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 .
Status of the Claims
The amendment filed 03/24/2026 has been entered. Claims 1 and 3-18 are pending and under consideration.
Specification
The amendment filed 03/21/2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: The incorporation by reference of the international patent application PCT/EP2022/076458 and of the patent application EP 21198395.2 is ineffective as it was added on the date of entry into the national phase, which is after the filing date of the instant application. The filing date of this national stage application is the filing date of associated PCT, in this case 09/22/2022, see MPEP 1893.03(b). Therefore the specification amendment of 03/21/2024 to include the incorporation by reference is new matter, per MPEP 608.01(p).
Applicant is required to cancel the new matter in the reply to this Office Action.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim1 of U.S. Patent No. 9265875 (hereinafter ‘875) in view of Hilal-Alnaqbi et al (US 20130333178 A1).
The differences between present claims and the patented claims do not identically recite each element of current claims (e.g., using substantially similar but not identical terms; different elements are in different claims; and/or different combinations of elements).
Regarding claim 1, ‘875 teaches the claim 1 as claimed except for conducting the separated plasma through a plasma-permeable hollow fiber filter and wherein step (b) is conducted as a dead-end filteration.
In the same field of endeavor, namely a serviceable bioreactor, Hilal-Alnaqbi teaches conducting the separated plasma through a plasma-permeable hollow fiber filter ([0050-0051]), and blood or plasma can be cleaned by a cleaner comprising a cell culture by dead-end filteration ([0028]).
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 modified Mitzner to incorporate the teachings of Hilal-Alnaqbi and provides the step (b) as claimed for the purpose of enabling the plasma diffuses through the membrane such that the plasma can be substantially cleaned as taught by Hilal-Alnaqbi ([0009]).
Claim Objections
Claim 4 and 7 are objected to because of the following informalities:
Claim 4 recites “the method of claim 1 of claims 1-3”, which should read “the method of claim 1”
Claim 7 recites “the inner surface of the hollow fibers” which should read “an inner surface of the hollow fiber filter”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9, 10, 13 and 15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The disclosure of the foreign priority application the claimed subject matter of claims 9, 10, 13 and 15 are not described and/or claimed in the foreign priority application EP 21198395.2 filed 03/21/2024. Accordingly the claimed are rejected under112 (a).
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.
Claims 1-18 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.
Claim 1 recites the limitation "the removal of toxic or inflammatory compounds from blood plasma and/or the supplementation of blood plasma with immunologically active proteins" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation is being interpreted as “a removal of toxic or inflammatory compounds from blood plasm and/or a supplementation of blood plasma with immunologically active proteins”.
Claim 1 recites “step (b)” in liens 9 and 10. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation is being interpreted as “the step (b)”
Claim 4 recites wherein the hollow fiber filter comprises 1 x 1010 to 1 x 1010 granulocytes, which renders the claim indefinite. For instance, t is not clear if the granulocytes refers to the immune cells previously recited in claim 1 or to an additional element. For the purpose of compact prosecution, the limitation is being interpreted as wherein the immune cells comprises 1 x 1010 to 1 x 1010 granulocytes.
Claim 6 recites “wherein less than 50%, preferably less than 10%, and more preferably less than 1% of the cells located on the hollow fiber filter are erythrocytes.”, which renders the claim indefinite. The recitation of the broad range, i.e., less than 50%, followed by the narrower range “preferably less than 10%”, is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of compact prosecution, the limitation is being interpreted as “wherein less than 50% of the immune cells located on the hollow fiber filter are erythrocytes”
Claim 9 recites “a donor that has survived one or more infections, infectious disease and/or immunological diseases” It is not clear if the claim encompasses any donor who survives, regardless of whether the donor has experienced the recited infection or disease, or only a donor who was infected with or affected by one or more of the recited infections and/or diseases and subsequently survived from the condition(s). Accordingly, the metes and bounds of the claim cannot be determined. For the purpose of compact prosecution, the limitation is being interpreted as any living donor regardless of they are affected by the claimed condition.
Claim 13 recites “wherein the immune cells are derived form different donors”, which renders the claim definite. For instance, it is not unclear whether “different donors” refers donors different from the patient or multiple distinct donors from whom the immune cells are obtained. For the purpose of compact prosecution, the limitation is being interpreted as wherein the immune cells are derived from a donor.
