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 .
Response to Arguments
Due to Applicant’s cancellation of all previous pending claims, all previous pending rejections have been withdrawn.
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
Regarding the previous rejection of the claims under 35 U.S.C. § 101, the applicant has argued the new claims are not directed towards an abstract idea. Specifically, the applicant argues “They recite a specific, integrated machine that extracts milk samples during physical milking operations, measures progesterone, compares to a stored threshold, and, in certain dependent claims, physically actuates dairy workflows (sorting, scheduling). Moreover, the claims are integrated into a practical application manipulating tangible milk streams and moving animals via a sorting gate based on in-parlor measurements within a narrow post-AI time window”. The Examiner agrees that physically routing animals to move to separation zones via a physical sorting gate, as recited in dependent Claims 25 and 32, amount to significantly more than the abstract idea. However, the recited milk sample extractor and progesterone level measurement device are used in mere data gathering steps. Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011).
The applicant has also argued “Even if individual blocks were conventional, the claimed combination and timing constraints (plural sampling during milking within >5 and <9 days post- AI; non-pregnancy only when each obtained measurement in the window is below TL) are not shown to be "routine." The Office's citations speak only to generic existence of input devices and processors, not to this integrated milking-workflow system with the conjunctive multi-measurement rule and physical animal routing”. However, it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. The claimed timing constraints and multi-measurement rules merely limit the recited abstract idea to a particular time frame.
Applicant’s arguments with respect to the previous rejection under 35 U.S.C. § 103 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Friggens and amended Claim 22, the applicant has preemptively argued “Friggens speaks generally to "repetitively providing" body-fluid samples and database modeling, not to parlor· linked extraction during milking sessions, nor to the particular hardware path from extractor [Wingdings font/0xE0] P4 device [Wingdings font/0xE0] sensor[Wingdings font/0xE0] controller in a milking system.” However, Friggens does teach milking parlor-linked extraction ([0040]) during a plurality of milking operations ([0091]), and as an apparatus-type claim, discloses under broadest reasonable interpretation an apparatus capable of performing the hardware path of: extractor ([0040]) [Wingdings font/0xE0] P4 device ([0047]) [Wingdings font/0xE0] sensor ([0048])[Wingdings font/0xE0] controller ([0049]) in a milking system ([0004], [0040]).
Regarding Lamming and the claim limitation “wherein the milk sample extractor is configured to extract a milk sample from the animal during a plurality of milking operations within a time window” in amended Claim 22, the Applicant has preemptively argued “Lamming emphasizes single-day thresholds (e.g., day-5 milk P4 <3 ng/ml) as an early indicator, but does not teach plural milking-operation samples across a 5-9 day window with an each-is-below rule nor the claimed parlor workflow integration” (page 8). However, the Examiner believes Lamming does teach the broadest reasonable interpretation of the claim language in 3:67 (“at least one of Day 4, 5 and 6 post insemination” includes measurements all three days), and Nation was also relied upon to teach this limitation ([0097]). In addition, Lamming suggests a use for measuring progesterone providing each extracted milk sample to the progesterone level measurement device within a time window, the time window being longer than 5 days and shorter than 9 days from the insemination to avoid indiscriminate use of medicating hormones with compound effects (4:1-6 of Lamming). This would have been obvious to add to the system of Friggens as explained below in the updated 35 U.S.C. § 103 rejection.
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.
Claim 22 is being interpreted under 35 U.S.C. § 112(f) as it:
(A) Uses the nonce term “means” for the apparatus performing the specified function;
(B) “means” is linked with the transitional phrase “configured to” and modified by the functional
language “receive a point in time of an insemination of the animal”;
(C) “means” is not modified by sufficient structure, material, or acts for performing the claimed
function.
This claim will be interpreted in accordance with the disclosure of the applicant on 8:36-9:3 of the instant specification filed 10/27/2022 as a mobile portable device, a peripheral device that is configured to receive and send data to a controller, a mouse, keyboard, graphics tablet, image scanner, barcode reader, microphone, digital camera, webcam, and equivalents thereof.
