DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6, alongside the species of SEQ ID NO: 113 and the newly added claims 20-24 in the reply filed on 17 August 2026 is acknowledged.
Claims 8-9, 11-15, and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 17 August 2026.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
For the purposes of examination, the species of SEQ ID NOs: 1-112 and 114-233 have been rejoined.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 (u)(1) states “View numbers must be preceded by the abbreviation "FIG."”
In the current case, the view numbers for Figures 1, 3-4, and 6-8 are preceded by the word "Figure" instead of the abbreviation "FIG.".
37 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 FIG. 5 that appear on several sheets are followed by "Cont." instead of a capital letter such as FIG. 1A, FIG. 1B, 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.
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/PatentLegalFramework), 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:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in Fig. 2, Figure 3-4, and 8 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pg. 4, 27, 29, 32. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-21 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.
Regarding claims 20, the claims claim that the polymerase contains in its amino acid sequence a substitution at the position which corresponds to position 424 of the amino acid sequence of E. coli pol I (SEQ ID NO: 234). It is unclear what the phrase “corresponds to” encompasses. It is unclear if the claim is intended to limit the polymerase to comprising a mutation at position 424 (i.e., a position that would equal position 424 of an E. coli pol I when the two sequences are adjacent in a sequence alignment) or if the claims are intended to limit the polymerase to a mutation that has a similar functional effect on the polymerase compared to the functional effect a 424 mutation has on the E. coli pol I (i.e., the mutational site is defined by the resulting function it imparts on the polymerase and not its position when present within the claimed SEQ ID NOs).
Regarding claim 21, as the claim is dependent on claim 20 and does not rectify the 35 USC 112(b) rejection above, the claim is also rejected under 35 USC 112(b).
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 1-6 and 20-24 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 a method of producing a DNA molecule comprising dZ instead of dA comprising the steps of: (i) providing a template DNA; (ii) providing dNTPs, wherein said dNTPs include dZTP; (iii) providing a polymerase that comprises a sequence selected from SEQ ID NOs: 112-113 and 115-116, lacks 5’exonuclease activity, accepts dZTP as a substrate, and does not accept dATP as a substrate; and incubating the components of (i) to (iii), does not reasonably provide enablement for the same method as claimed wherein the polymerase comprises an amino acid sequence with at least 50% identity to the claimed SEQ ID NOs: 1-233. 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.
Factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described by the court in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Wands states, on page 1404:
Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex part Forman. They include (1 the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (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 these in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
Regarding claim 52, the claim requires producing a DNA molecule comprising dZ instead of dA comprising the steps of: (i) providing a template DNA; (ii) providing dNTPs, wherein said dNTPs include dZTP; (iii) providing a polymerase that has at least 50% identity to SEQ ID NOs: 1-233, lacks 5’exonuclease activity, accepts dZTP as a substrate, and does not accept dATP as a substrate; and incubating the components of (i) to (iii) (see Claim 1).
The claims are not enabled for the production of the claimed DNA molecule via the use of any polymerase, so long as the polymerase comprises at least 50% identity to the claimed SEQ ID NOs.
Nature of the Invention
Regarding claim 52, the nature of the invention is a method of generating a DNA molecule through the use of an extraordinarily broad genus of polymerases that are required to comprise at least 50% identity to the claimed SEQ ID NOs: 1-233 and possess the claimed functions.
Breadth of the Claims
Regarding the claims, it is noted that the polymerases’ structures are limited only by identity to the claimed SEQ ID NOs: 1-233. Thus, the claimed genus of polymerases encompasses polymerases that can comprise mutations at any point along the length of the polymerase, at any residue, at any catalytic site, with any amino acid, so long as the overall percent identity remains at least 50% with the claimed SEQ ID NOs and they possess the claimed function.
State of the Art/Predictability of the Art
It was not well established in the closest prior art that the claimed SEQ ID NOs were known to be able to perform the claimed functions nor could they be utilized in the method as claimed.
A0A2H5BHJ5 is drawn towards a UniProt entry directed towards a DNA polymerase I from Acinetobacter phage SH-Ab 15497 that comprises 100% identity with the claimed SEQ ID NO: 113 (pg. 1).
However, prior to the effective filing date of the claimed invention, the protein’s ability to perform the claimed functions, or be utilized as claimed in the method as claimed, was unknown (pg. 2) (see Claim 1).
Therefore, the prior art provides evidence that it was unknown if the claimed structure could perform the claimed function, or that the claimed structure inherently possessed the claimed function such that it was able to be utilized in the claimed method.
