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 .
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 rechargeable electronic unit adapted to read out results…as in cl. 1.
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) A digital display with or without a USB port, and equivalents thereof (see par.[0064] of Applicant’s pre-grant publication US 2024/0329040). *However, clarification is required as seen below under 35 USC 112 b/2nd.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are drawn to use claims.
See MPEP 2173.05(q)
“Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)(“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101”). In Ex parteDunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: “The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction.” In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: “The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid.”
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 1-17 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 arrangement of the sought operative embodiment of the “reusable test device” are indefinitely defined herein.
Initially, the “reusable test device” is construed as three listed elements a), b), and c).
The structural and/or functional relationship among these elements a)-c) is indefinitely defined so as to set forth the operative embodiment of the reusable test device.
At present, the recitations are presented in a parts-type listing and does not provide structural and/or functional relationships among the elements.
From Applicant’s pre-grant publication in US 2024/0329040 and par.[0067], it appears that the wick 2 is removably connected through a slot of a housing of the electronics unit 4 that provides entry slot therefor as well as an additional entry slot for the sensor unit 3 (and its MIP layer 8 and electrode layer 7).
Claim 13 appears to provide this recitation.
Discussion in par.[0068] to “another embodiment” in which the wick is not connected to the reusable sensor unit when the sample is collected does not suffice for an operative embodiment of the device, but instead reads on a potential kit-type claim, or a method of application.
Similarly, the interrelation (i.e. structural and/or functional) of the electrode layer 7 to that of the MIP layer 8 is indefinitely set forth. From the disclosure, and from the discussion as such elements as “layers” it appears that they are attached to one another (or similar structural arrangements as in par.[0062]), or otherwise provided such that the electrode layer is configured to transduce an electrical response from the MIP layer indicative of a binding of the at least one analyte.
Lastly, the functionality of the rechargeable electronic unit is indefinitely set forth herein. The functionality of “to read out results from the reusable sensor unit” is without basis in the claims.
The claims, as presently recited, are without prior provision of “results” so as to correlate with the desired signal processing/readout herein.
For example, does Applicant intend to provide that the MIP/electrode layer provide an electrochemical transduction mechanism as in current, potential, conductance, resistance, or charge? And is it intended the rechargeable electronic unit merely displays this parameter (current, potential, or charge) as “results,” or are the results subject to processing therewithin to correlate to a quantified test result or positive/negative indication shown with respect to the at least one target analyte?
Examiner notes that pars.[0063,0065] speak to differences in resistivity between the MIP layer as a function of the analyte absorption.
With regard to claim 1 and the “rechargeable electronics unit adapted to read out results…” is indefinitely set forth for its recited functionalities as the specification provides that the constituent structure thereto is drawn to a digital display with or without a USB port.
A digital display alone (and USB port) does not suffice to provide the recited functionality with respect to reading out results. Similar to the above discussion regarding provision within the elements of the device to “results,” the MIP layer/electrode layer, and digital display are without discussion to a transduction means and signal processing so as to arrive at a digitized output that is then displayed. Clarification is required.
As in claim 3, 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 3 recites the broad recitation two or more, and the claim also recites three or four 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.
The recitation is also indefinitely defined in its metes and bounds by usage of the language “such as” which calls into question what is actually being set forth. See MPEP § 2173.05(d).
It appears that Applicant may desire two, separate dependent claims.
As in claim 5, the metes and bounds are indefinitely understood. The claims recites “at least one type…further comprises a third type…” in which the language itself is not clearly understood and it is also unclear how many different types of molecular imprinted polymers are being set forth by the recitation.
Further, the claims lack proper antecedent basis for “said first, second, and/or third analyte.” (Independent claim sets forth “at least one analyte”)
Initially, recitation to “at least one” followed by the recitation “further comprises…” appears to set forth a wholly-distinct second set of molecular imprinted polymers from those of the “at least one.”
Does Applicant intend to recite something on the order of –
“wherein said at least one analyte comprises a first, second, and third analyte, and said at least one type of molecular imprinted polymers comprises a second type and a third type of molecular imprinted polymers adapted to bind any one of said first, second, and third analytes”?
As in claim 7, 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 3 recites the broad recitation body fluid, and the claim also recites such as saliva, blood, sweat, and urine (as well as preferably urine) 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.
The recitation is also indefinitely defined in its metes and bounds by usage of the language “such as” which calls into question what is actually being set forth. See MPEP § 2173.05(d).
It appears that Applicant may desires separate dependent claims to delineate the groups from genus to species to sub-species.
Regarding claims 8 and 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further, as likewise above in cls. 3 and 7, the recitations of claims 8 and 9 presents a range within a range that by way of the broad “buffer solution” followed by species thereof and the range of 0.1mM to 100mM followed by narrower one in 1mM to 75mM.
With regard to claim 9, the recitation “said buffer” lacks antecedent basis, and it appears that Applicant intends for claim 9 to depend from claim 8.
Claims 14 and 17 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 14 and 17 are drawn to “use” claims, in which the metes and bounds of the sought methodology for accomplishing the “use(s)” are indefinitely defined.
What are the active steps provided so as to accomplish the “uses” as in claims 14 and 17?
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) 1-7, 10-12, and 14 as best understood, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Belbruno et al. (WO 2013/033541), hereafter Belbruno.
