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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 29 May 2026, the following has occurred: Claims 1, 3-5, and 7-14 have been amended; Claims 2 and 6 have been cancelled.
Claims 1, 3-5, and 7-14 are pending.
Priority
This application claims priority to German Patent Application No. DE102022124250.1 dated 21 September 2022.
Information Disclosure Statement
The Information Disclosure Statement(s) (lDS) submitted on 29 May 2026 and 10 July 2026 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been fully considered by the Examiner.
Claim Objections
Claim 12 recites “to a mobile device deposited in the memory of the mobile device of the donor of the breast milk.” The property was not previously saved in the memory of the mobile device and thus “deposited” appears to be incorrect. The Examiner believes the claim should read: “to a mobile device and depositing
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 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:
Claim 1
“an apparatus
by which the container is sealed…
by which a container identifier…is read out or the container is provided with a container identifier
by which at least the determined amount is provided…”
Claim 7, 14 (Claim 7 being representative)
an “apparatus” that performs “providing at least one of a device identification or a time indication with the container identifier in the memory for saving in the memory.”
Claim 13
“an accommodation for a container…
a closing device for sealing…
a system for treating…
a device for determining…
a reading device for reading… or attaching device for attaching…
an interface for transmitting”
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.
A review of the specification provides the following disclosure of the structural features that perform the recited functions:
Claim 1
“an apparatus
by which the container is sealed…:
Described as a cap. See Spec. Pg. 1.
by which a container identifier…is read out or the container is provided with a container identifier:
The container identifier is described as an RFID and thus a person having skill in the art would understand the reader to be an RFID reader. See Spec. Pg. 2.
No description of the apparatus that provides the container with a container identifier is provided. See Spec. Pg. 3, 5.
by which at least the determined amount is provided…”
Described as a PC.
Claim 7, 14
‘“apparatus” that provides’
Described as a PC.
Claim 13
a closing device for sealing…
The closing device is described as a screw cap. See Spec. Pg. 1.
a system for treating…
No description of the system for treating is provided. See Spec. Pg. 2, 3, 5.
a device for determining the amount…
The amount determination is described to alternately be performed by weighing, which a person having skill in the art would understand to be carried out by a scale. See Spec. Pg. 3.
a reading device for reading… or attaching device for attaching…
The container identifier is described as an RFID and thus a person having skill in the art would understand the reader to be an RFID reader. See Spec. Pg. 2.
No description of the device that provides the container with a container identifier is provided. See Spec. Pg. 3, 5.
an interface for transmitting”
Described as a PC.
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, 3-5, and 7-14 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 13 recite:
Claim 1: an apparatus […], by which the container is provided with an identifier.
Claim 13: An apparatus for treating breast milk comprising […], a system for treating the breast milk contained in the container to improve the shelf life of the breast milk, […], a […] attaching device for attaching a container identifier to the container
The written description is devoid of any description of the structure that corresponds to these noted features evidencing that the Applicant did not have possession of the invention at the time of filing. See claim interpretation, supra.
By virtue of their dependence from Claim 1, this basis of rejection also applies to dependent Claims 3-5, 7-12, and 14.
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, 3-5, and 7-14 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “after the breast milk has been expressed, transferring it to an apparatus by which the container is sealed, treating the breast milk within the sealed container to improve the shelf life in the container, and determining the amount of breast milk contained in the container, by which an identifier provided on the bag is read out or the container is provided with an identifier, and by which at least the determined amount is provided as a property together with the identifier for saving in a memory.” The claim is indefinite for several reasons. First, it is unclear what “the bag” is referring to as no bag was previously recited. Second, it is unclear from the claim language whether (1) the apparatus is performing only the “by which” functions or whether (2) the apparatus is also performing the “treating…and determining” steps as well. The recitation of gerunds (-ing words) after the container is sealed implies that these steps are separate from the apparatus. However, the limitations after the “treating…and determining” appear to be in reference to the apparatus because they also state “by which.” For the purposes of examination, the Examiner interprets only the “by which” features to be performed by the apparatus (see also 112(f) interpretation and associated rejections. Third, “by which an identifier provided on the bag” because an identifier was already recited in the claim in reference to the container (bag) and it is unclear whether this is the same identifier or a different identifier.
By virtue of their dependence from Claim 1, this basis of rejection also applies to dependent Claims 3-5, 7-12, and 14.
