DETAILED ACTION
Examiner acknowledges receipt of the reply filed 06/15/2026, in response to the restriction requirement mailed 4/22/2026.
Claims 1-6 are pending. Claims 1-4 and 6 are withdrawn from further consideration for the reasons set forth below.
Claim 5 is 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 following information is provided in the filing receipt dated 4/08/2026:
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Election/Restrictions
Applicant's election of group 2 (claim 5) with traverse in the reply filed on 6/15/2026 is acknowledged. The traversal is on the ground(s) that the cited reference:
Lummel et al. merely describes the interaction between 32-glycoprotein I and a platelet receptor. Nothing in this document suggests that the region of 32-glycoprotein I corresponding to SEQ ID NO:9 possesses any affinity for microorganisms or is involved in microorganism binding. Although SEQ ID NO:9 is mentioned in the reference, it is discussed exclusively in the context of platelet binding, which is functionally unrelated to the microorganism-binding properties underlying the present claims.
(reply filed 6/15/2026 pp. 1-2). Emphasis added.
This is not found persuasive because as noted in the restriction requirement, Lummel et al teaches the peptide CKNKEKKC which has 100% identity with instant SEQ ID NO:9. Binding of a microorganism by the peptide is deemed to be an inherent property of the peptide. See restriction requirement at p. 5.
MPEP § 2112.01 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-4 and 6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6/15/2026.
Status identifiers to claims 1-4 and 6 should be revised to reflect withdrawn status in a reply to this office action.
Applicant's election of the following elected species in the reply filed on 6/15/2026 is acknowledged. Election was made without traverse.
Peptide: peptide P11, H-((SSLAFWK)2-K)2-K-NH2 (SEQ ID NO:8)
Spacer: absent
Microorganism: E coli
Solid support material: magnetic beads
Claim 5 reads on the elected species.
Upon searching the elected species, an additional species was found e.g. SSLAFWK. Accordingly, for purposes of compact prosecution, the election of species is modified only to the extent of examining this additional species. Otherwise the election of species requirement is still retained.
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.
Claims and Specification - Sequence Compliance
Claim 1 still recites peptides not associated with a SEQ ID NO. See claim 1, ll. 12-13. Each instance of peptide or nucleotide comprising 4 or more amino acids, or 10 or more nucleotides is required to have a SEQ ID NO associated with the sequence. See MPEP §2422.
Per the sequence listing SEQ ID NOs 8 and 25 appear to correlate with the same sequence, SSLAFWK.
Per the claims and specification, SEQ ID NO:8 is assigned to two distinct and different peptides: SSLAFWK and the elected species H-((SSLAFWK)2-K)2-K-NH2. The elected species must be assigned a different SEQ ID NO:NO because the elected peptide is distinct peptide from that of SSLAFWK (SEQID NO:8).
Further regarding the elected peptide H-((SSLAFWK)2-K)2-K-NH2, it is unclear from the specification if H- at the N-terminus refers to hydrogen OR the amino acid histidine [H cannot to refer to both a chemical element and the amino acid histidine]. Applicant should indicate where in the specification support for the identity of “H” is explicitly found.
Applicant is required to submit a supplemental Sequence Listing, amend the specification and provide the required statement that the substitute specification requires no new matter.
Please see the file wrapper- notification to comply with requirements for applications – mailed 3/11/2026 for details. The requirements of the notice to comply with sequence disclosures in incorporated herein; e.g., supplemental sequence listing, etc.
Trademark in the Specification
The use of the trademarks Tween 20 and 80 and Triton X have been noted in this application at p. 15 of the as-filed specification. They should be capitalized wherever they appear and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks.
Examiner Comment
As a cursory note, claims 1, 2, and 6 (currently withdrawn) should be amended to remove all bullet points and hyphens separating the claim limitations. Claims 1 and 2 should have commas separating the recited peptides and/or structures.
Claim 5 should be amended to recite: A microorganism sensor comprising
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.
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.
