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 .
Priority
This application claims benefit of priority to Japan Application No. JP2020-198419 filed 11/30/2020. This application is also a 371 of PCT/JP2021/043758 filed 11/30/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, an English translation of the foreign patent document was not provided. Therefore, for the purposes of applying prior art, the effective filing date of the claimed invention is 11/30/2021.
Drawings
The Drawings filed 05/30/2023 are accepted by the Examiner.
Information Disclosure Statement
The Information Disclosure Statements filed 05/30/2023, 01/21/2025 and 02/12/2025 have been acknowledged and considered.
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 11/25/2025 is acknowledged. The traversal is on the grounds that claims 20-22, 25, 27, 29, 31 and 35 share the same technical feature as the elected group. This is not found persuasive because, as stated in the Requirement for Restriction/Election mailed 10/01/2025, these claims do not share the same technical feature as the elected group. The technical feature of claims 20-22, 29 and 31, Group IV, is the DNA of claim 20. DNA is comprised of nucleic acids, while the elected group is drawn to an amino acid sequence. The technical feature of claims 25, 27 and 35, Group VII, is the immobilized protein of claim 25. Thus, claims 20-22, 25, 27, 29, 31 and 35 do not share the same technical feature as the elected grouped.
The requirement is still deemed proper and is therefore made FINAL.
Applicant's election with traverse of the species of the elected protein of (b) in the reply filed on 11/25/2025 is acknowledged. The traversal is on the grounds that protein (b) is a mutant of protein (a) and should therefore be examined together. This is not found persuasive because, as stated in the Requirement for Restriction/Election mailed 10/01/2025, the different proteins have different structures and would be expected to have different functions and effects. Protein (b), being a mutant, has a different structure than protein (a) and would therefore, absent evidence to the contrary, be expected to have different functions and effects.
The requirement is still deemed proper and is therefore made FINAL.
Amendments and Claim Status
In the reply filed 11/25/2025, as stated above, Applicant elected Group II, claims 18, 33 and 36, the protein of (b) and D-allose. Claims 17, 19-32 and 34-35 are withdrawn by the Examiner as not being encompassed by the elected group.
Claims 17-36 are currently pending.
Claims 17, 19-32 and 34-35 are withdrawn by the Examiner.
Claims 18, 33 and 36 are under examination.
Specification Objections
The disclosure is objected to because of the following informalities: Bacterial species are recited throughout the instant Specification without being italicized. For example, in Paragraphs [0010] and [0012] Enterobacter roggenkampii is recited without being italicized. This issue is present throughout the instant Specification. Appropriate correction is required.
Claim Objections
Claims 33 and 36 are objected to because of the following informalities: Claims 33 and 36 lack appropriate punctuation throughout. For example, in both claims there should be a colon after the word ‘comprising’ at the end of the preamble. As-written, claim 33 reads “comprising causing the L-rhamnose” and claim 36 reads “comprising causing a protein …”. Both are grammatically awkward and should be corrected. Additionally, commas are missing throughout both claims. For example, line 1 of claim 33 recites “A method of producing a ketose or an aldose including a D-allulose or D-allose, comprising causing …”. There should be a comma after aldose. Appropriate correction is required.
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 18, 33 and 36 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.
Claim 18 recites “a protein described in the following” in the preamble of the claim. It is unclear how “described” is intended to limit the scope of the claim since a transitional phrase is not utilized. The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim. Described is given the plain meaning of relevant characteristics/qualities discussed. Thus, claim 18 is indefinite because it is unclear how the use of “described” is intended to limit the scope of the claim, especially in the absence of a transitional phrase.
Claim 18 recites “a protein (with the proviso that a protein having alanine as the 82nd amino acid is excluded)” in line 3. The use of parentheses makes it unclear if the limitation within the parentheses is optional or part of the claimed invention. That is, it is unclear whether proteins with an alanine at the 82nd amino acid position are actually excluded or if this limitation is simply optional and not required. Thus, claim 18 is rendered indefinite. If the above recited limitation is a required part of the claimed invention, it is suggested to remove the parentheses. For example, Applicant could replace each parenthesis with a comma.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 33 and 36 recite the broad recitation of a ketose or an aldose, and the claim also recites a D-allulose or D-allose, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 33 recites “causing the protein as claimed in claim 18, to act on a solution” in line 2 of the claim. It is unclear what ‘to act on’ means. It is unclear if ‘to act on’ means the protein is interacting with something within the solution or something else. It is further unclear how the protein acts on the solution. Thus, the metes and bounds of the scope of the claim are unclear, rendering claim 33 indefinite.
