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 .
DETAILED ACTION
Claims 1, 5, 32, 34, 37, 47-58, 61-64 and 66-69 are pending and claims 1, 5, 32, 34, 37, 47-58, 61-64 and 66-69 are examined on merits in this office action. See office action of 9/13/2023 for withdrawal of claim 61 as being directed to non-elected invention.
Claim Rejections maintained - 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, 5, 48, 50-53 and 62-64 and 66-69, are rejected under 35 U.S.C. 103 as being unpatentable over Chao et al (Biophysical Journal, hereinafter “Chao”) in view of Balasubramaniam et al (Current Opinion in Chemical Biology 2014, hereinafter “Balasubramanium”) and Chung et al (Surface Science 2007) and further in view of Murphy et al (US 7,723,123) and Ho et al (US 2016/0058887A1).
In regards to claims 1, 5, 48 and 50-53, Chao teaches nanometer-sized diamond particle as a probe for biolabeling for detection (Title). Chao teaches that from the point of view of bio-applications, available with variable sizes in nanoscale, diamond surfaces provide a convenient platform for bioconjugation. Chao teaches that the hydrogen-carbon bonding characteristics of most diamond surfaces are stable and convenient for bioconjugation either chemically (covalently or noncovalently) or physically (adsorption) (Introduction). Chao teaches providing functional groups on diamond surface through surface carboxylation and conjugating to protein through the surface carboxyl group (1st para of page 2200). Chao teaches modification of diamond surfaces with biomolecules such as DNA and different proteins (e.g. interacting antigens and antibodies) (Introduction) (i.e. configured for detection). Chao teaches that the naturally embedded defects create fluorescent centers and render them possible marker for detection without additional high-energy treatment on the diamond (conclusion). Chao teaches nanodiamond with nitrogen-vacancy (NV) can emit light efficiently, and have a very remarkable photostability (page 2205, 1st col.). Chao teaches conjugating specific binding partner/biomolecule to nanodiamond for specific interaction and detection (page 2207, 2nd col.). Chao teaches that the easily detected natural fluorescent and Raman intrinsic signals, penetration ability, and low cytotoxicity of CNDs render them promising agents in multiple medical applications (Abstract).
Chao teaches that diamond particle sizes of 50nm and above could provide peak clear enough for Raman detection. (page 2200). Chao discloses average diamond diameter of 5 and 100nm (page 2200, 1st para). Chao however, does not specifically teach nanodiamond particle having the range of 250nm to 1000nm.
Balasubramanium teaches nanodiamond for bioimaging and biosensing (Title). Balasubramanium teaches utilizing nanodiamon having nitrogen-vacancy (NV) defects for imaging and sensing (Abstract). Balasubramanium teaches particle size of about 200nm (Fig.2).
Chung teaches particle size-dependent photoluminescence of nanodiamonds (Title). Chung teaches 100-500nm nanodiamond and teaches that nanodiamonds with sizes 100 nm and larger, the Raman spectra have similar characters with sharp and intense diamond peak, with PL emitted in the range of 660-680nm, while the spectra for 5-50 nm nanodiamonds appear differently (page 3867, right col. and Fig.1) with PL is emitted in the range of 580-720nm.
Murphy teaches kits including reagents for performing the device's preferred function. For example, the kits optionally include any microfluidic device described along with assay components, reagents, sample materials, proteins, antibodies, detergents, dyes, particle sets, control materials, or the like. Such kits also typically include appropriate instructions for using the devices and reagents, and in cases where reagents are not predisposed in the devices themselves, with appropriate instructions for introducing the reagents into the channels and/or chambers of the device. In this latter case, these kits optionally include special ancillary devices for introducing materials into the microfluidic systems, e.g., appropriately configured syringes/pumps, or the like.
