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 18 May 2026 in which the specification and claims 1 and 8 were amended, no claims were canceled, and new claims 21-23 were added. All of the amendments have been thoroughly reviewed and entered.
All previous objections and/or rejections not reiterated below are withdrawn in view of the amendments.
Claims 1-19 and 21-23 are under prosecution.
3. This Office Action includes new rejections necessitated by the amendments.
Terminal Disclaimer
4. The terminal disclaimer filed on 6 May 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S Patent No. 12,252,740 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Specification
5. This Application discloses and claims subject matter disclosed in prior Application No. 18/177,238 filed 2 March 2023, and names the inventor or at least one joint inventor named in the prior application. In addition, Application No. 18/352,957, to which the instant Application claims priority, is a continuation of 18/177,238. Accordingly, this Application appears to further claim priority to 18/177,238 as well as PCT US22/27630, (filed 4 May 2022), which the ‘238 Application is a continuation of.
Should Applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
In addition, Applicant states that this application is a continuation or divisional application of the prior-filed applications. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this Application contains the matter not disclosed in the prior-filed application as discussed below.
Claim Interpretation
6. The claims are subject to the following interpretation:
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
7. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) are:
A “sample stage configured to receive…;”
A “light source “configured to provide…;” and
An imaging system device “configured to detect…” in claim 1:
A “heating element…configured to modulate…” in claim 11:
An imaging system “configured to scan” in claim 14; and
An imaging system “configured to detect” in claim 17;
However, these claim limitation(s) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the specification does not describe limiting corresponding structures material, for as performing the claimed function, or equivalents thereof.
If Applicant does intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, Applicant should indicate where in the specification sufficient limiting structures to perform the claimed functions are found.
B. Claims 1, 12, and 14-17 each recite a type of “system.” The specification recites “systems” wherein the “systems” are defined in terms of structural limitations. In addition, the claims recite structural limitations of the “systems.” Thus, the “systems” are interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
Claim Rejections - 35 USC § 112 and Claim Interpretation
8. 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.
9. Claims 1-19 and 21-23 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 2-19 and 21-23 depend) recited a sample stage configure to receive “a first solid support” or “a second solid support.” Claim 1 also recited an imaging system configure to detect emissions from the first solid support and the second solid support. Thus, the claims encompass embodiments requiring simultaneous detection of emission from both solid supports.
In addition, the imaging system is configured to detect “reagents bound … in the reaction chamber of the fist solid support and … the second solid support (emphasis added by the examiner).” Thus, the claim encompass embodiments where both solid supports are detected at the same time.
A review of all of parent specifications yields no teaching of a stage configured to receive two different solid supports, or an imaging system configured to detect fluorescent emissions from both solid supports at the same time.
However, based on the limitations present in claim 20, where oligonucleotides on the first solid support are detected, followed by removal of the fist solid support from the state and placement of the second solid support on the stage, claim 1 is interpreted as having a stage that can support either the first or the second solid support and an imaging system that can detect fluorescence emissions from sequencing reagents and from polynucleotides in a cell (but not at the same time).
B. Claim 17 recites an imaging system that detects “adjacent planes.” A review of all of parent specifications yields no teaching of “adjacent planes.”
C. New claim 21 requires the device to perform nucleic acid sequencing on the first solid support and in situ analysis on the second solid support. Thus, the claim encompasses embodiments wherein sequencing and in situ analysis are performed simultaneously. A review of all of parent specifications yields no teaching of a device that performs nucleic acid sequencing on the first solid support and in situ analysis on the second solid support at the same time.
Thus, each of the limitations discussed above constitutes new matter.
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
12. Claims 1-10, 12, 19, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Daugharthy et al. (U.S. Patent Application Publication No. US 2019/0155835 A1, published 23 May 2019) alternatively further in combination with Hilson et al. (U.S. Patent Application Publication No. US 2003/0032191 A1, published 13 February 2003).
Regarding claim 1, Daugharthy et al. teach devices (i.e., systems) comprising a stage for holding a sample holder, a connected heater, a fluidic dispenser for dispensing fluids to the sample holder, an imaging system (paragraph 0069), and a light source (paragraph 0043). Daugharthy et al. also teach solid supports for the sample, in the form of a vessel (paragraph 0041), which would necessarily comprise a chamber.
Daugharthy et al. also teach reservoirs having liquid reagents therein (paragraph 0069), and sequencing reagents (paragraph 0051); thus, it would have been obvious to have sequencing reagents in the reservoir.
