DETAILED ACTION
Examiner acknowledges receipt of the reply filed 3/30/2026, in response to the restriction requirement mailed 1/30/2026.
Claims 1-25 are pending. Claims 8-25 have been withdrawn from further prosecution for the reasons set forth herein.
Claims 1-7 are being examined on the merits in this office 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 .
Priority
The filing receipt dated 7/28/2023 provides the following information:
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Election/Restrictions
Applicant's election of Group I (claims 1-7) with traverse in the reply filed on 3/30/2026 is acknowledged. The traversal is on the ground(s) because the written opinion and IPRP (at the PCT stage) did not find lack of unity of invention that the examiner may not assert lack of unity of invention at the national stage. Applicant further asserts that such a finding leads to unnecessary delay and expenses, as well as duplicative examination by the Patent Office (reply filed 3/30/2026 at pp. 4-5).
Applicant provides an excerpt from MPEP 1893.03(d) [which correlates with form paragraph 18.18] for the definition of a special technical feature (reply at p. 4). Applicant further asserts:
The Office Action's requirement that the special technical feature recited by the claims be patentable over the cited reference(s) confuses the Unity of Invention requirement with the requirements for patentability. Unity of Invention is applied not to determine patentability, but whether the claims are sufficiently related that they should be examined in a single application. If the Office Action's apparent requirement that claims be patentable over the cited reference(s) to meet Unity of Invention was consistently applied, no claims could pass Unity of Invention without also being allowable. Such a result is clearly not consistent with the intent of Unity of Invention standards.
Reply at p. 4, para. 3. Applicant states “all of the claims are examined without issue at the international stage as acknowledged in the Written Opinion of the International Searching Authority (“WO/ISA”) dated February 14, 2022, and in the International Preliminary Report on Patentability ("IPRP") dated March 28, 2023, confirming that the international examiner agreed there was Unity of Invention”.
Applicant infers that the instant claims have a “significant technical overlap” because no lack of unity of invention was raised during the international stage of the PCT application (reply at p. 5). Applicant next states If the search and examination of all the claims in an application can be made without serious burden, the examiner must examine them on the merits, even though they include claims to independent or distinct invention, citing MPEP §803.
Examiner has reviewed and considered applicants arguments. However, this is not found persuasive for the following reasons.
Examiner first notes that applicant refers to two (2) separate sections of the MPEP relating to unity of invention. MPEP §1850 relates to unity of invention before the international searching authority, e.g., at the international stage. MPEP §1893.03 relates prosecution of US national stage application before the examiner, e.g., national stage entry of PCT applications.
Examiner notes that MPEP §1893.03(d) and 37 CFR §1.499 provide guidance for unity of invention during the national stage of a PCT application.
MPEP §1893.03(d) expressly states: The examiner may make a lack of unity requirement in a national stage application even if no such requirement was made by the ISA or IPEA. Emphasis added. Thus, contrary to applicant’s assertions, examiner can find lack of unity of invention even if that finding was not asserted at the international stage. Lack of unity of invention was properly set forth in the office action mailed 1/30/2026 at pp. 6-9 and will not be reiterated herein. See file wrapper and restriction requirement dated 1/30/2026 for specifics.
In the reply filed 1/30/2026, Applicant did not provide any arguments traversing the cited art found at pages 6-7 of the restriction requirement mailed 1/30/2026. Applicant did not traverse the alternative rationale/basis to split unity of invention disclosed in the office action at pp. 7-9. Accordingly, applicant’s reply filed 3/30/2026 is deemed to be incomplete.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-25 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 3/30/2026.
Applicant’s election of the following representative species in the reply filed on 3/30/2026 is acknowledged. Election was made with traverse as set forth above:
Porous structure: polyethylene with a pore diameter greater than 100 mm
Linker: SMCC
peptide: SEQ ID NO:1
polyalcohol: propane-1,2,3-triol
Claims 1-7 read on the elected species.
Specification
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The present applications relates to,” etc.
The following sentence at line 3 of the abstract appears to be incomplete: The present invention also relates and to a method for manufacturing such matrix.
