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 .
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 (i.e., “module” or “unit”) 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:
“wireless communication module configured to … ” in claim 1, and all claims depending therefrom.
“memory unit for storing historical milk volume data and user preferences” in claim 3
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.
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.
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 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.
Claims 1 and 9 have been amended to recite limitations directed towards a step of (1) receiving output from a model, and (2) “generating the lactation insights and data based on the output”.
The specification does not appear to disclose two separate steps of (1) receiving output from a model, and (2) “generating the lactation insights and data based on the output”. In contrast, the specification appears to disclose that the output of the model is the lactation insights/data itself ([0093], as published, and steps 914 - 918 in fig. 9), as opposed to disclosing a step of “generating the lactation insights and data based on the output” that is distinct from a step of ‘receiving output from the model’.
Claims 1, 9, and all claims depending therefrom thus appear to introduce new matter.
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 9 are indefinite because it is unclear what the output of the model is, and how the “lactation insights and data” are generated from the output. As discussed in the 112(a) rejections above, the specification does not appear to disclose a step of “generating the lactation insights and data based on the output” that is distinct from a step of ‘receiving output from the model’.
Claims 1 and 9 are indefinite because it is unclear if the ‘analyzing the data to (i) determine the changes in breast volume and (ii) generate lactation insights and data’ (4th paragraph) attempts to positively recite algorithmic steps of ‘determining the changes in breast volume and generating lactation insights and data’, or if these are merely a recitation of intended use/result of the positively recited analysis. If the steps are not merely intended use/result of the positively recited analysis, then it is unclear how “generating the lactation insights and data based on the output” that is recited in the last paragraph relates to the analysis to generate lactation insights and data that is recited in the 4th paragraph. It is unclear if there are two different steps of ‘generating the lactation insights and data’. Moreover, if the steps are not merely intended use/result of the positively recited analysis, it is unclear why the ‘changes in breast volume’ are determined, as the changes do not appear to be used in any way in the claimed algorithm. Those of ordinary skill in the art would not understand the algorithm of the claimed system/method. For the purposes of examination, the limitations in the 4th paragraph will be interpreted as intended use/result of the positively recited analysis, since the claim positively recites the steps that the analysis comprises in the last paragraphs.
Claims 1 and 9 are indefinite because a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claims recite the broad recitation “lactation … data”, and the claim also recites “lactation insights” and “changes in breast volume” which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is unclear what the difference is, if any, between ‘changes in breast volume’, ‘lactation insights’, and ‘lactation data’.
Dependent claims that are listed in the rejection header above as being rejected while not having been specifically addressed are rejected by virtue of dependency.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 - 8 and 17 - 20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 1 - 8 and 17 - 20 are determined to read on a human organism because claim 1 recites a “breast-mounted optical sensor system”, thereby requiring the breast as a structural feature of the claimed system. This rejection may be overcome by amending the claim to simply recite that the system is “configured to be mounted on a breast” instead of also reciting that the system is “breast-mounted”.
Claims 1 - 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a mental-process type abstract idea) without significantly more.1
Independent claim 1:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., an optical sensor system.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
analyzing data corresponding to the detected changes in light to determine the changes in breast volume;
analyzing data corresponding to the detected changes in light to generate lactation insights and data;
correlating the data corresponding to the detected changes in light with information about milk supply; and
analyzing data corresponding to the detected changes in light to generate lactation insights and data based on the output
As drafted, the limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper. Of note, the ‘correlating’ also reads on a mathematical process. Therefore, the limitation recites a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements as follows:
The claim recites that the optical sensor system is configured to be mounted on a breast, which merely limits the judicial exception to a particular technological environment.
The claim recites “an optical sensor configured to detect changes in light that pass through a breast tissue, wherein the detected changes in light are indicative of changes in breast volume”. However, the sensor is recited at a high level of generality, such that the limitation amounts to no more than generic hardware for extra-solution activity (i.e., data gathering).