Ho teaches functionalized nanodiamond complex for therapeutic application (Abstract). Ho discloses nanodiamond complexed with insulin (Fig.9). Ho teaches nanodiamond composition for injectable preparation including sterile injectable preparation (paragraph [0119]). Ho teaches nanodiamond complex for administration to a human ([0007]). Ho teaches a particular route of administration and the dosage regimen will be determined by one of skill in keeping with the condition of the individual to be treated and said individual's response to the treatment. Ho teaches that the therapeutic element is administered via any desired oral, parenateral, topical, intravenous, transmucosal, and/or inhalation routes (paragraph [0119]).
Since Chao teaches that diamond particle sizes of 50nm and above and given the fact the nanodiamonds of larger sizes are useful for bioimaging (Balasubramanium) and nanodiamonds of larger sizes provide sharp and intense peak with PL emitted in the range of 660-680nm, it would be obvious to one of ordinary skilled in the art to envisage various sized nanodiamonds including 200nm and above with the expectation of utilizing various sized nanodiamonds with various PL emission for various application with a reasonable expectation of success. In regards to the recitations “diagnostic agent configured for detection of an analyte …” and “wherein….the diagnostic agent is configured to bind to the analyte and wherein the subject is a human or a non-human animal”, Chao teaches conjugating specific binding partner/biomolecule to nanodiamond for specific interaction and detection and the combination of the reference as described above, provides obviousness for various sized nanodiamonds including 200nm, which obviously provides a diagnostic agent composition comprising a specific binding partner conjugated to a nanodiamonds having various size including 200nm and the composition would be considered as “configured for detection of an analyte in the subject” because the recitation “configured for detection of an analyte in the subject” does not provided any added limitation that differentiate the diagnostic agent of instant claim from the diagnostic agent composition of the combination of the reference. Further “diagnostic agent configured for detection of an analyte upon injection” and the recitation “wherein, upon injection of the diagnostic agent into the subject, the diagnostic agent is configured to bind to the analyte” are intended process/use of utilizing the diagnostic agent, which does not result in a structural difference. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Moreover, since Chao teaches immobilization of binding agent and/or antibodies for bio applications, various binding agent including binding agent directed to human or non-human proteins or antigens would be considered obvious and would provide a composition with the binding partner capable of binding to human protein or antigen. Furthermore, Balasubramanian teaches single particle tracking of fluorescent diamonds to the next level by monitoring stem cells transplanted in a mouse embryo and probed the location of the final delivery using fluorescence microscopy. Balasubramanian teaches injection of fluorescent nanodiamonds into the gonads of live C. elegans and observed the nanoparticles presence in their offspring. Thus the nanodiamonds having specific binding partner that are obvious from the combination of the references would be capable of detection of an analyte.
Therefore, Chao, Balasubramaniam, Chun makes obvious of fluorescent diamond nanoparticles chemically bonded to polypeptide or ligands, wherein the particles have an average cross-sectional dimension of between 250-1000 nanometers. The reference of Chao, Balasubramaniam and Chung differ from the instant claims 1, 5, 48, and 50-54 in failing to teach a kit comprising a syringe.
In regards to syringe in the kit for intravenous injection, as described above, Ho teaches functionalized nanodiamond complex for therapeutic sterile injectable preparation to different subject including administration to a human and that the therapeutic element can be administered via any desired oral, parenateral, topical, intervenous, transmucosal, and/or inhalation routes (paragraph [0119]). Therefore, one of ordinary skilled in the art can easily envisage the fluorescent diamond nanoparticles composition bonded to polypeptide or ligands as found obvious from the combination of Chao, Balasubramaniam, and Chun to be administered (via various routes including intravenously) to human and non-human animal for detection or as a therapeutic composition as taught by Ho with the expectation of detection and/or treatment with a reasonable expectation of success. Since syringe is an well-known device for intravenous administration and since kits comprising all necessary reagents to conduct an assay or field work including syringes are well known in the art as demonstrated by Murphy, including a sterile syringe including all necessary buffer in sterile condition would be obvious to one of ordinary skilled in the art.
