DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8 are pending and are being examined on the merits.
Priority
The instant application claims foreign priority to Chinese Application No. CN202410179060.8 filed on 02/09/2024.
Information Disclosure Statement
Applicant has not submitted an Information Disclosure Statement.
Objections to Specification
The disclosure is objected to because of the following informalities.
The use of the term CLONEXPRESS which is a trade name or mark used in commerce, has been noted in this application in paragraph 0059. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code with one instance at para 0051 and four instances at para 0052. 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.
The disclosure is objected to for the typo in the description of FIG. 3 in para 0041 which recites “FIGs. 8 to 14 on the right”, while the Drawings filed 02/07/2025 only contain FIGS. 1-9. If Applicant intended for this paragraph to describe lanes 8 to 14 of the gel depicted on the right panel of the figure, Applicant may consider an amendment to recite “lanes 8 to 14 on the right”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to for the phrase “a protein, the amino acid sequence of which is shown in SEQ ID NO: 2”. In the interest of improving claim form, Applicant should consider an amendment to recite “A protein comprising the amino acid sequence of SEQ ID NO: 2”.
Claim 2 is objected to for the phrase “The coding gene of the protein of claim 1, wherein the nucleotide sequence of the coding gene is shown as SEQ ID NO: 1”. In the interest of improving claim form, Applicant should consider an amendment to recite “A polynucleotide encoding the protein of claim 1, wherein the polynucleotide comprises the nucleotide sequence of SEQ ID NO: 1”.
Claims 3-4 are objected to for the phrase “the coding gene of claim 2”. In the interest of improving claim form, Applicant should consider amendments to recite “the polynucleotide of claim 2”.
Claims 6-8 are objected to for ending with a semicolon (“;”). According to MPEP 608.01(m), “Each claim begins with a capital letter and ends with a period”. Applicant should replace the semicolon after option (6) of each claim with a period.
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 1-8 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 regards as the invention.
Claim 1 (claims 2-8 dependent therefrom) is indefinite for the recitation of “the amino acid of which is shown in SEQ ID NO: 2”, as the phrase “shown in SEQ ID NO: 2” can be can be broadly but reasonably interpreted as “such as SEQ ID NO: 2”, which is considered exemplary claim language according to MPEP 2173.05(d) that states descriptions of examples or preferences is properly set forth in the specification rather than the claims, and stating such in the claims can lead to confusion over the scope of a claim.
Claim 2 (claims 3-4 and 8 dependent therefrom) recites “The coding gene”. There is insufficient antecedent basis for this limitation in the claims.
Claim 2 (claims 3-4 and 8 dependent therefrom) is indefinite for the recitation of “the nucleotide sequence of the coding gene is shown as SEQ ID NO: 1”, as the phrase “shown as SEQ ID NO: 1” can be broadly but reasonably interpreted as “such as SEQ ID NO: 1”, which is considered exemplary claim language according to MPEP 2173.05(d) that states descriptions of examples or preferences is properly set forth in the specification rather than the claims, and stating such in the claims can lead to confusion over the scope of a claim.
Claim 3 recites “The expression cassette, recombinant expression vector or recombinant bacterium”. There is insufficient antecedent basis for these limitations in the claims.
Claim 4 recites “The primer pair”. There is insufficient antecedent basis for this limitation in the claims.
Claim 4 is indefinite for the recitation of “wherein one primer sequence is shown in SEQ ID NO: 3, and the other primer sequence is shown in SEQ ID NO: 4”, as the phrase “shown in SEQ ID NO” can be can be broadly but reasonably interpreted as “such as SEQ ID NO”, which is considered exemplary claim language according to MPEP 2173.05(d) that states descriptions of examples or preferences is properly set forth in the specification rather than the claims, and stating such in the claims can lead to confusion over the scope of a claim.
Claim 5 (claim 6 dependent therefrom) recites “The use”. There is insufficient antecedent basis for this limitation in the claims.
Claim 6 recites “the glycotransferase”. There is insufficient antecedent basis for this limitation in the claims.
Claim 7 recites “The use”. There is insufficient antecedent basis for this limitation in the claims.
Claim 8 recites “The use”. There is insufficient antecedent basis for this limitation in the claims.
Claims 5-8 are indefinite for being identified as “use” claims which do not purport to claim a process, machine, manufacture or composition of matter (see MPEP 2173.05(q)). The claims recite the phrase “The use of” in the preamble, which is not considered a process according to MPEP 2106.03.I which states that a process defines “actions”, i.e. an invention that is claimed as an action or step, or a series of actions or steps, and as there is no recitation of any active step(s) in the claims, it is unclear as to the intended active process step(s) that is/are encompassed by the claims.
