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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/13/2026 has been entered.
Status of Claims
Cancelled: 3, 4, 13, 14
Examined Herein: 1-2, 5-12, 15-20
Priority
Priority to KR10-2018-0050838 filed on 5/2/2018, PCT/KR2019/0005250 filed on 5/2/2019, and US 17/052,275 filed on 2/8/2021 is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/12/2024 is in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98(d). Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings filed on 4/12/2024 are accepted.
Withdrawn Rejections
All rejections of claims 3 and 13 are hereby withdrawn; its cancellation moots the rejection.
The rejection of claims 1, 2, 5-12, and 15-20 over Nguyen, Kovacs, and Ly is hereby withdrawn in view of Applicant’s substantive amendments to claim 1.
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.
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.
Claims 1, 2, 5-12, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen (Development of SERS substrate using phage-based magnetic template for triplex assay in sepsis diagnosis, 5/14/2016, Biosensors and Bioelectronics, 85:522-528), in view of Kovacs (DualSurface-Modified Bacteriophage MS2 as an Ideal Scaffold for a Viral Capsid-Based Drug Delivery System,
6/30/2007, Biconjugate Chemistry, Volume 18, Issue 4), Ly (Detection of HIV-1 antigen by quartz crystal microbalance using gold nanoparticles, 6/21/2016, Sensors and Actuators B: Chemical, 237:452-458), and De Liu (Enhanced plasmon resonance light scattering signals of colloidal gold resulted from its interactions with organic small molecules using captopril as an example, 6/29/2006, Analytica Chimica Acta, 577:244-249).
With respect to claim 1, Nguyen discloses a method for detecting a target substance, CRP, PCT, and sTREM-1, in a sample using surface-enhanced Raman scattering (SERS) comprising:
preparing a gold nanohalo structure comprising gold-coated magnetic nanostars (Au-MNS);
immobilizing secondary antibodies, anti-CRP (ab13426), anti-PCT (ab124093), and anti-sTREM-1 (ab93717, Abcam), on the surface of the gold nanohalo structure, thereby forming immunogold colloids;
preparing a SERS tag comprising a gold nanoparticle (Au-NP) with secondary antibodies, anti-CRP (ab13426), anti-PCT (ab124093), and anti-sTREM-1 (ab93717, Abcam), immobilized on the surface, thereby forming immunogold colloids, and adding primary antibodies, ATP, r6G, and HS-A5-TAMRA, to the immunogold colloids;
binding the primary antibody of the SERS tag to the target substance, a serum sample comprising biomarkers CRP, PCT, and sTREM-1;
reacting the target substance with the gold nanohalo structure to obtain an analyte, a magnetic complex-biomarker-SERS-tag; and
analyzing a SERS spectrum obtained from the analyte;
wherein the Au-MNS are bound to a thiol-functionalized bacteriophage, M13, via thiol-gold atom interactions. [Nguyen, Page 524, Col. 1, Paragraph 2 and Page 525, Col. 2, Paragraph 2-3 and Page 527, Col.1, Paragraph 1-2 and Col. 2, Paragraph 1-2 & Figure 6] [Nguyen, Supplementary, Page 4 (PDF viewer), Paragraph 3, Page 5 (PDF viewer), Paragraph 1-2, Page 6 (PDF viewer, Paragraph 1]
The magnetic complex-biomarker-SERS-tag has the following sandwich structure because the magnetic complex and SERS-tag “sandwich” the biomarker:
Au-NP
|
Secondary Antibodies (anti-CRP, anti-PCT, anti-sTREM-1)
|
Primary Antibodies (ATP, r6G, and HS-A5-TAMRA)
|
Target Substance (Biomarkers CRP, PCT, sTREM-1
|
Secondary Antibodies (anti-CRP, anti-PCT, anti-sTREM-1)
|
Au-MNS
|
Thiol-functionalized M13 Phage
