Prosecution Insights
Last updated: October 02, 2026
Application No. 18/037,222

COMPOSITION FOR DETECTING TARGET NUCLEIC ACID AND METHOD FOR DETECTING TARGET NUCLEIC ACID USING SAME

Non-Final OA §103§112
Filed
May 16, 2023
Priority
Nov 16, 2020 — RE 10-2020-0153050 +1 more
Examiner
GIAMMONA, FRANCESCA FILIPPA
Art Unit
1681
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Korea Research Institute of Bioscience and Biotechnology
OA Round
3 (Non-Final)
38%
Grant Probability
At Risk
3-4
OA Rounds
7m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants only 38% of cases
38%
Career Allowance Rate
30 granted / 80 resolved
-22.5% vs TC avg
Strong +57% interview lift
Without
With
+57.4%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
46 currently pending
Career history
141
Total Applications
across all art units

Statute-Specific Performance

§101
8.3%
-31.7% vs TC avg
§103
43.6%
+3.6% vs TC avg
§102
9.7%
-30.3% vs TC avg
§112
29.7%
-10.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 80 resolved cases

Office Action

§103 §112
DETAILED 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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/9/2026 has been entered. Applicant’s arguments and amendments have been thoroughly reviewed and considered. Claims 20, 22, 28, 31, 33, and 35 have been canceled. Claims 18, 23-26, 30, 34, and 36-37 are pending and are examined on the merits herein. Response to Applicant’s Amendments 35 USC 112(a) Rejections Claims 18, 20, 22, 30-31, and 33-37 were rejected due to new matter issues associated with claims 18 and 34. Claim 18 has been amended so that the phrase “configured to hybridize with the target nucleic acid” has been amended to read “the target sequence.” This, as pointed out in Applicant’s Remarks on page 9, is supported by the instant specification. Therefore, this rejection has been withdrawn. The rejection for dependent claim 30 has also been withdrawn. Claims 20, 22, and 31 have been canceled, and so these rejections have been rendered moot. However, see the 35 USC 112(b) Rejections below associated with the amended language for this claim. Claim 34 has been amended so that the phrase “configured to hybridize with the target nucleic acid” has been amended to read “the target sequence configured to hybridize with the target nucleic acid.” This amendment still poses a new matter issue, as though the inventive second probe does contain the target sequence, this target sequence on the probe does not hybridize to the target nucleic acid sequence. Thus, this rejection has been maintained, and the rejections for dependent claims 36-37 have also been maintained. Claim 35 has been canceled, and so this rejection has been rendered moot. 35 USC 112(d) Rejections Claims 22, 31, and 35 were rejected for failing to further limit the subject matter upon which these claims depended. Applicant has canceled these claims, and so these rejections have been rendered moot. 35 USC 103 Rejections Claims 18, 20, 22-24, and 28 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Analytical Methods, 2014; cited in Applicant’s IDS), in view of Jakobsen et al. (Organic & Biomolecular Chemistry, 2016; cited in Applicant’s IDS), and in view of Gaillard et al. (US 2019/0307691 A1). Claims 25-26 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Analytical Methods, 2014), in view of Jakobsen et al. (Organic & Biomolecular Chemistry, 2016), in view of Gaillard et al. (US 2019/0307691 A1), and further in view of Rotem et al. (US 2019/0125937 A1). Claims 30, 31, and 33 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Analytical Methods, 2014), in view of Jakobsen et al. (Organic & Biomolecular Chemistry, 2016), in view of Gaillard et al. (US 2019/0307691 A1), and further in view of Lopez et al. (Langmuir, 2018). Claims 34-37 were rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Analytical Methods, 2014), in view of Jakobsen et al. (Organic & Biomolecular Chemistry, 2016), in view of Gaillard et al. (US 2019/0307691 A1), and further in view of Craighead et al. (US 2012/0028811 A1). In light of Applicant’s amendments to the claims submitted 7/9/2026, these rejections have been withdrawn for all currently pending claims, but see new grounds of rejection and “Response to Applicant’s Arguments” below. Claims 20, 22, 28, 31, 33, and 35 have been canceled, and so these rejections have been rendered moot. Response to Applicant’s Arguments Applicant argues that the combination of references presented in the Final Rejection mailed 4/9/2026 do not meet all of the limitations of the newly amended claims, particularly the