The claim recites a wireless communication module for transmitting data to a mobile device, which is also generic hardware for extra-solution activity (i.e., data output).
The claim recites limitations directed towards the judicial exception being performed by a processor. However, the processor is recited at a high level of generality, such that the limitation amounts to no more than instructions to implement the judicial exception on a computer.
The claim recites that the ‘correlating’ is in the context of use of a trained model. However, the use of a trained model to analyze data in the context of the medical imaging arts is interpreted as no more than an instruction to implement the judicial exception on a computer.
The claim recites that the model “was trained on historic data” to perform the correlation, which merely limits the judicial exception to a particular technological environment.
The claim recites retrieving the model, “providing the data … as input to the model”, and “receiving, from the model, output”, which are extra-solution activity.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards limiting the judicial exception to a particular technological environment, generic hardware for and/or steps of extra-solution activity, and instructions to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Independent claim 9:
With regard to Step 1, the claim is directed to one of the four statutory categories of invention, i.e., a method for determining lactation insights and.
With regard to Step 2A: Prong 1, the claim recites limitations directed towards:
analyzing data corresponding to the detected changes in light to determine the changes in breast volume;
analyzing data corresponding to the detected changes in light to generate lactation insights and data;
correlating the data corresponding to the detected changes in light with information about milk supply; and
analyzing data corresponding to the detected changes in light to generate lactation insights and data based on the output
As drafted, the limitations amount to nothing more than steps that can practically be performed in the human mind and/or with the aid of pen/paper. Of note, the ‘correlating’ also reads on a mathematical process. Therefore, the limitation recites a mental-process type abstract idea. See MPEP 2106.04(a)(2).
With regard to Step 2A: Prong 2, the claim recites additional elements as follows:
The claim recites “attaching an optical sensor to a breast of the user, wherein the optical sensor is configured to detect changes in light that passes through a breast tissue of the user, wherein the detected changes in light are indicative of changes in breast volume”. However, the sensor is recited at a high level of generality, such that the limitation amounts to no more than extra-solution activity (i.e., data gathering) and limiting the judicial exception to a particular technological environment.
The claim recites “automatically transmitting data corresponding to the detected changes in light to a processor”, which is also extra-solution activity (i.e., data output).
The claim recites limitations directed towards the judicial exception being performed automatically and by a processor. However, the processor is recited at a high level of generality, such that the limitation amounts to no more than instructions to implement the judicial exception on a computer.
The claim recites that the ‘correlating’ is in the context of use of a trained model. However, the use of a trained model to analyze data in the context of the medical imaging arts is interpreted as no more than an instruction to implement the judicial exception on a computer.
The claim recites that the model “was trained on historic data” to perform the correlation, which merely limits the judicial exception to a particular technological environment.
The claim recites retrieving the model, “providing the data … as input to the model”, “receiving, from the model, output”, and returning, by the processor, the lactation insights and data, which are extra-solution activity.
Therefore, the recited additional elements do not, either individually or as a whole, integrate the judicial exception into a practical application.
With regard to Step 2B, as explained above, the additional limitations are directed towards limiting the judicial exception to a particular technological environment, generic hardware for and/or steps of extra-solution activity, and instructions to implement the judicial exception on a computer. Therefore, when considered separately and in combination, the additional limitations do not result in the claim, as a whole, amounting to significantly more than the judicial exception.
Dependent claims:
Dependent claims 2 and 12 recite additional limitations directed towards the optical sensor comprising an optical fiber. However, the fiber is recited at a high level of generality, and amounts to no more than generic hardware for extra-solution activity (i.e., data gathering).
Dependent claim 3 recites additional limitations requiring a memory unit, which is a generic computer component for extra-solution activity.
Dependent claim 4 recite limitations directed towards the sensor being directly attachable to a breast, which merely limits the judicial exception to a particular technological environment.
