Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Status
2. This Office Action is in response to the amendment filed on 25 September 2023, wherein Applicant amended claims 3-4 and maintained claims 1-2 and 5-6.
Claims 1-6 are being considered.
Information Disclosure Statement
3. The information disclosure statements (IDS) submitted on 11 October 2023, 22 March 2024, and 21 November 2025, were filed after the mailing date of the Instant Application on 25 September 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
4. Claim 1 is objected to because of the following informalities: Examiner recommends changing “comprises” to “comprising” for clarity. Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
6. Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “acid-resistant” in claims 1 and 6 is a relative term which renders the claim indefinite. The term “acid-resistant” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 3-5, which depend on claim 1, are similarly rejected.
The term “strong acid” in claim 4 is a relative term which renders the claim indefinite. The term “strong acid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 5, which depends on claim 4, is similarly rejected.
Regarding claim 6, it is unclear what the term “purifying” means. Simply supplying the apparatus with alkaline solution does not purify microorganisms, so it is not clear what the step needs. Examiner is interpreting step as cleaning the membrane.
Regarding claim 1, the pores and surface are worded in a way where it can be interpreted to be a limitation of the membrane or the membrane filtration apparatus. Examiner is interpreting these characteristics as limitations of the membrane and not on another part of the apparatus. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.").
Claims 2-5, which depend on claim 1, are similarly rejected.
Claim Rejections - 35 USC § 103
7. 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 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.
8. Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kitade (JP 2007098321 A; published 19 April 2007) in view of TORAY (TORAY Pressurized PVDF Hollow Fiber Membrane Module “TORAYFIL™” Instruction Manual, Model: “HFU-2020HN”, October 2016), Boo (Environ. Sci. Technol., 20 October 2016, 50: 12275-12282), and Lenntech (Lenntech, Molecular weight cutoff (MWCO)).
Regarding claims 1-2, Kitade teaches a membrane filtration apparatus (Best Mode, ¶ 1) using an external pressure PVDF precision hollow fiber membrane module HFS-1010 (manufactured by Toray Industries, Inc.) (Example 1, ¶ 1). Kitade does not explicitly teach the membrane characteristics. However, TORAY teaches a PVDF hollow fiber membrane module HFU-2020HN, wherein the cleaning pH range is between 0-12, the operating pH range is from 1-10, and the MWCO is 150,000 (Pages 10-11). Thus, it is clear that the material is acid resistant owed to safe cleaning and operating acidic pHs. Since there is a permissive molecular weight (below 150,000), pores must be present. PVDF membranes are negative at a neutral to alkaline pH, as evidenced by Boo: “The control PVDF substrate was found to be negatively charged over the entire pH range investigated, consistent with other reported data. […] Zeta potential of the PVDF substrate became more negative and stable over the whole pH range after treatment with alkaline solution (7.5 M NaOH).” (Results and Discussion, ¶ 3. In addition, a MWCO of 150,000 will filter out microorganisms, as evidenced by Lenntech, which details that ultrafiltration MWCO ranges from 1-500 kDa and rejects “suspended solids, bacteria, viruses, colloidal silica, polypeptides, proteins, antibiotics, etc.”.
Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the apparatus of Kitade and replace the Toray HFS-1010 filter with a Toray HFU-2020HN filter as they are both PVDF hollow fiber membranes used in water filtration. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). One of ordinary skill in the art would have had a reasonable expectation of success for using the methods of Kitade and replacing the filter with a similar one from the same brand. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 3, the TORAY filter discussed above is a “hallow fiber membrane module”, wherein the membrane is housed inside a module that is pressure-resistant up to the maximum inlet pressure of 600 kPa (Page 11) and maximum trans-membrane pressure of 300 kPa (Page 10), which reads on a pressure-resistant pressure vessel that houses the membrane, as claimed.
9. Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kitade (Supra) and TORAY (Supra), Boo (Supra), and Lenntech (Supra), as applied to claims 1-3 above, and further in view of Iwai (JP 2016203034 A; published 08 December 2016).
