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 “T-shaped structure comprises a horizontal part and a vertical part” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
It is noted that although the specification provides support for this, the drawings do not show element 1035 as being “T-shaped.” Rather, the element 1035 in Fig. 5b appears to be “n” shaped.
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 1-14 are objected to because of the following informalities:
“of analyte” in the preamble of claim 1 should read as “of an analyte”
“the limit slot” in line 7 of claim 1 (recited twice) should read as “the at least one limit slot”
“the limit slot” in line 19 of claim 1 should read as “the at least one limit slot”
“of analyte” in the preamble of claims 2-14 should read as “of the analyte”
“the limit slot” in line 2 of claim 4 should read as “the at least one limit slot”
“the ribbed plates” in line 2 of claim 5 should read as “the at least two ribbed plates”
“the ribbed plates” in line 2 of claim 6 should read as “the at least two ribbed plates”
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 “at least two fixed buckle corresponding to a first buckle and an outer ring, which connects the fixed buckle and a luge into an integral whole,” as mentioned in [0090]-[0092] 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 1, 7, and 8 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 2-6 and 9-14 are further rejected due to their dependency to claim 1.
Claim 1 recites “T-shaped structure comprises a horizontal part and a vertical part” in lines 4-5. Although the specification provides support for this, the drawings do not show element 1035 as being “T-shaped.” Rather, the element 1035 in Fig. 5b appears to be “n” shaped. As such, it is unclear as to what the term “T-shaped” entails. For examination purposes, “T-shaped structure” is interpreted as any structure that can be located in the at least one limit slot.
Claim 7 recites “the at least one limit slot is a groove concave” in lines 2-3. It is unclear what a “groove concave” is. Clarification is requested. For examination purposes, this limitation is interpreted as “curved.”
Claim 8 recites “wherein the at least one limit slot is symmetrically distributed on the housing.” It is unclear what it means to be “symmetrically distributed.” Clarification is requested. For examination purposes, this is interpreted as being within the housing.
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 3 and 14 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 3 recites “the analyte detection device is in contact with the skin,” which is encompassing a human organism. Examiner suggests to amend the limitation to read as “the analyte detection device is configured to be in contact with the skin.” Claim 14 recites “an adhesive tape for fixing the analyte detection device on the skin,” which is also encompassing a human organism. Examiner suggests to amend the limitation to read as “an adhesive tape configured for fixing the analyte detection device on the skin.”
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 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yee et al. ‘357 (US Pub No. 2020/0397357).
Regarding claim 1, Yee et al. ‘357 teaches an installation unit of analyte detection device (Title, Figs. 30, 31 inserter 100 and [0110]), which comprises:
a housing (Figs. 30, 31 handle 102, base 142 and [0110]) provided with at least one limit slot (Figs. 30, 31 inner rail 128 and [0113]);
a parallel slider module (Figs. 30, 31 support member or shuttle 134 and [0114]), provided with a T-shaped structure (Figs. 30, 31 shuttle 134 and fingers 184 and [0121]; Shuttle 134 and fingers 184 form a T-shape structure.), wherein the T-shaped structure comprises a horizontal part (Length of shuttle 134 is the horizontal part.) and a vertical part (Length perpendicular of shuttle 134 at the finger 184 is the vertical part.), the horizontal part comprises a T-shaped-structure slider (Figs. 30, 31 fingers 184 and [0121]) corresponding to the limit slot, the T-shaped-structure slider is located in the limit slot (Fingers 184 is located in the inner rail 128.);
an analyte detection device (Figs. 30, 31 sensor housing 122 and [0117]) arranged at a front end of the parallel slider module (Sensor housing 122 is at a front end of the shuttle 134.), wherein the analyte detection device comprises a shell (Figs. 30, 31 sensor housing 122 and [0117]), a transmitter (Fig. 7 data transmitting unit 12 and [0099]), a sensor (Fig. 24 sensor 14 and [0118]) and an internal circuit (Fig. 24 electronics 80 and [0098]) arranged in the shell and electrically coupled with the sensor;
an auxiliary-needle module used to pierce the sensor under a skin (Figs. 30, 31 needle hub 136, sharp 124 and [0114]);
a triggering module (Figs. 30, 31 handle 102 and [0126]), which implements an installation action when the triggering module moves to a far end relative to the housing ([0126]; “…the handle 102 is depressed downward (arrow D) against the bias of spring 146…”); and
an elastic module used to provide an elastic force required to implement the installation action (Figs. 30, 31 spring 146 and [0126]),
wherein when the installation action is implemented, the T-shaped-structure slider slides in the limit slot to a near end ([0128]; “Flanges 170 on base 142 engage fingers 184 of shuttle 134. Fingers 184 are pivoted or bend inwards by contact with flanges 170 (as indicated by arrows F).”).