Claim limitations
Claim 1: an apparatus […] by which […] the container is provided with an identifier,
Claim 13: An apparatus for treating breast milk comprising […], a system for treating the breast milk contained in the container to improve the shelf life of the breast milk, […], a […] attaching device for attaching a container identifier to the container.
invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Aa noted in the 112(f) interpretation, supra, the as-filed disclosure fails to clearly link the “apparatus” to any type of structure. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For the purposes of examination, the Examiner interprets the structure that performs the recited functions to encompass a person or person/computer/device combination performing the tasks.
Claim 14 recites “The apparatus according to claim 11, wherein the
apparatus is adapted to provide at least one of an apparatus identification or a time
indication together with the container identifier at the interface for saving in the memory.” The claim is indefinite because Claim 11 is a method and thus it is unclear what statutory category “the according to claim 11” is referring to. Further, it is unclear if the body of Claim 14 is referring to the apparatus by which the container is sealed, the apparatus by which an identifier provided on the bag is read out or the container is provided with an identifier, or the apparatus by which at least the determined amount is provided. See 112(f) – “single means” interpretation as described in the basis of rejection and response to arguments. The Examiner interprets the “apparatus” associated with this function to be a PC (a computer).
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 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 of this title, 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.
Claim(s) 1, 3, 5, 7, 8, 10, 11, and 14 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Alvarez et al. (U.S. Pre-Grant Patent Publication No. 2016/0082165) in view of Snow et al. (U.S. Pre-Grant Patent Publication No. 2023/0103295).
REGARDING CLAIM 1
Alvarez teaches the claimed method for treating breast milk, comprising:
applying a breast pump to a female breast; [Fig. 1, 17, Para. 0074 teaches a milk expression device (breast pump) interfacing with a breast to provide vacuum (i.e., pumping).]
operating the breast pump to express breast milk and transfer it to a container; [Fig. 1, Para. 0074, 0104 teaches a collection vessel / reservoir that receives the breast milk from the milk expression device.]
which container is or will be provided with a machine-readable identifier identifying the container; [Para. 0103-0105, 0151 teaches a unique identifier (a machine-readable identifier) that is or will be disposed on the collection vessel / reservoir.]
[…], and
determining the amount of breast milk contained in the container, [Para. 0102, 0111, 0122 teaches that the volume of expressed milk into a collection vessel / reservoir is measured. This must occur after the milk has been expressed.]
by which
an identifier provided on the […container…] is read out or [Para. 0104, 0106, 0157 teaches that a unique identifier in the form of an RFID tag is disposed on the collection vessel / reservoir and is read by a tag reader (an apparatus).]
the container is provided with an identifier, and
by which at least the determined amount is provided as a property together with the identifier for saving in a memory, [Para. 0010, 0105 teaches that the unique identifier is digitally coupled with one or more of the attributes (volume, see Para. 0012, 0152) by a peripheral device (an apparatus). The Examiner notes that “for storage” is an intended use of the data and is not required to occur.]
generating an identifier that identifies the container and is or will be assigned to the container, and [Para. 0103-0105, 0151 teaches a unique identifier (a machine-readable identifier) that is or will be disposed on the collection vessel / reservoir.]
making the container available for feeding breast milk, [Para. 0152 teaches that the child is fed from a reservoir. Para. 0157, 0162 also teaches that the baby is fed from a reservoir.]
wherein the identifier is read in or out at a transfer point where the breast milk contained in the container is at least one of being stored [Para. 0157 teaches that an RFID reader scans the ID tags as they are added to or removed from the storage location.] or consumed to output the at least one property of the breast milk contained in the container. [The Examiner notes that “to output” is an intended use that is not required to occur.]
Alverez may not explicitly teach
after the breast milk has been expressed, transferring it to an apparatus by which the container is sealed,
treating the breast milk within the sealed container to improve the shelf life in the container, and
[…] on the bag […]
Snow at Para. 0012, 0018, 0019, 0132 teaches that it was known in the art of human milk processing, at the time of filing, to package breast milk in a container and sterilize the milk within the container
after the breast milk has been expressed, transferring it to an apparatus by which the container is sealed, [Snow at Para. 0118, 0132 teaches that human breast milk is transferred to a location where it is packaged in a container (the container of Alvarez). Snow at Para. 0118, 0119, 0132 teaches that the container is sealed.]
treating the breast milk within the sealed container to improve the shelf life in the container, and [Snow at Para. 0118, 0119 teaches that the container is sterilized via a retort process. Sterilizing the breast milk improves its shelf life.]