Therefore, given the teaching of Balasubramaniam and How that nanodiamond having specific binding partners can be injected into a subject for detection of specific analytes and given the teaching of Murphy that detection components including syringes can be compiled in a kit for convenience, it would have been obvious to one of ordinary skill in the art at the time the application was filed to assemble the necessary reagents as taught by Chao, Balasubramaniam and Chung into a kit as taught by Murphy because the use of kits is well known in the art and provides the advantage of convenience and economy. One of ordinarily skill in the art would have had a reasonable expectation of success in including all necessary as well as ancillary materials such as syringes or pumps as needed because Murphy teaches that these types of kits are very typical in the art. Different types of syringes and different configuration and sizing including sterile syringe would be obvious because Balasubrananiam teaches injection nanodiamonds having specific binding moiety into a subject Ho teaches injection to human, and one of ordinary skilled in the art can easily envisage injection of nanodiamonds of different sizes into different types of subject including injection intravenous and different types sizing and modification is considered routine modification and optimization based on needs. Moreover, since the combination of the references make obvious of providing nanodiamond conjugates including syringes in a kit for injection, various buffers including sterile buffer and sterile syringes as claimed in claims 66-69 would be obvious to one of ordinary skilled in the art.
In regards to claims 50-54, as described above, Chao teaches conjugating specific binding partner/biomolecule to nanometer-sized diamond particle as a probe for biolabeling for specific interaction and detection. Chao teaches naturally embedded defects create fluorescent centers and render them possible marker for detection without additional high-energy treatment on the diamond (conclusion). Chao teaches nanodiamond with nitrogen-vacancy (NV) can emit light efficiently, and have a very remarkable photostability (page 2205, 1st col.). Balasubramanium teaches nanodiamond for bioimaging and biosensing (Title). Balasubramanium teaches utilizing nanodiamon having nitrogen-vacancy (NV) defects for imaging and sensing (Abstract). Therefore, conjugation of various binding partners including polypeptides and polynucleotides to various nanodiamonds including nanodiamond having atomistic-type defect and having intrinsically fluorescent would be obvious to one of ordinary skilled in the art.
In regards to claim 62, Chao discloses detection of A549 human lung adenocarcinoma cells and teaches that nano-diamond conjugates are a useful prove for detecting cells and bacteria. Thus various analytes including analytes associated with human disease or condition would be obvious to one of ordinary skilled in the art. Further, it is noted that analyte is not a part of the kit.
In regards to claim 63, disclosed treating A549 cells with nanodiamond is RPMI-1640 which is a buffered media and washed with PBS after the treatment (page 2201). Therefore, various including various buffers in the kit depending on the cell culture and detection processes would be obvious to one of ordinary skilled in the art.
In regards to claims 64, as described above, kits optionally include special ancillary devices for introducing materials into the microfluidic systems, e.g., appropriately configured syringes/pumps, or the like. Therefore, various types of syringes including various needle adapted to be connected to the syringe would be obvious to one of ordinary skilled in the art.
Claims 1, 5, 32, 34, 37, 47-58 and 62-65 are rejected under 35 U.S.C. 103 as being unpatentable over Chao et al (Biophysical Journal, hereinafter “Chao”) in view of Balasubramaniam et al (Current Opinion in Chemical Biology 2014, hereinafter “Balasubramanium”), Chung et al (Surface Science 2007), Murphy (US 7,723,123) and Ho et al (US 2016/0058887A1) as described above for claims 1, 5, 48, 50-53 and 62-64 and 66-69, and further in view of Mecedo et al (Current Protein and Peptide Science).
In regards to claims 32 and 49, Chao in view of Balasubramanium, Chung, and Murphy as described above, teaches diagnostic agent comprising a fluorescent nanodiamond particle conjugated to a ligand/binding partner for detection and bioimaging. As described above, Chao in view of Balasubramanium and Chung make obvious of utilizing various sized nonodiamons including 200nm size noanodiamonds. Chao teaches modification of diamond surfaces with biomolecules such as DNA and different proteins (e.g. interacting antigens and antibodies), but however, does not teach disint egrin bonded to nanodiamond.
