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 .
Status of Claims
Claims 1-20 are under examination.
Priority
Applicant’s claim for the benefit of priority under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application claims priority to Provisional Application No. 63/186,135, filed 05/09/2021.
Drawings
The drawings filed 07/27/2022 are acceptable.
Information Disclosure Statement
The information disclosure statement (IDS) document(s) submitted on 07/27/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Guidance Step 1:
The instant invention (claim 1 being representative) is directed to a method that performs a series of processes. Thus, the claims are directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Regarding claim(s) 1, the claimed steps that are part of the abstract idea are as follows:
receiving information, including endogenous FSH level, about said patient; estimating optimal duration for said controlled ovarian stimulation;
estimating target level of FSH in said patient to achieve said optimal duration;
comparing said resulting FSH to said target level of FSH;
adjusting amount of said pharmacological formulation when said resulting FSH does not match target level of FSH;
Mental Processes
Under the broadest reasonable interpretation, the above italicized steps amount to observing data and manipulating/analyzing the data. Notably, the claims do not impose any boundaries on how the italicized functions are actually being achieved. In addition, the instant specification describes calculations and algorithms associated with at least some of the claimed functions [0026, 0029, 0031, 0042, 0045]. As such, the specification provides sufficient evidence that the claims are directed to an abstract idea since the specific descriptions provided for accomplishing these tasks include only data reception and analysis. Accordingly, the above steps clearly fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception or whether the claim is “directed to” the judicial exception. This evaluation is performed by (1) identifying whether there are any additional steps/elements recited in the claim beyond the judicial exception, and (2) evaluating those additional steps/elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). The additional steps/elements recited in the claim beyond the judicial exception are as follows:
prescribing a pharmacological formulation changing FSH level in circulation to achieve said target level of FSH; measuring resulting FSH in said patient; responsive to achieving said optimal duration, triggering oocyte's final maturation.
Under the BRI, the ‘prescribing’ step is interpreted as providing information and thus, by definition, cannot amount to a “particular treatment” because a prescription is not a treatment. See also MPEP 2106.04(d)(2), which clearly states the following: Examples of “treatment” and prophylaxis” limitations encompass limitations that treat or prevent a disease or medical condition, including, e.g., acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, and the like. For example, an immunization step that integrates an abstract idea into a specific process of immunizing that lowers the risk that immunized patients will later develop chronic immune-mediated diseases is considered to be a particular prophylaxis limitation that practically applies the abstract idea. See, e.g., Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1066–68, 100 USPQ2d 1492, 1500-01 (Fed. Cir. 2011). Accordingly, this step amounts to insignificant extra-solution activity and is not indicative of an integration into a practical application. MPEP 2106.05(g).
With regard to the measuring step, this is recited at a high of generality (without any details regarding how it is being performed) and results in nothing more than collecting data for use by the abstract idea. Accordingly, this step amounts to insignificant extra-solution activity and is not indicative of an integration into a practical application. See MPEP 2106.05(g). With regard to the ‘triggering’ step, this is also recited at a high of generality (without any details regarding how it is being performed) and amounts to generally linking the use of a judicial exception to a particular field of use. MPEP 2106.05(h). For a list of considerations when evaluating whether additional elements integrate a judicial exception into a practical application, see MPEP 2106.04(d)(1). [Step 2A, Prong 2: NO].
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05. In addition, Dozortsev et al. (IDS filed 07/27/2022) teaches methods for measuring FSH and hormones for triggering ovulation (page 221). Moreover, the courts have recognized the following laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017); iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017); v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs. Ltd., 818 F.3d at 1377; 118 USPQ2d at 1546.
Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract steps. See MPEP 2106.05(d)(Part II). Thus, the independent claim(s) as a whole do not amount to significantly more than the exception itself. Therefore, the claim(s) is/are not patent eligible. [Step 2B: NO].
