DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendments
Applicant's amendments filed 2/19/2026 to claims 3 and 9 have been entered. Claim 1 is canceled. Claims 14 and 15 have been added. Claims 2-15 remain pending, of which claims 2-4, 8-10, 14, and 15 are being considered on their merits. Claims 5-7 and 11-13 remain withdrawn from consideration. References not included with this Office action can be found in a prior action. Any rejections of record not particularly addressed below are withdrawn in light of the claim amendments and/or applicant’s comments.
Affidavit/Declaration
The 2/19/2026 under 37 CFR 1.132 filed 1.132 is insufficient to overcome the multiple and separate rejections of claims 2-4 and 8-10 under 35 U.S.C. § 103 as set forth in the last Office action because:
Inoperability of the prior art must be factually supported by objective evidence, see M.P.E.P. § 716.01(c). In this case, the proffered table of SMS cell and multipotent stem cell properties in the instant Declaration is not adequately factually supported at this time, such as but not limited to 1) by citation of the relevant factual support in the specification, 2) by citation of prior art, and/or 3) by presenting new data with the instant Declaration. As such, Declarant has not shown by a preponderance of evidence that the CD34+ and CD45+ hematopoietic stem cells of Ando or Burt and the CD45+ and Lin- stem cells obtained from cord blood and having a mesenchymal phenotype of Rodgers are not capable of meeting the CD45+ SMS cells of claim 2.
While the properties of the known multipotent stem cell types in the table of the instant Declaration could likely be established by the citation of relevant prior art, “small mobile stem cells” appears to be a term specific to the instant Application and related Applications by the same Inventor and/or Applicant. While Applicant may be their own lexicographer (see M.P.E.P. § 2111.01(IV)), the term “small mobile stem cells” was not was sufficiently characterized as a term of art before the effective filing date of the instant Application or defined in the specification to distinguish the claimed CD45+ SMS cells from the CD34+ and CD45+ hematopoietic stem cells of Ando or Burt and the CD45+ and Lin- stem cells.
It is noted that many of the features of the table are either 1) not likely to be inherent properties of the claimed CD45+ SMS cells, but reliant on unclaimed features (see M.P.E.P. § 2145 (VI)) to where the SMS cells are obtained from (e.g. “Niche Dependence”) or how the SMS cells are cultured in vitro (e.g. “Growth in Standard Culture”), 2) directed towards statements of intended use (e.g. “Primary Function”, “Clinical Use”, “immunologic Profile”) and so not reasonably germane to considerations of inoperability of the prior art, or 3) partially overlap (“Morphology”, “Size”, “Key Surface Markers”, “Colony Assay”) and so provide for a prima facie case for obvious based on the substantially identical cells of the cited prior art in the absence of any persuasive evidence to the contrary (see M.P.E.P. § 2112.01).
Therefore, Applicant has not yet shown by a preponderance of evidence and reasonable commensurate to the scope of the claims that the claimed CD45+ SMS cells of the claimed method are, in fact, distinct and separate from the CD34+ and CD45+ hematopoietic stem cells of Ando or Burt and the CD45+ and Lin- stem cells obtained from cord blood and having a mesenchymal phenotype of Rodgers
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 3 and 9 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.
The term “standard” in claims 3 and 9 is a relative term which renders the claims indefinite. The term “standard” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the claims are read in light of the specification, the examiner is precluded from importing limitations from the specification into the claims; see M.P.E.P. § 2111.01(II). Clarification and/or correction is required.
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.
Claims 2-4, 8-10, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ando et al. (Experimental Hematology 28 (2000) 690–699) in view of Burt et al. (Blood, Vol 92, No 10 (November 15), 1998: pp 3505-3514).
This rejection addresses the embodiment of CD34+ CD45+ hematopoietic stem cells for the small mobile stem cells of claims 2 and 8.
