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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first actuator coupled to the at least one substrate as in cl. 1, at least one processor electrically coupled to the recited chambers as in cl. 1, a plurality of substrates arranged in a stack such that the claimed chambers are configured to be rotated as in cl. 2, at least one heater coupled to the at least one substrate and at least one temperature sensor coupled to the at least one substrate and the at least one heater and at least one temperature sensor electrically coupled to the at least one processor as in cl. 3 must be shown.
Examiner notes that fig. 1 provides a high-level schematic drawing that includes general boxes to the first actuator, heater, and temperature sensor, however, such high-level schematic drawing does not show the features as claimed herein. Examiner further notes that fig. 4 provides the closest drawing to these elements, however, the first actuator 145 and at least one processor 202 are not shown in the constitution as claimed, notably with respect to the chambers and the substrate 120* (further noting that numerical identifier ‘120’ to the substrate is missing from the drawing, and likewise as in fig. 5 in which such figures appear to be intended places for showing such substrate ‘120’).
Further, fig. 2 provides a high-level schematic that includes processor(s) 202, however, such at least one processor is not shown as claimed and is absent particular coupling to the at least one substrate and chambers, and is instead shown schematically with connection to a communication bus 212 and various other electronics.
Fig. 4 and the discussion thereof in par.[0041] of Applicant’s disclosure as seen through US 2024/0269671 purports to show a plurality of substrates ‘120,’ however, the explicit showing of substrate ‘120’ is absent, and further, a clear showing of a plurality in a stack arrangement as recited in claim 2 is not shown.
Further, the mutant detection circuit on a rotatable substrate arranged in the housing and disposed beneath the at least one substrate as recited in claim 6 must be shown.
Examiner notes that fig. 6 shows a mutant detection circuit in isolation and wherein such figure provides a showing that is not disc-shaped to the “rotatable” aspect claimed and commensurate with the prior showings in figs. 3-5.
Further, fig. 6 is without the rotatable substate (that is claimed as a separate and distinct element from that of the at least one substrate), and without showing of its disposition beneath the at least one substrate.
Further, the electromagnet coupled to the at least one substrate and electrically coupled to the at least one processor as in cl. 7 must be shown.
As likewise discussed above, the high-level schematic of fig. 2 does not show such electromagnet in the fashion as recited herein.
Further, the plurality of pumps and reservoirs disposed within the housing and in fluid communication as recited in claim 8 must be shown.
As likewise discussed above, the high-level schematic of fig. 2 does not show such pumps and reservoirs in the fashion as recited herein.
Further, the at least one substrate having a reagent embedded in at least one of the plurality of wells and the microfluidic device comprising at least one pressure-based actuator or electrostatic actuator configured to seal a wetted-area on the paper substrate as in claim 11 must be shown.
The above features must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. This is likewise seen with respect to the method of claim 14 and dependents thereof that impart the recitation of claim 1 and likewise recitations as discussed above.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim 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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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) is/are:
1) A first actuator…configured to rotate the at least one substrate within the housing as in cl. 1
2) A second actuator…configured to rotate the recited chambers relative to the top surface of the at least one substrate as in cl. 1
3). A pressure-based actuator or electrostatic actuator configured to seal a wetted-area as in cl. 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
1) Unclear from the disclosure. *see rejection under 35 USC 112 b/2nd below.
2) Unclear from the disclosure. *see rejection under 35 USC 112 b/2nd below.
3. Unclear from the disclosure. *see rejection under 35 USC 112 b/2nd below.
If applicant does not 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 may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 discussed above, 1) A first actuator…configured to rotate the at least one substrate within the housing as in cl. 1, 2) A second actuator…configured to rotate the recited chambers relative to the top surface of the at least one substrate as in cl. 1, and 3). A pressure-based actuator or electrostatic actuator configured to seal a wetted-area as in cl. 11 are construed under 35 USC 112 F/6th as providing generic placeholders in that of “actuator” followed by functionality and absent sufficient recitation to the structure(s) to perform the recited functions.
The metes and bounds of the constituent structure(s), and equivalents thereof, for each of the recitations 1)-3) are indefinitely defined herein.
The specification does not remedy this as the specification merely discusses these elements in a likewise fashion that is generalized and without discussion to the particular structure(s) afforded to such elements to carry out their recited functionalities.
This is seen through pars.[0005,0042-0043,0053,0056,0058,0068,0073] of Applicant’s pre-grant publication US 2024/0269671.
With respect to the second actuator this is the only one of the three elements that has a visual depiction (beside the schematic block afforded to the “first actuator” in fig. 2).
However, the cylinder 150 (“second actuator”) as presented in fig. 4 does not appear to afford functionality to rotate the claimed chambers (seen as 130, 135, 140) as the cylinder has a matching contour to the inner surfaces of such chambers that does not afford the ability to affect a rotation of the chambers. Further discussion in the disclosure is not seen with respect to this second actuator and the structure(s), connecting element(s), or the like that afford such rotation of the chambers as claimed.
Further, as in cl. 11, the recitation “pressure-based” in and of itself presents indefinite metes and bounds. It is unclear what constitutes pressure-based, and the specification does not rectify this with a particular definition thereto.
Does Applicant intend to recite a “pressure actuator?” (Examiner assert that the above-discussed issues of clarity with respect to the structural constituency of the pressure actuator would remain, and this recitation would merely remove the indefinite nature of the -based qualification).
Claim 6 is 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.
The metes and bounds to the configuration of the mutant detection circuit are indefinitely defined with respect to its ability to receive a solution as in “Reverse Transcriptase/Polymerase” in which the forward slash notation calls into question what is being positively set forth by the claim.
