DETAILED 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 .
Election/Restrictions
2. Applicant’s election without traverse of Group I in the reply filed on 6 March 2026 is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 March 2026.
Claims 1-11 are under prosecution.
Information Disclosure Statement
3. The Information Disclosure Statements filed 21 October 2022, 24 August 2023, and 11 September 2025 are acknowledged and have been considered.
Claim Interpretation
4. The claims are subject to the following interpretation:
A. Regarding claims 1-11, the courts have stated:
even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP§ 2113.
Thus, any imitations that are part of the process of making the claimed chip rather than structural limitations of the claimed chip are not further limiting. Any art that teaches the structural elements of the claims therefore anticipates, or renders obvious, the claimed chip.
B. It is noted that any optional limitations, such as those found in claims 4 and 6-10, are not actually required the claims, and thus do not further limit them.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 1-11 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 (upon which claims 2-11 depend), is indefinite in the recitation “is obtained by.” It is unclear if the claim is drawn to the cut chip particle or the entire chip before it is cut.
B. Claim 3 is indefinite in the recitation of n=0. If n is 0, there are no phosphonates. It is also unclear how Formula I is a polymer is if n is only 1.
C. Claim 5 (upon which claims 6 and 10 depend) and 8 are each indefinite it the recitation “preferable,” as it is unclear if this is a required limitation of the cited claims.
In addition, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claims recites broad limitations, and the claims also recite the “preferable” limitations, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
7. 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.
8. 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.
9. Claims 1-2, 7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication).
Regarding claim 1, Li et al. teach a sequencing chip (i.e., flow cell; Abstract). comprising a chip main body, in the form of a composite wafer structure (paragraph 0018) comprising at least one chip particle in the same layer, in the form of particles (i.e., pieces) of the chip that are separated by cutting along scribe lines to form multiple dies (paragraph 0137). Li et al. also teach the wafer layer has a dielectric layer 121, wherein the dielectric layer is silicon dioxide (paragraph 0130) and is covered with a metal oxide layer 123 (Figure 2 and paragraph 0129), in the form of titanium dioxide (paragraph 0190). First surface layer 161 is on the transition metal oxide layer (paragraph 0139 and Figure 7), wherein biological sample 171 is bonded to the first surface layer 161 (paragraph 0146). The biological sample is a DNA molecule (paragraph 0150), and the metal oxide surface is treated with polyvinylphosphonic acid (paragraph 0191).
While Li et al. do not specifically teach the uniform arrangement of the cutting lines along a matrix, the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04.
It is also 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 placement of the cutting lines merely represents an obvious rearrangement and/or routine optimization of the placement of the cutting lines of 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.
Regarding claim 2, the chip of claim 1 is discussed above. Li et al. teach the polymer is a phosphate of a phosphonic acid (paragraph 0218). Thus, it would have been obvious to have a phosphate of polyvinylphosphonic acid.
Regarding claim 7, the chip of claim 1 is discussed above. Li et al. teach a second silicon dioxide layer 125 (paragraph 0130).
Regarding claim 9, the chip of claim 7 is discussed above. The limitations described in claim 9 further limit optional limitations of claim 7, and therefore are not actually required.
Regarding claim 11, the chip of claim 1 is discussed above. Li et al. also teach the wafer is a CMOS wafer (paragraph 0118) and the transition metal oxide is titanium dioxide (paragraph 0190).
10. Claims 1-2, 7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (U.S. Patent application Publication No. US 2019/0088463 A1, published 21 March 2019) based on the citations provided above.
11. Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication) as applied to claim 1 above, and further in combination with Gray et al. (U.S. Patent Application Publication No. US 2014/0175052 A1, published 26 June 2014).
Regarding claims 3-4, the chip of claim 1 is discussed above in Section 9.
Li et al. also teach the devices have the added advantage of improved fabrication (paragraph 0006). Thus, Li et al. teach the known techniques discussed above.
While Li et al. teach waveguides (paragraph 0251), Li et al. do not teach the size of the polyvinylphosphonate.
However, Gray et al. teach waveguides (Title and Abstract) for use in sequencing (paragraph 0173), wherein the waveguides are on wafers that are diced (paragraph 0129) and that have cationic transition metals (e.g., of titanium) having polyvinylphosphonic acid (i.e., PVPA) coatings (paragraph 0142), wherein the PVPA has the claimed structure with n=10 (i.e., claim 3; paragraph 0159-0160). Gray et al. also teach the PFPA forms strong bonds to metal oxide surfaces (i.e., claim 4; paragraph 0156) and that the PVPA has the added advantage of forming a smooth oxidation layer as required for use as a zero mode waveguide (paragraph 0152). Thus, Gray 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 Li et al. and Gray et al. to arrive at the instantly claimed chips with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in chips having the added advantages of improved fabrication as explicitly taught by Li et al. (paragraph 0006) and forming a smooth oxidation layer as required for use as a zero mode waveguide as explicitly taught by Gray et al. (paragraph 0152). 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 structures useful for nucleic acid sequencing.
12. Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019) as applied to claim 1 above, and further in combination with Gray et al. (U.S. Patent Application Publication No. US 2014/0175052 A1, published 26 June 2014) based on the citations discussed above.
13. Claims 5-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication) as applied to claims 1 and 7 above, and further in combination with Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002).