With respect to claim 11, Nguyen discloses a method for detecting a target substance, CRP, PCT, and sTREM-1, in a sample using surface-enhanced Raman scattering (SERS) comprising:
preparing a gold nanohalo structure comprising gold-coated magnetic nanostars (Au-MNS) and immobilizing anti-CRP (ab13426), anti-PCT (ab124093), and anti-sTREM-1 (ab93717, Abcam), on the surface of thereof, thereby forming immunogold colloids;
preparing a SERS tag comprising a gold nanoparticle (Au-NP) with anti-CRP (ab13426), anti-PCT (ab124093), and anti-sTREM-1 (ab93717, Abcam) immobilized on the surface thereof, thereby forming immunogold colloids, and adding antibodies, ATP, r6G, and HS-A5-TAMRA, to the immunogold colloids;
reacting the target substance, a serum sample comprising biomarkers CRP, PCT, and sTREM-1, with the gold nanohalo structure, to obtain an analyte, magnetic complex-biomarker-SERS-tag, which results in:
immobilized antibodies, ATP, r6G, and HS-A5-TAMRA, on the surface of the gold nanohalo structure; and
binding of the target substance to the antibodies; and
analyzing a SERS spectrum obtained from the analyte;
wherein the Au-MNS are bound to a thiol-functionalized bacteriophage, M13, via thiol-gold atom interactions. [Nguyen, Page 524, Col. 1, Paragraph 2 and Page 525, Col. 2, Paragraph 2-3 and Page 527, Col.1, Paragraph 1-2 and Col. 2, Paragraph 1-2 & Figure 6] [Nguyen, Supplementary, Page 4 (PDF viewer), Paragraph 3, Page 5 (PDF viewer), Paragraph 1-2, Page 6 (PDF viewer, Paragraph 1]
The magnetic complex-biomarker-SERS-tag has the following “sandwich” structure, wherein the magnetic complex and SERS-tag “sandwich” the biomarker:
Au-NPs
|
anti-CRP, anti-PCT, anti-sTREM-1
|
Antibodies (ATP, r6G, and HS-A5-TAMRA)
|
Target Substance (Biomarkers CRP, PCT, sTREM-1
|
anti-CRP, anti-PCT, anti-sTREM-1
|
Au-MNSs
|
Thiol-functionalized M13 Phage
With respect to claims 5 and 15, Nguyen discloses that the gold nanoparticles have a size of 35 nm. [Nguyen, Page 525, Col. 1, Paragraph 1]
With respect to claims 6 and 16, Nguyen discloses that the gold nanohalo structure has surface-enhanced Raman scattering (SERS) activity. [Nguyen, Page 527, Figure 6]
With respect to claims 7-8 and 17-18, Nguyen discloses that the target substances are biomarkers for sepsis, including procalcitonin (PCT), a C-reactive protein (CRP), and a soluble triggering receptor expressed on myeloid cells-1 (sTREM-1). [Nguyen, Page 524, Col. 1, Paragraph 2 – Col. 2, Paragraph 1 and Page 527, Col. 2, Paragraph 1-2 and Figure 6
With respect to claims 9-10 and 19-20, Nguyen discloses that the primary antibody is a SERS dye, including ATP, R6G, and TAMRA Raman dye. [Nguyen, Page 524, Col. 1, Paragraph 2 – Col. 2, Paragraph 1 and Page 527, Col. 2, Paragraph 1-2 and Figure 6]
Moreover, Nguyen discloses that a gold nanostructure is prepared by:
activating a carboxyl group of a linker, -SH-OEG-COOH- or -SH-(CH2)11-OEG-COOH-, containing a carboxyl group and a thiol group;
binding the thiol group of the linker to a gold nanoparticle; and
reacting the carboxyl group of the linker with groups present on a surface of antibodies.
Nguyen further discloses that activating the carboxyl group of the linker is performed by treating the linker with NHS and EDC. [Nguyen (Supplementary), Section 4 and 5]
Nguyen does not disclose that the bacteriophage is MS2, that the linker is captopril, or that the gold nanohalo structure is prepared by:
activating a carboxyl group of a linker containing a carboxyl group and a thiol group;
binding the thiol group of the linker to a gold nanoparticle; and
reacting the carboxyl group of the linker with a plurality of amine groups present on a surface of a bacteriophage.
