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 .
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:
“Driving unit” in claim 1 because the claim limitation uses a generic placeholder (i.e., “unit”) that is coupled with functional language (i.e., “driving” and “to drive the light emitting element”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to a LED driver board, as indicated in ¶ [0036] of the published application, and equivalents thereof.
“Control unit” in claim 1 because the claim limitation uses a generic placeholder (i.e., “unit”) that is coupled with functional language (i.e., “control” and “for sending signals to the driving unit or receiving signals from the driving unit”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to a circuit board, as indicated in ¶ [0036] of the published application, and equivalents thereof.
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 § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4, 5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0207581 A1 (Shen) (previously cited) in view of US 2024/0374155 A1 (Endoh) (previously cited) and US 8,786,689 B1 (Liu)
With regards to claim 1, Shen teaches a non-invasive blood glucose monitoring device (¶ [0027] discloses the optical sensing device for measuring blood sugar concentration; Fig. 12B and ¶ [0081] depict an embodiment of the optical sensing device), comprising: a flexible substrate (¶ [0081] depict a flexible substrate 609), at least one blood glucose monitoring module, arranged on the flexible circuit board (see annotated Fig. 12B below; Fig. 12B and ¶ [0082] depict a combination of optical structure 604 which covers cavities 605 in which light receiver 601 and the light emitter 602 reside), each blood glucose monitoring module including a barrier structure, having a first space and a second space isolated from each other (Fig. 12B and ¶ [0081] depict the housing 606 forming walls which define the cavities 605), a light emitting element, located in the first space (Fig. 12B and ¶ [0081] depict a cavity 605 in which a light emitter 602 resides), a light sensing element, located in the second space (Fig. 12B and ¶ [0081] depict a cavity 605 in which a light receiver 601 resides) and a cover, combined with the barrier structure to enclose the first space and the second space (Fig. 12B and ¶ [0082] depict an optical structure 604 which covers the cavities 605), and an adhesive layer (Fig. 12B and ¶ [0082] depict an adhesive layer 608).
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Annotated Fig. 12B of Shen
The above embodiment of Shen is silent regarding whether the flexible substrate is a flexible circuit board.
In a related embodiment, Shen teaches a substrate being a flexible circuit board (Fig. 1 and ¶ [0029] depict a substrate 103 being a flexible circuit board). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the substrate of the embodiment of Fig. 12B of Shen to incorporate that it is a flexible circuit board as taught in ¶ [0029] of Shen. The motivation would have been to provide the structure for electrically connecting the light receiver and emitter to other electronic elements (see ¶ [0029] of Shen).
The above combination is silent regarding whether the cover is transparent.
In a related embodiment, Shen teaches a cover being transparent (¶ [0032] and Fig. 1 depict light emitted by light emitter 102 passing through covers 104). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the optical structure 604 of the above combination of Shen to incorporate that it is transparent as taught by ¶ [0032] of Shen. The motivation would have been to allow for a more accurate diagnostic measurement.
The above combination is silent regarding whether the adhesive layer is arranged on the flexible circuit board and located around the at least one blood glucose monitoring module.
In a system relevant to the problem of adhering optical sensors to a subject, Endoh teaches an adhesive layer arranged on a flexible substrate and located around at least one monitoring module (Figs. 2-3 and ¶¶ [0051], [0068] depict an adhesive layer 111 on a substrate 110 and surrounding light emitters 11 and light receiving element array 12). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination of Shen to incorporate an adhesive layer arranged on the flexible circuit board and located around the at least one blood glucose monitoring module based on the teachings of Endoh. The motivation would have been to reduce discomfort to the skin (see ¶ [0068] of Endoh).
The Examiner notes that “driving unit” is being interpreted to correspond to a LED driver board, as indicated in ¶ [0036] of the published application, and equivalents thereof. “Control unit” is being interpreted to correspond to a circuit board, as indicated in ¶ [0036] of the published application, and equivalents thereof.
Although the above combination teaches a power module electrically connected to the flexible circuit board (Fig. 12B and ¶ [0081] of Shen depict a power module 611 electrically connected to the flexible substrate 609) and the power module is electrically connected to the light emitting element (see the related embodiment in Fig. 12A in which the conductor 509C electrically connects the power module 511 to the light emitter 502), the above combination is silent regarding a driving unit, electrically connected to the flexible circuit board to drive the light emitting element, and a control unit, electrically connected to the driving unit for sending signals to the driving unit or receiving signals from the driving unit.