requirement that the probes are encapsulated within the liposomes and only released after the degradation of the liposome by a surfactant. The Examiner agrees. The reference primarily used for the liposome teachings in the Final Rejection, Jakobsen, teaches oligonucleotides attached to the outside of the liposomes, and not encapsulated within the liposomes, and the reference does not require the use of a surfactant to release the nucleic acids from the liposomes (see Figure 1 of the reference). This is the basis for the withdrawal of the previous rejections and the presentation of the new grounds of rejections provided below. Claim Objections Claim 23 is objected to because of the following informality: in the penultimate paragraph, line 3 states “upon contact the first liposome” but should read “upon contact of the first liposome.” Appropriate correction is required. Claim Interpretation Regarding claim 18, the first probe must be “configured to hybridize with the target nucleic acid.” However, as this claim is a product claim, no specific method is required that mandates such hybridization occur for each probe. Thus, this limitation will be considered to be met if prior art teaches a probe that contains a region that is capable of hybridizing to a target nucleic acid, even if said hybridization is not taught by said prior art. Regarding claim 34, both the first and second probe must be “configured to hybridize with the target nucleic acid.” However, as this claim is a product claim, no specific method is required that mandates such hybridization occur for each probe. Thus, these limitations will be considered to be met if prior art teaches two probes that contain regions that are capable of hybridizing to a target nucleic acid, even if said hybridization is not taught by said prior art. Regarding claim 36, it is noted that “a house-keeping gene sensing part” is not specifically defined in the instant specification. Though this part is noted in the claim to be “for detecting a house-keeping gene,” there does not appear to be any particular structure of the part that limits or specifies its use for specifically detecting a house-keeping gene. Therefore, any sensor which contains a part that would be capable of detecting a house-keeping gene, even if it is not described as specifically for detecting a house-keeping gene, will be considered to meet this claim limitation. Claim Rejections - 35 USC § 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. 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 18, 23-26, 30, 34, and 36-37 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 18 is rejected because the phrase “comprising (i) the target sequence” is unclear given the other language presented in the claim. Applicant’s intention for the amendment, based on page 9 of their Remarks, appears to be for the second probe to contain a sequence in common with a sequence on the target nucleic acid, as is shown in Figure 1a of the instant specification. However, in claim 18, the phrase “a target sequence” is used in describing part of the sequence on the first probe. Thus, it is unclear if “the target sequence” as used to describe the second probe refers to a sequence on the target nucleic acid or refers to the same sequence as presented in the first probe. The claim will be interpreted as though the first scenario is the case. It is recommended that “comprising (i) the target sequence” be amended to read “comprising (i) the target nucleic acid.” Claim 30 is rejected due to its dependence on rejected claim 18. Claim 23 is rejected for a similar reason to claim 18, as this claim also describes the first probe as having “a target sequence” and the second probe as comprising “the target sequence.” It is recommended that line 2 of the second paragraph of the claim be amended from “comprising the target sequence” to “comprising the target nucleic acid.” The claim will be interpreted similarly to claim 18 in that “the target sequence” on the second probe will be considered to refer to the target nucleic acid and not the sequence complementary to the target nucleic acid present on the first probe. Claims 24-26 are rejected due to their dependence on rejected claim 23. Claim 34 is rejected for a similar reason to claims 18 and 23, as this claim also describes the first probe as having “a target sequence” and the second probe as comprising “the target sequence.” It is recommended that the paragraph of the claim describing the structure of the second probe be amended from “comprising (i) the target sequence” to “comprising (i) the target nucleic acid.” The