FINAL ACTION
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 .
Amendments and Status of the Claims
2. This action is in response to papers filed 27 May 2026 in which claims 1, 5, and 11 were amended, no claims were canceled, and no new claims were added. All of the amendments have been thoroughly reviewed and entered.
All previous rejections not reiterated below are withdrawn in view of the amendments.
Applicant’s arguments have been thoroughly reviewed and are addressed following the rejections necessitated by the amendments.
Claims 1-13 are under prosecution.
3. This Office Action includes new rejections necessitated by the amendments.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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 biosensors (i.e., sensors for detecting DNA; Abstract) 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 nanowire pillars are non-horizontally (i.e., vertically) aligned (paragraph 0095) and are exposed to a solution of interest (i.e., containing a target; paragraph 0229). Lai et al. further teach the array is 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.
It is noted that the Response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
While Lai et al teach electrically connected nanowires (paragraph 0091), connection through the bases (paragraph 0123), and p-n junctions (paragraph 0091), Lai et al do not teach the junction is below the nanowire array within the substrate.
However, Modawar et al. teach nanowire detectors (paragraph 0073) having p-n
junctions below the base of the nanowire array (paragraph 0015), which is within the
substrate (paragraph 0022), and which have the added advantage of increased
efficiency (paragraph 0065). Thus, Modawar et al. teach the known techniques discussed above.
While Lai et al. discuss 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), neither Lai et al. nor Modawar et al. 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 advantages of:
Enhanced concentration sensitivity as explicitly taught by Lai et al. (paragraph 0229);
Increased efficiency as explicitly taught by Modawar et al. (paragraph 0065); and
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), as do Modawar et al. (paragraph 0066).
Regarding claim 3, the method of claim 2 is discussed above. Lai et al. teach
the nanowires comprise silicon (paragraph 0118) , as do Modawar et al. (Abstract).
Regarding claim 10, the method of claim 1 is discussed above. Lai et al. teach
the nanowire pillars are vertically aligned (paragraph 0095), as do Modawar et al. (paragraph 0006).
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 front surface where the nanowires are exposed to the sample (e.g., Figure 11 and paragraph 0090). In addition, Modawar et al. teach the p-n junctions are below the base of the nanowire array (paragraph 0015), which is within the substrate (paragraph 0022); thus, the electrical connections are not at the front surface.
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).
7. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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 6.
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).
None of the cited prior art teaches 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.
8. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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 6.
None of the previously cited prior art teaches 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, and that the Response above should not be construed as an invitation to file an after final declaration.
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
9. 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-disclaimert
10. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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, p-n junctions, 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, or the specific arrangement of the p-n junction.
However, Lai et al., Modawar 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.
11. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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.
12. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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.
13. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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, p-n junctions, 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 the specific arrangement of the p-n junction, solutions of interest, irradiation, or determination of concentration.
However, Lai et al., Modawar 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.
14. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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.
15. 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), Modawar et al. (U.S. Patent Application Publication No. US 2012/0153250), 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).
Response to Arguments
16. Applicant's arguments filed (hereafter the “Remarks”) have been fully considered but they are not persuasive for the reasons discussed below.
A. Page 4 of the Remarks summarizes the amendments and the previous rejections.
B. Applicant argues on pages 4-5 of the Remarks that Lai et al. do not teach detection of concentrations and require a change in the mechanical resonance frequency as allegedly required by paragraphs 0110-0111 and 0228 of La et al. thus, Applicant argues La et al. individually.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Specifically, as noted in the rejections above, Fukushima et al. teach the detection of the concentrations.
With respect to the cited teachings of Lai et al, paragraph 0110 is cited as describing “one embodiment,” and paragraph 0111 references the embodiment of Figure 14k. Paragraph 0228 discuses “one of the application of the above sensing mechanism. Thus, none of Applicant’s citations are limiting.
D. Applicant states on page 6 of the Remarks that a Terminal Disclaimer will be filed upon allowance of the instant claims. Since the claimed are not in condition for allowance, the double patenting rejections are maintained for the reasons discussed above.
Conclusion
17. No claim is allowed.
18. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
19. 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.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights