DETAILED ACTION
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 .
Election/Restrictions
Applicant's election with traverse of Species A, embodiment drawn to Figure 1, in the reply filed on 4/13/26 is acknowledged.
The traversal is on the ground(s) that (i) the species election is improper because Figures 5A-5D (Species C) do not fall within the same genus as Species A, B, and D and (ii) a serious search burden has not been established.
This is not found persuasive because
as disclosed, Species C, corresponding to Figures 5A-5D, illustrates “an example of a flexible wearable potentiostat (FWP), in accordance with various embodiments of the present disclosure” ([0015]) and [0057] details the specific use of the FWP alternative in coordination with sample collection and the sensor as a separate and distinct embodiment, which is substantially the same genus as Species A, B, and D; and
the independentness and/or distinctness of the patentably distinct species is directed to the alternative configurations being substantially dissimilar and structurally divergent means for configuring an apparatus to harvest interstitial fluid for analytical analysis using gel osmosis and paper microfluidics, wherein the identified Species would require different searches and/or examination considerations as set forth in the Election of Species requirement mailed 2/11/26.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7, 11, 12, 15, 16, and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 4/13/26.
Regarding the non-elected and withdrawn claimed subject matter not indicated by Applicant, the Examiner respectfully notes:
Claims 7 and 18 are expressly drawn to non-elected Species B, see at least Fig 4E for opening patterns;
Claims 11, 12, 15, 16, 19 are expressly drawn to non-elected Species B, C and/or D, see at least Figs 4B, 4C, 4F, 5A, and 6 for processing circuitry coupled to the sensor.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they appear to be contain color photographs and/or charts, see especially Fig 1, 4A, 4B, 4F, 5B, and 6.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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:
“an extraction portion” in claims 5 and 17;
“a transport portion” in claims 5 and 17; and
“an evaporation portion” in claims 5 and 17.
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.
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(b)
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 1-6, 8-10, 13, 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.
Claim 1 positively recites the limitation "the microneedle patch and osmotic patch complex" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Depending claims 2-6, 8-10, 13, 14, and 17 inherit and do not remedy the indefiniteness.
The term “pure” in claim 3 is a relative term which renders the claim indefinite. The term “pure” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be explicitly, implicitly, inherently, and/or inferentially required and/or excluded to be considered “pure” and/or the degree of “pure”ness or purity required or excluded. In light of the instant Specification one of ordinary skill would not be apprised of the metes and bounds of the scope of the claimed invention, particularly given the infinite possibilities of the glycerin composition to be considered “pure”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 8-10, 13, 14, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Velev et al. (US 2020/0163656 A1, hereinafter Velev).
For claim 1, Velev discloses a microfluidic monitoring platform (Figs 9A-9D) ([006-0013, 0024, 0032-0090]), comprising inter alia:
a microneedle patch (150) comprising a plurality of microneedles (15) on a first side (Fig 9D);
an osmotic patch (120) disposed on a second side of the microneedle patch opposite the plurality of microneedles (Figs 9A-9D), the osmotic patch comprising glycerogel, hydrogel, or solid electrolyte ([0085]), equilibrated with an osmolyte ([0011, 0013, 0032, 0048, , 0064, 0066, 0088]); and
a microfluidic or fluid transport film or material channel (110) disposed between the osmotic patch and the microneedle patch (Figs 9A-9D), the microfluidic or fluid transport film or material channel configured to extract and transport fluid from the microneedle patch and osmotic patch complex ([0085]).
For claim 2, Velev discloses the microfluidic monitoring platform of claim 1, wherein the osmolyte is glycerin or glucose ([0011, 0013, 0032, 0048, 0064, 0066, 0088]).
For claim 3, Velev discloses the microfluidic monitoring platform of claim 1, wherein the osmolyte of the glycerogel comprises pure glycerin ([0011, 0013, 0032, 0048, 0064, 0066, 0088]).
For claims 4 and 13, Velev discloses the microfluidic monitoring platform of claims 1 and 10, wherein the fluid is interstitial fluid (ISF) or extracellular fluid (ECF) ([0024, 0073]).
For claims 5 and 17, Velev discloses the microfluidic monitoring platform of claims 1 and 10, wherein the microfluidic or fluid transport film or material channel comprises an extraction portion (111), a transport portion (112), and an evaporation portion (113) (Fig 9B).
For claim 6, Velev discloses the microfluidic monitoring platform of claim 5, wherein the extraction portion comprises a circular paper pad (111) (Fig 9B) ([0077-0090]).
For claim 8, Velev discloses the microfluidic monitoring platform of claim 5, wherein the transport portion comprises a rectangular section (channel 112) (Fig 9B) extending between the extraction portion and the evaporation portion (Fig 9B).
For claim 9, Velev discloses the microfluidic monitoring platform of claim 8, wherein the rectangular section comprises a linear path (Fig 9B).
For claim 10, Velev discloses the microfluidic monitoring platform of claim 8, wherein the evaporation portion comprises an evaporation pad (113) at an end of the rectangular section (Fig 9B).
For claim 14, Velev discloses the wearable electrochemical sensing system of claim 10, wherein the hydrogel is equilibrated with glycerin or glucose ([0011, 0013, 0032, 0048, 0064, 0066, 0088]).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for configuring microfluidics for interstitial fluid collection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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 A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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