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 .
Specification
The abstract of the disclosure is objected to because the text should be a single paragraph and the expression “Systems and methods for monitoring eye health” in line 1 should be deleted. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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:
“a component for determining the an angle of a recline of the user” in claim 3.
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 Objections
Claim 5 is objected to because of the following informalities:
in claim 5, line 4: a comma should be inserted after “asymmetric objects”.
Appropriate correction is required.
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 1-17 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.
Claim 1 recites “changes in distance between two or more preselected target regions on or in a sclera of the eye of a user” in lines 10-11, but it is not clear how one can obtain a single distance among three or more points when a distance is thought of as being between two points. As such, the expression “or more” in this recitation causes confusion that renders claim 1 indefinite.
Claim 1 recites “the eye” in line 11 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “changes in distance between the two or more preselected target regions” in lines 14-15, but it is not clear if this recitation is the same, related to, or different from “changes in distance between two or more preselected target regions on or in a sclera of the eye of a user” in lines 10-11. If they are the same, “changes in distance between the two or more preselected target regions” in lines 14-15 should be “the changes in the distance between the two or more preselected target regions”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent mention of such changes should make it clear which recitation is being referred to.
Related to the preceding paragraph, “changes in distance between the two or more preselected target regions” of claim 1, lines 14-15 (regardless of whether it is the same as or different from “changes in distance between two or more preselected target regions on or in a sclera of the eye of a user” of claim 1, lines 10-11) is indefinite since it is not clear how one can obtain a single distance among three or more points when a distance is thought of as being between two points. As such, the expression “or more” in this recitation causes confusion that renders claim 1 indefinite.
Claims 2-17 are rejected by virtue of their dependence from claim 1.
Claim 6 recites:
“[A] wherein the separated symmetric objects comprise two dots and
[B] the two separated asymmetric objects comprise a dot and an arc,
[C] wherein the two separated symmetric objects and the two separated asymmetric objects comprise markers, the markers comprising ink or dye, and the system further comprising a dual marking tool for applying markers to the surface of an eye as two markers that are separated by a fixed distance predetermined with the dual marking tool”
in lines 1-6, which renders the claim indefinite.
First, claim 5 recites “wherein the two or more preselected target regions are two separated symmetric implanted objects, two separated asymmetric implanted objects, two separated symmetric objects, two separated asymmetric objects or two distinct sclera regions” in lines 1-4, which connotes that two separated symmetric implanted objects, two separated asymmetric implanted objects, two separated symmetric objects, two separated asymmetric objects, and two distinct sclera regions are alternatives to each other such that the claimed system only requires that the preselected target region can only be one of two separated symmetric implanted objects, two separated asymmetric implanted objects, two separated symmetric objects, two separated asymmetric objects, or two distinct sclera regions. In contrast, claim 6 further defines the separated symmetric objects, the two separated asymmetric objects, the two separated symmetric objects, and the two separated asymmetric objects, which seems to connote that all of the separated symmetric objects, the two separated asymmetric objects, the two separated symmetric objects, and the two separated asymmetric objects are required. This contradiction renders claim 6 indefinite.
Second, under the interpretation that the claims system only requires one of the separated symmetric objects, the two separated asymmetric objects, the two separated symmetric objects, and the two separated asymmetric objects, it is not clear what meaning can be ascribed to those limitations that do not read on the said one of the separated symmetric objects, the two separated asymmetric objects, the two separated symmetric objects, and the two separated asymmetric objects. For example, if only recitation [A] is applicable, what are the meanings of the recitations [B] and [C] which further define elements not part of the claimed invention? Similarly, if only recitation [B] is applicable, what are the meanings of the recitations [A] and [C] which further define elements not part of the claimed invention? Also, if only recitation [C] is applicable, what are the meanings of the recitations [A] and [B] which further define elements not part of the claimed invention? Further, how is recitation [C] to be parsed out since it recites two mutually exclusive elements (the two separated symmetric objects and the two separated asymmetric objects) in its recitation.
Third, claim 6 recites “markers” in line 5, but it is not clear if this recitation is the same as, related to, or different from “markers” of claim 6, line 4. If they are the same, “markers” in line 5 should be “the markers”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent mention of such markers should make it clear which recitation is being referred to.
