Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED NON-FINAL ACTION
This is the initial Office Action (OA), on the merits, based on the 18/748,880 application filed on June 20, 2024. Claims 1-20 are pending. Claims 11-20 are examined, on the merits, in this Office action. The examined claims are directed to an apparatus.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 11-20, in the reply filed on July 30, 2026 is acknowledged. Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The Examiner has considered the information disclosure statements (IDS) submitted on 10/07/2024, 04/16/2025 and 07/23/2025. Please refer to the signed copy of the PTO-1449 form attached herewith.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. The inventive entity for a particular application is based on some contribution to at least one of the claims made by each of the named inventors. MPEP §2137.01.
Claims 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Gefroh et al. (US20200147550, Gefroh) in view of Saveliev et al. (US20090194478, Saveliev).
Note that these are apparatus claims. The analysis considers the alternate concepts of the various potential embodiments in a particular reference.
Regarding claims 11-20, Gefroh discloses a fluid filtration system (Abstract, [0002], Fig. 1, 5), comprising:
a fluid storage vessel 52 (feed tank or bioreactor);
a filter housing including a filter element 56, 210 therein ([0010], Fig. 1, 5, where a filter housing is implied; alternatively, it would have been obvious to incorporate a filter housing to protect and house the filter);
a first pump 54, 208 for transferring fluid from the fluid storage vessel to the filter housing;
a permeate pump 58 coupled to the filter housing ([0020]); and
a controller 122, 124 coupled to the first pump and the permeate pump, the controller including a processor programmed to execute instructions to:
transfer the fluid from the fluid storage vessel to the filter housing ([0067], [0068], Fig. 2);
direct the fluid through the filter element ([0067]);
remove permeate from the filter housing ([0067], [0068], Fig. 2); and
direct permeate into the filter housing ([0022]),
wherein said directing the fluid through the filter is performed concurrently with said selectively removing permeate from the filter housing ([0009], [0094], [0164], where the process is continuous).
Therefore, Gefroh discloses the claimed invention, except for explicitly describing a filter housing and all the specifics of the controller programming, including selectively removing and directing permeate from and into the filter housing, wherein said directing the fluid through the filter is performed concurrently with said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing.
Saveliev discloses a reverse osmosis system including a feed water inlet, a reverse osmosis module coupled to the feed water inlet, and at least one blend valve, where the blend valve can be coupled to a permeate outlet and the feed water inlet and can be capable of blending the feed water and the permeate water to produce mixed water (Abstract). Saveliev discloses a programmable controller executing routines to reverse a fluid pump or activate a back-flushing sequence that selectively directs collected permeate back into the filter housing to dislodge accumulated foulants ([0080], [0092]-[0094], [0103]).
When the claimed invention was effectively filed, it would have been obvious to one of ordinary skill in the art to implement the noted selective removing and directing of permeate from and into the filter housing, wherein said directing the fluid through the filter is performed concurrently with said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing to reduce membrane fouling and to optimize system performance and extend the filter lifecycles.
Additional Disclosures Included: Claim 12: The processor is programmed to execute instructions to, based on a pressure sensed by a pressure sensor disposed in a permeate line, switch between said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing (Gefroh, [0012], [0014], [0067], [0105]); Claim 13: Said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing are performed at the same flowrate (Gefroh, [0043], [0047], [0084]; Saveliev, [0084]); Claim 14: Said selectively removing permeate from the filter housing is performed at a flowrate that is different from a flowrate achieved during said selectively directing permeate into the filter housing (in the interest of optimizing the system, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attempt the same as well as different flow rates); Claim 15: A duration of said selectively removing permeate from the filter housing is controllable by a user (the controller is programmable which implies that all durations are controllable by a user; alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to program the controller such that various durations are controllable based on specific potentially variable parameters such as the nature of the filtered fluid, flow rates and vessel and filter sizes, such that a duration of said selectively removing permeate from the filter housing, a duration of said selectively directing permeate into the filter housing, and the respective durations of said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing are each controllable by a user to improve the ability to routinely experiment and thereby optimize the filtration process); Claim 16: A duration of said selectively directing permeate into the filter housing is controllable by a user (claim 15 analysis); Claim 17: The respective durations of said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing are controllable by a user (claim 15 analysis); Claim 18: The respective durations of said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing are dependent upon at least one of: a cell culture being filtered, a size of the fluid storage vessel, a size of the filter element, and a flow rate of the fluid through the filter element (claim 15 analysis); Claim 19: Said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing are performed using a permeate pump (claim 11 analysis); and Claim 20: A flowrate of the fluid through the filter element is synchronized with a flowrate of the permeate during said selectively removing permeate from the filter housing and said selectively directing permeate into the filter housing (it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to experiment with different flow rates including flowrate synchronization to maintain a stable flux and continuously balance trans-membrane pressures).
