DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the preliminary amendment filed on May 31, 2024. As directed by the amendment: claims 1, 3-9, 11-12 and 14 have been amended, no claims have been cancelled, and no claims have been added. Thus, claims 1-15 are presently pending in this application.
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: treatment module in claim 1, treatment control module of claim 8, massage unit of claim 9, light delivery unit of claim 9, rf delivery system of claim 11, ultrasound delivery system of claim 11, cooling system of claim 11, system for delivering topical medication of claim 11, and treatment monitoring sensor module of claim 12.
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
Claim 9 is objected to because of the following informalities: grammatical error, there is a missing period. 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 1-15 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 lines 8-10 recite “…a breast pump configuration with a first set of modules, integrated to form a single unit…without the treatment module…”. The meaning of “…without the treatment module…” is not clear, specifically how the single unit is without the treatment module. For purposes of examination, this is interpreted as “…and wherein the first set of modules that form a single unit do not include the treatment module…”. Claims 2-15 are rejected at least because they depend from claim 1.
Regarding claim 11, 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 12 recites the limitation "the application" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this interpreted as “an application”. Claim 13 is rejected at least because it depends from claim 12.
Claim 12 recites the limitation "the treatment" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this interpreted as “a treatment”. Claim 13 is rejected at least because it depends from claim 12.
Claim 12 recites the limitation "the interaction" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this interpreted as “an interaction”. Claim 13 is rejected at least because it depends from claim 12.
Claim 12 recites the limitation "the reaction" in line 4. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this interpreted as “a reaction”. Claim 13 is rejected at least because it depends from claim 12.
Claim 13 recites the limitation "the treatment monitoring sensor system" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “the treatment monitoring sensor module”.
Claim 14 recites the limitation "the same outer form factor" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, this is interpreted as “a same outer form factor”.
Claim Rejections - 35 USC § 102
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, 6, 8-9 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim Young Bon (Bon) KR 20210086320A (Examiner has provided an English translation).
Regarding claim 1, Bon discloses a wearable breast pump system comprising a set of modules (Fig. 1 and P0017 and P0031-0032), the set of modules comprising: a breast shield module (breast milk means B, P0057) including at least a breast shield (inhaler 16, P0057); a pump module (control body A, P0057, less the circuit device for controlling B and C) including at least a pump unit (pump 3, P0057); a milk container module (reservoir 13, P0057); and a treatment module (thermal massage means C, P0057), wherein the breast pump system is configurable in: a breast pump configuration with a first set of the modules (Fig. 2), integrated to form a single unit, including the breast shield module, the pump module and milk container module, and without the treatment module; and a treatment configuration (Fig. 5, note that Fig. 5 is labeled incorrectly, wherein B should be labeled C) with a second set of the modules integrated to form a single unit, in which one or more, but not all, of the first set of modules is exchanged for the treatment module (B and 13 are exchanged for C, and A remains).
Regarding claim 2, Bon discloses the breast pump system of claim 1, wherein the pump module comprises the pump unit and an electronics unit (main circuit board 5, P0032 and Fig. 9).
Regarding claim 3, Bon discloses the breast pump system of claim 1, wherein the breast shield module comprises the breast shield and a diaphragm (inhaler 16 and negative pressure absorption member 18, P0037).
Regarding claim 6, Bon discloses the breast pump system of claim 1, wherein the second set of the modules, for the treatment configuration, comprises the pump module and the treatment module without the milk container module and without the breast shield module (see claim 1 above).
Regarding claim 8, Bon discloses the breast pump system of claim 1, wherein the set of modules includes a treatment control module (circuit device for controlling B and C, P0032), wherein the second set of the modules, for the treatment configuration, comprises at least the treatment module and the treatment control module.
Regarding claim 9, Bon discloses the breast pump system of claim 1, wherein the treatment module comprises: a massage unit (massage means, P0031); or a light delivery unit for phototherapy (led, P0039).
Regarding claim 14, Bon discloses the breast pump system of claim 1, wherein the breast pump system has the same outer form factor in the breast pump configuration and in the treatment configuration (the first set of modules that remain between the breast pump configuration and the pump configuration, such as control body A, have the same outer form factor in both configurations because they are the same modules).
Regarding claim 15, Bon discloses the breast pump system of claim 14, wherein the breast pump system is adapted to fit under a bra in the breast pump configuration and in the treatment configuration (the breast pump system is fully capable of fitting under a bra in the breast pump configuration and in the treatment condition).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bon as applied to claim 3 above, and further in view of Felber et al. (Felber) US 2014/0121593 A1.
Regarding claim 4, Bon discloses the breast pump system of claim 3.
