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
This Non-Final Office Action is responsive to the communication received 4/27/2026.
Election/Restrictions
Applicant’s election without traverse in the Reply filed on 4/27/2026 of Group III, claims 16-28, 30 and 36 is acknowledged.
Applicant has elected without traverse in the Reply filed on 4/27/2026 the following species:
A. the tRNA fragments comprise SEQ ID NOs: 30912, 40728, 23049, 23730, 23902, 29278, 27419,2 27412, 30626, 30621, 33718, 39240, and 2016 (claim 16)
The Restriction/Election Requirements are deemed proper and are made FINAL.
Claims 1-28, 30 and 36-40 are pending.
Claims 1-15 and 37-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/27/2026.
Claims 24-28 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the Reply filed on 4/27/2026.
Claims 16-23 and 36 are under examination in this Office Action.
Claim Rejections - 35 USC § 112 (New Matter)
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.
The following is a quotation of the first paragraph of 35 U.S.C. 112 (pre-AIA ):
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 16-23 and 36 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(s) 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(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection. Claims 17-23 and 36 depend directly or indirectly from claim 16.
New/Amended claim 16 states "wherein the tRNA fragments comprise SEQ ID NOs: 30912, 40728, 23049, 23730, 23902, 29278, 27419,2 27412, 30626, 30621, 33718, 39240, and 2016".
Applicant has not shown where support is in the originally filed disclosure. The closest support appears to be found in original claim 16.
Original claim 16 states "wherein the signature comprises at least one sequence with identifiers selected grom the group consisting of SEQ ID NOs: 8596, 8601, 8622, 8657, 8664, and 8811".
There is no connection between the new claim/claim amendment and the cited apparent support.
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 16-23 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea, without significantly more. Claims 17-23 and 36 depend directly or indirectly from claim 16.
The claim 16 limitations directed to an abstract idea (mental processes) are characterizing the tRNA fragments and their relative abundances in the sample by deep sequencing; analyzing the tRNA fragments and their abundances; and determining the presence of breast cancer in the sample obtained from the subject based on the analysis of the tRNA fragments, thereby identifying a subject in need of therapeutic intervention
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 16 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are a method of identifying a subject in need of therapeutic intervention to treat breast cancer comprising, isolating fragments of tRNAs from a breast tissue sample obtained from the subject; and characterizing the tRNA fragments and their relative abundances in the sample by deep sequencing. Dutta et al. (02/27/2014) PCT International Patent Application Publication WO 2014/031631 A1 cited in the 10/6/2022 IDS (hereinafter known as "Dutta") teaches a subject in need of therapeutic intervention to treat breast cancer comprising, isolating fragments of tRNAs from a breast tissue sample obtained from the subject; and characterizing the tRNA fragments and their relative abundances in the sample by deep sequencing (see pages 4 to 13, 26 and 34-51).
Claims 16-23 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, a natural phenomenon, without significantly more. Claims 17-23 and 36 depend directly or indirectly from claim 16.
The claim 16 limitations directed to a natural phenomenon (a naturally occurring relationship) are the relationship between a subject in need of therapeutic intervention to treat triple negative breast cancer and tRNA fragments comprise SEQ ID NOs: 30912, 40728, 23049, 23730, 23902, 29278, 27419,2 27412, 30626, 30621, 33718, 39240, and 2016.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 16 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are a method of identifying a subject in need of therapeutic intervention to treat breast cancer comprising, isolating fragments of tRNAs from a breast tissue sample obtained from the subject; and characterizing the tRNA fragments and their relative abundances in the sample by deep sequencing. Dutta et al. (02/27/2014) PCT International Patent Application Publication WO 2014/031631 A1 cited in the 10/6/2022 IDS (hereinafter known as "Dutta") teaches a subject in need of therapeutic intervention to treat breast cancer comprising, isolating fragments of tRNAs from a breast tissue sample obtained from the subject; and characterizing the tRNA fragments and their relative abundances in the sample by deep sequencing (see pages 4 to 13, 26 and 34-51).
Closest Prior Art
The following is the closest prior art:
Dutta et al. (02/27/2014) PCT International Patent Application Publication WO 2014/031631 A1 cited in the 10/6/2022 IDS (hereinafter known as "Dutta") represents the closest prior art. Dutta teaches a method of identifying a subject in need of therapeutic intervention to treat triple negative breast cancer comprising, isolating fragments of tRNAs from a breast tissue sample obtained from the subject; and characterizing the tRNA fragments and their relative abundances in the sample by deep sequencing; analyzing the tRNA fragments and their abundances; and determining the presence of breast cancer in the sample obtained from the subject based on the analysis of the tRNA fragments, thereby identifying a subject in need of therapeutic intervention (see pages 4 to 13, 26 and 34-51). Dutta does not explicitly teach wherein the tRNA fragments comprise SEQ ID NOs: 30912, 40728, 23049, 23730, 23902, 29278, 27419,2 27412, 30626, 30621, 33718, 39240, and 2016.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
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/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
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