DETAILED ACTION
Notice of Pre-AIA or AIA Status and Status of the Claims
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Claims 1-13 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statement filed 19 July 2023 is acknowledged and has been considered.
It is noted that and additional document was also filed 19 July 2023, which has been crossed out because it lists the same non-patent literature documents already listed in the Information Disclosure Statement that is signed.
It is also noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection.
A. Claim 1 (upon which claims 2-13 depend) recites each of the following:
I. A “diode.” However, a review of at least parent Application No. 15/243,099 (henceforth “the Parent Application”) yields no teaching of a diode.
II. Nanowires “electrically connected to each other.” While the Parent Application discusses nanowires electrically connected to a substrate, the Parent Application does not teach nanowires electrically connected “to each other.”
B. Claim 4 recites each subarray functionalized “for” a different protein, which encompasses different proteins attached to the different subarrays. While the Parent Application discusses detection of different proteins by the different subarrays, the Parent Application does not teach each subarray itself is functionalized with a different protein.
C. Claim 11 recites nanowires are not electrically contacted “at tips of the nanowires.” The Parent Application does not teach anything about connection of the “tips.”
Thus, because the cited limitations are not supported by at least the Parent Application, each of the cited limitations constitutes new matter.
6. 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.
7. Claims 2-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 (upon which claims 3-5 depend) is indefinite in the recitation “the biosensor,” which lacks antecedent basis because there is no previous recitation of a “biosensor.”
Claim 5 is indefinite in the recitation “functionalization for,” as it is unclear of the claims requires the protein or nucleic acid.
Claims 6-9 are each indefinite in the recitation “the nanowire array,” which lacks antecedent basis because there is no previous recitation of a “nanowire array.”
Claim Rejections - 35 USC § 103
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. 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.
10. Claims 1-3 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006).
Regarding claim 1, Lai et al. teach a nanowire diode (paragraph 0132) comprising an array of nanowires on a substrate (Abstract, paragraph 0032, and Figure 19), wherein the nanowires are functionalized with binding agents, in the form of immobilized DNA molecules (paragraph 0240) for specific biomarkers, in the form of target DNA molecules that hybridize with the immobilized binding agents (paragraphs 0242-0244). Lai et al. also teach the pillars are non-horizontally (i.e., vertically) aligned (paragraph 0095), electrically connected (paragraph 0091), and are exposed to a solution of interest (i.e., containing a target; paragraph 0229). Lai et al. further teach the array in interacted with light (Abstract), including wavelengths of 400-1100 nm (paragraph 0133), which overlaps the claimed range. Lai et al. each generating electric current in response to the irradiation (i.e., electromagnetic radiation; paragraph 0090), and measuring the current (paragraph 0131). Lai et al. also teach the methods have the added advantage of enhanced concentration sensitivity (paragraph 0229). Thus, Lai et al. teach the known techniques discussed above.
It is noted that the courts have found that “where 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). See MPEP 2144.05 II. Thus, the claimed ranges merely represents routine optimization of valued discussed in the cited prior art.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
While Lai et al. discussed detection in the presence and absence of the substance (paragraph 0114), and while Lai et al. teach detection of concentration of targets in solutions (paragraph 0240). Lai et al. do not explicitly teach the functionally equivalent detection of concentration be comparing to the absence of target.
However, Fukushima et al. teach method wherein electrical signals (i.e., current) generated by target biomolecule binding is detected (paragraph 0027), and wherein the signal in the presence of the target material is compared to the signal in the absence of the target material so that the concentration of the material is calculated (paragraph 0042). Fukushima et al. also teach testing is done in solution(paragraph 0081), and that the method have the added advantage of allowing simple detection of a specific target material in a sample (paragraph 0042). Thus, Fukushima et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the cited prior art to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantage of enhanced concentration sensitivity as explicitly taught by Lai et al. (paragraph 0229) and the added advantage of allowing simple detection of a specific target material in a sample as explicitly taught by Fukushima et al. (paragraph 0042). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in reliable electronic determination of analyte concentration.
Regarding claim 2, the method of claim 1 is discussed above. Lai et al. teach the substrate comprises silicon (Figure 19).
Regarding claim 3, the method of claim 2 is discussed above. Lai et al. teach the nanowires comprise silicon (paragraph 0118).
Regarding claim 10, the method of claim 1 is discussed above. Lai et al. teach the pillars are vertically aligned (paragraph 0095).
Regarding claim 11, the method of claim 10 is discussed above. Lai et al. teach the nanowires are only electrically connected at the bases of the nanowires and not at the tips (e.g., Figure 11 and paragraph 0090).
Regarding claim 12, the method of claim 1 is discussed above. Fukushima et al. teach quantifying the amount (i.e., identifying the quantity) of target material in the sample based on the measure signal (paragraph 0077).
Regarding claim 13, the method of claim 1 is discussed above. Fukushima et al. teach the detection is that of a specific target material in a sample (paragraph 0041), including nucleic acids and proteins (paragraph 0067). Lai et al. also teach detection of specific substances, including nucleic acids (i.e., DNA; paragraph 0217).
11. Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006) as applied to claim 3 above, and further in combination with Offermans (U.S. Patent Application No. US 2012/0049854 A1, published 1 March 2012).
Regarding claims 4-5, the method of claim 3 is discussed above in Section 10.
Lai et al. teach different subarrays (Figure 13) each having a different attractant for a different substance (paragraph 0114 and Figure 13), wherein the different attractants are different DNA molecules (i.e., claim 5; paragraph 0109 and Table 1).
Neither Lai et al. nor Fukushima et al. teach the subarrays are electrically isolated from each other.
However, Offermans teaches methods using sensors comprising a plurality of nanowire arrays wherein each array receives a different applied voltage (paragraph 0053); thus, it would have been obvious to electrically isolate each subarray in order to provide a different voltage to each one. Offermans also teach the sensors have the added advantage of allowing reproducible fabrication (paragraph 0011). Thus, Offermans teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Offermans with the previously cited prior art to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in methods having the added advantage of allowing reproducible fabrication as explicitly taught by Offermans (paragraph 0011). In addition, it would have been obvious to the ordinary artisan that the known techniques of Offermans could have been combined with the previously cited prior art with predictable results because the known techniques of Offermans predictably result in structures useful in nanowire arrays.
12. Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006) as applied to claim 1 above, and further in combination with Blick et al. (U.S. Patent Application Publication No. US 2007/0023621 A1, published 1 February 2007).
Regarding claims 6-9, the method of claim 1 is discussed above in Section 10.
Neither Lai et al. nor Fukushima et al. teach the claimed densities.
However, Blick et al. teach methods utilizing biosensors comprising nanowire arrays (paragraph 0108) and light (i.e., electromagnetic radiation) sources (paragraph 0022), wherein the nanowire (i.e., nanopillar) densities are as high as 108/cm2, (paragraph 0034), which is in the range of claims 6-9.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where 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.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned to avoid merely relying upon counsel’s arguments in place of evidence in the record.
Blick et al. also teach the methods have the added advantage of having high sensitivity (paragraph 0029). Thus, Blick et al. teach the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Blick et al. with the previously cited prior art to arrive at the instantly claimed methods with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in methods having the added advantage of providing high sensitivity as explicitly taught by Blick et al. (paragraph 0029). In addition, it would have been obvious to the ordinary artisan that the known techniques of Blick et al. could have been combined with the previously cited prior art with predictable results because the known techniques of Blick et al. predictably result in useful nanowire array densities.
Double Patenting
13. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
14. Claims 1-3 and 10-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/848,689 in view of Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006).
Both sets of claims are drawn to biosensors for detecting analytes with silicon nanowires, vertically oriented nanowires, functionalized nanowires, etc. Any additional limitations of the ‘689 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘689 claims do not discuss solutions of interest, irradiation, or determination of concentration.
However, Lai et al. and Fukushima et al. teach these limitations, as well as the other limitations of the instant claims and the rationale for combining as discussed above. Therefore, the cited claims are provisionally rejected on the ground of nonstatutory double patenting based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
15. Claims 4-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/848,689 in view of Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006) as applied to claim 3 above, and further in combination with Offermans (U.S. Patent Application No. US 2012/0049854 A1, published 1 March 2012) based on the citations and rationale provided above.
This is a provisional nonstatutory double patenting rejection.
16. Claims 6-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 18/848,689 in view of Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006) as applied to claim 1 above, and further in combination with Blick et al. (U.S. Patent Application Publication No. US 2007/0023621 A1, published 1 February 2007).
This is a provisional nonstatutory double patenting rejection.
17. Claims 1-3 and 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,585,807 in view of in view of Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006).
Both sets of claims are drawn to biosensors for detecting analytes with silicon nanowires, vertically oriented nanowires, functionalized nanowires, etc. Any additional limitations of the ‘807 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘807 claims do not discuss solutions of interest, irradiation, or determination of concentration.
However, Lai et al. and Fukushima et al. teach these limitations, as well as the other limitations of the instant claims and the rationale for combining as discussed above. Therefore, the cited claims are rejected on the ground of nonstatutory double patenting based on the citations and rationale provided above.
18. Claims 4-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,585,807 in view of in view of Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006) as applied to claim 3 above, and further in combination with Offermans (U.S. Patent Application No. US 2012/0049854 A1, published 1 March 2012) based on the citations and rationale provided above.
19. Claims 6-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,585,807 in view of in view of Lai et al. (U.S. Patent Application Publication No. US 2012/0322164 A1, published 20 December 2012) and Fukushima et al. (U.S. Patent Application Publication No US 2006/0196769 A1, published 7 September 2006) as applied to claim 1 above, and further in combination with Blick et al. (U.S. Patent Application Publication No. US 2007/0023621 A1, published 1 February 2007).
Conclusion
20. No claim is allowed.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683