DETAILED ACTION
Claims 1-6, 8-11, 13-14, 16, 18, 29-30, 32-34, and 36-38 are pending.
Election/Restrictions
The restriction filed on 03/09/2026 has been withdrawn in view of further consideration of the claims and the arguments filed in the “Response to Election” filed on 08/30/2026.
The election of species has been withdrawn because the invention requires multiple sequences due to being a multiplex detection sensor.
Thus, the species election has been withdrawn, and SEQ ID NOs: 82-107 will be considered.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/28/2023 has been considered by the examiner.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
1.Claims 1-11, 13, 32-34, and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Motamedi et al., (US 20200300849A1) (IDS filed on 12/28/2023), in view of Bossmann et al., (US9731034B2) (IDS filed on 12/28/20263).
Motamedi teaches a nanosensor for rapid diagnosis of lung conditions via detection of a target biomarker (see entire document, see claim 1 of ‘849, see [0005]), said nanosensor comprising:
a central carrier particle comprising a core/shell nanoparticle selected from the group consisting of Fe/Au, Fe/Fe304, Fe/FexOy, and Au/Fe2O3 (see [0055] – [0056] teaching the carrier particle comprising a core/shell nanoparticle that is FexOy, Au/Fe2O3, and/or Fe/Fe2O3);
a detectable particle connected to said central carrier particle via an oligopeptide linkage (see [0011]),
said linkage specific to said target biomarker, wherein said recognition sequence is modified or cleaved in the presence of said target biomarker (see [0012], see [0038], see abstract); and
a quencher particle directly attached to said central carrier particle via a non- cleavable linkage (see [0037]);
wherein said detectable particle and quencher particle are separated by a distance that enables Förster resonance energy transfer (see [0013]) (instant claims 1 and 38).
While Motamedi does not explicitly state a first and second nanosensor, Motamedi teaches the use of multiple nanosensors, the use of two different sequences. And the use of two different detectable signals (see [0070], see [0103]) (instant claim 38).
Motamedi teaches said carrier particle and detectable particle are separated by a distance that enables surface plasmon resonance between said carrier particle and detectable particle (see [0041], see [0013]) (instant claim 2). Motamedi teaches said carrier particle and detectable particle are separated by a distance that enables said carrier particle to quench an excited state of said detectable particle (see [0043] “During this ultrafast process, the energy of the electronically excited state or surface plasmon of the detectable particle is at least partially transferred to the quencher particle.”) (instant claim 3). Motamedi teaches a plurality of said detectable particles and a plurality of said quencher particles, each of said detectable particles being connected to said central carrier particle by respective oligopeptide linkages, and each of said quencher particles being directly attached to said central carrier particle (see [0011] “The nanosensor comprises a central carrier particle, a first particle tethered to the carrier particle via an oligopeptide linkage, and a second particle directly attached to the carrier particle, wherein at least one of the first and second particles is a detectable particle and the other of the first and second particles is a quencher particle”) (instant claim 4). Motamedi teaches wherein said nanoparticle is a stabilized nanoparticle comprising an organic monolayer coating, said detectable particle and quencher particles being attached to said coating (see [0058]) (instant claim 5). Motamedi teaches the detectable particle being a porphyrin (see [0041], see [0066]) (instant claim 6). Motamedi teaches the lung condition being chronic obstructive pulmonary disease (COPD) (see [0005], see [0077]) (instant claims 9 and 37).
Motamedi teaches a method for rapid in vitro diagnosis of a lung condition via detection of a target biomarker in a biological sample (see [0011], see [0008]), said method comprising:
(a) contacting said biological sample with a nanosensor according to claim 1 (see claim 1 of ‘849);
(b) exposing said nanosensor to an energy source to generate a detectable signal from said detectable particle (see [0011], see [0014]); and
(c) detecting changes in said detectable particle signal during contact of said nanosensor with said sample, wherein said changes correspond to activity of the target biomarker in said sample (see claim 1 of ‘849, see [0014]) (instant claim 10).
Motamedi teaches wherein said changes comprise changes in the absorption or emission spectrum of the detectable particle (see [0043]) (instant claim 11). Motamedi teaches the biological sample being selected from the group consisting of sputum, bronchoalveolar lavage fluid, nasopharyngeal washes (in children), induced sputum, and exhaled breath condensate (see [0072]) (instant claim 13). Motamedi teaches incubating the biological sample with the nanosensors (see [0122], see [0127]) (instant claim 36). Motamedi teaches each nanosensor comprising a plurality of detectable particles attached to said central carrier particle via respective oligopeptide linkages, each nanosensor comprising at least two different detectable particles attached to said central carrier particle via respective oligopeptide linkages that each have a recognition sequence specific for different target biomarkers (see [0039] “The central carrier particle can be a variety of particles discussed herein, with the proviso that it can be attached with two or more different particles. Preferably, the nanosensor comprises a plurality of quencher particles attached to a single central carrier particle, and a plurality of detectable particles attached to the same carrier particle via respective oligopeptide linkages.”, see [0087], see [0103]) (instant claim 34). Motamedi teaches providing a microplate comprising a plurality of microwells, where one or more microwells comprises a plurality of nanosensors and adding said biological sample to said microwells to create reaction solutions in each of said microwells (see [0122], see [0127]) (instant claim 33).