Regarding claims 5 and 8, the chips of claims 1 and 7 are discussed above in Section 9.
Li et al. teach the wafer is a silicon wafer (i.e., claim 8; paragraph 0069). Li et al. also teach the devices have the added advantage of improved fabrication (paragraph 0006). Thus, Li et al. teach the known techniques discussed above.
Li et al. teach the silicon oxide layer (i.e., first passivation layer; paragraph 0125) is less than 100 nm (paragraph 0240), as well as the metal oxide regions (i.e., 223) being separate from one another (Figure 8 and paragraph 0162).
With respect to the second silicon oxide layer, it is reiterated that Li et al. teach silicon oxide layers (i.e., passivation layers; paragraph 0125) is less than 100 nm (paragraph 0240).
It is also noted that the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960); see MPEP 2144.04 VI.B), and that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device
Thus, it would have been obvious to have a second silicon oxide layer of less than 100 nm.
Li et al. do not teach the claimed thicknesses of the transition metal oxide layers.
However, Vinet et al. teach biochips for sequencing (paragraph 0002) comprising immobilized oligonucleotides on a silicon support having a silicon oxide layer thereon (paragraph 0008), and which has a further layer of titanium dioxide having a thickness of a few nanometers up to 1 micron (i.e., claims 5 and 8; paragraph 0027), Vinet et al. also teach the device has the added advantage of allowing a greater probed density (paragraph 0008). Thus, Vinet et al. teach the known techniques discussed above.
It is noted 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 (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
It is also reiterated that courts have also 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.
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 against merely relying upon counsel’s arguments in place of evidence in the record.
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 Li et al. and Vinet et al. to arrive at the instantly claimed chips with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in chips having the added advantages of improved fabrication as explicitly taught by Li et al. (paragraph 0006) and allowing a greater probe density as explicitly taught by Vinet et al. (paragraph 0008). 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 structures useful for nucleic acid sequencing.
Regarding claim 6, the chip of claim 5 is discussed above. Li et al.. teach first surface layer 161, which is on the transition metal oxide layer, further comprises second surface layer 162, which comprises amine groups (paragraph 0142).
14. Claims 5-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019) as applied to claims 1 and 7 above, and further in combination with Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002) based on the citations discussed above.
15. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication) and Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002) as applied to claim 6 above, and further in combination with Gertler et al. (Langmuir, vol. 26, pages 6457-6463, published online 30 March 2010).
Regarding claim 10, the chip of claim 6 is discussed above in Section 13.
The previously cited prior art does not teach binding of amines to the transition metal layer.
However, Gertler et al. teach the binding of amine groups to titanium dioxide, and that the interaction allows conditions resembling biologically relevant environments (Abstract). Thus, Gertler et al. each the know 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 Gertler et al. with Li et al. and Vinet et al. to arrive at the instantly claimed chips with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in chips having the added advantage of allowing conditions resembling biologically relevant environments as explicitly taught by Gertler et al. (Abstract ). In addition, it would have been obvious to the ordinary artisan that the known techniques of the Gertler et al. could have been combined with the cited prior art with predictable results because the known techniques of Gertler et al. predictably result in useful linkers for binding biological molecules to titanium dioxide.
16. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019) and Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002) as applied to claim 6 above, and further in combination with Gertler et al. (Langmuir, vol. 26, pages 6457-6463, published online 30 March 2010) based on the citations discussed above.
Double Patenting
17. 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.
18. Claims 1-2, 5, 7-9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication).
Both sets of claims are drawn to wafers, chips, chip matrices, cutting lines, phosphonic acids, silicon oxide layers, transition metal oxide layers, thicknesses, etc.
Any additional limitations of the ‘721 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘721 claims do not require nucleic acids.
However, Li et al. each this limitation, as well as the additional limitations and the rationale for combining as discussed above.
19. Claims 1-2, 5, 7-9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (TU.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019) based on the citations discussed above.
20. Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication) as applied to claim 1 above, and further in combination with Gray et al. (U.S. Patent Application Publication No. US 2014/0175052 A1, published 26 June 2014) based on the citations and rationale discussed above.
21. Claims 3-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019) as applied to claim 1 above, and further in combination with Gray et al. (U.S. Patent Application Publication No. US 2014/0175052 A1, published 26 June 2014) based on the citations and rationale discussed above.
22. Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication) as applied to claim 5 above, and further in combination with Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002) based on the citations and rationale discussed above.
23. Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019) as applied to claim 5 above, and further in combination with Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002) based on the citations and rationale discussed above.
24. Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (Taiwanese Patent Application Publication No. TW 201717218, published 1 May 2019; citations are to U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019, which is an English language equivalent of the Taiwanese Publication) and Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002) as applied to claim 6 above, and further in combination with Gertler et al. (Langmuir, vol. 26, pages 6457-6463, published online 30 March 2010) based on the citations and rationale discussed above.
25. Claim 10 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,538,721 B2 in view of Li et al. (U.S. Patent Application Publication No. US 2019/0088463 A1, published 21 March 2019) and Vinet et al. (U.S. Patent Application Publication No. US 2002/0076561 A1, published 20 June 2002) as applied to claim 6 above, and further in combination with Gertler et al. (Langmuir, vol. 26, pages 6457-6463, published online 30 March 2010) based on the citations and rationale discussed above.
Conclusion
26. No claim is allowed.
27. 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
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