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 with traverse of Group II in the reply filed on 8 May 2026 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because, as stated in the Requirement for Restriction/Election, the inventions have acquired a separate status in the art because of their recognized divergent subject matter as exemplified by their different classification. Furthermore, a search for the inventions of all of the groups would not be co-extensive because a search indicating the process is novel or nonobvious would not extend to a holding that the product itself is novel or nonobvious; similarly, a search indicating that the product is known or would have been obvious would not extend to a holding that the process is known or would have been obvious.
The requirement is still deemed proper and is therefore made FINAL.
3. Claims 1-7 are therefore withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 8 May 2026.
4. Claims 8-20 are under prosecution.
Information Disclosure Statement
5. The Information Disclosure Statement filed 10 January 2025 is acknowledged and has been considered.
It is noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
6. Claims 10 and 17 are objected to because of the following informalities:
Both claims contain the phrase “are substantially equal means,” which appears to
be a typographical error.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claims 8-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 (upon which claim 9-14 depend) and claim 15 (upon which claims 16-20 depend) are indefinite as it is unclear how a nucleic acid sequence is determined based on detecting emitted light; i.e., the claims contain no correlation of how the emitted light relates to a specific sequence or a nucleic acid.
Claim Rejections - 35 USC § 103
8. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
9. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
10. Claims 8, 13-15, 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (U.S. Patent Application Publication No US 2021/0333210 A1, published 28 October 2021) alternatively further in combination with Almogy et al. (U.S. Patent Application Publication No. US 2020/0363338 A1, published 19 November 2020).
Regarding claim 8, Chen et al. teach methods comprising capturing light emitted from nucleic acids disposed on a first (i.e., front) surface of a flow cell at a first (i.e., work) distance (e.g., Figure 1A) using a lens which has a field of view (paragraph 0005). Chen et al. also teach detection of emitted light (i.e., fluorescence) on a second surface at a different distance (paragraph 0112). Because the second surface image is of the back side of the flow cell (e.g., Figure 1), the two surfaces are separated from each other by the fluid in the flow cell (i.e., the claimed second fluid) and the lens is at a different distance from the flow cell (i.e., relative to the front surface; paragraph 0004). Chen et al. also teach the methods have the added advantage of allowing higher throughput image acquisition (Abstract). Thus, Chen et al. teach the known techniques discussed above.
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).
With respect to the claimed immersion in a first fluid, it is noted that Table 1 of the instant specification teaches air is an immersion fluid. As Figure 1 Chen et al. do not teach that the flow cell is submerged within a liquid fluid, the first and second images are believed to be obtained with the lens is immersed in air, and the
claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a “first fluid” (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111 [R-1]).
Alternatively, while Chen et al. teach imaging while the surfaces are immersed in buffer (paragraph 0004), Chen et al. do not explicitly teach the lens is immersed in a liquid fluid.
However, Almogy et al. teach methods for sequencing (paragraph 0019), wherein emissions are collected for imaging by a lens (i.e., objective) immersed in a fluid, including water of buffer (paragraph 0509), and that the methods have the added advantage of high efficiency (paragraph 0002). Thus, Almogy et al. teach the known techniques discussed above.
With respect to the optical paths, Chen et al. teach lens placement is designed to reduce optical aberration when imaging two surfaces of the flow cell (paragraph 0114), as well as restriction of the axial dimension (albeit for excitation; paragraph 0240) and equal resolution (claim 21 of Chen et al.).
It is noted that the courts have found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II. Thus, the claimed equalization of the claimed parameters merely represents routine optimization.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
It would therefore have been 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 the cited prior art to arrive at the instantly claimed method with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a method having the added advantages of allowing higher throughput image acquisition as explicitly taught by Chen et al. (Abstract) and high efficiency as explicitly taught by Almogy et al. (paragraph 0002). In addition, it would have been alternatively 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 techniques useful for imaging molecules.
Regarding claim 13, the method of claim 8 is discussed above. Chen et al teach the first surface is the top of the flow call and the second surface is the bottom of the flow cell (Figure 1A).
Regarding claim 14, the method of claim 8 is discussed above. Chen et al. teach the optical resolution of the images are diffraction limited (paragraph 0008).
With respect to the optical path differences, this limitation is addressed above in Claim 8.
In addition, It is noted that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim. See MPEP 2103 I.C. and MPEP § 2111.04.
It is also noted that a “wherein” clause, such as that in claim 14 , must give “meaning and purpose to the manipulative steps.” See, MPEP § 2111.04.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claims 15, 18, and 19, the methods of claims 8, 13, and 14 are discussed above. Chen et al. teach the methods are embodied in non-transitory software (paragraph 0380). Thus, because the media of claims 15, 18, and 19 code for the methods of 8, 13, and 14, respectively, the claimed media are obvious.
11. Claims 9-12, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (U.S. Patent Application Publication No US 2021/0333210 A1, published 28 October 2021) as applied to claims 8 and 15 above in combination with Almogy et al. (U.S. Patent Application Publication No. US 2020/0363338 A1, published 19 November 2020).
It is noted that the rejection of claims 9-12, 16-17, and 20 rely on the embodiments of claims 8 and 15 wherein the teachings of Almogy et al. are required; i.e., where the lens is immersed within a liquid fluid.
Regarding claims 9 and 11, the method of claim 8 is discussed above. In those embodiments wherein the lens is immersed in the buffer as taught by Almogy et al, (i.e., paragraph 0509), the fluids are the same (i.e., claim 11) and therefore have equal refractive indices (i.e., claim 9).
Regarding claim 10, the method of claim 9 is discussed above. Chen et al. teach the optical resolution of the images are diffraction limited (paragraph 0008).
In addition, it is reiterated that the subject matter of a properly construed claim is defined by the terms that limit its scope. It is this subject matter that must be examined. As a general matter, the grammar and intended meaning of terms used in a claim will dictate whether the language limits the claim scope. Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. “Wherein” clauses are examples of language that may raise a question as to the limiting effect of the language in a claim.
It is also noted that a “wherein” clause, such as that in claim 10, must give meaning and purpose to the manipulative steps.
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claim 12, the method of claim 9 is discussed above. In those embodiments wherein the lens is immersed in the water as taught by Almogy et al. (i.e., paragraph 0509), the fluids are the different (i.e., claim 11).
It is reiterated that In re Best and In re Fitzgerald 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.
In this instant case, the water (in which the lens is immersed) and the buffer in the flow cell are believed to have “substantially equal” refractive indices (i.e., claim 9).
Applicant is again cautioned to not merely rely upon counsel’s arguments in place of evidence in the record.
Regarding claims 16-17 and 20, the methods of claims 9-11 are discussed above. Chen et al. teach the methods are embodied in non-transitory software (paragraph 0380). Thus, because the media of claims 16, 17, and 20 code for the methods of 9, 10, and 11, respectively, the claimed media are obvious.
Conclusion
12. No claim is allowed.
13. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights