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 1-6, 12, 18-19 and 21-23 are pending.
Election
The requirement for an election of invention among the inventions of
Group I, claims 1-6, drawn to the technical feature of a nucleotide construct comprising a promoter sequence and an insert, said insert comprising galectin-1 fused to a signal peptide,
Group II, claim 12, drawn to the technical feature of a transformed Lactococcus lactis strain, and
Group III, claims 18-19 and 21-23, drawn to the technical feature of a method for controlling inflammation in a subject suffering from an inflammation-mediated disease, wherein the inflammation-mediated disease is an inflammatory bowel disease (IBD), or an immune-mediated inflammatory disease, wherein the immune-mediated inflammatory disease is selected from rheumatoid arthritis and multiple sclerosis, the method comprising orally administering to said subject a transformed Lactococcus lactis strain according to claim 12,
as set forth in the Office action mailed on 03/27/2026 is withdrawn.
The requirement for an election of species among the species of
the galectin-1 nucleotide sequence of
A1) SEQ ID NO: 1,
A2) SEQ ID NO: 2,
A3) SEQ ID NO: 3,
A4) SEQ ID NO: 4, and
A5) SEQ ID NO: 5,
and a transformed Lactococcus lactis strain expressing
B1) Galectin-1 WT, which is deposited under Accession No. RGM3045,
B2) Galectin-1 variant SG1, which is deposited under Accession No. RGM3046,
B3) Galectin-1 variant SG2, which is deposited under Accession No. RGM3047,
B4) Galectin-1 variant SG3, which is deposited under Accession No. RGM3048, and
B5) Galectin-1 variant SG4, which is deposited under Accession No. RGM3049,
as set forth in the Office action mailed on 03/27/2026 is withdrawn.
In view of the withdrawal of the restriction requirement and the requirements for election of species, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 1-6, 12, 18-19 and 21-23 are being examined on the merits.
Priority
The instant application is a national stage filing under 35 U.S.C. 371 of international application PCT/IB2022/060524 filed 11/01/2022, which claims domestic priority to U.S. Provisional Application No. 63/274,287 filed 11/01/2021.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 05/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the examiner.
The listing of references in the specification on pages 39-42 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objections to Specification
The disclosure is objected to because of the following informalities.
The use of the terms MILLIPORE, GENBANK, SIGMA, PIERCE, MULTISKAN, BIO-RAD, AMERSHAM, SYNGENE, COSTAR, NATACOR, TWEEN 20, THERMO ELECTRON, THERMO FISHER, BIOLEGEND, PROMEGA, and INVITROGEN, which are trade names or marks used in commerce, have been noted in this application on pages 20-26, 31, and 35. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to for the phrases “said insert” in line 2 and “said promoter sequence” in line 6. In the interest of improving claim form, Applicant should consider an amendment to recite “the insert” and “the promoter sequence”.
Claim 1 is objected to for the phrase “nucleotide sequence fused to a signal secretion peptide … wherein said secretion peptide” In the interest of improving claim form, Applicant should consider an amendment to recite “a nucleotide sequence fused to a nucleotide sequence encoding a signal secretion peptide … wherein the nucleotide sequence encoding the signal peptide”.
Claim 1 is objected to for the typo in the phrase “agalectin-1 nucleotide sequence” in line 2. In the interest of improving claim form, Applicant should consider an amendment to recite “a galectin-1 nucleotide sequence” to add a space between the words “a” and “galectin-1”.
Claim 1 is objected for the recitation of “a sequence” in line 6. In the interest of improving claim form, Applicant should consider an amendment to recite “the sequence”.
Claims 2-6 are objected to for the phrase “a nucleotide sequence” in line 2 of each claim. In the interest of improving claim form, Applicant should consider amendments to recite “the nucleotide sequence”.
Claim 12 is objected to for the phrase “which is deposited under Accession Number” recited throughout the claim. In the interest of improving claim form, Applicant should consider an amendment to recite “which is deposited with Chilean Collection of Microbial Genetic Resources under Accession Number”.
Claim 18 is objected to for the phrase “administering to said subject a transformed Lactococcus lactis strain according to claim 12”. In the interest of improving claim form, Applicant should consider an amendment to recite “administering to the subject the transformed Lactococcus lactis strain according to claim 12”.
Claim 21 is objected to for the phrase “wherein the transformed Lactococcus lactis strain is administered in combination with at least one additional therapeutic agent”. In the interest of improving claim form, Applicant should consider an amendment to recite “wherein the transformed Lactococcus lactis strain is co-administered with at least one additional therapeutic agent.
Claim 22 is objected to for the phrase “the at least one therapeutic agent”. In the interest of improving claim form, Applicant should consider an amendment to recite “the at least one additional therapeutic agent”.
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 1-6 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.