Dependent claims 5 and 13 recite additional limitations directed towards a second sensor, which is generic hardware for extra-solution activity (i.e., data gathering), and the sensor being or attached/attachable to a breast, which merely limits the judicial exception to a particular technological environment.
Dependent claims 6 - 8 and 13 - 16 recite additional limitations directed towards the light being pulsed and the wavelengths of the light, which merely limit the judicial exception to a particular technological environment.
Dependent claims 10 - 11 recite additional limitations directed towards characterizing the processor, which merely limit the judicial exception to a particular technological environment.
Dependent claims 17 - 19 recite additional limitations directed towards characterizing the output, which merely limit the judicial exception to a particular technological environment.
Dependent claim 20 recites additional limitations directed towards the model being a machine learning model that is stored locally by the processor, which merely limit the judicial exception to a particular technological environment.
Therefore, when considered separately and in combination, the additional limitations of the dependent claims do not integrate the judicial exception into a practical application, or result in the claims amounting to significantly more than the judicial exception.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 - 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 20 of copending Application No. 19/073,350 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because measuring and monitoring milk volume using optical sensors. In particular:
Claims 1 and 9 are suggested by reference claim 1, 10, 14, and/or 16.
Claims 2 and 12 are suggested by reference claim 2. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claim 2 to have the sensor comprise an optical fiber, in order to use conventional optical waveguide components.
Regarding claim 3, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claims to include a memory unit, in order to store the user data.
Claim 4 is suggested by reference claim 1, 10, 14, and/or 16. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claims have the attachment be direct, in order to facilitate effective light transmission relative to the user’s tissue.
Claims 5 and 13 are suggested by reference claim 1, 10, 14, and/or 16. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claims to include a second sensor, in order to monitor two breasts.
Claims 6 - 8 and 14 - 16 are each suggested by reference claim 3.
Claims 17 - 19 are each suggested by reference claim 5.
Claim 20 is suggested by reference claim 10 and /or 16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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 1, 3 - 5, 9 - 11, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hamelmann et al. (US 2022/0395218) in view of Bartlett et al. (US 2020/0078503). Regarding claims 1 and 9, Hamelmann shows a breast-mounted optical sensor system configured to be mounted on a breast (flow sensor arrangement 12 for application to the breast for monitoring milk flow levels from different regions of the breast, [0049] and figs. 1 - 3) for determining lactation insights and data, and method of use thereof. The system comprises:
an optical sensor (optical flow sensor arrangement, [0013]; [0020]; [0033]; [0056]) configured to detect changes in light (implicit) that pass through a breast tissue, wherein the detected changes in light are indicative of changes in breast volume (implicit - the optical signal collected by the sensors is necessarily at least in some manner “indicative of changes in breast volume”);
a wireless communication module configured to transmit data corresponding to the detected changes in light to a mobile device (“… transmits the measured signals wirelessly to the smartphone which then processes the data … remote data processing center”, [0080]. The hardware that performs the transmission is mapped to the claimed “module”); and
a processor configured to execute instructions that cause the processor to analyze the data corresponding to the detected changes in light (“processor 20 generates a map of milk flow levels for different regions of the breast based on the flow sensor arrangement signals”, [0052] and fig. 1) to (i) determine the changes in breast volume and (ii) generate lactation insights and data (note: the analysis is interpreted as being for the claimed intended use/result recitations, lacking positive recitation of a ‘determining’ and ‘generating’ step).
In use, the optical sensor is attached to the breast (figs. 1 - 4), and the data are automatically transferred ([0080]) and analyzed ([0052]).
Hamelmann fails to show that analyzing the data comprises: retrieving a model that was trained on historic data to correlate the data corresponding to the detected changes in light with information about milk supply conditions; providing the data corresponding to the detected changes in light as input to the model; receiving output from the model; and generating and returning the lactation insights and data based on the output.