Macedo teaches snake venom disintegrins for cancer detection (Abstract). Macedo teaches that disintegrins are capable of binding specifically to integrins (page 536, 2nd col; Table 1). Macedo teaches utilizing labeled Bitistatin (a disintegrin) as a probe for detection of tumor expressing αIIbβ3 and α vβ3 integrins (page 542, section 1.6 “Molecular Imaging”).
Therefore, given the fact that labeled disintegrin can be utilized as a binding partner for integrin for detection of tumor cells expressing integrins, it would be obvious to one of ordinary skilled in the art to easily envisage disintegrin for binding partner/biomolecule in the nanodiamond conjugate of Chao with the expectation of expanding the arsenal of nanodiamond conjugates of Chao for specific interaction and detection of integrin expressing tumor cells with a reasonable expectation of success.
Since Chao teaches nanodiamond with nitrogen-vacancy (NV) can emit light efficiently, and have a very remarkable photostability (page 2205, 1st col.). Balasubramanium teaches nanodiamond for bioimaging and biosensing (Title). Balasubramanium teaches utilizing nanodiamon having nitrogen-vacancy (NV) defects for imaging and sensing (Abstract). Chao teaches providing functional groups on diamond surface and bioconjugation covalently, one of ordinary skilled in the art can easily envisage covalent conjugation of disintegrin (e.g. bitstatin) to the nanodiamond surface with a reasonable expectation of success.
In regards to claims 34-37, 47, 49 and 55-57, the recitations “syringe is sized and adapted for intravenous injection” and “wherein subject is a human or a non-human animal”, Chao teaches conjugating specific binding partner/biomolecule to nanodiamond for specific interaction and detection and the combination of the reference as described above, provides obviousness for various sized nanodiamons including 200nm, which obviously provides a diagnostic agent composition comprising a specific binding partner conjugated to a nanodiamond having various size including 200nm and the composition would be considered as “configured to be administered to a subjected” because the recitation “sized and adapted for intravenous injection” does not provided any added limitation that differentiate the diagnostic agent of instant claim from the diagnostic agent composition from the combination of the reference. Further “wherein the syringe is sized and adapted for intravenous injection” have not been clearly described or defined in the specification and thus the recitation does not provide any particular added limitation that differentiate from the composition of the combination of the reference. Moreover, since Chao teaches immobilization of binding agent and/or antibodies for bio applications, various binding agent including binding agent directed human and non-human proteins or antigens would be considered obvious and would provide a composition with the binding partner capable of binding to human protein or antigen.
Claims 1, 5, 32, 34, 37, 47-58 and 62-64, and 66-69 are rejected under 35 U.S.C. 103 as being unpatentable over Knight et al (WO 94/09036) in view of and Zurbuchen et al (Nanodiamond Landmarks for Subcellular Multimodal Optical and Electron Imaging. Sci Rep 3, 2668 (2013)), Chang et al (US 2008/0118966), Ho et al (US 2016/0058887A1) and Hou et al (US 2015/0238639).
In regards to claims 1, 5, 32, 34, 37, 48-49, 55, 56, 62 Knight discloses radiolabeled peptides derived from the Viperidae disintegrins used for diagnosis and treatment of venous and arterial thrombi, pulmonary emboli and tumors or abscesses that have a thrombus component. See Abstract. Knight teaches that certain radiolabels are disadvantageous because they accumulate in the liver or remains in circulation thereby obscures images of the lungs. See page 6, lines 13-24. In regards Knight teaches disintegrins used for diagnosis and treatment of venous and arterial thrombi, pulmonary emboli and tumors or abscesses that have a thrombus component. One of ordinary skilled in the art can easily envisage various other analytes including analytes associated with human disease or condition would be obvious to one of ordinary skilled in the art. Further, it is noted that analyte is not a part of the kit.