In a system relevant to the problem of electrically powering LED’s, Liu teaches a driving unit, electrically connected to an element to drive the light emitting element (Figs. 4, 5a-b and Col. 5, lines 18-38 depict a LED drive board 412a connected to LED via an electrical line), and a control unit, electrically connected to the driving unit for sending signals to the driving unit or receiving signals from the driving unit (Figs. 4, 5a-b and Col. 5, lines 18-38 depict a control circuit board 440 for controlling the LED 210 via LED drive board 412a). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the structure for powering the light emitter of above combination to incorporate, based on the teachings of Liu, a driving unit, electrically connected to the flexible circuit board to drive the light emitting element, and a control unit, electrically connected to the driving unit for sending signals to the driving unit or receiving signals from the driving unit. Because both the elements of Shen and Liu are capable of powering the light emitter, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 4, the above combination is silent regarding whether the flexible circuit board defines an installation area, the at least one blood glucose monitoring module is arranged on the installation area, and the adhesive layer is located outside the installation area and surrounds the at least one blood glucose monitoring module.
In a system relevant to the problem of adhering optical sensors to a subject, Endoh teaches a flexible substrate defines an installation area, the at least one monitoring module is arranged on the installation area (see annotated Fig. 2 of Endoh below; Figs. 2-3 and ¶ [0068] depict an area of the substrate 110 which is not covered by the adhesive layer 11 but contains the light emitters 11 and light receiving element array 12), and the adhesive layer is located outside the installation area and surrounds the at least one monitoring module (Figs. 2-3 depict the adhesive layer 111 being disposed outside the area comprising 11 and 12 and surrounds the area comprising 11 and 12). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination, based on the teachings of Endoh, to incorporate the flexible circuit board defines an installation area, the at least one blood glucose monitoring module is arranged on the installation area, and the adhesive layer is located outside the installation area and surrounds the at least one blood glucose monitoring module. The motivation would have been to shield the optical module from outside light (see ¶ [0068] of Endoh).
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Annotated Fig. 2 of Endoh
With regards to claim 5, the above combination teaches or suggest a height of the adhesive layer is not less than an overall height of each blood glucose monitoring module (Fig. 3 of Endoh depicts the adhesive layer 111 having the same height as the optical measurement elements 11 and 12).
With regards to claim 8, the above combination is silent regarding whether the barrier structure is made of non-transparent materials.
In a related embodiment, Shen teaches a barrier structure is made of non-transparent materials (Fig. 1 and ¶ [0030] depict a housing 106 forming a barrier structure, wherein the housing 106 is an opaque structure to prevent ambient stray lights from entering the cavities 105 through lateral sides of the housing 106). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the barrier structure of Shen of the above combination to incorporate that it is opaque as taught by ¶ [0030] of Shen. The motivation would have been to prevent ambient stray lights from entering the cavities through lateral sides of the housing (¶ [0030] of Shen).
With regards to claim 9, the above combination teaches or suggests the first space and the second space is filled with a transparent packaging material for protecting the light emitting element and the light sensing element (¶ [0081] of Shen discloses the cavities 605 in which the light emitter 602 and the light receiver 601 reside can also be filled with a light-transmittable material 6051).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Endoh and Liu, as applied to claim 1 above, and further in view of US 2021/0121116 A1 (Kreuzer) (previously cited).
With regards to claim 2, the above combination is silent regarding whether the
the flexible circuit board includes a base layer, a first conductive layer, and a first protective layer, and the base layer has a first surface and a second surface, and wherein the first conductive layer is disposed on the first surface, and the first protective layer is disposed on the first conductive layer.
In a system relevant to the problem of forming flexible circuit boards, Kreuzer teaches a flexible circuit board (Fig. 2 and ¶ [0058] depict a flexible printed circuit board FPCB 5) which includes a base layer (Fig. 2 and ¶ [0058] depict a further dielectric layer 55), a first conductive layer (Fig. 2 and ¶ [0058] depict a signal layer 53 being a conductive layer), and a first protective layer (Fig. 2 and ¶ [0058] depict a first dielectric layer 52), and the base layer has a first surface and a second surface (Fig. 2 depicts further dielectric layer 55 having bottom and top surfaces), and wherein the first conductive layer is disposed on the first surface (¶ [0058] and Fig. 2 depict an optional adhesive layer 54 between signal layer 53 and further dielectric layer 55. Because Kreuzer teaches the adhesive layer 54 is optional, Kreuzer also contemplates an embodiment in which the signal layer 53 is directly on top of the further dielectric layer 55), and the first protective layer is disposed on the first conductive layer (Fig. 2 depicts first dielectric layer 52 being on the signal layer 53). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the flexible circuit board of Shen of the above combination with the flexible circuit board of Kreuzer. Because both circuit boards are flexible and are capable of providing a connection between elements, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
With regards to claim 3, the above combination teaches or suggests the
the flexible circuit board further includes a second conductive layer and a second protective layer (Fig. 2 and ¶ [0058] depict an optional further signal layer 56 (i.e., a second conductive layer) and a solder mask layer 57 and dielectric coating 58 (i.e., second protective layers), and wherein the second conductive layer is disposed on the second surface (Fig. 2 depicts the further signal layer 56 being disposed on the bottom surface of the further dielectric layer 55), and the second protective layer is disposed on the second conductive layer (Fig. 2 and ¶ [0058] depict or contemplate both solder mask layer 57 and dielectric coating 58 on the further signal layer 56).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Endoh and Liu, as applied to claim 1 above, and further in view of US 2015/0238098 A1 (Park) (previously cited).