Fourth, claim 6 recites “the surface” in which there is insufficient antecedent basis for this limitation in the claim.
Fifth, claim 6 recites “an eye” in line 5, but it is not clear if this recitation is the same as, related to, or different from “the eye” of claim 1, line 11. If they are the same, “an eye” in line 5 should be “the eye”. If they are different, their relationship should be made clear, they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent mention of the eye should make it clear which recitation is being referred to.
Claim 10 recites “the illumination levels” in line 3 in which there is insufficient antecedent basis for this recitation in the claim.
Claim 10 recites “a wearer” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a user” of claim 1, line 11. If they are the same, “an eye of a wearer” in claim 10 should be “the eye of the user”.
Claims 11-13 are rejected by virtue of their dependence from claim 10.
Claim 11 recites “the near-infrared range” in line 2 in which there is insufficient antecedent basis for this recitation in the claim.
Claim 16 recites “wherein the power source is a rechargeable battery or an external power source” in lines 1-2, but this recitation conflicts with the recitation “a) a wearable device comprising:…v) a power source” in lines 3-8. The power source is either part of the wearable device or it is an external power source. It cannot be both. This contradiction renders claim 16 indefinite.
Claim 17 recites “veins” in line 3 and “other veins” in line 3, but it is not clear if these recitations are the same as, related to, or different from “conjunctiva veins” of claim 17, line 2 or “sclera veins” of claim 17, line 2. The relationship among these recitations should be made clear.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 10,806,341 (the reference patent). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 of the reference patent has all the features of claim 1 of the present application.
Claim 4 of the reference patent has all the features of claim 5 of the present application.
Claims 2, 7, and 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of U.S. Patent No. 2002/0113943 (Trajkovic) and U.S. Patent Application Publication No. 2014/0055746 (Nistico).
Claim 1 of the reference patent includes a wearable device with image sensors, a CPU. a memory storage device, connecting wires, and a power source. FIG. 1 of Trajkovic discloses a single structure supporting cameras C1, C2; a control unit 100 housing a processor and a memory; and connecting wires (paragraphs 0025-0026 of Trajkovic). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a single structure to support the components of claim 1 of the reference patent since it makes the system more compact. Nistico discloses that frames can be such a structure (FIGS. 1A- 1D and 2 and paragraphs 0057-0060 of Nistico). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the frames of Nistico as the support structure since a support structure is required and Nistico teaches one such structure and/or it is a simple substitution of one known element for another to obtain predictable results. Thus, claim 1 of the reference patent as modified has all the features of claim 2 of the present application.
With respect to claim 7, claim 1 of the reference patent contemplates a plurality of image sensors. Trajkovic teaches two digital optical sensors (the CCD array of Trajkovic; paragraph 0031 of Trajkovic). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the CCD arrays of Trajkovic as the image sensors since image sensors are required and Trajkovic teaches such sensors and/or it is a simple substitution of one known element for another to obtain predictable results. Thus, claim 1 of the reference patent as modified has all the features of claim 7 of the present application.
With respect to claims 10-11, claim 1 of the reference patent recites a wearable device with one or more illumination sources capable of emitting light at the near-infrared range, and capable of controlling illumination levels of an eye of the user. Nistico discloses that frames can support such illumination sources (see the LEDs 9 in the frames of FIG. 2 and paragraph 0061-0062 of Nistico). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the frames of Nistico as the support structure for the illumination sources since a support structure is required and Nistico teaches one such structure and/or it is a simple substitution of one known element for another to obtain predictable results. Thus, claim 1 of the reference patent as modified has all the features of claims 10-11 of the present application.
Claims 2-4 and 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of U.S. Patent No. 2002/0113943 (Trajkovic) and U.S. Patent Application Publication No. 2012/0293773 (Publicover).
Claim 1 of the reference patent recites a wearable device with image sensors, a CPU. a memory storage device, connecting wires, and a power source. FIG. 1 of Trajkovic discloses a single structure supporting cameras C1, C2; a control unit 100 housing a processor and a memory; and connecting wires (paragraphs 0025-0026 of Trajkovic). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a single structure to support the components of claim 1 of the reference patent since it makes the system more compact. Publicover discloses that frames can be such a structure (FIGS. 1-2 and paragraph 0069 of Publicover). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the frames of Publicover as the support structure since a support structure is required and Publicover teaches one such structure and/or it is a simple substitution of one known element for another to obtain predictable results. Thus, claim 1 of the reference patent as modified has all the features of claim 2 of the present application.
