DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office action is in response to communications filed September 22, 2025.
Status of Claims
1. Claims 1-6 and 14 are pending and currently under consideration for patentability.
Claims 7-13 are withdrawn for being drawn to a nonelected invention and claim 14 is newly presented as of the September 22, 2025 claim amendment.
Response to Amendments
2. The claims have been amended to overcome the previously applied claim objections and 35 USC § 112(b) rejections; accordingly, these objections and rejections are withdrawn herein.
Double Patenting
3. 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.
4. Claims 1-6 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,559,617 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1-13 require at least one opening element configured to interact with a blood treatment device to remove a lid from the container, rather than at least one lever; otherwise, the claims are identical.
5. Claims 1-6 and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 12,653,935 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because patented claims 1-9 require at least one opening element configured to interact with a blood treatment device to remove a lid from the container, rather than at least one lever; otherwise, the claims are identical.
Allowable Subject Matter
6. Claims 1-6 and 14 are allowed over the prior art of record.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Namely, a non-statutory double-patenting rejection is outstanding and will require a properly filed Terminal Disclaimer prior to the claims being placed in condition for allowance.
7. The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Brehm et al. (US 2011/0125127), which teaches a container for concentrate 30 comprising a main body (31) for containing concentrate, a connection portion (6) having a flat end surface (see fig. 1-2) and configured to connect the container to a blood treatment device, two attachment elements (2, 4) arranged at two opposing sides of the connection portion and configured to reversibly attach the container to two corresponding attachment elements present on a blood treatment device (paragraph [0025]), and two connection elements (3, 5) each comprising an opening at the flat end surface of the connection portion and configured to interact with two corresponding connection elements present on a blood treatment device to fluidically couple the container with the blood treatment device by insertion of the connection elements present on the blood treatment device into the connection elements of the container (paragraphs [0019], [0032]). See Figures 1-8 and paragraphs [0011-0023].
Brehm, however, does not teach or suggest at least one lever, wherein when a lid is releasably attached to the connection portion, the at least one lever is arranged between the flat end surface of the connection portion and the lid, wherein the lever is configured to interact with a blood treatment device to remove the lid from the container.
Ramella et al. (US 2011/0137280) teaches a similar container and attachment means, but also fails to teach or suggest the claimed lid removal lever.
Instead, Brehm and Ramella teach the step of manually removing the lid of the container prior to use. It is unclear how one of ordinary skill in the art prior to the effective filing date of the instant application would have modified Brehm or Ramella to include a lid removal element that is configured to interact with an opening element on the blood treatment machine to remove the lid from the container.
Conclusion
8. 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.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781
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