Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
NON-PRIOR ART REJECTIONS
2. 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 7 and 14-16 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.
A) Claims 7 and 16 are indefinite because it cannot be determined what is encompassed by graphite ‘from the University of Idaho thermolyzed asphalt reaction (GUITAR)’. This defines or describes the graphite based on its source, rather than on its chemical structure, so the nature of the recited graphite cannot be determined. Clarification is required.
B) Claims 14-15 are indefinite because ‘the single stranded DNA’ lacks proper antecedent basis. Dependency from claim 13 may be intended. Correction is required.
C) Claim 16 is further indefinite because it cannot be determined what is encompassed by ‘substantially coated’. While the language ‘substantially’ may be permitted in claims in certain circumstances when the meaning is clear, here the specification does not make clear what constitutes an iron particle ‘substantially’ coated with a carbon layer. Clarification is required.
PRIOR ART REJECTIONS
3. 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.
4. 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.
5. Claims 1-2, 10, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TR 201507632.
Regarding independent claim 1, TR 201507632 discloses a composition comprising a magnetic material particle comprising an outer surface, and a carbon layer located on the outer surface. See the entire provided English translation.
Regarding claim 2, TR 201507632 discloses that the magnetic particle is iron (see page 5).
Regarding claims 10, 13, and 15, TR 201507632 discloses attaching a single-stranded DNA probe complementary to a target (see pages 5-10)
The composition of TR 201507632 cannot be distinguished from the claimed compositions.
6. Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ES 2373841.
Regarding independent claim 1, ES 2373841 discloses a composition comprising a magnetic material particle comprising an outer surface, and a carbon layer located on the outer surface. See the entire provided English translation.
Regarding claim 2, ES 2373841 discloses that the magnetic particle is iron (see ‘production example’ on pages 8-9).
The composition of ES 2373841 cannot be distinguished from the claimed compositions.
7. Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2005/0181202.
Regarding independent claim 1, US 2005/0181202 discloses a composition comprising a magnetic material particle comprising an outer surface, and a carbon layer located on the outer surface. See paragraphs 0012-0018.
Regarding claim 2, US 2005/0181202 discloses that the magnetic particle is iron (see paragraph 0014).
Regarding claim 3, US 2005/0181202 discloses that the magnetic particle has an average size of 10 um or less (see paragraph 0017).
Regarding claim 6, US 2005/0181202 discloses that the carbon layer comprises graphite (see paragraph 0018).
The composition of US 2005/0181202 cannot be distinguished from the claimed compositions.
8. 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.
9. 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.
10. 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.
11. Claims 4, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over any one of TR 201507632, ES 2373841, or US 2005/0181202.
The disclosures of these references are discussed above.
None of these references explicitly discloses an average magnetic particle size of from 15 um to 40 um (claim 4), carbon layer coverage of greater than 95% of the surface (claim 5), or average particle size together with carbon layer of from 15 um to 40 um.
One of ordinary skill in the art would have been motivated to select the further limitation of these claims because this would have merely involved routine optimization of a known-important reaction parameter, which as well established in U.S. patent practice does not support unobviousness (M.P.E.P. 2144.05). Routine optimization of particle size and carbon layer coverage would have merely involved straightforward, logical scientific reasoning based on the desired use of the particles. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed compositions.
12. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0181202 in view of Zhu et al. (2020).
The disclosure of US 2005/0181202 is discussed above.
This document does not disclose the use of graphite which is from the University of Idaho thermolyzed asphalt reaction (GUITAR).
Zhu teaches the benefits of using graphite from the University of Idaho thermolyzed asphalt reaction (GUITAR) in a pH sensor, and suggests using such electrochemically-distinct graphite in coated nanoparticles. See entire reference, especially pages 7252, 7253, and 7257.
One of ordinary skill in the art would have been motivated to use graphite from the University of Idaho thermolyzed asphalt reaction (GUITAR) as the graphite in the composition of US 2005/0181202 because Zhu taught that such distinct graphite has desirable electrochemical properties, and suggested it would be useful in making and using coated nanoparticles. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed composition.
13. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over TR 201507632 in view of KR 20120057691.
The disclosure of TR 201507632 is discussed above.
This document does not disclose the use of 4-amino benzoic acid to functionalize a carbon layer. Rather, this document discloses using APTES to functionalize a carbon layer.
KR 20120057691 discloses using 4-amino benzoic acid to functionalize a carbon layer. See top of page 4 of English translation.
One of ordinary skill in the art would have been motivated to substitute 4-amino benzoic acid for APTES in the composition of TR 201507632 because KR 20120057691 taught that 4-amino benzoic acid was useful in functionalizing a carbon layer. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed composition.
14. Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over TR 201507632.
The disclosure of TR 201507632 is discussed above.
TR 201507632 does not explicitly disclose the length of attached single stranded nucleic acids or probes.
One of ordinary skill in the art would have been motivated to select a nucleic acid probe length in the composition of TR 201507632, such as from 10-1000 bases, or 20-50 bases, or 200-500 bases, because this would have merely involved routine optimization of a known-important reaction parameter, which as well established in U.S. patent practice does not support unobviousness (M.P.E.P. 2144.05). Routine optimization of nucleic acid probe length would have merely involved straightforward, logical scientific reasoning based on the desired use of the probe. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed compositions.
15. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over TR 201507632 in view of Zilch et al. (US 2011/0008797).
The disclosure of TR 201507632 is discussed above.
While this document discloses attaching oligonucleotide probes to carbon-coated magnetic particles, it does not disclose attaching oligonucleotide primers for PCR.
Zilch discloses using magnetic particles functionalized with attached PCR primers to carry out PCR on the surface of the particles. See Fig. 1 and paragraphs 0010-0012, 0018-0022, 0037-0040, and 0047-0058.
One of ordinary skill in the art would have been motivated to substitute a PCR primer for the oligonucleotide probe in the composition of TR 201507632 because Zilch taught that attaching PCR primers to magnetic particles provided the benefit of direct amplification of desired nucleic acids on the particles. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed composition.
16. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over TR 201507632 in view of Zhu, and further in view of KR 20120057691.
The disclosures of each of these references are discussed above.
One of ordinary skill in the art would have been motivated to use graphite from the University of Idaho thermolyzed asphalt reaction (GUITAR) as the carbon source in the composition of TR 201507632 because Zhu taught that such distinct graphite has desirable electrochemical properties, and suggested it would be useful in making and using coated nanoparticles. The skilled artisan would have been further motivated to substitute 4-amino benzoic acid for APTES in the composition of TR 201507632 because KR 20120057691 taught that 4-amino benzoic acid was useful in functionalizing a carbon layer. As far as single stranded DNA length and average particle size, these would have been determined merely through routine optimization of known-important reaction parameters (see above). It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed composition.
17. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over TR 201507632 in view of Zilch et al. (US 2011/0008797).
The disclosure of TR 201507632 is discussed above.
While this document discloses attaching oligonucleotide probes to carbon-coated magnetic particles, it does not disclose attaching oligonucleotide primers for PCR.
Zilch discloses using magnetic particles functionalized with attached PCR primers to carry out PCR on the surface of the particles. See Fig. 1 and paragraphs 0010-0012, 0018-0022, 0037-0040, and 0047-0058.
One of ordinary skill in the art would have been motivated to substitute a PCR primer for the oligonucleotide probe in the composition and method of TR 201507632 because Zilch taught that attaching PCR primers to magnetic particles provided the benefit of direct amplification of desired nucleic acids on the particles. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
18. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over TR 201507632 in view of Sarkas et al. (US 2022/0093295).
The disclosure of TR 201507632 is discussed above; this document discloses a method of making the particles according to claim 1, as rejected above.
While this document discloses a method of making the particles of claim 1, it does not disclose doing so in the recited manner comprising first and second steps of chemical vapor deposition (CVD).
Sarkas discloses that CVD was a conventional process for making magnetic coated particles for attachment to nucleic acids suitable for isolation and detection of target nucleic acids. See paragraphs 0024-0036.
One of ordinary skill in the art would have been motivated to make the magnetic particles of TR 201507632 by using the process of CVD because CVD was a conventional process for producing such particles, as indicated by Sarkas. In the absence of evidence to the contrary, the exact two-step CVD process required in the claim is considered to be routine optimization of known-important reaction parameters, which as noted above does not support unobviousness. To optimize the conventional CVD process in one or more steps would have merely involved straightforward, logical scientific reasoning. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to make the claimed composition in the claimed manner.
19. Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over TR 201507632 in view of Sarkas et al. (US 2022/0093295), and further in view of KR 20120057691.
The disclosures of TR 201507632 and Sarkas are discussed above.
These documents do not disclose the use of 4-amino benzoic acid to functionalize a carbon layer. Rather, TR 201507632 discloses using APTES to functionalize a carbon layer.
KR 20120057691 discloses using 4-amino benzoic acid to functionalize a carbon layer. See top of page 4 of English translation.
One of ordinary skill in the art would have been motivated to substitute 4-amino benzoic acid for APTES in the composition and method of TR 201507632 as modified by Sarkas, because KR 20120057691 taught that 4-amino benzoic acid was useful in functionalizing a carbon layer. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to carry out the claimed method.
ALLOWABLE SUBJECT MATTER
20. Claim 17 is allowable. The closest prior art is TR 201507632, which discloses the use of carbon-coated functionalized magnetic particles with attached nucleic acids for various types of detection and manipulation of nucleic acids via hybridization. While the use of intercalating agents in various ways had long been known in the prior art of nucleic acid detection, no prior art has been found teaching or suggesting modifying the method of TR 201507632 by adding an intercalating agent to a mixture of probe-attached magnetic particles and target nucleic acid to allow formation of a double-stranded nucleic acid bound to intercalating agent and magnetic particles in solution, separating magnetic particles bound to double stranded nucleic acid and intercalating agent from the solution, and measuring the UV absorbance of free intercalating agent remaining in the solution.
CONCLUSION
21. EP 2 244 268 is made of record as a reference of interest.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH R HORLICK whose telephone number is (571)272-0784. The examiner can normally be reached Mon. - Thurs. 8:30 - 6:30.
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06/04/26
/KENNETH R HORLICK/ Primary Examiner, Art Unit 1681
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