DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
The preliminary amendments to the specification and claims, submitted 3/29/2023, have been entered. The replacement drawings, submitted 3/29/2023, are entered and accepted.
Non-Compliant Claim Amendment
The preliminary amendment to the claims, received 3/29/2023, fails to comply with 37 CFR 1.121(c), as not all changes to the claims are shown via proper mark-ups. For example, in claim 3, line 4, the word “patient” has replaced the word “mammal”, yet this change is not shown. In claims 6 and 7, the first word has been changed from “A” to “The”, and in claim 7, the phrase “and/or soluble factors derived therefrom” has been deleted. However, the biggest issue is that amended claim 2 is completely different than the originally presented claim 2. It appears the amended claim 2 is a copy/paste of claim 1, whereas the original claim 2 required the additional administration of precursors of bone marrow lineage cells.
In order to provide compact prosecution, the claim amendment will be entered, and the claims will be examined as they are presented in the amended form. Future claim amendments must comply with 37 CFR 1.121(c) or they will be held as non-compliant.
Priority
Acknowledgement is made of Applicants’ claim for priority as a continuation of prior-filed US Patent Application 17/077698 (abandoned), which is a continuation of prior-filed US Patent Application 16/131975 (now US Patent 10849932), which is a continuation of prior-filed US Patent Application 15/055221 (now US Patent 10105394), which is a continuation of prior-filed US Patent Application 13/808,093 (now US Patent 9301978), which is a national stage entry under 371 of PCT/AU11/000840 (filed 7/4/2011), which claims benefit of US Provisional Application 61/398950 (Filed 7/2/2010).
Claim Interpretation
The following facts are set forth to clearly describe the state of the art and terminology used:
STRO-1 is a marker on a subset of primitive multipotent stromal cells (synonymous with mesenchymal stromal cells, mesenchymal stem cells, and multipotent stem cells) (MSCs). STRO-1 is also expressed on a number of non-multipotent cells (i.e. erythrocytes).
STRO-1+ cells include STRO-1Bright, STRO-1Intermediate, and STRO-1dim cells.
STRO-1Bright cells defines a subset of MSCs. Thus all STRO-1Bright cells are MSCs, however, not all MSCs are STRO-1Bright. Not all MSCs are even STRO-1+ (MSCs can be STRO-1-, based on statement of instant specification at Pg. 7, ln 19-21).
Claims 1 and 2 are understood to be directed to a method for (a) preventing the development of GvHD complications in a patient, or (b) a method for treating GvHD complications in a patient, wherein the method comprises administering, to the patient, (i) a population of cells enriched for STRO-1Bright cells, and/or (ii) progeny of a population of cells enriched for STRO-1Bright cells. (letter designations added by Examiner for reference)
It is first necessary to define the patient populations covered by the instant claims:
For (a), patients in need of prevention of GvHD complications need not yet have GvHD or any related conditions. Everyone is in need of prevention of any and all diseases. Therefore, the patient population in need of prevention of GvHD includes everyone, including healthy individuals.
For (b), patients in need of treatment of GvHD complications are limited those who are currently experiencing GvHD complications. The specific complication is not defined, and thus any GvHD complication is included. However, one must still have GvHD to be included within this patient population.
Second, it is necessary to define what is being administered to the patients:
For (i) a population of cells enriched for STRO-1Bright cells: this covers STRO-1Bright/ALP+ cells present in bone marrow/freshly harvested bone marrow, as well as STRO-1Bright/ALP- MEMPs (as described by Gronthos et al WO 06/032092).
For (ii) progeny of a population of cells enriched for STRO-1Bright cells: STRO-1bright cells give rise to a variety of cell types. Gronthos et al term some cells multipotent progeny "Multipotential Expanded MPC Progeny (MEMPs).” MEMPs are characterized as STRO-1bright and ALP- (See Gronthos et al, WO 06/032092 Pg. 2, ln 25-Pg 3, ln 4). However, "progeny of STRO-1bright cells” is not limited to cells which retain multipotentiality, or even cells that retain STRO-1bright expression. STRO-1bright cells are capable of differentiating into a number of lineages, including fat, bone and cartilage (See Gronthos et al, WO 06/032092, Example 2, Pg. 52, ln 4-20). Therefore “progeny of STRO-1bright cells” includes, at least, fat cells (adipocytes), bone cells (osteocytes) and cartilage cells (chondrocytes), as well as any other cell into which the STRO-1bright MPC can differentiate.
It is further noted that the cell population enriched for STRO-1Bright cells can contain non-MSCs, such as hematopoietic stem cells found in the bone marrow. Thus, the scope of progeny of the cell population enriched for STRO-1Bright cells also covers hematopoietic stem cells and cells of the hematopoietic lineage (e.g. red blood cells).
