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 .
Request for Information under 37 CFR 1.105
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
Claim Interpretation
The recited “segment of liquid buffer” in claim 1 (and likewise to “segment of liquid buffer material” in claim 11) is given to a hydrogel and is not a liquid buffer, wherein it appears that the recitation is drawn to an improper translation of prior language. This is seen from par.[0057] of Applicant’s pre-grant publication US 2024/0210391 in which such terminology of “segment of liquid buffer” in claim 1 (and likewise to “segment of liquid buffer material” in claim 11) is drawn to Applicant’s own lexicography and is defined as being a hydrogel.
Claim Objections
Claim 16 is objected to because of the following informalities: The claim 16 recites in parentheses “streptavidin” that appears to be redundant to the prior recitation and an inadvertent inclusion. Appropriate correction is required.
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 1-19 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.
The metes and bounds of the sought device for detecting airborne pathogens as in both of independent claims 1 and 11 are indefinitely defined.
Initially, the structural/functional arrangement of the recited screening test piece (thereafter referred to in the claims as ‘test piece’) is indefinitely defined herein.
Both claims provide that this ‘test piece’ includes a carrier substrate on which at least those elements (sample collection area, segment of liquid buffer, conjugate pad, and test/control color detection zone) are listed.
Initially, Examiner asserts that it appears the language is missing a recitation to particularly bring together the initial “on which” recitation as to their structural disposition to the carrier substrate. For example, does Applicant intend to provide something on the order of “…are disposed”?
Further, the recitation that follows is drawn to a parts listing of 1) sample collection area, 2) segment of liquid buffer, 3) conjugate pad, and 4) test/control color detection zone, wherein such a parts listing provides indefinite metes and bounds as to the structural/functional relationship of the elements that form the operative device for its recited functionality of a screening test piece for airborne pathogens.
For example, Examiner notes fig. 2 as showing the mask connected with the carrier plate 13 (i.e. ‘carrier substrate’).
For example, does Applicant intend to provide particular fluid communication of the elements and their relative proximity to one another from the mask and its exit point (i.e. mouthpiece; wherein the sample pad is located closest thereto and subsequently further downstream as in the segment of liquid buffer, conjugated pad, and test/control detection zone).
It is also noted that the “segment of liquid buffer” (and likewise to “segment of liquid buffer material”) is given to a hydrogel and is not a liquid buffer as such recitation appears to be drawn to an improper translation of prior language. This is seen from par.[0057] in which the hydrogel acts as a block to liquid and absorbs the sample liquid up until swelling to a point at which the hydrogel expands to bridge the gap 4 to provide fluid communication with the conjugate pad.
With regard to the recited “test/control color detection zone,” the recitation is indefinitely understood.
Initially, utilizing the slash provides indefinite nature as to what zone or number thereof are provided. It appears that Applicant intends to claim a test zone and a control zone, and if so, should recite each zone individually. If Applicant desires to claim one of a test zone and a control zone than such language should be utilized in lieu of the “/.”
Further, with regard to the test/control color detection zone, Examiner asserts that this element being on the carrier substrate is indefinitely understood as a test/control color detection zone provide a recitation to a designation of space (given by zone) and does not constitute a physical, structural element. Are these zones provided by structure(s) on the carrier substrate?
With regard to claim 1, the structure of the mask is indefinitely defined herein.
Applicant’s recitation to the structure being set forth with respect to “is designed to provide…” is predicated on a series of prospective process steps in an intended use application with a user that have no particular bearing to the claimed device and which do not set forth clear metes and bounds to the structural arrangement of the mask.
Further, the recitation of “…to provide a droplet concentration unit aimed at the user’s mouth” is further not understood in the context of providing further structure to that already incurred by usage of the term “mask”. Is this “accommodation unit” an actual, physical component of the mask that is provided in a particular position thereof, or is this merely an inferential reference and re-naming of the mask?
Applicant should clearly set forth the positive structure(s) that constitute the confines of the mask and any functionalities correlated thereto as desired.
This is further seen through dependent claim 2, in which particulars to the droplet concentration unit, in which, as previously discussed above in claim 1, its initial positive inclusion to the device (and further, to specifically that of the mask) is indefinitely provided. Herein, for example, how is the C-shaped mouthpiece structurally/functionally related to the mask?
Claims 1 and 11 recite the limitation “the target pathogens,” "the inner surface of the mask" (in claim 1 only) and “the structure of the mask” (in claim 1 only). There is insufficient antecedent basis for this limitation in the claim.
With respect to “the target pathogens,” Examiner notes that the claims previously recite “airborne pathogens,” and Applicant appears to desire to link this terminology.
Applicant should establish the desired structure and inner surface of the mask so as to then reference such element in setting forth the placement of the test piece.
