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 .
Notice of Reply
This communication is responsive to the amendment(s) and/or argument(s) filed 7/23/26. The previous ground(s) of objection and/or rejection is/are withdrawn. The following new and/or reiterated ground(s) of rejection is/are set forth hereinbelow.
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 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, 6-10, and 16-17 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) configured to be pushed with a human finger and operable 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 the pushing finger force pushing said pushing member exceeds the predefined force (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) in which thefirst 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) in which 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, wherein the abutment comprises 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 when the elastic element is in a stressed or compressed state movement of the piercing element carrier is stopped (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
the 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, wherein the external piercing element (1404) is configured 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:
the 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, via controlled dissolution of a soluble material (1448) due to contact with the respective buffer solution, 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 the 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) 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 when the wicking is slow).
For claim 16, 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 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 when the wicking is coincident with flow control).
For claim 17, 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 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 when the wicking is fast).
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 the finger force exerted on the pushing member (as set forth hereinabove). Diebold does not specifically state the finger force exerting 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, hereinafter 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.
Response to Arguments
Applicant’s arguments, see pages 8-9, filed 7/23/26, with respect to the newly amended claims overcoming the 101 rejections of claims 1-11, the newly amended claims 4 and 7 overcoming the 112(b) rejections, and the newly amended claims 9-10 overcoming the 112(a), 112(b), and 112(d) rejections have been fully considered and are persuasive. The 101 rejection of claims 1-11, the 112(b) rejections of claims 4 and 7, and the 112(a), 112(b), and 112(d) rejections of claims 9-10 has/have been withdrawn in light of the newly amended claims.
Applicant's arguments filed 7/23/26 have been fully considered but they are not persuasive.
Regarding Applicant’s assertions with respect to the 112(f) interpretation, the Examiner respectfully notes the assertions do not provide a rebuttal to the 112(f) rebuttal presumption, particularly while lacking any specific correlation with the instant disclosure. Conversely the assertions on pages 6-8 merely state the interpretation and 112(f) interpretation guidance of the MPEP without providing any rebuttal and/or specific discussion of the claim limitations at hand, let alone with any regard to the instant Specification.
Regarding Applicant’s arguments with respect to the prior art rejection under Dieblod, the Examiner respectfully notes Diebold’s element 118, and corresponding element 1418, is disclosed as connection structure arranged and configured to induce a snap movement of the needle carrier relative to the support structure upon a finger pushing force (page 16).
Diebold explicitly states (page 16, emphasis added) inter alia the following:
“Fig. 1 shows a diagram of a cross section of an exemplary embodiment of a body fluid extraction device 100 for extracting body fluids through a skin surface 102. Fig. 1 depicts the situation before an extraction of body fluids has taken place. The extraction device 100 comprises hollow needles 104 having a base end and a tip and a channel 106 linking the base end and the tip in fluid communication. The hollow needles 104 are attached or integrated to a needle carrier 108 which has an outer side 1 10 configured to face the skin surface upon operation of the extraction device, and an inner side 1 12 opposite to the outer side 1 10. Furthermore, the needle tip extends out of the outer side of the needle carrier. The extraction device also comprises a support structure 1 14 connected to the needle carrier 108 and configured to allow a relative movement of the needle carrier relative to the support structure in a direction D substantially perpendicular to the skin surface 102. Further, the extraction device comprises a snap dome tripper 1 16, which is connected to the support structure by connection structures 1 18, and which is arranged and configured to induce a snap movement of the needle carrier relative to the support structure.
“Fig. 2 shows the body fluid extraction device 100 upon operation. A user has applied amount of force on the snap dome tripper 1 16 (e.g. by placing his finger on the snap dome tripper and pushing it downwards in the direction D, i.e. towards the skin surface 102), thereby inducing a snap movement that has facilitated the insertion of the needles 104 into the subject's skin. The needle carrier 108, which is connected with the snap dome tripper 1 16 by means of connection structures 1 18, is allowed to move relative to the support structure 1 14. The snap dome tripper comprises, in this exemplary embodi- ment, a dome-shaped applicator such as a monostable clicker which, after applying a predetermined amount of force, snaps to a state in which it remains for a predetermined amount of time span. Both the predetermined amount of force and the predetermined amount of time span are parameters that can be configured or set during the fabrication process of the extraction device, since they mainly depend of the choice of materials and dimensions of the snap dome tripper. After the predetermined time span has lapsed, the snap dome tripper returns to its stable state (as depicted in Fig.1 ), thus facilitating the removal of the needles from the skin surface. The skin of an adult has an average thickness of about 2 millimeters. The outermost layer of the skin is the stratum corneum, mostly consisting of dead cells. Its thickness varies from roughly 10 micrometers to over 150 micrometers depending on the body part. Situated below the stratum corneum is the epidermis, with a thickness ranging approximately from 30 to 130 micrometers. The dermis, which holds abundant blood vessels and a few nerve endings lies below the epidermis and has a thickness of approximately 800 micrometers to 1 .5 millimeters.“
Consistent with the instant Specification and absent any special definition upon which Applicant does not appear to rely, the Examiner notes the claims and terms therein have been examined on the merits with their broadest reasonable interpretation of the plain meaning of the terms therein. The term “break” may be plainly interpreted as interrupt or separate. As such, it is more than fair and reasonably to consider Diebold’s connection structure 1418 to “break” upon finger pushing force because the snap interrupts the initial configuration into a separate second configuration, wherein snap movement interrupts the prior static configuration and transitions to a separate and distinct compressed configuration. Indeed, even though Diebold’s connection structure remains intact to provide the snap motions, this does not preclude the connection structure(s) from being considered to “break” from the initial configuration to reach the compressed configuration while they aid in the controlled separation and interruption of static state movements.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “once the first breakable connection element is broken, the trigger element and the piercing element are free to move indepdently of the mounting element in at least the longitudinal direction”, “the actuator can only be used once in its intended form thus ensuring single-use operation”, “become divided or separated from other components”, “no longer connected”, “the trigger element is separated from the piercing element carrier”, and/or “no further force can be transferred”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Further, the Examiner respectfully notes that should Applicant recite the unclaimed features noted above, or the like, it would appear these may structurally distinguish over Diebold.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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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
Prosecution Insights