Claim 14 recites “step (b)” and “step (c)’ in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation is being interpreted as “the step (b)” and “the step (c)” respectively. Furthermore claim 14 recites “e.g., due to a membrane rupture of said plasma-permeable hollow fiber filter”, which renders the claim indefinite as it is not clear if the limitation following “e.g” is a merely exemplary of the remainder of the claim and therefore not required or a required feature of the claim. For the purpose of compact prosecution, recites “e.g., due to a membrane rupture of said plasma-permeable hollow fiber filter” is considered optional, and therefore does not limit the scope of the claim.
Claim 15 recites “step (a)” There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation is being interpreted as “the step (a)”
Claim 16 recites “use of plasma-permeable hollow fiber filter with immune cells located thereon”, which renders the claim indefinite. Specifically, the preambles sets forth a method of using filter with immune cells, while the body of the claim does not positively recite any step involving use of the hollow fiber filter, but instead merely recites “the ex vivo treatment of immunologically dysfunctional blood”. It is unclear whether use of the hollow fiber filter is a required limitation of the claimed method. For the purpose of compact prosecution, the claim is interpreted under the broadest reasonable interpretation, however appropriate correction is required.
Furthermore, Claim 16 recites “the ex vivo treatment of an immunological dysfunction of blood” There is insufficient antecedent basis for this limitation in the claim. For the purpose of compact prosecution, the limitation is being interpreted as “ex vivo treatment of an immunological dysfunction of blood”
Dependent claims are rejected for at least being depend from independent claims 1 or 16.
Examiner’s note: The above noted informalities should not be taken as an exhaustive list of all such instances. Therefore, it is requested that Applicant review the claims in their entirety for compliance with 35 U.S.C. 112(b)
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitzner (US 20110042313 A1).
Regarding claim 16, Mitzner teaches use of plasma-permeable hollow fiber filter with immune cells located thereon for
(a) ex vivo treatment of an immunological dysfunction of blood([0001]),
(b) removing toxic or inflammatory compounds from blood plasma and/or supplementing blood plasma with immunologically active proteins, or
(c) producing a blood sample depleted of toxic or inflammatory compounds and/or supplemented with immunologically active proteins.
Regarding claim 17, Mitzner further teaches wherein the immune cells comprises granulocytes, monocytes, macrophage and/or lymphocytes (Mitzner; [abstract] modified blood comprises granulocytes)
Regarding claim 18, Mitzner further teaches wherein the plasma-permeable hollow fiber filter has an average pore size of 0.5 um or less (Mitzner; [0043] membrane has an average pore diameter of about 0.2 um).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1, 3, 4-6, 8-11 and 13-15 are rejected under 35 U.S.C. 103 as obvious over Mitzner (US 20110042313 A1) in view of Hilal-Alnaqbi et al (US 20130333178 A1).
Regarding claim 1, Mitzner teaches ex vivo method for the treatment of an immunological dysfunction of blood, a removal of toxic or inflammatory compounds from blood plasma and/or a supplementation of blood plasma with immunologically active proteins, said method comprising the steps of:
(a) extracorporeally separating at least part of the plasma from blood obtained from a patient suffering from an immunological dysfunction of the blood ([0041] separating plasma from patient’s blood),
(b) conducting the separated plasma through a plasma-permeable hollow fiber filter comprising immune cells located thereon such that the plasma comes into contact with the immune cells (figure 1 [0047-0051 and 0080-0082] conducting the patient’s plasma with bioequivalent along the hollow-fiber membrane plasma filter 10 comprising the bioequivalent, e.g., granulocytes, thrombocytes and erythrocytes), and
(c) returning the plasma obtained from the step (b) to the blood (figure 1 [0047-0051 and 0080-0082], returning treated plasma to patient along tubing 1).
Mitzner does not expressly teach wherein the step (b) is conducted as a dead-end filtration.
In the same field of endeavor, namely a serviceable bioreactor, Hilal-Alnaqbi teaches a substance comprising blood or plasma can be cleaned by a cleaner comprising a cell culture by dead-end filteration ([0028]).
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 modified Mitzner to incorporate the teachings of Hilal-Alnaqbi and provides the step (b) as claimed for the purpose of enabling the plasma diffuses through the membrane such that the plasma can be substantially cleaned as taught by Hilal-Alnaqbi ([0009]).
Regarding claim 3, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein the immune cells comprises granulocytes, monocytes, macrophages and/or lymphocytes (Mitzner; [abstract] modified blood comprises at least granulocytes).
Regarding claim 4, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination does not expressly teaches wherein immune cell comprises 1 x 1010 to 1 x 1011 granulocytes;
though Mitzner teaches providing bioequivalent comprises at least 0.2-100 x 1010 granulocytes per L (Mitzner; [0023-0025] and claim 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified 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 modified Mitzner, as modified by Hilal-Alnaqbi, and provides Granulocytes as claimed since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” (MPEP 2144.05(I)). In the instant case, the applicant has not shown unexpected result gleaming from the claimed range (specification [0036-0037]), and therefore the claimed device is not patentably distinct from the prior art.