However, with respect to claims 1 and 11, Kovacs discloses that viral capsids serve as templates for the positioning of gold nanoparticles. [Kovacs, Page 1140, Col. 1, Paragraph 1] MS2, a viral capsid, has up to 360 accessible amino groups on the capsid exterior, which react with NHS esters to achieve bioconjugation. [Kovacs, Page 1144, Figure 2]
Furthermore, with respect to claims 1 and 11, Ly discloses a gold structure prepared by:
activating a carboxyl group of a linker, 11-mercaptoundecanoic acid (MUA), which contains a carboxyl group and a thiol group;
binding the thiol group of the linker to a gold structure; and
reacting the carboxyl group of the linker with a plurality of amine groups of the lysine residues present on the surface of streptavidin. [Ly, Page 453, Col. 2, Paragraph 6 and Page 454, Figure 1a]
With respect to claims 2 and 12, Ly discloses that activating the carboxyl group of the linker, 11-MUA, is performed by treating the linker with NHS and EDC. [Ly, Page 453, Col. 2, Paragraph 6 and Page 454, Figure 1a]
Moreover, with respect to claims 1 and 11, De Liu discloses a gold structure prepared by binding the thiol group of captopril, a linker containing a carboxyl group and a thiol group, to the surface of the gold structure. [De Liu, Abstract] De Liu further discloses that the captopril-derivatized gold nanoparticles may be extended to controlled cross-linking and is currently being pursued (as of 2006). [De Liu, Page 249, Col. 1, Paragraph 2]
Modifying the method disclosed by Nguyen by replacing the M13 bacteriophage with MS2 bacteriophage and by preparing the gold nanohalo structure by activating a carboxyl group of a captopril linker by treating the linker with NHS and EDC, binding the thiol group of the linker to a gold nanoparticle, and reacting the carboxyl group of the linker with the plurality of amine groups present on the surface of said MS2 bacteriophage, results in the method of instant claim 1, 2, 11 and 12.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Nguyen by replacing the M13 bacteriophage with MS2 bacteriophage and have a reasonable expectation of success. Nguyen discloses a SERS-based detection system comprising M13 bacteriophage conjugated to a gold nanostructure. M13 bacteriophage is a viral capsid. Kovacs discloses that, in general, viral capsids serve as templates for the positioning of gold nanoparticles. Kovacs further identifies MS2 bacteriophage as a viral capsid with up to 360 accessible amine groups (from lysine residues) on the surface, which react with NHS esters to achieve bioconjugation. Therefore, Nguyen discloses a viral capsid, M13 bacteriophage, with gold nanoparticles positioned on the surface thereof, in a SERS-based detection system. Kovacs discloses that a viral capsid may serve as a template for positioning gold nanoparticles, and MS2 bacteriophage, specifically, is a viral capsid with accessible amino groups on its exterior to facilitate bioconjugation, including this positioning. Accordingly, the combined teachings of Nguyen and Kovacs reasonably suggest that MS2 bacteriophage may serve as the viral capsid to position gold nanoparticles on its surface in the method disclosed by Nguyen. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II). In the present case, Kovacs discloses that MS2 bacteriophage possesses many desirable features, including impressive stability to a broad range of temperature, pH, ionic strength, and organic cosolvent conditions. [Kovacs, Page 1140, Col. 1, Paragraph 1 and Page 1143, Col. 2, Paragraph 3] Therefore, one would have been motivated by the expectation that replacing the M13 bacteriophage with the MS2 bacteriophage would import MS2’s desirable features into the method disclosed by Nguyen.
