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 action is in response to applicants correspondence mailed 07/08/2026.
Election/Restrictions
Applicant’s election without traverse of group I, claims 2-6 in the reply filed on 07/08/2026 is acknowledged.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2026.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/490753 and 63/490751, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
‘753 discloses only Alu transcripts in tissues by in situ hybridization using LNA probes. ‘753 provides support for LNA probes and hybridization to detect RNA however ‘753 does not provide support for detecting the level of Alu in a cell or organ as claimed. ‘753 does not provide support for full length Alu or small cytoplasmic Alu RNA in a sample (claim 2-3), PCR (claim 4), fl-Alu RNA produced from SINE (claim 5), primers comprising SEQ ID NO 1 and NO 2 (claim 6), sample comprising blood, serum, plasma, vaginal discharge, urine, lymphatic fluids, and amniotic fluids (claim 7) and detecting a level of C19MC Alu RNA (claim 8).
‘751 discloses performing competitive RT-PCR of Alu RNA using primer set that recognizes both fl-Alu and sc-Alu. ‘751 teaches using total RNA isolated from HeLA cells. ‘751 does not disclose a cell, tissue, or organ sample from a subject. ‘751 does not disclose any other nucleic acid sequence other than the primer set that comprises SEQ ID NO 1 and 2. While ‘751 discloses the primers of SEQ ID NO1 and NO 2 using RT-PCR, the only sample disclosed by ‘751 is HeLA cells. As such ‘751 does not provide support for cell, tissue or organ sample from a subject (claim 1-3), PCR, qPCR, RT-qPCR, and in sit hybridization (claim 4), fl-Alu RNa produced from SINE in the tissue (Claim 5), samples recited in claim 7, or detecting a level of C19MC Alu RNA.
Because neither ‘752 or ‘751 provide support for the instant claims, the effective filing date for each of the claims is 03/24/2024.
Drawings
The drawings are acceptable.
Sequence Rules
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). There are sequences in the specification in paragraph 74 and 86 that do not have sequence identifiers.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 3 and 5-6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception, an abstract idea without significantly more.
Claim 3 recite a method for detecting the presence and/or level of Alu RNA by comparing the level of sc-Alu to fl-Alu RNA. The recitation of “comparing” encompass a mental process step which could be practiced in the mind. Neither the claims nor the specification set forth limiting definitions for comparing and the claims do not set forth how the comparison of sc-Alu RNA to fl-Alu RNA is accomplished. The broadest reasonably interpretation of comparing is a step that can be accomplished mentally by evaluating data and critical thinking process wherein one mentally reads information in a database or report regarding sc-Alu RNA and fl-Alu RNA levels. Additionally the comparison can include a step that encompasses a mathematical calculation using the level of sc-Alu RNA and fl-Alu RNA levels and this also encompasses an abstract idea.
These judicial exception are not integrated into a practical application because the steps recited in the claims in addition to the judicial exceptions are data gathering steps that do not apply or integrate the judicial exceptions in any way. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition 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. The courts have recognized that amplifying nucleic acid sequences 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 Alu RNA levels in a sample. Prior to the invention, Kiesel (J Med Primatol, 2012, 41:176-182), Wickramage (University of South Florida, USF Graduate Theses and Disserations, July 2023) and Wickramage (Cell Host and Microbe, 2023, 31: 1185-1199 teaches obtaining samples from subjects and detecting Alu levels by PCR, including analysis using SEQ ID NO 1 and SEQ ID NO 2 (see Wickramage). This evidences that these steps were conventional at the time of the invention.
Claim 5, further limit the fl-Alu and sample, thus is a field of use limitation which does not amount to significantly more.
Claim 6, limits detection with primers comprising SEQ ID NO 1 and SEQ ID NO 2, Wickramage teaches these were routine and conventional at the time of the invention.
Claim Rejections - 35 USC § 112- Second Paragraph
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 2-3, 5-6 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.
Claim 2-3 further limit claim 1 and are indefinite for the reasons below. Claim 1 requires
a method of detecting the presence and/or level of Alu RNA by obtaining a sample, step (a), contacting the sample with a nucleic acid sequence that hybridizes to Alu RNA, step (b), and detecting hybridization of nucleic sequence to Alu RNA, step (c).
Claim 2 requires at step (b) contacting the sample with a primer sequence and step (c) comprising measuring a level of a small cytoplasmic Alu RNA in the sample. It is unclear if step (c) is intended to further limit step (c) of claim 1 or is there an additional step of measuring a level of sc-Alu RNA following step (c) of claim 1. It is unclear if step (b) is an additional step to step (b) of claim 1 or if step (b) recited in claim 2 is further defining the step (b) of claim 1. For example does claim 2 require that the nucleic acid sequence that hybridizes to Alue RNA to be detected in claim 1 is a primer sequence that hybridizes to small cytoplasmic Alu RNA in the sample or does claim 2 requires that in additional to the nucleic acid sequence that hybridizes to Alu RNA a primer sequence is hybridized to a portion of small cytoplasmic Alu RNA. It is unclear the metes and bounds of the limitations of claim 2 and therefore the claim is vague and indefinite.
