DETAILED 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 .
Applicants preliminary amendment filed January 4, 2023 has been received and entered. Claims 2-6, 8-14, 18-19, 21, 24-33, 35, 39-42, 44, 46-51, 53, 55-62 and 64 have been canceled, and new claims 65-66 have been added. Accordingly, claims 1, 7, 15-17, 20, 22-23, 34, 36-38, 43, 45-46, 52, 54, 63 and 65-66 are pending in the instant application.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
1. Claims 1, 7, 15-17, 20, 22-23, 34, 36-38, 43, 45-46, 52, 54 and 65-66 are not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1, 7, 15-17, 20, 22-23, 34, 36-38, 43, 45-46, 52, 54 and 65-66 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
Claims 1, 7, 15-17, 20, 22-23, 34, 36-38, 43, 45-46, 52, 54 and 65-66 are directed to methods for providing/identifying drug candidates.
Applicants attention is directed to the Revised Subject Matter Eligibility Guidance published by the Office in 2019.
https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility
Applicants claims recite a method of providing/identifying a drug candidate.
The claim recites a series of steps or acts. Thus the claim is directed to a process, which is one of the statutory categories of invention. (Step 1: Yes).
The claim is then analyzed to determine whether it is directed to any judicial exception. In the second step, the claim recites identifying sequences having a signal peptide, length of 20-500 amino acids and comprise at least two cysteine residues. This limitation sets forth a judicial exception, as this second step could be performed by a human using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas (e.g., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams. Thus, the claim is directed to at least one exception (Step 2: Yes), which may be termed a law of nature, an abstract idea, or both.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
Sberro et al (Cell Vol. 178, pp 1245-1259, 2019) set forth that at the time of the instant invention it was routine to provide multiple human microbiota proteins containing signal peptides around 50 amino acids or less in length. (See page 1245 and 1256). Sberro et al further report peptide MKTLYVYAADFDWIEETELVGELGYESLRSSDCYCFTLNDGCFEKNTEICF (Bacteroides sp. 3_1_19) containing multiple cysteine residues. (See online Data S1).
Zhou et al (US Publication 2002/0115610) set forth that it was routine in the art to provide and express/produce polypeptides containing multiple cysteine residues. (See paragraphs 0050-0051).
Claims drawn to diagnostic uses of underlying natural phenomena regardless of the reagents employed or the starting samples used have been found not patent eligible, because once the newly discovered natural phenomenon is removed from the claims, the remaining elements merely recite routine, conventional, and well-understood steps that cannot provide the inventive concept to transform the methods into patent eligible subject matter. See Myriad Genetics; In re BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation, 774 F.3d 755 (Fed. Cir. 2014); Arisoa Diagnostics, Inc. v. Sequenom Inc., 788 F.3d 1371 (Fed. Cir. 2015) (en banc petition denied) (cert. denied); Genetic Tech. Ltd. V. Merial LLC, 818 F.3d 1369 (Fed. Cir. 2016); Cleveland Clinic Foundation v. True Health Diagnostics LLC, 859 F.3d 1352 (Fed. Cir. 2017); Roche Molecular Systems, Inc. v. CEPHEID, 905 F.3d 1363 (Fed. Cir. 2018); Genetic Veterinary Sciences, Inc. v. Laboklin GmbH & Co. KG, 933 F.3d 1302 (Fed. Cir. 2019).
Accordingly, claims 1, 7, 15-17, 20, 22-23, 34, 36-38, 43, 45-46, 52, 54 and 65-66 are not patent eligible.
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.
2. Regarding claims 17, 22-23, 34, 43, and 45-46 the phrase "for example/in particular" 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).
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.
3. Claim(s) 1, 7, 15-17, 20, 22-23, 34, 36-38, 43, 45-46, 52, 54, and 65-66 are rejected under 35 U.S.C. 103 as being unpatentable over Sberro et al in view of Zhou et al.
The claims are drawn to a method for providing a human microbiota protein drug candidate, the method comprising the following steps:
(i) providing a plurality of human microbiota protein sequences and/or a plurality of nucleic acid sequences encoding a plurality of human microbiota proteins;
(ii) identifying in the sequences provided in (i) one or more sequences of a human microbiota protein drug candidate, wherein the sequences of the human microbiota protein drug candidate(s) is/are selected according to the following criteria:
(a) sequences having or coding for proteins having a signal peptide,
(a) sequences having or coding for proteins having a length of 20-500 amino acids and
(a) sequences comprising or coding for a protein comprising at least two cysteine residues and/or a primary and/or secondary structure element conferring a conformational rigid structure; and
(iii) preparing one or more human microbiota protein(s) having or encoded by the sequences identified in step (ii).
Sberro et al (Cell Vol. 178, pp 1245-1259, 2019) teach of providing 4,539 small protein families, including secreted proteins detected by signal peptide prediction, were selected from a human microbiome dataset to identify proteins used by a microorganism to interact with the host or other microorganisms, that secondary structure prediction was preformed on the small protein families, and that from the small protein families a protein family was identified that could have anti-microbial activity. It is stated that the secondary structure prediction was preformed on the protein families, and that the protein families with possible anti-microbial activity were identified from the small protein families, and that the small proteins were used for therapeutic purposes. (See page 1249). Sberro et al further teach of peptides of 50 amino acids. (See page 1245 and online S1).
Sberro do not teach of preparing one or more human microbiota proteins.
Zhou et al (US Publication 2002/0115610) teach that it was routine in the art to produce polypeptides comprising multiple cysteine residues. (See paragraphs 0050-0051).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have taken the method of providing human microbiota protein sequences having signal peptides, a length of 20-500 amino acids and at least two cysteine residues as taughy by Sberro et al and to have further produced the polypeptide in large amounts as taught by Zhou et al. One would have been motivated to produce the polypeptide in light of the teaching by Sberro that peptides of about 50 amino acids containing multiple cysteine residues have potential antimicrobial activity.
Claim 63 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark NAVARRO whose telephone number is (571)272-0861.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 October 9, 2025