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
Claims 1-4 and 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected method to determine a glycosylation identity, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/19/2026.
Applicant's election with traverse of claim 5 in the reply filed on 08/19/2026 is acknowledged. The traversal is on the ground(s) that claim 1-18 are linked by a single general inventive concept or a corresponding special technical feature. Furthermore, the applicant asserts that Shah reference is not directed at determining the particular glycan indices and does not disclose the indices of the present claims. This is not found persuasive because the special technical feature that is found in Groups 1-6 is "submitting the bio. However, Shah teaches submitting the biological molecule to an LC-MS analysis (pg. 1003, left column, para 2) and determining at least 3 glycan indices to determine the glycan identity (pg. 1003, left column, para 3). Shah recites how the absence or presence of core fucose, N-acetylneuraminic acid (NANA), NGNA and hybrid types were used to determine the glycan identity (pg. 1003, left column, para 3). Thus, the special technical feature does not make contribution over the Shah reference.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 5 and 15-18 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: The claim recites at least one step or act. Thus, the claim is directed to a method, which is one of the statutory categories of invention. Claims 15-18 also are dependent upon claim 5 (Step 1: Yes).
Step 2A Prong One: Claim 5 recites a judicial exception and identify the abstract idea/law of nature/natural phenomenon. In claim 5, step (c) recites the determining the deviation between the calculated value and the reference values. Comparing a sample with a control sample is a type of evaluation which can be done in the a human mind. The "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions (See MPEP 2106(a)(2)(III)). Thus, the comparing step would fall under the abstract idea groups of mental processes. Further, Claim 5 also calculates values in step (b), which is a mathematical correlation which can be done on pen and paper, thus also an abstract idea. (Step 2A -Prong 1: Yes)
Step 2A Prong Two: The judicial exception is not integrated into a practical application because the claims do not impose any meaningful limits on practicing the abstract idea. Claim 5 describes releasing the batch of test biologic molecule after comparison. Also, the use of LC-MS analysis in step (a) is a data gathering step to be used in the abstract idea and therefore insignificant extra-solution (pre-solution) activity, and not a particular practical application (MPEP 2106.05(g)). Claim 15 recites a use for the test sample after the releasing step. Claim 16-18 recite specific parameters for the method. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea. (Step 2A -Prong 2: No)
Step 2B: There appears to be no additional steps which are significantly more than the abstract idea. Claim 5 mentions the LC-MS analysis which is not particular and well-understood, routine, and conventional in the prior art as referenced by Shah et al. Claims 5 does not have any steps or features which are significantly more. Claim 5 is ineligible. Claims 15-18 do not appear to have ‘significantly’ more. Claim 15 adds a use for the test biologic molecules after the comparison and release steps. Claims 16-18 merely add parameters for the glycosylation indices that should be used which are well understood routine and conventional as referenced in the prior art below. Since it is claimed at a high level of generality, there are no meaningful limitation claimed, such as a particular or unconventional machine or transformation of a particular article. (Step 2B: No)
Thus, claim 5 is ineligible. Claims 15-18 are dependent on Claim 5 and are also rejected.
Claim Rejections - 35 USC § 103
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 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 5, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over non patent literature "LC-MS/MS Peptide Mapping with Automated Data Processing for Routine Profiling of N-Glycans in Immunoglobulins" by Shah et al. as cited in the IDS submitted on 09/25/2023 in view non-patent literature “Supplementing glycosylation: A review of applying nucleotide-sugar precursors to growth medium to affect therapeutic recombinant protein glycoform distributions” by Blondeel et al.
Regarding claim 5, Shah teaches a method including submitting the test biologic molecule to LC-MS analysis (‘peptides’, pg 1001, Section: LC-MS/MS Peptide Mapping). Shah further teaches how the absence or presence of core fucose, N-acetylneuraminic acid (NANA), NGNA and hybrid types were used to determine the glycan identity (pg. 1003, left column, para 3) and then releasing the batch (pg 1000, left column) .
Shah does not teach calculating the value of at least three indices, and determining deviation between the calculated and the respective reference values.
