Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Claims
Claims 1-9 are examined on merits in this office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Azam et al (Microchimica Acta 2020, published July 18, 2020).
In regards to claims 1 and 5, Azam discloses immunosensor comprising an electrode functionalized by nanocomposite film carbon nanohorns dispersed in Nafion perflurinated resin solution and magnetic particle (Fe3)4@Pd (Title, Abstract, page 3, 1st col., and Scheme 1). Azam teaches formation of oxidized carbon nanohorn (Abstract) by dispersing thereon in the nafion perflurinated resin solution (page 2, 1st col. and page 2, see “preparation of CNs-OH…….”).
In regards to claims 2-3, Azam teaches screen-printed electrode wherein the screen-printed electrode is carbon screen-printed electrode (Title, Abstract, and Table 1).
In regards to claim 4, Azam discloses binding agent (e.g. Ab) entrapped on the film (see Scheme 1) wherein the antibodies were entrapped on the nanocomposite film via electrostatic interaction and physical adsorption (page 2, 3rd paragraph of 1st col.).
In regards to claim 6, Azam discloses preparing nanocomposite film and the prepared firm comprising 0.1 mg/ml of oxidized carbon nanohorns (CHHs-OH) and 0.1% each of nafion-perflurinated resin and magnetic nanoparticles (page 2, see “preparation of CNs-OH…….”).
In regards to claim 7, Azam teaches the immunosensor being a point-of-care based device (page 2, 3rd para of col. 1).
In regards to claims 8-9, Azam teaches investigating the performance of the fabricated immunosensor via electrochemiluminescence (ECL) method, resulting from the chemical reaction between tris(bipyridine)ruthenium(II) chloride ([Ru(bpy)3]Cl2) and tripropylamine (TPrA) ECL system (abstract) utilizing redox reaction to take place (page 2, 1st col.).
Therefore, the reference is deemed to anticipate the cited claims.
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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Xin et al (BMEI 2009) in view of Moreno-Lanceta et al (Pharmaceutics 2020).
In regards to claims 1, Xin discloses immunosensor for determination of chloramphenicol (Title). Xin discloses immunosensor comprising modified electrode functionalized with nanocomposite film comprising nafion, carbon nanotube (CNTs) and Fe3O4 (abstract and Fig.1):
PNG
media_image1.png
239
289
media_image1.png
Greyscale
. Fig 1 discloses Nafion film on which CNTs and Fe3O4 are immobilized. Xin teaches that The choice of Fe3O4 nanoparticles is based in the magnetic feature of Fe3O4 that enables to achieve a rapid separation of the immobilized antigen in a magnetic field, as well as decrease of operation cost (page 2, 1st paragraph of 1st col.).
Xin teaches CNTs but however, does not teach carbon nanohorns for CNTs.
Moreno-Lacenta (hereinafter “Moreno”) that the biomedical applications of SWCNH have increased in the recent years, as well as other carbon-based materials such as carbon nanotubes or fullerene. Moreno teaches that SWCNH have a number of advantages over the use of carbon nanotubes such as the absence of potentially toxic metals as catalysts during the synthesis, unnecessary additional treatment with strong acids that can damage the carbon structure, and the capacity for high yield mass production at room temperature. Moreno teaches that SWCNH do not require metal catalysts for their synthesis and can be produced in industrial quantities. Moreno teaches that conical morphology of SWCNH with a wide apex angle and distorted tubule drastically influences the electronic and magnetic properties and reactivity and conical shape can help to entrap drugs or other substances into the structure and the tip can be chemically functionalized by the attachment of targeting moieties. These properties highlight SWCNH as an attractive alternative to carbon nanotubes and graphene oxide in a wide range of biomedical applications (page 2). Moreno teaches that SWCNH is useful for providing immunosensors for detection (pages 5 and 14).
Therefore, given the fact that SWCNH is a powerful alternative to CNTs for biomedical applications including immunosensors, it would be obvious to one of ordinary skilled in the art to easily envisage considering SWCNH for CNTs with the expectation of expanding the arsenal of immunosensor of Xin with other carbon nanotubes including SWCNH with a reasonable expectation of success. One of ordinary skilled in the art would be motivated to consider SWCNH in place of CNTs because Moreno teaches that SWCNH as an attractive alternative to carbon nanotubes and graphene oxide in a wide range of biomedical applications and SWCHN is useful for providing various immunosensors. Moreover, one of ordinary skilled in the art would be motivated to consider SWCNH because Moreno teaches that SWCNH have a number of advantages over the use of carbon nanotubes such as the absence of potentially toxic metals as catalysts during the synthesis, unnecessary additional treatment with strong acids that can damage the carbon structure, and the capacity for high yield mass production at room temperature and that SWCNH do not require metal catalysts for their synthesis and can be produced in industrial quantities. Furthermore, art-recognized equivalence betweenembodiments provide a strong case of obviousness in substituting one materialfor another. See MPEP 2144.06.
