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 the particular species that is the combination of FABP3 and FABP4 in the reply filed on 07/22/2026 is acknowledged.
In light of the Examiners search and analysis of the elected combination, the species election requirement as it was applied between the elected combination of FABP3 and FABP4 (i.e.: species (iii) in the requirement of 04/29/2026) and the subcombinations that are FABP3 (i.e.: species (i) in the requirement of 04/29/2026) and FABP4 (i.e.: species (ii) in the requirement of 04/29/2026) is withdrawn. This partial withdrawal of the species election does not affect the requirement as it was applied to the species identified as iv-xii in the requirement of 04/29/2026.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2026.
Claim Rejections - 35 USC § 112 – Failure to Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 depends from claims 2 and 1. Claim 13 recites the limitation “detecting … the respective level of the at least one biomarker … comprises using a RT-LAMP assay”. But the limitation related to using the particular assat that is RT-LAMP is already required by the limitations of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-4, 8-9, 11-14 and 29-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions, specifically natural phenomena and abstract ideas, without significantly more.
The claim(s) recite(s) “a respective level of at least one biomarker associated with pressure injuries” (as recited in claim 1). In so far as any biomarker may be associated with a pathology or risk there of, such an association is a part of how any biological system works (i.e.: a transcriptome:phenotype relationship), and so the claims are directed to a natural phenomenon (MPEP 2106.04(b)). Where the claims include comparisons among expression levels or to thresholds (e.g.: as recited in claim 9), and determination of the risk of pathology based on biomarker detection the claims include an abstract idea which is a mental process; the correlation of data and information to make a judgment or reach a conclusion which can be performed in the human mind (MPEP 2016.04(a)(2)(III).
This judicial exception(s) is not integrated into a practical application because there are no additional practical steps that are preformed based on the detection of a biomarker, or based on any particular comparison to a threshold or reference level. The claims end with a detection or the analysis of the detected biomarker level. The claims do not, for example, include any steps directed to the treatment or prevention of a pressure injury.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite routine and conventional activity at the highest level of generality. Here it is not that the claims are directed to the use of RT-LAMP for the detection of a biomarker. But the use of RT-LAMP to dectect a biomarker was well known in the related prior art. Cunningham et al (US PG Pub 20200023360) (cited on the IDS of 11/07/2025) teaches methods, devices and reagents for the detection of biomarkers using RT-LAMP. And Notomi et al (2000) also teaches methods and reagents for RT-LAMP detection of target nucleic acids. Here it is noted that while some claims specify a particular gene product as the biomarker of the method, the recitation of a biomarker as associated with a pathology is part of the judicial exception of the claims (i.e.: directing the claim to a natural phenomenon). Merely identifying the biomarker is not itself an additional element that creates a claim that is significantly more than the judicial expectations. Furthermore, the use of a generic computer to perform generic computer functions is not significantly more. See MPEP 2106.05(A).
Claim Rejections - 35 USC § 112
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 1, 4, 8 and 29 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 or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The rejection of claims is relevant where the claimed methods require detecting, using RT-LAMP, a biomarker associated with pressure injuries. The rejected claims do not recite any particular biomarker, and thus encompass the detection of any RNA species (i.e.: RT-LAMP detects RNA) in a sample from any organism. Thus the structures encompassed by the claims are generically broad: any RNA from any subject organism. Considering the generic breadth of any encompassed RNA with only human samples (though the claims are not limited to humans), the related art teaches that there are 134,135 transcripts from approximately 84,000 different genes that are detectable in human samples (Velculescu, et al (1999)). But it is not established by either the instantly filed application or the related art how one can select from the broadly encompassed RNAs those which are suitably considered “a biomarker associated with pressure injuries”. Where a detected level of any RNA may be a biomarker if some particular level is overrepresented with a particular phenotype, the prior art teaches that there is natural variation in gene expression among different individuals and among different genes (Cheung et al (2003)), and that validation of any asserted association requires standardization of analytic approaches and the evaluation of the clinical merit in broader heterogeneous populations by prospective clinical trials (Kim et al (2010)). While the instant application provides analyses of expression of two particular RNAs in human samples (i.e.: FABP3 and FABP4), there is no indication as to how the particular teachings of the specification are related to the association of any other different RNAs with pressure injuries. Neither the related art, nor the teachings of the application as filed, provide the skilled artisan with the ability to select from the boradly encompassed structures of the claimed methods (i.e.: any RNA from any sample from any subject) those particular RNAs which meet the functional assertion of the claims (i.e.: associated with pressure injuries), other than the particular biomarkers disclosed in the application as filed.
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.
Claim(s) 1-4, 8, 9, 11-14, 29-32, 35-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al (2020) (NPL citation 1 on the IDS of 11/07/2025) in view of Cunningham et al (US PG Pub 20200023360) (US Pat citation 1 on the IDS of 11/07/2025).
