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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. § 119 (a)-(d). The certified copy has been filed in parent Application No. JP2022-074096, filed on 04/28/2022.
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 limitations are: “a moving image acquisition unit configured to acquire a moving image,” “an image processor configured to perform processing, “an evaluation processor configured to perform processing”1 in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification (e.g., referring to Applicant’s Spec. ¶42, he discloses that his imaging apparatus comprises an image processor 1020 and an evaluation processor 1030 in Fig. 1) 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1–9 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to an abstract idea without significantly more. The limitations, under their broadest reasonable interpretation, cover mental process (concept performed in a human mind, including as observation, evaluation, judgment, opinion, organizing human activity and mathematical concepts and calculations). The claims recite “acquire a moving image of a subject’s eyelid,” “identifying a meibomian gland area from the moving image,” “generating evaluation information relating to a predetermined disease” in claims 1 and 8–9. This judicial exception is not integrated into a practical application because the steps do not add meaningful limitations to be considered specifically applied to a particular technological problem to be solved. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed language can be analyzed by an ophthalmologist without machine learning aid2—i.e., this process is the quintessential “mental process” exception. See Alice/Mayo test under MPEP § 2106, II. ESTABLISH BROADEST REASONABLE INTERPRETATION OF CLAIM AS A WHOLE.3
According to the USPTO guidelines, a claim is directed to non-statutory subject matter if:
STEP 1: the claim does not fall within one of the four statutory categories of invention (process, machine, manufacture or composition of matter), or
STEP 2: the claim recites a judicial exception, e.g., an abstract idea, without reciting additional elements that amount to significantly more than the judicial exception, as determined using the following analysis:
STEP 2A (PRONG 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
Using the two-step inquiry, it is clear that claims 1–9 are directed to an abstract idea as shown below:
STEP 1: Do the claims fall within one of the statutory categories? Yes. Claims 1–7 are directed to an apparatus; claim 8 is a method; and claim 9 is a computer-readable non-transitory recoding medium.
STEP 2A (PRONG 1): Is the claim directed to a law of nature, a natural phenomenon or an abstract idea? Yes. The claims are directed toward a mental process (i.e., abstract idea).4
With regard to STEP 2A (PRONG 1), the guidelines provide three groupings of subject matter that are considered abstract ideas:
Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations;
Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions); and
Mental processes – concepts that are practicably performed in the human mind (including an observation, evaluation, judgment, opinion).
These limitations, as drafted, is a simple process that, under their broadest reasonable interpretation, covers performance of the limitations in the mind or by a human. Examiner notes that under MPEP 2106.04(a)(2)(III), the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same). As such, a person could mentally analyze an image and determine a fill level, either mentally or using a pen and paper. The mere nominal recitation that the various steps are being executed by a device/in a device (e.g., processing unit) does not take the limitations out of the mental process grouping. Thus, the claims recite a mental process.
STEP 2A (PRONG 2): Does the claim recite additional elements that integrate the judicial exception into a practical application? No. The claims do not recite additional elements that integrate the judicial exception into a practical application.
With regard to STEP 2A (prong 2), whether the claim recites additional elements that integrate the judicial exception into a practical application, the guidelines provide the following exemplary considerations that are indicative that an additional element (or combination of elements) may have integrated the judicial exception into a practical application:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While the guidelines further state that the exemplary considerations are not an exhaustive list and that there may be other examples of integrating the exception into a practical application, the guidelines also list examples in which a judicial exception has not been integrated into a practical application:
an additional element merely recites the words “apply it” (or an equivalent) with the judicial exception, or merely includes instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea;
an additional element adds insignificant extra-solution activity to the judicial exception; and
an additional element does no more than generally link the use of a judicial exception to a particular technological environment or field of use.
These limitations are recited at a high level of generality (i.e., as a general action or change being taken based on the results of the acquiring step) and amounts to mere post solution actions, which is a form of insignificant extra-solution activity. Further, the claims are claimed generically and are operating in their ordinary capacity such that they do not use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? No. The claims do not recite additional elements that amount to significantly more than the judicial exception.5
With regard to STEP 2B, whether the claims recite additional elements that provide significantly more than the recited judicial exception, the guidelines specify that the pre-guideline procedure is still in effect. Specifically, examiners should continue to consider whether an additional element or combination of elements:
adds a specific limitation or combination of limitations that are not well-understood, routine, conventional activity in the field, which is indicative that an inventive concept may be present; or
simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, which is indicative that an inventive concept may not be present.
