DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on January 11, 2023, has been received and entered.
3. Applicant’s election with traverse of Group I (directed to polynucleotide, vector, host cell and method of making protein with species) on November 11, 2025, is acknowledged. The traversal is on the grounds that the Examiner has not provided any indication that the content of the claims interpreted in light of the description was considered in making assertion of lack of unity and therefore has not met the burden necessary to support the assertion. This argument is not persuasive because the lack of unity of record establishes that the invention of Group I does not escape the prior art thus unity of invention does not exist. In addition, applicant is entitled to the first product, method of making and using the same and that is encompassed by the DNA, vector, host cell and method of making. Thus the lack of unity is proper and made final.
Thus the Restriction Requirement of record is maintained and is final.
Claim Disposition
4. Claims 1-18 are pending. Claims 1-4, 6-8, 10-11, 13-15 and 18 are under examination. Claims 1, 5, 9 and 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim. The claims are only being examined to the extent that they pertain to the elected subject matter and species.
Information Disclosure Statement
5. The Information Disclosure Statement filed on January 11, 2023, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Drawing
6. The drawings filed on January 11, 2023, have been accepted by the examiner.
Abstract Objection
7. The abstract is objected to for the following informalities:
For clarity it is suggested that the abstract is amended to read, “A polynucleotide [[,encoding an amino acid sequence,]] encoding an oxidoreductase [[,]] that is….”.
Appropriate correction is required.
Specification Objection
8. The specification is objected to for the following informalities:
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. The following is suggested: "Polynucleotide encoding an Oxidoreductase".
The specification is also objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. See pages 1-2, for example. It is suggested that http:// is deleted.
The specification is objected to because organism names are not italicized see line 16 on page 19, for example.
The specification is objected to for the arrangement and content.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
The specification is objected to because FIGs. 5-12 depicts sequences, however, does not provide a discrete sequence number (i.e. SEQ ID NO:) for the alignments.
Appropriate correction is required.
Claim objection
9. Claims 1-4, 6-8, 10-11, 13-15 and 18 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “encoding [[an amino acid sequence, encoding]] an oxidoreductase[[,]] that is at least 90% [[> 50%]]….”. Claim 1 should be amended to recite, “…identical to the amino acid sequence of SEQ ID NO:1..”. The dependent claims hereto is also included.
For clarity it is suggested that claim 1 is amended to recite, “wherein the oxidoreductase [[polynucleotide]] has an amino acid exchange…. and wherein the amino acid exchange….”.See also claims 2-3 with similar language. The dependent claims hereto is also included.
Claim 1 is objected to because of the recitation of, “…..positions 202, 203, 204…..213 or 214 of SEQ ID NO:1……”., without a transitional phrase.
Claims 1-4, 6-8, 10-11, 13-15 and 18 are objected to for the recitation of non-elected subject matter.
For clarity it is suggested that claim 2 is amended to read, “The polynucleotide of claim 1…..[[,encoding an amino acid sequence, encoding an oxidoreductase, according to claim 1]]…”.See also claims 3-4 and 6-8 with similar language.
For clarity it is suggested that claim 7 is amended to read, “…..corresponding position, and wherein the amino acid sequence is selected from the group……”.
For clarity it is suggested that claim 10 is amended to delete ‘according to’ and instead recite ‘of’. See also claims 11, 13-15 and 18 with similar language.
For clarity and precision of claim language it is suggested that claim 11 is amended to delete the word “suitable”.
For clarity it is suggested that claim 14 is amended to recite, “….wherein the polynucleotide [[in which]]…”.
For clarity it is suggested that claim 15 is amended to recite, “….[[having a capability of producing a fine chemical]] that produces L-dihydroxyphenylalanine (L-DOPA).”
Appropriate correction is required.
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.
10. Claims 1-4, 6-8, 10-11, 13-15 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention is directed to “a polynucleotide encoding an amino acid sequence, encoding an oxidoreductase that is greater than 50% identical to an amino acid sequence of SEQ ID NO:1……wherein the polynucleotide has an amino acid exchange in one or more positions 202, 203…… or 214 of SEQ ID NO:1…… and wherein the amino acid exchange is not A210S or S212A” (see claim 1 in its entirety). The claimed invention is not adequately described because the invention encompasses a vast amount of variable and variation that is not adequately described (see the recitation of “identical to an amino acid sequence of SEQ ID NO:1”). It is noted that the DNA encodes any amino acid as well as an oxidoreductase and the language of greater than 50% identity encompasses a large variable genus of structures. The claimed invention also has mutations at one or more of 13 amino acid positions and incorrectly claims the amino acid sequence mutations as being the structure of the polynucleotide (i.e., “wherein the polynucleotide has an amino acid exchange in one or more positions”).
Note also that no correlation is made between structure and function. The encoded amino acid is not recited with any activity. Further, the invention encompasses a microorganism that is asserted as having the capability of producing a fine chemical and there are no indicia in the claim as to the “fine chemical”.
The art generally recognizes that several different DNA can encode the same protein, thus the gene needs to be described. The claimed invention is not adequately described and is overly broad. The claimed invention also encompasses a large variable genus of enzymes bearing the limitless mutations/modifications.
The claimed invention is not commensurate in scope with the disclosure and no correlation is made between structure and function (see for example no activity is provided for the modified enzyme). The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
11. Claims 1-4, 6-8, 10-11, 13-15 and 18 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.
Claims 1-4 and the dependent claims hereto are rejected as being indefinite because they recite that the polynucleotide has an amino acid sequence, and the polynucleotide has a nucleotide sequence that encodes an amino acid sequence.
Claim 1 and the dependent claims hereto are ambiguous for the recitation of “a polynucleotide encoding an amino acid sequence, encoding an oxidoreductase….”, because it is unclear if the amino acid sequence is the same as the oxidoreductase or two separate sequences.
Claim 15 is indefinite for the recitation of “having capability of producing a fine chemical” because it is unclear what fine chemical can be produced. The art recognizes that a fine chemical are high purity, complex single chemical substances produced in limited quantities via multi-step processes for use in pharmaceutical ingredients, electronics and agrochemicals; and there is no such process described herein.
Claim Rejections - 35 USC § 102
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.
12. Claim(s) 1-4 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by DATABASE UNIPROT XP055755964, 2012 (of record in the application).
The claimed invention is directed to a polynucleotide encoding an amino acid sequence, encoding an oxidoreductase that is greater than 50% identical to an amino acid sequence of SEQ ID NO:1 which reads on any fragment of SEQ ID NO:1 and has the wherein clause of a polynucleotide with an amino acid exchange in one or more of positions 202 to 214, however the gene does not have an amino acid sequence and the second wherein clause of wherein the amino acid exchange is not A210S or S212A is not linked by a transitional phrase of “And or Or”, thus can be construed as either or. The below art is being applied based on the broadest reasonable interpretation as set forth herein.
The reference discloses a 4-hydroxyphenylacetate 3-monoocygenase which 97.17% identical to SEQ ID NO:1 of the instant application and has substitutions A210S and S212A and a polynucleotide encoding the same. The reference meets the greater than 50% and since the claim does not recite ‘and’ wherein the amino acid exchange is not A210S or S212A, it can be construed in the alternative and not linked to the first portion of the claim. Therefore, the limitations of the claims are met by the reference.
Conclusion
13. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652