With respect to claims 3-4, Trajkovic teaches that movement of the head may be accommodated (paragraph 0037 of Trajkovic). Publicover teaches that an accelerometer may be used to detect movements of the user’s head as well as the overall user’s head orientation relative to the gravitational field of the earth (FIG. 2 and paragraph 0078 of Publicover). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the accelerometer on the combination so as to detect movements of the user’s head as well as the overall user’s head orientation relative to the gravitational field of the earth so as to provide the direction of the user’s head such that the system can accommodate the movement of the user’s head. Thus, claim 1 of the reference patent as modified has all the features of claims 3-4 of the present application.
With respect to claims 7-8, claim 1 of the reference patent contemplates a plurality of image sensors. Trajkovic teaches two digital optical sensors (the CCD array of Trajkovic; paragraph 0031 of Trajkovic). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use two optical sensors since a number of optical sensors are contemplated and Trajkovic teaches such a number. Publicover teaches that CMOS imagers attached to the frame are suitable imagers (paragraphs 0005 and 0070 of Publicover). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the two CMOS imagers attached to the frame as the image sensors of the combination since it is a simple substitution of one known element for another to obtain predictable results. Thus, claim 1 of the reference patent as modified has all the features of claims 7-8 of the present application.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4 of U.S. Patent No. 10,806,341 (the reference patent), in view of WO 2012/129405 (Brown).
Claim 4 of the reference patent includes that the two or more preselected target regions are two separated symmetric implanted objects, two separated asymmetric implanted objects, two separated asymmetric objects or two distinct sclera region. Brown teaches a marker device with a handle that permits the marking of the eye so as to provide target areas in the eye (abstract, FIG. 5; and paragraphs 0044-0056 of Brown) and Brown teaches that multiple marking tip configurations may be used (paragraph 0045 of Brown). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to the use of marker device, as suggested by Brown, that provides the inked dots as target areas since target areas and a method of delivery is required and Brown teaches such target areas and delivery method. Thus, claim 4 of the reference patent as modified has all the features of claim 6 of the present application.
Claim 9 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of U.S. Patent No. 2002/0113943 (Trajkovic) and U.S. Patent Application Publication No. 2012/0293773 (Publicover), and further in view of U.S. Patent No. 6,110,110 (Dublin).
The combination teaches the use of illumination sources and CCD array. Dublin discloses using a motor and platform so as to move the illuminating and detecting components (the motor 48 and platform 28 of Dublin; col. 13 of Dublin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a motor and platform so as to move the illuminating and detecting components so as to be able to ensure the relevant portions of the eye are measurement for a variety of different ocular geometries and arrangements. Thus, claim 1 of the reference patent as modified has all the features of claim 9 of the present application.
Claim 12 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of U.S. Patent No. 2002/0113943 (Trajkovic) and U.S. Patent Application Publication No. 2014/0055746 (Nistico), and further in view of U.S. Patent Application Publication No. 2012/0293773 (Publicover), and further in view of U.S. Patent Application Publication No. 2013/0128364 (Wheeler).
The combination includes the use of near-infrared wavelength as recited in claim 1 of the reference patent. Infrared wavelength includes those above 750 nm and below 1000 nm (paragraph 0073 of Nistico). Publicover teaches that 800 nm is of interest (paragraph 0039 of Publicover). From these teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the method so as to use a wavelength of 800 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see In re Aller, 105 USPQ 233) and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985) (Please see MPEP 2144.05).
Alternatively, Nistico is suggesting, with the teaching of a proposed range, that the selected infrared wavelength is subject to change. The selected infrared wavelength would depend upon the factors of preference, cost, availability, and accuracy. As such, the selected infrared wavelength is a results-effective variable that would have been optimized through routine experimentation based on the factors of preference, cost, availability, and accuracy. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, using the teachings of Nistico and Publicover as a starting points, to select the infrared wavelength so as to obtain the desired preference, cost, and accuracy based availability.