Claims 1-6 are indefinite for the phrases “said promoter sequence has a sequence depicted in SEQ ID NO: 19” in claim 1, and “the galectin-1 nucleotide sequence has a nucleotide sequence as depicted in SEQ ID NO: …” in claims 2-6, as the term “depicted in” can be interpreted as exemplary claim language (MPEP 2173.05(d)), wherein it is unclear if the phrases are intended to be limiting or exemplary. Applicant may consider amendments to recite “the promoter sequence comprises SEQ ID NO: 19” in claim 1, and “the galectin-1 nucleotide sequence comprises SEQ ID NO: …” in claims 2-6.
Claim 1 (claims 2-6 dependent therefrom) is indefinite for the phrase “wherein said secretion peptide is usp45 of SEQ ID NO: 20”, as it is unclear whether usp45 is a particular fragment of SEQ ID NO: 20 or if usp45 corresponds to the entire sequence of SEQ ID NO: 20. If Applicant intends for the entire SEQ ID NO: 20 to correspond to usp45, Applicant may consider an amendment to recite “wherein the nucleotide sequence encoding the secretion peptide is SEQ ID NO: 20”.
Claims 2-6 are indefinite for reciting both a broad and a narrow limitation range within the same claim (MPEP 2173.05(c).I) in view of the interpretation of the phrase “depicted in” as stated above. Claim 1 recites the narrower range with the limitation “wherein the galectin-1 nucleotide sequence is selected from the group consisting of SEQ ID NO: 1-5”, while dependent claims 2-6 each recite a broader range with the limitation “wherein the galectin-1 nucleotide sequence has a nucleotide sequence depicted in SEQ ID NO:”, as the phrase “depicted in SEQ ID NO:” can be broadly interpreted as exemplary claim language that is not limiting on the sequence of the galectin-1 recited in claims 2-6.
Claim Rejections - 35 USC § 112(a)
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.
Claims 12, 18-19 and 21-23 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. 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 claims recite transformed Lactococcus lactis strains deposited under the Budapest Treaty on November 11, 2020 at the Chilean Collection of Microbial Genetic Resources (CChRGM) under Accession Numbers RGM3045, RGM3046, RGM3047, RGM3048 and RGM3049. It is apparent that the recited bacterial strains are required to practice the claimed invention. Since the biological material is required for the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If the biological material is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit of the biological materials.
The recited Lactococcus lactis strains are disclosed in the specification (page 17, top) as having been deposited at Chilean Collection of Microbial Genetic Resources (CChRGM) under Accession Numbers RGM3045, RGM3046, RGM3047, RGM3048 and RGM3049 since November 11, 2020 in accordance with the Budapest Treaty.
However, there are no documents provided in the application supporting the deposit of the bacterial strains. Therefore, it is unclear if the deposit meets all the criteria set forth in 37 CFR 1.801-1.809.
For example, there is no documentation confirming the acceptance of the strains under the Budapest Treaty.
Additionally, the specification does not provide the address of the depository as set forth by 37 CFR 1.809(d)(4).
Furthermore, the Applicant has not stated that restrictions on the availability to the public of the materials so deposited will be irrevocably removed upon the granting of a patent. If the deposit was made under the Budapest treaty, then an affidavit or declaration by Applicant or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature and registration number, stating that the deposit has been made under the terms of the Budapest Treaty and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement made herein.
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 in the following manner:
SUGGESTION FOR DEPOSIT OF BIOLOGICAL MATERIAL
A declaration by applicant, assignee, or applicant's agent identifying a deposit of biological material and stating the following may be sufficient to overcome an objection and rejection based on a lack of availability of biological material:
Identifies declarant.
States that a deposit of the material has been made in a depository affording permanence of the deposit and ready accessibility thereto by the public if a patent is granted. The depository is to be identified by name and address.
States that the deposited material has been accorded a specific (recited) accession number.
States that all restriction on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
States that the material has been deposited under conditions that access to the material will be available during the pendency of the patent application to one determined by the Commissioner to be entitled thereto under 37 CFR 1.14 and 35 U.S.C § 122.
States that the deposited material will be maintained with all the care necessary to keep it viable and uncontaminated for a period of at least five years after the most recent request for the furnishing of a sample of the deposited microorganism, and in any case, for a period of at least thirty (30) years after the date of deposit for the enforceable life of the patent, whichever period is longer.
That he/she declares further that all statements made therein of his/her own knowledge are true and that all statements made on information and belief are believed to be true, and further that these statements were made with knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, under section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of the instant patent application or any patent issuing thereon.
Alternatively, it may be averred that deposited material has been accepted for deposit under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purpose of Patent Procedure (e.g., see 961 OG 21, 1977) and that all restrictions on the availability to the public of the material so deposited will be irrevocably removed upon the granting of a patent.
Additionally, the deposit must be referred to in the body of the specification and be identified by deposit (accession) number, date of deposit, name and address of the depository and the complete taxonomic description.
