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 .
REQUEST FOR CONTINUED EXAMINATION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/6/2026 has been entered.
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
Amendments to the claims filed 5/06/2026 are acknowledged. Claims 153-154 are new.
Claims 2-3, 6, 11-14, 18-19, 24-27, 30, 149 and 151, 153-154 are under examination.
Claims 1, 4-5, 7-10, 15-17, 20-23, 28-29, 31-148, 150 and 152 are cancelled.
Claim Rejections - 35 USC § 101
The instant rejection is maintained from the previous Office Action of 3/18/2026 and modified in view of Applicants amendments filed 5/6/2026.
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, 18-19, 24-27, 30, 149 and 151, 153-154 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, 18-19, 24-27, 30, 149 and 151, 153-154 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 with biological equipment.
This step encompasses mathematical measuring and analysis which can be performed as a mental process and is therefore an abstract idea. Under Broadest Reasonable Interpretation, the recited biological equipment can read on a generic computer. Also see Step 2B below.
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.
6. generating a fertility score by executing trained computational device prediction models automated computational transformation algorithm by extracting quantitative features from measured semen quantity, applying the features to trained computational prediction models configured to correlate quantitative features with male fertility related parameters.
The step of extracting features from semen quality can be performed by the human mind by evaluating data to determine needed features. The step of applying the features to a trained computational device prediction models automated computational transformation algorithm reads on inputting data into “prediction models” which reads on math and can also be performed by the human mind. The recitation of “computational device” and “automated computational transformation algorithm” merely sets forth that the models are executed by a computer which is a tangential recitation of a generic computer (as in MPEP 2106.05(f)). The models are also recited as generating a fertility score by executing the trained prediction models which reads on math or a mental process of analyzing data using models to determine a fertility score. Because the claimed process can be performed by the human mind or by math, the step reads on an abstract idea.
7. classifying said ejaculate of said male animal of said agricultural production system for said male animal based on said prediction models fertility score.
This step of classification can be performed as a mental process or with mathematics by analytically comparing ejaculate characteristics to model characteristics or criteria. 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.
Step 2A Prong Two: Consideration of Practical Application
The claimed method recites classifying ejaculate based on semen quality and physically processing said ejaculate based on the classification comprising: processing and using said ejaculate for use in artificial insemination, discarding said ejaculate or processing and processing using said ejaculate to a specific assisted reproductive protocol.
1. The additional element of processing and using said ejaculate for use in artificial insemination does not include an integration of how the classification is applied to the processing and using. Furthermore, the limitation does not recite how the ejaculate is processed or used so as to apply the abstract idea into a practical application such as a transformation of matter. The limitation is also not a particular treatment for a disease or medical condition.
2. The additional element of discarding said ejaculate also does not transform a article of matter into a different state or thing; such that the additional element effects a transformation or reduction of a particular article to a different state or thing.
3. The additional element of processing and using said ejaculate to a specific assisted reproductive protocol also does not integrate the step of classifying into how the ejaculate is processed and used nor does the step recite any transformation or reduction of a particular article to a different state or thing or a particular treatment or prophylaxis for a disease or medical condition.
It is noted that other potential categories of practical application are recited below. The recited additional elements do not integrate the abstract idea into a practical application because they do not meet any of the below listed criteria.
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. collecting an ejaculate from a male animal of an agricultural production system.
2. measuring semen qualities with biological equipment. In an alternative embodiment to a generic computer, the biological equipment reads on generically recited tools known to those of ordinary skill for assessing semen quality, such as a microscope.
3. physically processing said ejaculate based on the classification comprising: processing and using said ejaculate for use in artificial insemination, discarding said ejaculate or processing and processing using said ejaculate to a specific assisted reproductive protocol
4. “computational device” and “automated computational” 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 collecting animal semen, inspecting its quality using biological tools and processing it based on inspected quality is routine, conventional and well understood. The combination of “additional elements” does not add significantly more to the recited judicial exception because it is well understood, routine and conventional. Furthermore, the recited “computational device” and “automated computational” 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 5/06/2026 have been fully considered but they are not persuasive.
Applicants argue (Remarks, page 8, par. 2) that the claims are tied to a concrete technical purpose, improved decisions about how to use male animals in agricultural production systems for a breeding decision, culling decision or decision of the type of assisted reproductive technology.
In response, a concrete technical purpose is not a standard for evaluating statutory subject matter in the Two Step analysis outlined in MPEP 2106.04 and 2106.05. A breeding decision, culling decision or decision of the type of assisted reproductive technology per se is an abstract idea. While an abstract idea may be improved, it should be integrated into a practical application or, the claim should recite additional elements that are not routine, conventional and well understood while meaningfully limiting the judicial exception.
Applicants argue (Remarks, page 8, par. 3) that claim 2 has been amended to clarify that measuring of semen qualities is with biological equipment which is not a mental process.
In response, the step is drawn to and additional element however it is also an extra solution activity of data gathering as set forth in MPEP 2106.05(g). Additionally, using biological equipment to gather information about semen quality is routine, conventional and well understood.
For the reasons set forth above, the 35 USC 101 rejection is maintained.
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.
Suggestion for Examiner Interview
Applicant is advised to contact the Examiner at the below listed contact information in order to set up an Interview to discuss the rejections maintained and newly set forth herein. It is noted that an Interview with the Examiner serves to move prosecution forward and clarify remaining issues in the Office Action.
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
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
Prosecution Insights