The metes and bounds of claim 5 are deemed to be indefinite. Claim 5 is drawn to a microorganism sensor, characterized in that it comprises at least one peptide according to claim 1, coupled to a solid support. Claim 1 recites a Markush grouping of peptides that are “capable of binding microorganisms”. Peptides include SSLAFWK and the elected species H-((SSLAFWK)2-K)2-K-NH2. Regarding the elected peptide H-((SSLAFWK)2-K)2-K-NH2, it is unclear from the specification if H- at the N-terminus refers to hydrogen OR the amino acid histidine [H cannot to refer to both a chemical element and the amino acid histidine]. The chemical structure of the elected peptide is all unclear from the specification. Specifically, the branch connection points at lysine (K) within the peptide are unclear because the connection points could be via the alpha nitrogen-hydrogen or the epsilon nitrogen-hydrogen (ε-NH) of lysine. This results in distinct potential chemical structures, e.g. for example
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. It is further noted that claim 5 recites that the peptide is “coupled to a solid support”. It is unclear as to what exactly this means with respect to the chemical structure of the claimed peptide. For instance, if the peptide is covalently attached to the solid support- at what amino acid position (side chain, N-terminus, etc).
Claim clarification is required to clarify the structure of the elected species (with regard to SEQ ID NO, as well as chemical structure), as well as the chemical/physical connection between the claimed peptide and a “solid support”.
Claim Interpretation
Claim 5 is drawn to a microorganism sensor, characterized in that it comprises at least one peptide according to claim 1, coupled to a solid support. Peptides include SSLAFWK and the elected species H-((SSLAFWK)2-K)2-K-NH2.
Given the broadest reasonable claim interpretation, the instant claims are drawn to a solid structure [not limited to any particular chemical or physical material] coupled to a peptide comprising a sequence recited in claim 1. The peptide requires the full-length sequence with 100% identity to SEQ ID NO: X with any N-/C-terminal additions.
The preamble is deemed to recite an intended use “a microorganism sensor”. The recitation “a microorganism sensor “has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Roble, 88 USPQ 478 (CCPA 1951). See MPEP §2111.02.
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hood et al (U.S. 2012/0087862).
Hood et al disclose a diagnostic panel comprising a plurality of detection reagents wherein each detection reagent is specific for one organ-specific protein; wherein the organ-specific proteins detected by the plurality of detection reagents are selected from any one of the organ-specific protein sets provided in a recited Table (e.g., claim 1). The panels may be comprised of a solid phase surface having attached thereto a plurality of detection reagents each attached at a distinct location. The solid phase surface may be of any material, including, but not limited to, plastic, polycarbonate, polystyrene, polypropylene, polyethylene, glass, nitrocellulose, dextran, nylon, metal, silicon and carbon nanowires, nanoparticles that can be made of a variety of materials and photolithographic materials. In certain embodiments, the solid phase surface is a chip. In another embodiment, the solid phase surface may comprise microtiter plates, beads, membranes, microparticles, the interior surface of a reaction vessel such as a test tube or other reaction vessel (e.g., para [0507]). SEQ ID NO:66996 of Hood et al has 100% identity with and consists of SSLAFWK (instant SEQ ID NO:8). See Table 78B indicating SEQ ID NO:66996 identified from liver APOH protein.
The recitation “a microorganism sensor “has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Roble, 88 USPQ 478 (CCPA 1951). See MPEP §2111.02.
Thus, Hood et al disclose a peptide consisting of SEQ ID NO:8 coupled to a solid support. Although Hood et al do not explicitly disclose that the peptide is capable of binding to a microorganism, this is deemed to be an inherent property of the peptide.
MPEP § 2112.01 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The claimed composition appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Accordingly, the limitations of claim 5 are satisfied.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Durham et al (U.S. 2005/0163789).
Durham et al disclose methods and compositions for screening, diagnosis and prognosis of Alzheimer's disease (abstract). The reference discloses array(s) comprising one or more of Alzheimer's disease-Associated Features (AFs) and peptides, and/or Alzheimer's disease-Associated Protein Isoforms (APIs) that can be used to screen for Alzheimer’s (e.g., claims 1, 2, 23, 32-34). SEQ ID NO:89 (EHSSLAFWK) of Durham et al has 100% identity with and comprises SSLAFWK (instant SEQ ID NO:8). See Table IV. This peptide was identified in AF-224/API-379 (Table IV at p 11) and AF-337/API-418 (Table V at p. 19). The API, API fragment, API-related polypeptide or API fusion protein is immobilized on a solid phase [reads on coupled to a solid support] (e.g., claim 34).
The recitation “a microorganism sensor “has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Roble, 88 USPQ 478 (CCPA 1951). See MPEP §2111.02.
Thus, Durham et al disclose a peptide comprising SEQ ID NO:8 coupled to a solid support. Although Durham et al do not explicitly disclose that the peptide is capable of binding to a microorganism, this is deemed to be an inherent property of the peptide.