Claim Objections
Claims 3, 4, and 7 are objected to because of the following informalities:
Claim 3 recites an acronym LPS which should be written out in full name in 1st order appearance in the claims.
Claim 4 should be amended to recite “SEQ ID NO:1” twice in the claim.
Claim 7 should be amended to recite “the linker is a heterobifunctional cross-linkerselected from the group consisting of”.
Appropriate correction is required.
Sequence Interpretation/Claim Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising an amino acid sequence of SEQ ID NO: 1” requires only a dipeptide or more within SEQ ID NO: 1, “comprising the amino acid sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with or without additional amino acids at any N-/C-terminal ends or additional nucleotides at 5' /3' ends, “consisting of an amino acid sequence of SEQ ID NO: 1” would encompass any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, and “consisting of the amino acid sequence of SEQ ID NO: 1” would be limited to the sequence of the amino acids as specified by SEQ ID NO: 1, and nothing more or less; "an amino acid selected from the group consisting of SEQ ID NOs: 1, 2 and 3” is any sequence of two or more consecutive amino acids (dipeptide or more) fully contained within SEQ ID NO: 1, 2 or 3; and “the amino acid selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3.
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 1-7 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 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. Claim 1 is drawn to a matrix comprising a porous structure; a linker; a peptide covalently attached via the linker; and a coating of a poly alcohol. The omitted structural cooperative relationships are: the structural interactions/relationships between the linker, the porous structure, and the polyalcohol. As presently claimed, claim 1 does not recite that the linker is attached to the porous structure. Additionally, it is currently unclear as to the identity of exactly what is coated by the polyalcohol, e.g., the peptide(s), porous structure, etc.
Because claims 2-7 depend from indefinite claim 1 and do not clarify the point of confusion, they must also be rejected under 35 U.S.C. 112(b).
Examiner expressly notes that claim 1 was amended 3/30/2023 to delete reference to the peptide being covalently attached to matrix and that the matrix was coated with the polyalcohol.
Examiner recommends that claim 1 be amended to recite that the linker is covalently attached to the porous structure, and that the polyalcohol coats the matrix [provided there is claim support in the specification for such claim language].
Regarding claim 6, where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “residue” in claim 6
is used by the claim to mean “part of an amino or thiol group,” while the accepted meaning is “amino acid.” The term is indefinite because the specification does not clearly redefine the term.
Lee (“What Does Residue Mean in Biology?” (2018), accessed 5/23/2026 at URL ://education.seattlepi.com/residue-mean-biology-6172.html) states: In biology, and specifically in biochemistry, residues are the individual organic compounds called amino acids that comprise some of the building blocks of complete proteins.
Bywater (PLOS One 13(10): e0204883 (2018)) discloses it is well known that proteins that are 20 standard amino acid residues [major building blocks in all terrestrial proteins] (abstract and pp. 1-2).
To overcome this rejection, examiner recommends that claim 6 be amended to delete reference to “a residue”; e.g., the linker is covalently bound to
The metes and bounds of claim 6 are deemed to be indefinite. Claim 6 recites “the matrix according to claim 1, further comprising an amino-group wherein the peptide includes a thiol-group; and the linker is covalently bound to a residue of the amino-group and covalently bound to a residue of the thiol-group of the peptide”. Thus, claim 6 is structurally construed as follows: amino group - linker - thiol group[peptide]
However, there is no indication as to how the porous structure relates to the recited elements of claim 6. Specifically, there is no indication as to whether or not the amino group is attached to the porous structure, is part of a separate/larger moiety, or just merely a singular/stand-alone amino group. Claim clarification is required.
Examiner recommends that claim 6 be amended to recite similar claim language to that of original claim 6:
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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 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP 2163.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co., the court stated:
“A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials. Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284-85 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus. . . ."). Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618.
For written description, the analysis considers
(a) Actual reduction to practice,
(b) Disclosure of drawing or structural chemical formulas,
(c) Sufficient relevant identifying characteristic in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed and
(d) Representative number of examples.
