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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 for transmitting data to a mobile device” 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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 - 16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 9 are indefinite because it is unclear how the optical sensor is “configured to detect changes in breast volume”, rather than being configured to detect light. Those of ordinary skill in the art would not understand optical sensors to be capable of detecting “changes in breast volume”, but instead would understand optical sensors to be capable of detecting light. For the purposes of examination, the limitation will be interpreted as intending that the optical sensor is configured to detect changes in light that are indicative of changes in breast volume.
Claims 2 and 12 are indefinite because the claims recite “the optical sensor comprises one or more … lasers, or light emitting diodes configured to … detect light reflected from the breast tissue.” It is unclear how lasers and light emitting diodes may be configured to “detect light”, as lasers and light emitting diodes are light sources, rather than light detectors.
Claim 13 is indefinite because there is unclear antecedent basis for “a first optical sensor” and “a second optical sensor”. It is unclear how these relate to the optical sensor in claim 9. It is unclear how many optical sensors are used in the claimed method. For the purposes of examination, the limitation will be interpreted as intending that the optical sensor in claim 9 is either the first or second optical sensor.
Claim 13 is indefinite because there is unclear antecedent basis for “a first breast” and “a second breast”. It is unclear how these relate to the breast in claim 9. It is unclear how many breasts are used in the claimed method. For the purposes of examination, the limitation will be interpreted as intending that the breast in claim 9 is either the first or second breast.
Claims 3 - 8, 10 - 11, and 14 - 16 are indefinite by virtue of dependency.
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 - 16 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 and/or 11.
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 light emitters be LEDs, in order to use conventional light source 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 and/or 11.
Claims 5 and 13 are suggested by reference claim 1 and/or 11. 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 1 and/or 11 to include a second sensor, in order to monitor two breasts.
Claims 6 - 8 and 14 - 16 are each suggested by reference claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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 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 recite that the system is “configured to be mounted on a breast”.
Claims 1 - 16 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.
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 a limitation directed towards ‘analyzing the detected changes in breast volume and generating milk volume data’. As drafted, the limitation amounts to nothing more than a step that can practically be performed in the human mind and/or with the aid of pen/paper. For example, a human can ‘analyze detected changes in breast volume and generate milk volume data’ mentally, and/or with the aid of pen/paper. 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 an additional element 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 also recites “an optical sensor configured to detect 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 further 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). 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 an instruction to implement the judicial exception on a computer, and/or generic hardware for extra-solution activity. 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.
With regard to Step 2A: Prong 1, the claim recites a limitation directed towards ‘analyzing data corresponding to detected changes in the breast volume to generate milk volume data’. As drafted, the limitation amounts to nothing more than a step that can practically be performed in the human mind and/or with the aid of pen/paper. For example, a human can ‘analyze data corresponding to detected changes in breast volume and generate milk volume data’ mentally, and/or with the aid of pen/paper. 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 an additional element 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 also recites “attaching an optical sensor to a breast of the user, wherein the optical sensor is configured to detect 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 steps). The claim further recites “automatically transmitting data corresponding to the detected changes in the breast volume to a processor” and “returning, by the processor, the milk volume data” which are also extra-solution activity (i.e., data input/output). 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 an instruction to implement the judicial exception on a computer, and/or extra-solution activity. 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, laser, or light emitting diode configured to emit and detect light reflected from breast tissue. However, the fiber, laser, and light emitting diode are recited at a high level of generality, and amount 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 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.
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.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3 - 11, and 13 - 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodall et al. (US 20180214066).
Regarding claims 1 and 9, Goodall shows a breast-mounted optical sensor system (“[b]reast monitoring systems …conform to … breasts…”, abstract; “wearable breast monitor”, figs. 10, 11, 21, 30) for measuring and monitoring milk volume, and a method of use thereof. The method comprises:
attaching an optical sensor (photodetector, abstract; “fiber optic receiver, photodetector”, [0223] and 140 in fig. 3) to a breast of the user (abstract; “wearable breast monitor”, figs. 10, 11, 21, 30), wherein the optical sensor is configured to detect changes in breast volume (“receiver detects light … determines breast milk volumes”, [0223]);
automatically transmitting data corresponding to the detected changes in the breast volume to a processor (“microcontroller 160 including microprocessor 170”, [0051] and fig. 2; “receiver … signals to a microcontroller …”, [0223] and 160 in fig. 3), using a wireless communication module for transmitting data to a mobile device (“transmission unit and antenna … smart phone”, [0050]; transmission unit 228, [0107] - [0112] and fig. 2);
automatically analyzing, by the processor, the data to generate milk volume data;
and returning, by the processor, the milk volume data (“microcontroller … determines breast milk volumes”, [0223]).
Regarding claim 3, Goodall discloses the claimed invention substantially as noted above. Goodall further shows a memory unit for storing historical milk volume data (“record of breastfeeding events”, [0230]). The memory unit is at least physically capable of storing user preferences, and therefore meets the claim.
Regarding claims 4 - 5 and 13, Goodall discloses the claimed invention substantially as noted above. Goodall further shows attaching two different optical sensors to two different breasts (“at least one photodetector 140 is position on the medial side of each cup 1012”, [0073] and fig. 10).
Regarding claims 6 and 14, Goodall discloses the claimed invention substantially as noted above. Goodall further shows the optical sensor is configured to output light in a pulsing series (“light source … pulses of light”, [0095]) and detect the outputted light to detect the changes in the breast volume.
Regarding claims 7 - 8 and 15 - 16, Goodall discloses the claimed invention substantially as noted above. Goodall further shows the optical sensor is configured to output light having wavelengths of visible light, infrared light, or a combination thereof, comprising light with wavelengths of 550 nm, 660 nm, or 880 nm ([0092]; “wavelength of light emitted by the LED … 550 nm …near infrared … shades of red, orange, yellow, green, and blue”, [0093]).
Regarding claims 10 - 11, Goodall discloses the claimed invention substantially as noted above. Goodall further shows the processor is part of a mobile device of the user and/or a remote server (“microprocessor … separate computing device, e.g., a dedicated hand-held device, a mobile communication device, or a laptop or tablet computing device in communication with the other components of the system”, [0197] and fig. 29; mobile communication device (e.g., a smart phone)”, [0199] and fig. 30).
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.
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 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Goodall in view of Gelissen (US 2018/0318479).
Regarding claims 2 and 12, Goodall discloses the claimed invention substantially as noted above. Goodall further shows the optical sensor comprises one or more optical fibers (optical fibers, abstract) configured to emit and detect light.
Goodall fails to show that the light comprises light that is emitted to and detected from the breast tissue.
Gelissen discloses detection of the beginning of the milk flow in the breast ([0008]). Gelissen teaches light that is emitted to and detected from the breast tissue (“photoplethysmographic, PPG, sensor for transmitting an input signal into the breast and receiving a corresponding reception signal”, [0009]; [0019] - [0020]; “PPG sensors … known in the arts”, [0050]; “amount of reflected light will vary with varying degree of fluid contents in the breast tissue … milk flow in the breast tissue will be detectable by a change in fluid contents of the breast tissue”, [0053]).
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 Goodall to have the light comprise light that is emitted to and detected from the breast tissue, as taught by Gelissen, in order to provide a “cheap and easy to use possibility to obtain precise values about the start of the milk ejection reflex”, as suggested by Gelissen ([0019]).
Conclusion
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.
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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