DETAILED CORRESPONDENCE
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/17/26 has been entered.
Response to Amendment
With respect to the amended claims, filed on 2/17/26, the previous claim objections are withdrawn. However, new claim objections are entered.
As to the amended claims and remarks, filed on 2/17/26, most of the previous 112b rejections are withdrawn. However, new 112b rejections are entered based on the claim amendments.
Regarding the claim amendments and remarks, and due to the extensive ambiguities (see below), a prior art rejection has been applied as best understood in order to advance prosecution.
Claim Status
Claims 5, 6, 8, 9 are pending. Claims 1-4 and 7 are canceled.
Claim Objections
Claim 5 is objected to.
Claim 5 recites forming “one or more printed circuit” in line 24 where it should read as “the one or more printed circuit” since the printed circuit has already been recited.
Claim 5 recites “wherein where” in line 30 where it the “where” should be deleted.
Claim 5 recites “the one or more printed circuit in adjacent layers and are” in line 34 where the “and” should be deleted.
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.
Claim 5, 6, 8, 9 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 pre-AIA the applicant regards as the invention.
Regarding line 15 of claim 5, the one “or more” microchannel has not been previously recited and has insufficient antecedent basis. Therefore, this limitation is unclear. Further, previously, line 7 recites a singular microchannel, but the microchannel is also described as an alternative and is not actually required. Therefore, it is now unclear whether or not the microchannel is actually required or not, and it is further unclear if applicants are attempting to state that multiple microchannels are present. Line 18 of claim 5 recites a similar limitation and is similarly rejected.
Regarding line 16 of claim 5, the one “or more” hole has not been previously recited and has insufficient antecedent basis. Therefore, this limitation is unclear. Further, previously, line 7 recites a plurality of holes, but the holes are also described as an alternative and are not actually required. Therefore, it is now unclear whether or not the holes or hole is actually required or not, and it is further unclear if applicants are attempting to state that multiple holes are present as in line 7 or if only one hole could be present as in line 16. Line 19 of claim 5 recites a similar limitation and is similarly rejected.
Regarding line 18 of claim 5, the one “or more” space has not been previously recited and has insufficient antecedent basis. Therefore, this limitation is unclear. Further, previously, line 7 recites a singular space, but the space is also described as an alternative and is not actually required. Therefore, it is now unclear whether or not the space is actually required or not, and it is further unclear if applicants are attempting to state that multiple spaces are present.
Regarding lines 18-19 of claim 5, the one “or more” mixing and reaction cavity has not been previously recited and has insufficient antecedent basis. Therefore, this limitation is unclear. Further, previously, line 7 recites a singular mixing and reaction cavity, but the mixing and reaction cavity is also described as an alternative and is not actually required. Therefore, it is now unclear whether or not the mixing and reaction cavity is actually required or not, and it is further unclear if applicants are attempting to state that multiple mixing and reaction cavities are present.
As to claim 5, it is unclear what the alternatives are recited in lines 13-19. Specifically, the claims recited that each layer forms “one or more of” several alternatives. However, it is unclear where the alternatives end. For example, it is unclear if the last two lines that recite that the one or more microchannel and the one or more reaction cavity are connected by one or more holes is one of the alternatives or not. It is unclear if applicants are trying to define each layer here in lines 13-19. In lines 6-8, applicants attempt to describe how each layer is formed with additional potential alternatives, but then in lines 13-19 seem to attempt to only describe a few of the variants in the layers. The alternatives recited in lines 13-19 are not required because they are recited in the alternative in lines 6-8. Due to the multiple and different instances of alternatives, a potential infringer would find it unclear as to whether or not a device read on the claims. If applicants are trying to state that one layer has a microchannel and one layer has a mixing and reaction cavity and that holes in a plurality of layers connect the microchannel and mixing and reaction cavity then the examiner suggests that applicants clearly describe this.
Regarding line 22 of claim 5, “the layer” has not been previously recited and has insufficient antecedent basis because a singular specific layer has not been previously isolated and recited. Therefore, this limitation is unclear. Are applicants referring to a specific layer of the three or more layers, or are applicants referring to each layer? Further, with respect to line 22 it is unclear what “has one or more of the printed circuit” is attempting to state. The printed circuit is the only structure described and it is unclear what other limitations could be “one or more of”. Since the layer is described as having a printed circuit, it is unclear if applicants are stating that there are other features present in the layer aside from the printed circuit or not.