Daugharthy et al. further teach imaging within tissue and imaging nucleic acids (paragraph 0032). In addition, Daugharthy et al. teach the imaging system detects FISSEQ (which detects sequences within a cell; paragraph 0051) and other optical data (paragraph 0033), wherein the optical data includes using varied probes with an increased number of labels (paragraph 0055). Thus, the imaging system is “configured to” perform the claimed functions.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess the characteristic relied on” (205 USPQ 594, second column, first full paragraph).
Specifically, Daugharthy et al. teaches the components discussed above constitute “[a]n automated sequencing and volumetric sequencing device (paragraph 0069). The recitation of “[a]n automated….device” is interpreted as a single device comprising all of the listed components; thus, a physical structure is required to couple all of the components together in to “a” device.
Alternatively, the teaching of “[a]n” automated device renders the claimed physically coupled (i.e., single) structure obvious.
It is also noted 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 (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04. Thus, any arrangement of the claimed structures is an obvious variant of the teachings of the cited prior art.
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, counsel’s mere arguments cannot take the 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.
It is further noted that while the sample stage is configured to receive the claimed first solid support or the claimed second solid support, the claim does not actually require either of the solid supports to be part of the claimed device. Thus, any limitations regarding the solid supports (i.e., immobilized target polynucleotides or tissues/cells) do not further limit the claimed device.
Thus, Daugharthy et al. teach all of the required structural limitations.
Alternatively, Daugharthy et al. also teach tissue sections (paragraph 0045), fluorescence detection (paragraph 0051), and that the device has the added advantage of allowing multiplex in situ measurement of RNA, DNA, and other molecular substrates (paragraph 0082). Thus, Daugharthy et al. teach the known techniques discussed above.
While Daugharthy et al. teach immobilized naturally occurring (i.e., target) nucleic acids (paragraph 0032), covalent bonding of the nucleic acids to a polymer matrix (paragraph 0068), and tissue sections, Daugharthy et al. do not teach the solid supports comprise chambers.
However, Hilson et al. teach devices for detecting nucleic acid sequences (paragraph 0056), wherein the device comprises an input element 54 that places a plurality of supports housings 62 on a moving sample stage (i.e., carousel 66; Figure 1 and paragraph 0101). Hilson et al. further teach each support housing comprises a chamber (paragraph 0050) having immobilized polynucleotides therein (paragraphs 0004 and 0044). Hilson et al. also teach the nucleic acids (i.e., biopolymers) are attached to polymeric materials of the support (paragraph 0052), lasers to excite fluorescent labels (paragraph 0063), fluidic systems (i.e., components) for contacting reagents to the housing (i.e., supports; paragraph 0114). Hilson et al. also teach the chambers of the device have the added advantage of being resealable and allowing removal of the sample (paragraph 0051). Thus, Hilson et al. teach the known techniques discussed above.
It would therefore have alternatively 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 Daugharthy et al. and Hilson et al. to arrive at the instantly claimed device 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 device having the added advantages of allowing multiplex in situ measurement of RNA, DNA, and other molecular substrates as explicitly taught by Daugharthy et al. (paragraph 0082) and being resealable and allowing removal of the sample as explicitly taught by Hilson et al. (paragraph 0051). 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 devices useful for in situ detection.
Regarding claims 2-4 and 6-8, the device of claim 1 is discussed above. As noted in the rejection of claim 1, the second solid support is not actually required to be part of the claimed device. Thus, any limitations regarding the second solid support or the contents therein do not further limit the claimed device.
In addition, with respect to claim 8, the courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Thus, the claimed channel is an obvious variants of the shape of the chamber of the cited prior art. See MPEP 2144.04 IV B.
The courts have also held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” (Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984)). See MPEP 2144.04 IVA. Thus, the claimed “channel,” which is reasonably interpreted as having elongated dimensions relative to a “chamber,” is an obvious variant of the claimed “chamber.”
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.
Regarding claims 5, 8-10 and 19, the device of claim 1 is discussed above. As noted in the rejection of claim 1, the first solid support is not actually required to be part of the claimed device. Thus, any limitations regarding the first solid support or the contents therein do not further limit the claimed device.