It would be obvious to one of ordinary skill in the art to modify the method disclosed by Nguyen and Kovacs by preparing the gold nanohalo structure by activating the carboxyl group of a captopril linker by treating the linker with NHS and EDC, binding the thiol group of the linker to a gold nanoparticle, and reacting the carboxyl group of the linker with the plurality of amine groups present on the surface of the MS2 bacteriophage, and have a reasonable expectation of success. Nguyen and Kovacs disclose a SERS-based detection system comprising a gold nanohalo structure prepared by binding Au-MNS to an MS2 bacteriophage, which has amino groups (of lysine residues) present on its surface. Moreover, Nguyen discloses preparing a separate gold nanostructure by activating a carboxyl group of a linker containing a carboxyl group and a thiol group; binding the linker’s thiol group to a gold nanoparticle; and reacting the linker’s carboxyl group with groups present on the surface of antibodies. Ly discloses a gold structure prepared by activating a carboxyl group of a linker, 11-MUA, which contains a carboxyl group and a thiol group; binding the thiol group of the linker to a gold structure, and reacting the carboxyl group of the linker with the amine groups (of lysine residues) present on the surface of streptavidin. De Liu discloses another linker, captopril, which contains a carboxyl group and a thiol group and binds to a gold nanostructure via the thiol group. De Liu further discloses that the carboxyl group may be used for cross-linking, an endeavor that is being pursued (as of 2006). Thus, Nguyen and Kovacs disclose a gold nanostructure conjugated to an MS2 bacteriophage, and both Nguyen and Ly contemplate conjugating a gold structure and a biomolecule via a linker containing a carboxyl group and a thiol group. Ly, specifically, demonstrates that the linker’s carboxyl group may be conjugated to a biomolecule with amine groups (from lysine residues) on its surface. De Liu identifies captopril as a linker containing a carboxyl group available for crosslinking, which has been pursued in the art, and a thiol group that binds to a gold nanostructure. Accordingly, the combined teachings of Nguyen, Kovacs, Ly, and De Liu reasonably suggest that the gold nanostructure disclosed by Nguyen and Kovacs may be successfully prepared by conjugating the nanostructure to the MS2 bacteriophage via captopril, such that the thiol group binds to the nanostructure and the carboxyl group binds to the amine groups (of lysine residues) present on the surface thereof. One would have been motivated to do so because it is prima facie obvious to combine references when some advantage or expected beneficial result would have been produced by their combination. MPEP 2144(II). In the present case, Ly discloses that immersing a gold surface in thiol-containing MUA molecules generates self-assembled monolayers (SAMs) that are stable during system changes (e.g., pH changes). [Ly, Page 453, Col. 2, Paragraph 6] Moreover, De Liu discloses that the binding density of captopril to the surface of the gold nanoparticle is equivalent to the density of mercaptoundecanol that self-assembles on the surface of a gold nanoparticle. [De Liu, Page 248, Col. 1, Paragraph 3] De Liu further discloses that captopril-derivatized gold nanoparticles may be extended to controlled cross-linking, which is being pursued (as of 2006). [De Liu, Page 249, Col. 1, Paragraph 2] Therefore, one would have been motivated by De Liu’s suggestion that captopril is suitable for crosslinking a gold nanostructure to another molecule, and by the expectation that captopril would form self-assembled monolayers on the gold nanostructure disclosed by Nguyen and exhibit stability comparable to MUA during system changes (e.g., pH changes).
Response to Arguments
Applicant's arguments filed 2/20/2026 have been fully considered but they are not persuasive.
Applicant asserts, “Throughout the entire disclosure, Kovacs discloses MS2 as a scaffold for a viral capsid based drug delivery system, which is completely irrelevant to SERS. Specifically, referring to the disclosure of Kovacs below, Kovacs briefly discusses the versatility of viral capsid for application in the areas including bioconjugation reactions of organic molecules, templates for positioning of certain inorganic materials, etc….” [Remarks 2/20/2026, Page 8]
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. MPEP 2145(IV). The instant rejection relies on the combination of Nguyen, Kovacs, Ly, and De Lui, rather than Kovacs alone. Accordingly, attacking Kovacs’ disclosure fails to undermine the rejection, which is based on the combined teachings of these references.
Moreover, Applicant arbitrarily limits the Kovacs disclosure to a drug delivery system. Kovacs discloses that viral capsids are used in bioconjugation reactions as templates for positioning gold particles, depositing metal oxides, coordinating gadolinium ions, growing inorganic nanocrystals, displaying antigenic peptides on surfaces, and more. Kovacs also acknowledges that a goal is to add new functions to viral capsids. [Kovacs, Page 1140, Col. 1] In view of the expansive functions and uses of viral capsids disclosed by Kovacs, a POSITA would recognize that the applicability of viral capsids is not limited to drug delivery systems, especially since Nguyen discloses a viral capsid used in a SERS system.
