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 .
DETAILED ACTION
Applicant’s submission dated 12/09/2024 is duly acknowledged.
Claims 1-24 originally presented have been canceled by applicant’s current claim amendments.
Claims 25-44 as newly presented are pending in this application, and have been examined on their merits in this action hereinafter.
Priority
This application is a CON of 18/177,070 (filed on 03/01/2023, now PAT 12188056 B2), which claims foreign priority from an application from DENMARK, PA202270077 filed on 03/02/2022.
Claim Objections
1. Claims 25, 33 and 34 (as newly presented) are objected to because of the following informalities:
Claim 25 recites limitation in abbreviated for such as “HMO” (in line 4), which should be amended to recite the full form of “human milk oligosaccharide (HMO)”, at least the first time in appears in a claim or a claim set.
Claim 33 recites the abbreviation in the form of “MFS transporter protein” (in line 2), wherein the abbreviation “MFS” should be recited in full form at least the first time in appears in a claim or a claim set.
Claim 34 recites abbreviated names of “Fred”, “YberC” or “Nec” protein, which should be amended to recite the full names (and abbreviations in parenthesis, if needed), at least the first time they appear in a claim or a claim set. Appropriate correction is required.
2. Claim 37 is objected to because of the following informalities: Claim 37 recites the term “filamentous fungous” in line 3, which should be amended to recite “filamentous fungus”, instead. Appropriate correction is required.
3. Claim 39 is objected to because of the following informalities: Claim 39 recites the limitations “culturing a the genetically modified cell of claim 26”, which should be amended to recite “culturing [[a]] the genetically modified cell of claim 26”. Appropriate correction is required.
4. Claim 40 (as newly presented) is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed (See MPEP § 608.01(n)). Claim 40 has been reproduced hereinbelow:
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Accordingly, claim 40 has not been further treated on the merits. Appropriate correction is required.
5. Claim 41 is objected to because of the following informalities: Claim 41 recites the abbreviation “3’SL”, which should be recited in a full form “3’-sialyllactose (3’SL)”, at least first time presented in a claim set. Appropriate correction is required.
Claims
It is noted that the terms “genetically modified cell” and “recombinant” (see instant claim 25, in particular) have not been specifically defined by the applicant in the disclosure of record (see parent 18/177,070 SPEC, Summary on pages 2-3, for instance). The claimed product does not require any specific structural and/or genetic modification(s) of the “cell” in order to produce intermediates (such as sialic acid sugar nucleotide), and/or the end product as a sialylated human milk oligosaccharides (HMOs) such as 3’sialyllactose (3’SL), for instance. The claimed “genetically modified cell” does not comprise a “heterologous” recombinant nucleic acid sequence per se. Therefore, the product as claimed (i.e. the “genetically modified cell”) can read on Campylobacter lari cells that naturally comprise the a-2,3-sialyltransferase enzyme (i.e. 100 % amino acid sequence identity; applicant’s disclosure of record, per Table 1 on page 9) capable of forming “a sialylated HMO” as recited in claim 25 (i.e. a nature-based product). However, in the interest of compact prosecution, a rejection under 35 USC 101 for claiming natural product-based judicial exception has not been made by the examiner in light of the disclosure provided by the applicant for use of specific modified bacterial host cells (modified strains of Escherichia coli, in particular; see Examples 1-2, and page 38, section “Strains”, in particular).
Applicant is advised to amend claim 25 in order to recite “a heterologous recombinant nucleic acid sequence encoding an enzyme….”, in order to facilitate the prosecution forward.
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.
Claim 44 (Newly presented) is 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 44 recites the limitation "the culture medium" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 44 as presented directly depends from claim 39 (which in turn depends from the product claim 26, and ultimately from independent product claim 25), wherein claims 39 as recited does not provide a reasonable basis for the limitation of a “culture medium” per se. Appropriate correction is required.
Claim Rejections - 35 USC § 112 – WD Issue
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.
Claims 25-44 (as newly presented) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 entire scope of the claimed invention.
Claims 25 and 39 as currently presented have been reproduced as follows:
Claim 25 is directed to “A genetically modified cell comprising a recombinant nucleic acid sequence encoding an enzyme with a-2,3-sialyltransferase activity, wherein the enzyme is Clari1 with at least 80% identity to the amino acid sequence set forth in SEQ ID NO: 1, and wherein the cell produces a sialylated HMO.”
Claim 39 is directed to “A method for producing a sialylated human milk oligosaccharide (HMO) comprising: culturing a the genetically modified cell of claim 26.”
It is noted that the terms “genetically modified cell” and “recombinant” have not been specifically defined by the applicant in the instant disclosure of record (see parent SPEC, Summary on pages 2-3, for instance). The claimed product does not require any specific structural and/or genetic modification(s) of “the cell” in order to produce intermediates (such as sialic acid sugar nucleotide), and/or the end product as a sialylated human milk oligosaccharides (HMOs) such as 3’sialyllactose (3’SL), for instance. In addition, it is also noted that the scope of the claimed “genetically modified cell” may encompass any type of cell (not limited to any specific microbial cell per se, and may include for examples, any bacterial species/strain, animal (mammalian or non-mammalian), plant, fungal, protists, and mutants or variants thereof, etc., to name a few- that may not necessarily have the requisite precursors and/or pathway enzymes to synthesize the required end product, i.e. the sialylated HMO) that comprises nucleic acid encoding the a-2,3-sialyltransferase enzyme as currently recited in instant claim 25.
