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 .
Election/Restrictions
Applicant’s election without traverse of Group I claims 1-16 in the reply filed on 5/19/2025 is acknowledged.
Specification
The disclosure is objected to because of the following informalities: the specification does not include a brief description of figures 5A and 5B.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an apparatus” and “a decision support tool” 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 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.
The specification sets forth “the apparatus” as an ultrasound machine, paragraph [0008]. No specific structure is set forth for the “decision support tool”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claim 1-16 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The specification sets forth a generically recited ultrasound machine paragraph [0008] to perform the recited functions “to identify and measure follicle sizes”. The generically recited ultrasound machine does not set forth any structure capable of identifying and measuring the follicle sizes. A generically recited ultrasound machine uses high-frequency sounds to create a real time image. However, the generically recited ultrasound machine is not capable of identifying and measuring follicle sizes as recited in the function claim 1 line 3.
The specification does not set forth any specific structure for the “decision support tool” therefore the claims are indefinite under 112(A) because no structure is provided to perform the function “to calculate an optimized drug treatment plan”.
Further, the specification does not set forth how “calculating the optimal daily dosage” is completed given the entered data.
Applicant’s attention is invited to MPEP 2181.
Claims 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for imaging by ultrasound, does not reasonably provide enablement for identifying and measuring follicle sizes or calculating the optimum hormone dosage based on “first follicle size distribution and second follicle size distribution.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. With respect to the Wands factors:
The claims recite “an apparatus” and “a decision support tool” in a very broad manner.
The nature of the invention is directed to calculating and administering an optimal daily dose hormone based on “first follicle size distribution data” and “second follicle size distribution data” but does not disclose how to calculate the optimal daily dose based on “first follicle size distribution data” and “second follicle size distribution data”.
The state of the prior art is set forth by Nordkild et al(9,353,172) which determines follicle size using an ultrasound, section labeled (113). Nordkild does not describe the use of follicle size distribution data.
The level of ordinary skill in the art would be considered college level plus those experienced in the IVF practice.
The level of predictability in the art, is low in that each individual patient has their own unique medical history and genetics.
The amount of direction provided by the inventor sets forth broad brush of using nomograms, heuristics and differential equations to calculate the optimal dose. However, the inventor has not disclosed how to use these methodologies to get from “first and second follicle size distribution and the end result of “optimal daily hormone dose”.
The existence of working examples. The applicant has set forth a flow chart, figure 1 box 28 is the step in the flow chart to calculate optimal dose. No guidance is given regarding how to get from what is input into the so called “decision support tool” and the “optimal daily hormone dose”, particularly using “first and second follicle size distributions”.
The quantity of experimentation needed to make and use the invention would require one of ordinary skill in the art to determine the relationship between “first and second follicle size distribution” and the “optimal outcome” for IVF patients. This appears to be the entire invention claimed by the applicant.
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 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 – in line 12, “the first follicle size data” lacks antecedent basis. It appears the applicant is referring to the “first follicle size distribution data” set forth in line 4. In line 12, it is unclear if “second follicle size data” is the same or different than the “second follicle size distribution data” in line 8. In line 14 “the optimal daily hormone dosage” and in line 16 “the optimal daily hormone dosage” lack antecedent basis.
Claim 4 – in line 2, “the age” and “the FSH data” lack antecedent basis.
Claim 6 – in line 2, “the age” and “the FSH data” lack antecedent basis.
Claim 9 – “the optimal daily dosage” line 1 lacks antecedent basis.
Claim 10 – “the optimal daily dosage” line 1 lacks antecedent basis.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication 2023/0015833 teaches a personalized hormonal therapy but does not teach using first follicle size distribution and second follicle size distribution to determine the optimized treatment hormone dosage.
US Patent 9,353,172 teaches hormone therapy based on follicle size but does not use follicle size distribution data.
US Patent 11,679,145 teaches a method of treating infertility based on follicle size, as set forth in column 7 line 47 through column 8 line 20.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL G GILBERT whose telephone number is (571)272-4725. The examiner can normally be reached MaxiFlex; M-F 8-5.
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/SAMUEL G GILBERT/ Primary Examiner, Art Unit 3791