Amount of Direction Provided by the Inventor/Existence of Working Examples
Regarding the amount of direction provided by the instant specification, the instant specification provides working examples of four different polymerases that can perform the claimed function: SEQ ID NO: 112 (“Vibrio phage phiVC8”), 113 (“Acinetobacter phage SH-Ab15497”), 115 (“Arthrobacter phage Wayne”), and 116 (“Gordonia phage Ghobes”) (pg. 4, 24-25; see Figures 3-5). The instant specification also performs extensive sequence alignment analyses with the claimed SEQ ID NOs: 112-120 against a known E. Coli (polA) sequence (pg. 23-24; see Figure 1) and against one another (pg. 25; see Figure 6). The instant specification identifies and defines the function of conserved amino acids that are present with respect to the E. coli (polA) and the four different polymerases comprising the claimed SEQ ID NOs: 112-113 and 115-116 (pg. 26; see Figure 7).
However, when taken as a whole, the four working examples of polymerases alongside the sequence alignments of an additional five species of polymerases is not a sufficient amount of direction such that a person of ordinary skill in the art could utilize a genus of polymerases that can comprise mutations at any point along the length of the polymerase, at any residue, at any catalytic site, with any amino acid, so long as the overall percent identity remains at least 50% with the claimed SEQ ID NOs and they possess the claimed function because the instant specification further provides evidence that the claimed genus of polymerases comprising the claimed structures and functions cannot perform the claimed method.
The instant specification provides evidence that it is unpredictable if the claimed polymerases comprising the claimed structures and possessing the claimed functions can perform the method as claimed. Example 4 of the instant speciation teaches that mutations inactivating 3’ exonuclease activity diminished polymerase activity in the case of the Arthrobacter phage (i.e., SEQ ID NO: 115) and abolished it in the case of the Gordonia phage (i.e., SEQ ID NO: 116) (pg. 34). The instant specification also teaches that mutant polymerases lacking 3'-exonuclease activity produce longer elongation products with dATP, compared to wild-type DpoZ in the case of the proteobacterial phages PhiVC8 (i.e., SEQ ID NO: 112) and SH-Ab-15497 (i.e., SEQ ID NO: 113) (pg. 35). The instant speciation also teaches that only attenuated polymerase activity remains in the DpoZ mutant enzymes lacking 3-exonuclease activity in the case of Ghobes and Wayne actinobacterial siphoviruses (i.e., SEQ ID NOs: 116 and 115) (pg.35).
Thus, the instant specification provides examples of polymerases that possess both the structural and functional characteristics of the claimed polymerases yet do not possess the necessary polymerase activity required to perform the claimed method. Accordingly, the instant specification does not provide an adequate amount of direction in order to perform the claimed method.
Relative Skill of the Ordinary Artisan/Amount of Experimentation Required
With regard to the claims, the skill of those in the relative art is high, but still, given the
state and unpredictability of the art, undue experimentation would be required to determine if a genus of polymerases that can comprise mutations at any point along the length of the polymerase, at any residue, at any catalytic site, with any amino acid, so long as the overall percent identity remains at least 50% with the claimed SEQ ID NOs could perform the claimed function. For example, to even select a single suitable polymerase a person of ordinary skill in the art would need to identify candidate polymerases that fit the sequence requirements, obtain and/or produce a polymerase that fulfills the sequence requirements, assay it for 5’-exonuclease activity, assay it for dZTP acceptance, and assay it for dATP rejection. Therefore, a single polymerase requires multiple different assays in order to determine if it meets the functional requirements of the claim.
MPEP 2164.06 teaches that in “Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021), which the Supreme Court affirmed, the Federal Circuit relied on evidence showing that the scope of the claims encompassed millions of antibodies and that it was necessary to screen each candidate antibody in order to determine whether it met the functional limitations of the claim. Id. at 1088. Consequently, the Federal Circuit concluded that there was a lack of enablement." The instant case is similar to the cited Amgen case because the total scope of the claims easily encompasses millions of different polymerases that each require a screening step to determine if they meet the functional limitations of the claim.
Therefore, performing the method as claimed wherein the genus of polymerases can comprise mutations at any point along the length of the polymerase, at any residue, at any catalytic site, with any amino acid, so long as the overall percent identity remains at least 50% with the claimed SEQ ID NOs would require an unreasonable amount of experimentation.
Thus, the claim is not enabled commensurate in scope with the claimed invention.
Regarding claims 2-6 and 20-24, as the claims are ultimately dependent on claim 1 and do not rectify the 35 USC 112(a) enablement rejection above, the claims are also rejected under 35 USC 112(a).
Claims 1-6 and 20-24 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 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.
Regarding claim 1, the claim is broadly drawn towards a method of producing a DNA molecule comprising dZ instead of dA comprising the steps of: (i) providing a template DNA; (ii) providing dNTPs, wherein said dNTPs include dZTP; (iii) providing a polymerase that has at least 50% identity to SEQ ID NOs: 1-233, lacks 5’exonuclease activity, accepts dZTP as a substrate, and does not accept dATP as a substrate; and incubating the components of (i) to (iii) (see Claim 1).