In the instant case, the claims are drawn to a matrix for selective binding of at least one component from a body fluid, the matrix comprising a porous structure; a linker; a peptide covalently attached via the linker; and a coating of a polyalcohol. Claim 2 recites three polyalcohol: propane-1,2,3-triol (glycerol), glucose, and trehalose. Claim 3 recites that the peptide is an LPS-binding peptide. Claim 4 recites wherein the peptide is one of a peptide according to SEQ ID NO:1, or a peptide having at least 80% homology with a peptide according to SEQ ID NO:1. Claim 6 recites wherein the matrix according to claim 1, further comprising an amino-group (but fails to provide guidance as to whether or not the amino-group is merely a moiety of a larger element, e.g., an amino group derivatized polyethylene hydrogel).
The claims encompass numerous “at least one component from a body fluid”, “porous structures”, “peptides”, “linkers”, “polyalcohols”, and “amino-groups”, and combinations thereof. However, the specification is very limited as to teaching specific compounds that fall within each of these claim terms. The specification does not define any of the claim terms. The “at least one component” can be any material(s) from any “fluid” [blood, urine, cerebrospinal, pus, lysate, etc] from any “body”- not restricted to any particular species or organism.
The specification discloses that the peptide is selective for the “binding of at least one component from a body fluid”. Thus, the identity of the peptide is critical as to directing matrix binding selectivity. The specification is limited to disclosing a single, full-length peptide of SEQ ID NO:1. The specification did not reduce to practice any peptide other than full-length 100% with SEQ ID NO:1.
The specification generally refers to Matrix A, Matrix B, and Matrix C. However, no examples of a matrix of the instant claim scope was actually reduced to practice.
(a) Actual reduction to practice/ (b) disclosure of drawing or structural chemical formulas:
The specification did not reduce to practice any matrices of the instant claims.
(c) Sufficient relevant identifying characteristic in the way of complete/partial structure or physical and/or chemical properties, functional characteristics when coupled with known or disclosed: and (d) Representative number of examples:
The invention involves an unlimited number of “porous structures”, “components from a body fluid”, “peptides”, “linkers”, “polyalcohol”, and “amino-groups”, and combinations thereof. This is further complicated by the lack of guidance in the specification as to how the recited elements are structurally arranged/interconnected. Please refer to the indefinite rejection for details.
Given the broadest reasonable claim interpretation, with regard to “porous structures”, the instant claim scope includes but is not limited to, agarose, alginate, cellulose, bone, skin, concrete, limestone, polyethylene, wood, etc. Peptides are unlimited. As noted above, matrix binding selectively appears to be dependent on the identity of the peptide covalently attached to the porous structure. The specification is limited to disclosing a single peptide. The term linker is not expressly defined. Given the broadest reasonable claim interpretation, a link of the instant claims can be construed as a bond [direct linkage, covalent, ionic, van der waals forces], an amino acid(s), peptide, lipid, carbohydrate, nucleic acid, or a combination thereof. The term polyalcohol is not expressly defined. Given the broadest reasonable claim interpretation, a polyalcohol is construed as any compound of any chemical composition comprising at least 2 (poly) hydroxyl (-OH) groups.
Furthermore, the present application is attempting to patent what has not yet been invented and the fact that one of skill in the art can test for the effect used to determine the compounds does not necessarily confer sufficient written description. The claimed peptide sequence would entail testing limitless potential peptides and proteins, and one of skill in the art could afterwards still be faced with no hits with the desired functionality.
The specification is limited to a peptide having 100% identity with instant SEQ ID NO: 1. SEQ ID NO:1 is 27 amino acids in length. 80% sequence identity to SEQ ID NO:1 allow allows for up to 6 amino acid changes (e.g., substitution, insertion, deletion, or any combination thereof). There are 20 naturally occurring amino acids. Thus, there are 620 (or 3.65 x1015) potential polypeptides within the instant claim scope peptides having at least 80% identity to SEQ ID NO:1. The actual number of variants is much higher when one considers non-naturally occurring amino acids.