Knight differs from the instant claim in failing to teach kits comprising a diagnostic agent comprising a fluorescent nanodiamond particle chemical bonded to a disintegrin. Knight also fail to teach that the nanodiamond particles have an average cross-section dimension of between 250 nm and 1000 nm and including a syringe in the kit.
Zurbuchen discloses fluorescent nanodiamond particles for use as biolabels that can be used in both optical and electron microscopies, are non-cytotoxic and do not photobleach. Such biolabels could enable targeted nanoscale imaging of sub-cellular structures and help to establish correlations between conjugation-delivered biomolecules and function. See abstract. Zurbuchen also teaches Fluorescent nanodiamonds (NDs) have emerged as promising biomarkers. They have been used as optical labels, magnetic sensors, magnetic resonance imaging (MRI) contrast agents, cell division monitors, drug and gene delivery vectors, for single-molecule tracking in live cells and for nanometer-scale thermometry in living cells. See page 2, first column, second full paragraph.
Chang teaches a method for preparing luminescent diamond particles (e.g., fluorescent nanodiamonds). The method includes irradiating diamond particles with an ion beam and heating the irradiated diamond particles in a non-oxidizing atmosphere at a temperature between 600 and 1000.degree. C. The diamond particles have a diameter of 1 nm to 1 mm and the ion beam has a kinetic energy of 1 KeV to 900 MeV. Also disclosed are luminescent diamond particles prepared by this method and methods of using them. See abstract and [0014]. Chang teaches fluorescent diamond particles are chemically inert, biocompatible and optically transparent. Additionally, the surface of diamond particles can be easily functionalized for specific or nonspecific binding with nucleic acids and proteins without affecting its fluorescent properties. See paragraph 0006.
Ho teaches functionalized nanodiamond complex for therapeutic application (Abstract). Ho discloses nanodiamond complexed with insulin (Fig.9). Ho teaches nanodiamond composition for injectable preparation including sterile injectable preparation (paragraph [0119]). Ho teaches nanodiamond complex for administration to a human ([0007]). Ho teaches a particular route of administration and the dosage regimen will be determined by one of skill in keeping with the condition of the individual to be treated and said individual's response to the treatment. Ho teaches that the therapeutic element is administered via any desired oral, parenateral, topical, intervenous, transmucosal, and/or inhalation routes (paragraph [0119]).
Hou teaches kits comprising a reagent comprising a nanodiamond particle linked to a paramagnetic ion for use as a contrast agent in magnetic resonance. See abstract. Hou teaches kits having the reagent as well as additional elements such as syringes, connectors and valves that may be useful in the administration of the reagent is well known in the art. See paragraph 0057.
Therefore, given the fact that functionalized nanodiamond is useful as detection agent and for therapeutic applications (zuberchen, Ho and chang), it would have been obvious to one of ordinary skill in the art at the time the application was filed to modify the radiolabeled disintegrin peptide taught by Knight by replacing the radiolabel with the fluorescent nanodiamond particles taught by Zurbuchen, Ho and Chang for the advantage of having a labeled reagent that is non-cytotoxic and do not photobleach. A skilled artisan would have had a reasonable expectation of success in placing the modified disintegrin in a kit such as taught by Hou for convenience and economy and one of ordinary skilled in the art can easily envisage utilizing the nonodiamonds for injection into a subject for detection of specific targets. Since, Ho teaches functionalized nanodiamond complex for therapeutic sterile injectable preparation to different subject including administration to a human and that the therapeutic element can be administered via any desired oral, parenateral, topical, intervenous, transmucosal, and/or inhalation routes (paragraph [0119]), it would be obvious to one of ordinary skilled in the art to envisage various application of the nanodiamond conjugate including injection into human or non-human animal for detection of target biomolecules in vivo with a reasonable expectation of success. One of ordinary skilled in the art keeping in mind of the teaching of Ho, can easily envisage the fluorescent diamond nanoparticles composition bonded to polypeptide or ligands as found obvious from the combination of Chao, Balasubramaniam, and Chun, to be administered (via various routes including intravenously) to human and non-human animal for detection or as a therapeutic composition as taught by Ho with the expectation of detection and/or treatment with a reasonable expectation of success. Moreover, since syringe is an well-known device for intravenous administration and since Hou teaches kits comprising a reagent comprising a nanodiamond particle and teaches kits having the reagent as well as additional elements such as syringes, including a syringe in the kit would be obvious to one of ordinary skilled in the art.
