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 § 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.
Claims 1, 9-10, 13-14 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Bosshard et al. (USPGPub 2010/0016789) and Weber et al. (USPGPub 2012/0277728).
Re Claim 1, Khalil teaches a system to pump milk from a breast of a user (Khalil Figs. 9-11), the system comprising: a breast pump shaped to fit within a bra (Khalil ¶ 0032, 0066), the breast pump including: a shell (6"); a battery contained within the shell (6") (Khalil ¶ 0032 describing a power supply); a pump (8') contained within the shell (6") (Khalil ¶ 0066-0067); a flange (1, 72) including a rigid nipple receiving portion (4-1) and a bottom portion (72-1) below the rigid nipple receiving portion (4-1) (Khalil Annotated Fig. 5 and 10 below; ¶ 0066 describing embodiment of figures 9-11 of Khalil being similar to that of embodiment in figures 1-5), the rigid nipple receiving portion (4-1) including a proximal end defining an opening (Khalil Annotated Fig. 5 below showing nipple receiving portion having an outlet for milk flow leading to a duck-bill valve); a fluid container (7') connected to the rigid nipple receiving portion (4-1) (Khalil ¶ 0069; Annotated Figs. 5 and 10 below); wherein the pump (8') is associated with the rigid nipple receiving portion (4-1) and the pump (8') creates a suction force in the rigid nipple receiving portion (4-1) (Khalil ¶ 0051, 0058-0061) in a portion of the rigid nipple receiving portion (4-1) that is sized and shaped to receive a portion of a tissue of the breast (Khalil ¶ 0058-0059), the suction force being directed generally upward relative to the bottom portion (72-1) of the flange (1, 72) (Khalil ¶ 0058; Annotated Fig. 5 below).
However, Khalil fails to teach a wireless communication between the system and an external computer that automatically tracks pumping and communicates with the pump. Bosshard teaches a breast pump system (Bosshard Fig. 5) comprising a wireless communication between the system and an external computer (4') that automatically tracks pumping and communicates with the pump (Bosshard ¶ 0014-0016) wherein such a system has the advantage of no connector plugs, connections or cables are needed for viewing, tracking, and adjusting pumping (Bosshard ¶ 0016). 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 configured the system of Khalil to include a wireless communication between the system and an external computer that automatically tracks pumping and communicates with the pump as disclosed by Bosshard wherein such a system has the advantage of no connector plugs, connections or cables are needed for viewing, tracking, and adjusting pumping (Bosshard ¶ 0016).
Khalil also fails to teach at least a portion of the milk being directed generally upward relative to the bottom portion of the flange. Weber teaches a breast pump system (Weber Figs. 1-2) comprising a flange (4) (Weber Fig. 8; ¶ 0081-0085) wherein at least a portion of pumped milk is directed generally upward relative to a bottom portion of the flange (Weber Fig. 8 configured with any of embodiment Figs. 9-11). In the present case, it would have been an obvious matter of design choice to modify Khalil to have at least a portion of the milk being directed generally upward relative to the bottom portion of the flange since applicant has not disclosed that having at least a portion of the milk being directed generally upward relative to the bottom portion of the flange 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 at least a portion of the milk being directed generally upward relative to the bottom portion of the flange, 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).
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Re Claims 9 and 10, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. As to Claim 9, Khalil discloses wherein the breast pump defines a generally breast shaped profile (as seen in Khalil Fig. 9). As to Claim 10, Khalil discloses wherein the fluid container (7') forms part of the generally breast shaped profile (as seen in Khalil Fig. 9).
Re Claim 13, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. Khalil further teaches wherein the rigid nipple receiving portion (4-1) includes a first end (4-2) and a second end (4-3) (as seen in Khalil Annotated Fig. 5 above).
Re Claim 14, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 13. Khalil further teaches wherein the pump creates the suction force within the rigid nipple receiving portion (4-1) between the first end (4-2) and the second end (4-3) of the rigid nipple receiving portion (4-1) (as seen in Khalil Annotated Fig. 5 above).
Re Claim 20, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. Khalil further teaches wherein the flange (1, 72) is an integrally formed breast contacting adapter and connector removeable from the system (Khalil Fig. 11). In the present case, examiner has interpreted elements 1 and 72 as the flange. The use of a one piece construction as opposed to the two part structure disclosed in Khalil would be merely a matter of obvious engineering choice (In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)).
Re Claim 21, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. Khalil fails to teach a wireless transmitter; and a chip; wherein the wireless transmitter transmits pump information to an external device which displays the pump information. Bosshard teaches a wireless transmitter (Bosshard ¶ 0014); and a chip (Bosshard ¶ 0014 teaching a memory); wherein the wireless transmitter transmits pump information to an external device which displays the pump information (Bosshard ¶ 0014-0016) wherein such a system has the advantage of no connector plugs, connections or cables are needed for viewing, tracking, and adjusting pumping (Bosshard ¶ 0016). 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 configured the system of Khalil in view of Bosshard and Weber to include a wireless transmitter; and a chip; wherein the wireless transmitter transmits pump information to an external device which displays the pump information as disclosed by Bosshard wherein such a system has the advantage of no connector plugs, connections or cables are needed for viewing, tracking, and adjusting pumping (Bosshard ¶ 0016).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Bosshard et al. (USPGPub 2010/0016789) and Weber et al. (USPGPub 2012/0277728) as applied to Claim 1 above, and further in view of Barack (USPN 8,579,874).
Re Claim 2, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. However, Khalil in view of Bosshard and Weber fail to disclose wherein the flange is visually clear. Barack discloses a breast interface assembly (Barack Fig. 1) comprising a flange (104) wherein Barack describes breast flanges being made of a transparent plastic to allow the user to ensure proper fitting by visual inspection (Barack Col. 1 Lines 12-15 and Col. 3 Lines 37-53). 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 modified the flange of Khalil in view of Bosshard and Weber to be visually clear as disclosed by Barack to ensure proper fitting of the breast adapter by visual inspection (Barack Col. 1 Lines 12-15 and Col. 3 Lines 37-53).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Bosshard et al. (USPGPub 2010/0016789) and Weber et al. (USPGPub 2012/0277728) as applied to Claim 1 above, and further in view of Quackenbush et al. (USPGPub 2008/0255503).
Re Claim 3, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. Khalil further teaches a controller (Khalil ¶ 0068 - "breastpump unit further comprises a corresponding control system [...] arranged separately in the housing"). However, Khalil fails explicitly teach wherein the controller changes pressure. Bosshard teaches a controller for changing a pumping procedures or modes (Bosshard ¶ 0014). However, Bosshard fails to explicitly teach the controller changing pressure. Quackenbush teaches a system for controlling pumping cycles to pump milk from a human breast (Quackenbush ¶ 0015); the system comprising a controller wherein the controller automatically changes pressure (Quackenbush ¶ 0016) for hands free precision control of milk removal during a pumping session (Quackenbush ¶ 0020). 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 configured the controller of Khalil in view of Bosshard and Weber to change pressure automatically as disclosed by Quackenbush for hands free precision control of milk removal during a pumping session (Quackenbush ¶ 0020).
Re Claim 17, Khalil in view of Bosshard and Weber as applied to Claim 1 above, and further in view of Quackenbush disclose all of the limitations of Claim 3. Khalil fails to teach a sensor in communication with the controller to provide a control loop that is used to adjust the pressure. Quackenbush teaches a sensor (260) in communication with a controller (220) to provide a control loop that is used to adjust pressure for automatic breast pump control (Quackenbush ¶ 0063-0067). 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 configured the controller of Khalil in view of Bosshard and Weber as applied to Claim 1 above, and further in view of Quackenbush wherein a sensor is in communication with the controller to provide a control loop that is used to adjust the pressure as disclosed by Quackenbush for automatic breast pump control (Quackenbush ¶ 0063-0067).
Re Claim 18, Khalil in view of Bosshard and Weber as applied to Claim 1 above, and further in view of Quackenbush disclose all of the limitations of Claim 17. Khalil teaches wherein pump includes a flexible member (3) above the rigid nipple receiving portion (4-1) that creates the suction force (Khalil Annotated Fig. 5 above; ¶ 0061-0063, 0066).
Re Claim 19, Khalil in view of Bosshard and Weber as applied to Claim 1 above, and further in view of Quackenbush disclose all of the limitations of Claim 18. Khalil teaches wherein the flexible member (3) is held in a recess directly above the rigid nipple receiving portion (4-1) (Khalil ¶ 0054 describing membrane housing parts 2 and 4; Khalil Annotated Fig. 5 above).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Bosshard et al. (USPGPub 2010/0016789) and Weber et al. (USPGPub 2012/0277728) as applied to Claim 1 above, and further in view of Fridman et al. (USPGPub 2015/0065994).
Re Claim 4, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. Khalil in view of Bosshard and Weber fail to disclose wherein an operational setting of the system is based on time. Fridman discloses a system for controlling pumping cycles to pump milk from a human breast (Fridman ¶ 0167); the system comprising an operational setting of the system is based on time (Fridman ¶ 0160-0164) for improved milk pumping, comfort and functionality for the user (Fridman ¶ 0159). 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 configured the automated system of Khalil in view of Bosshard and Weber to have an operational setting of the system be based on time as disclosed by Fridman, the configuration for improved milk pumping, comfort and functionality for the user (Fridman ¶ 0159-0164).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Bosshard et al. (USPGPub 2010/0016789) and Weber et al. (USPGPub 2012/0277728) as applied to Claim 1 above, and further in view of Kamen et al. (USPGPub 2013/0177455).
