DETAILED ACTION
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
Newly submitted claims 21-25 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
In response to the election restriction of 28 August 2025, group II towards the method of manufacture and species II directed to the specific method of manufacture was elected without traverse (fig. 34). Claims 21-22 are directed towards further limitations with respect to the structure of the tip (i.e. orientation of channels of the tip), thus not directed towards any step of manufacture in the elected species. Claim 23 is directed towards shearing and polishing the sample probe opening to be configured to be brought in contact with the sample. Shearing and polishing are directed towards species I non-elected without traverse (see paragraphs [0160] and [0163] of the published application). Claims 24-25 are directed towards the diameter of the wire and the material of the wire, which belong to species I non-elected without traverse (see, paragraph [0160] discussing the material and diameter of the wire with reference to the first method 200 of figure 33 (i.e. species I non-elected without traverse)).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-22 and 24-25 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: method steps 202-218 of figure 33 and 302-312 of figure 34. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Rejections - 35 USC § 112
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.
Claims 16-20, 26 and 27 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.
Claim 16 has been amended to recite “forming, by shearing and polishing an edge of the thermoplastic sheet, a tip”. Specifically, the shearing and polishing is directed towards a nonelected invention of figure 33 (see paragraph [0160]). The second claimed embodiment does not require any shearing or polishing as indicated in paragraph [0161] and figure 34.
Since the second method of manufacture (figure 34) does not suggest any step of forming the tip by shearing and polishing, claim 16 fails to meet the written description requirement under 35 USC 112(a).
MPEP 2163 (I) (B) recites: “New or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement.”
Here, in the elected species, there is no support for shearing and polishing to form a tip. Instead, figure 34 is silent with respect to forming the tip and instead discloses a method of forming probes via the method of paragraph [0161]. In other words, there is no evidence to support that the applicant was in possession of the manufacturing process of figure 34 with an additional shearing and polishing step as required by the claim.
Claims 17-20, 26 and 27 fail to meet the written description requirement by virtue of their dependencies on rejected claim 16.
Claim 26 further lacks written description for “cutting the thermoplastic sheet to separate the plurality of systems into individual probes”. Specifically, the specification is silent with respect to separating the system into individual probes. Indeed, paragraph [0161] of the published application suggests that the probes are aligned with the MS inlet suggesting that the probes are not separated into individual probes. Additionally, paragraph [0161] points to figure 25, Paragraph [0057] additionally teaches figure 25G teaches positioning a single thermoplastic sheet and aligning a plastic probe at the MS inlet. Further suggesting no support for separating the individual probes.
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.
Claims 16-18 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US pgPub 2016/0168617) (submitted with IDS of 08/29/2023) in view of Kumar et al. (submitted with the office action of 03 September 2025) and further in view of Bajic (US pgPub 2021/0210320)
Regarding claim 16, Yang teaches a method for fabricating a system for analyzing a sample (as seen in figure 26a) the method comprising:
forming a tip (fig. 26a shows a hybrid T-probe where a tip is formed at sampling tip is 448) having;
i. a sampling port (fig. 26a, 450) that defines an opening at which a primary solvent channel (446 is at the solvent supply see paragraph [0106]) and a spray channel (444 to 454 which is at the emitting tip 452 of the ESI thus a spray channel) intersect at a fixed orientation (fixed orientation of 444 and 446 seen in figure 26a to intersect at 450), and
ii. A nanospray emitter (452) in fluid communication with the spray channel (452 in communication with 444).
Yang differs from the claimed invention by not disclosing how the channels are formed.
However, Yang teaches with respect to figure 25b or 25c, disposing a capillary or metal in a predetermined position (T-shape see paragraph [0103]. See paragraph [0104] for metal template);
disposing a thermoplastic sheet against the fused capillary or metal template ([0103] T-shaped capillary placed polycarbonate sheet and sandwiched between two glass sheets (i.e. the thermoplastic sheet is disposed on the fused capillary), [0104] modifies 0103 by substitution of metal template); and
imprinting the capillary into the thermoplastic sheet, thus forming the system ([0103] or substitution with template see paragraph [0104]).
Yang modifies figure 26a by suggesting how to fabricate different channels.