Ando teaches methods of culturing CD34+ and CD45+ hematopoietic stem cells obtained from cord blood and under adherent conditions on feeder cells (Abstract; detailed methods on p691-692), reading on claims 2, 3, 8, and 9. Ando teaches continuously generating more than 107 CD34+ and CD45+ hematopoietic stem cells, which would be useful in downstream methods of clinical transplantation (Abstract; p695, subheading “Generation of CD34+ cells from CD34- cells in vitro”), reading on claims 2 and 8. Ando teaches administering the CD34+ hematopoietic stem cells to subjects to reconstitute the bone marrow and that said cells are CD45+ (p695-696, subheading “CFU, LTC-IC, and SRC”), reading in-part on the elected species of treating arthritis for claims 2, 4, 8, and 10.
Regarding claims 2, 4, 8, and 10, Ando does not teach further treating subjects for elected species of disease of arthritis.
Burt teaches methods of treating arthritis in human subjects by administering an effective amount of autologous CD34+ hematopoietic stem cells obtained from bone marrow (Abstract; p3506, left column, subheading “RA” for rheumatoid arthritis subjects; p3506, subheading “Hematopoietic Stem Cell (HSC) Procurement”; p3506, right column, subheading “RA”; Table 1 for cell dosages), reading in-part on claims 2, 4, 8 and 10.
Regarding claims 2, 4, 8, and 10, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further treat subjects in need thereof for arthritis with the CD34+ and CD45+ hematopoietic stem cells of Ando in view of Burt. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because both Ando and Burt are directed towards hematopoietic stem cells, and because Burt teaches an effective dosage of hematopoietic stem cells to treat arthritis in subjects. The skilled artisan would have been motivated to do so because Ando expressly teaches that their methods generated a relatively large number of CD34+ and CD45+ hematopoietic stem cells and which would be useful in downstream methods of clinical transplantation and so would be predictably advantageous both treat arthritis in subjects in need thereof in view of Burt.
Regarding the functional properties of the small mobile stem cells of claims 3 and 9, 14, and 15, "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) See M.P.E.P. § 2112(V). In this case, the prior art CD34+ and CD45+ hematopoietic stem cells of Ando are substantially similar to the claimed CD45+ “small mobile stem cells” because Ando teaches that the hematopoietic stem cells are capable of adherent conditions on feeder cells. Therefore, the burden to establish non-obviousness over the prior art hematopoietic stem cells of Ando is shifted back to Applicant.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 2, 4, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Burt et al. (Blood, Vol 92, No 10 (November 15), 1998: pp 3505-3514) in view of Bender et al. (Clinical Immunology and Immunopathology (1994), 70(1), 10-18) and Ando et al. (Experimental Hematology 28 (2000) 690–699)
This rejection addresses the embodiment of CD34+ CD45+ hematopoietic stem cells for the small mobile stem cells of claims 2 and 8. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established and Applicant has the burden of showing that they are not; See M.P.E.P. § 2112.01.
Burt teaches methods of treating arthritis in human subjects by administering an effective amount of autologous CD34+ hematopoietic stem cells obtained from bone marrow (Abstract; p3506, left column, subheading “RA” for rheumatoid arthritis subjects; p3506, subheading “Hematopoietic Stem Cell (HSC) Procurement”; p3506, right column, subheading “RA”; Table 1 for cell dosages), reading in-part on claims 2, 4, 8 and 10.
Regarding claims 2 and 8, Burt does not teach the embodiment of CD34+ CD45+ hematopoietic stem cells for the claimed CD45+ “small mobile stem cells”. Regarding claims 2 and 8, Burt does not teach in vitro culturing.
Bender teaches obtaining CD34+CD45RA+ hematopoietic stem cells in-part from cord blood (Abstract; CD45RA being an isoform and the narrower embodiment of CD45), reading in-part on claims 2 and 8.