MPEP § 2112.01 recites, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
The claimed composition appears to be the same as the prior art, absent a showing of unobvious differences. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989).
Accordingly, the limitations of claim 5 are satisfied.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stefas et al (U.S. 2011/0143353), as evidenced by Unitprot Accession No. P02749 (accessed 7/24/2026 at URL uniprot.org/uniprotkb/P02749/entry).
Stefas discloses preparation of microbeads of a solid polymer material capable of binding bacteria. The microbeads are loaded with β2GPI (plasma glycoprotein called β2-glycoprotein I) proteins (abstract). The β2GPI proteins are coupled to the magnetic microbeads (e.g., claim 1, para [0004], [0019]-[0020]). Stefas teaches that the β2GPI proteins bind to bacteria (e.g., abstract, claims 1-7, examples 1-2). As evidenced by Unitprot Accession No. P02749, β2GPI is also known in the art as apolipoprotein H (ApoH). β2GPI comprises instant SSLAFKW (SEQ ID NO:8) in the C terminus of the protein.
Thus, Stefas disclose magnetic microbeads coupled to β2GPI, comprising instant SEQ ID NO:8. Accordingly, the limitations of claim 5 are satisfied.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Veas (APOH-technologies presentation, June 2015, accessed at URL apohtech.com/fileadmin/documents/documents/prcl15009_bethesda_kf-orion-chi_apoh-present.pdf), as evidenced by Unitprot Accession No. P02749 (accessed 7/24/2026 at URL uniprot.org/uniprotkb/P02749/entry).
Veas teaches that apolipoprotein H (β2-glycoprotein I or ApoH) interacts specifically with microorganisms including infectious viruses, bacteria, fungi, parasites and prions (p. 2). Interaction is mediated through the 5th domain of the protein (p. 3). ApoHa can be coupled to a solid support and used to capture bacteria, viruses, parasites and prions (pp. 4-6). Data indicates binding of the ApoH-beads to dengue fever virus, influenza, HCV, hantavirus (pp. 8-15, as well as bacteria (pp. 16-25). As evidenced by Unitprot Accession No. P02749, ApoH comprises instant SSLAFKW (SEQ ID NO:8) in the C terminus of the protein.
Thus, Veas discloses magnetic microbeads coupled to ApoH, comprising instant SEQ ID NO:8. Accordingly, the limitations of claim 5 are satisfied.
Relevant Art Not Relied Upon
APOH-technologies announcement CaptoBac (dated 6/05/2014 available at URL apohtech.com/index.php?id=76, under News tab) discloses that ApoH-CaptoBac kit is a solution for samples pretreatment to concentrate and purify bacteria, based on the property of the activated scavenger protein, apolipoprotein H (apoH) to interact with micro-organisms. Kits include ApoH nano-magnetic beads.
The technology can be used with any kind of sample (blood, urine, feces, environmental or food samples) with universal bacterial binding, including gram-positive and gram-negative bacteria.
APOH-technologies announcement, CaptoVir (dated 6/05/2014 available at URL apohtech.com/index.php?id=71, under News tab) discloses that ApoH-CaptoVir kit is a solution for samples pretreatment to concentrate and purify viruses, based on the property of the activated scavenger protein, apolipoprotein H (apoH) to interact with micro-organisms. Kits include ApoH nano-magnetic beads.
The technology can be used with any kind of sample (blood, urine, feces, environmental or food samples) with universal viral binding, including enveloped and a non-envelope viruses.
A rejection under 37 CFR 101 was considered, but not deemed appropriate. The specification states:
The term “solid support” refers to any solid support known in the field such as one of those described in “Current Protocols in Immunology by Editions Coligan J., Bierer B., Margulies D., Shevach E., Strober W., and Coico R., Wiley Interscience, 2013”. This support can for example be an ELISA type microtiter plate, a membrane, for example nitrocellulose, a chromatography gel, beads, for example made of polystyrene, tubes, for example made of polystyrene or polypropylene . . . .
As-filed Specification at p. 13, ll 14-19. A combination of a peptide of claim 1 coupled to a solid support is not construed as reading on a naturally occurring product.
Conclusion
No claims allowed.
Claims 1-6 are pending. Claims 1-4 and 6 are withdrawn.
Claim 5 is 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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/KRISTINA M HELLMAN/Examiner, Art Unit 1654
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