Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claim 1 is rejected under 35 U.S.C. 101 because they are directed to a judicial
exception without significantly more. Under the 35 U.S.C. 101 subject matter eligibility the 2019
guidance provides the following framework for analyzing the claims:
Step 1: whether the claimed subject matter is directed to one of the four statutory
categories of invention, i.e., process, machine, manufacture, or composition of matter.
Step 2A (prong 1): If the claim does fall within one of the statutory categories, it must
then be determined whether the claim is directed to a judicial exception (i.e., law of nature,
natural phenomenon, and abstract idea).
Step 2A (prong 2): If the claim is directed toward a judicial exception, it must then be
determined whether the judicial exception is integrated into a practical application. Finally, if the
judicial exception is not integrated into a practical application, it must additionally be determined
in Step 2B whether the claim recites "significantly more" than the abstract idea.
Step 1:
Claim 1 is considered to be in a statutory category (process)
Step 2A (Prong 1) :
Applying step 2A (prong 1) addresses whether the claim is directed to a judicial exception, i.e., law of nature, natural phenomenon, and abstract idea. Claim 1 is directed toward the judicial exception of an abstract idea of: performing a first scan of one or more bone regions using an imaging device to obtain first imaging data; receiving clinical information based on the first imaging data being processed using an artificial intelligence-based model; and initiating a first therapy after performing the first scan, wherein the clinical information is used to determine one or more parameters of the first therapy.
The recited limitations identified above under its broadest reasonable interpretation, cover performance of the limitations in the human mind or with the aid of pen and paper, but for the recitation of generic device and/or hardware That is, other than reciting the imaging device/computer and/or hardware, nothing in the claim elements preclude the step from practically being performed in the human mind. For example, a health care specialist or a therapist looking at the at the clinical data and observing the scanned image of bone regions processed using a trained algorithm may initiate or plan a particular type of therapy to cure and/or reduce the progression of a bone related disease. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic a device and/or hardware, then it falls within the "Mental Processes" grouping of abstract ideas.
Step 2A (Prong (2):
Step 2A (prong 2) addresses whether the judicial exception is integrated into a practical application. As claimed, the judicial exception is not integrated into a practical application. The relevant question under Step 2A (prong 2) is not whether the claimed invention itself is a practical application, instead the question is whether the claimed invention includes additional elements beyond the judicial exception that integrate the judicial exception into a practical application by imposing a meaningful limit on the judicial exception. In this case, it is clear that applicant's claim/s do not comprise any additional elements that, individually or in combination, have integrated the judicial exception into a practical application. Since the claim is implemented on a device/computer and/or hardware and there are no further limitations or structural elements that go beyond the device/processor and/or hardware, it can clearly be seen that the abstract idea of performing a first scan of one or more bone regions using an imaging device to obtain first imaging data; receiving clinical information based on the first imaging data being processed using an artificial intelligence-based model; and initiating a first therapy after performing the first scan, wherein the clinical information is used to determine one or more parameters of the first therapy. Please note, according to the USPTO released new examination guidelines dated January 7, 2019, for determining whether a claim is directed to non-statutory subject matter, 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;
additional element that applies or uses a judicial exception to effect 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 exception.
It is clear that applicant's claim does not comprise any of the above additional elements that, individually or in combination, have integrated the judicial exception into a practical application.
Step 2B:
Step 2B addresses whether the claim has additional elements that amount to significantly more than a judicial exception and form an inventive concept. Applicant's claims do not recite additional elements that provide significantly more than the recited judicial exception. At least the claims require an imaging device/computer and/or hardware which is claimed to perform its basic functions of performing a first scan of one or more bone regions using an imaging device to obtain first imaging data; receiving clinical information based on the first imaging data being processed using an artificial intelligence-based model; and initiating a first therapy after performing the first scan, wherein the clinical information is used to determine one or more parameters of the first therapy. The recitation of an imaging device/computer and/or hardware limitation amount to a mere instruction to implement the abstract idea on a computer system. Accordingly, claim 1 is not patent eligible.
