DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 1 is objected to because of the following informalities: Line 7 reading “the breast milk” should read --the quantity of breast milk--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 8 reading “transferred from one collection unit to another” should read --transferred from at least one of the first collection unit or the second collection unit to an other of the at least one of the first collection unit or the second collection unit--. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Line 10 reading “the breast milk” should read --the quantity of breast milk--. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Lines 2-3 reading “from one bottle to the other” should read --from one of the first bottle or the second bottle to an other of the first bottle or the second bottle--. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: Line 3 reading “and the second collection unit” should read --and a threaded portion of the second collection unit--. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: the two instances in Line 2 reading “the breast milk” should read --the quantity of breast milk--. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: Line 2 reading “the breast milk” should read --the quantity of breast milk--. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: Line 5 reading “from one collection unit to another” should read --from at least one of the first collection unit or the second collection unit to an other of the at least one of the first collection unit or the second collection unit--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: the two instances in Lines 1-2 reading “the breast milk” should read --the quantity of breast milk--. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: Lines 1-2 reading “the breast milk” should read --the quantity of breast milk--. Appropriate correction is required.. 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 1-11 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. Line 5 of Claim 1 recites the limitation “the quantity of breast milk possibly containing a quantity of PFAS.” This limitation is being found indefinite for failure to particularly point out the subject matter being claimed. A possibility is not patentable subject matter. Claims 2-11 are rejected by virtue of their dependence on Claim 1. Appropriate correction and/or clarification is required.
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 1-2, 4-5, 9-14 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rosenfeld (USPGPub 2007/0010760).
Re Claim 1, Rosenfeld teaches a filtration assembly configured to filter PFAS from breast milk (Rosenfeld ¶ 0042, 0072), comprising: a filtration device (300) configured to be positioned between a first collection unit (400) and a second collection unit (402) (Rosenfeld ¶ 0101; Figs. 9-10A), wherein the filtration device (300) is coupled to at least one of the first collection unit or the second collection unit and either including a quantity of breast milk (Rosenfeld ¶ 0097-0098); the quantity of breast milk possibly containing a quantity of PFAS, wherein the filtration device is integrated with a filter (307), selectively positioned within the filtration device (300), to reduce the quantity of PFAS contained within the breast milk, wherein the quantity of breast milk is transferred from one collection unit to another (Rosenfeld ¶ 0097-0098); and the quantity of breast milk processes through the filter (307) and reduces the quantity of PFAS contained within the breast milk (Rosenfeld ¶ 0072, 0097-0101).
Re Claim 2, Rosenfeld teaches wherein the first collection unit (400) is a breast pump (as seen in Rosenfeld Fig. 10A), such that the filtration device (300) is positioned in-line with the breast pump to deliver the quantity of breast milk through the filter (307) while the breast pump is in operation; and the second collection unit (402) to receive the quantity of breast milk (Rosenfeld ¶ 0097-0101).
Re Claim 4, Rosenfeld teaches wherein the filtration device (300) can define a first threading (301) at a first end and a second threading (305) at a second end (as seen in Rosenfeld Fig. 9), opposite the first end, configured to threadably couple a threaded portion of the first collection unit (400) and the second collection unit (402), respectively, to form a liquid seal (as seen in Rosenfeld Fig. 10A).
Re Claim 5, Rosenfeld teaches wherein the filtration device (300) relies on at least one of gravity or pressurization within the filtration device to process the quantity of breast milk through the filter (Rosenfeld ¶ 0101).
Re Claim 9, Rosenfeld teaches wherein a valve (304) is integrated into the filtration device (300) and is configured to release gas trapped within the first collection unit, second collection unit or the filtration device (Rosenfeld ¶ 0098).
Re Claim 10, Rosenfeld teaches wherein the filter (307) is integrated with a brace (309) configured to retain the filter in position relative to the filtration device (300) during use (Rosenfeld ¶ 0100).
Re Claim 11, Rosenfeld teaches wherein the filter (307) is a composed, compact disc and readily inserted and removed from the filtration device (300) (as seen in Rosenfeld Fig. 10).
Re Claim 12, Rosenfeld teaches a method of filtering PFAS from breast milk (Rosenfeld ¶ 0042, 0072), comprising: positioning a filtration device (300) between a first collection unit (400) and a second collection unit (402) (Rosenfeld ¶ 0101; Figs. 9-10A), wherein the filtration device (300) is coupled to at least one of the first collection unit (400) or the second collection unit (402) and either including a quantity of breast milk (Rosenfeld ¶ 0097-0098); transferring the quantity of breast milk from one collection unit to another, the quantity of breast milk passing through a filter selectively positioned within the filtration device (300), wherein the filter (301) reduces a quantity of PFAS possibly contained in the quantity of breast milk; and reducing the quantity of PFAS from the quantity of breast milk (Rosenfeld ¶ 0072, 0097-0101).
Re Claim 13, Rosenfeld teaches positioning the filtration device (300) in-line with a breast pump (as seen in Rosenfeld Fig. 10A), the breast pump being the first collection unit (400) (as seen in Rosenfeld Fig. 10A); delivering the quantity of breast milk from the breast pump through the filter (301); and receiving the quantity of breast milk by a collection bottle, the collection bottle being the second collection unit (402) (Rosenfeld ¶ 0097-0101; Fig. 10A).