With regards to claim 6, the above combination is silent regarding whether a quantity of the at least one blood glucose monitoring module is plural, and wherein the blood glucose monitoring modules are arranged in pairs at intervals on the flexible circuit board.
In the same field of endeavor of optical measurements of a subject, Park teaches a plurality of light sensor/detector modules, wherein the modules are arranged in pairs at intervals (Fig. 2B and ¶ [0061] depict a first pair of light sensor/detector modules comprising 210-1, 220-1, 210-2, 220-2 and a second pair comprising 210-3, 220-3, 210-4, 220-4). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the glucose monitoring module of Shen of the above combination to incorporate, based on the teachings of Park, that there are a plurality of blood glucose monitoring modules, wherein the blood glucose monitoring modules are arranged in pairs at intervals on the flexible circuit board. The motivation would have been to increase the number of modules such that diagnostic information of the object may be more precisely acquired (see ¶ [0061] of Park).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Endoh and Liu, as applied to claim 1 above, and further in view of US 2002/0026108 A1 (Colvin) (previously cited).
With regards to claim 7, the above combination is silent regarding whether each of the at least one blood glucose monitoring module further includes a ceramic substrate, and each of the at least one blood glucose monitoring module is connected to the flexible circuit board through the ceramic substrate.
In the same field of endeavor of electro-optical sensing devices, Colvin teaches at least one monitoring module further includes a ceramic substrate (Fig. 14C and ¶¶ [0147], [0148] depict a radiation source 18 and photosensitive element 20 arranged on a circuit board 70 made of a ceramic material), and each monitoring module is connected to the flexible circuit through the ceramic substrate (Fig. 14C and ¶ [0148] depict the sensors connected toa flexible circuit 70’ via the circuit board 70 and electrical leads or contacts 71). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the blood glucose monitoring modules of Shen of the above combination, based on the teachings of Colvin, such that each of the at least one blood glucose monitoring module further includes a ceramic substrate, and each of the at least one blood glucose monitoring module is connected to the flexible circuit board through the ceramic substrate. The motivation would have been to allow for the module to be detachable, thereby allowing for more flexibility in the circuit design.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Endoh and Liu, as applied to claim 1 above, and further in view of 2024/0159949 A1 (Shih) (previously cited).
With regards to claim 10, the above combination is silent regarding whether the transparent cover has a coating film, and the coating film is a layered structure formed by alternately stacking of silicon monohydride layers and silicon dioxide layers.
In a system relevant to the problem of selectively transmitting light, Shih teaches an transparent substrate having a coating film (Fig. 1 and ¶ [0035] depicts a substrate 100 having a filtering stack 110 thereon; ¶ [0032] depicts the substrate 100 being made of glass and being transparent) and the coating film is a layered structure formed by alternately stacking of silicon monohydride layers and silicon dioxide layers (¶¶ [0035]-[0036] depicts the filtering stack 110 including layers 112 and 114’ alternately arranged, wherein first layers 112 and second layers 114’ made of silicon hydride (SiH) and silicon dioxide, respectively). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the transparent cover of Shen of the above combination to incorporate that the transparent cover has a coating film, and the coating film is a complex layered structure formed by alternately stacking of silicon monohydride layers and silicon dioxide layers, as taught by Shih. The motivation would have been to provide an optical filter that would allow for the transmission of desired incident light to transmit (see ¶ [0004] of Shih), thereby improving the accuracy of the optical blood glucose monitoring modules.
Response to Arguments
Rejections under 35 U.S.C. §112(b)
In view of the claim amendments filed 03/04/2026, the rejection of claim 10 under 35 U.S.C. §112(b) was withdrawn.
Rejections under 35 U.S.C. §103
Applicant' s amendment and arguments filed 03/04/2026 with respect to the 35 USC 103 rejections set forth in the Non-Final Rejection mailed 12/04/2025 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 8,786,689 B1 (Liu). See the above rejections.
Conclusion
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 SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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