Prosecution Insights
Last updated: April 19, 2026
Application No. 18/250,936

HAND OPERATED ACTUATOR MECHANISM

Non-Final OA §101§102§103§112
Filed
Apr 27, 2023
Examiner
HOEKSTRA, JEFFREY GERBEN
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Homedicus GmbH
OA Round
1 (Non-Final)
54%
Grant Probability
Moderate
1-2
OA Rounds
4y 3m
To Grant
95%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allow Rate
272 granted / 499 resolved
-15.5% vs TC avg
Strong +41% interview lift
Without
With
+40.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 3m
Avg Prosecution
81 currently pending
Career history
580
Total Applications
across all art units

Statute-Specific Performance

§101
9.0%
-31.0% vs TC avg
§103
27.3%
-12.7% vs TC avg
§102
37.5%
-2.5% vs TC avg
§112
22.9%
-17.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 499 resolved cases

Office Action

§101 §102 §103 §112
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 Group 1, drawn to the hand operated actuator mechanism of claims 1-11, and Species F, embodiment drawn to Figure 5, in the reply filed on 10/22/25 is acknowledged. The traversal is on the ground(s) that a related European Application issued with claims substantially identical to the present claims and that the Species are linked and illustrate a single general inventive concept. This is not found persuasive because European patent issuance does not have bearing on the national stage entry of the instant Application before the USPTO and a general illustration of a similar inventive concept does not necessarily preclude the disclosed species from lacking unity of invention as set forth in the Restriction requirement mailed 8/22/25. The requirement is still deemed proper and is therefore made FINAL. Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/22/25. 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. 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: “a mounting element” in claim 1; “a trigger element” in claim 1; “a piercing element carrier” in claim 1; “an external piercing element” in claim 1; “a first breakable connection element” in claim 1; “a pushing member” in claim 1; “a second breakable connection element” in claim 1; “an elastic element” in claim 3; “a fluid sample receiving unit for receiving” in claim 8; “at least one fluid transport element” in claim 8; “at least one testing unit” in claim 8; “flow control means” in claim 9; “a conversion unit for converting” in claim 11; and “a transmitter unit for wirelessly transmitting” in claim 11. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. 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 Objections Claim 1 is objected to because of the following informalities: the positive recitation “an external piercing element” in line 5 should apparently read “the external piercing element” because it finds antecedent from claim 1 lines 1-2. Appropriate correction is required. Claim 5 is objected to because of the following informalities: the positive recitation “a pushing finger force” in lines 2-3 should apparently read “the pushing finger force” because it finds antecedent from claim 1. Appropriate correction is required. Claim 6 is objected to because of the following informalities: the positive recitation “a hand-operated actuator mechanism” in line 2 should apparently read “the hand-operated actuator mechanism” because it finds antecedent from claim 1. Appropriate correction is required. Claim 8 is objected to because of the following informalities: the positive recitation “a piercing device” in line 2 should apparently read “the piercing device” because it finds antecedent from claim 6. Appropriate correction is required. 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. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claims 1-11 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 positively recites “…to a pushing member that can be pushed with a human finger and that is arranged to transfer a finger force via the trigger element to the first breakable connection element so as to cause breaking of the first breakable connection element when a pushing finger force pushing said pushing member exceeds a predetermined threshold…”. The scope of claim 1 positively recites and includes a portion of the human body. Thus, it is non-statutory for encompassing a human organism. Claims 2-11 depend from or rely on claim 1 for completeness, inheriting and not remedying the non-statutory issue. In the interest of compact prosecution, the Examiner respectfully suggest Applicant may have intended to positively recite “to a pushing member configured to be pushed with a human finger and configured to transfer a finger force via the trigger element to the first breakable connection element so as to cause breaking of the first breakable connection element when a pushing finger force pushing said pushing member exceeds a