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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 5/4/26, amended claim(s) 1-2, 4-5, 7-8, 10, and 12, and canceled claim(s) 3 and 6 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
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: “auxiliary mounting module,” in claim 1, which corresponds to an “ejector mechanism” (see claim 1); “an ejector mechanism,” in claim 1, which has no corresponding structure; “a wake-up module,” in claim 1, which corresponds to “a light sensing element” (see claim 1); “light sensing element,” in claim 1, which corresponds to a “photoelectric switch” (see page 7, fifth full paragraph); “magnetic component,” in claim 7, which has no corresponding structure; “magnetic induction element,” in claim 7, which corresponds to a “hall element” (see claim 7); and “hall element,” in claim 7, which has no corresponding structure..
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 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.
Claim(s) 1-2, 4-5, and 7-12 is/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.
For claim 1, the claim term “auxiliary mounting module … the auxiliary mounting module includes an ejector mechanism” 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, at the time the application was filed, had possession of the claimed invention. Specifically, this claim term invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. Therefore, there is a lack of evidence that Applicant had possession of the claim term since the corresponding structure is not disclosed in the specification. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
For claim 7, the claim term “magnetic component” 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, at the time the application was filed, had possession of the claimed invention. Specifically, this claim term invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. Therefore, there is a lack of evidence that Applicant had possession of the claim term since the corresponding structure is not disclosed in the specification. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
For claim 7, the claim term “magnetic induction element, wherein the magnetic induction element comprises a hall element” 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, at the time the application was filed, had possession of the claimed invention. Specifically, this claim term invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. Therefore, there is a lack of evidence that Applicant had possession of the claim term since the corresponding structure is not disclosed in the specification. The examiner respectfully requests Applicant’s assistance in determining where support may be found or have the subject matter deleted from the claim(s).
Dependent claim(s) 2, 4-5, and 7-12 fail to cure the deficiencies of independent claim 1, thus claim(s) 1-2, 4-5, and 7-12 is/are rejected under 35 U.S.C. 112(a).
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.
Claim(s) 1-2, 4-5, and 7-12 is/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.
For claim 1, the claim term “auxiliary mounting module … the auxiliary mounting module includes an ejector mechanism” is ambiguous. Specifically, this claim term invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. Therefore, the scope of the claim language cannot be ascertained since it is unclear what structure(s) is/are supposed to be covered by the claim language and what structure(s) is/are not supposed to be covered by the claim language. The claim is examined as any and all structures that are capable of performing the recited function.
For claim 1, the claim language “wherein, before use, the shell is releasable connected with the housing, and the analyte detection device is configured to operate in a dormant state in which the transmitter transmits a signal to an outside equipment at a first frequency” is ambiguous. It is unclear whether the “before using” applies and limits the entire clause or just limits the releasable connection. That is, it is unclear whether the dormant state and transmitting of the signal is limited by “before using.” The claim is examined under the former interpretation.
For claim 7, the claim term “magnetic component” is ambiguous. Specifically, this claim term invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. Therefore, the scope of the claim language cannot be ascertained since it is unclear what structure(s) is/are supposed to be covered by the claim language and what structure(s) is/are not supposed to be covered by the claim language. The claim is examined as any and all structures that are capable of performing the recited function.
For claim 7, the claim term “magnetic induction element, wherein the magnetic induction element comprises a hall element” is ambiguous. Specifically, this claim term invokes 35 U.S.C. 112(f). However, the corresponding structure could not be found. Therefore, the scope of the claim language cannot be ascertained since it is unclear what structure(s) is/are supposed to be covered by the claim language and what structure(s) is/are not supposed to be covered by the claim language. The claim is examined as any and all structures that are capable of performing the recited function.
Dependent claim(s) 2, 4-5, and 7-12 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-2, 4-5, and 7-12 is/are rejected under 35 U.S.C. 112(b).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2 and 7-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2019/0336053 to Halac et al. (hereinafter “Halac”) in view of U.S. Patent Application Publication No. 2008/0114228 to McCluskey et al. (hereinafter “McCluskey”).
For claim 1, Halac discloses an analyte detection system (Abstract), comprising:
an auxiliary mounting device (7100) (Fig. 6A) (para [0251]) comprising a housing (7101) (Fig. 6A) (para [0251]) and an auxiliary mounting module (7102 and/or 7130) (Fig. 6B) (para [0254]), wherein the auxiliary mounting module is located in the housing (as can be seen in Fig. 6B) (also see para [0254]), and the auxiliary mounting module includes an ejector mechanism (7104) (Fig. 6A) (para [0251]);
an analyte detection device (360) (Fig. 3A) (para [0137]), comprising a shell (392/394) (Fig. 3A) (para [0137]), a sensor (338) (Fig. 3A) (para [138]), a transmitter (“telemetry module,” para [0137]), an internal circuit (“printed circuit board” and/or “integrated circuit” and/or “Application-Specific Integrated Circuit,” para [0137]), a battery (402) (Fig. 4) (para [0140]) and a wake-up module (520/545) (Fig. 5) (para [0143]), wherein the sensor comprises an external part and an internal part (unlabeled, but as can be seen in Fig. 4), the external part, the transmitter, the internal circuit, the battery and the wake-up module being located in the shell (as can be seen in Fig. 4 including elements 402 and 404),
wherein, before use, the shell is releasable connected with the housing (para [0251], [0254], and [0256]), and the analyte detection device is configured to operate in a dormant state (“low power state,” para [0150] and [0248]) in which the transmitter transmits a signal to an outside equipment at a first frequency (para [0035], [0221], and [0229]),
wherein, when the analyte detection device is installed on a skin surface through the auxiliary mounting module (para [0251] and [0253]-[0256]), the shell is separated from the housing (para [0252]-[0254]), and the wake-up module is configured to wake up the analyte detection device according to triggering conditions (para [0257]-[0260]), to enter a working state (para [0257]-[0260]), and to transmit a signal to the outside equipment (i.e., “display devices,” para [0095]) at a second frequency (para [0035], [0221], and [0229]), and after the outside equipment responds, a communication is established between the analyte detection device and the outside equipment (“two-way data communication,” para [0137]),
wherein the wake-up module comprises a light sensing element (“optical detection circuit,” para [0143]), the shell comprises a light-transmitting area, external light irradiates to the light sensing element through the light-transmitting area (para [0143], [0245], and/or [0263]).