Claim 36 recites “comprising causing a protein having L-rhamnose isomerase activity to a solution containing at least one selected from D-allose or D-allulose to produce a corresponding D-allulose or D-allose” in lines 1-3. The claim appears incomplete since it is unclear what the phrase “causing a protein” intends to limit. It is unclear what “causing a protein having L-rhamnose isomerase activity to a solution” means. It appears, when the claim is taken as a whole, the scope of the claim is intended to mean causing a protein having L-rhamnose isomerase activity to produce a D-allulose or D-allose by contacting the protein with a solution containing D-allose and/or D-allulose. However, the Examiner cannot ascertain the full scope or metes and bounds of the claim as it is unclear what “causing a protein having L-rhamnose isomerase activity to a solution” means. Thus, claim 36 is indefinite.
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.
Claim 18 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a product of nature.
STEP 1: Is the claim to a process, machine, manufacture or composition of matter?
Answer to STEP 1: Yes, claim 18 is directed to a protein, a product.
STEP 2: Is the claim directed to a law of nature, a natural phenomenon or an abstract idea
(judicially recognized exceptions)?
Step 2 comprises two, respective steps: Step 2A Prong 1 and Step 2A Prong 2.
STEP 2A, PRONG 1: Does the claim recite an abstract idea, law of nature or natural
phenomenon?
A claimed product is ‘directed to’ a natural phenomenon if the product of the claim is not
‘markedly different’ from its closest-occurring natural counterpart.
With regard to STEP 2A, PRONG 1:
The invention of claim 18 is a protein having an amino acid sequence with 90% or more identity to instant SEQ ID NO: 1 wherein the protein does NOT have alanine at the 82nd amino acid position. This amino acid sequence, according to a preponderance of evidence, is a naturally occurring amino acid sequence. Specifically, according to the instant Specification, instant SEQ ID NO: 1 is from Enterobacter roggenkampii NrT7-1 (Specification, Paragraph [0057]).
Thus, as there is no evidence the sequence is artificial in any way, the amino acid sequence encoding the protein of claim 18 is interpreted as a naturally-occurring amino acid sequence. Considering the amino acid sequence is naturally-occurring, there is no difference in the protein as claimed and the protein as it occurs in nature. Therefore, when compared to its closest naturally occurring counterpart, which is the naturally occurring protein in Enterobacter roggenkampii NrT7-1, there is no difference between the amino acid sequence of the protein as claimed and the naturally occurring counterpart in Enterobacter roggenkampii NrT7-1.
Even though the protein was isolated from a microorganism, being Enterobacter roggenkampii NrT7-1, as evidenced by the instant Specification (Specification, Paragraph [0038]), isolating is not demonstrative of a marked difference between the natural amino acid encoding the protein as there is nothing present within the claim which specifically focuses on any chemical changes due to isolating the protein from its natural habitat, the microorganism Enterobacter roggenkampii NrT7-1.
Answer to STEP 2A, PRONG 1: Yes, the claim recites a natural product (‘natural phenomenon’).
STEP 2A, PRONG 2: Does the claim recite additional elements that integrate the natural product into a practical application?
Integration into a practical application” according to the most recent PEG guidance:
1. Requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception.
2. Uses the considerations laid out by the Supreme Court and the Federal Circuit to evaluate whether the judicial exception is integrated into a practical application.
With regard to STEP 2A, PRONG 2:
There is nothing claimed in claim 18 other than the naturally-occurring product. Therefore, the naturally-occurring protein of claim 18 cannot demonstrate integration into a practical application.
The claim contains no element(s) in addition to the Judicial Exception and therefore does not integrate the Judicial Exception into a practical application.
ANSWER TO STEP 2A, PRONG 2: No, the claim does not recite additional elements that integrate the JE into a practical application.
ANSWER TO STEP 2A: Yes, the claim is directed to a Judicial Exception.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the JE?
As discussed under Step 2A, Prong 1, there are no additional elements in addition to the JE. Therefore, claim 18 does not set forth ‘significantly more’ than the JE.
Thus, the claimed amino acid sequence is no different than the amino acid sequence as it exists in nature to avoid non-eligibility.
ANSWER TO STEP 2B: No, the claim does not recite any additional elements that amount to significantly more than the Judicial Exception.
