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 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.
Claim 4 is 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 4 recites the limitation "the ring". There is insufficient antecedent basis for this limitation in the claim, as “the ring” is not recited in any of the preceding claims which claim 4 depends upon. For the purposes of examination, “the ring” is interpreted as the circular configuration of the second cavity portion.
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 1-4 and 7-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sutrina (US 20090099511).
Regarding claim 1, Sutrina discloses a breast shield for a breast pump (Fig. 15: funnel 350 of shield 212 of pump 210; para. [0100], sentence 2), comprising: a first cavity for placing over a first portion of the breast surface including the nipple of a breast (see annotated Fig. 15 below; 352; para. [0100], sentence 3), the first cavity coupled to a first pressure control port (Fig. 18: pressure control port connected to VE; para. [0097], sentences 1-2) for controlling milk expression (para. [0083], sentences 1-3; para. [0084]); and a second cavity (Fig. 15: most inwardly positioned 354; para. [0100], sentence 3; see annotated Fig. 15 below) positioned radially outwardly from the first cavity (Fig. 15: cavities 354 all positioned radially outwardly from center cavity at 352), the second cavity coupled to a second pressure control port (Fig. 18: pressure control port connected to VM; para. [0097], sentences 1 and 3) for providing a sealing, or positioning function (para. [0101], sentences 1 and 3-4), wherein the second cavity is for applying a pressure to a second portion of the breast surface radially outward from the first portion (para. [0101], sentence 4; Fig. 15: second cavity applies pressure on location of breast radially outward from central first cavity 352).
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Annotated Fig. 15, Sutrina
Regarding claim 2, Sutrina discloses the breast shield of claim 1, as described above, wherein the second cavity extends at least partially around the outside of the first cavity (Fig. 15: 354 cavities extending around nipple tunnel first cavity 352).
Regarding claim 3, Sutrina discloses the breast shield of claim 1, as described above, wherein the second cavity comprises: a closed shape around the first cavity; or an open shape extending partially around the first cavity (Fig. 15: 354 cavities extend around nipple tunnel first cavity 352, with small gaps).
Regarding claim 4, Sutrina discloses the breast shield of claim 3, as described above, wherein the first cavity has a milk output channel (see annotated Fig. 18 below, milk output channel located at first cavity) and the ring has an interruption located at the milk output channel (see annotated Fig. 18 below, the milk output channel not located at the second cavity).
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Annotated Fig. 18, Sutrina
Regarding claim 7, Sutrina discloses the breast shield of claim 1, as described above, wherein: the second cavity is rigidly mounted to the first cavity (Fig. 15: second cavity rigidly mounted to first cavity via the funnel 350); or the second cavity is elastically non-rigidly mounted to the first cavity.
Regarding claim 8, Sutrina discloses the breast shield of claim 1, as described above, further comprising at least one further cavity positioned radially outwardly of the second cavity (Fig. 15: third and subsequent cavities 354 all positioned radially outwardly from second cavity near center cavity at 352).
Regarding claim 9, Sutrina discloses the breast shield of claim 1, as described above, wherein the second cavity is non-circular (Fig. 15: each segment is non-circular) with a greater height than width (see annotated Fig. 15’ below).
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Annotated Fig. 15’, Sutrina
Regarding claim 10, Sutrina discloses a breast pump comprising: a vacuum pump system (Fig. 18: 216); an expression kit which comprises the breast shield of claim 1, as described above, coupled to the vacuum pump system (Fig. 18: 212 coupled to 216 via VE); and a controller for controlling the vacuum pump system (Fig. 18: 220).
Regarding claim 11, Sutrina discloses the breast pump system of claim 10, as described above, wherein the vacuum pump system comprises a vacuum pump (216), and a regulator system for controlling the pressure applied from the vacuum pump to the first and second cavities (para. [0112], regulators 260 and 280).
Regarding claim 12, Sutrina discloses the breast pump system of claim 10, as described above, wherein the vacuum pump system comprises a first vacuum pump for the first cavity and a second vacuum pump for the second cavity (para. [0097], last sentence: the vacuum pumps 216 being separate and independent).
Regarding claim 13, Sutrina discloses the breast pump system of claim 10, as described above, wherein the controller is adapted to apply a holding under-pressure to the second cavity (para. [0082], sentence 1; para. [0083], last sentence; para. [0101], sentence 3) which adapts over time from an intermittent application of a particular under-pressure level to a constant application of under-pressure when the breast shield is first positioned (Fig. 11: 700 being the pressure applied by vacuum being intermittently applied and then held; para. [0082]; para. [0101], sentences 1-3 showing that the vacuuming through the line 218 directs to the second cavity).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5, 6, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sutrina (US 20090099511) in view of Quackenbush (US 10016548).
Regarding claim 5, Sutrina discloses the breast shield of claim 1, as described above, but fails to disclose the second cavity having a covering membrane.
Quackenbush teaches an analogous breast shield with an analogous first and second cavities, wherein the second cavity (Fig. 1A: 30+40; col. 4, lines 18-20) has a covering membrane (col. 7, lines 22-23). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Sutrina breast shield by replacing the open second cavity with the bladder-contained expanding and contracting second cavity taught by Quackenbush, in order to be able to also apply positive pressure to that portion of the breast, in addition to the negative pressure, to massage and stimulate the breast for improved milk extraction (Quackenbush: col. 4, lines 9-12; col. 5, lines 40-47).
Regarding claim 6, Sutrina discloses the breast shield of claim 1, as described above, wherein the second cavity is separated into segments (Fig. 15: segmented 354; para. [0100], sentence 4). However, Sutrina fails to explicitly disclose each of the segments having their own pressure control ports.
Quackenbush teaches an analogous breast shield with an analogous first and second cavities, wherein the second cavity (Fig. 1A: 30+40) is segmented (segments 30 and 40), wherein each segment has its own pressure control port (Fig. 1A: pressure control ports 38 and 50). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the segmented second cavity of the Sutrina breast shield by incorporating Quackenbush’s teaching of each segment having its own pressure control port, in order to be able to simultaneously apply both positive and negative pressure to different portions of the breast (Quackenbush: col. 6, lines 43-51; col. 6, lines 26-30).
Regarding claim 14, Sutrina discloses the breast pump system of claim 10, as described above, wherein the controller is adapted to apply pressure sequence to the second cavity during milk expression using the first cavity (para. [0094], sentences 1 and 3-5). However, Sutrina fails to disclose this pressure sequence as a massage pressure profile.
Quackenbush teaches an analogous breast shield with an analogous first and second cavities, wherein the controller (Fig. 6: 64; col. 6, lines 6-7) is adapted to apply a massage pressure profile (col. 7, lines 14-17) to the second cavity (Fig. 1A: second cavity 30+40) during milk expression (col. 7, line 62 – col. 8, line 3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Sutrina breast shield by incorporating the pressure profile applied to the second cavity taught by Quackenbush, in order to massage and stimulate the breast for improved milk extraction (Quackenbush: col. 4, lines 9-12; col. 5, lines 40-47).
Regarding claim 15, Sutrina discloses the breast pump system of claim 10, as described above, but fails to explicitly disclose a user interface.
Quackenbush teaches an analogous breast shield comprising a user interface (Fig. 6: interface 62) to allow a user to select pressure characteristics for the first and second cavities (col. 7, lines 37-41). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Sutrina breast shield by incorporating the user interface taught by Quackenbush, in order to allow for the user to modify and fine-tune the pressure applied to increase the comfort and effectiveness of the pump.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Fridman (US 20150065994 and Khalil (US 20130023821).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL TSAI can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.A.W./Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783