Ando teaches methods of culturing CD34+ and CD45+ hematopoietic stem cells obtained from cord blood (Abstract; detailed methods on p691-692), reading on claims 2 and 8. Ando teaches continuously generating more than 107 CD34+ and CD45+ hematopoietic stem cells, which would be useful in downstream methods of clinical transplantation (Abstract; p695, subheading “Generation of CD34+ cells from CD34- cells in vitro”), reading on claims 2 and 8. Ando teaches administering the CD34+ hematopoietic stem cells to subjects to reconstitute the bone marrow and that said cells are CD45+ (p695-696, subheading “CFU, LTC-IC, and SRC”), reading in-part on claims 2 and 8.
Regarding the CD45+ “small mobile stem cells” and the in vitro culturing step of claims 2 and 8, it would have been obvious to a person of ordinary skill in the art before the invention was filed to substitute the CD34+ hematopoietic stem cells obtained from bone marrow of Burt with the CD34+CD45+ hematopoietic stem cells obtained from cord blood of Bender in Burt’s treatment methods further cultured in vitro in view of Ando. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Burt, Bender, and Ando are all directed in-part towards CD34+ hematopoietic stem cells. The skilled artisan would have been motivated to do so because Ando expressly teaches that the in vitro culture methods generated a relatively large number of CD34+ and CD45+ hematopoietic stem cells and so and so would be predictably advantageous to culture Bender’s CD34+CD45+ hematopoietic stem cells as a more readily available source of stem cells in Burt’s treatment methods.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 3, 9, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Burt, Bender, and Ando as applied to claims 2 and 8 above, and further in view of Stella et al. (Haematologica 1995; 80:367-387), Gao et al. (CRYOBIOLOGY 36, 40–48 (1998)), and Mayani et al. (Blood, Vol. 82, No 9 (November 1), 1993: pp 2664-2672).
The teachings of Burt, Bender, and Ando are relied upon as set forth above. In view of the indefiniteness rejections above and in the interest of compact prosecution, this rejection addresses the embodiment of cell size of 8.2 ± 1.1 or 8.7 ± 1.1 µm for the about 4.5-6.5 µm of claims 3 and 9.
Regarding claims 3, 9, 14, and 15, Burt, Bender, and Ando do not teach wherein said SMS cells have a size of between about 4.5µm to about 6.5µm, a geometrically defined nucleus, a translucent cytoplasm and, wherein said SMS cells grow in standard medium for more than 30 passages, are capable of growing in the absence of serum, are expressive of extracellular matrix (ECM) in a standard media, and form an organized ECM layer and cellular multilayers.
Stella teaches that CD34+ hematopoietic stem cells are also CD45RA+ (i.e. an isoform and the narrower embodiment of CD45) and have large nuclei surrounded by narrow rims of cytoplasm occasionally containing cytoplasm granules (e.g. geometrically defined nucleus and translucent cytoplasm) (p367, the paragraph spanning both columns, and the paragraph spanning p367-368).
Gao teaches that CD34+ hematopoietic stem/progenitor cells have a cell diameter of either 8.2 ± 1.1 or 8.7 ± 1.1 µm dependent on how the diameter is calculated (Abstract, and noting the diameter is mean ± SD).
Mayani teaches that CD34+ and CD45+ hematopoietic stem cells are capable of being cultured in serum-free media (Abstract).
Regarding the functional properties of the small mobile stem cells of claims 3, 9, 14, and 15 "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) See M.P.E.P. § 2112(V). In this case, the prior art CD34+ and CD45+ hematopoietic stem cells of Bender are substantially similar to the claimed CD45+ “small mobile stem cells” because Stella teaches that the hematopoietic stem cells possess a geometrically defined nucleus and translucent cytoplasm, Gao teaches that the hematopoietic stem cells have an average cell diameter that overlaps with the claimed cell size range, and Mayani teaches that hematopoietic stem cells are capable of being cultured in serum-free media. Therefore, the burden to establish non-obviousness over the prior art hematopoietic stem cells of Bender in view of Stella, Gao, and Mayani is shifted back to Applicant.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Claims 2-4, 8-10, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al. (EXPERIMENTAL CELL RESEARCH 313 (2007) 1839–1852) in view of Liu et al. (Arthritis Research & Therapy 2010, 12:R210, 13 pages).