D. Dependent Claims
Dependent claims 2-20 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. In particular, claims 2-4 are entirely directed to limitations that further limit the specificity of the abstract idea or the data being used by the abstract idea, as set forth above, as well as the same non-abstract steps set forth above. Accordingly, the above are not patent eligible for the reasons set forth above (Step 2A and 2B). Claims 5-13 further limit the specificity of the limitations directed to FSH levels and pharmacological formulations. Accordingly, the above steps amount to insignificant extra-solution activity for reasons discussed above (Step 2A, prong 2 and Step 2B analysis) and are not indicative of an integration into a practical application. See MPEP 2106.05(g). Claim 14, 15, 16, 17 further comprises prescribing, capturing, and measuring steps recited at a high of generality. Accordingly, the above steps amount to insignificant extra-solution activity for reasons discussed above (Step 2A, prong 2 and Step 2B analysis) and are not indicative of an integration into a practical application. See MPEP 2106.05(g). Claims 18-20 further comprise limitations that further limit the specificity of the abstract idea set forth above (claim 1). Accordingly, the claims are not patent eligible for the reasons set forth above (Step 2A, prong 1). For these reasons, the claims are not patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
This is a written description rejection.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement is separate and distinct from the enablement requirement. The specification must: (1) describe the claimed invention in a manner understandable to a person of ordinary skill in the art, and (2) show that the inventor actually invented the claimed subject matter.
Claim 1 is directed to a method for “achieving improved egg quality and simplified management” in a patient undergoing controlled ovarian stimulation. Regarding claim(s) 1, the specification fails to provide written description support for the following steps:
estimating optimal duration for said controlled ovarian stimulation;
estimating target level of FSH in said patient to achieve said optimal duration;
prescribing a pharmacological formulation changing FSH level in circulation to achieve said target level of FSH;
adjusting amount of said pharmacological formulation when said resulting FSH does not match target level of FSH;
With regards to the claimed “estimating”, “prescribing”, and “adjusting”, these limitations are broadly recited and lack any specificity with regards to the how these steps are actually being achieved. The specification fails to teach the requisite computational techniques (e.g. algorithms and/or models) or in silico examples demonstrating that applicant was in possession of the full scope computational methods embraced by the claim. The specification fails to provide sufficient examples of “optimal durations” of stimulation demonstrating that applicant was in possession of the full scope such knowledge. The specification also fails to provide any standard for ascertaining what amounts to “egg quality” (such that is can reasonably be improved). At best, the instant specification teaches a limited embodiment of using generically recited “algorithms” for predicting target levels of FSH [0026-0029] and a legacy AI algorithm for ovarian stimulation that includes specific patient parameters [Figure 2]. However, these limitations are not commensurate in scope with what is being claimed and also do not provide sufficient specificity with regards to how the claimed invention operates in order to achieve the claimed results. In other words, the claimed method is essentially a black box for estimating ‘optical duration’ for controlled stimulation and target FSH levels, and then prescribing a generically recited formulation to achieve target FSH levels. Moreover, one of ordinary skill in the art would recognize that the choice of the computational methods for improving ovarian stimulation protocols are not trivial. For example, Barnett et al. (Journal of Assisted Reproduction and Genetics (2020) 37:2405–2412) teaches machine learning and regression models for predicting IVF outcomes in patients [See entire]. Unlike the claimed method, Barnett teaches specific models (SVM and NN) based on specific clinical parameters (age, BMI, and clinical features) for predicting number of oocytes retrieved, mature oocytes, fertilized oocytes, top-quality embryos, positive beta-hCG, clinical pregnancies, and live births [page 2407, entire] and evaluating model performance [page 2408-09]. Barnett also teaches that methods for predicting of IVF outcomes remains one of the challenges in the field of fertility treatments [page 2409]. Accordingly, it is clear that the selection model and appropriate parameters directly impacts model performance. As such, the specification fails to provide sufficient guidance on specific computational operations for performing the full scope of functions embraced by the claims.
