DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on January 14, 2026, has been received and entered.
Claim Disposition
3. Claim 1 has been cancelled. Claims 2-58 are pending. Claims 2-56 are under examination. Claims 57-58 are withdrawn as directed to a non-elected invention. The claims are only being considered to the extent that they pertain to the elected subject matter.
Claim Objection
4. Claims 2-56 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 2 is amended to read, “comprising:
synthesizing a galactosylated disaccharide or oligosaccharide [[utilizing]] using an N-acetylglucosamine…….”. The dependent claims hereto are also included.
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.
5. Claims 2-56 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) contain 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 claimed invention is directed to a method of synthesizing a galactosylated disaccharide or oligosaccharide (see claim 2 in its entirety). The claimed invention is overly broad and encompasses variants/fragments of the claimed structures that recite percentages such as 80% sequence identity (to SEQ ID NOs: 3, 4, 6-9, for example). The claimed invention is not adequately described because there are no indicia as to what specific structure is assigned to the polypeptide or for the claimed in the method.
Thus, the claimed invention is not adequately described. In addition no structure-function correlation is made for the claimed genus of structures. The claimed invention encompasses large variable genus of polypeptides, modifications, homologues, derivatives and variants thereof.
The art recognizes several types of proteins can be encoded by the same gene and that a single amino acid change can be detrimental to the protein structure-function. The claimed invention is overly broad and broadly read on any structure at least 80% identical which is not adequately described. The claimed invention is overly broad and not commensurate in scope with the disclosure in the specification..
The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir.1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of structures, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims which is vast with respect to the genes, proteins and virus.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
6. Claim(s) 2-4 and 35-36 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Sheares et al. (J Biol Chem., 1982; 257(2):599-602).
Sheares et al. teach the biosynthesis of galactosyl-beta 1,3-N-acetylglucosamine has been demonstrated using membrane preparations from pig trachea. Unlike the UDP-galactose:2-acetamido-2-deoxy-D-glucose 4 beta-galactosyltransferase, which is inhibited by high levels of N-acetylglucosamine, the UDP-galactose:N-acetylglucosamine 3 beta-galactosyltransferase shows no inhibition at 200 mM N-acetylglucosamine. About 80% of the total disaccharide synthesized at 200 mM N-acetylglucosamine was base-labile suggesting the 1,3-linkage, alpha-Lactalbumin inhibits galactose incorporation into galactosyl-beta 1,4-N-acetylglucosamine but has little or no effect on the activity of the 1,3-galactosyltransferase. Escherichia coli beta-galactosidase readily hydrolyzed the base-stable product, but not the base-labile component. The apparent 1,3-linked disaccharide was reduced with NaBH4 and was isolated by Bio-Gel P-2 column chromatography. Methylation analysis by gas chromatography/mass spectrometry showed tetramethyl galactose and a 3-substituted N-acetylglucosaminitol. Neither the beta 1,4 nor the beta 1,3 disaccharide was hydrolyzed by green coffee bean alpha-galactosidase. Both disaccharides were readily hydrolyzed by bovine testes beta-galactosidase. This is the first report on the galactosyltransferase which catalyzes the synthesis of the galactosyl-beta 1,3-N-acetylglucosamine linkage such as found in the Type I chain of human blood group substances. A tissue survey in rats showed only rat intestine to have readily detectable UDP-galactose: N-acetylglucosamine 3 beta-galactosyltransferase activity. The intestinal membrane fraction like the tracheal enzyme catalyzes the synthesis of two disaccharides as judged by base treatment, and these appear to be the beta 1,3 and beta 1,4 isomers of galactosyl-N-acetylglucosamine (see abstract). The claims encompass any fragment, derivative or variant thereof, thus the art anticipates. Therefore, the limitations of the claims are met by the reference.
Response to Arguments
7. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed because applicant’s comments are moot. Note that the rejections of record under 112, first paragraph and under art remains for the reasons stated above and herein. Note also that the rejections have been altered to reflect amendments made to the claims. Applicant traverses the rejection under 112, first paragraph by stating that claim 2 has been amended, and that it is now structurally defined with a defined genus. This argument is not persuasive because the claim still recite at least 80% sequence identity to the recited sequences. Although the claim language has been amended to remove phrases such as homologues, variant and derivatives, the recitation of at least 80% sequence identity reads on variant, fragment, homologue, and derivative thereof. Therefore the claimed invention is not adequately described because there is no alignment between the recited activity in a specific structure. Applicant has not demonstrated possession of the entire genus that is encompassed by the claim language. The rejection under art remains meritorious because of the breath of the claims which still encompasses any fragment, variant or homologue with the recited at least 80% sequence identification. Applicant traverses the rejection stating that the amendments are not taught by the reference however the specific enzyme and synthesis is taught in the art and the structure being so varied with no specific modifications is within the skill of the ordinary artisan. The method has one simple step which is synthesizing and the art discloses synthesizing. Applicant argues that the activity is not disclosed in the cited art this argument is not persuasive because the product is disclosed and would inherently have the activity. Moreover, applicant asserts that the activity is retained with the at least 80% language, however, there is no guarantee as the claim language does not specify where in the sequence is mutated or what mutation, could be for instance deletion of a section of the structure. Therefore, the rejection has been maintained based on the breath of the claims.
Conclusion
8. No claims are presently allowable.
9. Applicant’s amendment necessitated the new/modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
Prosecution Insights