This rejection addresses the embodiment of CD45+ and Lin- stem cells obtained from cord blood and having a mesenchymal phenotype for the small mobile stem cells of claims 2 and 8. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established and Applicant has the burden of showing that they are not; See M.P.E.P. § 2112.01.
Rogers teaches a composition comprising human CD45+ and Lin- stem cells obtained from cord blood and which acquire a mesenchymal phenotype when cultured in vitro in serum-free FSFL medium (p1843, the paragraph starting “CD45pos/Linminus cells were tested…” through paragraph ending “…died within 5 days.”; p1840, paragraph starting “Written consent…” through paragraph ending “…occurred ever 48 h.” for obtaining and in vitro culturing of the human CD45+ and Lin- stem cells), reading in-part on claims 2, 4, 8, and 10. Rogers teaches administering the in vitro cultured human CD45+ and Lin- stem cells with mesenchymal properties to irradiated NOD/SCID mice and wherein the cells repopulated the bone marrow (paragraph spanning p1844-1845), reading in-part on the treating of claims 2, 4, 8, and 10.
Regarding claims 2, 4, 8, and 10, Rogers does not teach the elected species of treating arthritis.
Liu et teaches administering umbilical cord blood-derived mesenchymal stem cells (UC-MSCs) to subjects suffering from collagen-induced arthritis reduces tissue damage and inflammatory response in the subjects (p6, paragraph starting “The immunosuppressive effects…” through the end of the next paragraph; paragraph spanning p3-4 for treatment and cell dosage), reading on the treating of claims 2, 4, 8, and 10.
Regarding claims 2, 4, 8, and 10, it would have been obvious to a person of ordinary skill in the art before the invention was filed to further treat subjects suffering from arthritis with the CD45+ and Lin- stem cells having a mesenchymal phenotype of Rogers in view of Liu. A person of ordinary skill in the art would have had a reasonable expectation of success to do so because Rogers and Liu are both in-part directed towards stem cells obtained from cord blood and having a mesenchymal phenotype, because Rogers teaches administering the stem cells to subjects, and because Liu teaches an effective dosage of administering umbilical cord blood-derived mesenchymal stem cells to treat symptoms of arthritis in subjects. The skilled artisan would have been motivated to do so because the addition would be predictably advantageous to treat subjects for arthritis; . “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR International Co. v. Teleflex Inc., 550 U.S. 398, 414, 82 USPQ2d 1385, 1395-96 (2007) (quoting Sakraida v. AG Pro, Inc., 425 U.S. 273, 282 (1976)).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Regarding the functional properties of the small mobile stem cells of claims 3, 9, 14, and 15, "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) See M.P.E.P. § 2112(V). In this case, the prior art CD45+ stem cells having a mesenchymal phenotype of Rogers are substantially similar to the claimed CD45+ “small mobile stem cells” because Rogers teaches that stem cells are capable of being cultured in serum-free media. Therefore, the burden to establish non-obviousness over the prior art hematopoietic stem cells of Rogers is shifted back to Applicant.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
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 2 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17/905,851 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the copending ‘851 application is directed towards a method of promoting or improving repair or regeneration of damaged tissue comprising: selecting a subject that has or has had a viral, bacterial, or fungal infection or the sequela thereof; and administering to the selected subject a composition comprising a therapeutically effective amount of the same cells comprising small mobile stem (SMS) cells. Therefore, claim 1 of the copending application is the narrower embodiment of and thus anticipates instant claims 2 and 8. See M.P.E.P. § 804 (II)(B).
While the ‘851 Application does not claim CD45+ small mobile stem cells, M.P.E.P. § 2112.01 recites, "Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In this case, the ‘851 application and the instant application are claiming the same cells comprising small mobile stem cells, and so any further recitation of functional properties does not patentably distinguish the instant claims from the claims of the copending ‘851 application because the property of CD45+ is necessarily inherent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/916,445 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the copending ‘445 application is directed towards a method of ameliorating a wound of a subject comprising administering a composition comprising the same cells comprising small mobile stem (SMS) cells. Therefore, claim 1 of the copending application is the narrower embodiment of and thus anticipates instant claims 2 and 8. See M.P.E.P. § 804 (II)(B).
While the ‘445 Application does not claim CD45+ small mobile stem cells, M.P.E.P. § 2112.01 recites, "Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). In this case, the ‘851 application and the instant application are claiming the same cells comprising small mobile stem cells, and so any further recitation of functional properties does not patentably distinguish the instant claims from the claims of the copending ‘851 application because the property of CD45+ is necessarily inherent.
Response to Arguments
Applicant's arguments on pages 4-9 of the reply have been fully considered, but not found persuasive of error for the reasons given below. Any arguments dependent on the instant Declaration are fully addressed above with consideration of the Declaration.
On page 4 of the reply, Applicant alleges that the term “standard” is definite. This is not found persuasive because no special or explicit definition is clearly found in the specification that differs from its plain and ordinary meaning such as to clarify the scope of the claims, and the examiner is precluded from importing limitations from the specification into the claims; see M.P.E.P. § 2111.01. Particularly, “standard conditions” does not clearly set forth what culture methods and media are and are not encompassed by the scope of the claims.
Applicant’s arguments on pages 5-8 of the reply have been fully considered, but not found persuasive as the preponderance of evidence in the record does not yet support that allegation that the claimed SMS cells are distinct and separate cell type from the substantially identical CD34+ and CD45+ hematopoietic stem cells of Ando or Burt and the CD45+ and Lin- stem cells obtained from cord blood and having a mesenchymal phenotype of Rodgers. Applicant’s arguments rely entirely on the inherent properties of the claimed SMS cells that partially overlap with known species of multipotent stem cells taught in the prior art, and so reasonably meets the examiner’s burden to identify a “substantially identical” prior art product and shift the burden back to Applicant to show that prior art cells do not necessarily possess the characteristics of the claimed cell; see M.P.E.P. § 2112.01. While Applicant may be their own lexicographer (see M.P.E.P. § 2111.01(IV)), the term “small mobile stem cells” was not was sufficiently characterized as a term of art before the effective filing date of the instant Application or defined in the specification to distinguish the claimed CD45+ SMS cells from the CD34+ and CD45+ hematopoietic stem cells of Ando or Burt and the CD45+ and Lin- stem cells.
Applicant’s arguments regarding the previously presented and new grounds of rejection for nonstatutory double patenting have been fully considered, but not found persuasive of error as the case is not yet in condition for allowance, and the provisional double patenting rejections cannot be held in abeyance. The guidance given in M.P.E.P. § 804 subsection I, B, is clear that provisional double patenting rejections should continue to be made by the examiner in each application as long as there are conflicting claims in more than one application, unless the provisional double patenting rejections are the only rejections remaining in at least one of the applications. Or, until such time as a claim amendment in either the instant or copending cases would otherwise compel reconsideration of the nonstatutory double patenting rejections. Applications 17/905,851 and 18/916,445 are still pending before the Office and so the rejections must be maintained.
On page 8 of the reply, Applicant relies on arguments traversing the above and separate rejections of independent claims 2 and 8 over Ando in view Burt, Burt in view of Bender and Ando, and Rodgers in view of Liu to traverse the rejection of dependent claims 3, 4, 9, 10, 14, and 15. Therefore, the response set forth above to arguments also applies to this rejection.
Conclusion
No claims are allowed. No claims are free of the art.
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 SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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/Sean C. Barron/Primary Examiner, Art Unit 1653