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 .
Election/Restrictions
Applicant’s election without traverse of group II, drawn to a recombinant cell in the reply filed on December 17, 2025 is acknowledged. Applicant’s election of species drawn to a bacterium cell type, oligosaccharide R group, lacto-N-fucopentaose I (LNFP-I; Fuc-α1,2-Gal-β1,3-GlcNAc-β1,3-Gal-β1,4-Glc) as a type of Fuc-α1,2-Gal-R, GalNAc-α1,3-(Fuc-α1,2)-Gal-β1,3-Gal-β1,4-Glc(GalNAc-LNFP-1) as type of a α-1,3-glycosylated form of Fuc-α1,2-Gal-R, α-1,3-Nacetylgalactosaminyltransferase as a type of α-1,3-N-acetylgalactosaminyltransferase, and UDP-N-acetylgalactosamine (UDP-GalNAc) as a nucleotide sugar without traverse is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s state claims 50-54, 57, 69-72, 78, 82, 83, 85, 95, and 96 read upon the elected species. Upon review of claim 58, it appears to be included within the elected species and is not currently withdrawn. Claims 1-4, 8, 9, 14, 20-23, 27, 30, 34, 35, 38, 44, 46, 48, 61, 62, 63, 87, 88, 90, 91, 92, 93, 94, and 97 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 17, 2025.
Claims 50-54, 57, 58, 69-72, 78, 82, 83, 85, 95, and 96 are currently under examination.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application, filed on August 28, 2023. The priority date is August 10, 2020.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 14, 2023, December 12, 2023, and December 17, 2025 are being considered by the examiner. The signed IDS forms are attached with the instant office action.
Drawings
No drawings are filed in the instant application.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claims 50-54, 57, 58, 69-72, 78, 82, 83, 85, 95, and 96 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 claimed invention. The claims are rejected for failing to describe a genus of cells with a genus of components for metabolically engineering the cell with the ability to produce any α-1,3 glycosylated form of fucose-α-1,2-galactose-R, wherein the α-1,3 glycosylation occurs at the terminal fucose-α-1,2-galactose group of any fucose-α-1,2-galactose-R structure. The structure for the genus of components is not described.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
MPEP § 2163 further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163 does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163.
In the instant case, the claims are drawn to a genus of cells with a genus of components for metabolically engineering the cell with the ability to produce any α-1,3 glycosylated form of fucose-α-1,2-galactose-R, wherein the α-1,3 glycosylation occurs at the terminal fucose-α-1,2-galactose group of any fucose-α-1,2-galactose-R structure. The structure for the genus of components is not described.
The level of skill in the art is high and the knowledge in the art is still evolving and not predictable. The structure of components envisioned for the claimed genus of any cell with the genus of enzymes and substrates is undescribed. Cioce et al. a reference published after the priority date of the instant application still shows the difficulty of studying protein glycosylation (see entire document, particularly 1st paragraph of Introduction and last sentence of 1st paragraph). Cid et al. disclose the repertoire of functional amino acids varied among transferases, suggesting that structures around condons 266-268 of human A transferase / B transferase differentially affected the interaction between donor nucleotide-sugar and acceptor substrates (see entire document, with reference to table 1 for reaction products). Yamamoto and Hakomori disclose how sugar-nucleotide donor specificity of histo-blood group A and B transferases is based on amino acid substitutions (see entire document).
As stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad genus. Claims are broadly generic to all possible cells and any fucose-α-1,2-galactose-R structure, any α-1,3 glycosyltransferase, and any nucleotide-sugar donor encompassed by the claims. The possible variations are enormous. Since the MPEP states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure, it is "not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence." MPEP § 2163. Here, though the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of multiple fucose-α-1,2-galactose-R structures (encompassing any R structure), any α-1,3 glycosyltransferases, and any nucleotide-sugar donors encompassed by the claims. Moreover, the specification lacks sufficient variety of species to reflect this variance in the genus of components claimed.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 102
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 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(s) 50-54, 57, 58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cid et al. (Scientific Reports 9: 846 (2019)).
Cid et al. disclose the transformation of HeLa(FUT2) cells with B transferase with donor UDP-galactose to produce blood group B antigen (Galα1-3(Fucα1-2)Galβ1-3GlcNAc- (see entire document, particularly Table 1, 3rd row).
Conclusion
No claims are allowed.
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/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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