With regards to the claimed “pharmacological formulation”, this limitation is also generically recited and not associated with any particular compounds, amounts, or durations. A review of the specification fails to provide any evidence that applicant has actually disclosed sufficient correlations between “optimal durations” of stimulation and amounts of “pharmacological formulation” required to achieve the claimed results. The specification teaches administering specific ovulation trigger drugs to induce oocyte maturation and ovulation [0040]. However, this is not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Moreover, unlike the claimed method, Letterie et al. (Fertility and Sterility, 2020, Vol. 114, No. 5, pp.1026-1031) teaches the use of AI for IVF management including specific medications for ovarian stimulation including recombinant FSH and menotropins and dosages of FSH based on age, diagnosis, antral follicle count, and antimullerian hormone levels [pp.1027]. Therefore, it immediately becomes unclear how one of skill in the art would be able to determine prescribe a pharmacological formulation as claimed in order to achieve target levels of FSH as claimed. As such, the specification fails to provide sufficient guidance on specific computational operations for performing the full scope of functions embraced by the claims.
Regarding claim(s) 2, the specification fails to provide written description support for the following steps: “calculating target pace of said ovarian follicle expansion to not exceed said acceptable size of said ovarian follicles at said end of said optimal duration.” This limitation is broadly recited and lacks any specificity with regards to the how “target pace” is being calculated. The specification fails to teach the requisite computational techniques (e.g. algorithms and/or models) or in silico examples demonstrating that applicant was in possession of the full scope computational methods embraced by the claim. Given the breadth of what is claimed, there is no evidence that applicant has actually disclosed the requisite computational functionality for achieving the full scope of what is presently embraced by the claims.
For the reasons discussed above, the specification does not provide a sufficient disclosure of the critical aspects of the claim necessary to demonstrate to one of ordinary skill in the art that the inventor possessed the invention at the time the application was filed. For more information regarding the written description requirement, see MPEP §2161.01- §2163.07(b).
Claim rejections - 35 USC § 112, 2nd Paragraph
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 1-20 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 1 are also rejected due to said dependency.
Claim 1 recites a method for “achieving improved egg quality” (in the preamble). It is unclear as to the metes and bounds of “improved egg quality”, which is subjective term that is not defined in the body of the claim nor does the specification provide any standard or limiting definition for “egg quality” that would serve to clarify the scope. A review of the specification (Figure 2) teaches reaching a “desirable follicle size”. However, this is not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. In addition, a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone [See MPEP 2111.02]. In this case, the preamble merely results is “triggering oocyte’s final maturation” (which is clearly not representative of “egg quality”). As a result, it is also unclear what limiting effect is intended by the preamble. Clarification is requested via amendment.
Claim 1 recites the term “controlled ovarian stimulation” (in the preamble). In this case, the term “controlled” is a relative term which is not defined by the claim and the specification does not provide a standard for ascertaining the requisite degree of “control” such that one or skill in the art would be reasonably apprised of the scope (i.e. in what way is the ovarian stimulation controlled). Clarification is requested via amendment.
Claim 1 recite “estimating optimal duration for…ovarian stimulation.” This phrase is problematic for the following reasons. (1) With regards to said “estimating”, such generic claim language amounts to a description a of problem to be solved and covers all means or methods of performing the claimed function (and reasonably encompasses guessing). A review of the specification does not describe, to any appreciable extent, any specific algorithms, equations, parameters, or prose equivalent that correspond to the claimed function. The instant specification teaches a limited embodiment of using generically recited “algorithms” for predicting target levels of FSH [0026-0029] and a legacy AI algorithm for ovarian stimulation that includes specific patient parameters [Figure 2]. However, these are not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. As a result, it is unclear what computational techniques are included or excluded by this phrase such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment. (2) With regards to “optimal duration”, the term “optimal” implies that the duration is chosen by some existing criteria. However, the specification does not provide a standard or criteria for optimal proportions such that one of ordinary skill in the art would know the metes and bounds of an optimal duration, as claimed. Clarification is requested via amendment.