Claim Rejections - 35 USC § 112
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.
Claim 23 is 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 23 recites “wherein the one or more progesterone level measurements are made within a time window at 7 days from the insemination”. It is unclear if this time window is the same time window recited in Claim 1, or a different time window. For the purposes of substantive examination, the examiner is construing this claim limitation as “wherein the one or more progesterone level measurements are made after the insemination”.
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 30 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “a database configured to store information of animals of a herd, the information relating to insemination, pregnancy or non-pregnancy status, and/or scheduled hormone treatment, associated with an identity reference of the respective animal” is claimed as a product without any structural recitations. Products that do not have a physical or tangible form, such as information (often referred to as "data per se" or “information per se”) are not directed to any of the statutory categories required to satisfy Step 1 of 35 U.S.C. § 101 analysis.
Claims 22-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding Claim 22, the claim recites a milking system (comprising an arrangement and a milk sample extractor, wherein the arrangement is configured to evaluate a progesterone level in an analyte of an animal, wherein the analyte is milk). Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
receive the point in time of the insemination of the animal
obtain one or more progesterone level measurements of the analyte of the animal within the time window
determine that the animal is non-pregnant when, for a plurality of obtained progesterone level measurements within the time window, the progesterone level of each of the plurality of measurements is lower than the progesterone threshold limit
These limitations describe a mathematical calculation and/or a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is able to manually/mentally receive the point in time of the insemination of the animal , e.g. visually or audibly receiving a time stamp of insemination via word of mouth or an output on a sensor.
A human is able to manually/mentally obtain one or more progesterone level measurements of the analyte of the animal within the time window, e.g. via word of mouth or an output on a sensor.
A human is able to manually/mentally determine that the animal is non-pregnant when, for a plurality of obtained progesterone level measurements within the time window, the progesterone level of each of the plurality of measurements is lower than the progesterone threshold limit, e.g. in the mind, using pen and paper, or generic computing tools.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a progesterone level measurement device configured to measure a progesterone level of an analyte sample of the animal
a sensor configured to detect a result of the progesterone level measurement of the progesterone level measurement device
wherein the milk sample extractor is configured to extract a milk sample from the animal during a plurality of milking operations within a time window and to provide each extracted milk sample to the progesterone level measurement device, the time window being longer than 5 days and shorter than 9 days from the insemination
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a controller
an input means configured to receive a point in time of an insemination of the animal
a memory configured to store a progesterone threshold limit
wherein the controller is configured to…
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a progesterone level measurement device configured to measure a progesterone level of an analyte sample of the animal
a sensor configured to detect a result of the progesterone level measurement of the progesterone level measurement device
wherein the milk sample extractor is configured to extract a milk sample from the animal during a plurality of milking operations within a time window and to provide each extracted milk sample to the progesterone level measurement device, the time window being longer than 5 days and shorter than 9 days from the insemination
a controller
an input means configured to receive a point in time of an insemination of the animal
a memory configured to store a progesterone threshold limit
wherein the controller is configured to…
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The input means is considered to be well-understood, routine, and conventional based on a statement from the applicant' s specification filed 10/27/2022 (“The input means 160 may comprise a mobile portable device, carried by the farmer/ veterinarian engaged for the insemination. However, in other embodiments, the input means 160 may comprise a peripheral device that is configured to receive and send data to a controller 110, comprised in the arrangement 101. The input means 160 may comprise a mouse, keyboard, graphics tablet, image scanner, barcode reader, microphone, digital camera, webcam or similar means”, 8:3-9:3; mobile portable devices, mouses, keyboards, tablets, barcode readers, microphones, digital cameras, and webcams are all commercially available products).