Bartlett discloses an electric breast pump. Bartlett teaches retrieving a model that was trained on historic data to correlate the data corresponding to the detected changes in light with information about milk supply conditions (“processing is based on changes in data over time… machine learning algorithm trained to produce output based on data provided as input …”, [0113]); providing the data corresponding to the detected changes in light (optical sensors, [0036]) as input to the model; receiving output from the model (output, [0113]); and generating and returning the lactation insights and data based on the output ([0113] - the output, as well as any data derived therefrom, is mapped to the “lactation insights and data” ).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Hamelmann to have analyzing the data comprise: retrieving a model that was trained on historic data to correlate the data corresponding to the detected changes in light with information about milk supply conditions; providing the data corresponding to the detected changes in light as input to the model; receiving output from the model; and generating and returning the lactation insights and data based on the output, as taught by Bartlett, in order to help the user efficiently express milk, as suggested by Bartlett (abstract).
Regarding claim 3, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above. Hamelmann further shows a memory unit (memory, [0094]) that is at least physically capable of storing historical milk volume data and user preferences, and therefore meets the claim.
Regarding claims 4 - 5 and 13, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above. Hamelmann further shows attaching the optical sensor directly to the breast, and a second optical sensor directly to a second portion of the user, wherein the second optical sensor is different than the first optical sensor and the first portion of the user is different than the second portion of the user (optical flow sensor arrangement, [0013]; [0020]; [0033]; [0056]). The second sensor is at least physically capable of being attached to a second breast, and therefore meets claim 5.
Regarding claims 10 - 11, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above. Hamelmann further shows the processor is part of a mobile device and/or a remote server (“…smartphone … remote data processing center”, [0080]).
Regarding claim 20, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above, and further provides that the model is a machine learning model that is stored locally by the processor (Bartlett: “processing is based on changes in data over time… machine learning algorithm trained to produce output based on data provided as input …”, [0113]).
Claims 2, 6 - 8, 12, and 14 - 16 are rejected under 35 U.S.C. 103 as being unpatentable over Hamelmann and Bartlett as applied to claims 1 and 9 above, and further in view of Goodall et al. (US 2018/0214066, of record).
Regarding claims 2 and 12, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above.
Hamelmann is not specific to the optical sensor comprising an optical fiber.
Goodall discloses monitoring breastfeeding. Goodall teaches an optical sensor comprising an optical fiber (optical fibers, abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Hamelmann and Bartlett to have the optical sensor comprise an optical fiber, as taught by Goodall, in order to use conventional components to transmit the light, as is understood in the art.
Regarding claims 6 - 8 and 14 - 16, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above. Hamelmann further shows the optical sensor is configured to output light and detect the outputted light (implicit) to detect the changes in the breast volume.
Hamelmann is not specific to the output light being pulsed, and comprising light with wavelengths of 550 nm, 660 nm, or 880 nm.
Goodall discloses monitoring breastfeeding. Goodall teaches output light that is pulsed, and comprises light with wavelengths of 550 nm, 660 nm, or 880 nm ([0082]; [0092]; “wavelength of light emitted by the LED … 550 nm …near infrared … shades of red, orange, yellow, green, and blue”, [0093]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of combined invention of Hamelmann and Bartlett to the output light be pulsed, and comprising light with wavelengths of 550 nm, 660 nm, or 880 nm, as taught by Goodall, in order to provide suitable parameters for optical interrogation of the breast, as is understood in the art.
Claims 17 - 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hamelmann and Bartlett as applied to claim 1 above, and further in view of Bourquin et al. (US 2021/0093759).
Regarding claims 17 - 18, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above.
Hamelmann fails to show the output includes a milk supply over a past and current period of time.
Bourquin discloses breast status determination. Bourquin teaches output that includes a milk supply over a past (“amount of extracted milk in previous milk extraction session …”, [0015]), current (“amount of milk at the beginning of the milk extraction session …”, [0015]) period of time.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Hamelmann and Bartlett to have the output include a milk supply over a past and current period of time, as taught by Bourquin, in order to reduce the risk of mastitis caused by prematurely ending the milk extraction session when the breast is not empty, as discussed by Bourquin ([0016]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hamelmann and Bartlett as applied to claim 1 above, and further in view of Van Bentum et al. (US 2024/0096485 ).