Claim 3 recites the method of claim 2, the method further comprises at step (b), at step (c, and step (d) comparing the level of sc-Alu RNA to fl-Alu RNA. Neither claim 1 or claim 2 comprises a step (d) and it is unclear if this step is an additional step of the method. Additionally it is unclear if step (b) and step (c) include additional steps within steps (b) and (c) of claim 2 or are intended to further limit step (b) and (c) of claim 2. For example does claim 3 require step (b) to include contacting the sample with a nucleic acid sequence that hybridizes to a portion of Alu RNa, contacting the sample with a primer sequence that hybridizes to small cytoplasmic Alu in the sample and contacting the sample with a primer sequence that hybridizes to full length Alu RNA or is step (b) intended to further limit the nucleic acid sequence that hybridizes? For example is claim 2 and 3 only further limiting the nucleic acid sequence that hybridizes to Alu RNA to be detected in claim and not necessarily additional method steps? It is unclear the metes and bond of claim 3 and therefore the claim is vague and indefinite.
Claim 5 and 6 depend from claim 3 and are indefinite for the reasons applied to claims 2 and 3.
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 1-5 and 7, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kiesel (J Med Primatol, 2012, 41:176-182).
Kiesel teaches obtaining cells and tissue from rhesus monkey (see RNA isolation and elimination of genomic DNA). Kiesel teaches samples comprising peripheral Buffy coat cells (blood sample, claim 7). Kiesel teaches performing RT-PCR on RNA isolated from the samples (see RT reaction with oligo dT15, Alu primer). Kiesel teaches Alu-specific Hot-Start PCR (claim 4). Kiesel teaches distribution of Alu DNA elements in rhesus monkeys. Kiesel teaches measuring Alu RNA in sample, sc-Alu in sample and figure 2 represents a table that provides a comparison of the levels of each Alu and sc-Alu. The Alu primer of Kiesel is a primer that will hybridize to a portion of sc-Alu and full length Alu. The table of figure 2 demonstrates the level of fl-Alu and sc-Alu was measured and compared. Figure 2 further demonstrates full length Alu RNA were detected and produced from SINE in the tissue (claim 5).
Claims 2-3 have been interpreted to encompass the nucleic acid sequence of step (b) of claim 1 is a primer that hybridizes to a portion of sc-Alu and a primer that hybridizes to a portion of fl-Alu and step (c) encompasses detecting hybridization and measuring level of sc-Alu (claim 2) and measuring level of fl-Alu (claim 3). It is noted that the claim 2 and claim 3 require a primer that hybridizes to a portion of fl-Alu and portion of sc-Alu, therefore the primer does not need to comprise an entire sequence of sc-Alu or fl-Alu. The primers of Kiesel will bind a portion of sc-Alu and full length Alu, as demonstrated in figure 2.
Claims 1, 4, 7-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noguer-Dance (Human Mol Genetics, 2010, Vol 19, No 18, 3566-3582).
Noguer-Dance teaches detecting Alu RNA in C19MC microRNA gene cluster in placenta samples. Noguer-Dance teaches Alu-rich domains in C19MC (see fig 4) (claim 8). Noguer-Dance teaches obtaining samples comprising primary placenta cells (see materials and methods). It is noted that the primary placenta cells were originally obtained from a subject. Noguer-Dance teaches RNA was isolated and performing RT-PCR, qPCR and DNA probe hybridization (see materials and methods) (claim 4). Therefore Noguer-Dance teaches a method of detecting the presence of Alu-RNA by PCR amplification and hybridization of probe to detect Alu in C19MC in placenta samples.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wickramage et al (Cell Host & Microbe, 2023, 31, 1185-1199).
Wickramage et al detecting Alu RNA levels in a placenta sample in C19MC RNA (see pg. 1192, 2nd column) (claim 1, 7-8). Wickramage teaches RT-qPCR of C19MC in cells and human term placental tissues (see fig S1). The miRNA detected by Wickramage contains Alu RNA. Additionally Wickramage teaches reverse transcription PCR of Alu RNA in C19MC (see figure S4) (claim 4). Wickramage teaches detecting fl-Alu and sc-Alu RNA in a sample and comparing levels of sc-Alu to fl-Alu (see figure 3) (claim 2-3). Wickramage teaches SINE RNA levels by PCR (see fig 5) (claims 1-3 and 5). Wickramage teaches SEQ ID NO 1 and SEQ ID NO 2 were used for RT-qPCR and RT-PCR (see number 21, supplemental S6 table) (claim 6).
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wickramage (University of South Florida, USF Graduate Theses and Disserations, July 2023)
With regard to claims 1-6, Wickramage teaches Alu expression in human placenta by competitive RT-PCR for Alu using RNA isolated from human term placenta, human cardiac left ventricle samples. Wickramage teaches fl-Alu was increased in placentas and teaches Alu RAN is expressed in C19MC miRNA (See pg. 88) Wickramage et al detecting Alu RNA levels in C19MC RNA (see fig 19) Wickramage teaches RT-qPCR of Alu RNA in C19MC (see figure 19, pg. 78) (claim 4). Wickramage teaches detecting fl-Alu and sc-Alu RNA in a sample and comparing levels of sc-Alu to fl-Alu (see figure 19). Wickramage teaches the assay using a primer set that recognizes both fl-Alu and sc-Alu and determining the ratio of fl-Alu to sc-Alu (see pg. 78) (claim 2-3). Wickramage teaches fl-RNA is produced from SINE RNA levels (claim 5). Wickramage teaches SEQ ID NO 1 and SEQ ID NO 2 were used for RT-qPCR and RT-PCR (see number 21, table 1) (claim 6).
With regard to claim 7-8, Wickramage teaches detecting C19MC and Alu RNA transcripts in human placenta samples (claims 7-8) (see 6.2.7). Wickramage teaches obtaining placenta samples, hybridizing probes to detect Alu in a sample, and measuring Alu RNA level in C19MC Alu RNA.
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.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699