With respect to lines 26-28 of claim 5, it is unclear where the electronic components and spaces are. The limitations in lines 6-8 are reciting these components in the alternative so they are not actually required in the claim. However, lines 26-28 then appear to require the structures. It is unclear to a potential infringer whether these components and spaces are required or not.
Regarding line 34 of claim 5, “the one or more printed circuit in adjacent layers” has not been previously recited and has insufficient antecedent basis. Therefore, this limitation is unclear. Further, previously, line 7 recites a singular printed circuit, but the printed circuit is also described as an alternative and is not actually required. Therefore, it is now unclear whether or not the printed circuit is actually required or not, and it is further unclear if applicants are attempting to state that multiple printed circuits are present. Printed circuits have not been described in adjacent layers, and it is now unclear due to the various conflicting language whether or not a printed circuit is even required, and also unclear whether multiple different layers must contain printed circuits.
Overall, claim 5 is largely unclear was to what components may or may not form the three or more layers. The examiner suggests that each layer be clearly described as to what it includes. Based on the later limitations in lines 21-25 and lines 30-31 the printed circuit (metallized layer), electronic components, and a microchannel all seem to actually be required. However, since they are recited alternatively earlier in the claim then it is unclear. Further, it is unclear if these structures alone for the lab on the chip and it is unclear what the relationship of the layers (functionally and structurally) are with respect to each other. The examiner suggests that applicants clearly describe each of the layers with respect to what structures they include instead of reciting multiple and conflicting instances of alternative language.
As to claims 8 and 9, it is unclear what “any mixing and reaction cavity” of claim 8 and what “the mixing and reaction cavity” of claim 9 is referring to. Specifically, the mixing and reaction cavity has not been positively recited and is recited in the alternative ine lines 6-8. Therefore, a mixing and reaction cavity is not required and it is unclear what “any” or “the” mixing and reaction cavity is referring to. Again, the examiner suggests that applicants clearly describe each of the layers with respect to what structures they include instead of reciting multiple and conflicting instances of alternative language.
Appropriate correction and/or clarification is required. The examiner notes due to the extensive ambiguities within the claim amendments, a potential infringer would be unable to determine the precise configuration of what is attempting to be claimed or understand what would or would not read on the claims. Therefore, a prior art rejection has been applied as best understood in order to advance prosecution.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 5, 6, 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over McCaskill et al (US 20070111353; hereinafter “McCaskill”; already of record) in view of Wei et al (Translation of CN110487873; hereinafter “Wei”; already of record) in view of Pamula et al (US 20060194331; hereinafter “Pamula”; already of record).
As to claim 5, in as much as claimed and as best understood, McCaskill teaches a method of layered manufacturing a lab-on-chip which comprises three or more layers (McCaskill; abstract, Fig. 1. McCaskill teaches in Fig. 2 many different layers and levels so with channels/holes/cavities extending therethrough; Fig. 2, 6-10, 14, 15, 18, 35, 39), comprising the following steps:
Designing the three layers each having a biocompatible substrate and each layer including one or more of: a printed circuit, a mixing and reaction cavity, a microchannel, holes, a space for the placement of electronic components, where each layer has different structures to perform different microfluidic processes and the layers combine to perform analytic functions (McCaskill teaches a PDMS and PMMA microfluidic component; [6, 8, 9], Fig. 1. McCaskill teaches a PCD that is designed and patterned; [7]. All of the surfaces that form the many different layers of Fig. 2 are biocompatible; Fig. 2, [6-10, 12, 17, 18, 23-30]. The combination of various layers forms the biochip);
mechanizing in one or more biocompatible substrates the different voids and passages that will make up the mixing and reaction cavities, microchannels, holes that join the microchannels and spaces for the subsequent placement of electronic components (McCaskill teaches microchannels formed in PDMS or PMMA where the microchannels would have to be formed in some manner; [8,9], abstract. McCaskill teaches that the various layers are connected together, where there are connected via vias, fluidic connections, microvias; Fig. 2, [24-29]);
metallizing via lithography with a biocompatible conductive material those surfaces in which the printed circuit will be integrated according to the design made in the first step (McCaskill teaches lithography and adding gold over electrodes which is biocompatible; [31]);
generating the printed circuit by photolithography of the metallized surface (McCaskill; [7, 31]);
bonding the electronic components in the corresponding spaces; wherein the electronic components are actuators or sensors (McCaskill teaches electrodes or actuators on the device; [10, 22]),
joining all the layers that make up the final laboratory, wherein the metallization is carried out by the adhesion of a pre-elaborated biocompatible conductive material to the biocompatible substrate by means of a resin, wherein the biocompatible substrate/s comprise/s one or more of the following materials: polymethylmethacrylate (PMMA), polyethylene terephthalate (PET), polydimethylsiloxane (PDMS), poly 3,4-ethylenedioxythiophene (PEDOT), copolymer of cyclic olefin (COC), polycarbonate, or silicon (McCaskill teaches that the circuit is bonded via plasma assisted bonding which uses a resin, where the resin is placed on the conductive portion making up the circuit; [7, 32], claim 3, Fig. 1. McCaskill teaches a PDMS and PMMA microfluidic component; [8, 9], Fig. 1).