claim will be interpreted similarly to claims 18 and 23 in that “the target sequence” on the second probe will be considered to refer to the target nucleic acid and not the sequence complementary to the target nucleic acid present on the first probe. Claims 36-37 are rejected due to their dependence on rejected claim 34. Claim Rejections - 35 USC § 112(a) 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 34-37 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. Claim 34 recites that the second probe comprises “the target sequence configured to hybridize with the target nucleic acid.” As stated in the “Claim Interpretation” section above, this indicates that the second probe is capable of hybridizing to the target nucleic acid, even if such hybridization does not actually occur. However, such a feature of the second probe is not recited in the instant specification, and in Figure 1, Probe B (analogous to the second probe as claimed) contains regions a*, b*, and c. The target nucleic acid contains b*, which is the same as a portion of Probe B, but this region does not also hybridize to another portion of the target nucleic acid. Additionally, Probe B itself does not appear to generally contain a region that can hybridize to the target nucleic acid, and no such hybridization is shown in the figure. This is corroborated by para. 52 of the instant specification, which states that the second probe may comprise the target sequence. Thus, the disclosure of a second probe that comprises “the target sequence configured to hybridize with the target nucleic acid” is considered new matter. Claims 36-37 are rejected due to their dependence on rejected claim 34. It is noted that if claim 34 were amended similarly to claim 18 (in view of the guidance provided in the 35 USC 112(b) Rejections described above), in that the second probe were stated to be “comprising (i) the target nucleic acid,” without the phrase “configured to hybridize with the target nucleic acid,” this would likely overcome the new matter rejection. 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 18, 23-24, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Analytical Methods, 2014; cited in Applicant’s IDS), in view of Liu et al. (Analyst, 2013), and in view of Gaillard et al. (US 2019/0307691 A1). Jiang teaches a fluorescence assay for detecting miRNA involving catalyzed hairpin assembly. In this assay, two hairpin probes are used, one of which has a fluorophore/quencher pair that is quenched when the stem of the hairpin is in place, and the other which does not have a fluorophore or quencher (Abstract). The two hairpins also have sequences that are complementary to each other (page 9478, column 1, para. 1). The hairpin with the fluorophore/quencher (hereafter called the first probe) contains a sequence that is complementary to a target (see 1, 2, 3, of P1 in Figure 1, that is complementary to 1*, 2* and 3* of a miRNA), as well as a portion that is not complementary to the target (see 4* of P1). The hairpin without the fluorophore/quencher (hereafter called the second probe) contains a portion that is complementary to the target sequence (see 3 of P2), a sequence that is complementary to the off-target sequence of the first probe (see 4 of P2), and sequences that match the target (see 2* and 3*). The first probe contains a FAM reporter and a black hole quencher (BHQ; see Figure 1 caption). Jiang notes that their catalyzed hairpin assembly method, “provides a new method for the versatile, low-cost and sensitive detection of miRNAs in the field of biological research and clinical diagnosis,” (page 9481, column 2, para. 1). However, Jiang does not teach that each probe is encapsulated on separate liposomes, nor the use of hydrogels. Liu provides a review of liposomes as biosensors, and notes that they are “excellent carrier properties for encapsulation of signal marker compounds across a wide spectrum of sensing modalities,” (Abstract). Figure 2 shows the various uses for liposomes, including the encapsulation of various molecules such as DNA and fluorescent dyes (see also page 392, “1.1 Application of liposomes to biosensors”). Section 1.3 notes that controlled release of encapsulated materials can be done via the use of a surfactant/detergent, as these chemicals can lyse the liposome. This section also notes, “The aforementioned properties of responsive liposomes consequently signal their potential use in biosensor systems, as encapsulation of a signaling molecule within the liposome might be of use in signal amplification…and the need to rapidly release the encapsulated