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 .
Applicants’ amendment to the claims filed on 4/21/2026 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-2, 4-5, 8, 15-18, 22, 27-29, 37, 42, 44-45, 50, 52-53 are pending.
Claims 3, 6-7, 9, 19-21, 23-26, 30-36, 38-41, 43, 46-49, 51, 54-64 were canceled by prior amendment.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 4/21/2026 is acknowledged.
Claims 3, 6-7, 9, 19-21, 23-26, 30-36, 38-41, 43, 46-49, 51, 54-64 were canceled by prior amendment.
Claims 1-2, 4-5, 8, 15-18, 22, 27-29, 37, 42, 44-45 are pending and examined on the merits.
Claims 50, 52-53 are withdrawn pursuant to 37 CFR 1.142(b).
Priority
Acknowledgement is made of this national stage entry of PCT/AU2022/050653 filed on 6/24/2022, which claims foreign priority under 35 U.S.C. 119(a)-(d) to Australian Patent Application No. AU2021901926, filing date 6/25/2021. The certified copy has been filed in the present application on 12/20/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/20/2023 and 4/21/2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The drawings are objected to because the two figures on page 3 within figure 5 lack labels on the y-axis. 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.
Objection to the Title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Rejections - 35 USC § 112
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 2, 22, 45 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.
MPEP 2163.II.A.2.(a).i) states, “Whether the specification shows that applicant was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the 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”.
For claims drawn to a genus, MPEP § 2163 states the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
Claim 2 is drawn to the method of claim 1 (a method of producing bromoform) which is performed in the presence of at least one or more or all of: (i) a catalase activity inhibitor; (ii) catalase gene(s) modification; (iii) a compound that promotes the accumulation of acetoacyl- acyl-carrier-proteins; (iv) a FabG or FAS gene modification; (v) conditions that promote ϐ-oxidation. The structure of catalase gene modifications, a FabG or FAS gene modification encompasses a large number of mutants and variants.
Claims 45 is drawn to the method of claim 1, wherein the vanadate-dependent haloperoxidase comprises a sequence of amino acids provided in any one of SEQ ID NO's 1 to 8, or a sequence which is: at least 50%, at least 60%, at least 70%, at least 80%, at least 90% or at least 95% identical to any one or more or all of SEQ ID NO's 1 to 8. The structure and function of a process wherein a sequence comprising at least 50%, at least 60%, at least 70%, at least 80%, at least 90% or at least 95% sequence identity to vanadate-dependent haloperoxidaseis is a large number of sequences as the remaining 30%-50% of the sequence is a large number of sequences.
In this case, the specification discloses the following representative species of catalase, FabG, FAS gene modifications (i.e. a knock-down or knock-out, optionally wherein the catalase is a knock down or knock out of both cytosolic and peroxisomal catalase genes). Additionally, the specification discloses the following representative species of vanadate-dependent haloperoxidase as encompassed by the claims (i.e. SEQ ID NO: 1-8). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of species of vanadate-dependent haloperoxidase through modifications for production of bromoform. The breadth of the claims encompass any species of gene modifications or variants of catalase, FabG, FAS and vanadate-dependent haloperoxidase through genetic modification of genes encoding proteins or post-translational modifications, etc. via any modification technique such as deletion, mutation, etc. for the production of bromoform.
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004). Here, the disclosure fails to provide the number of sequences that encompasses catalase, FabG and FAS gene modifications and sequences with at least 50% - 80% sequence identity to vanadate-dependent haloperoxidase that encompasses a method for the production of bromoform.
Accordingly, one of skill in the art would not accept the disclosure of catalase, FabG, FAS gene modifications and vanadate-dependent haloperoxidase comprising at least 50% - 80% sequence identity to SEQ ID Nos: 1-8 as being representative of all catalase, FabG, FAS gene modification and vanadate-dependent haloperoxidase enzymes used in a process from producing bromoform as encompassed by the claims. As such, the specification, taken with the pre-existing knowledge in the art of catalase, FabG, FAS, vanadate-dependent haloperoxidase, fails to satisfy the written description requirement of 35 U.S.C. 112, first paragraph.