Further, the recitation presents a range within a range recitation.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation polymerase, and the claim also recites reverse transcriptase (i.e. a species of polymerase as in an RNA-dependent DNA polymerase) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 10 is 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.
The metes and bounds of the designed geometry(ies) that afford the recited functionality of controlling thermal flux around the plurality of wells are indefinitely defined herein.
Applicant’s specification does not remedy as this as the disclosure is absent particular discussion thereto such “geometry(ies)” that afford such functionality. See par.[0034] which provides a general prophetic discussion thereto.
Claims 14-20 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.
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the particular wire material and, accordingly, the identification/description is indefinite. See as discussed below with respect to claims 14, 15, 18, and 19.
Examiner notes that the nomenclature “SYBER Green” is not recognized as a term of art and it appears that Applicant intends this as “SYBR Green,” wherein this is a registered trademark of Molecular Probes Inc./Thermo Fischer Scientific. This is found in claims 14, 15, 18, and 19.
Does Applicant intend to claim an asymmetrical cyanine dye?
With regard to claim 15, the metes and bounds of the lysis buffer are indefinitely defined given the usage of the forward slash notation with respect to “…Acetate/pH 4.” Does Applicant intend to positively provide the pH of 4?
Further, the notation in the last paragraph of claim 15 to “(New England Biolabs”) provides unclear metes and bounds to the sought thermopool buffer. Designation of a place of manufacture or producer is improper and does not provide clear metes and bounds to the claim.
Applicant is invited to claim the particular buffer desired as likewise to the above discussion with respect to “SYBER [SYBR] Green” this appears to be a trademark registered to New England Biolabs.
With regards to claims 14-20, the provision to depositing at least one aqueous droplet after the “collecting” step is indefinitely provided herein.
The claimed “air-handling and precipitation chamber” is not provided with any further functionality and/or structure beyond that of a chamber (‘air handling and precipitation’ are nominal descriptors) that affords any liquefication/conversion of the airborne virus or bacterium to an aqueous droplet. This is likewise seen
Further, the general provision to “magnetic beads coupled to vRNA or pathogen DNA…” alongside a general provision to “collecting a virus or bacterium…” presents indefinitely defined metes and bounds to the claims.
Herein, it appear Applicant intends to provide a particular or target virus/bacterium, and providing a complementary sequence of vRNA to the particular virus or a complementary sequence of pathogen DNA to the particular bacterium.
Further, the final step of “determining…whether the [particular/target] virus or bacterium is present…based on either fluorescence of Sybr Green Dye Tm or affinity probes is indefinitely set forth.
The claims are absent prior provision to seeding a particular well with Sybr Green Dye TM or affinity probes, as well as the subsequent optical detection of the fluorescence in order to provide the basis for the processor to make such a determination. It appears Applicant intends to provide these steps subsequent to this “determination” step.
This is seen in claims 14, 17, 18, and 19 and relatedly within claims 15, 16, and 20.
Lastly, the recitation to “based on Sybr Green Dye TM or affinity probes” presents a range within a range.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, the claims recite the broad recitation affinity probes, and the claim also recites Sybr Green Dye TM which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Allowable Subject Matter
Claims 1-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, namely Zilch et al. (WO 2011/003941), Wu et al. (WO 2017/176970), and Pletcher et al. (US 2007/0186696), does not teach or fairly suggest a microfluidic device as recited in claim 1, which includes at least one substrate having a through-slot extending radially between a central axis and an outer edge of the at least one substrate, a second actuator coupled to and configured to rotate the air-handling and precipitation chamber, the reagent and reaction chamber, and the detection chamber relative to the top surface of the at least one substrate, and at least one processor electrically coupled as claimed.
Zilch discloses a device for detection of harmful biological agents in an air sample and comprises an amplification unit as a rotatable disc, which is rotatable by a first actuator, having a plurality of wells, a particle concentration unit that collects particles from the air sample and provides them as a liquid sample, a liquid collection chamber with magnetic beads capable of binding polynucleotides, and a dispensing unit and detection unit.
Wu discloses a device for aerosol collection and detection comprising a rotatable substrate with a through slot for accessing other substrates located below.
Pletcher discloses a self-wetting aerosol particulate wet collector apparatus in which the particle collection system comprises a rotatable disk in connection with a hollow tube that receives liquid near the first end thereof wherein incoming airborne particles within the air duct are deposited in the liquid on the flat surface of the rotatable disk, and wherein the collected liquid with deposited particles may then be transferred to a particle collection or analysis device.
However, none of Zilch, Wu, and Pletcher, alone or in combination, fairly suggest the claimed microfluidic device with the combined features of at least one substrate having a through-slot extending radially between a central axis and an outer edge of the at least one substrate, a second actuator coupled to and configured to rotate the air-handling and precipitation chamber, the reagent and reaction chamber, and the detection chamber relative to the top surface of the at least one substrate, and at least one processor electrically coupled as claimed.
Further, the prior art of record, namely Zilch, Wu, and Pletcher, does not teach or fairly suggest a method of claim 14 at least for the above reasons as claim 14 positively imparts the particular structure to that of the microfluidic device of claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pletcher et al. (US 2007/0186696) discloses a self-wetting aerosol particulate wet collector apparatus in which the particle collection system comprises a rotatable disk in connection with a hollow tube that receives liquid near the first end thereof wherein incoming airborne particles within the air duct are deposited in the liquid on the flat surface of the rotatable disk, and wherein the collected liquid with deposited particles may then be transferred to a particle collection or analysis device, which is relevant to Applicant’s field of endeavor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NEIL N TURK/ Primary Examiner, Art Unit 1798
Prosecution Insights