Accordingly, the claim is interpreted as claiming a genus of polymerases that have at least 50% identity to the claimed SEQ ID NOs: 1-233 and possess the functions of lacking 5’exonuclease activity, accepting dZTP as a substrate, and not accepting dATP as a substrate.
The instant specification does not provide support for the use of the claimed genus of polymerases that can perform the claimed function because the instant specification provides evidence that the function derived from the claimed sequences is unpredictable and it does not demonstrate sufficient description of a representative number of species by actual reduction to practice as required by MPEP 2163. Additionally, the closest prior art provides evidence that the claimed sequences were not known to be able to perform the claimed function prior to the filing date of the instant application.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would leave one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP 2163. A claimed genus may be satisfied through sufficient descriptions of a representative number of species or disclosure of relevant, identifying characteristics such as functional characteristics coupled with known or disclosed correlation between function and structure. MPEP 2163(3)a(II). The number of species that describe the genus must be adequate to describe the entire genus; if there is substantial variability, a large number of species must be described.
The analysis for adequate written description considers (a) actual reduction to practice, (b) disclosure of drawings or structural chemical formulas, (c) sufficient relevant identifying characteristics in the way of complete/partial structure or physical and/or chemical properties or functional characteristics when coupled with known or disclosed correlation with structure, and (d) representative number of samples.
As the claims currently recite, as described above, the claim is directed towards a method of producing a DNA molecule comprising the administration of polymerases that share a very low sequence identity to the claimed SEQ ID NOs: 1-233 yet possess the functions of lacking 5’exonuclease activity, accepting dZTP as a substrate, and not accepting dATP as a substrate. While claiming a genus of structures (i.e., polymerases) by a function (i.e., lacking 5’exonuclease activity, accepting dZTP as a substrate, and not accepting dATP as a substrate) is not prohibited, there must be a sufficient structure-function relationship described in the specification such that the claimed genus was represented by a representative number of species or the teachings of the specification, or, the prior art can be used to support a well-known structure-function relationship.
In the instant case, the instant specification does not provide support that the broadly claimed polymerases and their ability to perform the claimed functions. Further, the closest prior art provides evidence that the claimed sequences were not known to be able to perform the claimed function prior to the filing date of the instant application.
Working Examples
With regard to working examples, the specification provides little evidence on the possession of a sufficient number of species which are encompassed by the entirety of the claimed genus.
MPEP 2163 teaches that “for some arts, there is an inverse correlation between the level of skill and knowledge in the art and the specificity of disclosure necessary to satisfy the written description requirement. Information which is well known in the art need not be described in detail in the specification. See, e.g., Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379-80, 231 USPQ 81, 90 (Fed. Cir. 1986). However, sufficient information must be provided to show that the inventor had possession of the invention as claimed [emphasis added].”
In the instant case, it is noted that the claimed genus of structures that is claimed to be able to perform the claimed function is extraordinarily broad. As an example, with respect to a single claimed SEQ ID NO (i.e., SEQ ID NO: 113), the claimed structure encompasses mutations of any amino acid within the sequence to any other amino acid so long as the overall percent identity to the claimed SEQ ID NO: 113 remains at least 50%. The claimed genus of structures encompasses mutations at any point along the length of the polymerase, at any residue, at any catalytic site, with any amino acid, so long as the overall percent identity remains at least 50%.
The instant specification provides working examples of four different polymerases that can perform the claimed function: SEQ ID NO: 112 (“Vibrio phage phiVC8”), 113 (“Acinetobacter phage SH-Ab15497”), 115 (“Arthrobacter phage Wayne”), and 116 (“Gordonia phage Ghobes”) (pg. 4, 24-25; see Figures 3-5). The instant specification also performs extensive sequence alignment analyses with the claimed SEQ ID NOs: 112-120 against a known E. Coli (polA) sequence (pg. 23-24; see Figure 1) and against one another (pg. 25; see Figure 6). The instant specification identifies and defines the function of conserved amino acids that are present with respect to the E. coli (polA) and the four different polymerases comprising the claimed SEQ ID NOs: 112-113 and 115-116 (pg. 26; see Figure 7).
The instant specification asserts that “when comparing the amino acid sequences of all the sequences shown in SEQ ID NOs: 1 to 233 [(i.e., to SEQ ID NOs: 112-120)] it is evident that the sequences show identities of as low as about 30%. Nevertheless, as is shown in the appended Examples, despite the low degree of sequence identity, it could be shown that the corresponding polymerases nevertheless have the same functionality of being able to discriminate between dZ and dA as a substrate and preferring templates which contain dZ over templates which contain dA” (pg. 4). The instant specification further asserts that “the sequences shown in SEQ ID NOs: 112 to 120 which are structurally more closely analyzed and partly functionally analyzed in the appended Examples are merely representative examples of polymerases characterized by the features defined above which could be identified in the genomes of different types of Siphoviridae phages and closely related phage families” (pg. 5).
