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 .
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 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12121544. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to “A method of treating a subject with a stroke-induced motor deficit, comprising: determining a volume of an ischemic core of the subject; and administering, to a brain region surrounding the ischemic core of the subject, a therapeutically effective amount of cells only when the volume of the ischemic core is determined to be less than 50 cubic centimeters (cc), wherein the cells are vandefitemcel, which are cells descended from mesenchymal stem cells transiently-transfected by a polynucleotide encoding a Notch intracellular domain (NICD).” while the instant claims read “A method of treating a subject following a small-volume ischemic stroke suffered by the subject, comprising: administering, to a brain region surrounding a small-volume ischemic core of the subject, a therapeutically effective amount of cells, wherein the cells are vandefitemcel, which are cells descended from mesenchymal stem cells transiently-transfected by a polynucleotide encoding a Notch intracellular domain (NICD).” while no claims are identical the elements of the instant claims are all within the patented claims therefore the patented claims clearly strongly suggest and thus make obvious the instant claimed invention.
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.
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.
Claim(s) 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Tennekoon (20040208858) and Dezawa (7682825).
Tennekon teaches a composition of cells which are MSCs differentiated into cells which can be administered to a patient to treat a stroke. The MSC cells of Tennekon are not transfected to encode NICD however a pharmaceutical composition of vandefitemcel, which are descended from mesenchymal stem cells transiently-transfected by a polynuclcotide encoding a Notch intracellular domain (NICD) would have been obvious at the time the invention was filed to Dezawa had transfected MSCs with NCID because Dezawa teaches NCID transfected MSCS and differentiating those cells into a variety of neural cells which are the types of “descendent” cells Tennekon uses to treat stroke in their invention.
Applicant is directed to pages 12-13 of KSR v Teleflex (500 US 398 2007) “ … the Court has held that a “patent for a combination which only unites old elements with no change in their respective functions . . . obviously withdraws what is already known into the field of its monopoly and diminishes the resources available to skillful men.” Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp., 340 U. S. 147, 152 (1950). This is a principal reason for declining to allow patents for what is obvious. The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one(emphasis added). If a person of ordinary skill can implement a predictable variation, §103 likely bars its patentability. For the same reason, if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.” Applicant’s compositions for cotreatments were known in the art at the time the invention was filed and as such any known composition for cell therapy and cotreatment for stroke would have been obvious as a combination with the composition rendered obvious by the combination of Tennekon and Dezawa absent evidence to the contrary.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
Accordingly, the claimed invention was prima facie obvious to one of ordinary
skill in the art at the time the invention was made especially in the absence of evidence
to the contrary.
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.
The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 124-129 is/are directed to a naturally occurring cell population. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Analysis using the 2014 Subject Matter Eligibility Guidelines
Step 1: The claims are drawn to a composition of matter. (Step 1: YES.)
Step 2A: The claims are drawn to a natural phenomenon, namely the occurrence in nature of a human cello population that expresses CD90, CD49c, sox-9, sox-11, hox-A5, MSX-1, telomerase, are from bone marrow, and can differentiate into cardiac muscle cells and express IL-6, VEGF, MCP1 & BDNF. For claim 129, the carriers may consist entirely of molecules found in nature, e.g. salts, amino acids, sugars, and water.
The instant specification describes the invention as isolated multipotent mammalian stem cell. The cells have the natural ability to differentiate into cells endodermal, mesodermal or ectodermal cells( see esp pages 9-10).
The specification (esp pages 10-11) indicates that the cells are isolated from bone marrow and cultured to maintain their natural differentiation ability. Applicant’ describes their invention as a multipotent stem cell which persists after birth and speculate that the cells are a direct descendent of primordial germ cells(page 21-22). The markers claimed all are inherent properties of the multipotent adult stem cell and used to identify the cell as such. Applicant describes their invention as “the multipotent adult stem cells described herein were isolated by the method developed by the inventors, who identified a number of specific cell surface markers that characterize the MASCs” (page 22).
The specification contains no evidence, that the culturing of the cells imparts characteristics markedly different from those cells as they exist and function in nature. The “doublings” limitation is a question of cell growth and not indicative of any difference from the cells as they occur in nature. Fig 3 is used to show that the cells maintain their properties (specifically telomere length) after many doublings. As such, there is no evidence that the claimed population or composition of the population has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring cells and molecules.
For these reasons, the claimed invention does not appear to have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception. (Step 2A: YES.)
Step 2B: The claimed invention does not include any additional features that could add significantly more to the exception, so the claim does not qualify as eligible subject matter. (Step 2B: NO.)
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 21-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) a cells descendant from MSCs This judicial exception is not integrated into a practical application because the claims are drawn to the cells per se. The claims are drawn to a composition of matter however the claims are drawn to a natural phenomenon, namely the occurrence in nature of the differentiated cells. The instant specification describes the invention as being composed of all those cells naturally occurring. The cells are claimed as “transiently-transfected” which would indicate that the ultimate cells would
maintain no transfection and thus no differ from natural cells even if the process fro producing said cells was not natural.
The specification contains no evidence, that the method of making or culturing of the cells imparts characteristics markedly different from those cells as they exist and function in nature. As such, there is no evidence that the claimed population or composition of the population has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring cells and molecules. For these reasons, the claimed invention does not appear to have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed invention does not include any additional features that could add significantly more to the exception, so the claim does not qualify as eligible subject matter.
Further even if the transient- transfection causes a phenotypic change, then the question is whether or not that change results in something markedly different that a judicial exception:
Any phenotypic change alone does present as a marked difference. Many phenotypic changes are transient and not the result in a “real” change to the cells, e.g. temporary starving a cell will impart changes that will be reversed when proper feeding conditions are (re)introduced. Environment (culture conditions) would be expected to result in some phenotypic changes and said changes do not constitute marked difference. See In re Roslin Institute (Fed Cir 2014). http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1407.Opinion.5-6-2014.1.PDF
Concluding the analysis, the claimed invention is drawn to a judicial exception to the statute and must be rejected as ineligible under 35 USC101.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