Scope of Enablement
Claims 2, 22, 45 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 process wherein catalase, FabG and FAS are modified via gene knock out and knock down, it does not reasonably provide enablement for all methods of catalase, FabG and FAS gene modifications, as encompassed by the claims, as there are a number of processes for the modification of catalase, FabG and FAS genes. Furthermore, the specification, while being enabling for a process wherein vanadate-dependent haloperoxidase such as: SEQ ID NOs: 1-8 having at least 90% - 95% sequence identity, it does not reasonably provide enablement for all vanadate-dependent haloperoxidase having at least 50% - 80% sequence identity to SEQ ID NOs: 1-8, as encompassed by the claims, as the remaining 30%-50% of the sequence is a large number of sequences.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.” In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)) as follows: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01(a). The Factors considered to be most relevant to the instant rejection are addressed in detail below.
(A)The breadth of the claims:
Claim 2 is drawn to the method of claim 1 (a method of producing bromoform) which is performed in the presence of at least one or more or all of: (i) a catalase activity inhibitor; (ii) catalase gene(s) modification; (iii) a compound that promotes the accumulation of acetoacyl- acyl-carrier-proteins; (iv) a FabG or FAS gene modification; (v) conditions that promote ϐ-oxidation. The structure of a method of catalase, a FabG or FAS gene modifications encompasses many mutants and variants.
Claims 45 is drawn to the method of claim 1, wherein the vanadate-dependent haloperoxidase comprises a sequence of amino acids provided in any one of SEQ ID NO's 1 to 8, or a sequence which is: at least 50%, at least 60%, at least 70%, at least 80% identical to any one or more or all of SEQ ID NO's 1 to 8. The structure and function of a sequence comprising at least 50% - 80% sequence identity to vanadate-dependent haloperoxidaseis a large number of sequences as the remaining 30%-50% of the sequences encompass a large number of sequences.
B) The nature of the invention; C)The state of the prior art; (D) The level of one of ordinary skill; and (E) The level of predictability in the art: As noted above, the scope of the claimed catalase, FabG, FAS modifications are a large number of sequences. Furthermore, the scope of the claimed species of vanadate-dependent haloperoxidase with at least 50% - 80% sequence identity to SEQ ID Nos: 1-8 are a large number of sequences. The structure of the claimed species having vanadate-dependent haloperoxidaseis activity are a large number of sequences.
It is well-known in the prior art that the amino acid sequence of a polypeptide determines the polypeptide’s functional properties. The positions within a protein's sequence where modifications can be made with a reasonable expectation of success in obtaining a polypeptide having the desired activity/utility are limited in any protein and the result of such modifications is highly unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g., multiple substitutions. The reference of Singh et al. (Current Protein and Peptide Science, 2017; examiner cited) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes [see p. 7, column 1, top]. The reference of Zhang et al. (Structure, 2018; examiner cited) discloses that a mutation of a residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide [p. 1475, column 1].
It is well-known in the art that even a single amino acid alteration can alter the folding of a polypeptide. See, e.g., MPEP 2144.08.II.A.4.(c), which states, “[i]n the area of biotechnology, an exemplified species may differ from a claimed species by a conservative substitution (“the replacement in a protein of one amino acid by another, chemically similar, amino acid... [which] is generally expected to lead to either no change or only a small change in the properties of the protein.” Dictionary of Biochemistry and Molecular Biology 97 (John Wiley & Sons, 2d ed. 1989)). The effect of a conservative substitution on protein function depends on the nature of the substitution and its location in the chain. Although at some locations a conservative substitution may be benign, in some proteins only one amino acid is allowed at a given position. For example, the gain or loss of even one methyl group can destabilize the structure if close packing is required in the interior of domains. James Darnell et al., Molecular Cell Biology 51 (2d ed. 1990).”