predetermined threshold”, or the like, that appears to obviate the issue. Claim Rejections - 35 USC § 112(a) The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 9-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 9 positively recites “flow control means configured to control a transfer of the buffer solution to the at least one fluid transport element and/or to the fluid sample receiving unit”. Although the limitation finds support as filed and in the instant Specification (at least page 26), the disclosure lacks any description or detail of corresponding structure(s) that may comprise a “flow control means”. One of ordinary skill would be guessing as to what this limitation may be. It is merely a black box described with function and without any corresponding structural(s) and/or detail(s). Given the lack of any written description of what may structure(s) may be a “flow control means”, one of ordinary skill would not find demonstrated possession of the “flow control means” as claimed. Claim 10 depends from claim 9 and inherits without remedying the lack of written description. 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 4, 7, and 9-10 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 4 positively recites “wherein the abutment is the elastic element in a stressed or compressed state”. However, claim 1 introduces “an abutment” and claim 3 introduces “an elastic element” such that these are separate and distinct structure(s). The scope of claim 4 is indeterminate with respect to how the separate and distinct structure(s) are required to be the same but in a different state, rendering the scope of the claim indefinite as one of ordinary skill in the art in light of the instant Specification would not be apprised of the scope of the invention, particularly what may be required or excluded whether explicitly, implicitly, inherently, or inferentially. The scope of claim 4 is indefinite because it appears the same structure is recited multiple times with multiple names. Claim 7 positively recites “further comprising a piercing element connected to the piercing element carrier, the piercing element being arranged to remain within the inner volume at the initial position and to protrude from the inner volume at the stop position”. However, claim 7 depends from claim 6 which incorporates the subject matter of claim 1. Claim 1 positively recites “a piercing element carrier for an external piercing element”. The scope of claim 7 is indeterminate with respect to if “the piercing element connected to the piercing element carrier” is the same and/or different structure of claim 1’s “a piercing element carrier for an external piercing element”, rendering it indefinite. Claim 9 positively recites “flow control means configured to control a transfer of the buffer solution to the at least one fluid transport element and/or to the fluid sample receiving unit”. In light of the instant Specification, it is indeterminate what structure(s) are explicitly, implicitly, inherently, and/or inferentially required and/or excluded from the scope of the invention. Although the limitation finds support as filed and in the instant Specification (at least page 26), the disclosure lacks any description or detail of corresponding structure(s) that may comprise a “flow control means”. One of ordinary skill would be guessing as to what this limitation may be amongst infinite possibilities. It is merely a black box described with function and without structural detail. Given the lack of any written description of what structure(s) may be a “flow control means”, one of ordinary skill would not be apprised of the metes and bounds of the scope of the claimed invention such that it is indefinite. Claim 10 depends from claim 9 and inherits without remedying the indefiniteness. Claim Rejections - 35 USC § 112(d) The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 10 positively recites verbatim the same flow control means as claim 9, specifically “wherein the flow control means is configured to control a transfer of the buffer solution from the at least one solution chamber to the at least one fluid transport element or/and to the fluid sample receiving unit”. Claim 10 further recites when flow control may occur, i.e. “before…”, “while…”, “after….”, or “any combination thereof”. However, these process/method limitations, in the absence of any further claimed and/or disclosed structural detail to the contrary, fail to further limit the structure of the apparatus claim of claim 9. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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) 1-4 and 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Diebold et al. (WO 2017/191221, hereinafter Diebold). For claim 1, Diebold discloses a hand-operated actuator mechanism for driving an external piercing element with a predefined force (Fig 14,1-3) (Pgs 16-18,27-28), the actuator mechanism, comprising inter alia: a mounting element (1400) (Fig 14,1-3) (Pgs 16-18,27-28); a trigger element (1416) (Fig 14,1-3) (Pgs 16-18,27-28); and a piercing element carrier (1408) for an external piercing element (1404) (Fig 14,1-3) (Pgs 16-18,27-28), wherein: the trigger element is connected to the mounting element via a first breakable connection (one of 1418) element that is designed to break when a predefined force is applied to the trigger element (one of 1418 breaks/interrupts/snaps/separates from a first outward resting state to a second piercing compressed stressed state) (Fig 14,1-3) (Pgs 16-18,27-28), said trigger element further comprising or being connected to a pushing member (1408) that can be pushed with a human finger and that is arranged to transfer a finger force via the trigger element to the first breakable connection element so as to cause breaking of the first breakable connection element when a pushing finger force pushing said pushing member exceeds a predetermined threshold (Fig 14,1-3) (Pgs 16-18,27-28); and the piercing element carrier is connected to the trigger element and is movable between an initial position (first outward resting state initial position) (Fig 14,1-3) (Pgs 16-18,27-28) wherein the first breakable connection element and a second breakable connection (the other of 1418) (Fig 14,1-3) (Pgs 16-18,27-28) element are unbroken, and a stop position (second piercing compressed stressed stopped state) (Fig 14,1-3) (Pgs 16-18,27-28) wherein an abutment stops a movement of the piercing element carrier. For claim 2, Diebold discloses the actuator mechanism of claim 1, wherein the piercing element carrier is connected to the trigger element via the second breakable connection element (Fig 14,1-3) (Pgs 16-18,27-28), said second breakable connection element being configured to be broken when the piercing element carrier reaches the stop position (the other of 1418 breaks/interrupts/snaps/separates from a first outward resting state to a second piercing compressed stressed state) (Fig 14,1-3) (Pgs 16-18,27-28). For claim 3, Diebold discloses the actuator mechanism of claim 1, further comprising an elastic element (elasticity of materials and dimensions of snap dome tripper set during fabrication process) (Fig 14,1-3) (Pgs 16-18,27-28) that is arranged to act on the piercing element carrier for returning the piercing element carrier from the stop position in the direction of the initial position (Fig 14,1-3) (Pgs 16-18,27-28). For claim 4, Diebold discloses the actuator mechanism of claim 3, wherein the abutment is the elastic element in a stressed or compressed state (Fig 14,1-3) (Pgs 16-18,27-28). For claim 6, Diebold discloses a piercing device, comprising: a peripheral support structure (1414) forming an inner volume (Fig 14) (Pgs 27-28); and a hand-operated actuator mechanism in accordance with claim 1, wherein the mounting element is connected to the peripheral support structure (Fig 14) (Pgs 27-28). For claim 7, Diebold discloses the piercing device of claim 6, further comprising a piercing element (1404) connected to the piercing element carrier (Fig 14) (Pgs 27-28), the piercing element being arranged to remain within the inner volume at the initial position and to protrude from the inner volume at the stop position (Fig 14) (Pgs 27-28). For claim 8, Diebold discloses a testing device, comprising: a piercing device according to claim 6; a fluid sample receiving unit (1402) for receiving a fluid sample for testing (Fig 14) (Pgs 27-28); at least one fluid transport element (capillary wick not shown of Fig 14 pages 27-28) having an input end fluidly connected to the fluid sample receiving unit (Fig 14) (Pgs 27-28), the at least one fluid transport element arranged and configured to transport a fluid away from the input end (Fig 14) (Pgs 27-28); and at least one testing unit (1446) in fluidic communication with the at least one fluid transport element (Fig 14) (Pgs 27-28), the at least one testing unit comprising a respective reacting material (1448) configured to react in a predetermined manner to a pre-specified analyte or property of the fluid (Fig 14) (Pgs 27-28). For claim 9, Diebold discloses the testing device of claim 8, further comprising at least one solution chamber (1422) containing a respective buffer solution (1424) (Fig 14) (Pgs 27-28), and flow control means (1426.1, 1426.2) configured to control a transfer of the buffer solution to the at least one fluid transport element and/or to the fluid sample receiving unit (Fig 14) (Pgs 27-28). For claim 10, Diebold discloses the testing device of claim 9, wherein the flow control means is configured to control a transfer of the buffer solution from the at least one solution chamber to the at least one fluid transport element or/and to the fluid sample receiving unit (Fig 14) (Pgs 27-28) either: before a fluid sample is transferred to the at least one fluid transport element or/and to the fluid sample receiving unit (Fig 14) (Pgs 27-28); or while the fluid sample is being transferred to the at least one fluid transport element or/and to the fluid sample receiving unit (Fig 14) (Pgs 27-28); or after the fluid sample has been transferred to the at least one fluid transport element or/and to the fluid sample receiving unit (Fig 14) (Pgs 27-28); or any combination thereof (Fig 14) (Pgs 27-28). 