (i.e., PIF6), wherein the first protein (PhyB) and the second protein (PIF6) are suitable to form a heterodimer upon irradiation with red light, which can be optionally reversed upon irradiating with far-red light, wherein the second wavelength range is different from the first wavelength range, wherein the biological activity consists of triggering both the uptake of DNA, RNA, proteins or small molecules into a cell (for example, a therapeutic nucleic acid molecule included in the virus), and biological effects, and wherein at least one of the first and the second target itself has reduced biological activity as compared with the heterodimer (i.e., the first and second targets do not have as great of a nuclear uptake of the therapeutic molecule as compared with the heterodimer).
In regards to a kit of parts, Ho teaches of a kit including the virus and nucleic acid molecule of the invention (i.e., the second target comprising a second protein) [0104]. Ho does not teach a kit comprising a first target comprising a first protein. However, it would have been prima facie obvious to one having ordinary skill in the art at the time of the invention to collect both the first target comprising a first protein and the second target comprising a second protein into a single container (e.g. kit) for the predictable result of providing the composition in convenient packaging for distribution, thus meeting the limitation of claim 16. One of ordinary skill in the art would have been motivated to modify the kit of Ho in order to provide the components in a manner that is convenient for saving time and provides easier distribution of the composition components; thus one would have had a reasonable expectation of successfully collecting these items into a single container (e.g. kit) for the predictable result of providing the composition in convenient packaging for distribution.
Therefore, the claim is obvious and is properly rejected.
In regards to claim 17, Ho teaches claim 16. Further, Ho teaches the target cell can be in a human subject [0131]. As Ho does not teach the cell is genetically modified, it is thus assumed said target cells may be genetically unmodified. Therefore, the claim is obvious and is properly rejected.
In regards to claim 18, Ho teaches claim 16. Further, and as discussed supra in regards to claim 16, Ho teaches of a nuclear localization signal which reads on “the first target”. As a POSITA will appreciate, nuclear localization signals bind receptor proteins to initiate transport into the nucleus. Thus, Ho teaches wherein the first target is suitable to bind a protein. Therefore, the claim is obvious and is properly rejected.
In regards to claim 20, Ho teaches claim 18. Further, and as discussed supra in regards to claim 18, Ho teaches wherein the first target (i.e., the nuclear localization signal) is suitable to bind to a protein (i.e., a nuclear receptor protein). Examiner notes the specification teaches the biological effects of the present invention are caused by DNA/RNA/proteins etc provided by the heterodimer (p7). As the first target binding (i.e., the nuclear localization signal) to a protein (i.e., a nuclear receptor protein) and the subsequent biological effects of said binding (i.e., movement into the nucleus) is not caused by the heterodimer, (i.e., the biological effects of binding of the heterodimer would cause the nucleic acid molecule of the virus (i.e. second target) to be transported into the nucleus), Examiner thus notes the teachings of Ho read on the limitations of the instant claim. Therefore, the claim is obvious and is properly rejected.
In regards to claim 23, Ho teaches claim 16. Further, and as discussed supra, Ho teaches wherein the second target (i.e., the virus) comprises a nucleic acid molecule. Therefore, the claim is obvious and is properly rejected.
In regards to claim 30 and 31, Ho teaches claim 16. Further, and as discussed supra, Ho teaches wherein the first protein is a phytochrome (PhyB) and the second protein is a phytochrome interacting partner (PIF6). Therefore, the claims are obvious and are properly rejected.
In regards to claim 36, Ho teaches claim 16. Further, Ho teaches of the nucleotide sequences for the 2nd target (i.e., an AAV virus) and the second protein (i.e., PIF6) [0111], [0106]. Ho additionally teaches of the nucleotide sequences for the first protein (i.e., PhyB) [0112] and first target (i.e., nuclear localization signal) [0123].
Thus, as Ho teaches the limitations of claim 16 and thus a kit encompassing the first target comprising a first protein and a second target comprising a second protein as well as teaching said proteins form a heterodimer when exposed to light, it would thus be prima facie obvious to one having ordinary skill in the art at the time of the invention to collect the nucleotide sequences for both a first nucleotide sequence encoding a first target protein, as taught by Ho, as well as a second nucleotide sequence encoding a second target sequence, as taught by Ho, into a single container (e.g. kit) for the predictable result of providing the composition, in the initial nucleotide sequence state, in convenient packaging for distribution, thus meeting the limitation of claim 36. One of ordinary skill in the art would have been motivated to modify the kit of Ho in order to provide the components in their initial nucleotide sequences in a manner that is convenient for saving time and provides easier distribution of the composition components; thus one would have had a reasonable expectation of successfully collecting these items into a single container (e.g. kit) for the predictable result of providing the composition, in the initial nucleotide sequences, in convenient packaging for distribution.
Therefore, the claim is obvious and is properly rejected.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE R SMALL whose telephone number is (703)756-4783. The examiner can normally be reached Monday - Friday 8:30am-4pm.
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/KATHERINE R SMALL/Examiner, Art Unit 1633
/EVELYN Y PYLA/Primary Examiner, Art Unit 1633