Alternatively, with respect to claims 9-10, Daugharthy et al. teach fluorescently labeled nucleotides (paragraph 0051), and reversible terminators (paragraph 0054). Hilson et al. teach nucleotide analogs (paragraph 0054). Thus, it would have been obvious to have fluorescently labeled nucleotide analogs (i.e., claim 9), including those with reversible terminators (i.e., claim 10).
In addition, with respect to claim 19, Daugharthy et al. teach detection of amplicons within a cell (paragraph 0068).
Regarding claim 12, the device of claim 1 is discussed above. Daugharthy et al. tech detection of in-situ fluorescent hybridization (paragraph 0004); thus, it would have been obvious for the imaging system to detecting fluorescent emissions form a fluorescently labeled probe associated with a cellular component.
Regarding claim 21, the device of claim 1 is discussed above. Daugharthy et al. teach performs nucleic acid sequencing (Title and Abstract) and FISSEQ, which is an in-situ analysis within cells (paragraph 0051).
Regarding claim 23, the device of claim 1 is discussed above.
As noted above, In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to prove that subject matter shown to be in the prior art does not possess the characteristic relied on.
Specifically, Daugharthy et al. teaches the components discussed above constitute “[a]n automated sequencing and volumetric sequencing device (paragraph 0069). The recitation of “[a]n automated….device” is interpreted as a single device comprising all of the listed components; thus, a physical structure is required to couple all of the components together in to “a” device.
Alternatively, the teaching of “[a]n” automated device renders the claimed physically coupled (i.e., single) structure obvious.
Alternatively, Hilson et al. teach a devices (i.e., apparatuses) comprising frames to which the other components of the device are physically coupled (i.e., secured; paragraph 0066).
13. Claims 2-4 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Daugharthy et al. (U.S. Patent Application Publication No. US 2019/0155835 A1, published 23 May 2019) alternatively further in combination with Hilson et al. (U.S. Patent Application Publication No. US 2003/0032191 A1, published 13 February 2003) as applied to claim 1 above, and further in combination with Goodman et al. (U.S. Patent Application Publication No. US 2019/0113423 A1, issued 18 April 2019).
It is noted that while claims 2-4 and 18 are rejected as described above, the claims are also obvious using the interpretation outlined below.
Regarding claims 2-4 and 17-18, the device of claim 1 is discussed above in Section 12.
While Daugharthy et al. teach light sheet microscopy (paraph 0068), the previously cited prior art does not teach the dimensions of the tissue section (i.e., claims 2-3).
However, Goodman et al. teach devices for analyzing tissue samples (Abstract) wherein the tissues samples are in chambers (paragraph 0019) and are sections having a thickness of 4-20 microns (i.e., claim 3, paragraph 0003). Goodman et al. also teach the samples have widths (i.e., lengths) of about 10 microns (i.e., claim 2; paragraph 0007). Goodman et al. further teach fixed cells (i.e., claim 4; paragraph 0007), imaging fluorescence of adjacent planes (i.e., claim 17; paragraph 0202) and laser scanning (i.e., claim 18; paragraph 0209). Goodman et al. teach the device has the added advantage of allowing diagnosing or determining the prognosis of a tumor in a subject (paragraph 0008). Thus, Goodman 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).
The 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
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.
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 Goodman et al. with the previously cited prior art to arrive at the instantly claimed devices with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in devices having the added advantage of allowing diagnosing or determining the prognosis of a tumor in a subject as explicitly taught by Goodman et al. (paragraph 0008). In addition, it would have been obvious to the ordinary artisan that the known techniques of Goodman et al. could have been combined with the cited prior art with predictable results because the known techniques of Goodman et al. predictably result in devices useful for tumor detection.
14. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Daugharthy et al. (U.S. Patent Application Publication No. US 2019/0155835 A1, published 23 May 2019) alternatively further in combination with Hilson et al. (U.S. Patent Application Publication No. US 2003/0032191 A1, published 13 February 2003) as applied to claim 1 above, and further in combination with Hogan et al. (U.S. Patent Application Publication No. US 2018/0251758 A1, published 6 September 2018).
It is noted that while claim 5 is rejected as described above, the claim is also obvious using the interpretation outlined below.
Regarding claim 5, the device of claim 1 is discussed above in Section 12.
While Daugharthy et al. teach covalent binding of nucleic acids to a polymer (i.e., matrix; paragraph 0068), the previously cited prior art does not teach the polymer is attached to the solid support.