Relevant to the methods of the rejected claims, Schwartz et al teaches the detection of biomarkers related to the risk of pressure injuries. The reference teaches the RT-qPCR analysis of blood samples (relevant to claims 4 and 29) to detect levels of FABP3 and FABP4 (relevant to claims 1-3) and the normalization of expression levels using references genes (Beta-2-Microglobulin, Actin, Hypoxanthine phosphoribosyltransferase-1 and large ribosomal protein PO) (relevant to claims 11, 12 and 31) (e.g.: p.698 - RT-qPCR analysis). The reference teaches that FABP3 and FABP4 RNAs were detected at higher normalized levels in samples from subjects with pressure injuries than in samples from subject without pressure injuries, providing levels for results from each sample type (e.g.: FABP4 was approximately 1.50 in Group I and approximately 2.50 in Group II) (e.g.: Fig 3c) (relevant to the limitations of 9, 30 and 35-37).
Schwartz et al does not exemplify the detection of biomarkers using RT-LAMP (as recited in claim 1 and relevant to claim 32), the use saliva or urine (relevant to claim 8), or the use of computing devices to receive signals and output information (relevant to claim 37). However such methods in the analysis of target nucleic acids were known in the prior art and are taught by Cunningham et al.
Cunningham et al teaches methods for the detection of target RNAs using RT-LAMP (e.g.: para 0106), relevant to the limitations of claim 1. Cunningham et al teaches that samples for analysis may be blood (including less than 10ul) (e.g.: para 0039) and saliva and urine (e.g.: para 0085; para 0046) (relevant to claims 4, 8 and 29). Cunningham et al teaches RT-LAMP performed at 65o C (e.g.: para 0095) (relevant to claim 32), and fluorescent detection (e.g.: para 0008) (relevant to claim 14). Further relevant to the limitations of claims 9 and 30, Cunningham et al teaches the detection of threshold levels of target nucleic acids (e.g.: para 0098) and the use of computer-based systems to receive input and provide output (e.g.: p.8 – Example Detection Insturment; p.9 - Example Computing Device; p.10 – Example Cloud-Based Data Management System).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have used the RT-LAMP methods of Cunnigham et al for the detection of biomarkers as taught by Schwartz et al. The skilled artisan would have been motivated to use the RT-LAMP methods of Cunnigham et al based on the expressed teachings of Cunnigham et al that such methods can be part of a rapid point of care test requiring minimal intervention from the user (e.g.: para 0038), and the expressed teachings of Schwartz et al that detection of the biomarkersmay provide a clinically useful tool to assist in determination of an individual's risk status for pressure injury recurrence. The teachings of Schwartz et al provides normalized thresholds values related to the different analyzed groups (i.e.: Group I: No PrI history; Group II: Recurrent PrI history) which would be suitable for the classification of different pressure injury risks, for example high risk or low risk.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al (2020) (NPL citation 1 on the IDS of 11/07/2025) in view of Cunningham et al (US PG Pub 20200023360) (US Pat citation 1 on the IDS of 11/07/2025), as applied to claims 1-4, 8, 9, 11-14, 29-32, 35-37 above, and further in view of Notomi et al (2000) .
Schwartz et al in view of Cunningham et al renders obvious the detection of FABP3 and/or FABP4 RNA using RT-LAMP (as required by claims 1, 2 and 13, from which rejected claim 33 depends).
Cunningham et al, which teaches RT-LAMP, does not explicitly state targeting six regions of a target sequence with a set of four primers, as required by claim 33. However such elements in the application of LAMP were known in the prior art and are provided by Notomi et al (e.g.: Abstract, LAMP “employs a DNA polymerase and a set of four specially designed primers that recognize a total of six distinct sequences on the target DNA).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have used the particular teachings of Notomi et al for the designing of primers to perform the RT-LAMP rendered obvious by Schwartz et al in view of Cunningham et al. Where Notomi et al teaches the methods of loop mediated isothermal amplification (LAMP), using the particular methods of Notomi et al would be the simple substitution of one known element for another with predictable results. The skilled artisan would have a reasonable expectation of success in applying the methods of Notomi et al to the analysis rendered obvious by Schwartz et al in view of Cunningham et al because Notomi et al specifically teaches that such methods are applicable to detection of RNA (e.g.: Figure 5; p.v – LAMP for a RNA target).
Claim(s) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schwartz et al (2020) (NPL citation 1 on the IDS of 11/07/2025) in view of Cunningham et al (US PG Pub 20200023360) (US Pat citation 1 on the IDS of 11/07/2025), as applied to claims 1-4, 8, 9, 11-14, 29-32, 35-37 above, and further in view of Tanner et al (US Patent 10,968,493) .
Schwartz et al in view of Cunningham et al renders obvious the detection of FABP3 and/or FABP4 RNA using RT-LAMP and fluorescent detection (as required by claims 1, 2, 13 and 14, from which rejected claim 33 depends).
Cunningham et al, which teaches RT-LAMP, does not explicitly state detection via colorimetric output, as required by claim 34. However such elements in the application of RT-LAMP were known in the prior art and are provided by Tanner et al (e.g.: col.38).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have used the colorimetric detection of RT-LAMP products taught by Tanner et al in the detecting rendered obvious by Schwartz et al in view of Cunningham et al. Using the particular methods of Tanner et al would be the simple substitution of one known element for another with predictable results.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
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Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