The progesterone level measurement device is considered to be well-understood, routine, and conventional based on a statement from the applicant' s specification filed 10/27/2022 (“The arrangement 101 also comprises a progesterone level measurement device 140, configured to measure a progesterone level of an analyte sample of the animal 105. The progesterone level measurement device 140 may for example comprise a flow stick”, 9:6-8; flow sticks are commercially available products).
The sensor is considered to be well-understood, routine, and conventional based on a statement from the applicant' s specification filed 10/27/2022 (“The sensor 130 may comprise a camera, video camera or similar type of visual sensor”, 9:17-18).
The controller is considered to be well-understood, routine, and conventional based on a statement from the applicant' s specification filed 10/27/2022 (“The controller 110 also comprises a processing circuitry 620 configured for performing various calculations for conducting a computer-implemented method 500 as illustrated in Figure 5. Such processing circuitry 620 may comprise one or more instances of a processing circuit, i.e. a Central Processing Unit (CPU), a processing unit, a processing circuit, a processor, an Application Specific Integrated Circuit (ASIC), a microprocessor, or other processing logic that may interpret and execute instructions. The herein utilised expression "processor" may thus represent a processing circuitry comprising a plurality of processing circuits, such as, e.g., any, some or all of the ones enumerated above”, 18:18-27).
The memory is considered to be well-understood, routine, and conventional based on a statement from the applicant' s specification filed 10/27/2022 (“The optional memory 625 may comprise a physical device utilised to store data or programs, i.e., sequences of instructions, on a temporary or permanent basis. According to some embodiments, the memory 625 may comprise integrated circuits comprising silicon-based transistors. The memory 625 may comprise e.g. a memory card, a flash memory, a USB memory, a hard disc, or another similar volatile or non-volatile storage unit for storing data such as e.g. ROM (Read-Only Memory), PROM (Programmable Read-Only Memory), EPROM (Erasable PROM), EEPROM (Electrically Erasable PROM), etc. in different embodiments”, 18:31-36).
The milk sample extractor considered to be well-understood, routine, and conventional based on the drawings filed 10/27/2022 and a statement from the applicant' s specification filed 10/27/2022 (“The milking system 100 also comprises a milk sample extractor 130, configured to extract a milk sample from the animal 105 during a milking operation and provide the extracted milk sample to the progesterone level measurement device 140”, 17:33-35; Fig. 1A depicts element 130 as a commercially available milk extractor)
Dependent Claims 23-24 and 26-31 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claims 23-24, 26, 29, and 31 also fail to add subject qualifying as significantly more to the abstract independent claims as they recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claims 23-24, 26, 29, and 31 also fail to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claims as they do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, Claims 22-24 and 26-31 are not patent eligible under 35 U.S.C. § 101.
The Examiner notes that Claims 25 and 32 are not rejected under 35 U.S.C. § 101 as they amount to significantly more than the abstract idea.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22-23, 26, and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Friggens et al (US 20040098207 A1, cited in applicant’s IDS, hereinafter Friggens) in view of Nation et al (US 20090018778 A1, hereinafter Nation) and Lamming (US 6602676).
