3DETAILED 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 .
Information Disclosure Statement
The information disclosure statement filed September 13, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
No copy of NPL document #128 has been found.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims are directed to apparatuses not processes of use. It is noted that the “for” clauses in the preambles and recited throughout the claims such as “for serial femtosecond crystallography (SFX)” are directed to intended use. Although the claims mention an oil solution, a substrate solution, a crystal solution, a sample solution, segmented droplets, X-ray Free Electron Laser, and protein crystals, none of such are positively claimed as structural elements of the apparatuses. None such are required to be present. All of such are considered as articles and/or materials intended to be, can be worked upon, used the apparatuses. As noted above, the claimed apparatuses are defined by the positively claimed structural elements not by any intended possible uses, process of use with any further unclaimed materials and structures that are not structural elements of the apparatuses.
It is noted that the respective names of the channels “oil”, “crystal”, “substrate”, and “sample” do not provide for any further structural elements of the channels.
It is noted that the various “configured to…” clauses do not provide for any further structural elements, but such are directed to intended, possible uses possible process steps relative to further unclaimed materials and structures. Reciting the phrase “configured to…” prior to possible uses, process steps do not provide for further structural elements/limitations of the apparatuses. There is no requirement for the apparatuses to be used in any method at all, including as may be intended by applicant with the recited unclaimed materials and articles. An owner, operator, possessor, purchaser, etc. of the apparatuses would not be required to use the invention in any method at all. One could elect to use the apparatuses as desired, if all in a different manner, purpose, and with different materials and structures than that intended by applicant.
Although no flowing of any solutions at any flow rated is required to be performed, it is noted that the first and second flow rates are not precluded from being the same.
Claim Objections
Applicant is advised that should claims 1-8 be found allowable, claims 9-16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
There is no structural distinction between the claims. The invention of claims 9-16 is defined by the same positively claimed structural elements provided for in claims 1-8. Claim 9 only renames the MDI of claim 1 as being a “microfluidic droplet injection (MDI) system”.
Claim Rejections - 35 USC § 112
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 1-20 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.
As to claims 1, 3-4, 9, 11-12, and 17-18, it is unclear what is structurally required by the “configured to…” clauses because such do not provide for any further structure, but are directed to possible uses, process of uses with unclaimed materials and articles. Furthermore, it is unclear how the channels and nozzle can provide for any flow rates, jetting of anything because no source of pressure (pump, etc.) has claimed nor claimed as an element of such. The channels and nozzle themselves are not capable of producing any motive force nor determining and controlling any flow rate of anything to generate any droplet.
As to claims 1, 9, and 17, it is unclear if “a sample channel” is a distinct, different channel from the substrate channel and the crystal channel or if both, combination of the substrate channel and crystal channel together are considered as being a sample channel as implied by the “to form a sample channel implies”. Therefore, although not positively claimed as an element of the channel, it is unclear what is the nexus of “a sample solution” to the substrate solution and the crystal solution because it is unclear if a sample solution is distinct different from such or if the substrate solution and the crystal solution combined/mixed together are considered as the sample solution because the claims do not clearly indicate such.
Dependent claims 2-8, 10-16, and 18-20 are rejected via dependency upon a rejected claim.
As to claims 2 and 10, it is unclear what is structurally required (structural elements) of the nozzle to be considered as a gas dynamic virtual nozzle because such is not structurally defined in the claims.
It is unclear what is further structurally required by claims 3-4, 11-12, and 18 because of “the configured to” clauses. See prior remarks/rejections above. Furthermore, it as noted above an X-ray Electron Laser (XFEL) pulse for SFX is not a positively claimed structural element. No SFX nor pulse, pulsing of anything is ever required to be performed.
The term “optimized” in claims 5 and 13 is a relative term which renders the claim indefinite. The term “optimized” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What may be considered as an optimized size and configuration of the droplet generator, the droplet detector, and the nozzle to one person may not be considered as such to another.
Furthermore, it is unclear what is structurally meant by size and configuration of the droplet generator, the droplet detector, and the nozzle because the claim does not provide for such. The claim is not directed to any specific dimensions (length, width, height, weight, mass, etc.) of the structures. It is noted that the droplet generator comprises a number of elements (channels). Therefore, it is unclear if the phrase is directed to any specific channels.
Furthermore, it is unclear what is structurally meant, required by “use a 4-fold reduction in volume of the sample solution for output through the nozzle”. The volume of unclaimed sample or anything else that may be elected to be used with the structural elements is not a structural limitation. The sample solution is not a structural element of the apparatuses. There is no requirement for any sample solution nor anything else to be outputted through nozzle. See Claim Interpretations. However, it is unclear what is meant 4-fold reduction because the relative basis (reduced relative to what?) provided for in the claim.