Re Claim 14, Rosenfeld teaches threadably coupling the filtration device (300) at a first end with the first collection unit (400) (Rosenfeld Fig. 10A); and threadably coupling the filtration device (300) at a second end, opposite the first end, with the second collection unit (402), wherein the threadable connections form a liquid seal (Rosenfeld ¶ 0097-0098).
Re Claim 18, Rosenfeld teaches integrating a valve (304) with the filtration device (300) for automatic releasing of gas trapped within the first collection unit, the second collection unit or the filtration device (Rosenfeld ¶ 0098).
Re Claim 19, Rosenfeld teaches integrating a brace (309) with the filter (307) for retaining the filter (307) in position relative to the filtration device (300) during use (as seen in Rosenfeld Fig. 10).
Re Claim 20, Rosenfeld teaches constructing the filter (307) as a composed, compact disc for readable insertion and removal from the filtration device (300) (as seen in Rosenfeld Fig. 10).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Rosenfeld (USPGPub 2007/0010760) in view of DiMauro et al. (USPGPub 2017/0164630).
Re Claim 3, Rosenfeld teaches all of the limitations of Claim 1. Rosenfeld fails to teach wherein the first collection unit is a first bottle and the second collection unit is a second bottle, such that the quantity of breast milk is transferred from one bottle to the other and passes through the filter. DiMauro teaches a filtration assembly (as seen in DiMauro Fig. 1B) configured to filter chemicals from breast milk (DiMauro ¶ 0023), the filtration assembly comprising a first collection unit (1) and a second collection unit (2) (DiMauro Figs. 1A-1B), wherein the first collection unit (1) is a first bottle and the second collection unit (2) is a second bottle (as seen in DiMauro Fig. 1A; ¶ 0028, 0038), such that the quantity of breast milk is transferred from one bottle to the other and passes through a filter (5) for filtration between two bottles (DiMauro Figs. 1A-aB; ¶ 0028, 0038).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a first collection unit and a second collection unit of Rosenfeld be configured wherein the first collection unit is a first bottle and the second collection unit is a second bottle, such that the quantity of breast milk is transferred from one bottle to the other and passes through the filter, the configuration as disclosed by DiMauro 1. for filtration between two bottles (DiMauro Figs. 1A-aB; ¶ 0028, 0038).
Claims 6-8 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenfeld (USPGPub 2007/0010760) in view of First et al. (USPGPub 2019/0075835).
Re Claim 6, Rosenfeld teaches all of the limitations of Claim 1. Rosenfeld fails to teach the filter including cyclodextrin. First teaches the use of cyclodextrin in filters for milk for removal of phytosterols (First ¶ 0118). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the filter of Rosenfeld include cyclodextrin as disclosed by First for removal of phytosterols (First ¶ 0118).
Re Claim 7, Rosenfeld in view of First teach all of the limitations of Claim 6. Neither of Rosenfeld nor First explicitly teach wherein the filter reduces the quantity of PFAS from the breast milk without significantly changing the nutritional profile of the breast milk. This limitation is being determined to be a functional limitation. The structure of Rosenfeld in view of First comprise all of the functional characteristics of said structure. Therefore, without further structural detail, the structure of Rosenfeld in view of First perform the function of reducing the quantity of PFAS from the breast milk without significantly changing the nutritional profile of the breast milk (MPEP 2114-I).
Re Claim 8, Rosenfeld in view of First teach all of the limitations of Claim 7. Neither of Rosenfeld nor First explicitly teach wherein the without significantly changing the nutritional profile of breast milk includes reducing the quantity of PFAS concentration by 5% or less. As described above, the limitation “without significantly changing the nutritional profile of breast milk” is a functional limitation inherent in the structure of Rosenfeld in view of First. However, the prior art is silent with regard to “reducing the quantity of PFAS concentration by 5% or less.” However, it would have been an obvious matter of design choice to modify the filter of Rosenfeld in view of First to reduce the quantity of PFAS concentration by 5% or less since applicant has not disclosed that having the quantity of PFAS concentration by 5% or less solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the quantity of PFAS concentration by 5% or less, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Re Claim 15, Rosenfeld teaches all of the limitations of Claim 12. First teaches the use of cyclodextrin in filters for milk for removal of phytosterols (First ¶ 0118). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have had the filter of Rosenfeld include cyclodextrin as disclosed by First for removal of phytosterols (First ¶ 0118).
Re Claim 16, Rosenfeld in view of First teach all of the limitations of Claim 15. Neither of Rosenfeld nor First explicitly teach reducing the quantity of PFAS from the breast milk without significantly altering the nutritional profile of the breast milk. This limitation is being determined to be a functional limitation. The structure of Rosenfeld in view of First comprise all of the functional characteristics of said structure. Therefore, without further structural detail, the structure of Rosenfeld in view of First perform the function of reducing the quantity of PFAS from the breast milk without significantly changing the nutritional profile of the breast milk (MPEP 2114-I).
Re Claim 17, Rosenfeld in view of First teach all of the limitations of Claim 16. Neither of Rosenfeld nor First explicitly teach only reducing the quantity of PFAS from the breast milk by 5% or less. The prior art is silent with regard to “reducing the quantity of PFAS concentration by 5% or less.” However, it would have been an obvious matter of design choice to modify the filter of Rosenfeld in view of First to reduce the quantity of PFAS concentration by 5% or less since applicant has not disclosed that having the quantity of PFAS concentration by 5% or less solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to the criticality of the quantity of PFAS concentration by 5% or less, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553, 555, 188 USPQ 7, 9 (CCPA 1975).
Conclusion
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783