Regarding claims 4-5, Kitade in view of TORAY makes the limitations of claim 1 obvious, as seen above in section 8. Kitade further teaches the apparatus below (FIG. 1 & Best Mode, ¶ 2-6):
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wherein seawater or brine is stored in tank 10 (sample water supply) and supplied to membrane module 2 via pump 1, which is connected by pipes (which reads on the upstream pipe configured to supply the sample water), as seen in the figure above. Tanks 7 and 5 hold an alkaline solution and acid solution, respectively. These solutions are used with the water in tank 3 to backwash the membrane module 2 and are connected via pipe 11 (which reads on the washing solution supply pipe). Tank 3 is the collection container as it holds the filtrate, the water after it undergoes filtration through the membrane module 2. Part of this filtrate is mixed with the alkaline or acid solution when backwashing occurs. The backwash water is discharged out of the system via one of the pipes (which reads on the outlet to discharge fluid externally) on the raw water side of membrane module 2. The membrane filtration apparatus made obvious by Kitade, TORAY, Boo, and Lenntech would be the membrane module 2. Kitade does not disclose the sample water, acid tank, and alkaline tank all being upstream and in parallel. However, Iwai teaches this apparatus for wastewater treatment (Abstract & FIG. 2):
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wherein 50 is the sample water input stream, tank 90 stores a hypochlorite (basic) aqueous solution, and tank 92 stores an acid aqueous solution (Membrane separation activated sludge treatment system). 90 and 92 are parallel. All three of these streams are upstream of the membrane module 35, activated sludge treatment apparatus 30, and the tank main body 31 (Membrane separation activated sludge treatment equipment). Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the apparatus of Kitade and further use the design of Iwai with respect to certain pieces to place the acid solution tank, alkaline solution tank, and sample water all upstream of the membrane, as well as making the acid and alkaline solution tanks in parallel with each other. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Neither of the references teach all three input streams in parallel. However, it would have been obvious to make the sample water supply, acid solution tank, and alkaline solution tank in parallel so that they all flow through one input pipe to the membrane. This is advantageous in that the amount of piping used will be minimized, thus saving economy and construction labor. Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, F.). The results are predictable since the obvious apparatus with upstream parallel inputs can each still contact the filter.
One of ordinary skill in the art would have had a reasonable expectation of success for taking the apparatus of Kitade, further using the design of Iwai to modify the acid tank and alkaline tanks to be upstream, and putting the tanks and the supple sample stream in parallel for cost-effectiveness. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claim 6, Kitade, TORAY, Boo, Lenntech, and Iwai make the concentration apparatus obvious, as seen above. As discussed above, Kitade also teaches filtering the sample water with the membrane filtration apparatus, acid washing, and supplying the alkaline solution to the membrane. While Kitade teaches washing, they do not explicitly teach having multiple acid washing steps. However, TORAY further teaches “In the case of cleaning with acid and with sodium hypochlorite alternatively, rinse the cleaning line and the module with clean water thoroughly after each cleaning.” (Page 30). “Alternatively” implies that the acid and base washes can be done one after each other, so long as the line and module are rinsed with water between washes. In addition, cleaning the membrane module an additional time with acid should not impact the outcome of the process. Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the acid and alkaline tanks of Kitade, and further apply the method of TORAY to alternate between acid and base washes, as claimed. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). One of ordinary skill in the art would have had a reasonable expectation of success for taking the apparatus of Kitade and applying the method of alternating acid and alkaline washes of TORAY. There would have been a reasonable expectation of success given the underlying materials and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Double Patenting
10. 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.
11. Claims 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 12 of copending Application No. 18/274,490 in view of Kitade (JP 2007098321 A; published 19 April 2007), TORAY (TORAY Pressurized PVDF Hollow Fiber Membrane Module “TORAYFIL™” Instruction Manual, Model: “HFU-2020HN”, October 2016), Boo (Environ. Sci. Technol., 20 October 2016, 50: 12275-12282), Lenntech (Lenntech, Molecular weight cutoff (MWCO)), and Iwai (JP 2016203034 A; published 08 December 2016) as discussed above in sections 8-9.
Claim 1 of ‘490 recites a concentration apparatus comprising a negatively charged membrane, a sample water supply disposed upstream of the membrane, an acidic solution storge tank disposed upstream and in parallel with the sample water supply, an alkaline solution storage tank disposed upstream and in parallel with the sample water supply and acid solution storage tank, a first solenoid valve disposed on the flow path from the sample water supply to the membrane, an outlet disposed downstream of the membrane and operable to discharge fluid externally, and a collection container disposed downstream of the membrane and in parallel with the outlet and configured to collect fluid. Claim 1 of ‘490 does not discuss the membrane filtration apparatus or a washing solution tank/supply pipe. However, this claim in view of Kitade, TORAY, Boo, Lenntech, and Iwai make claims 1-5 of the Instant Application obvious, as discussed above in sections 8-9.
Claim 12 of ‘490 recites the concentration apparatus as discussed above, but further discloses a concentration method where solenoid valves are opened and closed. While not explicitly stated in the claims, the first step of opening valve 1 and 4 and closing the others drives the sample water through the membrane, the second step of opening valve 2 and 4 and closing the others will push the acid solution through the membrane, and the third step of opening valve 3 and closing the others will push the alkaline solution through the membrane. Claim 12 of ‘490 does not explicitly talk about a wash step. This claim in view of Kitade, TORAY, Boo, Lenntech, and Iwai makes claim 6 of the Instant Application obvious, as discussed above in section 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
12. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671