Claims 3-5 are being interpreted as requiring the method to further involve administration of precursors of bone marrow lineage cells. Precursors of bone marrow lineage cells include hematopoietic stem cells and mesenchymal stem cells.
Claim 6 is being interpreted as meaning the STRO-1Bright cells are allogenic to the patient being treated.
Claim Objection
Claim 1 is objected to for a minor informality:
The full term “Graft versus host disease” should be written out before the first use of the abbreviation “GvHD”. Correction is required.
Duplicate Claim Warning
Applicant is advised that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is not found enabling for the full scope of the claims.
The claims cover six embodiments:
(1) A method for preventing the development of GvHD complications in a patient, comprising administering to the patient a population of cells enriched for STRO-1bright cells.
(2) A method for preventing the development of GvHD complications in a patient, comprising administering to the patient progeny of a population of cells enriched for STRO-1bright cells.
(3) A method for preventing the development of GvHD complications in a patient, comprising administering to the patient a population of cells enriched for STRO-1bright cells and progeny of the population of cells enriched for STRO-1bright cells.
. (4) A method for treating GvHD complications in a patient, comprising administering to the patient a population of cells enriched for STRO-1bright cells.
(5) A method for treating GvHD complication in a patient, comprising administering to the patient progeny of a population of cells enriched for STRO-1bright cells.
(6) A method for treating GvHD complications in a patient, comprising administering to the patient a population of cells enriched for STRO-1bright cells and progeny of the population of cells enriched for STRO-1bright cells.
The following facts are relevant to the scope of each of the embodiments:
The specification is considered to be enabling for embodiments (1), (3), (4) and (6), but is not found to be enabling for embodiments (2) or (5). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to successfully carry out the invention commensurate in scope with these claims.
Embodiments (1), (3), (4) and (6) are limited to methods which require administration of a population of cells enriched for STRO-1bright cells, and optionally further contain progeny thereof. The specification shows that STRO-1bright cells are capable of suppressing T cell activation both in vitro and in vivo (See Examples 5-7). This information is sufficient to support claims to administering STRO-1bright to a patient either for prevention of and/or treatment of GvHD complications. Embodiments (3) and (6) require the presence of progeny of a cell population enriched for STRO-1bright cells along with the STRO-1bright cells, while there is no evidence the progeny of a cell population enriched for STRO-1bright cells would have any effect (see discussion below), there is also no evidence or reason to believe the progeny would negate the action of the STRO-1bright cells, they are considered additional non-active agents that may be further included.
Embodiments (2) and (5) are limited to methods which require administration of progeny of a population of cells enriched for STRO-1bright cells. As discussed above, progeny of a cell population enriched for STRO-1bright cells does include multipotential cells, such as STRO-1bright MEMPs, but it also includes terminally differentiated cells, such as chondrocytes, adipocytes and osteocytes, as well as hematopoietic lineage cells. There is teachings in the specification regarding immunosuppressive activity of STRO-1bright cells. No evidence or teachings are provided in the specification regarding the immunosuppressive activity of any progeny of STRO-1bright or progeny of any other cells that may be present in the cell population enriched for STRO-1Bright cells.
As there are no teachings or evidence in the instant specification, the state of the art is considered:
Nasef et al (Int J Lab Hematol, 2007) teach that STRO-1+ cells have immunosuppressive ability. Gronthos et al teach MEMPs are STRO-1bright, which means the MEMPs are STRO-1+; therefore, one having ordinary skill in the art would be able to conclude that at least the MEMPs (progeny of STRO-1bright cells) described by Gronthos et al would also have immunosuppressive activity and may be useful in preventing or treating GvHD complications, in the same manner as the STRO-1bright cells.
However, with regards to terminally differentiated cells, such as chondrocytes, adipocytes and osteocytes, while methods involving administration of these cells were known (See Siemionow et al, Semin Plast Surg, 2007; Giannetti et al (US 2002/0116063), Freund (US 2005/0123895), Ogushi (US Patent 6989030), there was no teachings that any of these cell types have immunosuppressive activity. In fact, immunorejection was a concern with these cell-based transplants (See Siemionow et al, pg. 205, 1st column, 1st paragraph).
Given that STRO-1bright cells are multipotent, the number and breath of “progeny thereof" is extremely broad, and can be beyond that which is recognized by the art at the time the invention was made. The cell types included within "progeny thereof" represent a broad phenotypically range, and do not have a consistent or conserved immunosuppressive activity. Thus it would be left up to the practitioner to determine (a) what cells are considered “STRO-1bright progeny” and (b) which of those progeny have immunosuppressive activity such that they could be used for prevention or treatment of GvHD. While testing the immunosuppressive activity of a cell is within the skill of the ordinary artisan, testing the immunosuppressive activity of all progeny which can be derived from a known multipotent cell is considered to rise to the level of ‘undue experimentation’.
