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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “when the lug is located in the second slot point, the fixed buckle does not contact with the first buckle” as mentioned in claim 6 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 5, and 7 are objected to because of the following informalities:
“the slot” in line 4 of claim 1 should read as “the at least one slot”
“converge” in line 4 of claim 5 should read as “converges”
“the fixing buckle” in line 2 of claim 7 should read as “the fixed buckle”
Appropriate correction is required.
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” 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.
“Triggering module” is interpreted as “a fixed buckle corresponding to the first buckle” as mentioned in [0008] of the PGPUB.
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 3, 5, and 9 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. Claims 4, 6, and 7 are further rejected due to their dependency to claim 3.
Claim 3 recites the limitation “the first buckle slot” in line 3. There is insufficient antecedent basis for this limitation in the claim. “First buckle slot” was not previously recited and it is unclear what this limitation is referring to. Clarification is requested.
Claim 5 recites the limitation "the contact surface" in line 3. There is insufficient antecedent basis for this limitation in the claim. “Contact surface” was not previously recited. However, “surface contact” was previously recited in claims 4 and 5. It is unclear if “the contact surface” should be amended to read as “the surface contact.” Clarification is requested.
The term “close” in claim 9 is a relative term which renders the claim indefinite. The term “close” 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. The disclosure does not provide a definition as to what it means for a structure to be “close” to something. It is unclear what range in distance is considered “close.” Clarification is requested.
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.
Claims 1-5, 8, 9, and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang ‘759 (US Pub No. 2016/0157759).
Regarding claim 1, Yang ‘759 teaches an installation unit of analyte detection device (Abstract, [0012]), which comprises:
a housing (Figs. 3, 5 inserter 122 and [0115]), provided with at least one slot (see Fig. 5) and a first buckle (Figs. 3, 5 second fastener unit 12212 and [0118]), wherein the slot comprises a first slot point (bottom of slot in Fig. 5) and a second slot point (top of slot in Fig. 5), the first slot point is closer to a near end of the second slot point (The bottom of inserter 122 is interpreted as a near end.);
a parallel slider module (Fig. 6 support mount 121 and [0116]) comprising a second buckle (Fig. 6 first fastener unit 1212 and [0118]) corresponding to the first buckle, wherein the second buckle is coupled with the first buckle ([0118]; “…the second fastener 12212…can form a fastened structure with the first fastener unit 1212.”);
an analyte detection device (Fig. 1 analyte sensing system 1 and [0105]) arranged at a front end of the parallel slider module (), wherein the analyte detection device comprises a shell (Fig. 16 sensor probe shell 125 and [0131]), a transmitter ([0107]; transmitter 13), a sensor (Fig. 2 sensor probe 11 and [0107]) and an internal circuit ([0029]) arranged in the shell and electrically coupled with the sensor (), and the shell connects the parallel slider module releasably ([0132]);
an auxiliary-needle module used to pierce the sensor under a skin (Fig. 9 puncture needle 12225 and [0126]);
a triggering module ([0120]) provided with a lug corresponding to the slot, wherein before an implementation of an installation action, the lug is located in the first slot point, when the triggering module moves towards a far end relative to the housing, the lug enters into the second slot point, the installation action is implemented ([0120]); and
an elastic module used to provide an elastic force required to implement the installation action (Fig. 9 outer spring 12224 and [0125]).
Regarding claim 2, Yang ‘759 teaches wherein the triggering module also comprises a fixed buckle corresponding to the first buckle (Fig. 6 first fastener unit 1212 and [0118]).
Regarding claim 3, Yang ‘759 teaches wherein the lug is located in the first buckle slot, the fixed buckle is in contact with first buckle (see Fig. 7).
Regarding claim 4, Yang ‘759 teaches wherein a contact between the fixed buckle and the first buckle is one of a point contact, a line contact or a surface contact ([0118] mentions that these structures are in contact with each other.).
Regarding claim 5, Yang ‘759 teaches wherein the fixed buckle and the first buckle is the surface contact ([0118]), the contact surface is at a fixed angle with a horizontal plane and converge at a proximal end (First fastener unit 1212 and second fastener unit 12212 contact at a fixed angle and converge.).
Regarding claim 8, Yang ‘759 teaches wherein the triggering module also comprises an outer ring (see Figs. 4 and 7) which connects the lug and the fixed buckle into an integral whole (When inserter 122 is attached to the support mount 121, the lug and fixed buckled are connected as an integral whole, as seen in Fig. 7.).
Regarding claim 9, Yang ‘278 teaches wherein the outer ring is close to the near end (The support mount 121 is close to the near end.).
Regarding claim 11, Yang ‘759 teaches wherein the front end of the analyte detection device also comprises an adhesive tape for fixing the analyte detection device on the skin (Fig. 3 medical adhesive tape 124 and [0115]).
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Yang ‘759 in view of Rao et al. ‘520 (US Pub No. 2018/0235520).
Regarding claim 10, Yang ‘759 teaches all of the elements of the current invention as mentioned above except for wherein the at least one slot comprises three slots, the slots are symmetrically distributed on the housing.
Rao et al. ‘520 teaches one or more slots (Figs. 8F, 8G one or more inner sheath ribs 6425) that interface with one or more corresponding rib notches 6519 ([0110]). It is noted that Figs. 8F-8H show that there are three slots that are symmetrically distributed.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the three slots of Rao et al. ‘520 for the one slot of Yang ‘759 as Rao et al. ‘520 teaches that having one or more inner sheath ribs, or slots, would obtain the predictable result of maintaining axial alignment ([0110]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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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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/AURELIE H TU/ Primary Examiner, Art Unit 3791