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 .
Claim Rejections - 35 USC § 112
Note that dependent claims will have the deficiencies of base and intervening claims.
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.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 6 requires “. . . ., wherein said pair of main electrodes and said pair of inspection electrodes are disposed adjacent to each other.[italicizing by the Examiner]” There is no need to go through the Wands undue experimentation factors (MPEP 2164.01(a)) as this claim 6 limitation is not enabled on its face. Claim 1 from which claim 6 depends clearly requires that said pair of main electrodes and said pair of inspection electrodes be on different areas of the chip and separate from each other. That is, claim 6 requires said pair of main electrodes and said pair of inspection electrodes to be separated and adjacent at the same time:
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Moreover, Applicant’s figures clearly show said pair of main electrodes and said pair of inspection electrodes being separated apart from each other:
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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 1-8 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) claim 1 requires “. . . ., . . . . at least one pair of inspection electrodes disposed between said main surface of said substrate and said liquid reservoir. [italicizing by the Examiner]” There is no indication in this claim as to what the inspection electrodes are inspecting and what the inspection is to determine. Applicant’s specification is also vague as what the inspection electrodes are inspecting and what the inspection is to determine. If Applicant is being his own lexicographer, please heed MPEP 2173.05.
b) claim 2 requires “wherein said liquid reservoir includes an inspection channel capable of passing a liquid therethrough, . . . .” It is not clear how, if at all, the “inspection channel” differs structurally or functionally from the main channel. If Applicant is being his own lexicographer, please heed MPEP 2173.05.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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.
Claims 1-4, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wakizaka et al. US 2019/0032103 A1 (hereafter “Wakizaka”) in view of Imai et al.
US 2019/0084011 A1 (hereafter “Imai”), Almasri et al. US 2016/0299138 A1 (hereafter “Almasri”), Terbrueggen et al. US 2004/0053290 A1 (hereafter “Terbrueggen”), Pennathur et al. US 2016/0130639 A1 (hereafter “Pennathur”), and David Dumas
US 2004/0118688 A1 (hereafter “Dumas”).
Addressing claim 1, Wakizaka discloses a channel device (100; Figure 2 and paragraph [0021]) comprising:
a main channel (5; Figure 2 and paragraph [0021]) capable of receiving a liquid therein (this feature is implied by paragraph [0021] – a flow channel (first flow channel) 5 through which a sample solution containing circulating cancer cells (CTC) 1 flows . . . .“ ); and
a pair of main electrodes (32, 33; paragraph [0033]) disposed in said main channel (Figure 2).
Wakizaka, though, does not disclose the following italicized features in claim 1
“[a] channel chip comprising:
a substrate;
a main channel disposed on one main surface of said substrate and capable of receiving a liquid therein;
a liquid reservoir disposed on said main surface of said substrate in spaced apart relation to said main channel and capable of receiving a liquid therein;
a pair of main electrodes disposed between said main surface of said substrate and said main channel; and
at least one pair of inspection electrodes disposed between said main surface of said substrate and said liquid reservoir.”
Imai discloses a channel chip (entire Figure 6) comprising: a substrate (10; Figure 6 and paragraph [0019], [0045], and [0046](from the latter two paragraphs one of ordinary skill in the art would understand that details of Figure 1 carry over to Figure 6); a main channel (20; paragraph [0019]) disposed on one main surface of said substrate and capable of receiving a liquid therein (Figure 6 and paragraph [0019], noting especially that 20 is a flow channel); and a pair of main electrodes disposed between said main surface of said substrate and said main channel (although this pair is not shown in Figure 6, it is clear from Figure 3 and paragraphs [0025], [0026](which discloses that the electrodes may be comb-shaped), [0045], and [0046] that Imai also contemplated such a pair of electrodes for the Figure 6 embodiment).
Almasri discloses a channel chip (entire Figure 1) comprising: a substrate (Glass (800) in Figure 8A. Also see paragraph [0053].); a main channel (the Examiner is construing the channel portion in detection region 104 in Figure 1 as a main channel. See also paragraph [0031].); and a pair of main electrodes disposed between said main surface of said substrate and said main channel (300 on Figure 3A and paragraph [0044]).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to have the channel device in Wakizaka be a channel chip comprising:
a substrate;
a main channel disposed on one main surface of said substrate and capable of receiving a liquid therein; and
a pair of main electrodes disposed between said main surface of said substrate and said main channel, as taught by Imai or Almasri because this will make the channel device of Wakizaka into a compact form that is convenient to handle, whether by hand or with an automated biochip analysis system, such as disclosed by Terbrueggen (the title, Figures 1H, 1K, 2A-C, and 4B, and paragraphs [0002] and [0150]), and the chip can be made using known manufacturing techniques, as discussed in Imai and Almasari.