Claims 2–8 do not recite any additional elements that are not well-understood, routine or conventional. For example, even if Applicant discloses “identifying the meibomian gland area from a frame of the moving image by using a trained model” after processing multiple images thereof, a technical improvement would have involved an advancement where his processor discloses a proprietary deep learning architecture and/or a unique geometric transformation that provides a superior result compared to existing methods.6 However, these claims can be done by a human—who looks a grayscale image of an eyelid—naturally finds target areas in the gland image.
Thus, since claims 1–9 are: (a) directed toward an abstract idea, (b) do not recite additional elements that integrate the judicial exception into a practical application, and (c) do not recite additional elements that amount to significantly more than the judicial exception, it is clear that claims 1–9 are not eligible subject matter under the 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1–2 and 8–9 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Arita et al. (U.S. 9,320,439 B2).
Regarding claim 1, Arita discloses an ophthalmic apparatus comprising:
a moving image acquisition unit configured to acquire a moving image of a subject's eyelid; (Per Fig. 1B, Arita’s image acquire 121 discloses an image illuminating an eyelid. Arita col. 6 lines 33–47. The image acquirer 21 acquires a photographed palpebral image (image data) of an eye through the interface from the ophthalmologic apparatus 6 or the storage 3 in accordance with the input from the operation part 42.)
an image processor configured to perform processing of identifying a meibomian gland area from at least one frame of the moving image; and (Per Fig. 1B, Arita’s designator 22 retrieves specifics of Meibomian glands from the image. Ibid. col. 6 lines 49–56. [a]nd shows a region from which the extractor 23 extracts information of Meibomian glands.)
an evaluation processor configured to perform processing of generating evaluation information relating to a predetermined disease based on the meibomian gland area. (Per Fig. 1B, Arita’s designator 22 analyzes an area segmenting boundary regions according to pixel difference values. Ibid. col. 6 line 65 – col. 7 line 21. [t]he designator 22 specifies the periphery of an image area that corresponds to the rear side of the eyelid in the photographed image, on the basis of the luminance value of each pixel.)
Regarding claim 8, Arita discloses a method of processing an ophthalmic image, the method comprising:
performing processing of identifying a meibomian gland area from at least one frame of a moving image of a subject's eyelid; and (Per Fig. 1B, Arita’s designator 22 retrieves specifics of Meibomian glands from the image. Arita col. 6 lines 49–56. [a]nd shows a region from which the extractor 23 extracts information of Meibomian glands.)
performing processing of generating evaluation information relating to a predetermined disease based on the meibomian gland area. (Per Fig. 1B, Arita’s designator 22 analyzes an area segmenting boundary regions according to pixel difference values. Ibid. col. 6 line 65 – col. 7 line 21. [t]he designator 22 specifies the periphery of an image area that corresponds to the rear side of the eyelid in the photographed image, on the basis of the luminance value of each pixel.)
Regarding claim 9, Arita discloses a computer-readable non-transitory recording medium in which a program is recorded, the program being configured to cause a computer to perform processing of an ophthalmic image, wherein the program is configured to cause the computer to perform:
processing of identifying a meibomian gland area from at least one frame of a moving image of a subject's eyelid; and (Per Fig. 1B, Arita’s designator 22 retrieves specifics of Meibomian glands from the image. Arita col. 6 lines 49–56. [a]nd shows a region from which the extractor 23 extracts information of Meibomian glands.)
processing of generating evaluation information relating to a predetermined disease based on the meibomian gland area. (Per Fig. 1B, Arita’s designator 22 analyzes an area segmenting boundary regions according to pixel difference values. Ibid. col. 6 line 65 – col. 7 line 21. [t]he designator 22 specifies the periphery of an image area that corresponds to the rear side of the eyelid in the photographed image, on the basis of the luminance value of each pixel.)