Regarding claim 19, the combined invention of Hamelmann and Bartlett discloses the claimed invention substantially as noted above.
Hamelmann fails to show the output includes a milk supply over a future period of time.
Van Bentum discloses a planning system breast feeding or milk expression. Van Bentum teaches output that includes a milk supply over a future (“indication of future milk expression and breastfeeding in terms of the timing, duration, quantity …”, [0087]; “predictions of the best times (and quantities) for milk expression and/or breast feeding”, [0117]; [0122] - [0123]) period of time.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the combined invention of Hamelmann and Bartlett to have the output include a milk supply over a future period of time, as taught by Van Bentum, in order to assist a mother in planning her milk production routine to best fit with her schedule as well as providing the best nutrition for the infant, as discussed by Van Bentum (abstract).
Response to Arguments
Applicant's arguments filed 5/13/2026 have been fully considered but they are not persuasive and/or are moot in view of the new grounds of rejection.
Rejections under 35 U.S.C. § 101
Regarding the 101 rejections, examiner notes that the eligibility of the claims under 101 was discussed with 101 specialist SPE Bui-Pho on 7/30/2026. The Remarks filed 5/13/2026 (see pages 8 - 11) were considered. It was determined that the 101 rejections should be maintained.
A. The Claims are Not Directed to an Abstract Idea.
Applicant argues on pages 8 - 9 that claim 1 is not directed to an abstract idea because the optical sensor is mounted directly on the breast, and the claim includes limitations directed towards use of a processor and wireless module.
This is not persuasive because the claim recites limitations that read on mental steps as identified in the 101 rejections above. The optical sensor, processor, and wireless module have been addressed in the 101 rejections above as additional elements.
B. The Claims Recite Significantly More Than Any Alleged Abstract Idea.
Applicant argues on pages 9 - 10 that “the currently pending claims recite an inventive concept that amounts to significantly more than any alleged abstract
idea”.
Examiner respectfully disagrees for reasons explained in the 101 rejections and art rejections above.
Applicant argues on page 9 that the recited optical sensor is not generic hardware.
Examiner respectfully disagrees because the claims do not recite any structural details of the sensor that render the sensor a particular machine.
Applicant argues on page 9 that the recited optical sensor is physically attached to the breast.
In response, examiner asserts that the limitations directed towards positioning the optical sensor on the breast merely limit the judicial exception to a particular field of use.
Applicant argues on page 10 that the “configuration is not routine, conventional, or well-understood”.
This argument is moot because the 101 rejections do not rely on whether or not the configuration is routine, conventional, or well-understood.
Applicant argues on pages 10 - 11 that “the currently pending claims reflect a technological improvement over existing monitoring approaches”.
In response, it is noted that the ‘monitoring’ as characterized In the claims is the judicial exception itself. The purported improvement cannot be an improvement to the judicial exception itself that is provided by the judicial exception itself. Instead, the improvement must be an improvement to a computer or another field, and the improvement must be provided by one or more additional elements (see MPEP 2106.05(a)).
C. The Claims are Integrated into a Practical Application
Applicant argues on page 11 that the “currently pending claims are further patent-eligible because they are integrated into a practical application.”
Examiner respectfully disagrees for reasons explained in the 101 rejections above.
Rejections under 35 U.S.C. §§ 102 and 103
Applicant’s arguments with respect to the art rejections 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.
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 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 AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
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, Pascal Bui-Pho can be reached at (571)272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798
1 Examiner notes that the eligibility of the claims under 101 was discussed with 101 specialist SPE Bui-Pho on 7/30/2026. The Remarks filed 5/13/2026 (see pages 8 - 11) were considered.
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