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 reply to the Restriction Requirement, dated January 26, 2026, has been received. By way of this reply, Applicant has elected Group I: claims 1-8, 14-17, 23-24, 26, 28 and 30.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 26, 2026.
Claims 1-8, 14-17, 23-24, 26, 28 and 30 are therefore under examination before the Office.
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, 14-17, 23-24, 26, 28 and 30 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 60% sequence identity to the heptad repeat sequence of SEQ ID NO. 1. As SEQ ID NO: 1 has 30 amino acid residues, the claim permits up to nine substitutions within the sequence, without limitation.
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.
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, especially since only a 60% identity to SEQ ID NO: 1 permits a genus of trillions of possible protein sequences, not all of which would possess the claimed functionality of binding 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 on 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.
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.
Claim 5 is 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.
Claim 5 recites exemplary claim language by the use of the term "preferably". Description of examples or preferences is properly set forth in the specification rather than
the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. It is not clear if the examples presented in the claims are meant to be limiting. MPEP 2173.05(d).
Claims 23-24 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.
Claim 23 depends upon claim 22, which is currently cancelled. It is impossible to determine how claim 23 is meant to limit the invention.
For the purposes of claim construction, it is assumed that claim 23 depends from claim 1.
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.
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 1-8 and 14-17 are 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).
Srivastava teaches a method, comprising contacting lipopolysaccharide (LPS) with a peptide that binds the LPS in solution (page 1984, left column, first paragraph and Figure 2).
Srivastava further teaches that it is the leucine zipper motif of this peptide that allows it to bind LPS (page 1984, right column).
Srivastava further teaches labeling the peptide with a fluorescent probe (i.e., a detection moiety, see Applicant's specification at page 27) (page 1982, left column, second paragraph), which is pertinent to claims 23 and 28.
Srivastava further teaches detection of binding of LPS to the peptide (Figure 9), which is pertinent to claim 24.
However, Srivastava does not teach the claimed polypeptide.
Harbury teaches that the leucine zipper peptide GCN4 has a coiled coil structure made of alpha-helices, and a characteristic seven-residue repeat a-b-c-d-e-f-g (i.e., a heptad motif), with hydrophobic residues at positions a and d (page 1401, left column, first paragraph), which is pertinent to claims 2-3.
Harbury further teaches that changing the leucine residues at the a and d positions of the heptad repeat to isoluecine, a hydrophobic residue (see Applicant's specification at page 12), result in a trimer configuration (page 1401, right column, second paragraph), which is pertinent to claims 8 and 14-17.
Wykes teaches that amino acid substitutions in the a and d residues of a synthetic peptide representing the GCN4 leucine zipper domain; for example, when all residues at position a and d are changed to isoleucine, the resultant peptide spontaneously forms a trimeric parallel coiled coil, and such a polypeptide would have a sequence of MKQIEDKIEEILSKIYHIENEIARIKKLI, which is greater than 90% identical to Applicant's SEQ ID NO: 1 (para. 0212-0213). According to Applicant's specification at page 9, this sequence comprises multiple repeats of the a-b-c-d-e-f-g heptad motif (IxxIxxx), which is pertinent to claims 4-6 and 8.
Wykes further teaches the use of linker sequences (para. 0227-0228), which is pertinent to claim 7.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Srivastava, Harbury, and Wykes to arrive at the claimed invention. Starting from the teaching of Srivastava, it was known that proteins with leucine zipper motifs were useful in binding LPS. Harbury and Wykes teach that modified versions of GCN4 are examples of proteins with leucine zippers. One of ordinary skill in the art could have applied the GCN4 variant of Harbury and Wykes to the method of Srivastava, with each component of the combination performing its known, usual function, and the combination would have yielded nothing more than predictable results.
Claims 23-24, 26, 28 and 30 are 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).
The teachings of Srivastava, Harbury, and Wykes have been described supra. However, Srivastava, Harbury, and Wykes do not teach removing LPS from a blood sample.
Adamik teaches a method of binding LPS, comprising treating blood with a device that comprises polyethylene porous plates with a covalently bound peptide with a high affinity for endotoxins such as LPS, then removing the LPS from the bloodstream (page 476, right column, second paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Srivastava, Harbury, Wykes, and Adamik to arrive at the claimed invention. Starting from the teachings of Srivastava, Harbury, and Wykes polypeptides such as those instantly claimed were known to be useful to bind LPS. Adamik teaches a device that relies upon a peptide binding LPS to remove the LPS from a blood sample. One of ordinary skill could apply the polypeptide of Srivastava, Harbury, and Wykes to the device and method of Adamik by simple substitution, with each component of the combination performing its known, usual function, and the combination would have yielded nothing more than predictable results.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644