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 election without traverse of group V, claims 20-21, in the reply filed on 11/10/2025 is acknowledged.
Claims 1-19 and 22-29 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11/10/2025.
Claims 20-21 are under examination.
Claim Rejections - 35 USC § 112(b)
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 20-21 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.
Claims 20 and 21 recite hybridizing a sample to a PathoChip array, wherein the Pathochip array comprises a plurality of probes specific for a plurality of respiratory pathogens, a plurality of probes specific for Coronaviruses, and a plurality of probes specific for immune markers of innate and adaptive responses to infections, inflammation, immune disorders, metabolism, and toxicological response. The recitation of “Pathochip” renders the claim indefinite. The specification does not provide a specific definition for PathoChip and asserts “this version of the PathoChip (ImmunoChIP) comprises 15,000 probes which specific for all know respiratory pathogens including Coronviridae, sexually transmitted agents, food borne pathogens, and other common transmissible agents” (see pg. 14, lines 12-14). The specification further addresses that additional probes are SEQ ID NO 1-37 and 38-4671. It is unclear what is encompassed by PathoChip. Do the claims encompass the use of the commercially available PathoChip by Agilent, a new version of the commercially available PathoChip, an ImmunoChIP as indicated in the specification or is the phrase “pathochip” nomenclature to define an array with the plurality of probes recited in the claim and is not in fact related to the commercially available PathoChip. The recitation of the PathoChip renders the claim vague and indefinite and one of ordinary skill in the art would not know the metes and bounds of what probes are encompassed by the chip for hybridization to a sample.
Claim 20 and 21 are vague and indefinite in that the metes and bounds of the claimed method are unclear. The preamble recites a method of detecting a Coronavirus in a sample from a subject (claim 20) and a method of identifying a high-risk subject (claim 21). However, it is not clear that hybridizing a nucleic acid from a sample to a PathoChip array will necessarily result in identifying a high risk subject or detecting Coronavirus because the claims do not require any other steps other than hybridizing a nucleic acid to a PathoChip array. While the claim recites wherein when the nucleic acid sample hybridizes, this is conditional and it is not clear the metes and bounds of “when”. Does when the nucleic acid sample hybridize mean any level? Increase? Decrease? an Therefore, it is unclear if one necessarily accomplishes what is intended for the method by practicing the recited method step(s).
Claim Rejections - 35 USC § 112(a)
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 20-21 rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without the knowledge or identity of the probes that are on the PathoChip, which are critical or essential to the practice of the invention but not included in the claim(s). See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
The claims require hybridizing a sample to PathoChip, wherein when the nucleic acid hybridizes to three Coronavirus probes on the PathoChip, a Coronavirus is detected (claim 19) and the subject is identified as high-risk (claim 20). The claims require using a Pathochip to hybridize to a sample to determine risk and detection of Coronavirus. The recitation of “PathoChip” is an attempt to improperly incorporate essential subject matter by reference. 37 CFR 1.57(d) provides
"Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference.
"Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f).
In the instant case the sequences of the probes on the PathoChip are necessary to enable a person skilled in the art to use the invention. Neither the specification or the claims disclose the sequences that comprise the PathoChip. As addressed in the 112(b) rejection above it is unclear if the PathoChip is a commercially available chip that is used or if it is a modification of the commercially available chip or not related at all.
The specification does not disclose PathoChip with respect to the sequences of the probes on the chip. While the specification addresses the PathoChip on page 14, the specification addresses the version of the PathoChip is referred to as ImmunoChip and comprises 15,000 probes however the specification only lists SEQ ID NO 1-4671 as “additional” probes (see lines 9-24). The specification further teaches the method comprises hybridization a sample to a PathoChip v5 array, comprises over 60,000 probes (See pg. 16, lines 9-12). The specification addresses PathoChip design and v1, v2, v3, and v4 have been previously described, however this is in reference to non-patent literature and these references do not define the probes located on the chip (see pg. 26, lines 15-17).
References to commercially available microarray chips are inappropriate for recitation of a claim limitation. Because the recitation is critical and essential to practice the claimed methods, the claims are thus rejection under 35 USC 112, first paragraph for failing to enable one of ordinary skill to practice the invention.
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.
Claims 20-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea and law of nature without significantly more.
The claims recite “wherein when the nucleic acid sample hybridizes to at least three Coronavirus probes on the PathoChip, a Coronavirus is detected in the sample” and “the subject is identified as high-risk”. These recitations are both a mental process abstract idea and sets forth a natural law correlation that the hybridization of the probes are correlated to Coronavirus and high-risk.
This judicial exception is not integrated into a practical application because the steps in addition to the judicial The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in additional to the judicial exceptions are data gathering steps that do not apply or integrate the judicial exception in any way. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in additional to the judicial exception are data gathering steps recited at a high level of generality employing techniques that were well-established, routine and conventional at the time of the invention. Hybridizing nucleic acids to commercially available microchips is a well-understood, routine, conventional activity in the life science arts when claimed in a merely generic matter. Here, the claims include steps of hybridizing a sample to a commercially available chip, PathoChip. Prior to the invention, Robertson et al. (WO2018200813A1) teaches hybridizing a detectably labeled nucleic acid from a tumor sample to a PathoChip array to generate a hybridization pattern (see pg. 2, lines 20-23).
Claim Rejections - 35 USC § 102
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.
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.
Claims 20-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robertson et al. (WO2018200813A1, cited on IDS).
Robertson teaches hybridizing a detectably labeled nucleic acid from a tumor sample to a PathoChip array to generate a hybridization pattern (see pg. 2, lines 20-23). The PathoChip array comprises probes for coronavirus, immune markers for infections, inflammation, immune disorders, metabolism and toxicological responses. Robertson teaches at least 3 nucleic acid probes from Coronaviridae (see pg. 2). The probes specific for the list of pathogens taught by Robertson meet the limitations of a plurality probes specific for immune markers of innate and adaptive responses to infection, inflammation, immune disorders and toxicological responses. Each of the pathogens have these characteristics. It is noted the only active process step of the claim is hybridizing a detectably labeled nucleic acid from a sample to a Patho chip array, for these reasons Robertson meets the limitations of the claims.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAE L BAUSCH whose telephone number is (571)272-2912. The examiner can normally be reached M-F 9a-4p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAE L BAUSCH/Primary Examiner, Art Unit 1699