[…] on the bag […] [Snow at Para. 0118 teaches that the container (the collection vessel / reservoir of Alverez) is a pouch (a bag).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the breast milk expression tracking and storage system of Alvarez to package breast milk in a container and sterilize the milk within the container as taught by Snow, with the motivation improving the safety of the milk product.
REGARDING CLAIM 3
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow further teaches
discharging the breast milk directly from the container during feeding. [Alvarez at Para. 0152 teaches that the reservoir is used for feeding (discharged directly).]
REGARDING CLAIM 5
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow further teaches
using a flexible bag as the container. [Alvarez at Para. 0151 teaches that the reservoir is a bag. Snow at Para. 0118 teaches that the container is a pouch.]
REGARDING CLAIM 7
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow further teaches
providing at least one of
a device identification or
a time indication by the apparatus together with the container identifier in the memory for saving in the memory. [Alvarez at Para. 0105 teaches that time information (a time indication) is provided by a controller (an apparatus) and stored with the identifier.]
REGARDING CLAIM 8
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow further teaches
applying an external pressure to the container during feeding for expelling the breast milk and regulating the external pressure to set an expelling amount of breast milk. [Alvarez at Para. 0152 teaches that the reservoir bag is used to feed the child/infant. Thus, the reservoir bag, as is known in the art and to every parent who has fed a child, is exposed to atmospheric pressure (external pressure) which regulates the amount the is fed to the child.]
REGARDING CLAIM 10
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow further teaches
treating the breast milk before feeding, the treating including at least one of filtering or concentrating the breast milk. [Snow at Para. 0140 teaches that the milk is concentrated in addition to being fortified.]
REGARDING CLAIM 11
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow further teaches
drawing a sample from the container, analyzing the drawn sample, and saving the result of the analysis in the memory assigned to the container identifier. [Alvarez at Para. 0127 teaches that spectrometry is performed on a sample of the breast milk that is transferred from the reservoir. Alvarez at Para. 0127 further teaches that the obtained composition data is stored locally (the peripheral device of Para. 0124) or remotely (i.e., the array / drive of Para. 0105).]
REGARDING CLAIM(S) 14
Claim(s) 14 is/are analogous to Claim(s) 7, thus Claim(s) 14 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 7.
Claim(s) 4 and 9 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Alvarez et al. (U.S. Pre-Grant Patent Publication No. 2016/0082165) in view of Snow et al. (U.S. Pre-Grant Patent Publication No. 2023/0103295) in view of Laurenzi et al. (U.S. Patent No. 8,172,129).
REGARDING CLAIM 4
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow may not explicitly teach
connecting the container for feeding to a tube comprising a feeding probe.
Laurenzi Col. 4, Lns. 20-22 teaches that it was known in the art of healthcare, at the time of filing, to utilize a feeding tube to feed a premature infant from a bottle
connecting the container for feeding to a tube comprising a feeding probe. [Laurenzi Col. 4, Lns. 20-22 teaches that a feeding tube is connected to the feeding bottle (the reservoir of Alverez).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the breast milk expression tracking and storage system of Alvarez having the packaging of breast milk in a container and sterilization of the milk within the container of Snow to utilize a feeding tube to feed a premature infant from a bottle as taught by Laurenzi, with the motivation of allowing for careful monitoring of milk amount provided to premature infants (see Laurenzi at Col. 1, Lns. 18-25).
REGARDING CLAIM 9
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow may not explicitly teach
adding at least one of nutrients or medications to the breast milk before feeding.
Laurenzi Col. 2, Lns. 9-13, Col. 5, Lns. 31-41 teaches that it was known in the art of healthcare, at the time of filing, to add nutrients to breast milk
adding at least one of nutrients or medications to the breast milk before feeding. [Laurenzi Col. 2, Lns. 9-13, Col. 5, Lns. 31-41 teaches that nutrients are added to breastmilk to fortify it.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the breast milk expression tracking and storage system of Alvarez having the packaging of breast milk in a container and sterilization of the milk within the container of Snow to utilize a feeding tube to feed a premature infant from a bottle as taught by Laurenzi, with the motivation of improving the health of the infant (see Laurenzi at Col. 1, Lns. 18-25).
Claim(s) 12 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Alvarez et al. (U.S. Pre-Grant Patent Publication No. 2016/0082165) in view of Snow et al. (U.S. Pre-Grant Patent Publication No. 2023/0103295) in view of Bhatnagar (U.S. Pre-Grant Patent Publication No. 2017/0354771).
