DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of the Species: SEQ ID NO: 2, in the reply filed on 1/22/26 is acknowledged.
Claims 1-11 are currently pending.
Claim Rejections - 35 USC § 112-2nd paragraph
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 1-11 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.
Claims 1-11 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “A recombinant microorganism transformed to express
is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The enzymes set forth in SEQ ID NOS: 1-5 are from different sources and comprise amino acid sequences that are significantly structurally different from one another, e.g., 40-50% similarity only. Accordingly, transformed microorganisms comprising these different sequences would be structurally different.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single substantial structural similarity as well as a common use.
Claim 1 is also vague and indefinite because it does not positively recite that the recombinant microorganism has been transformed with heterologous nucleic acid which encodes the having the amino acid sequence consisting of SEQ ID NO: 2, e.g., a vector or an expression cassette, etc. The claim should positively state, for example, a recombinant microorganism comprises a heterologous nucleic acid sequence as set forth in SEQ ID NO: X (insert nucleic acid) and/or a recombinant microorganism comprising a heterologous nucleic acid sequence which encodes the amino acid sequence set forth in SEQ ID NO: 2. The claim should be limited to the elected Species. Appropriate clarification and/or correction is required.
Claims 1-11 are also vague and indefinite because the recombinant microorganism according to the instant specification on page 5, lines 9-15, may have fucose synthesis activity, or improve fucose synthesis activity and in order to produce 2'- fucosyllactose, it is same that any microorganism fundamentally need to be introduced foreign α- 1,2-fucosyltransferase, but genetic characteristics of the strain of each microorganism itself are different, so Escherichia coli or Bacillus megaterium can produce 2'-fucosyllactose by inserting only α-1,2-fucosyltransferase, but Bacillus subtilis, Corynebacterium, yeast microorganism, and the like may additionally be introduced fucose synthase. The claims should be amended to include the specific microorganism used and not a vague ‘any microorganism from any source’ or a microorganism defined only by the expression of certain genes. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. The claims as they stand are incomplete and fail to provide adequate structural properties to allow for one to identify what is being claimed. Appropriate clarification and correction is required.
Claim 5 is vague and confusing for the wording:
“…does not have 2'-fucosyllactose productivity before recombination, and obtain 2'- fucosyllactose productivity by recombination”
because this is improper English. The metes and bounds of this claim are not understood. Further, it is unclear what type of microorganism this entails. The claim should positively state the host cell origin. Appropriate clarification and/or correction is required.
Claim 6 is vague and indefinite because it is unclear if this fucose synthesis gene is inherent to the recombinant host cell or also a heterologous nucleic acid. Further, it is unclear what microorganism this claim covers. Additionally, the mere recitation of a name, i.e., fucose synthesis gene, to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the amino acid sequence of the protein or nucleic acid which it encodes it, which would allow for one to identify the protein without ambiguity. The mere recitation of a name does not adequately define the claimed structure. Appropriate clarification and/or correction is required.
Claims 7-9 are also vague and indefinite because the mere recitation of a name, i.e., lactose membrane transport protein or Lac12 or phosphomannomutase, to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the amino acid sequence of the protein or nucleic acid which it encodes it, which would allow for one to identify the protein/gene without ambiguity. The mere recitation of a name does not adequately define the claimed structure. Additionally, it is unclear if these are intended to be inherent to the microorganism or if they are heterologous sequences. If they are inherent the name of the microorganism by Genus and species should be included to avoid unclarity. If they are heterologous, the sequences need to be included. As currently, written the claim is very confusing.
Appropriate clarification and/or correction is required.
Claim 10 is vague and confusing because it does not adequately define the recombinant microorganism and the functional requirements are not readily comparable. The claim recites:
The recombinant microorganism according to claim 1, wherein the recombinant microorganism has 2'-fucosyllactose productivity of 2-fold or higher compared to a control group comprising α -1,2-fucosyltransferase derived from Helicobacter pylori.
First, it is unclear what is meant by the “control group.” What microorganism type is in this group? Different results would occur with different types of recombinant microorganisms. This comparison, accordingly, cannot be readily made as the control group is variable.
Additionally, the name alone to describe the α-1,2-fucosyltransferase from Helicobacter pylori in claim 10 is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the amino acid sequence of the protein or nucleic acid which it encodes it, which would allow for one to identify the protein/gene without ambiguity. The mere recitation of a name does not adequately define the claimed structure. Also, the term “derived” does not provide the character or properties from the source that are to be retained in the final product, e.g., paper is derived from wood but is very different from wood. The phrase “derived from” should be changed to “isolated from”. Appropriate clarification and/or correction is made.
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.
Claim(s) 1-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo Jin Ho et al (KR 10-1731263 B1; May 2, 2017; provided by Applicants) in view of NCBI. Genbank accession no. WP_098448980.1 (19 October 2017; provided by Applicants)
Hoe discloses a recombinant Corynebacterium glutamicum transformed to express a transferase (α-1,2- fucosyltransferase); and a method for producing 2'-fucosyllactose, the method being characterized by culturing the recombinant Corynebacterium glutamicum in a medium supplemented with lactose (see abstract, claims 1 and 5, and paragraph [0001]). The claims differ only in that the instant claims recite the use of a α-1,2-fucosyltransferase that comprises SEQ ID NO: 2.
However, it would have been prima facie obvious to one of ordinary skill in the art that said difference could be easily derived by a person ordinary skill in the art by substituting α-1,2-fucosyltransferase in Ho for the α-1,2-fucosyltransferase taught in the NCBI database since α-1,2-fucosyltransferase that comprises SEQ ID NO: 2 which is 100% identical to Applicant’s SEQ ID NO: 2 and would be a functional equivalent.
Additionally, Corynebacterium glutamicum is considered to be a generally recognized as safe (GRAS) strain (see abstract, and paragraphs [0018] and [0030] of Ho). The features in instant claims 5-10 are inherent properties to the C. glutamicum host cell.
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.
Claim s 1-11 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/268,370 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims recite that the recombinant microorganism is Bacillus sp, while independent claim 1 allows for any recombinant microorganism. However, the instant claims 3 and 4 do include Bacillus sp as the recombinant microorganism. Co-pending claim 4 recites that the gene expression cassette in the recombinant Bacillus is a α-1,2-fucosyltransferase that comprises SEQ ID NO: 2. The SEQ ID NO: 2 in the co-pending application is identical to the SEQ ID NO: 2 of the instant application. The scope of the present claims and the scope of the co-pending claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Thomas Visone, can be reached at (571) 270-0684.
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist whose telephone number is (571) 272-0500.
/JENNIFER E GRASER/ Primary Examiner, Art Unit 1645 4/21/26
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