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/Restriction
2. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-19, drawn to a microneedle actuator for monitoring interstitial fluid of a user, classified in A61B5/14514 & A61B5/685.
II. Claim 20, drawn to a method of detecting a biomarker within the interstitial fluid, classified in A61B2010/008.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case invention III can be practiced with another materially different apparatus that does not include the specific microneedle structure and the apparatus could be used for other analyzing other biological fluids.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Invention I requires searching in A61B5/14514 for device level searching of microneedle actuators, requiring search queries related to ‘microneedle; gear cam; teeth; patch; actuat$; microneedle WITH opening; sensor; channel’, etc.
Invention II requires searching in A61B2010/008 for method searching of biomarker detection/identification, requiring search queries related to ‘adher$ with actuat$ or patch and skin’, etc.
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
The prior art applicable to one invention would not likely be applicable to another invention; and
The inventions are likely to raise different non-prior art issues under 35 U.S.C. § 101 and/or 35 U.S.C. § 112.
Complete examination of each invention would require nonoverlapping searches and would create a serious burden.
If Invention I is elected:
This applications contains claims directed to the following patentably distinct species within Invention I:
Species 1, directed to a microneedle actuator for monitoring interstitial fluid of a user directed to Paragraph 0006 and ISF 120 of the specification and Claims 1-14
Species 2, directed to a microneedle actuator for monitoring interstitial fluid of a user directed to Paragraph 0007 and ISF 200 of the specification and Claims 15-19
The species are independent or distinct because they present non-overlapping alternative configurations. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, claim 1 is generic within invention I.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
Species 1 requires searching in A61B5/14514 for device level searching of microneedle actuators, requiring search queries related to ‘microneedle; gear cam; teeth; patch; actuat$’, etc.
Species 2 requires searching in A61B5/685 for device level searching of specific microneedle structures, requiring search queries related to ‘microneedle WITH opening; sensor; channel’, etc.
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries);
The prior art applicable to one invention would not likely be applicable to another invention; and
The inventions are likely to raise different non-prior art issues under 35 U.S.C. § 101 and/or 35 U.S.C. § 112.
Complete examination of each invention would require nonoverlapping searches and would create a serious burden.
Applicant is advised that the reply to this requirement to be complete must include (i) an election Species 1 or Species 2 to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Megan Tappan on 27th January 2026 a provisional election was made without traverse to prosecute Invention I, Species 1, claims 1-14. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15-20 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 actuation device’ in claim 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.
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 § 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) 1-7 & 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210353267 A1 to Qin et al. (hereinafter, Qin) in view of “Integrated microsystems for continuous glucose monitoring, interstitial fluid sampling and digital microfluidics”, THESIS, 1 January 2020, pages 1-109, XP055848499, ISBM: 978-91-7-873415-5 to Federico.
Regarding Claim 1, Qin discloses a microneedle actuator for monitoring interstitial fluid (ISF) of a user (Qin: Para. [0081]; Fig. 5), said microneedle actuator comprising:
a rigid support defining a slot (Qin: Figs. 5-7, items 102 & 112 combined; Note: slot is defined as the top or bottom opening of the rigid support.);
a geared cam positioned within said rigid support and comprising an axle extending through the slot (Qin: Para. [0083]; Fig. 5 & Fig. 7, item 118);
a spring positioned within said rigid support and configured to rotate said geared cam about said axle (Qin: Para. [0084]; Fig. 5, item 116);
and comprising a plurality of microneedles (Qin: Fig. 5, item 130); and
an actuation device attached to said rigid support and said geared cam (Qin: Para. [0084]; Fig. 5, item 114),
wherein actuation of said actuation device releases said spring, rotating said geared cam to insert said plurality of microneedles into the user's skin (Qin: Para. [0084]), and
Qin does not explicitly disclose an ISF sensing module attached to said geared cam, each microneedle of said plurality of microneedles comprising at least one sensor for detecting the ISF of the user, wherein said at least one sensor detects constituents of the ISF of the user.
However, Federico teaches an ISF sensing module (Federico: Pg. 37, 4.6.1; Fig. 17), and a microneedle comprising at least one sensor for detecting the ISF of the user, wherein said at least one sensor detects constituents of the ISF of the user (Federico: Pg. 37, 4.6, 4.6.1; Fig. 16 & Fig. 17).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the microneedle array of Qin to include the sensing module with microneedle sensing design taught by Federico, motivated by the need to monitor analytes (e.g., glucose) in interstitial fluid (ISF) using minimally-invasive sampling techniques with a high degree of confidence (Federico: Pgs. 1-2, 1.1.1).
Regarding Claim 2, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 1, Qin further discloses wherein said spring comprises at least one of a compression spring, an extension spring, a torsion spring, a coil spring, and a leaf spring (Qin: Para. [0084]; Figs. 5 & 7, item 116).
Regarding Claim 3, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 1 further comprising a ram positioned within said rigid support between said spring and said geared cam (Qin: Para. [0087] Fig. 5 & 7, item 104 & 126 combined),
wherein actuation of said actuation device releases said spring, causing said spring to press on said ram, causing said ram to rotate said geared cam, and causing said geared cam to insert said plurality of microneedles into the user's skin (Qin: Para. [0083]; Para. [0087] ‘transfer of force from coil spring 104 inside device housing 102 to actuate the puncture-retraction-rotation cycle of the ISF extraction device.’; Fig. 5 & 7, item 104), and
wherein said ram comprises a curved surface configured to receive a portion of said geared cam and a face configured to receive said spring (Qin: Fig. 5 item 104 is a coil spring, pressed against the geared cam item 118; Fig. 7, item 126 shown to be configured to receive the spring, mapped to item 116).
