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 .
Claims 1-2 are under examination.
Response to Applicants Arguments/Amendments
The claims have been amended to clarify that the cell population is present in a sodium chloride solution. The claim amendment results in the withdraw of all the previously made rejections (112(a) enablement, 112(b), 112(d), and 102(a)(1)). The claims now recite a viable population of cells in a sodium chloride carrier solution.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more. The claims recite a composition of CD3+,CD4+,CD25+, CD127- T regulatory cells in a 0.9% sodium chloride solution.
The 101 analysis will be conducted using the 2019 Revised Patent Subject Matter Eligibility Guidance Analysis.
Step 1: Is the claim drawn to a process, machine, manufacture, or composition of matter?
Answer: The claim is drawn to a composition of CD3+CD4+CD25+CD127- T regulatory cells in a 0.9% sodium chloride solution.
Step 2A (Prong One)—Does the claim recite an abstract idea, law of nature, natural product, or a natural phenomenon which constitutes a Judicial Exception?
The composition is a natural product because the claimed regulatory T cells are T cells that have not been structurally and/or functionally altered so they represent a natural product. Furthermore, sodium chloride in a solution which can include water can be considered a natural product (salt water). Therefore, the recited composition is a judicial exception (natural product).
Step 2A (Prong Two)—Does the claim recite additional elements that integrate into a practical application?
The claims recite that the composition is composed of a population of CD3+CD4+CD25+CD127- T regulatory cells and a .9% sodium chloride solution. The components recited in the instant claims do not differ structurally and/or functionally from the natural counterparts existing in nature. The components of the claimed composition have not had their structures/function changed in such a way that would allow the components to function differently or to have a different application. The claims fail to integrate the natural product in a meaningful way that further limits the scope of the natural product in a manner that does not monopolize the natural product (CD3+CD4+CD25+CD127+ T regulatory cells and sodium chloride in a solution including salt water). The claimed composition is not markedly different from its naturally-occurring counterparts because there is no indication that the composition have any characteristics or properties that are different from the naturally-occurring counterparts (including the natural components found therein). Therefore, the claims do not recite elements that integrate the natural product into a practical application.
Step 2B—Does this claim recite additional element that amount to significantly more than the judicial exception?
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements that change the structure/function of either the solution components or the composition itself. The claims recite that only a specific population of regulatory T cells and a .9% sodium chloride solution is present. Solution is a broad term and can mean any solution that includes .9% sodium chloride including water which is a naturally occurring product. Although the solution imparts a structural distinction to a component recited in the claim language, the claim language fails to impart a structure or function to the components that transform the solution from a solution such as saline water or salt water that is naturally occurring in the environment. Furthermore, the structure or function of the T regulatory cells is not changed by the presence of the sodium chloride solution. Both the cells and the sodium chloride solution are not markedly different from their naturally occurring counterparts because there is no indication that the components have any characteristics or properties that are different from the naturally-occurring counterparts.
The instant claims do not amount to significantly more than the judicial exception because the structure and/or the function of the regulatory T cells and the sodium chloride solution do not amount to more than the judicial exception. The T cells and the sodium chloride solution are not altered by being mixed with one another or changed when placed into a solution. The claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences (properties and/or characteristics) when compared to the naturally-occurring counterparts (see, e.g. Diamond v. Chakrabarty, 447 U.S. 303 (1980)). Please note that combining natural extracts (such as from two or more plants) does not remove the claims from reading upon a judicial selection (Funk Brothers Seed Co. v. Kalo Inoculant Co.-333 U.S. 127 (1948)) because again there is no evidence of a marked difference brought about by combing the instantly clamed herbal extracts. Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter.
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 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.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Merek-Trzonkowska (WO2017105265) in view of Winqvist (US 20100015161)
Marek-Trzonkowska discloses a medicinal product consisting of CD3+CD4+CD25+CD127-T regulatory cells in a carrier (Page 13—Cell Populations sorted by FACS are typically suspended in a saline solution and/or salt solution). These cells are capable of being used for clinical treatment for multiple sclerosis (Page 1), and the cells can be administered intrathecally (Page 1) as in instant Claim 1-2
Marek-Trzonkowska does not teach that the CD3+CD4+CD25+CD127-T regulatory cells can be suspended in a solution of .9% sodium chloride. However, Winqvist discloses that such cells can be successfully suspended in .9% sodium chloride solution (Paragraph 98 of Winqvist). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have suspended the cells in .9% sodium chloride solution as taught by Winqvist. An artisan would have been motivated to have used .9% sodium chloride solution because it can maintain the viability and characteristics of cells that are administered into the body as a therapy (Paragraph 98 of Winqvist). Because a .9% solution of sodium chloride can be successfully used to deliver viable cells (Paragraph 98 of Winqvist), there would have been a high expectation for success. Winqvist also teaches intrathecal administration (Paragraphs 81-82) as in instant Claims 1-2. The instant claims state that the only two ingredients present are CD3+CD4+CD25+CD127- T regulatory cells and 0.9% sodium chloride solution. The composition claims also recite a method of administration and a disorder treated; however, these intended use limitations do not further limit the composition structurally and/or functionally.
Marek-Trzonkowska teaches a population of regulatory T cells that can be administered to treat conditions such as multiple sclerosis. Marek-Trzonkowska does not teach the specific carrier recited in the claims. However, an artisan would have been motivated to have used Winquist’s .9 % sodium chloride carrier since it is able to keep the therapeutic cells alive and preserve their important characteristics. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicant’s invention, it must be considered, absent evidence to the contrary, that the skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the clamed elements were known in the prior art, and one skilled in that art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predicable results to one of ordinary skill in the art at the time of the invention (See KSR International Co. v. Teleflex Inc., 82 USPQ 2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in immunotherapy. Therefore, the level of ordinary skill in the art is high.
Response to Applicants Arguments
The former art rejection is withdrawn and a new rejection has been put forward to address the new claim limitations.
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.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of copending Application No. 18,588,535 (reference application) in view of Winqvist (US 20100015161). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 7 of Application 18,588,535 recites the claimed cell population in the instant set of claims and Winquist recites a .9% sodium chloride solution that the cells can be placed in.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,944,672 in view of Winqvist (US 20100015161). Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 11,944,672 recites the administration of the claimed population of CD3+CD4+CD25+CD127- Treg cells and Winquist recites a .9% sodium chloride solution that the cells can be placed in. The patent’s T reg cells are the same T reg cells claimed in the instant set of claims.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 19/407,506(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method claims recite a composition that includes CD3+CD4+CD25+CD127- T regulatory cells and a .9% sodium chloride formulation which is recited in the instant set of claims. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants argue that the nonstatutory double patenting rejections regarding Application 18,588,535 and Patent 11,944,672 are incorrect because they are associated with diabetes and not multiple sclerosis as recited in the instant set of claims. The examiner was unpersuaded by this argument because a cell composition is being claimed and not a method of using a cell population to treat a specific disease or disorder; the intended use does not impact the structure/function of the claimed composition. Nonstatutory double patenting rejections are still appropriate because the same composition as claimed is recited in the claims of Patent 11,944,672 and Application 18,588,535.
Conclusion
All claims stand rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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