McCaskill does not teach that all of the components are designed by a computer program. However, Wei teaches the analogous art of fabricating a microfluidics component where CAD is used to initially design the components prior to fabrication (Wei; [15]). It would have been obvious to one of ordinary skill in the art to have designed each of the microfluidic component and the electronic component of McCaskill using CAD as in Wei because Wei teaches that it is well-known to design the components in CAD as an initial step (Wei; [15]).
Although McCaskill teaches using photolithography to form the circuit, McCaskill does not teach using acid attack to form the circuit. However, Pamula teaches the analogous art of printed circuit boards which can be used in microfluidic devices (Pamula; [31]) where the circuit boards include a metallized layer that can be fabricated via a mask followed by etching (Pamula; [47]) and where the circuit board with the metallized layer can be joined to other structures via epoxy or polyimide (Pamula; [53]). It would have been obvious to one of ordinary skill in the art to have used the known fabrication techniques of photolithography and etching of McCaskill to have fabricated the printed circuit using a mask and etching as in Pamula because Pamula teaches that these are well-known fabrication techniques for circuit boards.
As to claim 6, in as much as claimed and as best understood, McCaskill teaches the method according to claim 5, wherein the biocompatible conductive materials are one or more of the following: aluminum, silver, gold, platinum, titanium, ITO, graphene or nitinol (McCaskill teaches adding gold which is biocompatible; [31]).
As to claim 8, in as much as claimed and as best understood, McCaskill teaches the method of claim 5, and where the cavity/channels are formed and span multiple layers (McCaskill; [1, 2], Fig. 2).
As to claim 9, in as much as claimed and as best understood, McCaskill teaches the method of claim 8, and various cavities are formed and where the cavities span multiple layers and are reaction cavities as they are used to detect biological/chemical compositions (McCaskill; [1, 2], Fig. 2).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include:
Lavelle et al (US 20070111353; hereinafter “Lavelle”) teaches biocompatible materials [7, 24, 25] to form various layers (Fig. 1-5) where lithography and etching of metal is used to form a PCB [19-20] and where there are multiple channels, holes and cavities connecting all of the layers (Fig. 1-5) and where various components serve as actuators [43-45].
Perdigones et al (US 20190070603; hereinafter “Perdigones”) teaches a lab on a chip formed of a biocompatible material ([67, 69], claim 11), and includes multiple different layers (Figs. 1-15) and the various layers include a circuit, channels, holes, chambers and actuators [48], and where the various layers are all interconnected (Figs. 1-15).
Response to Arguments
Applicant's arguments filed on 2/17/26 have been fully considered but are moot because the arguments apply to the claim amendments and not the current grounds of rejection. The examiner believes applicants claims are still ambiguous for the reasons noted in the 112(b) rejections above, and the examiner is unable to determine the precise configuration of what is attempting to be claimed. Further, some of applicants arguments are not commensurate in scope with the claim language. For example, applicants argue on page 8 of their remarks that the microchannels in adjacent layers are connected; however, nowhere in the claims is this recited in a clear manner. The examiner notes that a prior art rejection has been applied as best understood in order to advance prosecution
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571)272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
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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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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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