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 claims at issue 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); and 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 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-23 of U.S. Patent No. US 11,673,083 and claims 11-20 of U.S. Patent No. 12,427,454. Although the claims at issue are not identical, they are not patentably distinct from each other because the patents and application recite the same or similar limitations relating to a fluid filtration system with a fluid storage vessel, filter housing and filter element, a controller and first and permeate pumps that control the fluid flow rate through a filter housing in a specific manner.
Conclusion
Examiner recommends that Applicant carefully review each identified reference and all objections/rejections before responding to this office action to properly advance the case in light of the pertinent objections/rejections and the prior art. With respect to the patentability analysis, Examiner has attempted to claim map to one or more of the most suitable structures or portions of a reference. However, with respect to all OAs, Examiner notes that citations to specific pages, columns, paragraphs, lines, figures or reference numerals, in any prior art or evidentiary reference, and any interpretation of such references, should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably disclosed and/or suggested to one having ordinary skill in the art. The use of publications and patents as references is not limited to what one or more applicant/inventor/patentee describes as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain. MPEP §2123.
Examiner further recommends that for any substantive claim amendments made in response to this Office Action, or to otherwise advance prosecution, or for any remarks concerning support for added subject matter or claim priority, that Applicant include either a pinpoint citation to the original Specification (i.e. page and/or paragraph and/or line number and/or figure number) to indicate where Applicant is drawing support for such amendment or remarks, or a clear explanation indicating why the particular limitation is implicit or inherent to the original disclosure.
Electronic Inquiries
Any inquiry concerning this communication or an earlier communications from the examiner should be directed to Hayden Brewster whose telephone number is (571) 270-1065. The examiner can normally be reached M-Th 9 AM - 4 PM.
Alternatively, to contact the examiner, Applicant may send a communication, via e-mail or fax. Examiner’s direct fax number is: (571) 270-2065. Examiner's official e-mail address is: "Hayden.Brewster@uspto.gov." However, since e-mail communication may not be secure, Examiner will not respond to a substantive e-mail unless Applicant’s communication is in accordance with the provisions of MPEP §502.03 & related sections that discuss the required Authorization for Internet Communication (AIC). Nonetheless, all substantive communications will be made of record in Applicant’s file.
To facilitate the Internet communication authorization process, Applicant may file an appropriate letter, or may complete the USPTO SB439 fillable form available at https://www.uspto.gov/sites/default/files/documents/sb0439.pdf, preferably in advance of any substantive e-mail communication. Since one may use an electronic signature with this particular form, Applicant is encouraged to file this form via the Office’s system for electronic filing of patent correspondence (i.e., the electronic filing system (Patent Center)). Otherwise, a handwritten signature is required. In addition to Patent Center, Applicant can submit their Internet authorization request via US Postal Service, USPTO Customer Service Window, or Central Fax. Examiner can also provide a one-time oral authorization, but this will only apply to video conferencing. It is improper to request Internet Authorization via e-mail.
Examiner interviews are available via telephone, in-person, and via 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) form available at http://www.uspto.gov/interviewpractice, or Applicant may call Examiner, if preferable. Applicant can access a general list of patent application forms at either https://www.uspto.gov/patent/forms/forms-patent-applications-filed-or-after-september-16-2012 (applications filed on or after September 16, 2012) or https://www.uspto.gov/patent/forms/forms (applications filed before September 16, 2012). Note that the language in an AIR form is not a substitute for the requirements of an AIC, where appropriate. The mere filing of an Applicant Initiated Interview Request Form (PTOL-413A) or a Letter Requesting Interview with Examiner, in EFS-Web, may not apprise Examiner of such a request in a timely manner.
If attempts to reach the Examiner are unsuccessful, Applicant may reach Examiner’s supervisor, Bobby Ramdhanie at 571-270-3240. The central 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.
/HAYDEN BREWSTER/Examiner, AU 1779
Prosecution Insights