In regards to claims 47, 50-54, 57 and 58, Zurbuchen discloses fluorescent nanodiamond particles for use as biolabels and Chang teaches a method for preparing luminescent diamond particles (e.g., fluorescent nanodiamonds). The method includes irradiating diamond particles with an ion beam and heating the irradiated diamond particles in a non-oxidizing atmosphere at a temperature between 600 and 1000.degree. C. The diamond particles have a diameter of 1 nm to 1 mm and the ion beam has a kinetic energy of 1 KeV to 900 MeV. Also disclosed are luminescent diamond particles prepared by this method and methods of using them. See abstract and [0014]. Chang teaches fluorescent diamond particles are chemically inert, biocompatible and optically transparent. Additionally, the surface of diamond particles can be easily functionalized for specific or nonspecific binding with nucleic acids and proteins without affecting its fluorescent properties. See paragraph 0006. Therefore, nanodiamond of various sizes and various fluorescent nanodiamonds would be obvious to one of ordinary skilled in the art.
In regards to claim 63, including various buffers in the kit depending detection processes would be obvious to one of ordinary skilled in the art.
In regards to claims 64 and 66-69, as described above, Hou teaches kits having the reagent as well as additional elements such as syringes. Therefore, various types of syringes including various needle adapted to be connected to the syringe would be obvious to one of ordinary skilled in the art. Since the sizing and adaptation for intravenous injection has not been clearly described in the specification, the structure of the syringe could not be ascertained and thus syringe that are obvious from the combination of the reference would be considered as similar to the claimed syringe.
Response to argument
Applicant's arguments and amendments filed 12/03/2025 have been fully considered and are persuasive to overcome the rejections under 35 USC 112(f) and 35 USC 112(b)for “syringe is sized and adapted for intravenous injection” in view of the arguments, but the arguments are not found persuasive to overcome the rejections under 35 USC 103.
Applicant argued that the person of ordinary skill in the art would not have been motivated nor taught to inject nanodiamonds of the claims size range intravenously (and thus would have been included them in a syringe sized and adapted for intravenous injection), because nanodiamonds of the claimed size range were known to bioaccumulate and thus to exhibit a far higher toxicity than smaller nanodiamonds of the type relied upon by Paten Office. Applicant argued that nothing in the cited portions of Ho would have provided the person of ordinary sill in the art any more reason than the teaching of Chao, Balasubramanium, Chung, or Murphy to believe that nanodiamonds two full orders-or-magnitude larger could have been safely formulated for intravenous injection into a subject based upon the disclosures of Ho. Applicant further argued that none of these references, alone or in combination, would have lead the person of ordinary skill in the art to assume the viability of such a formulation, much less to recognize any therapeutic purpose or advantage to it.