Wheeler teaches that the infrared may operate continuously, operate at discrete times, or be modulated at particular frequencies (paragraph 0050 of Wheeler).1 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modulate the infrared light for illumination and detection since (1) a method of operation is required and Wheeler teaches one such operation and/or (2) it is a simple substation of one known element for another to obtain predictable results and/or (3) it helps distinguish the infrared light of the system from other sources.
In view of the above, the feature of “wherein the one or more illumination sources is capable of being modulated at 800 nm” of claim 12 would have been obvious.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of U.S. Patent No. 2002/0113943 (Trajkovic) and U.S. Patent Application Publication No. 2014/0055746 (Nistico), and further in view of U.S. Patent Application Publication No. 2013/0128364 (Wheeler).
The combination includes the use of near-infrared wavelength as recited in claim 1 of the reference patent. Infrared wavelength includes those above 750 nm and below 1000 nm (paragraph 0073 of Nistico). Wheeler teaches that the infrared may operate continuously, operate at discrete times, or be modulated at particular frequencies (paragraph 0050 of Wheeler).2 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modulate the infrared light for illumination and detection since (1) a method of operation is required and Wheeler teaches one such operation and/or (2) it is a simple substation of one known element for another to obtain predictable results and/or (3) it helps distinguish the infrared light of the system from other sources
With respect to claim 13, the combination teaches or suggests that the one or more illumination sources is capable of being modulated in time (the modulation suggested by Wheeler). Thus, claim 1 of the reference patent as modified has all the features of claim 13 of the present application.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of U.S. Patent No. 2002/0113943 (Trajkovic) and U.S. Patent Application Publication No. 2012/0293773 (Publicover), and further in view of U.S. Patent Application Publication No. 2005/0165321 (Fischell), and further in view of U.S. Patent No. 6,110,110 (Dublin).
Fischell teaches the use of a programmer that works with a wireless communication interface and display collected/processed information (paragraphs 0054-0057 of Fischell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a programmer that works with a wireless communication interface so as to provide technical support to the device when programming assistance is required and to review collected/processed information to confirm proper operation. Dublin discloses the RF telemetry is a suitable wireless transmission (col. 13 of Dublin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use RF telemetry as the wireless communication interface since a wireless communication interface is required and Dublin teaches one such interface and/or it is a simple substitution of one known element for another to obtain predictable results. Thus, claim 1 of the reference patent as modified has all the features of claim 15 of the present application.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of U.S. Patent Application Publication No. 2013/0030257 (Nakata).
Claim 1 of the reference patent requires a power source. Nakata discloses a computing device with a rechargeable battery (paragraph 0223 of Nakata). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the wearable device include a rechargeable battery since it provides a renewable source of power to power the components of the CPU and/or a power source is required and Nakata teaches one such power source. Thus, claim 1 of the reference patent as modified has all the features of claim 16 of the present application.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,806,341 (the reference patent), in view of JP 2008104628 A (Giyourin). Citations to Giyourin will refer to the accompanying English machine translation.
Giyourin teaches a conjunctiva and sclera imaging apparatus which can image blood vessels, blood flow, and blood corpuscles of the conjunctiva and the sclera (Abstract of Giyourin). Giyourin further teaches that the imaging apparatus performs image processing on an image captured by the imaging unit so as to be able to recognize and track the conjunctival and scleral blood vessel pattern of the eyeball (pages 1-2 of Giyourin). These images may then be displayed (page 3 of Giyourin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform image processing on an image captured by the imaging unit so as to be able to recognize and track the conjunctival and scleral blood vessel pattern of the eyeball so as to provide useful diagnostic information to the practitioner.
With respect to claim 17, the combination teaches or suggests computer software that tracks and categorizes conjunctiva veins versus sclera veins using relative image intensity or distinguishing veins that move relative to other veins as the user moves the eye (the image processing and display of Giyourin). Thus, claim 1 of the reference patent as modified has all the features of claim 17 of the present application.
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.
Claims 1, 5, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 2002/0113943 (Trajkovic), in view of U.S. Patent Application Publication No. 2013/0030257 (Nakata).