(F) The amount of direction provided by the inventor and (G) The existence of working examples: The specification discloses the following representative species of catalase, FabG, FAS gene modifications (i.e. a knock-down or knock-out, optionally wherein the catalase is a knock down or knock out of both cytosolic and peroxisomal catalase genes). Additionally, the specification discloses the following working examples of vanadate-dependent haloperoxidaseis (i.e. SEQ ID NO: 1-8). Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of catalase, FabG, FAS gene modifications and vandate-dependent haloperoxidase sequences that are at least 50% - 80% identical to SEQ ID NO: 1-8 for the production of bromoform. Other than the above disclosed species, there is no prior-art or disclosed teaching as to the large number of catalase, FabG, FAS variants and vanadate-dependent haloperoxidaseis enzymes through genetic modification of genes encoding proteins or post-translational modifications, etc. via any modification technique such as deletion, mutation, etc. for a method for producing bromoform. Other than these working examples, the specification fails to disclose any other working examples of species of catalase, FabG, FAS gene modifications and vanadate-dependent haloperoxidaseis used in a method for the production of bromoform.
In view of the overly broad scope of the claims, the lack of guidance and working examples provided in the specification, the high level of unpredictability, and the state of the prior art, undue experimentation would be necessary for a skilled artisan to make and use the entire scope of the claimed invention. Applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
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 15, 22 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 15, 22, the term/phrase “preferably”, "most preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. The metes and bounds of the claims are not clear. See MPEP § 2173.05(c)(I).
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-5, 8, 15-18, 27-29, 37, 42, 45, 50, 52-53 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is a naturally occurring microorganism.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Yes, the claim is drawn to a process, which is one of the four statutory categories.
Step 2, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes, the claim is directed to a natural phenomenon. Said natural phenomenon is a method (process) of producing bromoform by incubating an organism in the presence of vanadate-dependent haloperoxidase and acetoacetyl coenzyme A. Supporting the Examiner’s position is the reference of Cikoš et al (2019, marine drugs, Examiner cited) that demonstrates bromoform is naturally produced by Red macroalgae in the presence of acetoacetyl coenzyme A, same as Formula I of the instant application, by the action of vanadate-dependent bromoperoxidases (fig, 1., page 6, para 1). Furthermore, the evidentiary reference of Williams et al (WO2020243792A1, Date Published: 10 December 2020, cited on IDS dated 12/20/2023) is cited to demonstrate that bromoform is naturally produced by Red macroalgae in the presence of hydrogen peroxide by the action of vanadate-dependent bromoperoxidases (para 005, 006).
Claims 1-2, 4-5, 8, 15-18, 27-29, 37, 42, 45, 50, 52-53 are drawn to a method of producing bromoform, the method comprising incubating an organism or part thereof, cells, a lysate of the organism or part thereof or cells, or a mixture thereof, or conditioned medium obtained from culturing a microorganism, cells, a lysate of the microorganism or cells, comprising a vanadate-dependent haloperoxidase, in the presence of at least one compound of Formula 1: ,wherein R1 and R2 are independently selected from: hydrogen, hydroxyl. In the broadest reasonable interpretation of the claim said microorganism is Red macroalgae of which Williams et al (WO2020243792A1, Date Published: 10 December 2020, cited on IDS dated 12/20/2023) {herein Williams} demonstrates naturally produces bromoform by the action of vanadate-dependent bromoperoxidases which catalysis the halogenation of organic substrates in the presence of hydrogen peroxide (para 005, 006). According to Cikoš et al (2019, marine drugs, examiner cited) {herein Cikoš} red macroalgae also naturally produces acetoacetyl coenzyme A which is the precursor of HMG-CoA within the mevalonate pathway (abstract). As such, it is the Examiner’s position that the recited formula 1, in the instant application claim 1 and 18, is naturally occurring in red macroalgae. Thus, the method does not have markedly different characteristics from what occurs in nature, and is a “naturally occurring process” exception. Although the claim is a process claim, it has been drafted such that there is no difference in substance from a product claim to the process of producing bromoform itself. Accordingly, this process claim is focused on the process of producing bromoform per se (a nature-based product), and must be analyzed for markedly different characteristics, to determine whether the claimed process of making bromoform is a “product of nature” exception. There is no indication in the specification that the claimed process has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring process for producing bromoform provided by Red macroalgae. Thus, the claimed process for producing bromoform 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 2, Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claim 37 recites incubating occurs in the presence of hydrogen peroxide. However, the presence of hydrogen peroxide with Red macroalgae is a naturally occurring phenomenon (Williams: para 006}.
