Detailed 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 02 April, 2026. Claims 12, 13, 17-25, 29-36, 50, and 56-59 are pending in the instant application.
35 U.S.C. § 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.
Claims 12, 13, 17-25, and 56-59 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
The amended claims are directed toward a method of assessing disease severity and progression in a SARS-CoV-2-infected subject by obtaining cfDNA sample from a subject, measuring the total amount of cfDNA in the sample, measuring the amount of tissue-specific (e.g., erythroblast, kidney, lung, and liver) cfDNA molecules in the sample, and determining the fraction of tissue-specific cfDNA relative to the amount of total cfDNA, wherein a tissue-specific cfDNA fraction above an upper limit of control is indicative of increased severity and disease progression in the subject, and wherein the upper limit of control is determined based on fractions observed in a reference population. The claims are vague and indefinite because the control population is not identified and the upper limits are not clearly set forth. Moreover, the claim language fails to correlate any given measurement with disease severity and progression. Accordingly, the skilled artisan cannot readily ascertain the metes and bounds of the patent protection desired. Applicant’s arguments have been carefully considered but are not deemed to be persuasive for the reasons of record set forth supra.
Claims 29-36 stand rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant. The amended claims are directed toward a method for detecting tissue damage in a SARS-CoV-2-infected subject comprising obtaining cfDNA molecules from a sample, determining the profiles of a tissue-specific epigenetic marker within the cfDNA, identifying the tissues of origin based on the profile, and measuring the level of cfDNA molecules from the tissue, wherein (i) the level or (ii) an increased level of cfDNA molecules from said identified tissue of origin as compared to a control level, is indicative of damage in said identified tissue of origin. The claims are vague and indefinite because the control population is not identified and the upper limits are not clearly set forth. Moreover, the claim language fails to correlate any given measurement with tissue damage in any specific tissue. Accordingly, the skilled artisan cannot readily ascertain the metes and bounds of the patent protection desired. Applicant’s arguments have been carefully considered but are not deemed to be persuasive for the reasons of record set forth supra.
Claim 50 stands rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant. The amended claim is directed toward a method for detecting a microbial coinfection of a SARS-CoV-2-infected subject comprising obtaining cfDNA a sample, determining the sequences of the cfDNA molecules, and identifying a microbial cfDNA sequence. The claim is vague and indefinite because it fails to identify the precise biomarkers that are predictive of microbial infection. What sequences are actually being measured? How are these sequences being measured? What types of controls are provided to ensure the cfDNA sequences measured are accurate and specific to any given microorganism. Absent further clarification, the metes and bounds of the patent protection desired cannot be readily ascertained. Applicant’s arguments have been carefully considered but are not deemed to be persuasive for the reasons of record set forth supra.
35 U.S.C. § 112(a)
The following is a quotation 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.
Enablement
The previous rejection of claims 12, 13, and 17-25 under 35 U.S.C. § 112(a), as failing to comply with the enablement requirement, is hereby withdrawn in response to Applicant’s arguments.
The previous rejection of claims 29-36 under 35 U.S.C. § 112(a), as failing to comply with the enablement requirement, is hereby withdrawn in response to Applicant’s arguments.
The previous rejection of claim 50 under 35 U.S.C. § 112(a), as failing to comply with the enablement requirement, is hereby withdrawn in response to Applicant’s arguments.
Action Is Final
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 C.F.R. § 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Janet L. Andres, Ph.D., can be reached at (571) 272-0867. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
Information regarding the status of an application may be obtained from the Patent Center. Status information for published applications may be obtained from the Patent Center. Status information for unpublished applications is available through the Patent Center for authorized users only. Should you have questions about access to Patent Center, 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.
Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 14 June, 2026
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