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 IDS filed 3/31/2022 has been considered by the Examiner.
Priority
Applicant’s claim for priority to US 62/908743 filed 10/1/2019 and 63/049608 filed 7/8/2020 and PCT/US20/53651 filed 9/30/2020 is acknowledged in view of the deletion of the limitation “wherein the semen qualities are chosen from cellular motion, cellular function, regulation of intracellular information, and reduction-oxidation balance” in claim 2 and cancellation of claim 1.
Status of claims
Claims 2-3, 6, 11-14, 18-20, 24-27, 30, 149 and 151-152 are under examination.
Claims 1, 4-5, 7-10, 15-17, 21-23, 28-29, 31-148 and 150 are cancelled.
Claim Rejections - 35 USC § 101
The instant rejection is maintained from the previous Office Action of 9/10/2025 and modified in view of Applicants amendments filed 3/09/2026.
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 2-3, 6, 11-14, 18-20, 24-27, 30, 149 and 151-152 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claims 2-3, 6, 11-14, 18-20, 24-27, 30, 149 and 151-152 are drawn to a method, so a process.
Step 2A Prong One: Identification of an Abstract Idea
The claim(s) recite(s)
1. measuring semen qualities from an ejaculate collected from of a male animal of an agricultural production system.
This step encompasses mathematical measuring and analysis which can be performed as a mental process and is therefore an abstract idea.
2. establishing a computational device prediction models automated computational transformation algorithm trained on a plurality of established semen qualities related to male factor fertility to predict male fertility-related parameters.
This step can be performed as a mental process and is therefore an abstract idea. The establishing prediction models with an automated computational transformation algorithm reads on a mathematical model. A model trained on a plurality of semen qualities related to male fertility reads on embodiments including a mathematical model such as a mathematical function or simple neural network or a list of information..
3. Inputting measured semen qualities from the ejaculate into the computational model automated computational transformation algorithm to create prediction model transformation algorithm to create prediction model transformed data of the measured semen qualities based on training from the established semen qualities.
This step reads on performing mathematical calculations on data by inputting numbers into a mathematical function to transform one form of information into another form of information. The step is therefore an abstract idea.
5. generating prediction models completed prediction output based on said prediction model transformed data of said measured semen qualities.
This step reads on generating a result from the prediction model and is therefore an abstract idea because it can be performed by the human mind.
7. predicting male fertility-related parameters of said ejaculate of said male animal of said agricultural production system for said male animal based on said prediction models completed prediction output.
This step can be performed as a mental process or with mathematics using the prediction system which reads on math. The step is therefore an abstract idea.
8. using said male fertility-related parameters in making a decision about a reproductive use of said male animal wherein said decision is chose from a breeding decision, a culling decision, and a decision of a type of assisted reproductive technology.
This step can be performed as a mental process by evaluating parameters and formulating a decision, and is therefore an abstract idea.
9. wherein said measured semen qualities from said ejaculate collected from said male animal are chosen from cellular motion, cellular function, regulation of intracellular information, and reduction-oxidation balance.
This step can be performed as a mental process and is therefore an abstract idea. Choosing the recited qualities can be performed as a mental process.
10. managing said male animal in said agricultural production system based on said decision made about breeding decision, culling or decision about type of assisted reproductive technology.
This step reads on a mental process because the recited “managing” reads on further decision making rather than an additional element. See Step 2A Prong Two.
Step 2A Prong Two: Consideration of Practical Application
The claimed method recites a fertility prediction and fertility related decisions which results in a step of managing said male animal in said agricultural production system based on said decision made about breeding decision, culling or decision about type of assisted reproductive technology. The recited step of “managing” is broad and does not recite any of the particular practical applications listed below. Instead, the recited managing reads on further decision making and not an additional element.
The claims do not recite any additional elements that integrate the abstract idea into a practical application.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
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 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 the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
1. applying “automated computational” transformation which reads on a generic computer.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the recited automated computation is a recitation of generic computer structure that serves to perform generic computer functions that are well-understood, routine, and conventional activities previously known to the pertinent industry. Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 3/09/2026 have been fully considered but they are not persuasive.
Applicants argue (Remarks, page 9, par. 3) that the claims are tied to a concrete technical purpose, improved decisions about male animals in agricultural production systems for breeding, culling and reproductive technology decisions.
In response, the claims do not recite any additional elements that reflect an improvement to technology. Improved decisions by way of math or mental process steps are drawn to abstract ideas. Even if the claimed calculations result in improved information, the claims are non-statutory if the calculations rely only on math or mental processes without additional elements that serve as a practical application under Step 2A Prong Two or are non-routine and add significantly more under Step 2B.
Applicants argue (Remarks, page 10-11, connecting par. ) that “dynamic functional” predicative modeling including zinc signature, acrosomal modifications, and plasma membrane integrity performs better than conventional semen analysis parameters with static morphology.
In response, Applicants are arguing limitations not recited in the claims. The claims do not recite prediction parameters of zinc signature, acrosomal modifications, and plasma membrane integrity. Furthermore, the claims do not recite a practical application of the abstract idea, such as administering a particular treatment or a transformation of matter. The claims recite predicting “male fertility-related parameters,” which is generic information and then applying these parameter to “making a decision” about breeding, culling or reproductive technology.” There is no recited specific result of the abstract idea that is integrated into a particular additional element that would reflect a practical application (e.g. a particular treatment or particular transformation of matter) or improvement to technology.
Claim Rejections - 35 USC § 112-2nd paragraph
The rejection of claims 6 and 21-23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of applicant’s amendments filed 3/09/2026.
Claim Rejections - 35 USC § 103
The rejection of claims 1-3, 6, 11, 12, 19-27, 30 and 149 under 35 U.S.C. 103(a) as being unpatentable over Javadi et al. (Computers in Biology and Medicine, vol. 109 (2019) pgs. 182-194) is withdrawn in view of Applicant’s arguments and amendments.
The rejection of claims 14 and 18 under 35 U.S.C. 103(a) as being unpatentable over Javadi et al. in view of Agarwal et al. (Investig. Clin. Urol. vol. 58 (2017) pgs. 385-399) is withdrawn in view of Applicant’s arguments and amendments.
The rejection of claim 13 under 35 U.S.C. 103(a) as being unpatentable over Javadi et al. in view of Tvrda et al. (JMBFS, vol. 3 (2031) pgs. 1-14) is withdrawn in view of Applicant’s arguments and amendments.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Skibinsky whose telephone number is (571) 272-4373. The examiner can normally be reached on 12 pm - 8:30 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on (571) 272-7035. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anna Skibinsky/
Primary Examiner, AU 1635