Therefore, it does not integrate the judicial exception into a practical application for the same reasons discussed above.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The judicial exception is recited without additional limitations amounting to significantly more than the exception. All of the signified additional elements to the judicial exception are considered to be native to the bacterium on which the judicial exception is to be performed as noted in Step 2A, Prong 2, and, therefore, do not amount to significantly more than the judicial exception that is claimed because the claim does not include any additional features that could add significantly more to the exception.
In this regard, as the instant claims recites judicial exceptions that are not integrated into practical application, and no elements that amount to significantly more than the judicial exception as recited, the claims were found not to be drawn to eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4-5, 8, 15-18, 22, 28-29, 37, 42, 44-45 are rejected under 35 U.S.C. 102a1 as being anticipated by Williams et al (WO2020243792A1, Date Published: 10 December 2020, cited on IDS dated 12/20/2023) {herein Williams} as evidenced by Zhou et al (Date Published: 2018, Structural Biology Communications, Examiner cited) {herein Zhou}. See MPEP 2131.01 regarding multiple reference 102 rejections.
Claims 1-2, 4-5, 8, 15-17 are drawn to a method of producing bromoform, the method comprising incubating an organism or part thereof, cells, a lysate of the organism or part thereof or cells, or a mixture thereof, or conditioned medium obtained from culturing a microorganism, cells, a lysate of the microorganism or cells, comprising a vanadate-dependent haloperoxidase, in the presence of at least one compound of Formula 1: ,wherein R1 and R2 are independently selected from: hydrogen, hydroxyl, optionally substituted aliphatic, optionally substituted S- alkyl, or optionally substituted S-alkyl, or R, and R2 are joined to form an optionally substituted six membered ring of Formula la: wherein R3, R4, R5, R6, and R8 are each independently selected from hydrogen or an optionally substituted aliphatic.
Claims 18, 22, 28-29, 37, 42, 44-45 are drawn to a method of producing bromoform, the method comprising incubating a vanadate-dependent haloperoxidase in the presence of at least one compound of Formula 1, wherein R, and R2 are: independently selected from: hydrogen, hydroxyl, optionally substituted aliphatic, optionally substituted 0- alkyl, or optionally substituted S-alkyl, or Ri and R2 are joined to form an optionally substituted six membered ring of Formula la: wherein R3, R4,R5, R6, R7, and R8 are each independently selected from hydrogen or an optionally substituted aliphatic, and wherein one or more or all of the following apply: i) the vanadate-dependent haloperoxidase is not present in a protein extract obtained from an organism which naturally produces the vanadate-dependent haloperoxidase, ii) the vanadate-dependent haloperoxidase is incubated with the at least one compound for greater than 90 minutes, iii) the incubating occurs in the presence of hydrogen peroxide, and if hydrogen peroxide is added more than once, then at least two of the additions are greater than 10 minutes apart, iv) the compound is not oxaloacetic acid nor acetylacetone.