EXAMINER COMMENT
The closest prior art to the subject matter recited in claim 1 of “a nucleotide construct comprising a promoter sequence and an insert, wherein said insert comprises a galectin-1 nucleotide sequence fused to a signal secretion peptide, wherein the galectin-1 nucleotide sequence is selected from the group consisting of SEQ ID NO: 1-5” is considered to be Forsythe et al. (Euro J Pharmacol, 2016, 778:169; cited on the attached Form PTO-892; herein Forsythe), Mobergslien et al. (Human Vac Immunother, 2015, 11:2664; cited on the attached Form PTO-892; herein Mobergslien), NCBI Accession No. AY888707 (2 pages, 29 Mar 2005; cited on the attached Form PTO-892; herein NCBI1), and NCBI Accession No. DQ892263 (2 pages, 21 Mar 2007; cited on the attached Form PTO-892; herein NCBI2).
Forsythe relates to microbes taming mast cells and the implications for allergic inflammation and beyond [title], and discusses the physiological role of galectins in inflammation via suppression of pro-inflammatory molecules, and diets containing prebiotic molecules with probiotic organisms correlate to increased galectin production [Section 4.2]. Forsythe does not teach any nucleotide sequences. Mobergslien relates to the effects on immune responses of recombinant Lactobacillus plantarum [title] and discusses that L. plantarum expressing galectin-1 did not induce immunity in experiments designed to promote oral immunization through the natural adjuvant activities of lactic acid bacteria [abstract]. Mobergslien describes the construction of a bacterial expression vector for galectin-1 comprising the fusion of a signal peptide with a codon-optimized human galectin-1 gene [p 2670, col 1, para 2] which corresponds to a nucleotide construct comprising a promoter and nucleotide sequences encoding human galectin-1 and a signal peptide. Mobergslien does not teach the nucleotide sequences of any of SEQ ID NOs: 1-5.
NCBI1 and NCBI2 relate to nucleotide sequences encoding the human galectin-1 protein, wherein the nucleotide sequence of NCBI1 shares 70.5% sequence identity with SEQ ID NO: 1 [see Appendix A], and the nucleotide sequence of NCBI1 shares 69.6% sequence identity with the SEQ ID NOs: 2-5 [see Appendices B, C, D and E, respectively]. NCBI1 and NCBI2 do not teach the nucleotide sequences of any of SEQ ID NOs: 1-5.
Forsythe, Mobergslien, NCBI1 and NCBI2, either alone or in combination with the other prior art of record, do not teach or suggest a galectin-1 with the nucleotide sequence of any of SEQ ID NOs: 1-5, and therefore the subject matter of “a nucleotide construct comprising a promoter sequence and an insert, wherein said insert comprises a galectin-1 nucleotide sequence fused to a signal secretion peptide, wherein the galectin-1 nucleotide sequence is selected from the group consisting of SEQ ID NO: 1-5” as recited in claim 1 is considered to be free of the prior art of record.
The closest prior art to the subject matter recited in claim 12 is considered to be Mobergslien, which relates to the effects on immune responses of recombinant Lactobacillus plantarum [title] and discusses that L. plantarum expressing galectin-1 did not induce immunity in experiments designed to promote oral immunization through the natural adjuvant activities of lactic acid bacteria [abstract]. Mobergslien describes the construction of a bacterial expression vector for galectin-1 comprising the fusion of a signal peptide with a codon-optimized human galectin-1 gene [p 2670, col 1, para 2] which corresponds to a nucleotide construct comprising a promoter and nucleotide sequences encoding human galectin-1 and a signal peptide.
Mobergslien, either alone or in combination with the other prior art of record does not teach transformed Lactococcus lactis strains having the Accession numbers RGM3045, RGM3046, RGM3047, RGM3048, or RGM3049, and therefore the subject matter of “a transformed Lactoccocus lactis strain selected from the group consisting of: a transformed Lactoccocus lactis strain expressing Galectin-1 WT, which is deposited under Accession Number RGM3045, a transformed Lactoccocus lactis strain expressing Galectin-1 variant SG1, which is deposited under Accession Number RGM3046, a transformed Lactoccocus lactis strain expressing Galectin-1 variant SG2, which is deposited under Accession Number RGM3047, a transformed Lactoccocus lactis strain expressing Galectin-1 variant SG3, which is deposited under Accession Number RGM3047, a transformed Lactoccocus lactis strain expressing Galectin-1 variant SG3, which is deposited under Accession Number RGM3048, or a transformed Lactoccocus lactis strain expressing Galectin-1 variant SG4, which is deposited under Accession Number RGM3049” is considered to be free of the prior art of record.
Conclusion
Status of the Application:
Claims 1-6, 12, 18-19 and 21-23 are pending.
Claims 1-6, 12, 18-19 and 21-23 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at (571) 272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
APPENDIX A
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267
645
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Alignment of SEQ ID NO: 1 with NCBI Accession No. AY888707
APPENDIX B
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Alignment of SEQ ID NO: 2 with NCBI Accession No. DQ892263
APPENDIX C
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Alignment of SEQ ID NO: 3 with NCBI Accession No. DQ892263
APPENDIX D
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Alignment of SEQ ID NO: 4 with NCBI Accession No. DQ892263
APPENDIX E
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Alignment of SEQ ID NO: 5 with NCBI Accession No. DQ892263
Prosecution Insights