DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6 are pending.
This action is Final.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 the first “the skin” in line 2 should read “skin”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-6 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.
Regarding claim 1, the following amendments raise issues of new matter/lack of adequate written description for the scope being claimed including:
“a switch configured for turning on/off power supply of the battery to the main substrate or the electrochemical sensor, the switch provided in the housing at a portion where the housing and the transmitter support face each other;
the switch is an elastically operating toggle switch configured to block power supply when pressed and to start power supply when released;”
The issue lies in the lack of support for anything with the switch related to “elastically” and to the correct meaning of “toggle switch”. The response does not identify where support is found for the amendments. For the first part, elasticity is never discussed with regards to the switch, thus there is no express support. It is also not clear what aspects could supply implicit or inherent support for such feature. For the second issue, “toggle switch” has a known and defined meaning in electro-mechanical arts. While the term finds literal repeated reference of the term “toggle switch” in the description as filed, it is clear from the arguments, drawings, and additional passages that the scope and applicant arguments do not actually mean “toggle switch” in the way such is known in the art. The “toggle switch” includes known defined structures in the art including “an electric switch operated by pushing a projecting lever through a small arc” (Merriam-Webster), “an electric switch operated by means of a projection lever that is moved up and down” (Oxford dictionary). As the usage of toggle switch being argued by applicant does not match the known structures of a toggle switch, nor do the drawings include such details, the disclosure as filed lacks adequate written description support. It appears the switch operates by a pressing/contact protocol, but not a toggle switch. As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed. The dependent claims are rejected for depending on a rejected claim.
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 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “toggle switch” in claim 1 is used by the claim to mean “an electronic switch elastically pressed and released” while the accepted meaning is “an electric switch operated by pushing a projecting lever through a small arc” (Merriam-Webster), “an electric switch operated by means of a projection lever that is moved up and down” (Oxford dictionary).” The term is indefinite because the specification does not clearly redefine the term.
Regarding claims 2-4, 6, applicant has amended claim 1 to recite many common elements that were present in original claims 2-6 but creates uncertainty in the correct scope being claimed. The following limitations are unclear how they relate to, cooperate with, function with, have adequate antecedent basis, and/or are the same or different elements from the features amended into claim 1:
Claim 2 (original): The continuous analyte meter of claim 1, wherein the transmitter and the needle are moved to the second position in a state in which an end of the inserter is in contact with the skin, the needle is returned from the second position to a third position inside the inserter and the needle is separated from the transmitter, and when contact between the inserter and the skin is released or the inserter is separated from the skin, the switch is turned on and power supply of the battery to the main substrate or the electrochemical sensor is started.
Claim 3 (original): The continuous analyte meter of claim 1, wherein the housing is detachably coupled to a transmitter support, the needle is provided with a needle handle, an actuator comprising a return member to which the needle handle is detachably coupled is provided, the actuator moves the transmitter support from the first position toward the second position and moves the return member from the second position toward a third position, a switch activator turning on/off the switch is provided, the switch is turned on when contact between the switch activator and the switch is released, and the switch activator is installed at a specific position of the transmitter support facing the switch of the transmitter.
Claim 4 (original): The continuous analyte meter of claim 1, wherein the housing is detachably coupled to a transmitter support, a switch activator turning on/off the switch is provided at the transmitter support, and the switch activator presses the switch of the transmitter to keep the switch in an off state before the inserter is separated from the skin.
Claim 6 (original): The continuous analyte meter of claim 1, wherein an end of the inserter that is brought into contact with the skin upon movement of the transmitter or the needle and is fixed on the skin is a portion of an inserter casing, a switch activator turning on/off the switch is provided in the inserter casing, and when the inserter is separated from the skin, contact between the switch activator and the switch is released, the switch is turned on, and power supply of the battery to the main substrate or the electrochemical sensor is started.