Regarding Claim 22, Friggens discloses a milking system comprising an arrangement (See Abstract) and a milk sample extractor (“Milking device”, Figs. 4-7b; See [0040], [0162], [0172], [0174]), wherein the arrangement is configured to evaluate a progesterone level in an analyte of an animal, wherein the analyte is milk (“body fluids of animals, in particular milk, urine and blood may be analysed in order to obtain values of parameters, such as … progesterone, or others, each of which by itself or in combination with others indicates a certain physiological state. For example…the progesterone content may indicate a pregnancy state”, [0003]), and wherein the arrangement comprises:
a controller (“a computer comprising a processor and being operatively connected to a database…”, Abstract);
an input means configured to receive a point in time of an insemination of the animal (“the computer, including the processor, may be comprised in an analysis apparatus provided near an animal herd, for example in a stable, whereas the database may be comprised in a personal computer in an office separate from the stable, or in a mainframe located at a remote data processing facility”, [0055]; see the interpretation of this limitation under 35 U.S.C. § 112(f) above);
a progesterone level measurement device configured to measure a progesterone level of an analyte sample of the animal (“Preferably, the analysing means are designed to perform quantitative measurements. In one useful embodiment the analysing means comprises solid support analytical means or devices which e.g. may be in the form of test strips (also known as dry sticks) comprising appropriate reagent(s) that in the presence of the compound being analysed generate(s) a detectable signal”, [0089]; “FIGS. 7a-7d shows information flow according to an embodiment of the present invention when analysing for progesterone and reproduction”, [0085]);
a sensor configured to detect a result of the progesterone level measurement of the progesterone level measurement device (“at least one sample providing device for repetitively providing at least one sample of a body fluid of the animal”, Abstract; “analysing the at least one sample, so as to obtain at least one sample value of each of a plurality of parameters of the body fluid”, [0048); and
a memory (“a computer comprising a processor and being operatively connected to a database”, Abstract);
wherein the milk sample extractor is configured to extract a milk sample from the animal (See [0159], [0128]) during a plurality of milking operations (“Embodiments of the system of the invention may be arranged close to the animals, for example in a milking parlour of a farm, and they may be operable by a farmer or a farm technician”, [0040]; “The most likely trigger for the transition to status 1 should be the first rise in progesterone to a level higher than LThreshR. As this is an important anchor point for subsequent sampling frequency and reproductive statistics the farmer must be sure that the sample or the measurement is not just an outlier. Therefore, two consecutive progesterone values above LThreshR will likely be required to cause the shift to Status 1”, [0202]; “sample values of a particular cow are determined during and after milking of the cow,”, [0091]) within a time window (“Wait = AIDate+5”, Fig. 7d) and to provide each extracted milk sample to the progesterone level measurement device (FIGS. 7a-7d shows information flow according to an embodiment of the present invention when analysing for progesterone and reproduction”, [0085]; and
wherein the controller is configured to (“a computer comprising a processor and being operatively connected to a database…wherein the processor is programmed to…”, Abstract):
receive the point in time of the insemination (“Insemination Date”, Fig. 7d; “The change to StatusR=2 could be triggered in 2 ways; because an oestrus is detected or because an insemination has been recorded”, [0213]; “AIdateR = Date of latest insemination”, [0221]) of the animal (“In another preferred embodiment of the present invention reproduction and progesterone is detected in animals, as shown in FIGS. 7a-7d”, [0185]); ; and
obtain one or more progesterone level measurements of the analyte of the animal (“ProgTimeR = Date and time of latest Progesterone sample”, [0221]) within the time window (“Wait = AIDate+5”, Fig. 7d).