In addition, it is well known in the peptide/protein art that even single amino acid changes or differences in the amino acid sequence of a protein can have dramatic effects on the protein’s function. As an example of the unpredictable effects of mutations on protein function, Drumm et al (Annu. Rev. Pathol. Mech. Dis., 2012, 7, pages 267-282) teach cystic fibrosis is an autosomal recessive disorder caused by mutations in the CFTR (cystic fibrosis transmembrane conductance regulator) gene, for example, page 268, Section “CYSTIC FIBROSIS”. Drumm et al further teach several mutations can cause cystic fibrosis, including two mutations G551D and G551S; and clinical consequences are quite different for these two changes, as the G551D variant has virtually no detectable activity, and consequently a classic, severe phenotype is associated; G551S, however, has reduced but clearly detectable function and is associated with a much milder presentation of CF, for example page 269, left column, the last paragraph. Drumm et al also teach that in the most common cystic fibrosis mutation ΔF508 (the absence of amino acid 508 of the normally 1,480-amino acid protein) gives rise to the cystic fibrosis phenotype, for example, page 268, right column, the 2nd paragraph. Thus, even the substitution or deletion of a single amino acid can have dramatic and unpredictable effects on the function of the protein. The unpredictability of the effect of amino acid substitution on the function and/or property of peptide/protein is further confirmed and discussed in Yampolsky et al (Genetics, 2005, 170, pages 1459-1472). Yampolsky et al teach even conservative substitution can significantly affect the function of the protein/peptide, for example, page 1465, Table 3. Although the disclosures of Drumm et al and Yampolsky et al are directed to peptides other than those used in matrix binding selectivity of a body fluid component, they illustrate the inherent unpredictability with respect to the biological activity of a given protein/peptide after even minor changes to the primary amino acid sequence.
Therefore, based on the state of art, a person of ordinary skill in the art would not be able to determine what structural feature is required for the claimed peptide sequence to have the functional characteristics of binding of a body fluid component for suitability in a claimed matrix.
As stated earlier, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It must not be forgotten that the MPEP states that if a biomolecule is described only by a functional characteristic (e.g., “porous structure” or “LPS-binding peptide”) and/or a functional/structural characteristic without any disclosed correlation between function and structure of the biomolecule beyond the examples presented, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed biomolecule.” MPEP 2163. Here, though the claims may recite some functional characteristics, and even some generic structural features and several distinct species are given (e.g. polyalcohol of claim 2 and linkers of claim 7), the claims lack written description because there is no disclosure of a correlation between function and structure of the recited at least one component from a body fluid, porous structures, peptides, linkers, polyalcohols, and amino-groups that give rise to the form the claimed matrices for selective binding of at least one component from a body fluid. Accordingly, there are not only many distinct components (components from a body fluid, porous structures, peptides, linkers, polyalcohols, and amino-groups), there are also numerous combinations of components that fall within the instant claim scope to give rise to a claimed matrix. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate").
The skilled artisan cannot extrapolate to the myriad of matrices that fall within the instant claim scope based on the limited guidance in the specification. It is noted that no matrices were reduced to practice.
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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.
Claims 1-3 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (U.S. 2003/0231981), in further view of Bohannon (U.S. 20050239214).
Johnson teaches a method for selectively binding and separating at least one component from whole blood or a body fluid, whereby the blood or body fluid is allowed to pass through a rigid integral separation matrix without being excluded therefrom. The matrix has a porous structure. A ligand, e.g. peptide, is covalently attached to the matrix via a linker (e.g., paras [0051]-[0063], claims 27-29). Example 20 teaches a porous polyethylene matrix wherein the polymyxin B sulfate (LPS-binding peptide) is covalently conjugated to primary amines on the surface of the polyethylene matrix via glutaraldehyde. Examiner notes that the claim term “linker” was not expressly defined in the specification. Given the broadest reasonable claim interpretation, the linker can be construed as encompassing a covalent bond between the polyethylene porous structure and the peptide, e.g., polymyxin B (Ex 5, Ex 20, Table 2).
Johnson does not explicitly teach that the matrix can be coated with a polyalcohol.