Trajkovic discloses a method and a system for having two cameras and a control unit with a processor, a memory, and connecting wires (paragraph 0025-0026 of Trajkovic). Nakata discloses a computing device with a rechargeable battery (paragraph 0223 of Nakata). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the computing device of Trajkovic include a rechargeable battery since it provides a renewable source of power to power the components of the control unit of Trajkovic.
With respect to claim 1, the combination teaches or suggests a system for monitoring eye health, the system comprising:
a scleral strain monitor comprising
a) a wearable device comprising:
i) one or more image sensors (the image capturing components of Trajkovic),
ii) a CPU (the processor of Trajkovic; paragraph 0026 of Trajkovic),
iii) a memory storage device (the memory of Trajkovic; paragraphs 0026 and 0029 of Trajkovic),
iv) one or more connecting wires (the wires of Trajkovic; paragraph 0026 of Trajkovic), and
v) a power source (the battery of Nakata); and
wherein the one or more image sensors monitor a scleral stretch corresponding to changes in distance between two or more preselected target regions on or in a sclera of the eye of a user by recording at least two photographic images of the eye of the user, each of the at least two photographic images recorded at different times (FIGS. 1C-1D of Trajkovic; paragraphs 0033-0035 of Trajkovic), and
wherein the CPU receives the at least two photographic images from the one or more image sensors and determines changes in distance between the two or more preselected target regions based on changes in the at least two photographic images, then transmits the at least two photographic images to the memory storage device (FIGS. 1C-1D of Trajkovic; paragraphs 0033-0035 of Trajkovic).
With respect to claim 5, the combination teaches or suggests that the two or more preselected target regions are two separated symmetric implanted objects, two separated asymmetric implanted objects, two separated symmetric objects, two separated asymmetric objects or two distinct sclera regions (FIGS. 1C-1D of Trajkovic; paragraphs 0033-0035 of Trajkovic).
With respect to claim 16, the combination teaches or suggests that the power source is a rechargeable battery or an external power source (the battery of Nakata).
Claims 2, 7, 10-11, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Trajkovic, in view of Nakata, and further in view of U.S. Patent Application Publication No. 2014/0055746 (Nistico).
With respect to claim 2, FIG. 1 of Trajkovic discloses a structure supporting the cameras C1, C2; the control unit 100 housing the processor and the memory; and the connecting wires (paragraphs 0025-0026 of Trajkovic). Nistico discloses that frames can be such a structure (FIGS. 1A- 1D and 2 and paragraph 0057-0060 of Nistico). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the frames of Nistico as the support structure of Trajkovic since a support structure is required and Nakata teaches one such structure and/or it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 2, the combination teaches or suggests that the wearable device is a pair of eyeglass frames (the frames of Nistico) comprising the one or more image sensors, the CPU, the memory storage device, the one or more connecting wires, and the power source (as suggested by FIG. 1 of Trajkovic).
With respect to claim 7, the combination teaches or suggests that the one or more image sensors comprise 2, 3 or 4 digital optical sensors attached to the eyeglass frames or built into the eyeglass frames (the CCD arrays of Trajkovic; paragraph 0031 of Trajkovic).
With respect to claims 10-11, Trajkovic discloses a method and a system for having a camera and a control unit with a processor, memory, and connecting wires (paragraph 0025-0026 of Trajkovic). Nistico teaches that an infrared wavelength range is a suitable illumination wavelength for the camera since the human eye is not sensitive to it and it provides efficient capturing of the reflections created by the eye (paragraph 0023 of Nistico). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use an infrared wavelength as the illumination wavelength since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) the human eye is not sensitive to it and it provides efficient capturing of the reflections created by the eye.
With respect to claim 10, the combination teaches or suggests that the eyeglass frames further comprises one or more illumination sources capable of controlling the illumination levels of an eye of a wearer (the infrared illumination capability of the combination; paragraph 0023 of Nistico).
With respect to claim 11, the combination teaches or suggests the one or more illumination sources is capable of emitting light at the near-infrared range (the image capturing components of Trajkovic using the infrared capability suggested by Nistico; paragraph 0023 of Nistico).
With respect to claim 14, the combination teaches or suggests that the eyeglass frames further comprises prescription lenses or non-prescription lenses (the zoom lenses Z1 and Z2 of Trajkovic).
Claims 2-4, 7-8, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Trajkovic, in view of Nakata, and further in view of U.S. Patent Application Publication No. 2012/0293773 (Publicover).