Friggens discloses the claimed invention except for expressly disclosing a memory configured to store a progesterone threshold limit;
wherein the milk sample extractor is configured to provide each extracted milk sample to the progesterone level measurement device within a time window, the time window being longer than 5 days and shorter than 9 days from the insemination; and
wherein the controller is configured to:
determine that the animal is non-pregnant when, for a plurality of obtained progesterone level measurements within the time window, the progesterone level of each of the plurality of measurements is lower than the progesterone threshold limit
However, Nation, which is also directed towards reproductive diagnoses and management within bovine livestock (Abstract), teaches wherein the arrangement (See Figs. 2-4) comprises:
a controller (Elements 30, 36, 48, and 52, Fig. 2);
an input means configured to receive a point in time of an insemination of the animal (“Reproductive data 42 is also maintained in the database 40 and includes data relating to the date of last calving, dates of artificial insemination, periods of exclusive artificial insemination, known mating dates and nominated voluntary waiting periods. The reproductive data is typically provided by a farmer, by means of a user terminal 44 or mobile communication device 46 and mobile server 48 connected to the network 38”, [0080]; see the interpretation of this limitation under 35 U.S.C. § 112(f) above);
a memory configured to store a progesterone threshold limit (“In one embodiment, the memory means of the system includes a database structure, said database structure being configured to store at least one or more of the following types of data… [0050] one or more parameters used in the regression formula”, [0046]; Fig. 6 discloses numerical limits for a pregnancy indicator used in the formula, which [0017] discloses can be progesterone.);
wherein the milk sample extractor is configured to extract a milk sample from the animal during a plurality of milking operations (“In a preferred embodiment of the invention, the pregnancy indicator values are determined from milk that has already been collected for the purposes of determining the quantity and quality, including fat and protein content, of the milk”, [0074]) within a time window (See [0022]-[0026] of Nation; a plurality of samples is disclosed to happen within a time window of less than 70 days) and to provide each extracted milk sample to the progesterone level (“The pregnancy indicator may be a steroid or other protein associated with pregnancy selected from the group including estrone sulphate… progesterone”, [0017]) measurement device (“In the first computer based environment 26, ES values from one or more milk samples are read from a milk sample reader 28 and provided to a server 30 in a laboratory”, [0079]; “The milk or other sample is analysed for the presence and value of the pregnancy indicator, preferably ES, at step 88”, [0090]) within a time window (“If there is an earlier sample, preferably the earlier example was taken within a predetermined period, such as 70 days”, [0097]; the Examiner notes the time window of longer than 5 days and shorter than 9 days is within the disclosed 0-70 day range under broadest reasonable interpretation, although Lamming is relied upon to clearly disclose this limitation below); and
wherein the controller is configured to:
receive the point in time of the insemination of the animal (“This validation process relies upon reproductive data, typically provided by the farmer to the management server 36, such as a date of last calving of each cow, one or more dates of artificial insemination”, [0103]);
obtain one or more progesterone level measurements of the analyte of the animal (“Cows are routinely tested for the presence of hormones or other pregnancy indicators that change during pregnancy in blood and blood derived products, milk, faecal or urine samples”, [0088]; “The pregnancy indicator may be a steroid or other protein associated with pregnancy selected from the group including estrone sulphate… progesterone”, [0017]) within the time window (Step 106-108, Fig. 6); and
determine that the animal is non-pregnant when (Step 110, Fig. 6), for a plurality of obtained progesterone level measurements within the time window (“Yes”, Step 108, Fig. 6; “If there is an earlier sample, preferably the earlier example was taken within a predetermined period, such as 70 days”, [0097]), the progesterone level of each of the plurality of measurements (See the measurements at connected steps 106, 112, and 107 in Fig. 6; “The pregnancy indicator may be a steroid or other protein associated with pregnancy selected from the group including estrone sulphate… progesterone”, [0017]) is lower than the progesterone threshold limit (“No” to “ES conc. in test sample > 100 pg/ml?” in steps 112/107, Fig. 6; If the ES value in the sample is less than approximately 100 pg/mL, the pregnancy status of the cow is equated at step 110 to be "not yet confirmed pregnant"…”, [0096]; [0017] discloses this indicator can also be progesterone).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Friggens in view of Nation, because knowing which cows are pregnant and when conception happened are highly beneficial to the effective management by farmers of their herds of cows, as taught by Nation ([0076]).
Modified Friggens discloses the claimed invention except for expressly disclosing the time window being longer than 5 days and shorter than 9 days from the insemination. However, Lamming teaches wherein the milk sample extractor is configured to provide each extracted milk sample to the progesterone level measurement device within a time window, the time window being longer than 5 days and shorter than 9 days from the insemination ("The present inventors have previously shown that a delay of as little as one day in the availability of adequate progesterone concentration can induce a sub-optimal uterine environment which is detrimental to embryo survival and speculated that determining critical levels of P4 after insemination may assist in developing a non-pregnancy test possibly as early as day 7 post [artificial insemination]", 2:49-55; “there is provided a method of improving pregnancy success in cows, the method comprising analysing milk progesterone levels from a cow and supplying the cow with progesterone, or a functional equivalent thereof if the milk [progesterone] level is <3 ng/ml-1, and where the progesterone levels are measured from at least one of Day 4, 5 and 6 post insemination”, 3:61-67). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Friggens in view of Lamming, because this allows the farmer to avoid indiscriminate use of medicating hormones with compound effects (See 4:1-6 of Lamming).
