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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 11/25/2025.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 11/25/2025 of group II, claim 14 is acknowledged.
Upon further consideration, the previous restriction among groups I-II and IV-V has been withdrawn. Thus, the restriction groups has been changed: present Group I = claims 1-14 and 16-20, present Group II = claim 15. The previous groups related to present groups are converted to species elections.
Applicant has elected in the Reply filed on 11/25/2025 the following species:
A. the glycosylation is N-linked glycosylation (claim 11).
B. the method of the method of producing a protein or lipid or cell or tissue or organism having a desired lipid or glycosylation pattern comprising determining a glycosylation pattern and producing the glycosylated protein or lipid or cell (claim 14).
Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The Restriction/Election Requirements are thus deemed proper and are made FINAL.
Claims 1-20 are pending.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 11/25/2025.
Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the Reply filed on 11/25/2025.
Claims 1-14 and 19-20 are under examination in this Office Action.
Claim Rejections - 35 USC § 112 - (b)
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 the second paragraph of 35 U.S.C. 112 (pre-AIA ):
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 1-14 and 19-20 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 applicant regards as the invention. Claims 2-14 and 19-20 depend directly or indirectly from claim 1.
Claim 1 is indefinite and unclear in the recitation of “activities of other enzymes”. Clarification and/or correction is required.
Claim 6 states "the control product" which lacks antecedent basis. Clarification and/or correction is required.
Claim 19 is indefinite and vague in the recitation of Tables. See Ex parte Fressola, 27 USPQ2d 1608 (Bd. Pat. App. & Inter. 1993). MPEP § 2173.05(s) states the following: Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). Correction is required.
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.
Claims 1-14 and 19-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. Claims 2-14 and 19-20 depend directly or indirectly from claim 1.
The claim 1 limitations directed to an abstract idea are a method for determining the biosynthetic basis of a glycosylation pattern or lipid pattern on a cell, glycolipid, tissue, or a protein to be produced by a cell, or an organism to be engineered, comprising: a. quantifying the impact on the abundance of a glycan or lipid, stemming from enzyme mutation, gene/protein expression changes, or activities of other enzymes to learn enzyme specificity and enzyme interaction rules b. applying learned enzyme specificity and enzyme interaction rules for glycosylation pattern or lipid pattern to predict an outcome of enzyme mutations or gene/protein expression changes on the glycosylation or lipid pattern on a studied protein, lipid, or cell.
The claim 7 limitations directed to an abstract idea are wherein the method utilizes a Markov model.
The claim 8 limitations directed to an abstract idea are wherein the method to quantify enzyme mutational effects on reactions catalyzed by other enzymes utilizes Markov transition probabilities.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not recite any additional elements.
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.
Claims 1-14 and 19-20 are rejected under 35 U.S.C. 102(a) as being anticipated by Spahn et al. (11/24/2016) PCT International Patent Application Publication WO 2016/187341 A1 cited in the 9/27/2022 IDS corresponding to (04/12/2018) US Patent Application Publication 2018/0101643 A1 (hereinafter referred to as "Spahn").
With regards to claims 1-14 and 19-20, Spahn teaches:
a) as in claims 1-14 and 19-20, a method for determining the biosynthetic basis of a glycosylation pattern to be engineered, comprising: a. quantifying the impact on the abundance of a glycan or lipid, stemming from enzyme mutation, gene/protein expression changes, or activities of other enzymes to learn enzyme specificity and enzyme interaction rules b. applying learned enzyme specificity and enzyme interaction rules for glycosylation pattern to predict an outcome of enzyme mutations on the glycosylation pattern on a studied protein; where the enzyme is a glycosyltransferase (GT); wherein the enzyme mutations occur by natural mutations; wherein the mutations or gene occur on a single enzyme; wherein the lipids or glycans are free; wherein the biological source of the glycosylation pattern pattern is the same product; wherein the method utilizes a Markov model; wherein the method to quantify enzyme mutational effects on reactions catalyzed by other enzymes utilizes Markov transition probabilities; wherein enzyme mutations are in different enzymes; wherein the cell is a eukaryotic cell; wherein the glycosylation is N linked glycosylation; wherein the organism is a microbe;. a method of producing a protein having a desired lipid or glycosylation pattern comprising determining a glycosylation pattern and producing the glycosylated protein; where the enzyme is selected from table 1; wherein the tissue is skin (see Table 1, Figures 7-11, 37 and 38, and [0006] to [0089]). Thus, Spahn anticipates the present claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684