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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/21/2026 has been entered.
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 13 and 17-19 are rejected under35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Pirzada et al. (USPGPub 2015/0112298), Weber et al. (USPGPub 2012/0277728), and Pacini (USPGPub 2009/0194116) above, and further in view of Myers et al. (USPGPub 2002/0193731).
Re Claim 13, Khalil teaches a wearable, portable self-powered breast pump system for pumping milk from a breast and sized and shaped to fit within a bra (Khalil Figs. 9-11; Abstract), the breast pump system comprising: a shell (6', 6"); a power source contained within the shell (6', 6") (as described at Khalil ¶ 0051); a pump (80, 81) contained within the shell (6', 6") (Khalil ¶ 0058, 0061); a skin contact member (1) configured to contact and form a seal with the breast and to mate with the shell (6', 6") (Khalil ¶ 0060, 0066), the skin contact member (1) including a nipple receiving portion (4-1) (Khalil Annotated Fig. 5 below; ¶ 0066 describing embodiment of figures 9-11 of Khalil being similar to that of embodiment in figures 1-5) and a bottom portion (72-1) below the nipple receiving portion (4-1) (as seen below in Khalil Annotated Figs. 5 and 10 below).
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 below), the first end (4-2) defining an opening for the breast (Khalil Annotated Fig. 5) and the second end (4-3) in line with and opposite the first end (4-2) and defining a closed end (Khalil Annotated Fig. 5). Khalil is silent with regard to the first end and the second end are formed from a single piece. However, one piece construction is obvious to one of ordinary skill in the art, being merely a matter of obvious engineering choice. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”
Khalil also teaches a milk collection container (7') having a rigid exterior surface configured to contact the bra (Khalil Figs. 9-11; ¶ 0069), the milk collection container (7') connected to the nipple receiving portion (4-1) (Khalil Figs. 4-5; ¶ 0066); and, a conduit suction path (20, 21, 22, 41, 42, 80) above the nipple receiving portion (4-1), the pump (80, 81) positioned to create an upward suction within the nipple receiving portion (4-1) (Khalil ¶ 0058, 0061 - wherein upward suction is achieved by vacuum applied to conduit suction path elements 20, 21, 22, 41, 42, 80), the upward suction being directed generally upward relative to the bottom portion (72-1) of the skin contact member (Khalil ¶ 0058, 0061; Khalil Annotated Fig. 10 below).
However, Khalil fails to teach a wireless communication between the wearable, portable self-powered breast pump system and an external computer that automatically tracks pumping and communicates with the pump. Pirzada teaches a breast pump system (Pirzada Abstract) comprising a wireless communication between the breast pump system and an external computer that automatically tracks pumping and communicates with the pump for providing feedback or assistance where the user is not using the breast pump system correctly or where the user is feeling uncomfortable (Pirzada ¶ 0040-0041, 0048-0049; Fig. 7; Claims 4 and 16). Therefore, it would have been obvious to one of ordinary skill in the art before the effective foiling date of the claimed invention to have included with the breast pump system of Khalil an external computer that automatically tracks pumping and communicates with the pump as disclosed by Pirzada for providing feedback or assistance where the user is not using the breast pump system correctly or where the user is feeling uncomfortable (Pirzada ¶ 0040-0041, 0048-0049; Fig. 7; Claims 4 and 16).
Khalil also fails to teach wherein upward suction in a portion of the nipple receiving portion that is sized and shaped to receive a portion of a tissue of the breast directs at least a portion of pumped milk generally upward relative to the bottom portion of the skin contact member. Weber teaches a breast pump system (Weber Figs. 1 and 2) comprising a conduit suction path (31) (Weber embodiment of Figs. 10 or 11) and a skin contact member (421) configured to contact and form a seal with the breast (Weber ¶ 0085), the skin contact (421) including a nipple receiving portion (42) sized and shaped to receive a portion of a tissue of the breast (Weber ¶ 0084); wherein upward suction in a portion of the nipple receiving portion (42) directs at least a portion of pumped milk generally upward relative to a bottom portion of the skin contact member (421) for extraction through the conduit suction path (31) positioned above the nipple receiving portion (42) (Weber ¶ 0092-0094; Figs. 8 and 10-11).
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 nipple receiving portion of Khalil such that upward suction in a portion of the nipple receiving portion that is sized and shaped to receive a portion of a tissue of the breast directs at least a portion of pumped milk generally upward relative to the bottom portion of the skin contact member as disclosed by Weber for extraction through a conduit suction path positioned above the nipple receiving portion (Weber ¶ 0092-0094; Figs. 8 and 10-11 - wherein the conduit suction path of Khalil leading to the duckbill valve could be positioned above the nipple receiving portion for purposes of ergonomics or shaping of the breast profile of the device).
Khalil fails to teach the nipple receiving portion is positioned below a center of the shell
so that the breast pump system rides in a higher position relative to the breast. Pacini teaches a
breast shield (1) comprising a shell (3) and nipple receiving portion (22), the nipple receiving
portion (22) is positioned below a center of the shell (3) (Pacini Fig. 2) for aligning the mother's
nipple when the breast shield is placed on the breast (Pacini ¶ 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 nipple receiving portion of Khalil to be positioned below a
center of the shell as disclosed by Pacini for aligning the mother's nipple when the breast shield
is placed on the breast (Pacini ¶ 0020), the modification of Khalil via the teaching of Pacini
resulting in the breast pump riding in a higher position relative to the breast.
