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 4/2/2024 is acknowledged. This listing of claims replaces all prior listings of claims in the application.
Claims 1-19 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-4, 17 in the reply filed on 5/22/2026 is acknowledged. Applicant respectfully traverses the Restriction Requirement on the grounds that the asserted technical feature is not merely a generic metal-chelating resin, but a novel and non- obvious combination of structural, functional, and application-specific elements that constitute a "special technical feature" as defined under PCT Rule 13.2. Applicant contends that the claimed technical feature - a large-particle, methacrylic resin with covalently bound IDA groups - makes a contribution over the prior art and constitutes a special technical feature. Therefore, unity of invention is present between the carrier (Group I) and its preparation method (Group II), as the method claims are directly tied to producing the novel carrier defined in Group I. Applicant contends that Claim 1 and Claim 5 involve the same or corresponding special technical features, therefore, the group I and group II so linked as to form a single general inventive concept under PCT Rule 13.1.
Examiner acknowledges and appreciates Applicant’s remarks. However, MPEP § 1893.03(d) states "the principles of unity of invention are used to determine the types of claimed subject matter and the combinations of claims to different categories of invention that are permitted to be included in a single international or national stage patent application." See MPEP § 1850 for a detailed discussion of Unity of Invention. The basic principle is that an application should relate to only one invention or, if there is more than one invention, that applicant would have a right to include in a single application only those inventions which are so linked as to form a single general inventive concept." A group of inventions is considered linked to form a single general inventive concept where there is a technical relationship among the inventions that involves at least one common or corresponding special technical feature. The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art.
Claims 1-4, 17 are pending and examined on the merits.
Claims 5-16, 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Acknowledgement is made of this national stage entry of PCT/CN2021/131878 filed on 11/11/2019, which claims domestic priority to U.S. non-provisional application 18/697,925, filed on 11/11/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/2/2024 and 8/8/2025 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.
Claim Objections
Claim 2 is objected to because of the following informalities: repeat of the phrase ‘the amino-type methacrylic resin'. 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.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement for the reasons of record and the reasons set forth below. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification fails to provide an enabling disclosure, because the specification does not provide evidence that the claimed biological materials are: (1) known and readily available to the public; (2) reproducible from the written description; or, (3) deposited in compliance with the criteria set forth in 37 CFR 1.801-1.809.
If the deposits are made under the terms of the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific strains, have been deposited under the Budapest Treaty, that the strains, will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and that the strains, will be replaced should they ever become non-viable, would satisfy the deposit requirement made herein.
If the deposits have not been made under the Budapest Treaty, then in order to certify that the deposits meet the criteria set forth in 37 CFR 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number.
For each deposit made pursuant to these regulations, the specification shall contain:
The accession number for the deposit;
The date of the deposit;
A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
The name and address of the depository.
A viability statement for each deposit of a biological material not made under the Budapest Treaty on the International Recognition of the deposit of Microorganisms for the Purposes of Patent Procedure must be filed in the application and must contain:
The name and address of the depository;
The name and address of the depositor;
The date of deposit;
The identity of the deposit and the accession number given by the depository;
The date of the viability test;
The procedures used to obtain a sample if the test is not done by the depository; and
A statement that the deposit is capable of reproduction.
Applicant must assure that:
Access to the deposit will be available during pendency of the patent application making reference to the deposit.
All restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
In the instant case, the specification does not disclose if strains Chromobacterium violaceum DSM30191, Sciscionella sp. SE31, Acetobacter sp. CCTCCM209061, Rhodococcus sp. Phil, Rhodococcus ruber-SD, Chryseobacterium sp. CA49, Thermoactinomyces intermedius ATCC33205 are deposited under the provisions of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purpose of Patent Procedure and the Regulations. Additionally, the date of the viability test, procedures used to obtain a sample if the test is not done by the depository, a statement that the deposit is capable of reproduction, and there is not an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the strains, have been deposited under the Budapest Treaty, that the strains, will be irrevocably and without restriction or condition released to the public upon the issuance of a patent and that the strains, will be replaced should they ever become non-viable. A verified statement is required from a person in a position to corroborate that the biological material described in the specification as filed is the same as that deposited in the depository, stating that the deposited material is identical to the biological material described in the specification and was in the Applicant’s possession at the time the application was filed.
As a possible means for completing the record, applicant may submit a copy of the contract with the depository for deposit and maintenance of each deposit along with the necessary statements in order to meet the criteria set forth in 37 CFR 1.801-1.809.
Applicant’s attention is directed to In re Lundak, 773 F.2nd. 1216, 227 USPQ 90 (CAFC 1985) and 37 CRF 1.801-1.809 for further information concerning deposit practice.
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 2-4 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 2 (claim 3 dependent thereof) contains the trademark/trade names Seplite*LX-1000HA, Seplite*LX-1000EPN, Seplite*LX- 1000EA, LifetechTMECR8309, LifetechTMECR8409, ESR-1, ESR-3, or ESQ-1, Seplite*LX-1000HA, Seplite *LX-1000EPN, LifetechTMECR8309, Seplite*LX-1000EP, Seplite® LX-103B, EP200, Seplite*LX-107B, Seplite*LX-1000SW, Seplite*LX-1000SD, Seplite® LX-109s, Seplite*LX-1000HFA, LifetechTMECR8285, LifetechTMECR8204, LifetechTMECR8209, ES-1, ES103, ES-101, ReliZymeTMHFA403, ReliZymeTMEC-HFA, Seplite*LX-1000EP, Seplite*LX-109s, Seplite*LX-1000HFA, ReliZymeTMEC-HFA. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe resin and, accordingly, the identification/description is indefinite.