However, when taken as a whole, the four working examples of polymerases alongside the sequence alignments of an additional five species of polymerases is not representative of the claimed genus as a whole because the claimed genus broadly encompasses mutations at any point along the length of the polymerase, at any residue, at any catalytic site, with any amino acid, so long as the overall percent identity remains at least 50%.
Additionally, the instant specification provides evidence that it is unpredictable if the claimed structure is capable of performing the claimed function. Example 4 of the instant speciation teaches that mutations inactivating 3’ exonuclease activity diminished polymerase activity in the case of the Arthrobacter phage (i.e., SEQ ID NO: 115) and abolished it in the case of the Gordonia phage (i.e., SEQ ID NO: 116) (pg. 34). The instant specification also teaches that mutant polymerases lacking 3'-exonuclease activity produce longer elongation products with dATP, compared to wild-type DpoZ in the case of the proteobacterial phages PhiVC8 (i.e., SEQ ID NO: 112) and SH-Ab-15497 (i.e., SEQ ID NO: 113) (pg. 35). The instant speciation also teaches that only attenuated polymerase activity remains in the DpoZ mutant enzymes lacking 3-exonuclease activity in the case of Ghobes and Wayne actinobacterial siphoviruses (i.e., SEQ ID NOs: 116 and 115) (pg.35).
Because the claimed structures of the polymerases are so broad as to encompass the mutations demonstrated in the specification to diminish or abolish polymerase activity (i.e., polymerase activity required in order to perform the claimed method), the instant specification teaches that it is unpredictable if the entirety of the claimed genera of structures is capable of performing the claimed function.
Thus, the instant specification does not provide written description for the entirety of the claimed genus of structures that can possess the claimed function and be utilized in the claimed method to generate DNA molecules comprising dZ instead of dA because it does not disclosure a representative number of species and provides evidence that the claimed structure does not predictably result in being able to perform the clamed function (see Claim 1).
Prior Art
Regarding the state of the prior art, the closest prior art demonstrates that the claimed SEQ ID NOs were not known in the art to possess the claimed function.
A0A2H5BHJ5 is drawn towards a UniProt entry directed towards a DNA polymerase I from Acinetobacter phage SH-Ab 15497 that comprises 100% identity with the claimed SEQ ID NO: 113 (pg. 1).
However, prior to the effective filing date of the claimed invention, the protein’s ability to perform the claimed functions, or be utilized as claimed in the method as claimed, was unknown (pg. 2) (see Claim 1).
Therefore, the prior art provides evidence that it was unknown if the claimed structure could perform the claimed function, or that the claimed structure inherently was able to be utilized in the claimed method by performing the claimed function.
Conclusion
The specification does not identify a representative number of species of the broadly claimed polymerases as provides evidence that the claimed structure could not predictably perform the claimed function. Further, the prior art shows that prior to the effective filing date of the claimed invention that the structure of the claimed polymerases were not known to possess the claimed function nor be able to be utilized in the claimed method as claimed.
Therefore, a person of ordinary skill in the art would not have concluded that Applicant was in possession of the invention as claimed. Thus, claim 1 is rejected under 35 U.S.C. 112(a).
Regarding claims 2-6, 20-21, and 23-24, as the claims are ultimately dependent on claim 1 and do not rectify the 35 USC 112(a) rejection above, the claims are also rejected under 35 USC 112(a).
Regarding claim 22, the claim further specifies that the sequence identity is at least 55% to the claimed SEQ ID NOs: 1-233. The claimed genus of polymerases is still so broad that the claim is rejected under 35 USC for the same reasons as described above and applied to claim 1.
Closest Prior Art
Regarding claim 1, the closest prior art is A0A2H5BHJ5. A0A2H5BHJ5 is drawn towards a UniProt entry directed towards a DNA polymerase I from Acinetobacter phage SH-Ab 15497 that comprises 100% identity with the claimed SEQ ID NO: 113 (see pg. 1 of ).
However, prior to the effective filing date of the claimed invention, the protein’s ability to perform the claimed functions, or be utilized as claimed in the method as claimed, was unknown (pg. 2) (see Claim 1).
Thus, the claimed method is both novel and nonobvious in view of the closest prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE T REGA whose telephone number is (571)272-2073. The examiner can normally be reached Mon-Fri, 9AM-5PM (EDT/EST).
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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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/KYLE T REGA/Examiner, Art Unit 1636
/NEIL P HAMMELL/Supervisory Patent Examiner, Art Unit 1636
Prosecution Insights