Dependent claims 2-18 merely reiterate the same abstract idea using the same additional elements as identified above, without imposing any meaningful limits, using the additional elements as generic computer system components to perform the abstract idea, providing nothing more than generally linking the use of the abstract idea to a technological environment or field of use, without significantly more since there are no additional elements that impose any technical non-generic limits. Therefore, claims 2-18 are also rejected under 35 U.S.C. 101, and thus are not patent eligible.
Notice re prior art available under both pre-AIA and AIA
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 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.
Examiner's Note
Examiner has cited particular columns and line numbers or figures in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant, in preparing the responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 1-3, 7-12, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Han (Computer English Translation of Korean Patent No. KR 20220164361 A) in view of Patil (US 2023/0116332).
Before advancing the detailed rejections, it will be helpful to briefly describe the diagnosing osteoporosis and osteoporotic fracture risk of a subject to be diagnosed by an electronic device of Han. At page 2, paragraph 6, Han obtains: clinical covariate information of the subject to be diagnosed; and an X-ray image of the body tissue of the subject. Thereafter, Han pre-processes the clinical covariate information and the X-ray image; When the preprocessed clinical covariate information and the X-ray image are input, the preprocessed clinical covariate information and the X-ray image are input to an artificial intelligence model that outputs diagnostic information on osteoporosis and osteoporotic fracture risk of the subject to be diagnosed, and then obtains diagnostic information; and outputs the obtained diagnostic information.
With regard to claim 1, Han discloses a method of treating a bone-related disease (See for example, page 5, paragraphs 2 and 5-6), comprising: performing a first scan of one or more bone regions using an imaging device to obtain first imaging data (See for example, page 2, paragraph 7, line 4; page 7, paragraph 4; page 5, paragraphs 12-13; page 7, paragraph 10 contd. Page 8); receiving clinical information based on the first imaging data being processed using an artificial intelligence-based model (See for example, page 2, paragraph 7, lines 4-8; page 7, paragraph 2; and page 3, paragraphs 15 and 17; page 5, paragraphs 12-13; and Fig. 4); and initiating a first therapy after performing the first scan, wherein the clinical information is used to determine one or more parameters of the first therapy, i.e., treatment related to a past diagnosis history of the subject to be diagnosed. It may include at least one of information or drug prescription information (i.e., parameter: added by the examiner) prescribed to the subject to be diagnosed (See for example, page 7, paragraph 9; and item 460, in Fig. 4). Han does not expressly call for initiating a first therapy after the first scan. However, Patil (See for example, paragraphs 0034-0037) teach this feature. Han and Patil are combinable because they are from the same field of endeavor, i.e., diagnosing bone and muscle related disorders using artificial intelligence (See for example, paragraph 0002). Before the effective filing date of the claimed invention, it would have been obvious to incorporate the teaching as taught by Patil into the system of Han, and to do so would at least allow treatment recommendation based analysis bone disorder performed by convolutional neural network (See for example, paragraph 0034 and 0040). Therefore, it would have been obvious to combine Han with Patil to obtain the invention as specified in claim 1.
With regard to claim 2, the method of claim 1, wherein the one or more parameters of the first therapy are selected from the group consisting of: an initiation of the first therapy, a non-initiation of the first therapy, a type of the first therapy, a dose of the first therapy, a route of administration, a duration of the first therapy, a timepoint of one or more subsequent scans, and a timepoint of one or more subsequent follow-ups (See for example, paragraph 0036 of Patil).
With regard to claim 3, the method of claim 1, wherein the clinical information is selected from the group consisting of: a bone strength, a bone mineral density, one or more outputs generated by dual-energy X-ray absorptiometry scanners, a bone quality, a bone score, a fracture resistance, one or more locations of bone sites at high risk of fracture, a fracture risk, a presence or absence of osteoporosis, a severity of osteoporosis, a predicted or expected progression of osteoporosis, and a predicted response to one or more therapies (See for example, page 8, paragraphs 3 and 5 of Han).
With regard to claim 7, the method of claim 1, wherein the first imaging data is obtained after repositioning the one or more bone regions relative to one or more regions of the imaging device (See for example, Figs. 2A and 2B of Wilson).