However, Blondeel teaches the glycosylation of therapeutic proteins and how there is a lack of standardized metrics for observing shifts in glycoform distributions (glycosylation indices) (pg 1505, Abstract). Blondeel further teaches calculating the value of at least three indices (pg 1513, Section: 3.2 Glycoform distribution indexes), determining deviation between the calculated and the respective reference values (pg 1515, Fig. 5). Blondeel further teaches matching biosimilars to their reference biologics in glycan distribution to show that the differences are clinically insignificant (pg 1505, Section Introduction). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Shah by calculating the value of at least three indices, determining deviation between the calculated and the respective reference values, and matching the test biologic as biosimilar as taught by Blondeel for the benefit of comparing different degrees of glycosylation (pg 1514, Fig. 4) and determining if the differences are clinically insignificant (pg 1505, Section Introduction).
Regarding claim 15, Shah in view of Blondeel teaches the invention of claim 5. Shah further teaches the having glycosylation patterns like those found in human serum-derived antibodies could be important for activity and immunogenicity of the therapeutics (pg 1000, left column, para 1). Shah further teaches CHO cells are used in the biopharmaceutical industry (pg 1000, left column, para 1). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Shah with using the test biologic molecule for an active pharmaceutical ingredient because Shah teaches biologic molecules being used in the biopharmaceutical industry (pg 1000, left column, para 1) and biologic molecules with glycans have been known to be important for activity in therapeutics (pg 1000, left column, para 1).
Regarding claim 16, Shah in view of Blondeel teaches the invention of claim 5.
Shah does not teach that at least three indices are selected from: sialylation Index (S-index), Antennarity Index (A-Index), Sialylation extent (S-extent), Galactosylation Index (G-index), Mannose Index (M-Index), Core Fucosylation extent (F-Index).
Blondeel teaches that at least three indices are selected from: Sialylation Index (S-index), Antennarity Index (A-Index), Galactosylation Index (G-index), Mannose Index (M-Index), Core Fucosylation extent (F-Index) (pg 1513, Section: 3.2 Glycoform distribution indexes). Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify Shah with at least three indices are selected from: sialylation Index (S-index), Antennarity Index (A-Index), Galactosylation Index (G-index), Mannose Index (M-Index), Core Fucosylation extent (F-Index) as taught by Blondeel for the benefit of using common degrees of glycosylation (pg 1513, Section: 3.2 Glycoform distribution indexes).
Regarding claim 17, Shah in view of Blondeel teaches the invention of claim 16.
Shah does not teach Galactosylation Index (G-index), Mannose Index (M-Index), and Core Fucosylation extent (F-Index).
Blondeel teaches that at least three indices are selected from: Galactosylation Index (G-index), Mannose Index (M-Index), Core Fucosylation extent (F-Index) (pg 1513, Section: 3.2 Glycoform distribution indexes). Thus it would be obvious to one of ordinary skill in the art before the effective filing date to modify Shah with at least three indices are selected from: Galactosylation Index (G-index), Mannose Index (M-Index), Core Fucosylation extent (F-Index) as taught by Blondeel for the benefit of observing the effects of sugars (pg 1521, Section: 5 Conclusions).
Regarding claim 18, Shah in view of Blondeel teaches the invention of claim 16.
Shah does not teach Sialylation Index (S-Index), Antennarity Index (A-Index), and Sialylation Extent (S-Extent).
Blondeel teaches that at least three indices are selected from: Sialylation Index (S-Index), Antennarity Index (A-Index), and Sialylation Extent (S-Extent) (pg 1513, Section: 3.2 Glycoform distribution indexes). Although, Blondeel doesn’t explicitly teach sialyation extent, it teaches sialyation index which requires the same variables to calculate, thus the sialyation extent can be calculated as a matter of design choice. Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Shah with at least three indices are selected from: Sialylation Index (S-Index), Antennarity Index (A-Index), and Sialylation Extent (S-Extent) as taught by Blondeel for the benefit of observing sialic acid moieties as they are therapeutically more desirable (pg 1515, left column).
Conclusion
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/H.R.B./ Examiner, Art Unit 1798
/CHARLES CAPOZZI/ Supervisory Patent Examiner, Art Unit 1798
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