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 .
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract currently exceeds 150 words. Furthermore, the abstract of the disclosure has the following informalities:
Line 2 of the Abstract recites “infants” but should read “infant’s”
Line 11 of the Abstract recites “paediatrician” but should read “pediatrician”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Drawings
The drawings are objected to because Figure 10 does not provide a label for the x-axis. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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:
“nipple resilience system” in Claim 1: Claim 3 recites wherein the system comprises “a resilience element, such as a bellows device”. Page 8 of the Applicant’s Specification recites wherein “the bellows is a device comprising an elastic container filled with a fluid, and of elastic spring element(s), which is/are mechanically connected to the outer surface of the container and have an adjustable spring constant”
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 Objections
Claims 1, 4-5, 11, 17, 20, and 22 are objected to because of the following informalities:
Claim 1 recites “comprising” in line 1, but should read “comprising:”
Claim 1 recites “comprising” in line 2, but should read “comprising:”
Claim 1 recites “measure” in line 13, but should read “measures”
Claim 4 recites “channel.” in line 7, but should read “channels.”
Claim 5 recites “adjust” in line 5, but should read “adjusts”
Claim 11 recites “nipple a second” in line 7, but should read “nipple, and a second”
Claim 17 recites “a breastfeeding” in line 3, but should read “the breastfeeding”
Claim 20 recites “a breastfeeding” in line 3, but should read “the breastfeeding”
Claim 22 recites “a breastfeeding” in line 3, but should read “the breastfeeding”
Appropriate correction is required.
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 1-26 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.
Claim 1 recites “preferably” in line 6. It is unclear whether the claim requires the cavity to be positioned at the distal end or not. Therefore, the claim is indefinite.
Claim 1 recites the limitation "the resilience of the cavity" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 3, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 7 recites “fluid channel(s)” in line 2. It is unclear as to whether this limitation was meant to refer to the “first fluidic channel” from Claim 1, or meant to refer to both the “first fluidic channel” and “second fluidic channel”. Examiner further notes that although the “first fluidic channel” was recited in independent claim 1, the “second fluidic channel” was only introduced later on in dependent claim 4, and that claim 7 is only dependent on claim 1.
Claim 7 recites “fluidic connectors” in line 4. It is unclear as to whether this limitation was meant to refer to the previously introduced “fluid connectors” from line 2 of Claim 7, or a separate element.
Claim 7 recites “enabling the artificial nipple to be detachable from the breastfeeding device” in lines 5-6. This limitation is unclear since the artificial nipple is part of the breastfeeding device. The Examiner suggests that the Applicant amend the claim to specify which part of the breastfeeding device the artificial nipple is detachable from, such as the pressure sensor or nipple resilience system.
Claim 9 recites the limitation "the sidewall" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially” in claim 10 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 12 recites “an end opposite to the distal end” in lines 6-7. It is unclear as to whether this “end” is referring to the previously introduced “proximal end” or a separate element.
Claim 16 recites “one or more of” in line 8. Further in line 9, Claim 16 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 18 recites the limitation "the measurements" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the pressure sensor(s) (PS1, PS2)" in line 6. There is insufficient antecedent basis for this limitation in the claim. Examiner further notes that although “pressure sensor (PS)” was recited in independent claim 1, the “second pressure sensor (PS2)” was only introduced later on in dependent claim 9.
Claim 18 recites “The method according to claim 18” in line 1. It is unclear as to how a claim can be dependent on itself. For examination purposes, the Examiner will interpret the claim as being dependent on claim 17 instead.
Claim 19 recites “The method according to claim 18” in line 1. It is unclear as to whether the claim was meant to be dependent on claim 18 or claim 17.
Claim 20 recites the limitation "the nursing" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites “The decision support system according to claim 21” in line 1. It is unclear as to how a claim can be dependent on itself. For examination purposes, the Examiner will interpret the claim as being dependent on claim 20 instead.
Claim 21 recites “an infant” in line 4. It is unclear as to whether this limitation is referring to the previously introduced “infant” or a separate element.
Claim 23 recites “The breastfeeding analysis kit according to claim 23” in line 1. It is unclear as to how a claim can be dependent on itself. For examination purposes, the Examiner will interpret the claim as being dependent on claim 22 instead.
Claim 24 recites “The breastfeeding analysis kit according to claim 23” in line 1. It is unclear as to whether the claim was meant to be dependent on claim 23 or claim 22.
Claim 24 recites the limitation "the atmospheric pressure" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites “The breastfeeding analysis kit according to claim 23” in line 1. It is unclear as to whether the claim was meant to be dependent on claim 23 or claim 22.
Claim 25 recites “preferably” in line 3. It is unclear whether the claim requires the fluid or liquid to be a saline suspension or not. Therefore, the claim is indefinite.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Uitbeijerse (U.S. Publication No. 2018/0116913) teaches a pacifier with controllable hardness of the nipple portion (Abstract), comprising an artificial nipple (nipple portion 14 formed of an elastomer; [0032]), and wherein the resilience of the artificial nipple is adjustable (the hardness of the nipple portion 14 of the pacifier 10 is changed, as indicated by the arrows of FIG. 1b. By compressing or decompressing the solid material, a gas or a liquid a certain stress is applied to the elastomer of the nipple portion 14 and thus the hardness of the elastomer changes, which reduces or increases the suckling comfort; [0033]).
Chin et al (U.S. Publication No. 2016/0287481) teaches systems and devices for controlling delivery of breast milk supplementation (Abstract), comprising an artificial nipple comprising a proximal end, a distal end, and a channel (a breast milk supplement delivery device includes a nipple component sized for placement in an infant's mouth, the nipple component having a first end and a second end, the first end of the nipple component including an aperture; [0311]) and a system configured to control the amount of fluid flow through the artificial nipple (a flow conduit disposed within at least a portion of the nipple component, a first end of the flow conduit in fluid communication with the aperture on the first end of the nipple component and a second end of the flow conduit in fluid communication with the port of the supplement reservoir…the control unit operably coupled to the controllable valve and to the data storage component, the circuitry including actuation circuitry configured to actuate the controllable valve to modulate release of the one or more breast milk supplements from the supplement reservoir based on the breast milk supplement regimen; [0311]).
Conneely et al (U.S. Publication No. 2020/0060940) teaches a breastfeeding device adapted to fit over a natural breast (Abstract), comprising an artificial nipple (nipple 205) attached to a flexible reservoir (the flexible reservoir 105 is a sterile collection pouch that may easily be cleaned for reuse. The reservoir 105 may be made of various materials that are both flexible and safe for skin contact. For example, the reservoir 105 may be made of a silicon material, an organic silk, a pliable plastic, or other well-known materials; [0040]) and further comprising a suction sensor (various sensors may be disposed within the reservoir. For example, a temperature sensor may be included within the reservoir to measure the temperature of the liquid and a volume sensor may be included therein to determine an amount of liquid available within the reservoir. Additionally, a sensor may be provided to measure the amount of suction required to discharge the liquid through the nipple or an amount of oxidation may be measured. Yet another example includes a sensor capable of measuring the suction of an infant on the nipple. In particular, the suction attempt of an infant may be determined by detecting the pressure and displacement of the nipple. This measurement is useful for children with low muscle tone in which the muscle strength is strengthened over time. However, the sensors are not limited to these specifically discussed sensors and various other sensors may also be mounted within the reservoir or on the breastfeeding device itself; [0040]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J YOON/Examiner, Art Unit 3791
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