While Motamedi does not explicitly recite a “kit” or “instructions”, it would have been obvious to one of ordinary skill in the art at the time of the instant application to include instructions on how to use a kit, as including instructions to a testing device is common practice in the art (instant claims 36 and 37). Motamedi teaches all the claimed elements together, and the use of a kit is widely known in the art.
It would have been obvious to one of ordinary skill in the art to routinely optimize the amount of time the biological sample and the nanosensor incubate. Absent evidence of unexpected results, it would have been prima facia obvious to have arrived at the claimed time (less than 10 minutes) as an obvious matter of routine optimization, namely performing routine experimentation to determine the optimum and workable time needed for the assay (instant claim 32).
As noted in In re Aller, 105 USPQ 233 at 235, More particularly, where the general
conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or
workable ranges by routine experimentation.
Routine optimization is not considered inventive, and no evidence has been presented
that the timing of incubating the biological sample with the nanosensor was anything other than routine, and should be considered unexpected in any way as compared to the closest prior art.
Motamedi does not teach comprising a recognition sequence selected from the group consisting of SEQ ID NOs: 82-107.
Bossmann teaches a recognition sequence selected from the group consisting of SEQ ID NOs: 82-107 (see entire document, see SEQ ID NO: 29 of Bossmann which is the same as SEQ ID NO: 84 of the instant application, see SEQ ID NO: 3 of Bossmann which is the same as SEQ ID NO: 88 in the instant application) (instant claims 1 and 38).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the nanosensor for biological marker detection taught by Motamedi with the assay that is comprised of two particles linked via an oligopeptide linkage that comprises a consensus sequence taught by Bossmann. Bossmann teaches that in the presence of protease, the consensus sequence of the nanoplatform assembly is cleaved, and the spectral change caused by this cleavage is detected by assay (see column 6 lines 25-30). Bossmann teaches that once the protease cleaves the consensus sequence, the quantum dot or porphyrin is released and lights up, allowing for more sensitive detection (see column 14 lines 34-38). The artisan would have had reasonable expectation of success based on the cumulative disclosures of these prior art references.
2.Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Motamedi and Bossmann as applied to claims 1-11, 13, 32-34, and 36-38 above, in view of Rubio et al., “Linkage of neutrophil serine proteases and decreased surfactant protein-A (SP-A) levels in inflammatory lung disease.” Thorax vol. 59,4 (2004): 318-23. doi:10.1136/thx.2003.014902.
The teachings of Motamedi and Bossmann as it pertains to claims 1-11, 13, 32-34, and 36-38 are discussed in the 35 USC 103 rejection above.
Motamedi teaches a subject having chronic inflammatory lung disorder (see [0005], see [0077] teaching chronic obstructive pulmonary disease (COPD)) (instant claim 14).
Motamedi does not teach measuring Cathepsin G and Proteinase 3.
Rubio teaches measuring both Cathepsin G and Proteinase 3 in subjects with chronic inflammatory lung disorder (see pages 319-320 under “degradation of pure SP-A by neutrophil elastase cathepsin G, and proteinase-3) (instant claim 14).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the nanosensor for biological marker detection taught by Motamedi with the assay that is comprised of two particles linked via an oligopeptide linkage that comprises a consensus sequence taught by Bossmann, with the biomarkers taught by Rubio. Rubio teaches that cathepsin G and proteinase-3 contribute the degradation of surfactant protein A (SP-A) and thereby diminishes innate pulmonary antimicrobial defenses (see page 318 under “conclusion”). The artisan would have had reasonable expectation of success based on the cumulative disclosures of these prior art references.
Allowable Subject Matter
3.Claims 16, 18, and 29-30 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 16 would be allowable if rewritten in independent claims because it is not found or suggested in the prior art to measure MMP-12 and MMP-8 with MMP-7.
Claim 18 would be allowable if rewritten in independent claims because it is not found or suggested in the prior art to measure MMP-14 with MMP-2 and MMP-9.
Claim 29 would be allowable if rewritten in independent claims because it is not found or suggested in the prior art to measure MMP-10, MMP-12, MMP-15, Cathepsin H, Arginase II, and neutrophil elastase with MMP-1, MMP-2, and Cathepsin L.
The closest prior art for claimed 16, 18, and 29-30 is Bossmann et al., (US9731034B2) (IDS filed on 12/28/20263).
Bossmann teaches measuring MMP-1, MMP-2, MMP-7, MMP-9, and Cathepsin L (see table 1, see table 2).
Bossmann does not teach or suggest measuring MMP-12, MMP-14, MMP-10, MMP-15, Cathepsin H, Arginase II, and neutrophil elastase.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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