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 with traverse of the invention of Group I, claims 1-9 and 16, in the reply filed on 05/26/2026 is acknowledged. The traversal is on the ground(s) that the cited reference does not teach the newly-added limitation in the amended claims of 05/26/2026. This argument has been fully considered but is not found persuasive because the prior art does teach or suggest all of the limitations of amended claim 1; see full discussion below under Claim Rejections – 35 USC 103.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 05/26/2026 has been entered. Claims 1-5 and 7-19 are pending in this US patent application. Claims 10-15 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/26/2026.
Claims 1-5, 7-9, and 16-17 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statement filed in this application on 05/26/2026 has been received and considered.
Claim Interpretation
Instant claim 1 is drawn to a composition. Claim 9 depends from claim 1 and recites a product-by-process limitation (“…wherein the exoglycosidases mixed together are co-dialyzed to reduce negative salt effect”) that seeks to limit the composition of claim 1 by a method step of dialysis. A product-by-process claim is limited only by the structure implied by the recited steps, not by the specific manipulations of the steps themselves. See MPEP § 2113. As such, any prior art composition that could have been produced by a process involving a step of co-dialysis will be interpreted to read on claim 9, regardless of whether the prior art specifically recites a step of co-dialysis. The Examiner notes that claim 9 does not establish any particular concentration of any ingredient in the composition that must be present after the recited co-dialysis. The Examiner further notes that any mixture of enzymes will result in a composition that theoretically could have been produced by a process involving a step of co-dialysis against a solution equivalent to the solution of buffers, salts, etc. that results from the mixing of the enzymes. As such, any prior art that reads on claim 1 will be interpreted to read on claim 9 as well.
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.
Claims 1-5, 7-9, and 16-17 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 and 8 recite a neuraminidase, “preferably alpha neuraminidase.” The phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). As such, one of ordinary skill in the art would be unable to determine the metes and bounds of claims 1 and 8, rendering them indefinite.
Because claims 2-5, 7-9, and 16-17 all either depend from or incorporate all of the limitations of the indefinite claim 1 and provide no further clarification of the indefinite language therein, these claims are also indefinite. Therefore, claims 1-5, 7-9, and 16-17 are rejected under 35 U.S.C. 112(b).
In the interest of compact prosecution, the Examiner has interpreted claim 1 without the indefinite phrase “preferably alpha neuraminidase.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-9, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Guttman et al., Fast Glycan Sequencing Using a Fully Automated Carbohydrate Sequencer, https://sciex.com/content/dam/SCIEX/pdf/tech-notes/all/Carbohydrate-Sequencer.pdf, 09/14/2017 (cited on the IDS filed 05/26/2026); in view of Mateo et al., Enz. Microb. Technol. 40: 1451-1463 (2007); Xu et al., Enz. Microb. Technol. 120: 36-42 (2019); Prozyme, Sialidase S Product Specification, 2017 (cited on the IDS filed 05/26/2026); R&D Systems, Recombinant human beta-Galactosidase-1, 2019 (cited on the IDS filed 05/26/2026; hereafter ‘R&D Systems A’); and R&D Systems, Recombinant human hexosaminidase A, 2020 (cited on the IDS filed 05/26/2026; hereafter ‘R&D Systems B’).
Guttman teaches sets of exoglycosidases for sequencing monoclonal antibody N-glycans, including sialidase, beta-galactosidase, and hexosaminidase (see entire document, including page 4; cf. claims 1 and 9; the Examiner notes that sialidase is a synonym for neuraminidase as recited in instant claim 1).
However, Guttman does not teach the presence of a peptide tag on the exoglycosidases, the immobilization of the glycosidases through the peptide tag, or the amounts of enzyme recited in instant claim 1.
Mateo teaches that the immobilization of enzymes improves the stability and activity of the enzymes and allows for them to be easily recovered for reuse (see entire document, including page 1452, left column, paragraphs 1-2).
Xu teaches that enzymes may be immobilized onto surfaces by engineering a common His-tag onto the enzyme and then incubating the His-tagged enzymes with Co2+-NTA agarose beads (see entire document, including page 37, left column, paragraph 2, to right column, paragraph 3). Enzymes can be engineered with His-tags on the N- and C-termini (page 37, left column, paragraph 3; cf. claims 1, 4-5, and 17).
His-tagged variants of sialidase, β-galactosidase, and hexosaminidase are all commercially available (see entire documents of Prozyme 2017, R&D Systems A, and R&D Systems B, respectively).
While Guttman does not teach that the three exoglycosidase enzymes used in the set of exoglycosidases for sequencing monoclonal antibody N-glycans are immobilized, it would have been obvious to one of ordinary skill in the art to do so because Mateo teaches that immobilizing enzymes improves the stability and activity of the enzymes and allows for them to be easily recovered for reuse. It would have been obvious to perform this immobilization by engineering His-tags onto either or both of the N- and C-termini of the three exoglycosidase enzymes because Xu teaches that enzymes may be immobilized onto surfaces by engineering a common His-tag onto the enzyme and then incubating the His-tagged enzymes with Co2+-NTA agarose beads and that enzymes can be engineered with His-tags on the N- and C-termini. In addition, His-tagged variants of the three exoglycosidase enzymes used in Guttman’s glycan sequencing method are all commercially available, as taught by Prozyme and the two references cited from R&D Systems. One of ordinary skill in the art would have a reasonable expectation that performing the method of Guttman with sialidase, β-galactosidase, and hexosaminidase that had been His-tagged as taught by Prozyme and R&D Systems and attached to Co-NTA beads as taught by Xu would successfully allow for the sequencing method of Guttman to be performed with the improved ability to recycle and reuse the immobilized enzymes as taught by Mateo. The Examiner notes that generating the composition suggested by the combination of Guttman, Mateo, Xu, Prozyme, R&D Systems A, and R&D Systems B would intrinsically result in the enzymes being immobilized on the same matrix support (cf. claim 1) and in the presence of ‘subsets’ as recited in instant claims 7-8 (the sialidase present in the composition could be interpreted as the sialidase ‘subset’ of claims 7-8, and any portion of the composition containing sialidase and β-galactosidase can be interpreted as that ‘subset’ of claim 8) and would intrinsically require a kit as recited in instant claim 16.
Guttman, Mateo, Xu, Prozyme, R&D Systems A, and R&D Systems B do not teach the ratio of hexosaminidase amount to sialidase/β-galactosidase amount recited in instant claims 1-3. However, the levels of the various enzymes in the composition would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of the enzymes in a set of enzymes for glycan sequencing because the concentration of a glycosidase enzyme in a set of enzymes for glycan sequencing is an art-recognized, result-effective variable known to affect the cleavage of the glycans to be sequenced, which would have been optimized in the art to provide the desired amount of cleavage.
Therefore, claims 1-5, 7-9, and 16-17 are rendered obvious by Guttman in view of Mateo, Xu, Prozyme, R&D Systems A, and R&D Systems B and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 08/17/2026
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