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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2023 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Species A, claims 1-3 and 7-10, in the reply filed on 4/21/2026 is acknowledged. The traversal is on the grounds that there would be no undue burden on the examiner to consider all of the claims in a single application. This is not found persuasive because as previously outlined in the restriction requirement, the species require a different field of search (e.g. searching different CPC classes/symbols or electronic resources or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species; and/or the species are likely to raise different non-prior art issues under 35 U.S.C. 101 and/or 35 U.S.C. 112(a). In the instant case, prior art that applies to the currently elected claims would not be applicable to another species regarding the concave structure of the cover and/or substrate and thus would require additional different fields of search that would result in undue burden on the examiner.
The examiner notes that the restriction requirement between species would be withdrawn if generic independent claim 1 were amended to be in condition for allowance over the prior art of record (and such amendments did not cause any 112(a) written description issues for mixing of embodiments that are not supported in the specification to show possession at the time of filing).
The requirement is still deemed proper and is therefore made FINAL.
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.
No claim limitations in the instant claims are being interpreted as invoking 35 USC 112(f).
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 1-3, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Chu et al (US 2019/0137332 A1) or, in the alternative, under 35 U.S.C. 103 as obvious over Chu in view of Hong et al (US 2019/0082985 A1).
Examiner’s note on claim interpretation: The preamble of independent claim 1 recites “a curved non-invasive blood glucose monitoring module”; but the body of the claim does not incorporate or recite any additional limitations that tie the structure or function of any of the elements within the body of the claim to carrying out the blood glucose monitoring limitation of the preamble. Accordingly, the examiner contends that the “blood glucose monitoring” limitation of the preamble could be interpreted as the intended use of a curved non-invasive monitoring module having the structure as recited in the body of the claim. See MPEP 2111.02. However, in order to be thorough and promote compact prosecution, the examiner is providing the following rejections in the alternative, a first interpretation rejected under 35 USC 102(a)(1) where the preamble does not carry patentable weight in the scope of the claim (i.e. the prior art structure is capable of carrying out the intended function of glucose monitoring); and a second interpretation rejected under 35 USC 103 where the preamble does carry patentable weight in the interpretation of the claim scope.
Regarding claims 1-3, 7 and 8; Chu discloses a curved non-invasive blood glucose monitoring module, comprising:
a substrate (element 140),
a barrier structure (element 130), disposed on the substrate and forming a first space (space accommodating light emitting element 110) and a second space (space accommodating light sensing element 120) isolated from each other (figures 50A-C),
a light emitting element (element 110), disposed on the substrate and located in the first space (figures 50a-c),
a sensing element (element 120), disposed on the substrate and located in the second space (figures 50a-c), and
a transparent cover (combined element 150 and 152), combined with the barrier structure (element 130) to enclose the first space and the second space (wherein first and second spaces are enclosed by elements 130, 150 and 152; see figures 50a-c),
wherein at least one of the substrate (element 140) and the transparent cover (combined element 150 and 152) is a curved structure (wherein cover elements 150 and 152 has a curvature; paragraph [0171], figures 50a-c) .
As noted in the examiner’s note, the examiner contends that Chu meets the BRI of currently recited claim 1 under 35 USC 102(a)(1) given the interpretation where “blood glucose monitoring” is an intended use of the curved non-invasive monitoring module.
In the alternative, regarding the interpretation of claims 1-3, 7 and 8 where “blood glucose monitoring” is given patentable weight such that it affects the structure of the claims; Chu is described above but does not explicitly disclose that the curved non-invasive monitoring module is configured to monitor blood glucose.
Hong teaches a similar non-invasive optical monitoring module wherein the non-invasive optical monitoring module (figures 3a, 3b, 4a-c) can use the data collected by the optical emitter and receiver to monitor blood glucose (paragraph [0141]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Chu’s optical curved non-invasive monitoring module to utilize to collected/sensed optical data to monitor glucose as taught by Hong in order to monitor additional physiological parameters of interest.
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Further regarding claim 2; Chu discloses the barrier structure (element 130) includes a main retaining wall (wall separating first and second spaces; figures 50a-c; see annotated figure above) and a peripheral retaining wall (wall that forms outer circular perimeter of first and second spaces; figures 50a-c; see annotated figure above), and wherein the main retaining wall is disposed between the first space and the second space, and the peripheral retaining wall connects the main retaining wall and surrounds the main retaining wall, the first space and the second space (figures 50a-c; see annotated figure above).
