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) filed on 11/21/2023 has been considered by the examiner.
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 4 and 5 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.
Regarding claim 4, the claim recites “the plurality of OCT images in a pullback process” in line 8. There is a lack of antecedent basis for this limitation in the claim. It is unclear if the plurality of OCT images is intended to refer to the “OCT images” obtained in the pulling back step of claim 1. Clarification is requested.
For the purposes of examination, the claim is interpreted as “the OCT images in a pullback process”.
Regarding claim 5, the claim recites “when a distance between the positions of two times of movement is equal to a set distance” in lines 6-7. It is unclear what the intended distance is because the phrase “two times of movement” is indefinite. It is unclear whether the claim is intended to refer to two separate positions acquired at different times or if the claim is intended to refer to a distance obtained from a position, multiplied by two. Clarification is requested.
For the purposes of examination, the claims are interpreted as “when a distance between two positions of movement is equal to a set distance”.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Step 1
Regarding claim 1, the claim recites a series of steps or acts, including indicating a current state of awareness of a patient based on the comparison of acquired data. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
Step 2A, Prong One
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of a source area of OCT images are divided into four areas, namely a uterine fundus area, a uterine upper section area, a uterine lower section area, and a cervical area, where the OCT images are originated respectively and consequently analyzed sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Step 2A, Prong Two
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites consequently analyzing the images, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The analyzing step is recited at such a high level of generality that it does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change, nor does the method use a particular machine to perform the Abstract Idea.
Step 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of inserting an OCT probe into a uterine cavity and pulling back the OCT probe and starting an image acquisition apparatus at the same time to obtain OCT images. The inserting and pulling back steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and details of OCT systems. The inserting and pulling back steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Endometrial Vascularization Characterized by Optical… (2019) by Law et al. – cited by Applicant, hereinafter “Law” in view of Antenatal diagnosis of placenta… (2021) by Yu et al., hereinafter “Yu”.
Regarding claim 1, Law teaches a detection method directly applying noninvasive Optical Coherence Tomography (OCT) to an endometrium (2.3 Optical Coherence Tomography; OCT images were obtained of the endometrium), comprising: inserting an OCT probe into a uterine cavity through a cervical orifice until reaching a fundus of a uterus (2.3 Optical Coherence Tomography; “To obtain images of endometrium, speculum examination was performed and OCT probe was inserted into the women’s uterus via cervix. The OCT probe was placed at the fundus of uterine cavity”); pulling back the OCT probe, and starting an image acquisition apparatus at the same time to obtain OCT images (2.3 Optical Coherence Tomography; “while simultaneously operating a pull-back along the uterine cavity to cervix to perform a scan of the whole uterine cavity.”); a source area of OCT images are divided into areas, namely a uterine fundus area, a uterine area and a cervical area (2.4. High Density Area Determined by OCT; “Three random OCT images were selected from uterine fundus, uterine body and isthmus region”. The uterine body section is a uterine area (containing both the upper and lower section areas) and the isthmus is analogous to the cervical area, as it refers to the isthmus of the cervix.), where the OCT images are originated respectively and consequently analyzed (2.4. High Density Area Determined by OCT; The scoring (e.g., analysis) was performed for each area.).
Law does not teach there being four areas, including a uterine upper section area and a uterine lower section area.
Yu teaches a method of diagnosing placenta accreta spectrum (PAS) disorders associated with vasculature of the lower uterine segment (Table 5; The role of a staging or scoring system for PAS; pg. 21) . Determining the likelihood of these pathologies can be vital, as PAS is life-threatening and it is associated with significant maternal morbidity, mainly due to postpartum hemorrhage, local organ damage, hysterectomy and postoperative complications (Introduction).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Law to include there being four areas, including a uterine upper section area and a uterine lower section area, as Yu teaches that the vascularization of the lower uterine segment has discriminatory information related to the diagnosis of life-threatening pathologies, as taught by Yu (Introduction).
Regarding claim 2, Law in view of Yu teaches the detection method directly applying the noninvasive OCT to the endometrium according to claim 1, wherein the inserting an OCT probe into a uterine cavity through a cervical orifice until reaching a fundus of a uterus comprises: connecting a catheter provided with the OCT probe (Law; 2.3 Optical Coherence Tomography; “The OCT probe is a catheter”) by using a reproductive tract guide (Law; 2.3 Optical Coherence Tomography; the probe is sealed with a transparent outer sheath, the sheath can be considered a reproductive tract guide as it is guided through the reproductive tract to reach the fundus); and manually or automatically controlling the reproductive tract guide to drive the catheter to be inserted into the uterine cavity through the cervical orifice until reaching the fundus of the uterus (The guide is sealed to the probe, therefore the “OCT probe was inserted into the women’s uterus via cervix. The OCT probe was placed at the fundus of uterine cavity” comprises controlling the reproductive tract guide and driving the catheter to place it at the fundus of the uterus. To place the probe, this must be done by machine actuation or actuated by hand. If actuated by machine, this would comprises automatically controlling, and if actuated by hand, this would comprise manually controlling).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Law in view of Yu, as applied to claims 1 and 2, in view of US Patent Publication 2006/0173299 by Romley et al., hereinafter Romley, as evidenced by WIPO Patent Publication 2019/080158 by Song et al., hereinafter “Song”.