Bohannon teaches methods, compositions, and kits for rapid detection of analytes in a sample. Bulking materials having non-sugar sweeteners effectively enhance chromatographic detection methods by providing component stability and controlled release (abstract). Bohannon teaches stabilizing a protein/peptide in a dry state, e.g. comprising a multi-material such as a non-sugar senior compound, e.g. sugar alcohols (paras. [0176], claims 31, 40). Various chromatographic substrate materials may be used as such in suitable shapes such as films, strips or sheets. They may also be coated onto or bonded or laminated to appropriate inert support materials. The support material may provide structural support to the chromatographic substrate material as well as prevent evaporation of reagent and solvent materials during the assay procedure (e.g., para [0117]).
It would have been obvious to one of ordinary skill in the art to coat the matrix of Johnson with a non-sugar sweetener in order to stabilize the peptide bound to the matrix of Johnson. One of ordinary skill in the art would have had a reasonable expectation of success because Bohannon taught that the non-sugar sweeter (e.g., sugar alcohol – glycerol) not only stabilized the peptide but also acted as a humectant, preventing evaporation during assay procedures. Accordingly, instant claim 1 is rendered obvious.
Regarding claim 2, Bohannon teaches sugar alcohol can be glycerol (Propane-1,2,3-triol) or sorbitol (paras [01587], claim 22, 40). Regarding claim 3, polymyxin B is a LPS binding peptide. Regarding claim 5, Johnson teach that the matrix can be obtained by means of a sintering process (e.g., paras [0031], [0037], [0044]-[0046], claim 2, 15-16). The examples disclose a matrix of porous polyethylene commercially available from Porous Technologies, Germany. Regarding claims 6 and 7, Johnson teaches that the surface of the matrix can be modified with at least one functional group, e.g. an amine group (e.g., paras [0026]-[0032], [0038]-[0063], claims 15 and 26). The linker can be a heterobifunctional cross-linker, i.e. a succinimidyl reagent (e.g., paras [0059]-[0063], claim 30-32), wherein the peptide is bound via a thiol group to the linker, and an amino group (matrix) to the linker.
Claims 1-3 and 5-7 are obvious in view of the teachings of the cited references.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable 1 over Johnson (U.S. 2003/0231981) and Bohannon (U.S. 20050239214), as applied to claims 1-3 and 5-7 above, and further in view of Gustafsson (Scand J Clin Lab Invest 70:194-200 (2010) -cited in IDS filed 3/30/2023).
The teachings of Johnson and Bohannon are set forth above. The references do not explicitly teach the peptide of SEQ ID NO:1.
Gustafsson teaches LPS binding peptides (Tables I-II). HA27 has 100% identity with instant SEQ ID NO:1.
It would have been obvious to 1 of ordinary skill in the art to substitute the LPS binding peptide of Johnson with a LPS binding peptide of Gustafsson. The skilled artisan would have been motivated to expand the availability of peptides in matrix used for separating at least one component from whole blood or a body fluid, as taught by Johnson. A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the LPS binding peptides because both were explicitly taught as being useful for LPS binding peptides. Therefore, these compositions are functional equivalents in the art, and substituting one for the other would have been obvious at the time of the invention. “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) at 1395-1396, quoting Sakraida v. AG Pro, Inc., 425 U.S. 273 (1976) and In re Fout, 675 F.2d 297, 301 (CCPA 1982) (“Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious”).
Accordingly, claim 4 is rendered obvious.
Claims 1-7 are obvious in view of the teachings of the cited references.
Relevant Art not Relied Upon
Pini (WO2018/193011) discloses methods for removing bacterial toxins such as lipopolysaccharide and lipoteichoic acid from a biological fluid. In such method a peptide, selected from the list of KKIRVRLSA, RRIRVRLSA, KRIRVRLSA and RKIRVRLSA, is covalently attached to a solid support through its C-terminus, optionally with the interposition of a linker, and is used to capture the toxins (abstract).
Conclusion
No claims are allowed.
Claims 1-25 are pending. Claims 8-25 have been withdrawn.
Claims 1-7 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA M HELLMAN whose telephone number is (571)272-2836. The examiner can normally be reached M-F 9:00 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
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