Further, “the structure” lacks antecedent basis, and Applicant may intend to provide a recitation to the structure itself in lieu of the present “the structure is designed to…” (noting that changing to “a structure” would literally avoid the antecedent basis issue, but remains to provide a recitation that goes down a path that may provide indefinite metes and bounds thereto).
Claims 3 and 12 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.
The metes and bounds of the device are indefinitely defined by the recitation “the liquid buffer segment selected from hydrogel…”
Initially, the recitation “the liquid buffer segment” lacks proper antecedent basis in both of claims 3 and 12. Claim 1, from which claim 3 depends, initially sets forth “a segment of liquid buffer,” and claim 11, from which claim 12 depends, sets forth a “segment of liquid buffer material.” Applicant should utilize concordant, parallel language within claims 3 and 12.
Further, “the other end” as in claims 3 and 12 lacks proper antecedent basis in which Applicant has not particularly set forth such ends to the hydrogel. Does Applicant intend to recite that “another end…” or initially set forth the hydrogel comprising first and second ends?”
Further, the recitation “selected from” is indefinitely understood as Applicant has not provided a group of alternative choices as is implied by the use of selected from, and instead presents “hydrogel.”
Does Applicant intend to recite that the “segment of liquid buffer/material” is a hydrogel?
Examiner further notes from Applicant’s disclosure to “segment of liquid buffer/material” is Applicant’s own lexicography and such terminology is defined to be a hydrogel (see par.[0057]), in which the specification does not discuss other options.
Clarification is required.
Claims 4-7, 13-16 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.
Claims 4-7 and 13-16 recites the limitation "the screening test piece production program," which lacks proper antecedent basis in the claims. Claim 1 recites “a screening test piece” that is drawn a device as in the included carrier substrate recited therein.
The metes and bounds of the sought device as in claims 4-7 and 13-16 in constitution with the recited “screening test piece production program" are indefinitely understood.
The statutory class of invention presented is drawn to a device and the recitations in claims 4-7 do not appear to provide further structure or structural definition to the device, wherein the recitation “on the carrier substrate” does not appear as a structural definition, but instead, as the place at which the recited methodology occurs.
The claims further recite at the conclusions thereof “thus completing the screening test piece,” which is not understood in terms of providing further structure or structural delineation to the test device and its test piece itself as the preceding recitations are drawn to method steps that have no bearing in the device claims.
Further, the steps themselves are codified in narrative discussion in parts that render the steps themselves unclear in their metes and bounds.
Further, as discussed above, the methodology references structural terminology that does not have antecedent basis in the claimed device.
The claims appear to provide a switch of statutory class of invention from a device to a method and should be canceled or clarified in terms of added structure or structural detail to be given to the device form which they depend.
Further, claim 4 recites “the nitrocellulose membrane substrate”, “the test line”, “the control line”, “the same time,” “the control aptamer,” “the aptamers combined with gold nanoparticles” and “the other for the aptamer-modified gold nanoparticles,” which lack proper antecedent basis in the claim.
Claim 5 recites “the nitrocellulose membrane substrate”, “the test line”, “the control line”, “the aptamer for capture,” “the biotinylated aptamer,” “the target pathogen,” “the right end of the nitrocellulose membrane,” “the sample,” “the aptamer for detection,” “two options for the aptamer…”, which lack proper antecedent basis in the claim.
Claim 6 recites “the nitrocellulose membrane substrate,” “the control line,” “the right end of the nitrocellulose membrane substrate,” “the sample,” “the test line,” “the extract (appears intended as extract compound),” “the extracted target analyte,” “the highly specific aptamer,” which lack proper antecedent basis in the claim.
Claim 7 recites “the nitrocellulose membrane,” “the control line,” “the target pathogen,” “the test line,” “the right end of the nitrocellulose membrane substrate,” “the sample,” “the aptamer-modified gold nanoparticles,” “the spike protein,” “the sample collection layer,” “the detection area of the conjugate pad,” which lack proper antecedent basis in the claim.
Claim 10 recites “the aptamers specific to the target analytes of the pathogens,” which lacks proper antecedent basis in the claim.
Claim 13 recites “the carrier board,” “the nitrocellulose membrane substrate,” “test line,” “the control line,” “the biotinylated aptamer,” “the target pathogen,” “the complementary DNA fragment,” “the control aptamer,” “the right end of the nitrocellulose membrane substrate,” “the sample,” “the aptamers combined with gold nanoparticles through thiolation,” “the aptamer-modified gold nanoparticles for control,” “the other for the aptamer-modified gold nanoparticles for detection,” which lack proper antecedent basis in the claim.