Bon does not teach wherein the diaphragm is formed of a flexible membrane and comprises a cavity having an open end for receiving a nipple of a user and a closed end, wherein the diaphragm fits over an opening in the breast shield.
However, Felber teaches a breast shield (Figs. 1-5 and P0053-0054) wherein the diaphragm (media separation device 3, P0053) is formed of a flexible membrane (flexible, P0025) and comprises a cavity (cavity, see annotated Fig. 2 below) having an open end for receiving a nipple of a user (Fig. 3) and a closed end (closed end, see annotated Fig. 2 below), wherein the diaphragm fits over an opening in the breast shield (opening in the breast shield, see annotated Fig. 2 below).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to substitute the breast shield module of Bon for the breast shield module of Felber for the purpose of massaging the nipple, similarly to the palate and tongue of a baby, having a positive effect on the amount of milk, Felber P0016.
Claims 10 and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Bon as applied to claim 9 above, and further in view of Jafarzaheh US 2023/0065561 A1.
Regarding claim 10, Bon discloses the breast pump system of claim 9.
Bon does not teach wherein the treatment module comprises a light delivery unit for delivering light with a peak intensity at a wavelength in the range 400nm to 470nm; or infrared light with a peak intensity at a wavelength in the range 600nm to 800nm.
However, Jafarzadeh teaches a wearable apparatus for the treatment of mastitis wherein the treatment module comprises a light delivery unit for delivering light with a peak intensity at a wavelength in the range 400nm to 470nm (light source elements emit electromagnetic radiation having a wavelength in the range of 380-1050 nm, P0007).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the wavelength of light emitted as claimed for the purpose of treating mastitis, Jafarzaheh P0007.
Regarding claim 12, Bon discloses the breast pump system of claim 1.
Bon does not teach wherein the set of modules further comprises a treatment monitoring sensor module to monitor the application of the treatment or to monitor the interaction between the application of the treatment and the reaction of the breast and user, and the second set of the modules, for the treatment configuration, includes the treatment monitoring sensor module.
However, Jafarzadeh teaches a wearable apparatus for the treatment of Mastitis further comprises a treatment monitoring sensor module (temperature sensors 114, P0094) to monitor the application of the treatment or to monitor the interaction between the application of the treatment and the reaction of the breast and user (P0094).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the second set of modules to include sensors for the purpose of measuring a temperature profile across the mammary gland, Jafarzadeh P0094.
Regarding claim 13, Bon in view of Jafarzadeh teaches the breast pump system of claim 12, wherein the treatment monitoring sensor system comprises one or more of: a temperature sensor for measuring skin temperature (Jafarzadeh, temperature sensors 114 able to measure a temperature profile across the surface of the mammary gland, P0094).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Bon as applied to claim 1 above, and further in view of Rao et al. (Rao) US 2021/0402204 A1.
Regarding claim 11, Bon discloses the breast pump system of claim 1.
Bon does not teach wherein the treatment module comprises: an RF delivery system or an ultrasound delivery system or a cooling system such as using a Peltier cooling element; or a system for delivering topical medication, wherein the set of modules further comprises a topical medication storage container.
However, Rao teaches a breast care device wherein the treatment module comprises: a system for delivering topical medication, wherein the set of modules further comprises a topical medication storage container (P0007-P0008).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the treatment module of Bon as taught by Rao for the purpose of delivering a therapeutic fluid to the breast, Rao P0008.
Potentially Allowable Subject Matter
Claims 5 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims, and by successfully addressing the §112(b) rejections above.
Reasons for Potential Allowance
The following is an Examiner's statement of reasons for potential allowance: the claims in this application are potentially allowed because the prior art of record fails to disclose either singularly or in combination the claimed breast pump system.
The closest prior art is Kim Young Bon (Bon) KR 20210086320A.
Regarding claim 5, Bon fails to teach among all the limitations or render obvious a breast pump system as claimed, which includes wherein the breast shield and the diaphragm form a rear assembly and the pump module is part of a front assembly that fits over the rear assembly, wherein the front assembly further comprises a cover for fitting over the diaphragm to define a sealed space between them, in combination with the total structure and function of the breast pump system as claimed.
Regarding claim 7, Bon fails to teach among all the limitations or render obvious a breast pump system as claimed, which includes wherein the second set of the modules, for the treatment configuration, comprises the pump module, the treatment module and the breast shield, without the milk container module and without the diaphragm, in combination with the total structure and function of the breast pump system as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN A DOUBRAVA whose telephone number is (408)918-7561. The examiner can normally be reached M-F 9-5 Pacific Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.D./Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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