signaling molecule in response to a selective stimulus is key to their potential application in rapid biosensing technologies,” (page 392). Page 393 discusses using liposomes as biosensors more specifically, and notes that they can be used to detect DNA/RNA analytes with low detection limits (see the introduction to section 3). Figure 5 and pages 397-398 joining para. show that liposomes may be filled with fluorescently labeled probes, and once the liposomes are lysed, those probes may hybridize to the targets and release a fluorescent signal. Page 402 discusses methods of immobilizing liposomes, such as on gel particles to bind the liposome to a substrate, which can increase stability (paras. under section 4 and para. 1 of section 4.2). Liu concludes that liposomes, “offer much utility in biosensor field due to their large internal volume of cavity, high surface area and ability of conjugate bilayer liposome with a variety of biorecognition elements. Low limit of detection for the analyte of interest down to pmol/mL or fmol/mL levels has been achieved using liposome based biosensors through liposomal signal amplification in optimized conditions. A wide variety of analytes are able to be detected due to the possibility to conjugate bilayer lipids with biorecognition elements. Furthermore, simple preparation techniques, low cost and successful commercialization experience in medicine are also obvious advantages for the commercialization of liposome-based biosensors,” (page 404, under section 6). Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Jiang and Liu to arrive at the probe and liposome combination of instant claim 18. Liu teaches many advantages to the use of liposomes in detection/diagnostic contexts, and specifically points out that nucleic acids (that contain fluorescent moieties) may be encapsulated in liposomes and released upon lysis of the liposome with a surfactant. Jiang tests their probes in vitro with serial dilutions of a miRNA target (page 9478, column 2, para. 1), but by utilizing the liposomes of Liu, these probes could be incorporated into a simple, low-cost, low limit of detection assay that can detect targets in biological samples, thus making the probes of Jiang readily relevant to diagnostic assays. Jiang notes that their probes may prove useful for clinical diagnosis (page 9481, column 2, para. 1), so by incorporating them into the methods described by Liu that perform such diagnoses, the research presented by Jiang would be advanced. These reasons would motivate the ordinary artisan to combine these references. Specifically, a hybridization assay similar to that of Figure 5 of Liu utilizing the probes and targets of Jiang would be obvious. There would be a reasonable expectation of success as Liu specifically teaches successful use of liposomes with fluorescent reagents and DNA/RNA. Furthermore, Liu generally teaches a single species within each particular liposome (see the practical applications of the liposomes in Figures 3-5). Additionally, Jiang notes that their probes are kept separate before use (page 9478, column 2, para. 1). As the focus of the reaction of Jiang depends on the sequential interaction of the first probe with the target followed by the second probe with the first probe, it would also be prima facie obvious to keep the probes separate before they interact with the target sequence. Thus, it would be prima facie obvious to keep the probes in separate liposomes until they are mixed via the lysis of the liposomes. Though Jiang states that background fluorescence and binding of the probes with each other before target introduction is low (see page 9478, column 2, para. 2), this separation would prevent background noise entirely. This would also alleviate any concerns about the amount of each probe present in each liposome (e.g. concerns regarding whether both probes are both present in each single liposome, or whether enough of one probe is present in a liposome to generate sufficient amplification). In other words, separating the probes into distinct liposomes would allow for more consistency in the amount of each probe provided, and would lead to more consistent, reproducible, accurate, and efficient detection reactions. As the creation of probes within liposomes is well-known in the art, as shown by Liu, there would be a reasonable expectation of success. However, though Liu does discuss the immobilization of liposomes and the use of gel particles, neither Jiang nor Liu specifically teaches that the liposomes can be situated in a hydrogel. Gaillard teaches compositions for releasing molecules through hydrogels containing liposomes (Abstract). The reference teaches that hydrogels can be used for diagnostic purposes, where liposomes entrapped in hydrogels can contain fluorescently labeled probes. These hydrogels can be used by being injected into a sample (para. 216, which also references Figures 17-20 and 22-27, see also paras. 