With respect to claim 2, FIG. 1 of Trajkovic discloses a structure supporting the cameras C1, C2; the control unit 100 housing the processor and the memory; and the connecting wires (paragraphs 0025-0026 of Trajkovic). Publicover discloses that frames can be such a structure (FIGS. 1-2 and paragraph 0069 of Publicover). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the frames of Publicover as the support structure of Trajkovic since a support structure is required and Publicover teaches one such structure and/or it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 2, the combination teaches or suggests that the wearable device is a pair of eyeglass frames (the frames of Publicover) comprising the one or more image sensors, the CPU, the memory storage device, the one or more connecting wires, and the power source (as suggested by FIG. 1 of Trajkovic).
With respect to claims 3-4, Trajkovic discloses that movement of the head may be accommodated (paragraph 0037 of Trajkovic). Publicover teaches that an accelerometer may be used to detect movements of the user’s head as well as the overall user’s head orientation relative to the gravitational field of the earth (FIG. 2 and paragraph 0078 of Publicover). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the accelerometer on the combination so as to detect movements of the user’s head as well as the overall user’s head orientation relative to the gravitational field of the earth so as to provide the direction of the user’s head and so that the system can accommodate the movement of the user’s head.
With respect to claim 3, the combination teaches or suggests that the wearable device further comprises a component for determining the an angle of a recline of the user (the accelerometer of Publicover).
With respect to claim 4, the combination teaches or suggests that the component is an accelerometer (the accelerometer of Publicover).
With respect to claim 7, the combination teaches or suggests that the one or more image sensors comprise 2, 3 or 4 digital optical sensors attached to the eyeglass frames or built into the eyeglass frames (the CCD arrays of Trajkovic; paragraph 0031 of Trajkovic).
With respect to claim 8, the combination includes CCD arrays (paragraph 0031 of Trajkovic). Publicover teaches CMOS imagers are suitable substitutes for CCD imagers (paragraphs 0005 and 0070 of Publicover). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the CMOS imagers for the CCD imagers of Trajkovic since it is a simple substitution of one known element for another to obtain predictable results. Thus, the combination teaches or suggests that the one or more image sensors are CMOS imagers.
With respect to claim 14, the combination teaches or suggests that the eyeglass frames further comprises prescription lenses or non-prescription lenses (the zoom lenses Z1 and Z2 of Trajkovic).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Trajkovic, in view of Nakata, and further in view of Publicover, and further in view of U.S. Patent No. 6,110,110 (Dublin).
The combination teaches the use of illumination and CCD array. Dublin discloses using a motor and platform so as to move the illuminating and detecting components (the motor 48 and platform 28 of Dublin; col. 13 of Dublin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a motor and platform so as to move the illuminating and detecting components so as to be able to ensure the relevant portions of the eye are measurement for a variety of different ocular geometries and arrangements.
With respect to claim 9, the combination teaches or suggests the image sensors are motorized (using the motor 48 and platform 28 of Dublin).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Trajkovic, in view of Nakata, and further in view of Nistico, and further in view of Publicover, and further in view of U.S. Patent Application Publication No. 2013/0128364 (Wheeler).
The combination teaches that the infrared wavelength includes those above 750 nm and below 1000 nm (paragraph 0073 of Nistico). Publicover teaches that 800 nm is of interest (paragraph 0039 of Publicover). From these teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the method so as to use a wavelength of 800 nm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see In re Aller, 105 USPQ 233) and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,227 USPQ 773 (Fed. Cir. 1985) (Please see MPEP 2144.05).
Alternatively, Nistico is suggesting, with the teaching of a proposed range, that the selected infrared wavelength is subject to change. The selected infrared wavelength would depend upon the factors of preference, cost, availability, and accuracy. As such, the selected infrared wavelength is a results-effective variable that would have been optimized through routine experimentation based on the factors of preference, cost, availability, and accuracy. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, using the teachings of Nistico and Publicover as a starting points, to select the infrared wavelength so as to obtain the desired preference, cost, and accuracy based availability.