With respect to claims 1-2, 4-5, 8, 15-16, 18, 22, 28-29, 37, 42, 44-45, Williams teaches a method of expressing heterologous vanadate-dependent bromoperoxisae (appendix A) for the production of bromoform by culturing recombinant yeast cells (para 001, 024). The yeast may be Saccharomyces (par 021). Evidentiary reference of Zhou is cited to demonstrated that Saccharomyces naturally produces acetoacetyl coenzyme A, same as Formula I of the instant application (abstract). As such, absent evidence otherwise, it is the Examiner’s position that the recombinant yeast taught by Williams inherently produces the recited formula I, since Williams does not teach said enzyme is deleted from the recombinant yeast. Additionally, since Williams teaches the structure of a method for producing bromoform from a recombinant organism in the presence of acetoacetyl coenzyme A, it is the Examiner’s position that said method would necessarily produce at least 5, at least 6, at least 7, at least 8, at least 9 fold, at least 10, at least 15, at least 20, at least 25, at least 30, at least 35, at least 40, at least 45 or at least 50 fold more bromoform than a method performed under the same conditions in the absence of the at least one compound of Formula 1, as recited in the instant application claim 42. Furthermore, said vanadate-dependent bromoperoxisae is 58.8% identical to the instant application SEQ ID NO: 2 (appendix A). Additionally, said yeast is catalase deficient (para 020). Therefore, it is the Examiner’s position that said teaching by Williams is the same as catalase being knocked-down or knocked-out since Williams teaches the recombinant yeast is catalase deficient (para 020). Williams further teaches that bromoform is naturally produced by Red macroalgae in the presence of hydrogen peroxide by the action of vanadate-dependent bromoperoxidases in the presence of hydrogen peroxide (para 005, 006). Said organism is harvested and added to cattle feed to reduce the accumulation of methane within their rumen (para 005). On page 3, para 9 of the instant application specification, Applicant defines a plant as being macroalgae (Instant application specification page 3, para 9). As such, Examiner is interpreting the Red macroalgae taught by Williams to be a plant, as recited in the instant application claim 5.
It is the Examiner’s position that the claim limitations ‘optionally substituted aliphatic, optionally substituted S- alkyl, or optionally substituted S-alkyl, or R, and R2 are joined to form an optionally substituted six membered ring of Formula la: wherein R3, R4, R5, R6, and R8 are each independently selected from hydrogen or an optionally substituted aliphatic’ are not required limitations of the claim due to the recitation ‘optionally.’
With respect to claim 17, Williams teaches the culturing of recombinant yeast from the production of bromoform (para 0121). After culturing, the medium was analyzed for the presence of bromoform (para 0123).
For the reasons stated herein, the teachings of Williams anticipates claims 1-2, 4-5, 8, 15-18, 22, 28-29, 37, 42, 44-45.
Claim Rejections - 35 USC § 103
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Williams et al (WO2020243792A1, Date Published: 10 December 2020, cited on IDS dated 12/20/2023) {herein Williams} as evidenced by Zhou et al (Date Published: 2018, Structural Biology Communications, Examiner cited) {herein Zhou}.
Claims 27 is drawn to the method of claim 1, wherein the at least one compound has a pKa of: 11 or less, 10 or less, 9 or less, between 4 and 12, or between 5 and 10.7.
The teachings of Williams as applied to claims 1-2, 4-5, 8, 15-18, 28-29, 37, 42, 44-45 are set forth in the 102a1 rejection above.
However, Williams does not teach the method of claim 27, wherein the at least one compound has a pKa of: 11 or less, 10 or less, 9 or less, between 4 and 12, or between 5 and 10.7 (claim 27).
With respect to claim 27, although the reference of Williams does not explicitly teach the limitations of claim 27, MPEP 2144.05 states"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the pka of the compound depending on the particular application. It would be routine for one to arrive at the pka for the application they intend on using the method for producing bromoform. Therefore, the above invention would have been prima facie obvious.
Conclusion
Status of claims
Claims 3, 6-7, 9, 19-21, 23-26, 30-36, 38-41, 43, 46-49, 51, 54-64 were canceled by prior amendment.
Claims 1-2, 4-5, 8, 15-18, 22, 27-29, 37, 42, 44-45 are pending and examined on the merits.
Claims 50, 52-53 are withdrawn pursuant to 37 CFR 1.142(b).
Claims 1-2, 4-5, 8, 15-18, 22, 27-29, 37, 42, 44-45 are rejected.