Regarding claims 3-4, Law in view of Yu teaches the detection method directly applying the noninvasive OCT to the endometrium according to claims 1 and 2, wherein the pulling back the OCT probe, and starting an image acquisition apparatus at the same time to obtain OCT images comprises: pulling back the OCT probe, and starting the image acquisition apparatus at the same time to acquire the plurality of OCT images in a pullback process at a fixed frequency (Law; 2.3. Optical Coherence Tomography; The probe is simultaneously pulled back and performs a scan of the whole uterine cavity. The image acquisition speed is at 20 frames per second).
Law in view of Yu does not teach wherein a speed of manual or automatic control is not greater than 0.3 cm/s, or wherein the pulling back the OCT probe, and starting an image acquisition apparatus at the same time to obtain OCT images comprises: starting a power mechanism to drive the OCT probe to pull back from the fundus of the uterus to the cervical orifice at a constant speed, wherein a speed of pullback is 0.1 to 0.3 cm/s.
Romley teaches a method of providing an imaging device to an internal body lumen and imaging the lumen, by methods such as OCT, by using an automatic, powered pull-back mechanism at a constant, metered rate. An exemplary metered rate is 0.5mm/s ([0027, 0041]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Law in view of Yu such that a speed of manual or automatic control is not greater than 0.3 cm/s, and wherein the pulling back the OCT probe, and starting an image acquisition apparatus at the same time to obtain OCT images comprises: starting a power mechanism to drive the OCT probe to pull back from the fundus of the uterus to the cervical orifice at a constant speed, wherein a speed of pullback is 0.1 to 0.3 cm/s, as taught by Romley. Song teaches that using a stable, metered rate is preferable because if effectively avoids jitter that may occur during manual operations and human body tissue injury during withdrawal (Abstract). It is noted that the pull back occurs from the fundus of the uterus to the cervical orifice. It is also noted that as Song teaches a stable metered rate is preferable to avoid injury to tissues, it would be obvious to constrain the insertion of the probe to be at the same, metered speed to avoid injury to tissues.
Claims 5-6 is rejected under 35 U.S.C. 103 as being unpatentable over Law in view of Yu, as applied to claim 1, in view of US Patent Publication 2013/0216114 by Courtney et al., hereinafter “Courtney”.
Regarding claim 5, Law in view of Yu teaches the detection method directly applying the noninvasive OCT to the endometrium according to claim 1, wherein the pulling back the OCT probe, and starting an image acquisition apparatus at the same time to obtain images comprises: driving the OCT probe to pull back from the fundus of the uterus to the cervical orifice (Law; 2.3 Optical Coherence Tomography, “OCT probe was inserted into the women’s uterus via cervix”. The OCT probe was placed at the fundus of the uterine cavity”). Law in view of Yu does not teach acquiring a position of movement of the OCT probe through a displacement sensor; and when a distance between the positions of two times of movement is equal to a set distance, starting the image acquisition apparatus to acquire the plurality of OCT images in the pullback process.
Courtney teaches a method of using position sensor information from position sensor 150 from multiple points along with other features in order to determine the starting and stopping points for image acquisition. This technique can be used to determine an accurate starting position for the region of interest ([0157]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Law in view of Yu in order such that the pulling back the OCT probe, and starting an image acquisition apparatus at the same time to obtain images comprises: acquiring a position of movement of the OCT probe through a displacement sensor; and when a distance between the positions of two times of movement is equal to a set distance, starting the image acquisition apparatus to acquire the plurality of OCT images in the pullback process, in order to determine an accurate starting position for the region of interest, as taught by Courtney ([0157]).
Regarding claim 6, Law in view of Yu teaches the detection method directly applying the noninvasive OCT to the endometrium according to claim 1, but does not teach wherein a source area of OCT images are divided into four areas comprises: equally dividing the OCT images into four parts, and sequentially classifying into a uterine fundus area image, a uterine upper section area image, a uterine lower section area image, and a cervical area image according to an acquisition time sequence of each OCT image; or, dividing the OCT images into four parts according to a certain proportion, and sequentially classifying into the uterine fundus area image, the uterine upper section area image, the uterine lower section area image, and the cervical area image according to the acquisition time sequence of each OCT image.