Halac does not expressly disclose the light-transmitting area comprises at least one light-transmitting hole in which a light-transmittance film is arranged.
However, McCluskey teaches wherein a light-transmitting area comprises at least one light-transmitting hole in which a light-transmittance film is arranged (para [0031]).
It would have been obvious to a skilled artisan to modify Halac wherein the light-transmitting area comprises at least one light-transmitting hole in which a light-transmittance film is arranged, in view of the teachings of McCluskey, because such a structural arrangement is a suitable structural arrangement for optical detection systems, such as the system in Halac.
For claim 2, Halac further discloses wherein after the shell is separated from the housing, external light irradiates to the light sensing element through the shell, and one of the triggering conditions is a change of the external light irradiated to the light sensing element (para [0143], [0245], and/or [0263]).
For claim 7, Halac further discloses wherein the housing is provided with a magnetic component (para [0215]-[0217] and/or [0219]-[0220]), and the wake-up module comprises a magnetic induction element (para [0215]-[0217] and/or [0219]-[0220]), wherein the magnetic induction element comprises a hall element(para [0216-[0217] and [0219]).
For claim 8, Halac further discloses wherein the magnetic induction element senses a magnetic field of the magnetic component (para [0215]-[0217] and/or [0219]-[0220]), and one of the triggering conditions is a change of the magnetic field sensed by the magnetic induction element (para [0215]-[0217] and/or [0219]-[0220]).
For claim 9, Halac further disclose wherein the wake-up module comprises an acceleration sensor (para [0224]-[0231], [0234], and [0236]-[0237]).
For claim 10, Halac further discloses wherein the acceleration sensor senses a motion state of the analyte detection device (para [0224]-[0231], [0234], and [0236]-[0237]), and one of the triggering conditions is a change of a motion parameter of the analyte detection device (para [0224]-[0231], [0234], and [0236]-[0237]).
For claim 11, Halac further discloses wherein the first frequency is less than the second frequency (para [0221] and [0229]).
For claim 12, Halac further discloses wherein the second frequency is 12-3600 times/hour (para [0231]).
Halac does not expressly disclose wherein the first frequency is 0-12 times/hour.
However, Halac does teach wherein the first frequency is greater than sampling every 1 minute (para [0231]).
It would also have been obvious to a skilled artisan to optimize Halac wherein the first frequency is 0-12 times/hour given that Halac recognizes that the sampling frequency may be greater 1 minute and that greater time may be dependent on the specific application (see para [0231] of Halac). In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969); See also In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). A skilled artisan would have been motivated to make such a modification for the obvious advantage of reducing power consumption (even further).
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Halac in view of McCluskey, and further in view of U.S. Patent Application Publication No. 2020/0030530 to Huang et al. (hereinafter “Huang”).
For claim 4, Halac and McCluskey do not expressly disclose wherein a material of the shell or the light-transmitting area is one of polymethyl methacrylate, polystyrene, polycarbonate and poly 4-methyl-1-pentene.
However, Huang teaches wherein a material of a shell is one of polymethyl methacrylate, polystyrene, polycarbonate and poly 4-methyl-1-pentene (para [0064]).
It would have been obvious to a skilled artisan to modify Halac wherein a material of the shell or the light-transmitting area is one of polymethyl methacrylate, polystyrene, polycarbonate and poly 4-methyl-1-pentene, in view of the teachings of Huang, because such materials are suitable materials that would work well with the optical detection system of Halac.
For claim 5, Halac and McCluskey do not expressly disclose wherein a light transmittance of the shell or the light-transmitting area is 40%-95%.
However, Huang teaches wherein a light transmittance of the shell or the light-transmitting area is 40%-95% (Examiner’s Note: see paragraph that bridges pages 3-4 of Applicant’s specification as originally filed, which provides evidence of what materials can achieve this light transmittance) (para [0064]).
It would have been obvious to a skilled artisan to modify Halac wherein a light transmittance of the shell or the light-transmitting area is 40%-95%, in view of the teachings of Huang, because such a light transmittance is a suitable light transmittance that would work well with the optical detection system of Halac.
Response to Arguments
Applicant’s arguments filed 5/4/26 have been fully considered.
With respect to the claim objections, Applicant’s amendments and arguments are persuasive and thus the objections are withdrawn.
With respect to the 112 invocations and 112 rejections, some of these are withdrawn in view of Applicant’s amendments and arguments and some are maintained. With respect to the ones that are maintained, the reasoning for the rejections is provided above. Mainly, there is a lack of evidence that the terms are structural and a skilled artisan would not have recognized them as being a definitive structural term.
With respect to the 102/103 rejections, Applicant’s arguments will be treated in the order they were presented. With respect to the first argument, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Specifically, McCluskey is not relied upon for “device wake-up or state transition (see page 14 of the response filed 5/4/26), Halc is. With respect to the second argument, this argument is a red herring. McCluskey is not being relied upon for the analyte it is detecting, it is merely being relied upon for the structure of the light-transmitting area and the light-transmitting film. Therefore, arguing that the analyte of McCluskey is immaterial to the rationale that McCluskey is being relied upon for the modification in the rejection.
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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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