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
Claim Status
The amendment on January 28, 2026 is acknowledged. Claims 1-8 are currently pending. Claims 9, 11-12, 15-17 have been withdrawn. There are no new claims and claims 10, 13 are canceled. Claims 1-8 will be examined on the merits herein.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8 in reply filed on January 28, 2026 is acknowledged. Claims 9, 11-12, 15-17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
The application 18/542,054 filed on June 17, 2022 claims priority from the PCT/EP2022/066584 filed on June 17, 2021.
Information Disclosure Statement (IDS)
Accordingly, the information disclosure statement is being considered by the examiner.
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 1-2, 4-5, 6-7 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 1-2, 4-5, 6-7 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. This is a written description rejection.
Regarding claim 1, the claim recites a method of determining an analyte in a sample wherein one of said first affinity partner and said second affinity partner is a polypeptide comprising the amino acid sequence of SEQ ID NO:1 or a sequence at least 85% identical thereto, and wherein the other of said first affinity partner and said second affinity partner is a polypeptide comprising the amino acid sequence of SEQ ID NO: 2 or a sequence at least 85% identical thereto.
The instant claim recites a sequence at least 85% identical to SEQ ID NO: 1 and SEQ ID NO: 2. Thus, the claims are drawn to a broad genus of amino acids including fragments of SEQ ID NO: 1 and 2. It is noted that the specification does not provide a written description of the genus by providing a representative number of species, but instead teaches additional genus and sub-genus. For example, the specification teaches a polypeptide comprising an amino acid sequence as specified in SEQ ID NO:1 or a sequence at least 50% identical thereto, wherein the amino acid at position corresponding to position 77 in SEQ ID NO: 1 is not a histidine, and wherein the amino acid at position corresponding to position 17 SEQ ID NO: 2 is not a cysteine, in a embodiment is alanine, serine, leucine, isoleucine , or glycine and/or (ii) said polypeptide further comprises at least one functional peptide; and to fusion polypeptides, polypeptide complexes, polynucleotides and kit related to the aforesaid. See page 1, lines 10-20. The specification further teaches the term "at least 50% identical" includes at least 70% identity, in an embodiment at least 80% identity, in a further embodiment at least 85% identity, in a further embodiment at least 90% identity, in a further embodiment at least 95% identity, in a further embodiment at least 98% identity, in a further embodiment at least 99% identity. See page 7, lines 20-25.
The specification teaches the affinity pair comprises one affinity partner comprising the amino acid sequence of at least a fragment of the Colicin polypeptide from Geobacillus thermoglucosidasius (also referred to as Parageobacillus thermoglucosidasius). The specification further teaches “The E group Colicins have been subdivided into nine types (ColE1 to ColE9) and these fall into one of three cytotoxic classes; membrane-depolarizing agents such as ColE1, non-specific DNases such as Colicins E2, E7, E8 and E9, and RNases such as Colicins E3, ES and E6 (reviewed in Cascales et al. (2007) Microbiol Mol Biol Rev 71(1):158). The Protein-Protein Interactions in Colicin E9 DNase-Immunity Protein Complexes were described by (Wallis et al. 1995 Biochemistry 34(42):13743); the mode of interaction is based on a diffusion-controlled association and femtomolar binding for the cognate complex. Garinot-Schneider et al. ((1996) J Mol Biol 260(5):731) performed random and site-directed mutagenesis on Colicin E9 and identified highly conserved active site residues responsible for DNase activity. In the full length Colicin sequence a single His575Ala mutation completely inactivated the Colicin 9 enzymatic activity”. See specifications page 2, lines 1-10.
The SEQ ID NOs: 1, 2 comprise G. thermoglucosidasius Colicin polypeptide and have the activity binding of the corresponding immunity polypeptide with specified affinity (See pages 14-16).
Hence, the first and second affinity partners are drawn to an extremely large genus and sub-genus of polypeptides with affinity and non-affinity characteristics.
The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art, as of the filing date sought, inventor was in possession of the invention as now claimed. See e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of fragments of SEQ ID NOs: 1, 2 and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention.
An original claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163.
Thus, one of skill in the art would not readily recognize the use of “a sequence at least 85% thereto” to use the method of determining an analyte in a sample claimed by the applicant if there is a lack of written description of method and use of the genus (a sequence at least 85% of SEQ ID NOs: 1, 2) in the claim.
The written description requirement is not fulfilled by the applicant. In order to comply with the written description requirement, the applicant must fully disclosure all the genus related to the claimed “a sequence at least 85% identical thereof” in claim 1.
Claim 1 is rejected for failing to demonstrate possession of the claimed invention. Dependent Claims 2, 4-5, 6-7 are also rejected because they depend on rejected Claim 1 and do not limit the claim in a manner that remedies the rejection.
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 2-5, 8 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.
Regarding claims 2-5, 8, the phrase "in an embodiment" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). While the phrase is defined by some examples in the specifications (page 4, lines 26-34; page 5, lines 1-13), it is unclear what is encompassed in the phrase “in an embodiment”, in claims 2-5, 8.
Therefore, the boundary of claims 2-5, 8 is indefinite.
Allowable Subject Matter
Claims 1-8 are rejected. However, the SEQ ID NOs: 1-2, 3-4, 10, 11, 12, 13-14 of claims 1, 3, 8 have been searched. All the searched SEQ IDs are free of art, except for SEQ ID NO: 11. The SEQ ID NO: 11 has a match of 100% with SEQ ID NO: 30 of Patent US 9,273,144. See figure below.
Nevertheless, the searched SEQ IDs of claims 1, 3, 8, whereby each would otherwise be allowable, including SEQ ID NO:11 if they depend from SEQ ID NOs: 1-2, 3-4, 10, 11, 12, 13-14, and thus necessarily require the specific sets of affinity partners (first and second) of claims 1, 3, 8.
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Conclusion-
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRICILA HAUK TEODORO whose telephone number is (571) 272-2784. The examiner can normally be reached M-F 6:15AM-3:00PM.
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/PRICILA NMN HAUK TEODORO/Examiner, Art Unit 1645
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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