However, Hogan et al. teach polymer linkers attached to solid supports, wherein nucleic acids are attached to the polymers (paragraph 0014), which has the added advantage of allowing a multiplex assay in a 3-D lattice (paragraph 0002). Thus, Hogan et al. teach the known techniques 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 Hogan et al. with the previously cited prior art to arrive at the instantly claimed device 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 device having the added advantage of allowing a multiplex assay in a 3-D lattice as explicitly taught by Hogan et al. (paragraph 0002). In addition, it would have been obvious to the ordinary artisan that the known techniques of Hogan et al. could have been combined with the cited prior art with predictable results because the known techniques of Hogan et al. predictably result in reliable immobilization of nucleic acids.
15. Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Daugharthy et al. (U.S. Patent Application Publication No. US 2019/0155835 A1, published 23 May 2019) alternatively further in combination with Hilson et al. (U.S. Patent Application Publication No. US 2003/0032191 A1, published 13 February 2003) as applied to claim 1 above, and further in combination with MacBeath (U.S. Patent Application Publication No. US 2003/0026739 A1, published 6 February 2003).
It is noted that while claims 6-7 are rejected as described above, the claims are also obvious using the interpretation outlined below.
Regarding claims 6-7, the device of claim 1 is discussed above in Section 12.
While Daugharthy et al. teach tissue sections (i.e., claim 7; paragraph 0027), which comprise a plurality of cells (i.e., claim 6), the previously cited prior art does not teach the claimed discrete regions.
However, MacBeath et al. teaches tissue samples within discrete regions of a solid support, in the form of microarrays of tissues (paragraph 0041). The microarrays are scannable (paragraph 0009), and the discrete regions of the microarrays are wells separated by walls about 1.3 mm wide, which has the added advantage of being a commercially available plate (paragraph 0093). Thus, MacBeath et al. teach the known techniques 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 MacBeath et al. with the previously cited prior art to arrive at the instantly claimed devices with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in devices having the added advantages of using commercially available solid supports as explicitly taught by MacBeath et al. (paragraph 0093). In addition, it would have been obvious to the ordinary artisan that the known techniques of MacBeath et al. could have been combined with the cited prior art with predictable results because the known techniques of MacBeath et al. predictably result in reliable supports for tissue and cell arrays.
16. Claims 11, 13-14, 18 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Daugharthy et al. (U.S. Patent Application Publication No. US 2019/0155835 A1, published 23 May 2019) in combination with Hilson et al. (U.S. Patent Application Publication No. US 2003/0032191 A1, published 13 February 2003).
It is noted that while claim 18 is rejected as described above, the claim is also obvious using the interpretation outlined below.
It is noted that these rejections apply to the rejection claim 1 where the teachings of Hilson et al. are required based on the citations discussed above.
Regarding claims 11, 13-14, 18, and 22, the device of claim 1 is discussed above in Section 112.
Hilson et al. teach a heating element, in the form of a thermal source for applying heat energy (paragraph 0072), wherein fluids directed to the solid supports (i.e. housing) are heated (paragraph 0105); thus, it would have been obvious the have the heating element thermally coupled to the sample stage to modulate the temperature of the solid support (i.e., claim 11).
Hilson et al. also teach a motor for moving the holding device (paragraph 0079), wherein the holding device is the claimed stage because it holds the support housings (Abstract), which are the solid supports (i.e., claim 13). Hilson et al. also teach the imaging system scans the support housing (i.e., the reaction chamber of claim 14) using a laser (i.e., claim 18; paragraph 0063).
Hilson et al. further teach the solid supports (i.e., support housings) are removable (paragraph 0101).
17. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Daugharthy et al. (U.S. Patent Application Publication No. US 2019/0155835 A1, published 23 May 2019) alternatively further in combination with Hilson et al. (U.S. Patent Application Publication No. US 2003/0032191 A1, published 13 February 2003) as applied to claim 1 above, and further in combination with Liu et al. (Proc. SPIE 9701, Multimodal Biomedical Imaging XI, 97010U, pages 1-7, 10 March 2016).
Regarding claim 15, the device of claim 1 is discussed above in Section 12.
The previously cited prior art does not teach a kinematic mount.
However, Liu et al. teach optical imaging systems comprising kinematic mounts, which have the added advantage of ensuring good repeatability and accuracy (Conclusion). Thus, Liu et al. teach the known techniques 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 Liu et al. with the previously cited prior art to arrive at the instantly claimed device 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 device having the added advantage of allowing good repeatability and accuracy as explicitly taught by Liu et al. (Conclusion). In addition, it would have been obvious to the ordinary artisan that the known techniques of Liu et al. could have been combined with the cited prior art with predictable results because the known techniques of Liu et al. predictably result in reliable optical detection.
18. Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Daugharthy et al. (U.S. Patent Application Publication No. US 2019/0155835 A1, published 23 May 2019) alternatively further in combination with Hilson et al. (U.S. Patent Application Publication No. US 2003/0032191 A1, published 13 February 2003) as applied to claim 1 above, and further in combination with Halpern et al. (U.S. Patent Application Publication No. US 2012/0095697 A1, published 19 April 2012).
Regarding claim 16, the device of claim 1 is discussed above in Section 12.
While Daugharthy et al. teach cameras (paragraph 0062), the previously cited prior art does not teach a functionally equivalent TDI array.
However, Halpern et al. teach optical imaging systems for imaging nucleic acids comprising a functionally equivalent TDI CCD array camera, which has the added advantage of providing a spatial image (paragraph 0038). Thus, Halpern et al. teach the known techniques 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 Halpern et al. with the previously cited prior art to arrive at the instantly claimed device 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 device having the added advantage of providing a spatial image as explicitly taught by Halpern et al. (paragraph 0038). In addition, it would have been obvious to the ordinary artisan that the known techniques of Halpern et al. could have been combined with the cited prior art with predictable results because the known techniques of Halper et al. predictably result in a reliable functionally equivalent detector.
Response to Arguments
19. Applicant's arguments filed 18 May 2026 (hereafter the “Remarks”) have been fully considered but they are not persuasive for the reasons discussed below.
A. Pages 1-2 of the Remarks refer to the amendments, priority claims, and the previous objections.
It is noted that the comments regarding the presence of trademarks in the previous Office Action was not an objection.
The priority issues based on the new matter rejections are reiterated above, and the new matter rejections are addressed below.
B. Pages 2-4 of the Remarks discuss the Claim Interpretation section, and argue that the indicated phrases are not subject to interpretation under 112(f) and that the claimed “system” should not be subjected to the interpretation discussed above.
As noted in the previous Office Action and reiterated above, the noted claim limitation(s) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the specification does not describe limiting corresponding structures material, for as performing the claimed function, or equivalents thereof.
With respect to the claimed “systems,” it is reiterated that both the claims and the specification recites each “system” terms of structural limitations. Thus, the “systems” are interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter. Applicant has provided no citation from the specification that any of the individually claimed “systems” are anything more than a collection of reagents and or parts.
New claim 23 is not drawn to a “system,” and therefore has no bearing on the claim interpretation discussed above.
C. Applicant argues on pages 4-5 of the Remarks that the specification reasonably conveys possession of a dual purpose device.
However, as noted in the rejections above, the claims encompass embodiments wherein both solid supports are detected simultaneously. Because the claims encompass embodiments not found in the parent specifications, the limitations constitute new matter.
D. With respect to the arguments concerning claim 17 presented on page 5 of the Remarks, while paragraph 0128 (as cited by Applicant) discusses images and different depths, neither the instant specification nor the parent specification teach “adjacent planes.” The rejection the therefore maintained.
E. The arguments concerning claim 19 and the previous indefiniteness rejections presented on pages 6-7 of the Remarks are convincing and the rejections are withdrawn.
F. Applicant argues on pages 7-8 of the Remarks that the supports and analytes further limit the claims.
However, claim 1 clearly states the stage is “configured to receive (i) a first solid support…; or (ii) a second solid support,” and that the support comprises either immobilized target polynucleotides or tissues/cells, respectively. The phrase “configured to” clearly indicates an intended use and does not require the supports to be present.
It is also noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). Because the cited prior art teaches the structural elements of the claims, the claims are obvious. See MPEP § 2114.
G. Applicant argues on page 8 of the Remarks that the device of Daugharthy et al. is configured for two different support/detection contexts.
However, as noted above, Daugharthy et al. teach imaging within tissue and imaging nucleic acids (paragraph 0032). Daugharthy et al. also teach the imaging system detects FISSEQ (which detects sequences within a cell; paragraph 0051) and other optical data (paragraph 0033), wherein the optical data includes using varied probes with an increased number of labels (paragraph 0055). Thus, the imaging system is “configured to” perform the claimed functions.