With regard to claim 8, the method of claim 1, further comprising performing a second scan, wherein the second scan is performed with one or both of: a same distance or a same orientation of the one or more bone regions with the imaging device as the first scan (See for example, Figs. 2A and 2B of Wilson).
With regard to claim 9, the method of claim 8, further comprising comparing a result of the first scan with a result of the second scan (dividing the medical condition of the bone related disorder into four grades inherently requires a comparison process : Paragraph 0044 of Patil) .
With regard to claim 10, the method of claim 9, wherein the comparing is used for one or more of: detecting changes in bone, detecting bone growth, detecting bone loss, detecting effect of a therapy, or a combination thereof (See for example, paragraphs 0044-0045 of Patil).
With regard to claim 11, the method of claim 8, further comprising modifying the first therapy after performing the second scan (See for example, paragraph 0045 of Patil: modifies one or more of the treatments based “severity”)
With regard to claim 12, the method of claim 11, wherein the modifying the first therapy comprises one or more of: changing a dose of the first therapy, stopping the first therapy, starting a second therapy, starting a drug holiday, or stopping a drug holiday (See for example paragraph 0045, initiates multiple treatments based on the severity of the disorder).
With regard to claim 15, the method of claim 1, further comprising performing a second scan, wherein the one or more parameters of the first therapy are modified after the second scan (See for example, paragraph 0045, wherein Patil changes/modifies the treatment type based on the severity of disorder).
With regard to claim 19, claim 1 encompasses the limitation this claim, and is rejected the same as claim 1. Claim 19 distinguishes from claim 1 only in that X-ray imaging, X-ray imaging data; and detecting a presence or a severity of osteoporosis using the artificial intelligence-based model. Fortunately, Han (See for example, page 5: X-ray imaging; and page 5, paragraph 8; and page 7, paragraph 3: presence or a severity, i.e., level, of osteoporosis) teaches these features.
Claims 4-6 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Han in view of Patil as applied to claims 1-3, 7-12, 15, and 19 above, and further in view of Tu, et al. (Osteoporosis: A Review of Treatment Options).
With regard to claim 4, Han (as modified by Patil) discloses all of the claimed subject matter as already addressed above in paragraph 7, and incorporated herein by reference.
While Han (as modified by Patil) discloses the first therapy as a non-bisphosphonate (See for example, paragraph 0036 of Patil: exercises, physiotherapy, surgery, and known treatments), Han (as modified by Patil) does not expressly call for wherein the clinical information is a predicted response to a bisphosphonate therapy. However, Tu, et al. (See for example, the Abstract; and page 95, a section entitled “PHARMACOLOGICAL TREATMENT”) teach this feature. Before the effective filing date of the claimed invention, it would have been obvious to incorporate the teaching as taught by Tu, et al. into the system of Han (as modified by Patil) so that bisphosphonate may be used to treat osteoporosis (See page 2). Therefore, it would have been obvious to combine Han (as modified by Patil) with Tu, et al. to obtain the invention as specified in claim 4.
With regard to claim 5, the method of claim 3, wherein the clinical information is a probability of treatment success with a drug therapy (See pages 95-101 of Tu, et al.).
With regard to claim 6, the method of claim 5, further comprising selecting (via preferred option)the first therapy based on a calculated probability of treatment success of the first therapy (See pages 95-101 of Tu, et al.).
With regard to claim 13, Han (as modified by Patil) discloses all of the claimed subject matter as already addressed above in paragraph 7, and incorporated herein by reference. Han (as modified by Patil) does not expressly call for wherein the first therapy is an anabolic therapy, and the second therapy is an anti-resorptive therapy. However, Tu, et al. page 95, a section entitled “PHARMACOLOGICAL TREATMENT”) teach this feature. Before the effective filing date of the claimed invention, it would have been obvious to incorporate the teaching as taught by Tu, et al. into the system of Han (as modified by Patil) in order to provide treatments including anabolic and anti-resorptive, and as a result, ant-resorptive primarily decrease the rate of bone resorption while anabolic increase bone formation more than bone resorption (page 95, a section entitled “PHARMACOLOGICAL TREATMENT”). Therefore, it would have been obvious to combine Han (as modified by Patil) with Tu, et al. to obtain the invention as specified in claim 13.