Finally, Khalil in view of in view of Pirzada, Weber and Pacini fail to explicitly teach the power source contained within the shell being a battery. Myers teaches a breast pump system (Myers Fig. 5) comprising a shell (12) and a battery (26) contained within the shell (12) for wireless, hands-free power of said breast pump system (Myers ¶ 0048-0049). 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 power source in the breast pump system of Khalil in view of in view of Pirzada, Weber and Pacini be a battery contained within the shell as disclosed by Myers for wireless, hands-free power of said breast pump system (Myers ¶ 0048-0049).
PNG
media_image1.png
644
489
media_image1.png
Greyscale
PNG
media_image2.png
673
541
media_image2.png
Greyscale
Re Claim 17, Khalil in view of in view of Pirzada, Weber and Pacini above, and further in view of Myers teach all of the limitations of Claim 13. Khalil further teaches wherein the breast pump system defines a generally breast shape (as seen in Khalil Figs. 9 and 10).
Re Claim 18, Khalil in view of in view of Pirzada, Weber and Pacini above, and further in view of Myers teach all of the limitations of Claim 17. Khalil further teaches wherein the milk collection container (7') forms part of the generally breast shape of the breast pump system (as seen in Khalil Figs. 9 and 10).
Re Claim 19, Khalil in view of in view of Pirzada, Weber and Pacini above, and further in view of Myers teach all of the limitations of Claim 18. Khalil further teaches wherein the milk collection container (7') has a valve (5) (Khalil ¶ 0069).
Claims 14 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Khalil et al. (USPGPub 2013/0023821) in view of Pirzada et al. (USPGPub 2015/0112298), Weber et al. (USPGPub 2012/0277728), and Pacini (USPGPub 2009/0194116) above, and further in view of Myers et al. (USPGPub 2002/0193731) as applied to Claim 13 above, and further in view of Quackenbush et al. (USPG Pub 2008/0255503).
Re Claim 14, Khalil in view of in view of Pirzada, Weber and Pacini above, and further in view of Myers teach all of the limitations of Claim 13. Khalil in view of Pirzada, Weber and Pacini above, and further in view of Myers fail to teach wherein the breast pump system includes a letdown mode and an extraction mode. Quackenbush teaches a wearable, portable self-powered breast pump system (Quackenbush Abstract; Fig. 1) for pumping milk from a breast wherein the breast pump system includes a letdown mode and an extraction mode (Quackenbush ¶ 0016) for reaching a maximum negative pressure, and then a desired minimum negative pressure still less than ambient, without the need to return to atmospheric pressure for successful milk expression for improved comfort to the nursing mother in that the reciprocation of a breast or nipple within the breastshield is minimized (Quackenbush ¶ 0013).
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 breast pump system of Khalil in view of in view of Pirzada, Weber and Pacini above, and further in view of Myers to include a letdown mode and an extraction mode as disclosed by Quackenbush for reaching a maximum negative pressure, and then a desired minimum negative pressure still less than ambient, without the need to return to atmospheric pressure for successful milk expression for improved comfort to the nursing mother in that the reciprocation of a breast or nipple within the breastshield is minimized (Quackenbush ¶ 0013).
Re Claim 16, Khalil in view of in view of Pirzada, Weber and Pacini above, and further in view of Myers as applied to Claim 13 above, and further in view of Quackenbush teach all of the limitations of Claim 14. Khalil further teaches a controller (control system) (Khalil ¶ 0068). Khalil fails to teach the controller configured to change a pumping magnitude upon a predetermined time. Quackenbush teaches the wearable, portable self-powered breast pump system (Quackenbush Abstract; Fig. 1) comprising a controller (220) configured for comfort to the nursing mother (Quackenbush ¶ 0013). 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 in view of Pirzada, Weber and Pacini above, and further in view of Myers as applied to Claim 13 above, and further in view of Quackenbush to be configured to change a pumping magnitude upon a predetermined time as disclosed by Quackenbush for comfort to the nursing mother (Quackenbush ¶ 0013).
Response to Arguments
Applicant's arguments filed 07/21/2022 have been fully considered but they are not persuasive. On Page 5 of the response, applicant argues Claim 13 has been amended and the prior art fails to teach wherein the rigid nipple receiving portion includes a first end and a second end formed from a single piece, the first end defining an opening for the breast and the second end in line with and opposite the first end and defining a closed end.” Applicant goes on to argue that the arrangement “allows for the easy cleaning and assembly of the breast pump. It is respectfully submitted that the cited prior art does not disclose such subject matter.” It would seem the breast pump would be easier to clean where it were of multi-piece construction. Regardless, examiner concedes that prior art Khalil in view of Khalil in view of in view of Pirzada, Weber and Pacini above, and further in view of Myers fail to teach “the first end and the second end are formed from a single piece.” However, one piece construction is merely a matter of obvious engineering choice and cannot form the grounds for the present case to be found allowable over the prior art. Examiner is available for interview at applicant’s leisure.
Conclusion
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.
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, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM R FREHE/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