Claim 14 recites “the nitrocellulose membrane substrate,” “the test line,” “the control line,” the aptamer for capture,” “the biotinylated aptamer,” “the target pathogen,” “the right end of the nitrocellulose membrane,” “the aptamer for detection,” “two options for the aptamer,” “the same as the aptamer for capture,” “the other is different from the aptamer for capture,” “the aptamer is thiolated with gold nanoparticles,” “the aptamer-modified gold nanoparticles,” which lack proper antecedent basis in the claim.
Claim 15 recites “the test line,” “the nitrocellulose membrane substrate,”, “the control line,” “the right end of the nitrocellulose membrane substrate,” “the extract,” “the extracted target analyte,” which lack proper antecedent basis in the claim.
Claim 16 recites “the nitrocellulose membrane substrate,” “the control line,” “the target pathogen,” “the test line,” “the body,” “the right end of the nitrocellulose membrane substrate,” “the aptamer-modified gold nanoparticles,” “the spike protein,” which lack proper antecedent basis in the claim.
Claim 17 recites “the pathogen,” which lacks proper antecedent basis in the claim.
Claim 19 recites “the aptamers,” and “the target pathogen,” which lack proper antecedent basis in the claim.
Claims 10 and 19 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.
The metes and bounds of the sought aptamers are indefinitely defined herein.
While the claim sets forth “the aptamers specific to the target analyte of the pathogens are selected from one of…” the listing that follows is not drawn to various aptamers.
This listing that follows is drawn to various elements such as in virulent components, such as with ManLAM, in which it is known that aptamers are used to bind to such a virulent component.
Does Applicant intend to set forth recitations with respect to the prospective pathogens and particular virulent components thereof? To this end, Examiner further makes mention that the claims are drawn to a device in which the pathogens/their particular virulent components are not a positively claimed element of the device, while “at least one kind of aptamer-modified gold nanoparticle” is a positively recited element.
Clarification is required.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 11-19 as best understood, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kamei et al. (US 2019/0187140), hereafter Kamei.
Kamei discloses a hydrogel platform in lateral flow assay strips (abstract). With regard to claim 11, Kamei discloses a detection test strip, the test strip includes carrier substrate (adhesive vinyl backing; see fig. 1A) on which at least a sample collection area (par.[0241],sample pad, and wherein such sample pad may be provided with reagents as to an extract or lysate, such as in surfactants/Triton X-100, Tween 20, buffers as in PBS, HEPES, Tris, proteins as in albumin, etc…and further discloses pre-soaking and drying thereof; see also fig. 1A, for example), pre-soaked or dripped into the extraction solution, and allowed to dry into a dry extraction compound (wherein Examiner notes that the claim recitation is drawn to a sample collection area, wherein the recitations to “pre-soaked or dripped into…and allowed to dry into…” are drawn to process recitations not afforded patentable weight in the device claim). Kamei further discloses a segment of liquid buffer material (hydrogel, par.[0241fig. 1A, for example), a conjugate pad provided with at least one kind of aptamer-modified gold nanoparticles specific to the target pathogens (pars.[0160-0161,0169,0244,0304] , fig. 2, for example), and a test/control color detection zone (see fig. 2 and the at least two layers of the detection component).
With regard to claim 12, Kamei discloses the liquid buffer segment is selected from hydrogel, as discussed above, and wherein one end of the hydrogel is connected to the sample collection area (see fig. 1A) and the other end is kept in a gap with the conjugate pad without contact (see fig. 1A and 2 wherein the hydrogel is in contact with the sample collection area and another end of the hydrogel is kept at a gap with the conjugate pad without contact as such conjugate pad is separate downstream therefrom. Examiner further notes that the recitation to “after a period of liquid sample collection time…” is drawn to conditional process recitations that are not afforded patentable weight in the device claim.
With regards to claims 13-16, the recitations are drawn to process recitations not afforded patentable weight in the device claims.
With regard to claims 17 and 18, the pathogen and including the prospective source as in breath condensate, exhaled aerosol, are drawn to an intended workpiece not afforded patentable and is not a positively claimed element of the device. The commensurately structured and arranged device as in Kamei is fully capable of such for such a pathogen as recited herein (see also par.[0074] to target analytes as in bacterium, protozoan, virus, etc…).
With regard to claim 19, the recitation “the aptamers specific to the target analyte of the pathogens are selected from one of…” is a listing that is not drawn to various aptamers. The listing that follows is drawn to various elements such as in virulent components, such as with ManLAM, in which it is known that aptamers are used to bind to such a virulent component. Examiner asserts that the claims are drawn to a device in which the pathogens/their particular virulent components are not a positively claimed element of the device, and as the claim herein does not present particular aptamers to that of the generally, prior-claimed “at least one kind of aptamer-modified gold nanoparticles,” Examiner asserts that Kamei likewise provides such at least one kind of aptamer-modified gold nanoparticles as claimed and wherein the virulent components are drawn to intended workpieces that are not afforded patentable weight and are not positively claimed elements of the device.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-10, as best understood, are is/are rejected under 35 U.S.C. 103 as being unpatentable over Kamei in view of Daniels (US 2021/0325381) and Meka et al. (USPN 8,002,713), hereafter Meka.
