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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-13, 15, 17-19, 22, 24-26, and 28-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because independent Claim 11 could be interpreted as positively claiming “milk from a breast of a user.” Examiner recommends using terms such as ‘configured’ or ‘designed’ to modify the structure that performs the function leading to “milk from a breast of a user.” Appropriate correction and/or clarification is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 11-13, 15, 17-19, 22, 24-26 and 28-29 are rejected on the ground of nonstatutory
double patenting as being unpatentable over Claims 1-2, 5, 7-9, 12, 14-16 and 18 of USPN
10,589,009, hereinafter Patent '009, in view of Khalil et al. (USPGPub 2013/0023821).
Re Claim 11: Claims 1, 9 and 27 of Patent '009 teach all the limitations of Claim 11. Claim
1 of Patent '009 teaches an automated system for controlling pumping cycles to pump milk
from a breast of a user, the system comprising: a closed control system capable of sensing and
controlling suction pressure waveforms to optimize filling milk ducts of a user; a breast adapter
configured and dimensioned to form a seal with the breast, the breast adapter having a first
open end that receives the breast and a second end opposite the first open end; a storage
container for storing the milk pumped from the breast; a chamber positioned adjacent the
breast adapter, the chamber having a face; a conduit providing a path from the chamber to the
breast adapter near the second end of the breast adapter; and a compression member driven
by the motor, the compression member moving perpendicular to the face of the chamber to
accomplish compression and expansion of the chamber, wherein compression and expansion of
the chamber creates a suction within the conduit which is applied to an interior of the breast
adapter through the path from the chamber to the breast adapter near the second end of the
breast adapter; wherein natural physiology of producing the milk is facilitated.
Claim 9 of Patent '009 teaches a motor whereas Claim 27 of Patent '009 teaches the
compression member driven by the motor. However, the claims of Patent '009 fail to teach the
motor positioned adjacent the breast adapter. Khalil teaches a wearable breast pump system
comprising a breast adapter (1) and a motor (8'), wherein the motor (8') is positioned adjacent
the breast adapter (1), the configuration for providing a compact design with elements in a
single wearable housing (Khalil Figs. 9 and 10; ¶ 0066-0069). Therefore, it would have been
obvious to one or ordinary skill in the art before the effective filing date of the claimed
invention to have had the motor of Patent '009 be positioned adjacent the breast adapter as
disclosed by Khalil, the configuration for providing a compact design with elements in a single
wearable housing (Khalil Figs. 9 and 10; ¶ 0066-0069).
Re Claim 12: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 2 of Patent '009 teaches the automated system further comprising first and second pump systems, wherein pumping of the milk from a first breast is coordinated with pumping of the milk from a second breast.
Re Claim 13: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 1 of Patent '009 teaches structure attached to the conduit to facilitate expansion of the conduit.
Re Claim 15: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 5 of Patent '009 teaches wherein suction applied to the breast for expression of the milk comprises a first suction level, and wherein, during expulsing, a second suction level is maintained against the breast, the second suction level being lower than the first suction level, wherein the second suction level is a latch suction which is maintained throughout a pumping session.
Re Claim 17: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 7 of Patent '009 teaches a sensor that senses flow rate.
Re Claim 18: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 8 of Patent '009 teaches a display configured to display an image of a baby or project recorded sounds of the baby.
Re Claim 19: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 9 of Patent '009 teaches a sensor for tracking a position of the motor.
Re Claim 22: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 12 of Patent '009 teaches a controller, wherein the controller adaptively controls one or more of maximum suction pressure level, latch suction pressure level, suction pressure waveform over a pumping cycle, phases of extraction or feeding times, rest times, heating temperatures and times, vibration frequency and duration, and pumping session time.
Re Claim 24: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 14 of Patent '009 teaches the chamber includes a non-circular region.
Re Claim 25: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 15 of Patent '009 teaches wherein the chamber includes a section with opposing flat sections.
Re Claim 26: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the
limitations of Claim 11. Claim 16 of Patent '009 teaches a contouring shell configured to provide
an appearance of a natural breast contour when the breast adapter is sealed to the breast.
Re Claim 28: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. The claims of Patent '009 fail to teach a living gate configured to inhibit loss of the milk. Khalil teaches a wearable breast pump (Khalil Figs. 4 and 5) comprising a living gate (5), a duckbill valve, configured to inhibit loss of milk, and preventing milk from being suctioned into the pump (Khalil ¶ 0053 and 0058). 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 included with the system of Patent '009 in view of Khalil a living gate configured to inhibit loss of milk as disclosed by Khalil for preventing milk from being suctioned into the pump (Khalil ¶ 0053 and 0058).
Re Claim 29: Claims 1, 9 and 27 of Patent '009 in view of Khalil teach all of the limitations of Claim 11. Claim 18 of Patent '009 teaches wherein walls of the conduit are collapsible to suck out the milk remaining in the conduit.
Terminal Disclaimer
A terminal disclaimer may be effective to overcome a nonstatutory double patenting rejection over a reference patent (37 CFR 1.321(b) and (c)). A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional, the reply must be complete. MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/PatentForms. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/TerminalDisclaimer.
Response to Arguments
Applicant’s arguments filed 04/10/2026 with respect to claim objections and 112 rejections have been fully considered and are persuasive. Due to clarifying amendments, the claim objections and 112 rejections are hereinafter withdrawn.
As to the double patenting rejection, on Page 6 of applicant’s response, the applicant “respectfully traverses the double patenting rejections and reserves its right to file terminal disclaimers should the claims be deemed otherwise allowable.” Examiner is available at applicant’s leisure to discuss the present case during interview should applicant require.
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.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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