The above arguments have fully been considered but are not found persuasive because the claim is a composition/kit claim and the composition comprises 1) a fluorescent nanodiamond particle chemically bonded to a polypeptide, ligand or polypeptide, wherein the fluorescent nanodiamond particle has an average dimension of 250 nm to 1000 nm and 2) a syringe capable of injecting the nanodiamond composition. The recitation “wherein upon injection of the diagnostic agent into the subject , the diagnostic agent binds to the analyte, and wherein the subject is a humon or a non-human” is a intended process of utilizing the nanodiamond. The subject or the process language “wherein upon injection ……. binds to the analyte. …….non-human analyte” including intravenous injection, are not considered a part of the kit composition and does not differentiate the prior art nanodiamond from the diagnostic agent composition. The recitation “the syringe is configured to inject the diagnostic agent into the subject” does not differentiate the syringes of Murphy that were found obvious by the combination of the references because nowhere in the specification, size of the syringe or thickness of the syringe needle are disclosed or described and as long as the prior art syringe is capable of injecting the nanodiamond composition, it meets the limitation. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Different types of syringes and different configuration and sizing including sterile syringe would be obvious because Balasubrananiam teaches injection nanodiamonds having specific binding moiety into a subject and Ho teaches injection to human, and one of ordinary skilled in the art can easily envisage injection of nanodiamonds of different sizes into different types of subject including intravenous injection and different types of sizing and modification would be considered routine modification and optimization based on needs. Balasubramanium teaches nanodiamond for bioimaging and biosensing and Murphy teaches microfluidic device comprising channels having particles comprising binding moiety for detection of analytes (Summary of invention) and as described above in the rejection, teaches kit comprising appropriately configured syringes for introducing reagents into the channels and/or chambers of the microfluidic systems. Thus, utilizing the nanodimond particles for intravenous injection and for use of detection purposes are obvious and including different sizes of syringes sized and adapted for injection different sizes of nanodiamond particles would be obvious to one of ordinary skilled in the art. In view of the combination of the references, the utilization of the nanodiamond particle is not limited to intravenous injection but for utilization for different detection system including microfluidic detection system requiring injection into microfluidic channels with syringes sized and adapted for injection of various sizes of particles.
In regards to arguments for rejection of Knight in view of Zurbuchen, Dhang, Ho and Hou, the combination of the references, as described in the above rejection provides obviousness of modifying the radiolabeled disintegrin peptide taught by Knight by replacing the radiolabel with the fluorescent nanodiamond particles taught by Zurbuchen, Ho and Chang for the advantage of having a labeled reagent that is non-cytotoxic and do not photobleach. One of ordinary skilled in the art can easily envisage utilizing the nonodiamonds for injection into a subject for detection of specific targets. Since, Ho teaches functionalized nanodiamond complex for therapeutic sterile injectable preparation to different subject including administration to a human and that the therapeutic element can be administered via any desired oral, parenateral, topical, intervenous, transmucosal, and/or inhalation routes (paragraph [0119]), it would be obvious to one of ordinary skilled in the art to envisage various application of the nanodiamond conjugate including injection into human or non-human animal for detection of target biomolecules in vivo. One of ordinary skilled in the art keeping in mind of the teaching of Ho, can easily envisage the fluorescent diamond nanoparticles composition bonded to polypeptide or ligands as found obvious from the combination of Chao, Balasubramaniam, and Chun, to be administered (via various routes including intravenously) to human and non-human animal for detection or as a therapeutic composition as taught by Ho with the expectation of detection and/or treatment. The references do not disclose that large nanodiamond are toxic and do not teach away utilizing large fluorescent nanodiamond for injection into a subject as asserted by Applicant. Moreover, since syringe is an well-known device for intravenous administration and since Hou teaches kits comprising a reagent comprising a nanodiamond particle and teaches kits having the reagent as well as additional elements such as syringes, including a syringe in the kit would be obvious to one of ordinary skilled in the art.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
If Applicants should amend the claims, a complete and responsive reply will clearly identify where support can be found in the disclosure for each amendment. Applicant should point to the page and line numbers of the application corresponding to each amendment, and provide any statements that might help to identify support for the claimed invention (e.g., if the amendment is not supported in ipsis verbis, clarification on the record may be helpful). Should Applicants present new claims, Applicants should clearly identify where support can be found in the disclosure.
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678