Kamei has been discussed above as in claims 11-19.
With regard to claim 1, as it pertains to the subcombination of cl. 11, Kamei discloses those particulars thereof as discussed above, but does not particularly disclose that the test piece is set on the inner surface of a mask.
With regard to claim 2, Kamei does not disclose that the droplet concentration unit includes a C-shape mouthpiece and a hydrophobic layer as claimed.
Claims 1-10 are otherwise akin to that of claims 11-19 discussed above with respect to Kamei aside from the added feature of the test piece being set on the inner surface of a mask of claim 1 and the particulars of the mask as in cl. 2
With respect to claim 3, Examiner references the above discussion to Kamei as in cl. 12.
With respect to claims 4-7, With regards to claims 13-16, the recitations are drawn to process recitations not afforded patentable weight in the device claims.
With respect to claims 8 and 9, the pathogen and including the prospective source as in breath condensate, exhaled aerosol, are drawn to an intended workpiece not afforded patentable and is not a positively claimed element of the device. The commensurately structured and arranged device as in Kamei is fully capable of such for such a pathogen as recited herein (see also par.[0074] to target analytes as in bacterium, protozoan, virus, etc…; and further notes, though not positively required herein, the cited art to Daniels is drawn to EBC and with respect to COVID-19, for example).
With regard to claim 10, the recitation “the aptamers specific to the target analyte of the pathogens are selected from one of…” is a listing that is not drawn to various aptamers. The listing that follows is drawn to various elements such as in virulent components, such as with ManLAM, in which it is known that aptamers are used to bind to such a virulent component. Examiner asserts that the claims are drawn to a device in which the pathogens/their particular virulent components are not a positively claimed element of the device, and as the claim herein does not present particular aptamers to that of the generally, prior-claimed “at least one kind of aptamer-modified gold nanoparticles,” Examiner asserts that Kamei likewise provides such at least one kind of aptamer-modified gold nanoparticles as claimed and wherein the virulent components are drawn to intended workpieces that are not afforded patentable weight and are not positively claimed elements of the device.
Daniels discloses an apparatus for detecting a biomarker comprising a droplet harvesting structure for converting breath vapor to a fluid droplet (abstract). Daniels shows in fig. 13 an exhaled breath condensate (EBC) droplet sample collector applied to a later flow assay testing system (test strip with carrier on which a sample pad, conjugate release pad, test zone, control zone, absorbent pad are provided), and in which a hydrophobic field is provided for receiving body fluid vapor and forming a fluid droplet from the received body fluid vapor and the hydrophilic channel is for receiving the fluid droplet and channeling the fluid droplet towards the LFA testing system (pars[0147,0148,0150,0151,0154,0155], figs. 13-15), and further discloses application therewith in wearable garment as in a face mask (pars.[0054,0094,0164,0168,0169], figs. 29, 38-41]).
Meka discloses a breath and breath condensate analysis system (abstract). Meka discloses providing a C-shaped mouthpiece 19 (C-Shaped given the curvature and correspondence to a person’s mouth, which is likewise to that of Applicant’s discussion thereto) for delivering breath/breath condensate to a sensor element for analysis thereof and including a condensing element 52 (lines 46-57, col. 4, figs. 1A,B, for example).
It would have been obvious to one of ordinary skill in the art to modify Kamei and its test piece to be utilized within an inner surface of a mask and a droplet concentration unit comprising a C-shaped mouthpiece and a hydrophobic layer surrounding the sample collection area such as taught by the analogous art of Daniels to that of a lateral flow assay arrangement for sensing pathogens such as a virus and to that of analogous art of Meka (to the C-shaped mouthpiece in particular) in that of sampling a user’s breath and analyzing such for biomarkers pertaining to health indicators in which such a modification affords an integrated arrangement that suitably and effectively concentrates a user’s sample in droplets through the hydrophobic layer in constitution with the sample collection area and may be effectively conveyed thereto with a conformably-shaped mouthpiece, in which the arrangement is wearable by a user for portable, field-of-use application in which one may be apprised of their condition so as to aid in preventing further spread of ailments while within the general public.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kanzer (US 2007/0199567) discloses droplet collection devices and methods to detect and control airborne communicable diseases, which is relevant to Applicant’s field of endeavor.
Heemstra (US 2014/0011193) discloses aptamer-based lateral flow assays that is relevant to Applicant’s field of endeavor that is likewise concerned with aptamer-based lateral flow assays.
Simplot et al. (US 2023/0176036) discloses detection of viruses in facemasks, which is pertinent 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.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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