However, the disclosure of record regarding the claimed product only pertains to genetically modified Escherichia coli cells (the specific MDO strains of E. coli which have been specifically modified as disclosed in applicant’s example on pages 38-39, under section “Strains”, in particular; and Table 4) that incorporate specific promoter to control the expression of the claimed sialyltransferase enzyme and with expression of enzymes required for making sialic acid sugar nucleotide and ultimately for producing the required end product, 3’SL (see Examples 1-2, starting on page 40, for instance). Thus, other than specific E. coli strains, there is no disclosure for any other cell type (animal, plant, fungal, protist, etc.) that has been genetically modified using specific promoters, enzyme systems for expressing and producing the sialylated HMO, as currently required by the claim. In fact, even using E. coli as a host cell for expressing various known a-2,3-sialyltransferase enzymes, applicant’s own disclosure provides evidence that not all types of bacterial cells and promoters would be suitable for growth and stability of host cells (see page 15, section “A deficient sialic acid catabolic pathway”; page 23, 2nd paragraph; and entire Example 2 on page 42, for instance). No such disclosure has be provided on record as to the genetic modification of fungal cells such as a particular strain of yeast, or for that matter any animal or any specific mammalian cell, or variants thereof in order to demonstrate nexus between the system disclosed and/or used to express said a-2,3-sialyltransferase enzyme and for production of 3’SL as claimed and its applicability for all other cell types (or at least a relevant species therefrom) using the same expression system (such as specific promoters, transport proteins, biosynthetic pathway for generating sialic acid sugar nucleotide, for instance). Given the inherent variability and/or unpredictability of the different bacterial host cells expressing similar sialyltransferase enzymes, as evidenced on record by applicant’s own disclosure, a reasonable guidance and/or written description commensurate with scope would be needed (for employing any other type of host cell) in order to make and/or use the invention as claimed.
Thus, given the present disclosure of record, it appears that applicant is not in possession of the entire scope of the invention as currently claimed. Appropriate correction and/or explanation is required.
Prior Art
Claims 25-44 appear to be free of prior art issues as they pertain to SEQ ID NO: 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25-44 (as newly presented) are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1-2 of copending Application No. 18/843,530 (reference application; filed by the same inventor and assignee). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims are directed to essentially the same “genetically modified cell” (that is “capable of producing” a sialylated HMO; see claims 1 and 2 of application ‘530 reproduced hereinbelow):
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It is to be noted that the SEQ ID NO: 5 (as recited in claim 2 of ‘530 application) is the same “Clari 1” (100% identical amino acid sequence; see below for sequence homology) enzyme protein as currently required by claim 25 of the instant application under examination (i.e. the SEQ ID NO: 1).
US-18-843-530-5
Filing date in PALM: 2024-09-03
Sequence 5, US/18843530
Publication No. US20250297296A1
GENERAL INFORMATION
APPLICANT: DSM IP Assets B.V. (en)
TITLE OF INVENTION: NEW SIALYLTRANSFERASES FOR IN VIVO SYNTHESIS OF LST-A (en)
FILE REFERENCE: 032991-8020 (34348-US-PCT)
CURRENT APPLICATION NUMBER: US/18/843,530
CURRENT FILING DATE: 2024-09-03
NUMBER OF SEQ ID NOS: 56
SEQ ID NO 5
LENGTH: 301
TYPE: PRT
FEATURE:
NAME/KEY: source
LOCATION: 1..301
QUALIFIERS: mol_type = protein
organism = Campylobacter lari
%
Result Query Filing
No. Score Match Length ID Date
1 1608 100.0 301 US-18-177-070-1 2023-03-01
NEW SIALYLTRANSFERASES FOR IN VIVO SYNTHESIS OF 3'SL (en)
ALIGNMENT:
Query Match 100.0%; Score 1608; Length 301;
Best Local Similarity 100.0%;
Matches 301; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MVGGGNAVICGNGPSLKNIDYKRLPKEFDVFKCNQFYFEDRYFVGKNIKYAFFNPFVFFE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MVGGGNAVICGNGPSLKNIDYKRLPKEFDVFKCNQFYFEDRYFVGKNIKYAFFNPFVFFE 60
Qy 61 QYYTSKKLIQNGEYIIENIVCSTFNLPLIDNENFIKLFPSYFCDALLGHEVLAKINDFFA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 QYYTSKKLIQNGEYIIENIVCSTFNLPLIDNENFIKLFPSYFCDALLGHEVLAKINDFFA 120
Qy 121 FVKYNEIYENKRITSGIYMCAAAVALGYKNIYLTGIDFYDDKNNMYAFESKQHNILSLLP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 FVKYNEIYENKRITSGIYMCAAAVALGYKNIYLTGIDFYDDKNNMYAFESKQHNILSLLP 180
Qy 181 NFKNKDSVYEAHSKNFDLETLIFLKEKYNVNFYALNENSPISKYIDLAPIENSNFILKDK 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 NFKNKDSVYEAHSKNFDLETLIFLKEKYNVNFYALNENSPISKYIDLAPIENSNFILKDK 240
Qy 241 PSNYINDILIPNSKYKNTIYKVQNQDSKLKQNIYYKLFKDLFHLPSDIKHYLKEKYANKN 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 PSNYINDILIPNSKYKNTIYKVQNQDSKLKQNIYYKLFKDLFHLPSDIKHYLKEKYANKN 300
Qy 301 R 301
|
Db 301 R 301
Since, the amino acid sequence of enzyme protein is the same, the intrinsic functional capability is deemed to be the same for the genetically modified cell comprising said enzyme protein. Thus, given the disclosure on record, an ODP rejection is deemed proper.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
Prosecution Insights