Regarding Claim 23, Modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing wherein the one or more progesterone level measurements are made within a time window at 7 days from the insemination. However, Nation teaches wherein the one or more progesterone level measurements are made within a time window at 7 days from the insemination (“If there is an earlier sample, preferably the earlier example was taken within a predetermined period, such as 70 days”, [0097]; the time window 7 days is within the disclosed 0-70 day range). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Friggens in view of Nation, because knowing which cows are pregnant and when conception happened are highly beneficial to the effective management by farmers of their herds of cows, as taught by Nation ([0076]).
Regarding Claim 26, modified Friggens discloses the milking system according to claim 22, wherein the controller is further configured to alert a farmer when the animal is determined to be non- pregnant (“Suggested Outputs to the End User”, “NotPregFlagR”, [0222]).
Regarding Claim 29, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing wherein the controller is further configured to determine that the animal is pregnant when a single obtained progesterone level measurement within the time window exceeds the progesterone threshold limit. However, Nation teaches wherein the controller is further configured to determine that the animal is pregnant when a single obtained progesterone level measurement within the time window exceeds the progesterone threshold limit (“YES”, Step 106, Fig. 6; see [0017], which discloses this pregnancy indicator can be progesterone). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Friggens in view of Nation, because knowing which cows are pregnant and when conception happened are highly beneficial to the effective management by farmers of their herds of cows, as taught by Nation ([0076]).
Regarding Claim 30, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing further comprising a database configured to store information of animals of a herd, the information relating to insemination, pregnancy or non-pregnancy status, and/or scheduled hormone treatment, associated with an identity reference of the respective animal. However, Nation teaches a database configured to store information of animals of a herd (“In one embodiment, the memory means of the system includes a database structure, said database structure being configured to store at least one or more of the following types of data”, [0046]), the information relating to insemination (“one or more known dates of artificial insemination”, [0052]), pregnancy or non-pregnancy status, and/or scheduled hormone treatment, associated with an identity reference of the respective animal (See [0046]-[0054], where each external parameter is clearly associated with only one animal). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Friggens in view of Nation, because knowing which cows are pregnant and when conception happened are highly beneficial to the effective management by farmers of their herds of cows, as taught by Nation ([0076]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Friggens in view of Nation and Lamming, and further in view of Veenhuizen et al (US 3636193 A, hereinafter Veenhuizen).
Regarding Claim 24, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing wherein the controller is further configured to schedule the animal for hormone treatment according to an oestrus synchronisation programme when the animal is determined to be non-pregnant. However, Veenhuizen teaches scheduling the animal for hormone treatment according to an oestrus synchronisation programme when the animal is determined to be non-pregnant (“Our invention is particularly adapted for use in an estrus synchronization programs with cows. This term includes, of course, young cows or heifers. In such a program, a group of cycling cows is synchronized by treatment for 14 to 18 days with a progestational agent such as chlormadinone acetate. The drug is then withdrawn, the cows coming into estrus during the next five days”, 2:18-25). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Friggens such that the controller is further configured to schedule the animal for hormone treatment according to an oestrus synchronisation programme when the animal is determined to be non-pregnant, because it is most desirable in actual practice to have all female domestic animals in the group come into estrus during a one- or two-day period so that a technician in charge of the artificial insemination program need not be in attendance every day during an estrus cycle of the particular species, as taught by Veenhuizen (1:37-42).