Regarding claim 2, the phrases “preferably” and "more 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 4 recites the limitation "the enzyme" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is unclear if Applicant is referring to an immobilized enzyme or an enzyme immobilized carrier or an enzyme that is not disclosed. Appropriate correction is suggested.
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.
Claims 1-4, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (2018, Bioprocess and Biosystems Engineering, Examiner cited) {herein Wang} in view of Ley et al (2011, Colloids and Surfaces B, Examiner cited) {herein Ley} as evidenced by Expasy (2026, Enzyme, Examiner cited) {herein Expasy} and Koper et al (2022, JBC Reviews, Examiner cited) {herein Koper} and Zhang et al (1993, Arch Microbiol. Examiner cited) {herein Zhang}.
Claims 1-4, 17 are drawn to an enzyme immobilization carrier, wherein the enzyme immobilization carrier comprises a resin matrix, a -N(CH2COOH)2 group linked on the resin matrix by means of a chemical bond, and a metal ion adsorbed on the -N(CH2COOH)2 group in a chelating manner through coordination, wherein, the resin matrix is an amino-type methacrylic resin or an epoxy- type methacrylic resin, and the resin matrix has a particle size of 200-700 µm.
With respect to claims 1-4, 17, Wang teaches Seplite LX-1000EP (as epoxy-activated
acrylic beads) as a resin matrix that immobilizes cephalosporin-acid synthase for the synthesis of beta-lactam antibiotic cefazolin (abstract, page 1854, column 1, para 1, page 1852: list of abbreviations table). Said resin matrix has a particle size of 150-350µm (page 1854, column 1, para 1). Evidentiary reference of Expasy is cited to demonstrate that cephalosporin-acid synthase is a transaminase (page 1) Furthermore, the evidentiary reference of Zhang is cited to demonstrate that cephalosporin-acid synthase is produced by Arthrobacter sp. (abstract). It would be obvious to one of ordinary skill in that art that said Seplite LX-1000EP would immobilize the recited transaminases (also called aminotransferases) as transaminases share a high degree of structural similarity. Furthermore, transaminases (aminotransferases) rely on a highly conserved active site and a shared, overall protein fold despite having diverse amino acid sequences. This structural similarity allows these enzymes to perform identical chemical tasks across widely different species, from bacteria to humans. Supporting the Examiner’s position is the evidentiary reference of Koper which recites many aminotransferase enzymes retained considerable substrate promiscuity and multifunctionality because of their inherent mechanistic, structural, and functional constraints (abstract). As such, it is the Examiner’s position that the transferases recited in claim 17 would bind Seplite LX-1000EP as Wang teaches Seplite LX-1000EP binds an enzyme of microbial origin of which the transaminases recited in the instant application claim 17 are derived from, therefore they would necessarily all be structurally similar and behave in a similar fashion by binding Seplite LX-1000EP.
However, Wang does not teach a resin matrix, a -N(CH2COOH)2 group linked on the resin matrix by means of a chemical bond, and a metal ion adsorbed on the -N(CH2COOH)2 group in a chelating manner through coordination (claim 1).
With respect to claim 1, Ley teaches enzyme immobilization using iminodiacetic as a metal chelating group to foster tighter enzymatic binding (abstract, page 542, column 1, para 2).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to apply the teachings of Wang et al of Seplite LX-1000EP (as epoxy-activated
acrylic beads) as a resin matrix that immobilized cephasporin-acid synthase for the synthesis of beta-lactam antibiotic cefazolin (abstract, page 1854, column 1, para 1, page 1852: list of abbreviations table) or combine the teachings of Ley et al because Ley teaches enzyme immobilization using iminodiacetic as a metal chelating group to foster tighter enzymatic binding (abstract, page 542, column 1, para 2).
One of ordinary skill in the art would be motivated to either use the teachings of Wang et al. by itself or combine the teachings of Ley because Ley provides the motivation for Wang to combine a -N(CH2COOH)2 group linked to Seplite LX-1000EP resin matrix because Ley teaches when N(CH2COOH)2 (iminodiacetate) is added to resin, it acts as a metal ion chelating agent thereby strengthening the bond between the enzyme and the resin (page 542, column 1, para 1-2). One of ordinary skill in the art knowing the benefit of enzyme immobilization based on the teachings of Wang and Ley would have a reasonable expectation of success to combine Seplite LX-1000EP resin matrix and a -N(CH2COOH)2 group because one of ordinary skill in the art would expect them both to increase enzyme immobilization. MPEP 2143.I.A. states ‘The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396. Furthermore, Ley teaches any application requiring immobilized biocatalysts can make use of this immobilization approach using iminodiacetate, making future biocatalytic technologies more sensitive, simpler, reusable and less expensive while only requiring mild enzyme modifications (Ley: abstract). Thereby, adding an iminodiacetate ligand to an epoxy-activated resin like SEPLITE® LX-1000EP creates a metal-chelate support that allows the carrier to tightly bind metal ions, which subsequently act as anchors to capture enzymes.
One of skill in the art would have a reasonable expectation of success to make and use the claimed enzyme immobilization carrier because Wang provides the basic enzyme immobilization carrier and its uses and methods of making it. Reference of Wang provides the teaching of Seplite LX-1000EP (as epoxy-activated acrylic beads) as a resin matrix that immobilized cephalosporin-acid synthase for the synthesis of beta-lactam antibiotic cefazolin (abstract, page 1854, column 1, para 1, page 1852: list of abbreviations table). Whereas Ley provides the teaching of enzyme immobilization using iminodiacetic as a metal chelating group to foster tighter enzymatic binding (abstract, page 542, column 1, para 2).
Conclusion
Status of Claim
Claims 1-4, 17 are pending.
Claims 5-16, 18-19 are withdrawn from consideration pursuant to 37 CFR 1.142(b).
Claims 1-4, 17 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
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