As to claims 6-8, 14-16, and 20, it is unclear what is further structurally required by the claims because the claims do provide for any additional structural element of the apparatuses nor any prior positively claimed elements. The claims are directed to the unclaimed sample solution that does not further structurally define the claimed apparatuses. See Claim Interpretations.
As to claims 18-19, it is unclear what is further structurally required by the claims because the claims do provide for any additional structural element of the apparatuses nor any prior positively claimed elements. The claims are directed to an intended possible use relative to an unspecified, claimed stream and segmented droplets that are not structural elements of the droplet generator. However, it is unclear what is the nexus of the continuous stream and plurality of segmented droplets to prior recited solutions and a segmented droplet recited in claim 17 because the claims do not provide for such (what defines the stream and the plurality of segmented droplets; and is the segmented droplet of claim 17 amongst or different from the plurality of segmented droplets).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-9, and 11-20 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Cayer et al., US 2021/0107004.
As to claims 1, 9, and 17, Cayer discloses a microfluidic droplet injector comprising:,
a droplet generator (Figure on the face, first page of the document; Figure 2B and description of such) including
an oil channel (see channel “carrier fluid”) configured to supply an oil solution at a first flow rate;
a substrate channel (see channel “beads inlet region”) configured to supply a substrate solution at a second flow rate;
a crystal channel (see further channel “inlet region”) configured to supply a crystal solution at the second flow rate;
a first intersection point of the substrate channel and the crystal channel (see where bead inlet and inlet region channel connect) to form a sample channel (see channel above the text “extrusion region”) configured to supply a sample solution, the droplet generator configured to mix the substrate solution and the crystal solution at the first intersection point to initiate a reaction between the substrate solution and the crystal solution in the sample solution, the reaction including a first delay based on the second flow rate; and
a second intersection point of the oil channel and the sample channel (see connection of “carrier fluid” channel; where droplets in the carrier fluid are formed), the droplet generator configured to generate a segmented droplet of the sample solution surrounded by the oil solution at the second intersection point based on the first flow rate and the second flow rate;
a droplet detector (See “detection region”) connected to the droplet generator, the droplet detector configured to
receive the segmented droplet of the sample solution surrounded by the oil solution from the droplet generator; and
detect a presence of the segmented droplet; and
a nozzle (see “Outlet (hits)”) connected to the droplet detector, the nozzle configured to receive the segmented droplet of the sample solution surrounded by the oil solution from the droplet generator and jet the segmented droplet of the sample solution surrounded by the oil solution from the MDI for SFX, such that SFX occurs on the segmented droplet including the reaction at the first delay.
As to the dependent claims 3-8, 11-16, and 18-20, as noted above the claims do not provide for any further structural elements nor further structure of any prior positively claimed element. See above Claim Interpretations and 112 rejections. Therefore, the claims are rejected.
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.
Claim(s) 2 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cayer et al., US 2021/0107004 as applied above, and further in view of Ros et al. US 202/00363348.
Cayer does not specify that the outlet (nozzle) comprises a gas dynamic virtual nozzle.
The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143).
Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness.
Ros et al. discloses a droplet device that comprises a nozzle 119 that is a gas dynamic virtual nozzle (GDVN) configured to receive pressurized helium gas from a pressurized helium gas source 121. (paragraphs 0022, 31).
It would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to modify the device of Cayer to include a GDVN as a means of dispensing droplets to a desired location as taught by Ros.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Stubbington; Michael John Terry et al.; Ros; Alexandra et al.; Ismagilov; Rustem F. et al.; ABEYWARDANE; Asitha Adrian et al.; WU; George et al.; Link; Darren Roy et al.; Wheeler; Tobias Daniel et al.; Griffiths; Andrew David et al.; ZHOU; Hongbo et al.; Weitz; David A. et al.; Link; Darren R. et al.; Abate; Adam R. et al.; Craig; Frank F. et al.; Bharadwaj; Rajiv et al.; ALIX - PANABIERES; Catherine Michèle Marilou et al.; Ismagilov; Rustem F. et al.; Yurkovetsky; Yevgeny et al.; Laser; Daniel et al.; Abate; Adam R. et al.; Link; Darren R.; Weitz; David A. et al.; Kwon; Sunghoon et al.; Renaud; Philippe et al.; Inoue; Hiroshi et al.; Griffiths; Andrew et al.; and Parce; John Wallace et al. disclose droplet devices and methods of use.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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