Claim 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Friggens in view of Nation and Lamming, and further in view of Beckley (WO 2019133920 A1, hereinafter Beckley).
Regarding Claim 27, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing wherein the progesterone threshold limit is 3-8 ng/ml. However, Beckley teaches wherein the progesterone threshold limit (TL) is 5 ng/ml (“a serum progesterone value of 25ng/ml is 98% of the time associated with a viable pregnancy, while a value of < 5 ng/ml identifies a nonviable pregnancy”, [0019]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the progesterone threshold limit (TL) of modified Friggens 3-8 ng/ml, as taught by Beckley, as a matter of routine optimization and experimentation.
Regarding Claim 28, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing wherein the progesterone threshold limit is 5 ng/ml. However, Beckley teaches wherein the progesterone threshold limit (TL) is 5 ng/ml (“a serum progesterone value of 25ng/ml is 98% of the time associated with a viable pregnancy, while a value of < 5 ng/ml identifies a nonviable pregnancy”, [0019]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the progesterone threshold limit (TL) of modified Friggens 5 ng/ml, as taught by Beckley, as a matter of routine optimization and experimentation.
Claims 25 and 31-32 are rejected under 35 U.S.C. 103 as being unpatentable over Friggens in view of Nation and Lamming, and further in view of Dinger et al (US 20160157979 A1, cited in applicant’s IDS, hereinafter Dinger).
Regarding Claim 25, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing wherein the controller is further configured to sort the animal into a separation zone when the animal is determined to be non-pregnant. However, Dinger, which is also directed to a method of detecting pregnancy in animals (Abstract), teaches wherein the controller is further configured to sort the animal into a separation zone when the animal is determined to be non-pregnant (“For example, the data processing system may be configured to generate control signals for, directly or indirectly, controlling the position of one or more mechanical drafting gates to sort cows into particular holding pens, paddocks, or to otherwise sort the cows based on their respective reproductive status indication of pregnant, non-pregnant, or undetermined, and optionally based on any visual alert that indicates that a cow might have reproductive problems”, [0183]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Friggens with the sorting of Dinger, because sorting animals by pregnancy status allows each group of animals to be treated according to their reproductive status more efficiently.
Regarding Claim 31, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing the system further comprising an output device configured to alert a farmer when the animal is determined to be non-pregnant. However, Dinger teaches an output device configured to alert a farmer when the animal is determined to be non-pregnant (“if the reproductive status indication system detects that a cow is in oestrus after a breeding event and well prior to the time of her next expected oestrus, the system generates a reproductive status indication of non-pregnant and also provides a visual alert that indicates that the cow may have a reproductive problem and/or that she is short cycling”, [0168]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the output device of Dinger to the milking system of modified Friggens for the advantages of detecting reproductive problems and/or miscarriages, as suggested by Dinger ([0168]).
Regarding Claim 32, modified Friggens discloses the milking system according to claim 22. Modified Friggens discloses the claimed invention except for expressly disclosing the system further comprising a sorting gate configured to separate the animal into a separation zone when the animal is determined to be non-pregnant. However, Dinger teaches a sorting gate configured to separate the animal into a separation zone when the animal is determined to be non-pregnant (“For example, the data processing system may be configured to generate control signals for, directly or indirectly, controlling the position of one or more mechanical drafting gates to sort cows into particular holding pens, paddocks, or to otherwise sort the cows based on their respective reproductive status indication of pregnant, non-pregnant, or undetermined, and optionally based on any visual alert that indicates that a cow might have reproductive problems”, [0183]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Friggens with the sorting gate of Dinger, because sorting animals by pregnancy status allows each group of animals to be treated according to their reproductive status more efficiently.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Scott (US 4224949 A).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN EPHRAIM COOPER whose telephone number is (571)272-2860. The examiner can normally be reached Monday-Friday 7:30AM-5:30PM 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, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791