In regards to claims 2-3, Xin teaches modified screen printed carbon electrodes.
In regards to claim 4, Moreno discloses binding agent entrapped on the film via electrostatic interaction and physical adsorption (See Fig.1) wherein the binding agents are BSA and antibody.
In regards to claim 6, Xin teaches Nafion concentration of 0.1%, Fe3O4 concentration of CNT concentration of optimal CNT concentration of 0.6 mg/ml which reads on at least 0.1 mg/mL. Xin does not mention regarding the concentration of Fe3O4, but however, since the basic concept of adsorbing magnetic particle on Nafion film has been taught for providing the composite with the ability to separate in magnetic field, the various percentage of Fe3O4 can routinely be optimized by one of ordinary skilled in the art. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454,456, 105 USPQ 233, 235 (CCPA 1955). Moreno teaches oxidized SWCNH and teaches that oxidized SWCNH has a larger surface area than non-oxidized SWCNH which provided added advantage of adsorbing large amount of molecules to the surface (page 4; section 3.1 and page 7, section 3.2). Moreno teaches that oxidation provides oxygen functional groups useful for functionalization (page 4, section 3.1). Therefore, it would be obvious to one of ordinary skilled in the art to considered oxidized SWCNH for the CNTs of Xin because utilizing oxidized SWCNH would provide SWCNH with larger surface area for adsorption of various molecules and also would provide oxygen function group for further functionalization.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Xin et al (BMEI 2009) in view of Moreno-Lanceta et al (Pharmaceutics 2020) as described for claims 1-4, and 6 above and further in view or Jang et al (Processes 2019).
Xin in view of Moreno has been described above of nanocomposite film comprising Nafion, carbon nanohorn and magnetic particle.
Xin discloses Fe3O4/Au hybrid nanoparticle immobilized on the Nafion film but however does not teach Fe3O4 magnetic particle supported by palladium such as Fe3O4/Pd nanoparticle as claimed in claim 5.
Jang teaches that fusion multimetallic nanoparticles (NPs) have generally been synthesized for use as catalysts, due to properties such as high selectivity for target material, catalytic activity, and physical/chemical stability when compared with equivalent catalysts based on a single metal Jang teaches the Pd-iron oxide (Pd-Fe3O4) has attracted much attention owing to high catalytic performance and magnetically recoverable (Fe3O4) properties of each of the components of the components of the nanocatalyst (introduction).
Therefore, it would be obvious to one of ordinary skilled in the art to envisage other types of magnetic hybrid particles in place of Fe3O4/Au with the expectation of providing the Nafion-SWCNH composit film with magnetic and catalyst property for various biochemical applications with a reasonable expectation of success.
Claims 1-4 and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Xin et al (BMEI 2009) in view of Moreno-Lanceta et al (Pharmaceutics 2020), as described for claims 1-4 and 6 above, and further in view Martinez-Perinan et al (Biosensors 2020).
Xin in view of Moreno-Lanceta has been described above providing obviousness for immunosensor comprising an electrode functionalized by a nanocomposite film comprising carbon nanohorns dispersed in Nafion perfluorinated resin stabilized by magnetic nanoparticles.
Xin in view of Moreno-Lanceta do not teach the immunosensor for being a point-of care (POC)-based device and do not teach the immunosensor further comprising engagement with [Ru(bpy)3]2+/TPA electrochemical system as claimed in claims 7-9.
Martinez-Perinan is directed to electrochemiluminescence (ECL) immunosensor comprising screen-printed electrodes (Title and Abstract). Martinez teaches the electrode functionalized with film composed of Nafion and carbon nanotubes (page 18, para 4). Martinez-Perinan teaches that the ECL biosensor can be adapted to point of care (POC) systems (page 3, last para and page 25, section 4.2). Martinez-Perinan teaches that the nanocomposite can be employed together with the widely used co-reactant tri-n-propylamine (TPrA) (page 7, section 2.1). Martinez-Perinan teaches bioassays engagement with [Ru(bpy)3]2+/TPA electrochemical system having [Ru(bpy)3]2+ as luminophore and Tripropylamine (TPrA) as a co-reactant with the system for detection using EC (page 2 and page 8 and Table 1).
Therefore, given the fact that SPE-based immunosensors can be utilizing as POC system and given the fact that SPE-based ECL immunosensor utilizing luminophore [Ru(bpy)3]2+ with co-reactant TPrA is widely known for generating ECL for detection, one of ordinary skilled in the art can easily envisage the biosensor or Xin in view of Moreno-Lanceta for adapting to POC system and engaging [Ru(bpy)3]2+/TPA electrochemical system for ECL detection with a reasonable expectation of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAFIQUL HAQ whose telephone number is (571)272-6103. The examiner can normally be reached on Mon-Fri 8-4:30.
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, Gregory S. Emch can be reached on 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
Prosecution Insights