Since both figures are directed towards fabricating spray and solvent channels, it would have been obvious to one of ordinary skill in the art to fabricate the channels of figure 26 in a similar manner to that of figure 25 because it would resolve the issue of how to fabricate at least a portion of the channels suggested in figure 26a.
Yang teaches a fused capillary or other template (see paragraph [0104] made of metal) and therefore fails to disclose the use of a metal wire.
However, Kumar teaches using a copper wire to form a microchannel (see abstract).
Since both inventions are directed towards microfluidic devices, it would have been obvious to one of ordinary skill in the art to use a slender copper wire instead of the silica capillary or as the metal template of Kumar because the silica capillary is likely to break and the copper wire has higher strength, flexibility and good surface properties (see page 222, right column, second paragraph), thus avoiding dangers of breaking the glass capillary (i.e. damage to the device or fingers of the operator performing the fabrication process) and providing more choices of different geometries of the microfluidic device (see conclusions section). Alternatively, using the copper wire as a template is advantageous because of it’s easy availability, flexibility and non-reactive nature (see section 2.3)
Yang in view of Kumar suggest fabricating a system with a tip using a copper wire, however Yang fails to expressly suggest how the tip is manufactured to achieve the flat cut tip as illustrated in figure 26b. That is, figure 26A merely shows the tip 448 exists, therefore fails to disclose forming, by shearing and polishing an edge of the thermoplastic sheet, the tip.
However, Bajic teaches forming, by shearing and polishing an edge of the thermoplastic sheet, the tip ([0013], note first and second conduits may be substantially coterminous by simultaneously grinding, polishing and/or cutting the tip wherein the nebulizer (i.e. including tip) is formed of a polymer or plastic material e.g. PFA which is a known thermoplastic).
Bajic modifies the combined device by suggesting an additional cutting and polishing of the tip of the ESI source.
Since both inventions are directed towards the fabrication of an ESI source, it would have been obvious to one of ordinary skill in the art to shear and cut the thermoplastic of Yang in view of Kumar as suggested by Bajic because it would allow for a coterminous outlet at the tip which is desired by Yang (see figure 26b).
Regarding claim 17, Yang further teaches wherein the molded metal wire is imprinted into the thermoplastic sheet via a hot press (press seen in figure 25b and discussed in paragraph [0103])
Regarding claim 18, Yang et al. teach a step of aligning the system at a mass spectrometer inlet (fig. 1 shows the probe system 120 aligned with inlet 112 of the mass spectrometer).
Regarding claim 27, Yang in view of Kumar teach wherein disposing the at least one metal wire in the predetermined position comprises arranging the at least one_metal wire on a template defining a probe pattern (Yang, paragraph [0104] teaches model of a metal template, thus requiring arranging wire along a pattern, as modified by Kumur to suggest a wire).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Kumar in view of Baji and further in view of Pu et al. (Pu et al., “On-Chip Micropatterning of Plastic (Cyclic Olefin Copolymer, COC) Microfluidic Channels for the fabrication of Biomolecule Microarrays Using Photografting Methods”, Langmuir, 2007) (copy of publication submitted with the office action of 03 September 2026)
Regarding claim 19, the combined device fails to disclose a plurality of copper wires.
Pu is further evidence that COC permits easy replication of micrometer features by embossing or molding techniques hold the promise for the mass production of disposable microfluidic sensors (see introduction). Kumar teaches copper wires (see discussion above). However, the combined device fails to disclose the metal wires comprise a plurality of metal wires.
Since Pu envisioned mass production of microfluidic sensors and the plates may be cut into the desired sizes (page 1579, left column under “fabrication of COC plates and microfluidic chips), it would have been obvious to one of ordinary skill in the art to place two or more wires on the COC plate to be pressed by glass substrates because it would allow for the manufacture of multiple microfluidic chips during a single process therefore improving throughput of the fabrication process by generating multiple channels on a single chip.
Regarding claim 20, Yang in view of Kumar in view of Baji and further in view of Pu further teaches wherein the thermoplastic sheet includes a cyclic olefin copolymer material (Pu, page 1579, left column under section “fabrication of COC Plates and Microfluidic chips”, note it would have been obvious to use COC instead of the polycarbonate of Yang because of its easy replication of micrometer features).
Relevant art:
US20210325351 teaches in figure 6 an integrated probe with a solvent channel and a spray channel.
Conclusion
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).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881