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 .
The preliminary amendments of 03/20/2024 have been entered in full. Claims 46-65 are pending and under consideration.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 46-58 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 9-12, 16, 17, 19, and 20 of U.S. Patent No. 11786558. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The pending and patented claims are all drawn to methods comprising administering CD34+ cells to a subject that has received an organ transplant. Patented claim 1 is drawn to an embodiment of the generic method of pending claims 46 and 52. The limitations in patented dependent claims 2, 3,4,5,7, 9, 10, 12, 16, 17, 19, and 20 recite species within or overlapping with the broader limitations in corresponding pending dependent claims 47, 49, 50, 51, 53, 54, 55, 56, 57, 58, 60, and 60, respectively.
Claim Rejections - 35 USC § 112
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 63-65 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.
Claims 63-65 recite the limitation "said population of CD34+ cells" in 59. There is insufficient antecedent basis for this limitation in the claim.
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)(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 46 and 52 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20210369782 (‘Agarwal’; of record).
Claims 46 and 52 are drawn to a method that recites the single step of administering a population of CD34+ cells to a subject that has received an organ transplant. Claim 52 further stipulates that the cell population comprises no more than 1 x 104 CD3+ cells per kilogram of the subject. Preamble language in claims of patents directed to administration of a drug are expressions of purpose and intended result, and as such are non-limiting, since language does not result in manipulative difference in steps of claims. See Bristol-Myers Squibb Co. v. Ben Venue Labs Inc., 246 F.3d 1368, 58 USPQ2d 1508 (Fed. Cir. 2001) (61 PTCJ 623, 4/27/01), where a patent for administering the anti-cancer drug paclitaxel was anticipated by a scientific article describing the same method but with no anti-tumor response. That court held that expressions of anti-tumor efficacy did not distinguish the claimed method from the prior art. The court further held that preamble language in claims of patents directed to administration of anticancer drug are expressions of purpose and intended result, and as such are non-limiting, since language does not result in manipulative difference in steps of claims. Expressions of efficacy in claims of patents directed to administration of anticancer drug will not be given limiting effect, even though new uses of old processes are patentable, since claimed process in present case is not directed to new use, and it consists of same steps described in prior art reference, and since newly discovered results of known processes directed to same purpose are inherent, and thus are not patentable.
Therefore in the instant case, Applicant's assertions of alternative intended results (“establishing a mixed chimerism, establishing a T-cell macrochimerism of at least about 4%, preventing a host-versus-graft response,” in claim 46) do not distinguish the claimed method over prior art that teaches the same single step of administering a population of CD34+ cells to a subject that has received an organ transplant, wherein the cell population comprises no more than 1 x 104 CD3+ cells per kilogram of the subject.
Agarwal teaches a method of stem cell transplantation that facilitates engraftment and reconstitutes immunocompetence of the recipient (Abstract). Agarwal teaches that hematopoietic stem cell transplantation can also be performed to induce immune tolerance to donor matched solid organ grafts [0003][0012]. Donor cell populations for transplantation are enriched for CD34+ hematopoietic stem cells [0072]. The dose of cells may be higher than 106 CD34+ cells/kg, with the proviso that not more than about 3×103 CD3+ cells/kg are administered ([0073]; claim 5). Agarwal, therefore, teaches the same method step as in claim 52, which would necessarily produce all of the same results.
Claims 46, 47, 49-51, 53, 57, and 59-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 9974807 (‘Strober’; of record).
While teaching the same intended outcomes is not necessary for a finding of anticipation, it is nevertheless noted that Strober does in fact teach the intended outcomes of establishing mixed chimerism and preventing rejection, as in instant claims 46 and 59 (see Strober claim 1). Strober teaches that these outcomes are achieved by a method comprising administering CD34+ cells to the recipient of a solid human organ transplantation (see claim 1). The method of Strober claim 1 is a species that anticipates the generic method of pending claim 46. At least 1×106 purified CD34+ cells/kilogram recipient weight are administered, as in pending claim 47 (see Strober claim 5). The solid human organ is selected from a group consisting of a kidney, a heart, an intestine, a liver, a lung, and a pancreas (Strober, claim 9) as in pending claims 49, 50, 61, and 62. Claim 51 recites an inherent property of the transplanted organs. In one embodiment, the organ donor and the donor of the CD34+ cells are the same individual (Strober, claim 7); this would necessarily result in HLA-matching of the organ and CD34+ cells, as in pending claim 53. The cells are administered from 1 to 30 days after solid organ transplantation (col.32, lines 13-46), as in pending claims 59-62. Strober, therefore, teaches the same method steps as in pending claims 46, 47, 49-51, 53, 57, 59, 60, and 62, which would necessarily produce all of the same results.
Claims 46-51, 53, 57, 59-62 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200088718 (‘Zdanowski’; of record).
Zdanowski teaches methods for establishing mixed chimerism in a solid organ transplant recipient. The methods include providing to a subject that has received or will receive a solid organ transplant a product containing CD34+ cells derived from bone marrow of a deceased donor [0011]. This method is a species that anticipates the generic method of pending claims 46 and 57. Zdanowski further teaches the dosage recited in instant claim 47 [0012-0013]. The cellular product may be provided prior to, during, one, two, three, four, five, or six days or one, two, three, or four weeks after the solid organ transplant [0173] as in claims 48 and 59. The solid organ may be a kidney, lung, pancreas, heart, intestine, colon, liver, as in claims 49, 50, 61 and 62 [0020]. Claim 51 recites an inherent property of the transplanted organs. A single donor may be the source of the transplanted organ and the CD34+ cells, which assures HLA matching as in claim 53 [0181]. Zdanowski, therefore, teaches the same method steps as in pending claims 46-51, 53, 57, and 59-62, which would necessarily produce all of the same results.
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.
Claims 46-65 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210369782 (‘Agarwal’), as applied to claims 46 and 52 above, US 9974807 (‘Strober’), as applied to claims 46, 47, 49-51, 53, 57, and 59-62 above, and further in view of US 20200088718 (‘Zdanowski’), as applied to claims 46-51, 53, 57, 59-62 above, and the following.
Even if it could be argued that any of Agarwal, Strober or Zdanowski do not fully anticipate claims as detailed above, it is clear that these references provide teaching, suggestion, and motivation to administer a population of bone marrow derived CD34+ cells to a subject that has received an organ transplant, and they set forth general conditions for doing so. Additional teachings in the references are as follows.
Strober teaches the administration of anti-thymocyte globulin as in claim 54 (col. 34, line 41 to col. 35, line 34), administration of a corticosteroid as in claim 55 (col. 35, line 34 to col. 37, line 35) and administration of tacrolimus as in claim 56 (col. 9, lines 6-13; col. 44, line 28 to col. 46 line 31). In each case, the doses and scheduling times in Strober include or overlap with the corresponding values in the instant claims.
Zdanowski complements Strober in teaching the general conditions of pending claims 54-56 and 58. Zdanowski teaches that administering a population of CD34+ cells to a subject that has received an organ transplant may be accompanied by administration of anti-thymocyte globulin, corticosteroids [0174], tacrolimus and mTOR inhibitors [0175]; these agents may be tapered or withdrawn after stable mixed chimerism is established [0177-0178].
"[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).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL C GAMETT, Ph.D., whose telephone number is (571)272-1853. The examiner can normally be reached on M-W. Please note the examiner’s part-time schedule. 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, Joanne Hama can be reached on 5712722911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL C GAMETT/Primary Examiner
Art Unit 1647