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. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diebold et al. (WO 2017/191221, hereinafter Diebold). For claim 5, Diebold discloses the actuator mechanism according to claim 1, wherein the first breakable connection element is adapted to be broken upon exertion of a pushing finger force on the pushing member (as set forth hereinabove). Diebold does not specifically state the pushing finger force is 20-100 N. Diebold appears silent regarding any particular numerical value or measure of finger pushing force. However, Diebold is explicitly concerned with the finite number of solutions involved in optimizing pushing finger force via material properties and geometries of the snape dome tripper and needle to pierce the skin (Pgs 7,16-17) while achieving the result effective variable of advantageously minimizing pain while guaranteeing a sufficient volume of extracted fluid for analytical testing (Pgs 7,16-17). Thus, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to optimize Diebold’s result effective variable through routine experimentation (see MPEP 2144.05), resulting in a pushing finger force of 20-100N, to achieve the recognized predictable result of piercing skin while advantageously minimizing pain and guaranteeing a sufficient volume of extracted fluid for analytical testing. Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diebold et al. (WO 2017/191221, hereinafter Diebold) in view of Chickering et al. (US 2011/0251562 A1, hereinaftere Chickering). For claim 11, Diebold discloses the claimed testing device according to claim 8, except for explicitly disclosing: an optical sensor, arranged and configured to detect light reflected from the at least one testing unit and to convert the detected light into an electrical signal representing an intensity and/or a color of the detected light; a conversion unit for converting the electrical signal into digital data representing the intensity and/or the color of the detected light; and a transmitter unit for wirelessly transmitting the digital data. For claim 11, Chickering, in the same field of skin pricking for blood sampling and analyte testing, discloses a hand-operated actuator mechanism (90) (Fig 1A) ([0167) for driving an external piercing element (needle or microneedle [0167]) with a predefined force including fluid sample receiving (92) and transport (99) to a testing unit (97) with a reacting material (agents, particles, enzymes, dyes, [0167]). Chickering discloses an optical sensor (95), arranged and configured to detect light reflected from the at least one testing unit and to convert the detected light into an electrical signal representing an intensity and/or a color of the detected light (Fig 1A) ([0149, 0152-0155, 0167, 0204]); a conversion unit (93) for converting the electrical signal into digital data representing the intensity and/or the color of the detected light ([0149-0155]); and a transmitter unit (transmitter [0167]) for wirelessly transmitting the digital data ([0189, 0204]). For claim 11, Dieblod and Chickering are both considered to be analogous to the claimed invention because they are in the same field of blood sampling and analyte testing. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyte specific reacting material of Diebold to incorporate the teachings of Chickering to provide a sensor, convertor, and transmitter for communicating the blood sample analysis results. Doing so would aid in and achieve the predictable results of providing a hand-held system for obtaining, testing and communicating analyte results from a blood sample. 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 hand operated means for piercing skin. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Jeffrey G. Hoekstra Primary Examiner Art Unit 3791 /JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
Read full office action

Prosecution Timeline

Apr 27, 2023
Application Filed
Sep 04, 2025
Examiner Interview Summary
Sep 04, 2025
Applicant Interview (Telephonic)
Jan 11, 2026
Non-Final Rejection — §101, §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
54%
Grant Probability
95%
With Interview (+40.8%)
4y 3m
Median Time to Grant
Low
PTA Risk
Based on 499 resolved cases by this examiner. Grant probability derived from career allow rate.

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