Re Claims 5 and 6, Khalil in view of Bosshard and Weber disclose all of the limitations of Claim 1. However, Khalil in view of Bosshard and Weber fail to disclose a first driver and a second driver, wherein the first driver and the second driver are configured in a series arrangement and configured to cooperate to facilitate generating vacuum pressure within the pump; and wherein the first driver and the second driver are compression drivers. Kamen discloses a mechanism of a peristaltic pump (as seen in Kamen Fig. 186-187), the mechanism comprising a first driver (721) and a second driver (724), wherein the first driver (721) and the second driver (724) are configured in a series arrangement (wherein the drivers of the peristaltic pump are arranged in a series in a linear manner) and configured to cooperate to facilitate generating vacuum pressure within the pump (719) (Kamen ¶ 0649); and wherein the first driver (721) and the second driver (724) are compression drivers (as seen in Kamen Fig. 186-187 - wherein drivers 721 and 724 compress tube 728), wherein occlusion of the tubing creates increased pressure ahead of the squeezed area and reduced pressure behind that area, thereby forcing a liquid through the tubing as the rotor assembly moves the pinch rollers along the tubing, wherein such peristaltic action provides for greater control and precision (Kamen ¶ 0028).
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 configured the pump of Khalil in view of Bosshard and Weber to consist of a peristaltic pump comprising a first driver and a second driver, wherein the first driver and the second driver are configured in a series arrangement and configured to cooperate to facilitate generating vacuum pressure within the pump; and wherein the first driver and the second driver are compression drivers as disclosed by Kamen, wherein occlusion of the tubing creates increased pressure ahead of the squeezed area and reduced pressure behind that area, thereby forcing a fluid through the tubing as the rotor assembly moves the pinch rollers along the tubing, wherein such peristaltic action provides for greater control and precision (Kamen ¶ 0028).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Bosshard et al. (USPGPub 2010/0016789) and Weber et al. (USPGPub 2012/0277728) as applied to Claim 1 above, and further in view of Jordan et al. (USPGPub 2006/0106334).
Re Claims 7 and 8, Khalil in view of Bosshard and Weber teach all of the limitations of Claim 1. However, Khalil in view of Bosshard and Weber fail to teach a first piezoelectric device and a second piezoelectric device, the first piezoelectric device and the second piezoelectric device each configured as a driver to facilitate stimulating milk letdown and milk extraction; and wherein the first piezoelectric device and the second piezoelectric device are mounted to the flange. Jordan discloses a breast milk expression system comprising a breast adapter (2614) configured to fit within a bra (202) (Jordan Fig. 26; ¶ 0082), a first piezoelectric device and a second piezoelectric device (2602) (Jordan ¶ 0082), the first piezoelectric device and the second piezoelectric device (2602) each configured as a driver to facilitate stimulating milk letdown and milk extraction; and wherein the first piezoelectric device and the second piezoelectric device (2602) are mounted to a flange (2614), the configuration to maximize the effectiveness for milk expression (Jordan ¶ 0082).
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 configured the automated system of Khalil in view of Bosshard and Weber to comprise a first piezoelectric device and a second piezoelectric device, the first piezoelectric device and the second piezoelectric device each configured as a driver to facilitate stimulating milk letdown and milk extraction; and wherein the first piezoelectric device and the second piezoelectric device are mounted to the flange as disclosed by Jordan to maximize the effectiveness for milk expression (Jordan ¶ 0082).
Response to Arguments
Applicant's arguments filed 01/08/2026 have been fully considered but they are not persuasive. In the second full paragraph of Page 5 of the response, applicant argues the following:
Claim 1 has been amended to recite a system to pump milk from a breast including, among other things, wherein the pump is associated with a rigid nipple receiving portion and the pump is configured to create a suction force in the rigid nipple receiving portion in a portion of the rigid nipple receiving portion that is sized and shaped to receive a portion of a tissue of the breast, the suction and at least a portion of the milk being directed generally upward relative to the bottom portion of the flange. It is respectfully submitted that the cited prior art does not disclose such subject matter.
Applicant goes on to argue primary reference Weber does not include “a rigid nipple receiving portion and a pump that creates a suction force in the rigid nipple receiving portion in a portion of the rigid nipple receiving portion that is sized and shaped to receive a portion of a tissue of the breast, the suction force and at least a portion of the milk being directed generally upward relative to the bottom portion of the flange.” However, examiner does not rely upon Weber to teach applicant’s Claim 1 amendment. Rather, examiner relies upon primary reference Khalil wherein Khalil teaches a rigid nipple receiving portion (4-1) (Khalil Annotated Fig. 5 above) and a pump (8’) that creates a suction force in the rigid nipple receiving portion (4-1) in a portion of the rigid nipple receiving (4-1) portion that is sized and shaped to receive a portion of a tissue of the breast (Khalil ¶ 0058-0059). Examiner relies upon Weber to teach at least a portion of the milk being directed generally upward relative to the bottom portion of the flange.
Conclusion
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781