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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the in vivo treatment method and apparatus of claims 21 and 22 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 21 and 22 are 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. While the Specification contains adequate description of an ex vivo blood treatment system and method, there is no description in the Specification for such a method to be carried out in vitro, or within the human body. No blood connections, implantable filters, or pumps are disclosed or described. Since the Specification lacks any such description, the Examiner has determined that the Inventor did not, at the time of filing, have possession of an in vitro blood treatment method.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-9, 23-27, are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 8,480,607 to Davies et al.
In the specification and figures, Davies discloses the method as claimed by Applicant. With regard to claims 1, 23-26, Davies discloses a method of treating a patient comprising selectively removing albumin from the blood of an individual, selectively removing endotoxin from the blood of an individual, wherein the albumin removal may be via dialysis using a 50 kDa pore membrane (see column 1, lines 52-55, column 6, lines 60-67). The step of selecting a patient based on their current condition (see also claims 23-26) is a mental step performed by a practitioner. As such, the selection step is not eligible for patent protection and does not patentably distinguish the claim from the cited prior art.
With regard to claim 2, Davies discloses that the albumin may be removed by membrane dialysis, while the endotoxins may be removed via affinity binding (see column 6, lines 60-67, column 9, lines 8-25).
With regard to claim 4, Davies discloses that the method includes the removal of albumin-bound toxins (see column 4, lines 50-53).
With regard to claim 5, Davies discloses the use of a solid support capable of selectively binding albumin (see column 6, lines 41-55).
With regard to claim 6, Davies discloses the use of a solid support capable of selectively binding endotoxins (see column 9, lines 50-63).
With regard to claims 7-9, Davies claims an apparatus and an ex vivo method that selectively removes albumin, endotoxins, and means for supplying allogenic pharmaceutical grade albumin, where other components are returned to the patient (see claims 1, 4, 12, 17, column 12, lines 48-65).
With regard to claim 27, Davies claims a method of method of treating a patient comprising selectively removing albumin from the blood of an individual, selectively removing endotoxin from the blood of an individual, wherein the albumin removal may be via dialysis using a 50 kDa pore membrane, introducing allogenic albumin from a donor, wherein removal and introduction of albumin are carried out via dialysis (see claim 13).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 8,480,607 to Davies et al in view of US 2020/0069860 to Rammo et al.
In the specification and figures, Davies discloses the method substantially as claimed by Applicant (see rejections above). With regard to claim3, Davies does not disclose a step of cytokine removal. However, Rammo discloses a multi-component blood filtration system that comprises at least an adsorber, and a dialysis device, wherein the adsorber may be used for cytokine removal (see all FIGS, ¶0034, 0087, 0160). Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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, Brian Casler can be reached at 571-272-4956. The 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.
/LESLIE R DEAK/Primary Examiner, Art Unit 3799 27 May 2025