H. Applicant argues on page 8 of the Remarks that In re Best does not allow an examiner to supply missing claim limitation merely by asserting the prior art may be capable of performing the claimed functions.
However, as noted in the rejections above, Daugharthy et al. teaches the components discussed above constitute “[a]n automated sequencing and volumetric sequencing device (paragraph 0069). The recitation of “[a]n automated….device” is interpreted as a single device comprising all of the listed components; thus, a physical structure is required to couple all of the components together in to “a” device.
Alternatively, the teaching of “[a]n” automated device renders the claimed physically coupled (i.e., single) structure obvious.
In addition, the rejection is not based on the performance of a function; rather, it is based on the obviousness of having a single device based on the teachings of Daugharthy et al. that the components constitute “[a]n automated… device (emphasis added by the examiner).”
I. Applicant argues on pages 8- of the Remarks that Hilson et al. do not tech the claimed imaging system. Thus, Applicant argues Hilson 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, the imaging system is taught by Daugharthy et al. as discussed above.
J. Applicant argues on pages 9-10 of the Remarks that the rationale for combining is too general and that the cited prior art does not teach the imaging system as claimed.
However, if is noted that the courts have stated “[A] prior art reference must be considered in its entirety, i.e., as a whole” W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983) (see MPEP 2141.02 [R-3] VI).
Thus, even a teaching of an allegedly “general” advantage within a reference is sufficient grounds for an ordinarily skilled artisan to consider the teaching of the reference as a whole.
In addition, it is also noted that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness. See Ex parte Smith (USPQ2d, slip op. at 20 (Bd. Pat. App. & Interf. June 25, 2007).
The arguments regarding the claimed imaging system have already been discussed above.
J. In response to Applicant's arguments on pages 9-10 of the Remarks that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., single cell and spatial analysis) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
K. Applicant’s arguments on pages 10-11 of the Remarks state that Goodman et al. do not teach the claimed imaging system and the rationale for combining is too general.
However, as noted above, Daugharthy et al. teach the claimed imaging system.
It is reiterated that even a teaching of an allegedly “general” advantage within a reference is sufficient grounds for an ordinarily skilled artisan to consider the teaching of the reference as a whole.
It is also reiterated that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.
L. Applicant’s arguments on pages 11-12 of the Remarks state that Hogan et al. do not teach the claimed imaging system and there is no motivation to combined and the rationale is too general.
However, as noted above, Daugharthy et al. teach the claimed imaging system.
It is reiterated that even a teaching of an allegedly “general” advantage within a reference is sufficient grounds for an ordinarily skilled artisan to consider the teaching of the reference as a whole.
In addition, arguing that the rationale is too general and arguing that there is no motivation is contradictory.
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation to combine is clearly articulated in the rejection above.
It is also reiterated that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.
M. In response to Applicant’s argument on pages 12-14 of the Remarks that there is no teaching, suggestion, or motivation to combine the references, it is reiterated that the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, the motivation to combine is clearly articulated in the rejection above.
It is also reiterated that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.
N. Applicant argues on pages 14-15 of the Remarks Liu et al. do not teach the claimed imaging system and there is no motivation to combined and the rationale is too general.
However, as noted above, Daugharthy et al. teach the claimed imaging system.
It is reiterated that even a teaching of an allegedly “general” advantage within a reference is sufficient grounds for an ordinarily skilled artisan to consider the teaching of the reference as a whole.
It is further reiterated that the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, the motivation to combine is clearly articulated in the rejection above.
It is also reiterated that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.
O. Applicant argues on page 5 of the Remarks Halpern et al. do not teach the claimed imaging system and there is no motivation to combined and the rationale is too general.
However, as noted above, Daugharthy et al. teach the claimed imaging system.
It is reiterated that even a teaching of an allegedly “general” advantage within a reference is sufficient grounds for an ordinarily skilled artisan to consider the teaching of the reference as a whole.
It is further reiterated that the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. In this case, the motivation to combine is clearly articulated in the rejection above.
It is also reiterated that the Supreme Court ruling for KSR Int’l Co. v. Teleflex, Inc. (No 04-1350 (US 30 April 2007) forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness.
P. Pages 15-17 discuss the new claims and the previous double patenting rejections.
The new claims are rejected for the reasons discussed above.
As noted above, the double patenting rejections are withdrawn in view of the approved Terminal Disclaimer.
Conclusion
20. No claim is allowed.
21. 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).
22. 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.
23. 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
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