Further regarding claim 3; Chu discloses the transparent cover (element 152) is a convex cover, the substrate is a flat substrate, and a height of the main retaining wall is greater than a height of the peripheral retaining wall (figures 50a-c; see annotated figure above).
Further regarding claim 7; Chu discloses the barrier structure (element 130) is made of non-transparent materials (wherein partition element 130 blocks light from the light source and is made of an opaque material; paragraph [0102]; figures 50a-c).
Further regarding claim 8; Chu discloses a transparent encapsulant material (elements 111 and 121) is filled within the first space (element 111) and the second space (element 121) to protect the light emitting element and the sensing element (wherein providing protection is functional and the structure of Chu’s encapsulant is also provided and meets the BRI of the claim, and therefore the encapsulant elements 111 and 121 also provides protection; paragraph [0098]; figures 50a-c).
Claim Rejections - 35 USC § 103
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Chu or, in the alternative, Chu in view of Hong.
Chu and/or Chu in view of Hong is described in the rejection of claim 1 above; furthermore, Chu discloses the cover elements 150 comprise a curvature (paragraph [0171]). However, Chu and/or Chu/Hong do not explicitly disclose that the radius of curvature is between 10 mm and 1000 mm.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have Chu’s radius of curvature to be between 10 mm and 1000 mm since it has been held that “where the only difference between the prior art and the claims was the recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Chu would not operate differently with the claimed radius of curvature between 10 and 1000 mm and since the cover element 150 has a curvature for dispersing and receiving light, the device would function appropriately having the claimed radius of curvature. Further, the applicant does not provide any criticality to the use of a curvature of between 10 mm and 1000 mm, as the applicant’s specification merely discloses the simple statement that the curvature of radius is between 10 mm and 1000 mm (specification page 11, line 17 – page 12, line 1) with no rationale or criticality.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Chu in view of Hong.
The Chu and the Chu/Hong combination is described in the rejection of claim 1 above; however, Chu does not explicitly disclose the transparent cover includes a light emitting coating film and a light receiving coating film, and wherein a configured position of the light emitting coating film corresponds to the position of the first space, and a configured position of the light receiving coating film corresponds to the position of the second space.
Hong, as described above, teaches a similar curved optical non-invasive monitoring module, and further teaches that any in any of the light-transmissive structures, the exposed surfaces of the optics or device body may include a hard coat paint, hard coat dip, or optical coating and that the characteristics or materials of the coatings are to improve the operation, accuracy and/or longevity of the physiological monitoring device (paragraph [0149]).
Regarding claim 10; Chu discloses light transmissive structures (elements 152) on the cover (element 150) disposed over the light emitting and light receiving elements of the module (see figures 50a-c). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Chu and/or further modify the Chu/Hong combination to include a coating on the light transmissive structures (elements 152) disposed over the light emitting element and the light receiving element as taught by Hong in order to improve the operation, accuracy and/or longevity of the physiological monitoring device. Therefore, the Chu/Hong combination would transparent cover would include a light emitting coating film and a light receiving coating film, and wherein a configured position of the light emitting coating film corresponds to the position of the first space, and a configured position of the light receiving coating film corresponds to the position of the second space, as required by the claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2022/0085231 A1 to Liu; discloses an optical sensor package which can measure physiological parameters including a curved surface.
US 2016/0061726 A1 to Ness; discloses a reflective surface treatment for optical sensors and includes at least one embodiment with a curved transparent cover (see figures 3c and 3e)
US 2021/0278561 A1 to Mehra et al; discloses an optical sensor which can measure physiological parameters including a curved transparent cover (see figures 3-5a)
US 12,204,289 B1 to Allec et al; discloses an optical sensor module which can measure physiological parameters including a curved transparent cover (see figures 6a-c)
US 10,918,322 B2 to Shao et al; discloses an optical sensor module which can measure physiological parameters including a curved transparent cover (see figures 2b, 2d, and 3a-g)
US 10,015,582 B2 to Wagner et al; discloses earbud monitoring devices including an optical sensor module which can measure physiological parameters including a curved transparent cover (see at least figures 2, 6 and 12b)
US 10,080,527 B2 to Golda et al; discloses a health monitoring system including an optical sensor module which can measure physiological parameters including a curved transparent cover (see figures 1k).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
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, 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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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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