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 .
Applicant's response to the previous Office action, dated April 20, 2026, and supplemental response, dated September 3, 2026, have been received. By way of these submissions, Applicant has amended claims 1, 5, 15, and 23, cancelled claims 16, and introduced new claim 34.
Claims 1-8, 14-15, 17, 23-24, 26, 28, and 30-34 are pending in the application. Claims 31-33 remain withdrawn from consideration, pursuant to the Restriction Requirement mailed December 2, 2025.
Claims 1-8, 14-15, 17, 23-24, 26, 28, 30, and 34 are therefore under examination before the Office.
The rejections of record can be found in the previous Office action, dated March 23, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 6, 2026 was filed after the mailing date of the first Office action on the merits on March 23, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 1 as amended recites that each protein monomer comprises "at least one core sequence having at least 90% sequence identity to the heptad repeat sequence of SEQ ID NO. 1." This limitation is interpreted to mean that each monomer must comprise a sequence with at least 90% sequence identity to only the heptad recited in SEQ ID NO: 1. According to Applicant's specification, this heptad repeat sequence is IxxIxxx, wherein x can be any amino acid. The heptad repeat sequence of Applicant's SEQ ID NO: 1 is seven amino acids long. A 90% sequence identity permits no substitutions, as one substitution in this sequence would result in an 85% sequence identity.
Response to Amendment
Claims 1-8, 14-15, 17, 23-24, 26, 28, and 30 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for GCN4-pII, does not reasonably provide enablement for performing the claimed method with the entire scope of oligomeric proteins permitted by the claim.
Applicant argues that that the claims as amended recite a percentage identity to 90%, which is a permissible and minimal degree of variation, and a skilled person could practice the full scope of the claim without undue experimentation.
Applicant's arguments have been considered fully but are not found to be persuasive.
As stated above, the heptad repeat sequence of Applicant's SEQ ID NO: 1 is seven amino acids long. A 90% sequence identity permits no substitutions, as one substitution in this sequence would result in an 85% sequence identity.
However, the claim is broader than just requiring this heptad repeat. The protein must also have a coiled coil structure comprising at least two monomer peptides, wherein each monomer peptide, which may be the same or different, is capable of forming an alpha helix and comprises at least one core sequence with at least 90% sequence identity to only the heptad recited in SEQ ID NO: 1, and must bind LPS to form a protein-lipopolysaccharide complex.
Applicant's specification does not describe other features which are essential to make a protein with the claimed properties of binding LPS, and wherein each monomer peptide, which may be the same or different, is capable of forming an alpha helix. Applicant's specification suggests that a great deal of leeway is possible in making the claimed protein (see page 11), but gives no guidance as to how one might make a protein with these properties, besides trial and error.
Applicant's arguments in the reply dated August 20, 2026 also states alterations to the peptide sequence may abolish LPS binding, and the act of altering amino acids while conserving or improving the LPS binding properties of the protein. This further suggests that this field was highly unpredictable.
Given the breadth of the scope of the claims, the lack of predictability in the art, the lack of direction provided by the specification, the presence of only one working example within the vast genus, the quantity of experimentation needed to make or use the invention based on the content of the disclosure, it would take undue trials and errors to practice the entire scope of the invention.
This rejection is therefore maintained and extended to encompass new claim 34.
Claim 5 was previously 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.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claims 23 and 24 were previously 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.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
Claims 1-8 and 14-17 were previously rejected under 35 U.S.C. 103 as being unpatentable over Srivastava (J Biol Chem. 2012 Jan 13;287(3):1980-95, cited in IDS) in view of Harbury (Science. 1993 Nov 26;262(5138):1401-7, cited in IDS) and Wykes (US20190389929A1).
Claims 23-24, 26, 28 and 30 were previously rejected under 35 U.S.C. 103 as being unpatentable over Srivastava, Harbury, and Wykes as applied to claims 1 and 2 above, and further in view of Adamik (Arch Immunol Ther Exp (Warsz) 2015 Dec;63(6):475-83).
Applicant argues that not every leucine zipper or isoleucine zipper would possess the claimed properties of being able to bind to LPS, and the cited references do not teach a peptide with the claimed properties. Applicant further argues that modifications to the peptide of Srivastava may result in loss of binding affinity for LPS. Applicant further argues that GCN4-pII performs substantially better in binding LPS than the peptide of Srivastava, and the specific sequences of the GCN4-pII peptide causes drastic structural and functional changes that also led to very different mechanisms of LPS interaction, which could not have been predicted by the skilled person.
Applicant's arguments are persuasive, and the above rejections under 35 U.S.C. 103 are hereby withdrawn.
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 1-8, 14-15, 17, 23-24, 26, 28, 30, and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for GCN4-pII, does not reasonably provide enablement for performing the claimed method with the entire scope of oligomeric proteins permitted by the claim. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) (reversing the PTO’s determination that claims directed to methods for detection of hepatitis B surface antigens did not satisfy the enablement requirement). In Wands, the court noted that there was no disagreement as to the facts, but merely a disagreement as to the interpretation of the data and the conclusion to be made from the facts. In re Wands, 858 F.2d at 736-40, 8 USPQ2d at 1403-07. The court held that the specification was enabling with respect to the claims at issue and found that "there was considerable direction and guidance" in the specification; there was "a high level of skill in the art at the time the application was filed;" and "all of the methods needed to practice the invention were well known." Id., 8 USPQ2d at 1406. After considering all the factors related to the enablement issue, the court concluded that "it would not require undue experimentation to obtain antibodies needed to practice the claimed invention." Id., 8 USPQ2d at 1407.
The claimed subject matter pertains to a method of binding lipopolysaccharide (LPS), by contacting LPS or a sample containing LPS to an oligomeric protein, wherein the oligomeric protein has a coiled coil structure comprising at least two monomer peptides, wherein each monomer peptide, which may be the same or different, is capable of forming an alpha-helix and comprises at least one core sequence having at least 90% sequence identity to the heptad repeat sequence of SEQ ID NO. 1. This creates a large genus of many possible peptides, not all of which would be able to perform the claimed method.
Applicant's specification at pages 2-4 states that detection of LPS is problematic, due to a variety of concerns in specificity of the binding agent, false positive results, and masking of LPS in a sample. The ability to a protein to bind LPS is highly dependent upon its structure. For example, Srivastava (J Biol Chem. 2012 Jan 13;287(3):1980-95, cited in IDS) teaches that the leucine zipper motif is necessary for a protein to bind LPS, and alterations in this sequence may reduce or abolish LPS binding. This suggests a high level of unpredictability in the art.
Applicant's specification only recites one working example, that of GCN4-pII and its ability to bind LPS. The specification lacks guidance or further examples that may suggest to one of ordinary skill as to what alterations to the protein may be made that would retain the ability to bind LPS. There also does not appear to be a means to determine which sequence would possess the desired property besides making and testing each sequence.
There is insufficient guidance and direction as well as objective evidence provided for performing the claimed method with the scope of proteins permitted. In view of the lack of guidance and working examples, undue experimentation would be required to practice the claimed method with a reasonable expectation of success across the entire claim scope.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. MPEP 2164.02. In view of the quantity of experimentation necessary, the limited working examples, the nature of the invention, the unpredictability of the art and the breadth of the claims, it would take undue trial and error to practice the claimed invention.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 6:00 to 2:00.
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, Samira Jean-Louis can be reached at (571) 270-3503. 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.
/PETER JOHANSEN/Primary Examiner, Art Unit 1644