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 1-2 and 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Applicant’s attention is directed to the "Guidance for Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products”, released on December 16, 2014.
Claim Interpretation: Claims 1-2 are drawn to a protein comprising the amino acid of SEQ ID NO: 2 and the coding gene of the protein of claim 1, respectively. The specification states the present invention involves the flavonoid glycoside glycotransferase LbUGT71BX1 in laportea bulbifera and the coding gene and use thereof [para 0007]. The specification discloses the laportea bulbifera was collected from Leigong Mountain in the southeast of Guizhou Province, and divided into five parts: root, stem, leaf, flower and bulbil, wherein the second and third generations were sequenced by Illumina platform and PacBio platform [para 0051], wherein LbUGT71BX1 cloned from a gene fragment of the plant [para 0058].
Claims 5-8 are drawn to the use of the protein of claim 1 (corresponding to claims 5-7) or of the coding gene of claim 2 (corresponding to claim 8), and as such these claims are considered drawn to an intended use of the claimed protein and claimed coding gene, which does not structurally limit the claimed protein and claimed coding gene according to MPEP 2111.02.II.
Given a broadest reasonable interpretation, claims 1-2 and 5-8 are drawn to a naturally-occurring protein and nucleic acid.
Patent Eligibility Analysis Step 1: The claims are drawn to a composition of matter, which is one of the statutory categories of invention.
Patent Eligibility Analysis Step 2A Prong 1: The claims recite a naturally occurring protein and nucleic acid, which is considered to be a law of nature or natural phenomena (a natural product). Accordingly, claims 1-2 and 5-8 are directed to a judicial exception.
Patent Eligibility Analysis Step 2A Prong 2: There are no additional elements recited in the claims beyond the judicial exception.
Patent Eligibility Analysis Step 2B: The claims only recite the product of nature, without more and do not include any additional elements that could add significantly more to the judicial exception.
As such, the claims do not qualify as eligible subject matter. For these reasons the claim is rejected under section 101 as being directed to non-statutory subject matter.
Claims 5-8 are directed to nonstatutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because they have been identified as “use” claims which do not purport to claim a process, machine, manufacture or composition of matter (see MPEP 2173.05(q)). The claims recite the phrase “The use of” in the preamble, which is not considered a process according to MPEP 2106.03.I which states that a process defines “actions”, i.e. an invention that is claimed as an action or step, or a series of actions or steps, and as there is no recitation of any active step(s) in the claims, the claim are not considered drawn to a process or any of the other statutory categories as stated above.
Examiner Comment
The limitation in claim 1 of “a protein, the amino acid sequence which is shown in SEQ ID NO: 1” is free of the prior art.
The limitation in claim 2 of “the nucleotide sequence of the coding gene is shown as SEQ ID NO: 1” is free of the prior art.
The closest prior art is considered to be Yang et al. (Trends Food Sci Technol, 2018, 79:116; cited on the attached Form PTO-892; herein Yang) and McIntosh et al. (Phytochem Rev, 2016, 15:1075; cited on the attached Form PTO-892; herein McIntosh).
Yang discusses the bioactivities of flavonoid glycosides [title] that have health benefits to the human body due to their glycosylation [abstract]. Yang discloses glycosylation of flavonoids happens via glycosyltransferase enzymes to produce O-glycoside or O-glucoside modifications that can further vary based on the donor substrate [p 116, col 2, para 2], an example of which is a glycosyltransferase from the bacteria Bacillus licheniformis that can act on flavonoids such as quercetin, myricetin and kaempferol to produce diverse glycosylation patterns [p 121, col 1, para 1].
McIntosh discusses advances in flavonoid glycosyltransferase research [title] and discusses these enzymes have potential for development in a variety of agricultural, medicinal and biotechnological applications [abstract], as flavonoid glycosides produced by these enzymes play a large role in the health benefits associated with citrus consumption [p 1076, col 1, final paragraph; col 2, para 1]. McIntosh further discloses a list of known plant glycotransferases that include enzymes that have been co-crystallized with myricetin and kaempferol to indicate their ability to act on these molecules as substrates [Table 4].
Yang and McIntosh, either alone or in combination, do not teach or suggest the amino acid sequence of SEQ ID NO: 2 or the nucleotide sequence of SEQ ID NO: 1.
Conclusion
Status of the Application:
Claims 1-8 are pending.
Claims 1-8 are rejected.
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH SPANGLER whose telephone number is (571)270-0314. The examiner can normally be reached M-F 7:30 am - 4:30 pm.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
