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 .
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: triggering module and elastic module 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 § 112
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 2-3 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.
The term “approximate plane” in claims 2-3 is a relative term which renders the claim indefinite. The term “approximate plane” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-8, 10-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by “Antonio”, US Publication 20170290546.
Regarding claim 1, Antonio discloses an installation unit of analyte detection device [e.g., fig.26, 27], which comprises:
a housing [1521] provided with an auxiliary-needle limit slot [1528];
a parallel slider module [e.g., 1570, 1572] arranged in the housing, which is slidable relative to the housing, a far end face of the parallel slider module is provided with at least one slider-buckle [fig. 27, 1540; inwardly facing hooks] [0115+];
an analyte detection device [100] arranged at a front end of the parallel slider module, wherein the analyte detection device comprises a shell, a transmitter, a sensor and an internal circuit [e.g., transmitter] arranged in the shell and electrically coupled with the sensor [0121];
an auxiliary-needle module, comprising an auxiliary-needle slide block [fig.28, 1540], an auxiliary-needle fixed block [fig.28, 1590] and an auxiliary-needle [fig. 27, 410], wherein the auxiliary-needle slide block is clamped with the auxiliary-needle fixed block, and is located in the auxiliary-needle limit slot, the auxiliary-needle fixed block and the auxiliary-needle are fixedly connected [e.g., fig. 326, 27];
a triggering module [1510], wherein when the triggering module moves towards the far end relative to the housing, an installation action is implemented; and
an elastic module [e.g., 1530, 1550] used to provide an elastic force required to implement the installation action;
wherein when the installation action is implemented, the parallel slider module and the auxiliary-needle module move to a near end relative to the housing [fig.27], and when the slider-buckle is detached from the auxiliary-needle limit slot, a connection between the auxiliary-needle slide block and the slider-buckle is released, and the auxiliary-needle slide block returns back to an initial position [fig.28, 29; 0116].
Regarding claim 2, Antonio discloses wherein the connection [inwardly facing hooks interface] of the slider-buckle and the auxiliary-needle slide block is at a plane or an approximate plane [e.g., fig.26, 27; 0115+].
Regarding claim 3, Antonio discloses wherein the plane or the approximate plane is at a fixed angle with a horizontal plane and converges at the far end [fig.26, interfaces at far end before compression].
Regarding claim 4, Antonio discloses wherein the slider-buckle comprises a flexible material [the slider-buckle or inwardly facing hooks is flexible in order to allow auxiliary needle slide block tab to come out from slider-buckle as seen in fig.28 in contrast with fig.27] or an elastic material.
Regarding claim 5, Antonio discloses wherein when the slider-buckle is located in the auxiliary-needle limit slot, an inner wall of the auxiliary-needle limit slot prevents the slider-buckle from bending [when inside limit slot 1528 as seen in fig.27, the cylindrical wall of 1528 prevents the inwardly facing hooks or slider-buckle from bending so the auxiliary needle slide block tab don’t come out as seen in fig.28].
Regarding claim 6, Antonio discloses wherein the auxiliary-needle comprises a semi-enclosed needle body [0032].
Regarding claim 7, Antonio discloses wherein the sensor [e.g., filament] is located in the semi-enclosed needle body [0032].
Regarding claim 8, Antonio discloses wherein when the slider-buckle detaches from the auxiliary-needle limit slot, the semi-enclosed needle body pierces subcutaneously [0116].
Regarding claim 10, Antonio discloses wherein a diameter of the auxiliary-needle fixed block is smaller than a diameter of the auxiliary-needle slide block [0115; 1590 inside 1540].
Regarding claim 11, Antonio discloses wherein a number of the at least one slider-buckle is two [e.g., fig.26].
Regarding claim 12, Antonio discloses wherein the slider-buckles are symmetrically distributed on the parallel slider module [e.g., fig. 26].
Regarding claim 13, Antonio discloses wherein a front end of the analyte detection device also comprises an adhesive tape for fixing the analyte detection device on a skin surface [0032+].
Claim Rejections - 35 USC § 103
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) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antonio as applied to claim 6 above.
Regarding claim 9, Antonio did not disclose explicitly a fully-enclosed needle body. However, it would have been obvious to one of ordinary skill to include a fully-enclosed needle between a fixed block and a semi-enclosed needle body to improve sensor protection and insertion profile.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791