REGARDING CLAIM 12
Alvarez/Snow teaches the claimed method for treating breast milk of Claim 1. Alvarez/Snow may not explicitly teach
sending at least one property saved to the breast milk in the memory to a mobile device deposited in the memory of the mobile device of the donor of the breast milk.
Bhatnagar at Para. 0073, 0076, 0081, 0204 teaches that it was known in the art of healthcare, at the time of filing, to access breast milk information on a server and transmit that information to a mobile device of the mother
wherein at least one property saved to the breast milk in the memory is sent to a mobile device deposited in the memory as the mobile device of the donor of the breast milk. [Bhatnagar at Para. 0073 teaches that a mobile client device of a donor mother receives information from a management server database (the server/array of Alvarez). Bhatnagar at Para. 0076, 0204 teaches that the information is expiration date (at least one property; interpreted to correspond to the attributes of Alvarez). Bhatnagar at Para. 0081 teaches that the received information is stored on the mobile client device.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the breast milk expression tracking and storage system of Alvarez having the packaging of breast milk in a container and sterilization of the milk within the container of Snow to access breast milk information on a server and transmit that information to a mobile device of the mother as taught by Bhatnagar, with the motivation of improving milk tracking, verification, and organization (see Bhatnagar at Para. 0040).
PRIMARY BASIS OF REJECTION
Claim(s) 13 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Alvarez et al. (U.S. Pre-Grant Patent Publication No. 2016/0082165) in view of Christen et al. (U.S. Pre-Grant Patent Publication No. 2017/0142992).
REGARDING CLAIM 13
Alvarez teaches the claimed apparatus for treating breast milk comprising
an accommodation for a container containing breast milk [Para. 0152 teaches a refrigerator (an accommodation).] and a closing device for sealing the container, [Para. 0152 teaches that the reservoir is sealed meaning there is a sealing (closing) device.]
a device for determining the amount of breast milk contained in the container, [Para. 0122 teaches a scale.]
a reading device for reading out a container identifier provided on the container or attaching device for attaching a container identifier to the container and [Para. 0157 teaches an RFID reader.]
an interface for transmitting information to a memory characterizing the container identifier and the determined amount of breast milk and at least one property of the breast milk contained in the container. [Para. 0124 teaches a server having Bluetooth functionality (an interface).]
Alvarez may not explicitly teach
a closing device for sealing the container,
a system for treating the breast milk contained in the container to improve the shelf life of the breast milk,
Christen at Fig. 9, 12, 13, Para. 0068 teaches that it was known in the art of healthcare, at the time of filing, to pasteurize breast milk in a storage container and provide a lid to the container
a closing device for sealing the container, [Assuming arguendo that Alvarez does not teach a closing device, Christen at Fig. 12, 13 teaches that the milk container has a lid (a closing device).]
a system for treating the breast milk contained in the container to improve the shelf life of the breast milk, [Christen at Fig. 9, Para. 0068 teaches a UV light for Pasteurizing.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of healthcare, at the time of filing, to modify the breast milk expression tracking and storage system of Alvarez t to pasteurize breast milk in a storage container and provide a lid to the container as taught by Christen, with the motivation of reducing the amount of biological contaminants in human milk to improve infant health (see Christen at Para. 0002).
The Examiner notes that MPEP 2114(II) states that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).”). Here, and pursuant to the 112(f)/112(a)/112(b) interpretation/rejection, the various devices subject to the 112(a)/112(b) rejection are not defined and are interpreted to be taught by Alvarez/Christen.
Alternatively, assuming the functions are required by the claim, Claim 13 is rejected in the same manner as Claim 1 as described below.
SECONDARY BASIS OF REJECTION
Claim(s) 13 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Alvarez et al. (U.S. Pre-Grant Patent Publication No. 2016/0082165) in view of Snow et al. (U.S. Pre-Grant Patent Publication No. 2023/0103295).
REGARDING CLAIM(S) 13
Claim(s) 13 is/are analogous to Claim(s) 1, thus Claim(s) 13 is/are similarly analyzed and rejected in a manner consistent with the rejection of Claim(s) 1.
Response to Arguments
Specification Objections
Regarding the objection(s) to the Specification, the Applicant has provided a substitute Specification and a revised abstract which has alleviated the objection issues.
Claim Objections
Regarding the objection(s) to Claim 7, the Applicant has amended the claims to overcome the basis/bases of objection.