Regarding claim 2, Yee et al. ‘357 teaches wherein when the T-shaped-structure slider slides to a predetermined position (When handle 102 is depressed downward, as mentioned in [0126], fingers 184 more downward to a predetermined position. [0128]; “Flanges 170 on base 142 engage fingers 184 of shuttle 134.”), the horizontal part bends around the vertical part ([0128]; “Fingers 184 are pivoted or bend inwards by contact with flanges 170 (as indicated by arrows F).”), and the analyte detection device is separated from the parallel slider module. (Figs. 30, 31 show that sensor sound 122 is separate from shuttle 134.).
Regarding claim 3, Yee et al. ‘357 teaches wherein at the predetermined position, the analyte detection device is in contact with the skin ([0127]).
Regarding claim 4, Yee et al. ‘357 teaches wherein the limit slot comprises at least two ribbed plates adjacent to each other (Fig. 25 axial notches 188 and [0121]).
Regarding claim 5, Yee et al. ‘357 teaches wherein the ribbed plates protrude from an inner wall of the housing (Fig. 25 shows that axial notches 188 protrude from an inner wall as the notches 188 extend outward, as seen on upper surface 186.).
Regarding claim 6, Yee et al. ‘357 teaches wherein the ribbed plates are parallel to each other (Axial notches 188 are parallel to each other, as seen in Fig. 25.).
Regarding claim 7, Yee et al. ’357 teaches wherein each of the at least one limit slot is a groove concave in an inner wall of the housing (To best to the Examiner’s understanding, Fig. 25 shows that the inner rail 128 is curved within the handle 102 and base 142.).
Regarding claim 8, Yee et al. ‘357 teaches wherein the at least one limit slot is symmetrically distributed on the housing (To best to the Examiner’s understanding, the inner rail 128 is “symmetrically distributed” within the handle 102 and base 142.).
Regarding claim 9, Yee et al. ‘357 teaches wherein a number of the at least one limit slots is three (Fig. 25 shows three limit slots: the two axial notes 188 and the central opening.).
Regarding claim 10, Yee et al. ‘357 teaches wherein the vertical part comprises a flexible or elastic material ([0128] mentions that the fingers 184 are pivoted or bend inwards, indicating that the fingers 184 are a flexible or elastic material.).
Regarding claim 11, Yee et al. ‘357 teaches wherein the vertical part is integrated with the horizontal part (Fingers 184 and inner rail 128 are integrated with each other.).
Regarding claim 12, Yee et al. ‘357 teaches wherein the vertical part and the horizontal part are fixedly connected by welding or hot melt (One of ordinary skill would understand that the fingers 184 and inner rail 128 are integrated together via either welding or hot melt.).
Regarding claim 13, Yee et al. ‘357 teaches wherein the T-shaped-structure slider protrudes outside the parallel slider module (Fingers 184 protrude outside of the shuttle 134, as seen in Figs. 30, 31.).
Regarding claim 14, Yee et al. ‘357 teaches wherein the analyte detection device also comprises an adhesive tape for fixing the analyte detection device on the skin (Figs. 30, 31 adhesive pad 118 and [0127]).
Examiner’s Note
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Boecker et al. ‘907 (US Pub No. 2012/0238907) teaches a fluid sampling device that is similar to the installation unit of analyte detection device. However, Boecker et al. ‘907 does not teach “wherein when the installation action is implemented, the T-shaped-structure slider slides in the limit slot to a near end.” Baker et al. ‘493 (US Pub No. 2018/0360493) teaches applicators for applying transcutaneous analyte sensors that is similar to the installation unit of analyte detection device. However, Baker et al. ‘493 fails to teach a parallel slider module provided with a T-shaped structure. Muller et al. ‘768 (US Pub No. 2019/0223768) teaches an injector for transcutaneously introducing a sensor into a patient that is similar to the installation unit of analyte detection device. However, Muller et al. ‘768 fails to teach a parallel slider module provided with a T-shaped structure. Rather, the auxiliary-needle module is T-shaped. The Incoming Written Opinion filed 21 March 2024 discloses that Chinese Patent 102,307,518 teaches an analyte sensor and apparatus similar to the installation unit of analyte detection device. The Examiner has rejected the claims using Yee et al. ‘357, which the published US version of the Chinese Patent.
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.
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, 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.
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.
/AURELIE H TU/ Primary Examiner, Art Unit 379118