Wheeler teaches that the infrared may operate continuously, operate at discrete times, or be modulated at particular frequencies (paragraph 0050 of Wheeler).3 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modulate the infrared light for illumination and detection since (1) a method of operation is required and Wheeler teaches one such operation and/or (2) it is a simple substation of one known element for another to obtain predictable results and/or (3) it helps distinguish the infrared light of the system from other sources.
In view of the above, the feature of “wherein the one or more illumination sources is capable of being modulated at 800 nm” would have been obvious.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Trajkovic, in view of Nakata, and further in view of Nistico, and further in view of Wheeler.
The combination teaches that the infrared wavelength includes those above 750 nm and below 1000 nm (paragraph 0073 of Nistico). Wheeler teaches that the infrared may operate continuously, operate at discrete times, or be modulated at particular frequencies (paragraph 0050 of Wheeler).4 It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modulate the infrared light for illumination and detection since (1) a method of operation is required and Wheeler teaches one such operation and/or (2) it is a simple substation of one known element for another to obtain predictable results and/or (3) it helps distinguish the infrared light of the system from other sources
With respect to claim 13, the combination teaches or suggests that the one or more illumination sources is capable of being modulated in time (the modulation suggested by Wheeler).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Trajkovic, in view of Nakata, and further in view of U.S. Patent Application Publication No. 2012/0293773 (Publicover), and further in view of U.S. Patent Application Publication No. 2005/0165321 (Fischell), and further in view of Dublin.
Fischell teaches the use of a programmer that works with a wireless communication interface and display collected/processed information (paragraphs 0054-0057 of Fischell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a programmer that works with a wireless communication interface so as to provide technical support to the device when programming assistance is required and to review collected/processed information to confirm proper operation. Dublin discloses the RF telemetry is a suitable wireless transmission (col. 13 of Dublin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use RF telemetry as the wireless communication interface since a wireless communication interface is required and Dublin teaches one such interface and/or it is a simple substitution of one known element for another to obtain predictable results.
With respect to claim 15, the combination teaches or suggests that the eyeglass frames further comprises an RF antenna capable of transmitting the at least two photographic images received by the CPU to a wearable receiver or a Smartphone (paragraphs 0054-0057 of Fischell; col 13 of Dublin).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Trajkovic, in view of Nakata, and further in view of JP 2008104628 A (Giyourin). Citations to Giyourin will refer to the accompanying English machine translation.
Trajkovic discloses a method and a system for having two cameras and a control unit with a processor, a memory, and connecting wires (paragraph 0025-0026 of Trajkovic).
Giyourin teaches a conjunctiva and sclera imaging apparatus which can image blood vessels, blood flow, and blood corpuscles of the conjunctiva and the sclera (Abstract of Giyourin). Giyourin further teaches that the imaging apparatus performs image processing on an image captured by the imaging unit so as to be able to recognize and track the conjunctival and scleral blood vessel pattern of the eyeball (pages 1-2 of Giyourin). These images may then be displayed (page 3 of Giyourin). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to performs image processing on an image captured by the imaging unit so as to be able to recognize and track the conjunctival and scleral blood vessel pattern of the eyeball so as to provide useful diagnostic information to the practitioner.
With respect to claim 17, the combination teaches or suggests computer software that tracks and categorizes conjunctiva veins versus sclera veins using relative image intensity or distinguishing veins that move relative to other veins as the user moves the eye (the image processing and display of Giyourin).
Claims 1-2, 5, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over EP 1241976 (Clarke), in view of Publicover. Citations to Clarke will refer to the accompanying English machine translation.
Clarke discloses a method and a system for having an optoelectronic sensor, the computing architecture for digital image processing, and LEDs for infrared lighting (pages 1, 4-5, of Clarke). Publicover discloses the use of processing units for housing imaging processing (paragraphs 0022-0024 of Publicover), memories for storing images (paragraph 0077 of Publicover), a power source 18 for powering the components (paragraph 0069 of Publicover), connecting wires for electrically connecting the components (paragraph 0076 of Publicover), and frames supporting such components plus sensors (FIGS. 1-2 and paragraph 0069 of Publicover). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to (1) the use of the processing units of Publicover since it provides a medium for the computing architecture to be implemented; (2) to use the memories of Publicover for storing images so as to permit subsequent analysis, (3) to use the power source of Publicover so as to provide power to the electrical components; (4) to use the connecting wires of Publicover so that the components may interact as designed; and (5) to use the frames of Publicover so as to support such components plus the sensors in a compact way.