Regarding Claim 4, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 1, Qin further discloses wherein said geared cam comprises a body, a first flat surface, a second flat surface, and a plurality of gear teeth extending from said body and said second flat surface (Qin: Para. [0083]; Fig. 5, item 118; See Annotated Fig. 5 for flat surfaces of item 118 below).
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Regarding Claim 5, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 4. Qin is silent on an ISF sensing module attached to said first flat surface. Federico teaches an ISF sensing module (Federico: Pg. 37, 4.6.1; Fig. 16a; Note: See motivation to combine in the rejection of Claim 1 above.).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the system of Qin in view of Federico by rearranging its parts through attaching the ISF module taught by Federico to the first flat surface of the geared cam disclosed by Qin, requiring no more than shifting position of the module which would not have modified the operation of the device, and thus is held to be an obvious matter of design choice. See MPEP 2144.04 VI. C..
Regarding Claim 6, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 4. Qin further discloses wherein said rigid support defines a plurality of grooves, and wherein rotation of said geared cam rotates a gear tooth of said plurality of gear teeth into a groove of said plurality of grooves (Qin: Para. [0083] ‘When the top of the teeth on the plunge gear 118 are pushed against the top of the teeth inside the device housing 102 due to the compression from the coil spring 104, the width of the gear teeth on the plunge gear 118 align inside the teeth of the device housing 102. This determines the interval between two sequential stamping or penetration events. Once the top of the gears on the plunge gear 118 meets the spacing between the teeth on the gear inside the device housing 102 the plunge gear 118 starts to travel downwards until it hits the gear root surface, providing both a vertical and rotational mechanism.’ Emphasis added.).
Regarding Claim 7, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 6, Qin further discloses wherein each gear tooth within each groove defines a pivot point about which said geared cam pivots during rotation of said geared cam (Qin: Para. [0083] ‘When the top of the teeth on the plunge gear 118 are pushed against the top of the teeth inside the device housing 102 due to the compression from the coil spring 104, the width of the gear teeth on the plunge gear 118 align inside the teeth of the device housing 102. This determines the interval between two sequential stamping or penetration events. Once the top of the gears on the plunge gear 118 meets the spacing between the teeth on the gear inside the device housing 102 the plunge gear 118 starts to travel downwards until it hits the gear root surface, providing both a vertical and rotational mechanism.’).
Regarding Claim 14, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 1, Qin further discloses wherein said rigid support comprises a base, two vertical supports attached to said base, and a horizontal support spaced from said base and extending between said vertical supports (Qin: Fig. 5, items 102 & 112 combined makes up the rigid support with the bottom surface of item 102 as a base, the side walls of item 102 as having two vertical supports, and item 112 as the horizontal support).
Claim(s) 8 & 9 are rejected under 35 U.S.C. 103 as being unpatentable over Qin in view of Federico in further view of US 20210169518 A1 to Shimizu et al. (hereinafter, Shimizu).
Regarding Claim 8, Qin in view of Federico discloses the microneedle actuator in accordance with Claim 1, Qin does not explicitly disclose wherein said rigid support defines a plurality of grooves embossed in said rigid support along a first plane, and wherein the slot is a pair of slots that are defined within said rigid support to cooperatively define a second plane extending through the pair of slots that is parallel to the first plane.
However, Shimizu teaches wherein said rigid support defines a plurality of grooves embossed in said rigid support along a first plane, and wherein the slot is a pair of slots that are defined within said rigid support to cooperatively define a second plane extending through the pair of slots that is parallel to the first plane (Shimizu: Para. [0185]; Para. [0186]; Fig. 25 & 26; See annotated Fig. 25 below).
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One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the rigid support of Qin to define grooves and slots in parallel planes as taught by Shimizu for improved dynamic mechanical stability (Shimizu: Para. [0192]).
Regarding Claim 9, Qin in view of Federico in view of Shimizu discloses the microneedle actuator in accordance with Claim 8. Qin further discloses wherein said geared cam comprises a body and a plurality of gear teeth extending from said body (Qin: Fig. 5 & Fig. 7, item 118)
Qin is silent on wherein a first distance between a center-line of the pair of slots and the first plane is the same as a radius of the body of the geared cam.
However, Shimizu teaches wherein a first distance between a center-line of the pair of slots and the first plane is the same as a radius of the body of the geared cam (Shimizu: Para. [0185]; Para. [0186]; Fig. 25 & 26; See annotated Figure 25 in the rejection of Claim 8 above; Note: the distance between the two planes would inevitably be the radius of the geared cam as a result of the recited structure.).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the rigid support of Qin to define grooves and slots in parallel planes as taught by Shimizu for improved dynamic mechanical stability (Shimizu: Para. [0192]).
Allowable Subject Matter
Claims 10-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 5408987 to Mifune et al. is considered the most pertinent art for Claims 10-13.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAWN CURTIS BROUGHTON/ Examiner, Art Unit 3791
/PATRICK FERNANDES/ Primary Examiner, Art Unit 3791