Claim 1 recites “estimating target level of FSH…to achieve said optimal duration.” Such generic claim language amounts to a description a of problem to be solved and covers all means or methods of performing the claimed function (and reasonably encompasses guessing). A review of the specification does not describe, to any appreciable extent, any specific algorithms, equations, parameters, or prose equivalent that correspond to the claimed function. The instant specification teaches a limited embodiment of using generically recited “algorithms” for predicting target levels of FSH [0026-0029] and a legacy AI algorithm for ovarian stimulation that includes specific patient parameters [Figure 2]. However, these are not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. As a result, it is unclear what computational techniques are included or excluded by this phrase such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment
Claim 1 recites “responsive to achieving said optimal duration, triggering oocyte's final maturation.” This phrase merely describes the environment in which “maturation” occurs. As a result, it is unclear as to the metes and bounds of said “triggering”, i.e. who or what is performing said “triggering” and in what way is the triggering “responsive to…said optimal duration”. The specification teaches administering specific ovulation trigger drugs to induce oocyte maturation and ovulation [0040]. However, this is not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Clarification is requested via amendment.
Claim 2 recites “calculating target pace of said ovarian follicle expansion to not exceed said acceptable size of said ovarian follicles at said end of said optimal duration.” It is unclear as to the metes and bounds of the term “calculating”, which ambiguously reads on “doing math”. Such generic claim language amounts to a description a of problem to be solved and covers all means or methods of performing the claimed function. A review of the specification does not describe, to any appreciable extent, any specific algorithms, equations, parameters, or prose equivalent that correspond to the claimed function. As a result, it is unclear what computational techniques are included or excluded by this phrase such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment. In addition, it is unclear what is meant by the “target pace of said ovarian follicle expansion”. A review of the specification does not provide any limiting definition such that the artisan would know how to avoid infringement. For purposes of examination, this phrase is interpreted as calculating follicle growth. Clarification is requested via amendment.
Claim 20 recites “training an artificial intelligence model utilizing said case studies to map said plurality of patients P (P1, P2, ..., Pn) with corresponding demographics D (D1, D2, ..., Dn) to a corresponding treatment plans TP (TP1, TP2, ..., TPn) to achieve said target level of FSH.” It is unclear as to the metes and bounds of said “artificial intelligence model”. A review of the specification does not describe, to any appreciable extent, any specific algorithms, equations, parameters, or prose equivalent that correspond to the claimed model. The instant specification teaches a legacy AI algorithm for ovarian stimulation that includes specific patient parameters [Figure 2]. However, this is not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. As a result, it is unclear what computational techniques are included or excluded by this phrase such that one of ordinary skill in the art would know how to avoid infringement. Clarification is requested via amendment.
Cited Prior Art
The following prior art made of record and not relied upon is considered pertinent to applicant' s disclosure.
Cheng et al. (WO 2013090787 A1), which teaches methods for stimulating ovarian preantral and antral follicles in a mammal.
Dozortsev et al. (US 20220354810 A1), which teaches a method for improving oocytes quality by increasing a follicular phase of an ovarian cycle of a patient. A target duration of the follicular phase of the patient is determined. The follicular phase is extended to improve the quality of the oocyte which improves the change of reproductive success. Non-steroidal anti-inflammatory medications is prescribed to be consumed for at least one day during the target duration by the patient. A plurality of ovary stimulating medications to be consumed only during the target duration to stimulate ovaries of the patient.
It is noted for the record that Figure 2 of the instant drawings recites the term “PRIOR ART”. Accordingly, this Figure may be relied upon as prior art in a subsequent Office action. See MPEP 2129 [R-6] and MPEP 706.02 (III).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619