Wakizaka, though, does not disclose the following italicized features in claim 1 “. . . . a liquid reservoir disposed on said main surface of said substrate in spaced apart relation to said main channel and capable of receiving a liquid therein; . . . .; and at least one pair of inspection electrodes disposed between said main surface of said substrate and said liquid reservoir.” As a first matter, the phrase “a liquid reservoir” may be broadly construed to include a fluid channel (for example an inspection channel 41) in the same manner as the main channel. See Applicant’s paragraph [0040] and Figure 1 in the originally filed specification.1 Also, Applicant’s specification is vague as to any necessary structural, compositional, or even functional difference between “the at least one pair of inspection electrodes” and the “pair of main electrodes”. Indeed, it appears that the at least one pair of inspection electrodes may be identical in composition and structure (if not also function) to the pair of main electrodes. See Applicant’s paragraphs [0046] and [0053]-[0055] in the originally filed specification. As such, the claimed liquid reservoir and at least one pair of inspection electrodes is prima facie obvious as duplication of parts (the main channel and the pair of main electrodes) for a multiplied effect, namely allowing the channel chip to be able to separate out and/or analyze particles or molecules of interest in two samples simultaneously. See MPEP 2144.04(VI)(B). It will be noted that duplicating channels and electrodes on a (dielectrophoresis) channel chip is known in the art. See, for example, Imai Figure 6 and Almasri Figure 5.
Alternatively, Pennathur and Dumas each disclose a channel chip comprising:
a substrate; a main channel disposed on one main surface of said substrate and capable of receiving a liquid therein; a liquid reservoir2 disposed on said main surface of said substrate in spaced apart relation to said main channel and capable of receiving a liquid therein; a pair of main electrodes disposed in said main channel; and at least one pair of inspection electrodes disposed in said liquid reservoir. See in Pennathur the title, and Figures 1B, 3, and 4, noting especially main channel 304 in Figure 3 and main channel 404 in Figure 4, liquid reservoir 304 in Figure 3 and liquid reservoir 406 in Figure 4, and electrodes 314, 316A, and 316B in Figure 3 and electrodes 418, 420, and 422 in Figure 4. See also Pennathur paragraphs [0065] and [0098]-[0106]. In Dumas see the title, Figures 1 and 4, noting especially in Figure 4 main channel 200 and liquid reservoir 205 and the respective electrodes associated with these channels, which may be inferred from the electrical schematic diagram in Figure 4. See also paragraphs [0014](which discloses dielectrophoresis), [0035], and [0093]. The main point about Pennathur and Dumas is that they disclose the concept of providing an inspection channel similar in structure to the main channel. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide an inspection channel as taught by Pennathur and Dumas in the channel chip of Wakizaka because as taught by Pennathur and Dumas the inspection channel may be used as a reference channel to measure changes in electrical parameters of the main channel, such as conductivity, resistance, capacitance, and/or impedance as a sample separated and/or analyzed in the main channel. Such changes in one or more electrical parameters may be used to detect sample constituents or for error-checking the detection system of the main channel. See Dumas paragraphs [0093]-[0095] and claim 28. In Pennathur see Figures 8-15 and paragraphs [0076]-[0080] and [0098]-[0108].3
Addressing claim 2, for the additional limitations of this claim recall from the rejection of claim 1 that the liquid reservoir and at least one pair of electrodes will be substantially the same as the main channel and pair of main electrodes, respectively, so the liquid reservoir will inherently include an inspection channel capable of passing a liquid therethrough, and a pair of inspection electrodes are disposed between said main surface of said substrate and said inspection channel.
Addressing claim 3, for the additional limitations of this claim recall from the rejection of claim 1 that the liquid reservoir and at least one pair of electrodes will be substantially the same as the main channel and pair of main electrodes, respectively, so a first overlapping portion of said pair of main electrodes which overlaps said main channel will be inherently equal in area to a second overlapping portion of said pair of inspection electrodes which overlaps said liquid reservoir.
Addressing claim 4, for the additional limitations of this claim recall from the rejection of claim 1 that the liquid reservoir and at least one pair of electrodes will be substantially the same as the main channel and pair of main electrodes, respectively, so the at least one pair of inspection electrodes will include not less than two pairs of inspection electrodes, which will be similar to electrode pair 22, 23 and electrode pair 32,33 in that main channel of Wakizaka Figure 2.
Addressing claim 8, for the additional limitations of this claim see Wakizaka Figure 2 noting electrode pair 32,33 (which will duplicated in the liquid reservoir, as discussed in the reject of underlying claim 1).
Addressing claim 9, for the additional limitations of this clam first recall from the rejection of underlying claim 1 the discussion of “a channel chip”, said “pair of main electrodes”, and said “pair of inspection electrodes”. Now see Wakizaka the Abstract, paragraphs [0002] and [0034], and Figure 2 for them being part of a dielectrophoresis device and for power supply 34.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Wakizaka in view of Imai, Almasri, Terbrueggen, Pennathur, and Dumas as applied to claims 1-4, 8, and 9 above, and further in view of Emaminejad et al. Lab Chip, 2014, 14, 2105 (hereafter “Emaminejad”).
Addressing claim 5, as discussed in the rejection of underlying claim 4 the at least one pair of inspection electrodes will include not less than two pairs of inspection electrodes, which will be similar to electrode pair 22, 23 and electrode pair 32,33 in that main channel of Wakizaka Figure 2.