Courtney teaches a method of determining the starting and stopping points of successive regions of interest by using a position sensor and/or other features. Once the starting and stopping points are determined, the images from each region are captured sequentially in a pullback operation and can be analyzed separately ([0157, 0163]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Law in view of Yu, to determine the starting and stopping points of each region of interest such that dividing the OCT images into four parts according to a certain proportion, and sequentially classifying into the uterine fundus area image, the uterine upper section area image, the uterine lower section area image, and the cervical area image according to the acquisition time sequence of each OCT image in order to determine an accurate starting position for the region of interest, as taught by Courtney ([0157, 0163]). It is noted that the determined starting and stopping points can represent proportions of the total area to be imaged, thereby comprising dividing the OCT images according to a certain proportion.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Law in view of Yu, as applied to claim 1, in view of Optical coherence tomography: fundamental principles… (2011) by Popescu et al., hereinafter “Popescu”.
Law in view of Yu teaches the detection method directly applying the noninvasive OCT to the endometrium according to claim 1, but does not teach wherein the image acquisition apparatus comprises a light source, an optical splitter, and a detector; the starting an image acquisition apparatus to obtain OCT images comprises: starting the light source, wherein light emitted by the light source is split into reference light and signal light by the optical splitter; emitting the signal light to an image acquisition area through the probe, and returning the light reflected and scattered by the image acquisition area to the detector to form a signal arm; directly emitting the reference light to the detector through an optical path having the same optical distance as the signal arm to form a reference arm; enabling the signal arm and the reference arm interact with each other to form an interference optical signal, which is photoelectrically converted into an electrical signal through the detector; and obtaining the OCT images through analog-to-digital conversion and Fourier transform.
Popescu teaches fundamental principles of OCT systems, including the light from a low-coherence source (e.g., light source) is split into two paths by a coupler (e.g. optical splitter) directing it along two different arms (reference arm and sample (e.g., signal) arm) of an interferometer. The light exits the fiber end of the arms and is reflected (e.g., scattered) back by a mirror in the reference arm and by the sample in the signal arm. The returning light recombine to generate an interference pattern, which is converted into an electrical signal by the detector (Introduction, par. 8; pg. 156). The signals can be converted into images by using Fourier transform (Optical coherence tomography systems, pp. 158-159).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Law in view of Yu such that the image acquisition apparatus comprises a light source, an optical splitter, and a detector; the starting an image acquisition apparatus to obtain OCT images comprises: starting the light source, wherein light emitted by the light source is split into reference light and signal light by the optical splitter; emitting the signal light to an image acquisition area through the probe, and returning the light reflected and scattered by the image acquisition area to the detector to form a signal arm; directly emitting the reference light to the detector through an optical path having the same optical distance as the signal arm to form a reference arm; enabling the signal arm and the reference arm interact with each other to form an interference optical signal, which is photoelectrically converted into an electrical signal through the detector; and obtaining the OCT images through analog-to-digital conversion and Fourier transform, as taught by Popescu (Introduction; Optical coherence tomography systems). It is noted that Popescu teaches the fundamental principles of Optical Coherence Tomography, and therefore it would be obvious that the OCT method taught by Law in view of Yu would include the details of the fundamental principles of Optical Coherence Tomography in order to complete OCT imaging.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Law in view of Yu, as applied to claim 1, in view of US Patent Publication 2003/0103212 by Westphal et al. , hereinafter “Westphal”.
Law in view of Yu teaches the detection method directly applying the noninvasive OCT to the endometrium according to claim 1, but does not teach after the OCT images are obtained, further comprising: performing image enhancement processing on the OCT images, wherein the image enhancement processing is to perform Red Green Blue (RGB) three-color mapping on the OCT images by using different pseudo-color palettes to obtain pseudo-color images of different tones.
Westphal teaches a known method of pseudo-color image coding scheme that has been employed to combine depth-resolved blood flow imaging or spectroscopy with conventional OCT reflectivity imaging. The RGB method uses an RGB model and obtains the relative contributions from red, green, and blue are used to describe these properties for an arbitrary color (i.e., a different pseudo-color palette) ([0178]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Law in view of Yu such that the OCT images are obtained, further comprising: performing image enhancement processing on the OCT images, wherein the image enhancement processing is to perform Red Green Blue (RGB) three-color mapping on the OCT images by using different pseudo-color palettes to obtain pseudo-color images of different tones, in order to enable depth-resolved blood flow imaging with conventional OCT reflectivity imaging, as taught by Westphal (0178]). It is noted that Law uses OCT for understanding blood flow characteristics through a depth of tissue, and therefore would use a method that enables depth-resolved blood flow imaging with conventional OCT reflectivity imaging.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication 2019/0008674 by Myers et al. teaches a method of determining characteristics of different regions of the uterus using OCT.
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/NELSON ALEXANDER GLOVER/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791