Furthermore, the claimed invention is drawn to a method of detecting a target substance using SERS, comprising binding a gold nanostructure to a bacteriophage. Kovacs’ disclosure is directed to a bacteriophage, MS2, and Kovacs discloses that bacteriophages are known in the art to be used for positioning gold nanoparticles. Accordingly, Kovacs disclosure, especially in combination with Nguyen, is relevant to SERS.
Applicant asserts, “Even assuming Kovacs's disclosure of MS2 having up to 360 accessible amino groups on the capsid exterior may be relevant to maintaining the functionality as viral capsids in terms of viral capsid-based drug delivery system, there is no teaching or suggestion that this would enable the unique, highly reproducible SERS-active gold nanohalo structure achieved by the claimed invention… However, "feasible attachment' does not equate to the realization of the specific, functional "nanohalo structure" with regularly arranged gold nanoparticles, which results in significantly improved signal reproducibility that the claimed invention achieves.” [Remarks 2/20/2026, Page 9]
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. MPEP 2144(IV). A POSITA need not be motivated to achieve regularly arranged gold nanoparticles that significantly improve signal reproducibility to be motivated to modify the reference disclosed by Nguyen.
Moreover, Applicant continues to conflate a reasonable expectation of success in modifying Nguyen with the motivation to do so. In the CTFR of 11/25/2025, the Examiner stated:
“Kovacs disclosure of "positioning of gold nanoparticles" is relied on to establish a reasonable expectation of success, not a motivation. Kovacs establishes that the attachment of gold nanoparticles to MS2 is feasible.” [CTFR 11/25/2025, Page 12, Paragraph 2]
As explained therein, it is reasonable to expect that the gold nanoparticles can be successfully attached to MS2 because the surface of MS2 has amine groups that enable conjugation to the surface of gold nanoparticle structures via a thiol carboxyl linker. However, the rejection of record does not take the position that, because the attachment is feasible, a person of ordinary skill in the art would therefore be motivated to make the attachment.
Applicant asserts, “In contrast, referring Kovacs, Page 1140, Col. 1, Paragraph 1, which allegedly discloses "feasible attachment" of gold nanoparticles to MS2, below, this "feasible attachment" of gold nanoparticles was described in the context of MRI, but not SERS” [Remarks 2/20/2026, Page 10]
Applicant’s arguments are not persuasive because the rejection of record does not rely on Kovacs’ disclosure of gadolinium-ion coordination for magnetic resonance imaging.
Moreover, Kovacs does not discuss the positioning of gold nanoparticles as being limited to magnetic resonance imaging. Instead, Kovacs discusses gadolinium-ion coordination in the context of MRI. This is evidenced by the fact that Kovacs cites reference (12) as support following the phrase “the capsids have also served as templates for the positioning of gold nanoparticles” and reference (13) as support following the phrase “the deposition of metal oxides.” Neither reference mentions MRI. However, references (3) and (14) following the phrase “and the coordination of gadolinium ions” are both drawn to MRI.
Even if, arguendo, Kovacs was referring to using viral capsids to position gold nanoparticles in the context of MRI, Nguyen discloses positioning gold nanostructures on a viral capsid in the context of SERS. Thus, a POSITA would understand that positioning gold nanoparticles on viral capsids is applicable not only in the context of MRI, but also in SERS. Attacking Kovacs individually when the instant rejection relies on the combined teachings of Nguyen, Kovacs, Ly, and De Lui fails to undermine the rejection of record.
Applicant asserts “De Liu discloses using captopril to link to a gold nanoparticle for plasmon resonance light scattering signals. De Liu is primarily concerned with colloidal gold and small organic molecules. While De Liu suggests that captopril-derivatized gold nanoparticles may be extended to controlled cross-linking, there is absolutely no disclosure of linking to a bacteriophage, let alone MS2, or the resulting SERS application.” [Remarks 2/20/2026, Page 12]
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. MPEP 2145(IV). “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.” MPEP 2144(I). “In considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom." MPEP 2144.01.