Drawings
Regarding the drawing objection(s), the Applicant has submitted drawings. The drawings are accepted.
Rejection under 35 U.S.C. § 112
Regarding the written description and indefiniteness rejection of Claims 6, 7, 13, and 14 related to the 112(f) interpretation, Applicant has cancelled claim 6 and incorporated certain features into Claim 1. The Examiner has considered the Applicant’s arguments and finds them partially persuasive. Portions of the arguments are not persuasive. Applicant argues:
Also as to claim 6, according to the Office action, the specification fails to describe a treatment apparatus. Applicant respectfully submits that the specification explains the system for treating the breast milk contained in the container may be, for example, pasteurization by UV irradiation. As such, the specification provides adequate description of a treatment apparatus.
Additionally as to claim 6, according to the Office action, the specification does not provide a description of the apparatus that provides the information that provides the determined amount of breast milk. Applicant respectfully submits that the specification explains the container identifier is saved in an online memory with at least one property of the milk contained in the container, which property may, for example, be the amount of milk
Regarding (a), the Examiner initially submits that in accordance with Applicant’s arguments and per MPEP 2181(V), the Examiner is interpreting “an apparatus” as a single-means claim such that the claim requires “an apparatus by which the container is sealed, […], a second apparatus by which an identifier provided on the bag is read out or the container is provided with an identifier, and a third apparatus by which at least the determined amount is provided as a property together with the identifier for saving in a memory.” The Examiner notes that the claim is either meant to be interpreted this way or the Applicant lacks any written description of a single apparatus that can perform all of the claimed functions. The Examiner assumes the former.
In that regard and as argued by the Applicant, “an apparatus by which the container is sealed” corresponds to a cap or lid for the container. A second apparatus by which an identifier provided on the bag is read corresponds to an input device such as a PC. However, the Examiner finds that there is no description of the structure that performs “the container is provided with an identifier” and thus the associated rejections with respect to this feature remain. The Applicant has not provided arguments for this feature and the Examiner suggests deleting this optional feature.
The Examiner also notes that Applicant’s argument with regard to the prior art rejection appear to be in opposition to the arguments regarding the 112(f/a/b) interpretation/rejections. In the 112(f/a/b) arguments the Applicant argues that the apparatuses are different than one another, while in the prior art arguments, the Applicant argues that they are one device. As noted above, there is no written description of one device that performs all the noted functions and thus the Examiner is interpreting, based on Applicant’s 112(f/a/b) arguments, that the claim is a single-means claim in which multiple apparatuses are implied.
The specification further explains that the determination of the amount of breast milk contained in the container can be carried out by detecting the volume contained in the container and/or by weighing, in which the tare weight of the container may be communicated to the apparatus, such as by reading a container identifier provided on the container, which also contains information about the tare weight of the container.
Regarding (b), the Examiner submits that, per the above interpretation, the claim requires “a [third] apparatus by which at least the determined amount is provided as a property together with the identifier for saving in a memory.” The Examiner finds that these features correspond to a PC (a computer; the apparatus of Applicant’s arguments) that receives weight/volume and associates it with the identifier “for storing in memory.”
Finally as to claim 6, according to the Office action (as the rejection is best understood), the specification does not describe the apparatus that provides the identification of time together with the container to the interface.
Regarding (c), the Examiner submits that, per the above interpretation, the Examiner finds that these features correspond to a PC (a computer; the apparatus of Applicant’s arguments) that provides the identification of time together with the container identifier to memory.
As to claim 13, according to the Office action, the specification does not provide a description of an accommodation for a container. Applicant respectfully submits that "accommodation" in this capacity is a general term such, such as "apparatus", and needs no further description.
Regarding (d), the Examiner has reconsidered the 112(f) interpretation of “an accommodation” and finds that this item does not perform a function in the claim and thus interpretation under 112(f) is not warranted.
Also as to claim 13, according to the Office action, the specification does not provide a description of a system for treating. As explained above with respect to claim 6, the specification describes that the system for treating may include pasteurization by UV irradiation. As such, the specification provides adequate description of a system for treating.
Regarding (e), the Examiner respectfully disagrees. UV radiation is a wavelength of light, not particular physical structure that performs the irradiation/treatment. There is no description of the structure that performs the treatment and the associated rejections are maintained.
Additionally as to claim 13, according to the Office action, the specification does not provide a description of the device that provides the container with a container identifier. The specification describes that the container identifier, which may be a machine-readable identifier, such as an RFID or a barcode, and discloses a system for attaching a container identifier to the container. It is respectfully submitted that a person of ordinary skill in the art would be sufficiently familiar with the fundamentals of RFID and barcodes to understand from this disclosure how these container identifiers would be applied to the container.