No claims are in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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/ERICA NICOLE JONES-FOSTER/Examiner, Art Unit 1656
/MANJUNATH N RAO/Supervisory Patent Examiner, Art Unit 1656
Appendix A
Instant Application SEQ ID NO: 2 vs Williams et al SEQ ID NO: 8 (STIC search results #18 .rag)
Query Match 58.8%; Score 1817.5; Length 605;
Best Local Similarity 60.8%;
Matches 365; Conservative 72; Mismatches 136; Indels 27; Gaps 10;
Qy 13 AFKVRVSAAELARARGSPTHLSNNSESRFRNP-DGTRSLLANFTKGLPHIKETALVVSAI 71
|: || || :|::| | |:||| | |:| | | | : ::|||||| : | :: :
Db 11 AYAVREQAALMAKSRPHPLHVSNNEELRYRIPTSGEPSHIGSYTKGLPHDRNTGVLSNPD 70
Qy 72 DYDNFVRAIDSGDPRDFADLPLGPQGVEPRFTSGIASDPEVGTRAWESGGAGLVFDLEGP 131
|: :|:||:|:|| |:||||| : | |||| | ||||| ||| :|||||
Db 71 DFQSFIRAMDAGDQFSIRDVPLGPQNEQQAFQSGIAKG--VSARAWESMAAGLTYDLEGP 128
Qy 132 DAQAVTMPPAPELDSDELVTEVTECYWMSLLRDVPFPTFESDPH--IQSAAESINNTQWI 189
|||:||||||| ||||||:||||| |||:||||||| | | : || | :|:|:| |:
Db 129 DAQSVTMPPAPALDSDELLTEVTELYWMALLRDVPFSEFNGDKNNDIQEAVDSLNSTPWV 188
Qy 190 KFKDS--PPAHLTAAERSRLRGPITTANVFRGITPGDEVGPYLSQFLLVGTTGIANGNEV 247
: : | || ||| ||||| | ||||| | || |||||||:|:| ||| ||| :
Db 189 QIAKNGVVPTTLTDAERVRLRGPFTVDNVFRGTTRGDRDGPYLSQFMLIGNTGIGNGNRI 248
Qy 248 GDGFIQYGGMRMDQRVRVAKSHIDYMTTFGAYLDVQNAANVSGRELYNEEEPRFRFIHTP 307
||||:|| |:|||||||: |:|||: |::|||| |:| |||:|| : |:||| ||
Db 249 EDGFIRYGAHRVDQRVRVAEMGRDFMTTWSAFVDVQNGADVRGREVYN-NDVRYRFISTP 307
Qy 308 RDLATYVHFDALYQAYLNACIILLDIGAPFDSGIPFQLDNDIDKQQGFATFGGPHILSLV 367
||||||||||||||||||||:||| : ||| |:||| ::||| || ||||| |||||||
Db 308 RDLATYVHFDALYQAYLNACLILLGMRVPFDKGLPFQREDDIDHQQTFATFGAPHILSLV 367
Qy 368 TEVATRALKAVRFQKFNVHRRLRPEAIGARVDRYC-ATKAPEFAGAAKLSEALDKKLLQK 426
||||||||||||||||||||||||||:| : || | : || :|:| || || |
Db 368 TEVATRALKAVRFQKFNVHRRLRPEAVGGLLHRYMQETTNDLYRGAKQLAENLDANLLDK 427
Qy 427 VHDHNKKQNLLSDRGNPRANDFNPDGDVSEGNLLMPMAFPEGSPMHPAYGAGHATVAGAC 486
| || |||: || ||||| | | || ||||||||||||:||||||||||||
Db 428 VKRHNAKQNMKSDGDAPRANDLGECEDADEITLL-PMAFPEGSPMHPSYGAGHATVAGAC 486
Qy 487 VTVLKAFFDGGYRL-----------PFCYITNEDGTGLQAVEIDE-----PLTVDGELNK 530
||:|||||| || | || :: ||:||: | | |||:|||||
Db 487 VTILKAFFDHGYELRMLDEDGETMIPFAFVPTADGSGLEN-RIGEYRNLTALTVEGELNK 545
Qy 531 ICSNISIGRNWAGVHYFTDYIESIRIGEEIAIGILQEQKLTFSENFSMTLNKFDGSTIRI 590
:|||| ||||| |||||:|| ||||:||::|||:|:|||||: ||||||: |||| ||
Db 546 VCSNICIGRNWGGVHYFSDYRESIRVGEQVAIGLLEEQKLTYGENFSMTVPLFDGSVHRI 605
Prosecution Insights