Accordingly, De Liu does not need to explicitly disclose that the captopril-derivatized gold nanoparticles can be cross-linked to MS2 or that such a conjugate has applicability in SERS because the reasonable expectation of success in doing so and the motivation for doing so can be gleaned from the combination of references that form the basis of the instant rejection.
Applicant asserts, “the instant specification provides objective evidence of nonobviousness by demonstrating that the claimed structure, specifically the MS2-based gold nanohalo structure, exhibited excellent signal reproducibility in several measurements…. Indeed, none of the cited references suggests the above unexpected results in a method for detecting a target substance by SERS.” [Remarks 2/20/2026, Page 13-14]
Allegations of unexpected results must show that the difference in properties between the prior art and the claimed invention is truly unexpected and not a predictable result. MPEP 716.02. Applicant states that the SERS signal amplification effect of the gold nanohalo structure was better than that of pristine gold nanoparticles. However, this result is not truly unexpected because it is known in the art that the morphology of gold nanoparticles affects their optical properties.
For example, Kwon discloses that icosahedral gold particles show size-dependent SERS activities and give much stronger signals than do spherical particles. SERS intensities obtained with the icosahedral particles are at least 4 times greater than those with spherical particles. The enhanced SERS intensities of icosahedral particles may be ascribed to their intrinsic structural properties, which include more well-defined edges and corners and generally sharper surface features than spheres. Large enhancement of the local electromagnetic field is generally observed in these active regions because they can serve as hot sites for surface plasma enhancement. This morphological characteristic results in greater localized field enhancement for icosahedral particles than spherical ones. [Kwon, Page 1164, Col. 2, Paragraph 1; Controlled Synthesis of Icosahedral Gold Nanoparticles and Their Surface-Enhanced Raman Scattering Property, J. Phys. Chem. C. 2007, 111, 1161-1165]
Accordingly, it is already known in the art that gold particles with well-defined edges and corners and generally sharper surfaces, like the gold nanohalo depicted in the instant specification (Fig. 1), achieve much stronger signals than spherical particles.
Furthermore, "Where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention." MPEP 716.01(b). The nexus between the signal reproducibility and Applicant’s attribution of this result to MS2 is unclear. Applicant contends that the gold nanohalo structure exhibits excellent signal reproducibility but also contends that the high degree of reproducibility is attributable to the unique structural characteristics of MS2 compared to other phages. To that end, the evidence provided does not compare the MS2 phage against other phages to demonstrate that only MS2 can exhibit the results obtained and that other bacteriophages, such as M13 disclosed by Nguyen, would not. Nor does Applicant identify what structural characteristics of MS2 are unique and not exhibited by other phages.
Moreover, evidence supporting allegations of unexpected results must be reviewed to see if the results occur over the entire claimed range. MPEP 716.02(d). Applicant states that the gold nanohalo structure exhibited excellent signal reproducibility for one type of analyte. However, the claimed invention is not limited to one type of analyte, and the results provided do not demonstrate that all of the claimed analytes exhibit excellent signal reproducibility.
Furthermore, evidence supporting allegations of unexpected results must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. Applicants may compare the claimed invention with prior art that is more closely related to the invention than the prior art relied upon by the examiner. MPEP 716.02(e). Applicant relies on Figure 6 to support that the gold nanohalo structure exhibited excellent signal reproducibility for one type of analyte. However, Figure 6 compares the first, second, and third measurements of the gold nanohalo structure’s SERS signal intensity. Therefore, Figure 6 compares the gold nanohalo structure against itself rather than the prior art or a more closely related invention. Figure 6 amounts to an affirmation that the claimed subject matter functions as it was intended to. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. Additionally, the evidence provided in Fig. 3 & 4 compares the gold nanohalo against gold nanoparticles rather than against the closest prior art, Nguyen’s gold nanostructure.
Therefore, the evidence provided in the specification does not support Applicant’s assertion that the difference in properties between the prior art and the claimed invention is truly unexpected or nonobvious.
Conclusion
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/K.A.C./Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
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