Regarding claim 2, Arita discloses the ophthalmic apparatus, wherein the image processor identifies a meibomian gland area from each of plurality of frames of the moving image by sequentially processing the plurality of frames. (Per Fig. 1B, Arita’s extractor discloses photographed images. Arita col. 8 lines 7–31. The threshold value is stored in advance as a constant value in the storage 3 or can be specified for each of the photographed images from which Meibomian-gland subareas are extracted,)
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.
Claims 3–7 are rejected under 35 U.S.C. § 103 as being unpatentable over Arita in view of Huang (CN 113706564 A).
Regarding claim 3, Arita fails to specifically disclose the ophthalmic apparatus, wherein the image processor performs at least a part of the processing of identifying the meibomian gland area from a frame of the moving image by using a trained model constructed by means of machine learning with training data including an eyelid image.
In related art, Huang discloses the ophthalmic apparatus, wherein the image processor performs at least a part of the processing of identifying the meibomian gland area from a frame of the moving image by using a trained model constructed by means of machine learning with training data including an eyelid image. (Huang discloses a supervised learning where a first gland image is rendered. Huang Spec. ¶69. The loss acquisition module is also used to determine the fully supervised learning loss based on the prediction result of the first meibomian gland sample image and the real image label;)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of Huang into the teachings of Arita to reduce an impact of label noise while performing a segmentation network performance. Ibid. ¶12.
Regarding claim 4, Arita as modified by Huang, discloses the ophthalmic apparatus, wherein the image processor performs processing of determining an analysis target area from the frame using the trained model, and identifies a meibomian gland area based on the analysis target area. (Per Fig. 1 at step 104, Huang discloses a region of interest in the gland sample image. Huang Spec. ¶113. Determine the region of interest in the first meibomian gland sample image based on the real image labels,)
Regarding claim 5, Arita as modified by Huang, discloses the ophthalmic apparatus, wherein the image processor performs segmentation of dividing at least a part of the frame into a plurality of image areas using the trained model, and identifies a meibomian gland area based on the plurality of image areas. (Huang discloses region of interests in his segmentation network processing the first sample image. Huang Spec. ¶139. Regions of interest (ROIs) in the first meibomian gland sample image are determined based on the real image labels, and regions of interest in the second meibomian gland sample image are determined based on the pseudo-image labels.)
Regarding claim 6, it has been rejected in the same manner as claim 4.
Regarding claim 7, it has been rejected in the same manner as claim 5.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Abou Shousha et al. (U.S. 10,468,142 B1) discloses a method of predicting a disease of an anterior segment of an eye.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENEDICT LEE whose telephone number is (571)270-0390. The examiner can normally be reached 10:00-17:00 (EST).
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, Stephen R. Koziol can be reached at (408) 918-7630. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENEDICT E LEE/Examiner, Art Unit 2665
/Stephen R Koziol/Supervisory Patent Examiner, Art Unit 2665
1 Examiner construed that the claimed language “configured to perform processing of…” is modified by functional language (i.e., surrogate for “means for” in this context reciting a generic, nonce term that does not denote a specific, well-known structure to a person of ordinary skill in the art) without providing any structural details how the hardware is specifically constructed or configured to achieve the recited outcome.
2 Imagine he reads a textbook to squarely determine whether a meibomian gland exists in an image.
3 The court disagreed, because it interpreted the claims as encompassing nothing other than pure mental steps (and thus falling within an abstract idea grouping) because the claims did not include any limitations requiring computer implementation.
4 Per Applicant’s Spec. ¶51, he states that a related gland area in an image is identified by “a part having relatively high brightness from the entirety of an image of an eyelid depicted in an eyelid image.” Examiner determined that this process is a fundamental, well-known, and conventional data in the person of ordinary skill in the art. And, the last limitation, “generating evaluation relating to a predetermined disease” can be achieved by an ophthalmologist without a computer.
5 To be patent-eligible, the claim must include an inventive concept that is “significantly more” than the abstract idea. If the identification of the meibomian gland area is performed by a routine technique (e.g., brightness thresholding) that anyone skilled in the art could implement without any specialized technical innovation, the hardware (i.e., a processor) is a merely a tool used in a conventional way.
6 Claims 2–9 recite merely “identifying a meibomian gland area” in multiple frames.
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