Regarding (f), the Examiner respectfully disagrees. There is no description of the apparatus that provides the container with the identifier. The issue is not whether a person having skill in the art would know how an RFID works, the issue is that the Applicant has not described the structure that physically provides the identifier.
Finally as to claim 13, according to the Office action, the specification does not provide a description of the interface that transmits. The specification describes an interface for transmitting information to an online memory. It is respectfully submitted that a person of ordinary skill in the art would be sufficiently familiar with the fundamentals of information-transmitting interfaces to understand a PC-based information interface is an example of what is used to transmit information.
Regarding (g), the Examiner submits that, per the above interpretation, the Examiner finds that these features correspond to a PC (a computer; the apparatus of Applicant’s arguments) that receives weight/volume and associates it with the identifier “for storing in memory.”
Regarding the indefiniteness rejection of Claim 12, the Applicant has amended the claim to overcome the basis of rejection.
Rejection under 35 U.S.C. § 102/103
Regarding the rejection of Claims 1-14, the Applicant has cancelled Claims 2 and 6 rendering the rejection of those claims moot. Regarding the remaining claims, the Examiner has cited new prior art as necessitated by amendment. The Examiner notes that functions of the claim are now actively required to occur. The Arguments presented as they pertain to the previously-cited prior art have been considered; however, the arguments are not persuasive. Applicant argues:
Applicant respectfully submits that amended claim 1 is not obvious from, and is patentably distinguishable over, Alvarez in view of Christen because, according to the method of amended claim 1, the bag is used to collect the expressed milk, which bag is sealed and treated, within the apparatus, the amount of breast milk contained in the bag is determined, and respective information is assigned to the container identifier and to the
Regarding (a), the Examiner notes that the Applicant in their 112(f) – related arguments stated that the sealing is performed by a sealing apparatus (cap/lid/equivalent), that the treating is performed by UV radiation, and the data is collected by a PC. These features were specifically stated to be performed by different devices and thus Applicant’s argument that the bag is sealed and treated within a singular apparatus is opposite to their prior arguments and are not persuasive.
However, Applicant respectfully submits [as it pertains to Claim 13] that there is no disclosure or suggestion of how Alvarez might be combined or modified to permit such in-container pasteurization. Moreover, Christen's disclosure of the use of UV light to achieve such pasteurization may be incompatible with Alvarez's light sensors, leading to inaccurate volume measurements. Christen also does not disclose providing information on the quality of the pasteurization, nor does Christen provide any disclosure of storing information relative to the pasteurization treatment.
Regarding (b), the Examiner disagrees. The Examiner initially notes that claim 13 does not require the in-container pasteurization to actually occur. As noted in the basis of rejections, the claim is met where it discloses the structural features of the claim. The function of the structure is currently all intended use and is not required to occur. In any event, a motivation to combine was provided and the Applicant has not provided any particular arguments as to why it is incorrect. Applicant’s strawman argument about events that may occur and which may interfere with one another does not negate the motivation provided.
The atmospheric pressure may be assumed to be equilibrium inside the bag and outside the bag. Moreover, the method of Applicant's claim 8 provides for regulating the external pressure for setting the expelling amount of breast milk, which cannot be accomplished purely by relying on static atmospheric pressure.
Regarding (c), the Examiner disagrees. There is no indication in the claim that the pressure in the bag is atmospheric pressure. This cannot be assumed based on what is claimed or based on the prior art disclosure. Even assuming they are at equilibrium, that pressure is still applied during feeding and assists in expelling the content of the container (“for expelling,” which is an intended use in any event). Further, the container’s height above sea level regulates the atmospheric pressure applied. There is nothing in the claim that states how the pressure is applied or how it is regulated, merely that it occurs. Given the broadest reasonable interpretation, the Examiner submits that the claim language is met.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
McKendry (U.S. Pre-Grant Patent Publication No. 2008/0228134) which discloses a container for storing bulk amounts of breast milk under vacuum.
Chang et al. (U.S. Pre-Grant Patent Publication No. 2022/0339329) which discloses a breast pump that uses suction to extract milk from the breast and collected in a container.
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 JASON S TIEDEMAN whose telephone number is (571)272-4594. The examiner can normally be reached 7:00am-4:00pm, off alternate Fridays.
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/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
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