Emaminejad discloses an enhanced dielectrophoresis (DEP) system comprising an array of interdigitated electrode pairs along a channel. See the title, abstract, and Figure 1. In light of Emaminejad, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide in the channel chip of modified Wakizaka (as per the rejection of claim 4) one or more additional interdigitated electrode pairs similar to the electrode pair 32,33 already present in Wakizaka Figure 2 because this will allow the channel chip to be able to selectively extract more than analyte of interest from the same sample (see the Emaminejad
Figure 1 caption).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wakizaka in view of Imai, Almasri, Terbrueggen, Pennathur, and Dumas as applied to claims 1-4, 8, and 9 above, and further in view of Zenhausern et al. US 2004/0011650 A1 (hereafter “Zenhausern”).
Addressing claim 7, Wakizaka as modified by Imai, Almasri, Terbrueggen, Pennathur, and Dumas does not disclose the claim 7 limitation “. . . ., wherein said pair of main electrodes and said pair of inspection electrodes have respective surfaces covered with an insulating protective film, . . . .”
Zenhausern discloses a method an apparatus for manipulating polarizable analytes via dielectrophoresis. The field-generating electrodes may be covered with a permeating layer, which may compose a passivating oxide. See the Zenhausern title and paragraph [0054], especially the last two sentences. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date of the application to provide an insulating protective film as taught by Zenhausern for the pair of inspection electrodes in the channel chip of modified Wakizaka (as per the ejection of claim 1) because Zenhausern discloses “Field-generating electrodes may be coated with a permeating layer to prevent damage to target analytes that come into contact with the electrodes. [italicizing by the Examiner]” See Zenhausern paragraph [0054].
As for the claim 7 limitation “. . . ., and wherein said main channel and said liquid reservoir are disposed on said insulating protective film…”, this will be inherent in channel chip of modified Wakizaka (further modified by Zenhausern as just discussed) as the insulating protective film adopted from Zenhausern will be directly on the top surface of the pair of inspection electrodes and indeed likely on the other electrodes to similarly provide protection to the analytes.
Other Relevant Prior Art
The International Search Report for international application no. PCT/JP2022/026048 cites WO 2007/046484 A1 as a “X” document against claims 1-3 and 6-9 of that application. However, it is not clear, from the English language translation provided by Applicant, that WO 2007/046484 A1 discloses “a pair of main electrodes disposed between said main surface of said substrate and said main channel; and at least one pair of inspection electrodes disposed between said main surface of said substrate and said liquid reservoir…” as required by claim 1 of U.S. application 18/575193. It seems that the “main electrodes” and the “inspection electrodes” are just different portions of the same electrodes (6) that transversely intersect different electrophoresis lanes (3). See Figures 1, 2,5, 6, 7, 9, 10, and 12, and translation paragraphs [0047]-[0055]. In any event, WO 2007/046484 A1 is at best redundant with Wakizaka and the secondary references applied in the rejections under 35 U.S.C 103 above.
The supplementary European Search Report for application 22833234.2-1201/4365581 PCT/JP2022026048 cites WO 2007/046484 A1 as a “X” document against claims 1-3 and 6-9 of that application, US 2019/084011 A1 as a “X” document against claims 1-3 and 6-9, US 2020/016608 A1 as a “X” document against claims 1-3 and 6-9, and CN 112703057 A as a “X” document against claims 1-3 and 6-9.
WO 2007/046484 A1 has already been commented upon above in the discussion about the International Search Report.
US 2019/084011 A1 is Imai used as a secondary reference I the rejections under 35 U.S.C. 103 above.
US 2020/016608 A1 does not appear to disclose “a pair of main electrodes disposed between said main surface of said substrate and said main channel; and at least one pair of inspection electrodes disposed between said main surface of said substrate and said liquid reservoir…” as required by claim 1 of U.S. application 18/575193.
CN 112703057 A, based on an English language translation provided by Applicant, appears to be at best redundant with the prior art used in the rejection of claim 1 under 35 U.S.C. 103 above.
The Second Notice of Reasons for Refusal dated January 21, 2025, form corresponding Japanese Application No. 2021-108280, relies upon JP 2006-351246 A to reject claims in that application. JP 2006-351246 A, based on an English language translation provided by Applicant, appears to be at best redundant with the prior art used in the rejection of claim 1 under 35 U.S.C. 103 above.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER STEPHAN NOGUEROLA whose telephone number is (571)272-1343. The examiner can normally be reached on Monday - Friday 9:00AM-5:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached on 571 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER S NOGUEROLA/ Primary Examiner, Art Unit 1795
1 The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
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See MPEP 804 II.B.2(a).
2 Recall from earlier in this claim rejection that “a liquid reservoir” may be broadly interpreted to include an inspection channel in the same manner as the main channel.
3 Note that Pennathur paragraph [0098] states, “The provision of multiple channels may allow redundancy and error-checking functionalities, whereby different detection results in the channels may indicate that the detection system is not performing reliably and whereby the same result in the channels may indicate that the detection system is performing reliably. In the former case, the detection system may need to be repaired, recalibrated or discarded.”