In view of the requirement of claim 1 to recite:
an electrochemical sensor configured to invasively be inserted into the skin;
a transmitter including a main substrate to which a battery is connected and a housing in which the main substrate is accommodated, the housing configured for being attached to the skin and the main substrate configured for controlling a signal measured by the electrochemical sensor;
a needle configured for inserting the electrochemical sensor into the skin and having a needle handle;
an inserter configured for moving the transmitter and the needle from a first position to a second position so that the needle is configured to penetrate the skin;
a transmitter support provided in the inserter, the transmitter support being configured to removably receive and support the transmitter during insertion;
a switch configured for turning on/off power supply of the battery to the main substrate or the electrochemical sensor, the switch provided in the housing at a portion where the housing and the transmitter support face each other;
a switch activator configured to press and release the switch, the switch activator provided on the transmitter support: and
an actuator comprising a return member to which the needle handle is detachably coupled, the actuator configured to (i) move the transmitter support from the first position toward the second position, and (ii) move the return member from the second position toward a third position,
wherein the housing is detachably coupled to the transmitter support;
the needle is returned from the second position to the third position inside the inserter such that the needle is separated from the transmitter;
the switch is an elastically operating toggle switch configured to block power supply when pressed and to start power supply when released;
until the inserter is configured to be separated from the skin, the switch activator presses the switch to maintain the switch in an off state and to block power supply of the battery to the main substrate;
when contact between the inserter and the skin is released or the inserter is separated from the skin, contact between the switch activator and the switch is released, pressing of the switch is released, and power supply of the battery to the main substrate or the electrochemical sensor is started; and
when the needle is returned from the second position to the third position and separated from the transmitter inside the inserter, the transmitter remains received in the transmitter support such that contact between the switch activator and the switch is maintained until the inserter is separated from the skin.
Applicant should amend to make clearer the meaning of the dependent claims in view of the new requirements of the independent claims, or delete the features which are unnecessary/redundant to the structures and features required in amended claim 1. For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite.
Claim 5 is rejected for depending on a rejected claim.
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 2-6 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). Under a broadest reasonable interpretation, the features claimed in recitation with human organisms encompass or are directed to human subject matter. The structures claimed should be amended to be adapted to/for such interactions, or rearranged to make such limitations in such form. These limitations include:
Claim 2:
wherein the transmitter and the needle are moved to the second position in a state in which an end of the inserter is in contact with the skin,
when contact between the inserter and the skin is released or the inserter is separated from the skin, the switch is turned on and power supply of the battery to the main substrate or the electrochemical sensor is started.
Claim 4
wherein the housing is detachably coupled to a transmitter support, a switch activator turning on/off the switch is provided at the transmitter support, and the switch activator presses the switch of the transmitter to keep the switch in an off state before the inserter is separated from the skin.
Claim 6
wherein an end of the inserter that is brought into contact with the skin upon movement of the transmitter or the needle and is fixed on the skin is a portion of an inserter casing,
when the inserter is separated from the skin, contact between the switch activator and the switch is released, the switch is turned on, and power supply of the battery to the main substrate or the electrochemical sensor is started.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims and specification filed 12/31/2025.
Applicant’s arguments regarding the specification objections have been fully considered and are persuasive due to the amendments to the specification; the objections are withdrawn.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the presented form of the claims; one new objection has been raised.
Applicant’s arguments regarding the double patenting have been fully considered and are persuasive due to the amendments to the claims to create significantly divergent claimed features than the co-pending application. The rejections are withdrawn, but should amendments necessitate double patenting in the future may be presented again at such time, if applicable.
Applicant’s arguments regarding the rejection of the claims under 35 U.S.C. 101 have been fully considered and are partially persuasive due to the amendments to claim 1, but the original dependent claims with issues were not addressed at all and are respectfully maintained as presented above.
Applicant’s arguments regarding the rejection of the claims in view of prior art have been fully considered and are persuasive due to the inclusion of the amended features; the rejections have been withdrawn for the scope presented.
Conclusion
No prior art rejections have been applied, but the claims are not in condition for allowance to the rejections under 35 U.S.C. 112/101.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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