Regarding claim 5, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein the immunological dysfunction of the blood is associated with sepsis or a septic shock (Mitzner; [0066-0067]).
Regarding claim 6, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein less than 50% of the immune cells located on the hollow fiber filter are erythrocytes (Mitzner; [0066-0067] the bioequivalent comprises 0.2-100 x 1010 granulocytes per L, 1 x 109 thrombocytes per L and 1 x 109 erythrocytes per L, wherein the erythrocytes constitutes approximately 0.1% to 25% of the total cells in the bioequivalent).
Regarding claim 8, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein the immune cells are derived from a healthy donor (Mitzner; [0035]).
Regarding claim 9, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein the immune cells are derived from a donor that has survived one or more infections, infectious diseases and/or immunological diseases (Mitzner; [0035] healthy donors).
Regarding claim 10, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches the immune cells are derived from a lymphocyte concentrate or a mononuclear cell (MNC) concentrate of a donor
Regarding claim 11, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein the plasma- permeable hollow fiber filter has an average pore size of 0.50 um or less (Mitzner; [0043] membrane has an average pore diameter of about 0.2 um).
Regarding claim 13, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein the immune cells are derived from a donor (Mitzner; [0043]).
Regarding claim 14, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein subsequent to step (b) and prior to step (c) the plasma is conducted through a further filter to remove any residual cells from the plasma (Mitzner; figure 1 and [0082] the treated plasma is conducted through the cell filter 11 to remove cells of bioequivalent).
Regarding claim 15, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination further teaches wherein the separation of the plasma from blood in the step (a) is performed by centrifugation (Mitzner; [0041])
Claim 7 is rejected under 35 U.S.C. 103 as obvious over Miztner (US 20110042313 A1) in view of Hilal-Alnaqbi et al (US 20130333178 A1), and in further view of Rossini (US 5026365 A).
Regarding claim 7, Mitzner, as modified by Hilal-Alnaqbi, teaches the method of claim 1.
The combination does not expressly teach wherein the immune cells are located at an inner surface of the hollow fiber filter;
though Mitzner teaches the hollow fiber filter retain the cells of the bioequivalent ([0082]).
In the same field of endeavor, namely a method and apparatus for therapeutically treating immunological disorders, Rossini teaches wherein the immune cells are located at an inner surface of the hollow fiber filter (figures 3 and 4, leukocyte suspensions 94 located within the hollow fiber filter 92).
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 modified Mizner, as modified by Hilal-Alnaqbi, to incorporate the teachings of Rossini and provides the immune cells located at an inner surface of the hollow fiber filter for the purpose of enabling the release of secretory products from the immune cells into the plasma through the hollow fiber membrane, wherein the secretory product act as therapeutic agents to cure immunological disorder or diseases and aid in preventing further injury to the cells and tissues of the affected individual as taught by Rossini (col 8 line 60 col 9 line 57). One of skill in the art motivated to do so for the purpose of delivering therapeutic factors secreted by the immune cells to the patient’s plasma while retaining the immune cells within the hollow fiber filter, thereby reducing the likelihood of allogeneic reactions associated with the patient exposed to the foreign immune cells.
Allowable Subject Matter
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Prior art, alone or in combination, could be found to teach “(a) extracorporeally separating at least part of the plasma from blood obtained from a patient suffering from an immunological dysfunction of the blood, (b) conducting the separated plasma through a plasma-permeable hollow fiber filter comprising immune cells located thereon such that the plasma comes into contact with the immune cells, wherein step (b) is conducted as a dead-end filtration, and (c) returning the plasma obtained from step (b) to the blood; (Claim 12) “wherein the method does not comprise a circulation of the immune cells”
The closest prior art Mitzner teaches the method as claimed except for the method does not comprises a circulation of the immune cells. Rather, Mitzner relies on circulating the immune cells along the plasma-permeable hollow fiber filter (figure 1 and [0081]). The examiner did not find any teachings/motivation to modify the device to incorporate the claimed limitation above. There is not an apparent/obvious reason/motivation for this modification as this modification increases the complexity of the system in the prior art in terms of structure, function, and design without an improvement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SETH HAN whose telephone number is (571)272-2545. The examiner can normally be reached M-F 0900-1700.
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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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/SETH HAN/Examiner, Art Unit 3781
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