With regard to claim 14, the method of claim 1, further comprising determining a lack of efficacy of the first therapy; and administering a second therapy, wherein the first therapy is an anti-resorptive therapy, the second therapy is an anabolic therapy (See for example, paragraph 0045 of Patil; and page 95, a section entitled “PHARMACOLOGICAL TREATMENT”).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Han in view of Patil as applied to claims 1-3, 7-12, 15, and 19 above, and further in view of Nicholson, et al. (US 2005/0037515).
With regard to claim 16, Han (as modified by Patil) discloses all of the claimed subject matter as already addressed above in paragraph 7, and incorporated herein by reference. Han (as modified by Patil) does not expressly call for wherein the second scan is used to determine one or more of: a loss or tapering of an effect of the first therapy, one or more side-effects of the first therapy, an achievement of a peak therapeutic effect, and a lowering of a rate of bone gain. However, Nicholson, et al. (See for example, paragraph 0802) teach this feature. Before the effective filing date of the claimed invention, it would have been obvious to incorporate the teaching as taught by Nicholson, et al. into the system of Han (as modified by Patil), and to do so would at least allow identifying therapies with side-effects so that the therapy may be discontinued (See for example, paragraph 0803). Therefore, it would have been obvious to combine Han (as modified by Patil) with Nicholson, et al. to obtain the invention as specified in claim 16.
With regard to claim17, the method of claim 16, further comprising discontinuing the first therapy and initiating a second therapy (See for example, paragraph 0803 of Nicholson, et al.).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Han in view of Patil and Nicholson, et al. as applied to claims 16-17 above, and further in view of Tu, et al. (Osteoporosis: A Review of Treatment Options).
With regard to claim 18, Han (as modified by Patil and Nicholson, et al.) discloses all of the claimed subject matter as already addressed above in paragraph 10, and incorporated herein by reference. Han (as modified by Patil and Nicholson, et al. ) does not expressly call for wherein the first therapy is an anabolic therapy, and the second therapy is an anti-resorptive therapy. However, Tu, et al. page 95, a section entitled “PHARMACOLOGICAL TREATMENT”) teach this feature. Before the effective filing date of the claimed invention, it would have been obvious to incorporate the teaching as taught by Tu, et al. into the system of Han (as modified by Patil) in order to provide treatments including anabolic and anti-resorptive, and as a result, the ant-resorptive primarily decrease the rate of bone resorption while anabolic increase bone formation more than bone resorption (page 95, a section entitled “PHARMACOLOGICAL TREATMENT”). Therefore, it would have been obvious to combine Han (as modified by Patil) with Tu, et al. to obtain the invention as specified in claim 18.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Han in view of Patil as applied to claims 1-3, 7-12, 15, and 19 above, and further in view of Wilson (US 9,153,021 B2).
With regard to claim 20, Han (as modified by Patil) discloses all of the claimed subject matter as already addressed above in paragraph 7 regarding claim 19, and incorporated herein by reference. Han (as modified by Patil) further discloses performing a second scan of one or more bones using the X-ray imaging device to obtain second X-ray imaging data, i.e., more than one x-ray scanned image, wherein the second scan is performed (See for example, page 5, paragraphs 1 and 7: Osteoporosis risk prediction method and apparatus using a deep learning model trained on the basis of DXA scan images (emphasis added)and clinical Covariates; and Dual-Energy X-ray Absorptiometry (DXA) scan images (emphasis added) can be used to diagnose osteoporotic diseases, and bone density measurement through DXA scan images is the most basic tool for diagnosing osteoporosis and osteoporotic fractures) been obvious to combine Han (as modified by Patil) with Wilson to obtain the invention as specified in claim 20.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Patent Application Publication No. 2024/0127928 (See for example, paragraphs 0034-0038); and 2026/0191489 (See for example, the Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL G MARIAM whose telephone number is (571)272-7394. The examiner can normally be reached M-F 7:30-5:00 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, Mathew Bella can be reached at (571)272-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL G MARIAM/Primary Examiner, Art Unit 2675
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