49-52 and 54-59). The reference specifically notes that the hydrogels aid in minimally-invasive diagnostic purposes (para. 216). Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the teachings of Gaillard to attach the liposome composition of Jiang in view of Liu to a hydrogel to arrive at the invention of claim 18. Gaillard teaches that hydrogels containing a composition with probes and liposomes can be used for diagnostic purposes, which is in line with the goals of Jiang and Liu described above. Liu briefly discusses that immobilization with hydrogels can aid in liposome stabilization, so by fully immobilizing the liposomes in a hydrogel rather than just attaching them to a gel particle, additional stabilization could be achieved. Gaillard also discusses that their hydrogels can be injected, allowing for precise control over where the liposomes enter a sample or assay. This would allow for targeted detection in particular areas of a sample, which would be motivating to the ordinary artisan in the context of detection/diagnosis of localized diseases, such as cancer. There would be a reasonable expectation of success as Gaillard is mainly directed to the use of hydrogels with liposomes, and teaches their combination with fluorescent probes, which would encompass the liposome teachings of Jiang in view of Liu. Thus, claim 18 is prima facie obvious over Jiang, in view of Liu, and in view of Gaillard. Instant claim 23 requires the same limitations as instant claim 18, except the claim is drawn to a hydrogel containing the liposomes rather than a composition. As Jiang, in view of Liu, and in view of Gaillard teaches a hydrogel containing the liposomes with the structure described in instant claim 23, the references read on these claims for the same reasons described above for claim 18. Regarding claim 24, Gaillard teaches examples where the hydrogel is made of a polyacrylic acid mixture or polyacrylamides (paras. 158 and 217), a hyaluronic acid mixture (para. 158), polylactic acid (para. 217), soluble celluloses (para, 218), and poly(ε-caprolactone) (para. 218). As the hydrogel of Gaillard is used in the combination of Jiang, in view of Liu, and in view of Gaillard, it would be prima facie obvious to have this hydrogel be made of materials also taught by Gaillard. Regarding claim 30, as noted above, Liu teaches that a surfactant can be used in lysing the liposomes (page 392, column 2, para. 1). As the detecting/diagnosing assay of Jiang, in view of Liu, and in view of Gaillard relies on the lysis of the liposomes to release the probes of Jiang, this combination of references renders this claim prima facie obvious. Claims 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Analytical Methods, 2014), in view of Liu et al. (Analyst, 2013), in view of Gaillard et al. (US 2019/0307691 A1), and further in view of Rotem et al. (US 2019/0125937 A1). Jiang, in view of Liu, and in view of Gaillard teaches the inventions of claims 18, 23-24, and 30 as described above. And though Gaillard teaches materials for the hydrogel, they do not teach that the hydrogel is photocured or a mixture of polyethylene glycol (PEG) and polyethylene glycol diacrylate (PEG-DA). Rotem teaches creating composite membranes via the use of polyethers and a photoinitiator (Abstract). A matrix made of hydrogels can be created, where the hydrogel can be a combination of PEG and PEG-DA (para. 70). Rotem notes that liposomes can be incorporated into the hydrogel (para. 85). The membrane can be photocured with the photoinitiator via exposure to UV light (para. 7), and Rotem specifically teaches performing this utilizing PEG-DA (para. 114). The reference teaches that their membranes can have medical uses, such as implantation into a subject (paras. 2 and 12). Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to use the hydrogel of Rotem in the method of Jiang, in view of Liu, and in view of Gaillard. This would amount to simple substitution of the hydrogel material and method of creation. MPEP 2143 I (B) states, “The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art.” Making hydrogels with PEG and PEG-DA and utilizing photocuring were known in the art, as evidenced by Rotem, and this substitution would yield predictable results, as the hydrogel would still be able to include liposomes and be capable for use within a subject, as in the case of Jiang, in view of Liu, and in view of Gaillard, as these aspects are also taught by Rotem. Thus, claims 25-26 are prima facie obvious over Jiang, in view of Liu, in view of Gaillard, and further in view of Rotem. Claims 34-37 are rejected under 35 U.S.C. 103 as being unpatentable over Jiang et al. (Analytical Methods, 2014), in view of Liu et al. (Analyst, 2013), in view of Gaillard et al. (US 2019/0307691 A1), and further in view of Craighead et al. (US 2012/0028811 A1). Jiang, in view of Liu, and in view of Gaillard teaches a hydrogel/liposome/probe composition as recited in instant claim 34, as each limitation of the claim related to this composition is recited above in the rejection of claim 18. However, none of these references teach a sensor as claimed in claim 34, though it is noted that Liu does generally teach the use of liposomes as biosensors in conjunction with immobilization methods and microfluidic chips (e.g. page 402, under section 4 and section 4.2). Craighead teaches methods associated with microfluidic chips and their use in detection methods (Abstract and para. 3). The microfluidic device can contain fluid channels between an inlet and an outlet (para. 38). Each fluid channel can contain two or more separate chambers for different target molecules (para. 52). The reference also shows the use of positive controls (para. 33 and Figure 12A) and specifically states that a control chamber can be used (para. 53). Targets can be identified by their binding to macromolecules, such as liposomes (para. 64). Craighead specifically states that use of liposomes would require immobilization within a sol-gel matrix, where such a matrix can be a hydrogel (paras. 55 and 64). Use of fluorescent detection methods in the chip are also recited (e.g. paras. 86 and 90). The reference teaches that the use of this chip is high-throughput, can be multiplexed, and decreases time, sample volume, and cost (para. 19). Prior to the effective filing date of the claimed invention, it would have been prima facie obvious for one of ordinary skill in the art to combine the teachings of Craighead with those of Jiang, in view of Liu, and in view of Gaillard to arrive at the sensors of claims 34-37. Craighead teaches many benefits of the use of their chip, and by incorporating the hydrogel-liposome composition of Jiang, in view of Liu, and in view of Gaillard, it would allow for easier and more effective assaying with said composition. Craighead also teaches the use of multiplexing and control chambers, so multiple target groups and a control group could be analyzed simultaneously, allowing for more accurate results and the ability to analyze multiple samples quickly. The ordinary artisan would also be motivated to utilize the hydrogel-liposome composition of Jiang, in view of Liu, and in view of Gaillard in the chip of Craighead, as hydrogels are one of the matrices taught by Craighead that would be needed in order for the liposomes to function. There would be a reasonable expectation of success as Craighead teaches that hydrogels and liposomes may be used in their chip, and teaches that fluorescence can be detected. Thus, claims 34-37 are prima facie obvious over Jiang, in view of Liu, in view of Gaillard, and further in view of Craighead. Conclusion No claims are currently allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA F GIAMMONA whose telephone number is (571)270-0595. The examiner can normally be reached M-Th, 7-5pm. 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 by telephone are unsuccessful, the examiner’s supervisor, Gary Benzion can be reached at (571) 272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, 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. /FRANCESCA FILIPPA GIAMMONA/Examiner, Art Unit 1681
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Prosecution Timeline

Show 1 earlier event
Nov 18, 2025
Non-Final Rejection mailed — §103, §112
Mar 18, 2026
Response Filed
Apr 09, 2026
Final Rejection mailed — §103, §112
Jun 24, 2026
Applicant Interview (Telephonic)
Jun 24, 2026
Examiner Interview Summary
Jul 09, 2026
Request for Continued Examination
Jul 13, 2026
Response after Non-Final Action
Sep 23, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
38%
Grant Probability
95%
With Interview (+57.4%)
4y 0m (~7m remaining)
Median Time to Grant
High
PTA Risk
Based on 80 resolved cases by this examiner. Grant probability derived from career allowance rate.

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