With regard to claim 1, Belbruno discloses a reusable test device comprising a wick adapted to collect fluid to be analyzed (lines 12-15, pg. 18, and absorbent tip). Belbruno further discloses a reusable sensor unit comprising an MIP layer comprising at least one type of molecular imprinted polymers adapted to bind at least one analyte present in the fluid (lines 1-18, pg. 9, lines 12-15, pg. 18), and an electrode layer comprising at least one electrode (lines 14-22, pg. 17, fig. 6; lines 12-20, pg. 18), and wherein the reusable sensor unit is regenerable upon cleansing (lines 11-18, pg. 9, lines 14-20, pg. 14). Belbruno further discloses a rechargeable electronic unit adapted to read out results from the reusable sensor unit (digital multimeter; and wherein said digital multimeter is detachably connected to the reusable sensor unit as it may be selectively placed in operative contact therewith when desired for reading out a change in resistance, as in cl. 13).
With regard to claim 2, the analyte is not a positively claimed element of the device and is drawn to an intended workpiece not afforded patentable weight. It is further noted that Belbruno discusses such analytes (lines 12-20, pg. 18).
With regard to claims 3-5, Belbruno discloses the MIP layer comprises two or more types of molecular imprinted polymers, and wherein said MIP layer comprises a first type of molecular printed polymers adapted to bind a first analyte, and a second type of molecular imprinted polymers adapted to bind said first analyte and/or a second analyte, and wherein the at least one type of molecular imprinted polymers further comprise a third type of molecular imprinted polymers adapted to bind any one of said first, second, and/or third analyte (lines 19-34, pg. 9, lines 29-31, pg. 17, for example).
With regard to claim 6, the analyte is not a positively claimed element of the device and is drawn to an intended workpiece not afforded patentable weight.
With regard to claim 7, the fluid is not a positively claimed element of the device and is drawn to an intended workpiece that is not afforded patentable weight (further noting that Belbruno discloses such fluids as in lines 12-20, pg. 18).
With regard to claim 10, Belbruno discloses said reusable sensor unit contains no antibodies (lines 14-22, pg. 17, lines 5-16, pg. 19, for example).
With regard to claim 11, Belbruno discloses a physical property associated with the presence of an analyte in the MIP is change in resistance (line 31, pg. 9 – line 4, pg. 10).
With regard to claim 12, Belbruno discloses the MIP layer and electrode layer together form an integral layer (lines 19-24, pg. 9).
With regard to claim 14, Belbruno discloses use of the reusable test device for pregnancy testing (lines 17-19, pg. 18, and such as a target molecule of estrogen).
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.
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) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belbruno in view of Davis et al. (US 2009/005378), hereafter Davis.
Belbruno has been discussed above.
Belbruno does not specifically disclose that the wick comprises a buffers solution as best understood in claims 8 and 9.
Davis discloses a pregnancy test strip in which the strip is soaked with a buffer wash including 0.01M (10mM)PBS (par.[0051]).
It would have been obvious to one of ordinary skill in the art to modify Belbruno to provide a buffer (as in phosphate by PBS) to the wick and in a concentration from 0.1 mM to 100mM (and as in 10mM, which is also between 1mM and 75mM) such as suggested by Davis in the analogous art of a pregnancy assay device and provides for suitable dilution and controlled sample preparation to the wick to assure a proper pregnancy assay as likewise desired in Belbruno.
Claim(s) 13 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Belbruno in view of Campuzano et al (“New challenges in point of care…”), hereafter Campuzano.
Belbruno has been discussed above.
With regard to claims 13 and 15-17, Belbruno does not specifically disclose that the wick is detachably connected to the reusable sensor unit as in cl. 13, and removing the wick from the reusable sensor unit as in cl. 15, and wherein the step of collecting is performed with the wick connected to the reusable sensor unit and the reusable sensor unit connected to the rechargeable electronic unit in an assembled state.
Campuzano discloses detection POC devices and detection methods by molecular imprinted polymers and electrodes for aqueous samples, in which measurement of analytes from a blood sample are utilized with a removable filtration unit provided detachably for both before and after assembly (p. 11, col. 2, par. 3; figs. 4, 7).
It would have been obvious to one of ordinary skill in the art to modify Belbruno to provide the wick detachably connected to the reusable sensor unit and removing the wick from the reusable sensor unit before washing to remove unbound analyte such as suggested by the analogous art of Campazuno to point of care electrochemical analysis of analytes in order to afford an arrangement selective coupling and decoupling of the wick when desired for carrying out the assay and subsequent washing (wherein Belbruno discloses likewise washing so as to selectively isolate the target molecules and provide a state that is ready for detection; see lines 15-19, pg. 9) and detection thereof that allows the reusable sensor unit to be simply and repeatedly engaged for multiple different assays. Further, it would have been obvious to one of ordinary skill in the art to provide the collecting of the fluid sample on the wick while connected to the reusable sensor unit and with the reusable sensor unit connected to the rechargeable electronic unit in an assembled state such as suggested and likewise appreciated in Belbruno in order to engage the operative features to suitably carried out the assay for target analytes in the assembled test device.
Further, as likewise discussed above, Belbruno in view of Campazuno remains to provide a use of the test device for pregnancy testing in as much as recited in claim 17 (and as likewise discussed above in cl. 14).
Conclusion
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.
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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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/NEIL N TURK/Primary Examiner, Art Unit 1798
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