For the foregoing reasons, claim 18 is rejected under 35 U.S.C. § 101 for being directed to non-eligible subject matter because the claim merely identifies an amino acid encoding a protein which is naturally-occurring, a Judicial Exception which is not markedly different from its naturally-occurring counterpart and does not recite additional elements which integrate the natural product into a practical application or contribute significantly more than the Judicial Exception itself.
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.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by UniProt (A0A3D2B908_9ENTR, 01/16/2019).
Regarding claim 18, UniProt discloses A0A3D2B908_9ENTR, an L-rhamnose isomerase, with gene name rhaA from Enterobacter wuhouensis (Page 1). A0A3D2B908_9ENTR shares 96.8% sequence identity to instant SEQ ID NO: 1 and does not have an alanine at the 82nd amino acid position. A sequence alignment is provided below wherein Qy represents instant SEQ ID NO: 1 and Db represents A0A3D2B908_9ENTR of UniProt.
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While UniProt does not disclose the specific activity indicated in part (A) or (B) of the claim, it appears, absent evidence to the contrary, the protein disclosed by UniProt would necessarily provide the claimed activity as it is also an L-rhamnose isomerase that falls within the limitations set forth in (b). Therefore, it appears the claimed activity is inherent to the protein and the protein disclosed by UniProt would necessarily provide the claimed activity. Thus, UniProt anticipates instant claim 18.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 33 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Iyappan et al. (US 9752170 B2, 09/05/2017) in view of UniProt (A0A3D2B908_9ENTR, 01/16/2019).
Regarding claims 33 and 36, Iyappan et al. disclose a gene encoding rhamnose isomerase and the use of the rhamnose isomerase in a process to produce rare monosaccharides such as psicose and allose (See entire document, Abstract). More specifically, Iyappan et al. disclose:
A process of overproduction of rare monosaccharides from fructose, said process comprising the steps of:
1. culturing host cells transformed with an expression construct comprising SEQ ID NO:1 and SEQ ID NO:2 in a separate suitable medium in the presence of IPTG or lactose for a period in the range of 2-3 hours to produce D-tagatose 3-epimerase and rhamnose isomerase respectively,
2. isolating the expressed protein from the host cells by conventional method, and purifying the isolated protein using chromatographic techniques,
3. immobilizing D-tagatose 3-epimerase and rhamnose isomerase thus produced in the previous step in a suitable matrix,
4. contacting fructose with immobilized D-tagatose 3-epimerase for a period in the range of 5 to 10 hours to produce psicose, and
5. contacting D-psicose produced in the previous step with immobilized rhamnose isomerase for a period in the range of 6-12 hours to produce D-allose (Claim 13 of Iyappan et al.).
Thus, Iyappan et al. disclose a method of producing D-allose, the elected species of what is produced, comprising contacting rhamnose isomerase with D-psicose to produce D-allose. It is noted D-psicose is another name for D-allulose.
Iyappan et al. do not disclose the rhamnose isomerase has 90% sequence identity to instant SEQ ID NO: 1.
However, UniProt discloses A0A3D2B908_9ENTR, an L-rhamnose isomerase, with gene name rhaA from Enterobacter wuhouensis (Page 1). A0A3D2B908_9ENTR shares 96.8% sequence identity to instant SEQ ID NO: 1 and does not have an alanine at the 82nd amino acid position. A sequence alignment is provided below wherein Qy represents instant SEQ ID NO: 1 and Db represents A0A3D2B908_9ENTR of UniProt.
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While UniProt does not disclose the specific activity indicated in part (A) or (B) of the claim, it appears, absent evidence to the contrary, the protein disclosed by UniProt would necessarily provide the claimed activity as it is also an L-rhamnose isomerase that falls within the limitations set forth in (b). Therefore, it appears the claimed activity is inherent to the protein and the protein disclosed by UniProt would necessarily provide the claimed activity.
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have utilized the L-rhamnose isomerase disclosed by UniProt in the method of Iyappan et al. as it amounts to simple substitution of one known element for another because the L-rhamnose isomerase was a known an L-rhamnose isomerase. Therefore, it would have been obvious to one of ordinary skill in the art to utilize the L-rhamnose isomerase disclosed by UniProt motivated by the desire to effectively produce D-allose. Exemplary rationales that may support a conclusion of obviousness include simple substitution of one known element for another to obtain predictable results. See MPEP 2143(I)(B).
Conclusion
Claims 18, 33 and 36 are rejected.
No claims are allowed.
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/A.T.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653