With respect to claim 1, the combination teaches or suggests a system for monitoring eye health, the system comprising:
a scleral strain monitor comprising a) a wearable device comprising:
i) one or more image sensors (the optoelectronic sensor of Clarke),
ii) a CPU (the processing units of Publicover housing the computing architecture of Clarke),
iii) a memory storage device (the memory of Publicover),
iv) one or more connecting wires (the wires of Publicover), and
v) a power source (the battery of Publicover); and
wherein the one or more image sensors monitor a scleral stretch corresponding to changes in distance between two or more preselected target regions on or in a sclera of the eye of a user by recording at least two photographic images of the eye of the user, each of the at least two photographic images recorded at different times (pages 4-6 of Clarke; FIGS. 4A-6C of Clarke), and
wherein the CPU receives the at least two photographic images from the one or more image sensors and determines changes in distance between the two or more preselected target regions based on changes in the at least two photographic images, then transmits the at least two photographic images to the memory storage device (pages 4-6 of Clarke; FIGS. 4A-6C of Clarke).
With respect to claim 2, the combination teaches or suggests that the wearable device is a pair of eyeglass frames (the frames of Publicover) comprising the one or more image sensors, the CPU, the memory storage device, the one or more connecting wires, and the power source (as suggested by Publicover).
With respect to claim 5, the combination teaches or suggests that the two or more preselected target regions are two separated symmetric implanted objects, two separated asymmetric implanted objects, two separated symmetric objects, two separated asymmetric objects or two distinct sclera regions (the dots of Clarke; FIGS. 4A-6C of Clarke).
With respect to claim 10, the combination teaches or suggests that the eyeglass frames further comprises one or more illumination sources capable of controlling the illumination levels of an eye of a wearer (the infrared LEDs of Clarke).
With respect to claim 11, the combination teaches or suggests that the one or more illumination sources is capable of emitting light at the near-infrared range (the infrared LEDs of Clarke).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Clarke, in view of Publicover, and further in view of WO 2012/129405 (Brown).
The combination teaches or suggests that the two or more preselected target regions are two separated symmetric implanted objects, two separated asymmetric implanted objects, two separated symmetric objects, two separated asymmetric objects or two distinct sclera regions (the dots of Clarke; FIGS. 4A-6C of Clarke). Brown teaches a marker device with a handle that permits the marking of the eye (abstract, FIG. 5; and paragraphs 0044-0056 of Brown) and Brown teaches that multiple marking tip configurations may be used (paragraph 0045 of Brown). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to the use of marker device, as suggested by Brown, that provides the configuration of inked dots of Clarke since (1) a method of delivery is required and Brown teaches one such delivery method and Brown teaches that multiple marking tip configurations may be used (paragraph 0045 of Brown), and/or (2) it permits application at multiple locations without reapplying ink and Brown teaches that multiple marking tip configurations may be used (paragraph 0045 of Brown).
With respect to claim 6, the combination teaches or suggests that the separated symmetric objects comprise two dots and the two separated asymmetric objects comprise a dot and an arc, wherein the two separated symmetric objects and the two separated asymmetric objects comprise markers (the configuration of inked dots of Clarke), the markers comprising ink or dye (the ink of Clarke), and the system further comprising a dual marking tool for applying markers to the surface of an eye as two markers that are separated by a fixed distance predetermined with the dual marking tool (the marker device of Brown).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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.
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.
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 U.S. Patent Application Publication No. 2011/0279666 (Strombom) also teaches the modulation of IR light can distinguish IR sources from other source (paragraph 0020 of Strombom).
2 U.S. Patent Application Publication No. 2011/0279666 (Strombom) also teaches the modulation of IR light can distinguish IR sources from other source (paragraph 0020 of Strombom).
3 U.S. Patent Application Publication No. 2011/0279666 (Strombom) also teaches the modulation of IR light can distinguish IR sources from other source (paragraph 0020 of Strombom).
4 U.S. Patent Application Publication No. 2011/0279666 (Strombom) also teaches the modulation of IR light can distinguish IR sources from other source (paragraph 0020 of Strombom).