In total, only a limited scope of the claims is enabled. Specifically, use of STRO-1bright cells, optionally in combination with progeny thereof, for prevention or treatment of GvHD complications, and use of STRO-1bright progeny that are also STRO-1+ for treatment or prevention or treatment of GvHD complications. Determination of what other, if any, progeny of STRO-1bright cells are capable of being successfully used in the claimed invention would require undue experimentation.
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 1-16 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 pre-AIA the applicant regards as the invention.
Regarding claims 1 and 2: There is insufficient antecedent basis for the limitation ‘the mammal” in line 3 of each of claims 1 and 2.
Each of claims 3-16 depends directly or indirectly from either claims 1 or 2, and thus inherit the deficiency, and are rejected on the same basis.
Regarding claims 3-5: There is insufficient antecedent basis for the limitation “the precursors of bone marrow lineage cells” in each of these claims.
Regarding claim 11: The term "low dose [of STRO-1bright cells]" in claim 11 is a relative term which renders the claim indefinite. The term "low dose" is not defined by the claim, 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. It cannot be determined how many (or few) STRO-1bright cells must be administered to meet the claim limitation. Though claims 12 and 13 depend from claim 11, each of the dependent claims recite values limiting the term ‘low dose’, and thus they are not included in this rejection.
Regarding claims 15 and 16: There is insufficient antecedent basis for the limitation “the mammal” in the second or third line of the claims, respectively.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1, 2 and 14 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Gronthos et al (WO 06/032092).
Gronthos et al disclose multipotent progenitor cells (MPCs) which are non-hematopoietic progenitor cells capable of forming large numbers of multipotential cell colonies. MPCs can be obtained from bone marrow, amongst other sources. A proportion of MPCs are STRO-1bright. Gronthos et al report that, upon ex vivo culturing, these MPCs have a tendency to loss their multipotentiality (See Gronthos et al, Pg. 1, ln 10-Pg. 2, ln 21). Gronthos et al report that progeny obtained by ex vivo culture of the MPCs can be separated into at least two populations based on the level of expression of the STRO-1 marker: STRO-1bright and STRO-1dim. Gronthos et al state that the STRO-1bright population are less committed and have a greater potential to retain multipotentiality. Gronthos et al term these STRO-1bright progenitors of the MPCs Multipotential Expanded MPC Progeny (MEMPs) (See Gronthos et al, Pg. 10, ln 13-23). Gronthos et al further disclose that these MEMPs are capable of stimulating proliferation of tissue specific committed cells (TSCCs) both in vitro and in vivo, and thus the MEMPs have potential use in therapeutic applications for tissue repair (See Gronthos et al, Pg. 10, ln 25-28).
In the Examples Gronthos et al report isolating MPCs from human bone marrow and expanding the MPCs in vitro. After expansion in vitro Gronthos et al separate the progeny cells into STRO-1bright population (MEMPs) and STRO-1dim populations (See Gronthos et al, Example 1, Pg. 51). In Example 3 in one in vivo experiment, Gronthos et al injected athymic nude rats that had undergone ligation of the left anterior descending coronary artery with the STRO-1Bright MEMPs, STRO-1dim or fresh aspirates of STRO-1 depleted bone marrow Gronthos et al report those rats injected with MEMPs demonstrated greater numbers of proliferating rat cardiomyocytes than those rats injected with the STRO-1dim cells (See Gronthos et al, Pg. 53, ln 10-23).
The in vivo experiment in Example 3 wherein Gronthos et al inject MEMPs (which are STRO-1bright cells) into athymic nude mice who have undergone ligation of the LAD coronary artery reads on the instant claims as follows:
Regarding claims 1 and 2: The MEMPs read on STRO-1bright cells. The athymic nude mice read on mammalian patients. By administering the MEMPs (STRO-1bright cells) to the mice (patient), Gronthos et al effectively reads on the claimed embodiment "A method for preventing development of GvHD complication comprising administering to the patient a population of cells enriched for STRO-1bright cells”, noting that everyone is in need of prevention of conditions, regardless of the likelihood they may actually develop said condition.
Still further, as MEMPs are actually progeny of STRO-1bright MPCs, the methods administering the MEMPs also reads on the claimed embodiment, "A method for preventing the treatment of GvHD complications in a patient which comprises administering to the [patient] a population of cells enriched for progeny of STRO-1bright cells.”
Regarding claim 14: The mice only receive one injection of the MEMPs, this is considered to meet the limitation “once weekly or less often”.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 2 and 6-14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gronthos et al (WO 06/032092).
The teachings of Gronthos et al are set forth above. Gronthos et al anticipates certain embodiments of claims 1, 2 and claim 14. The disclosure of Gronthos et al further renders obvious the following claims:
Regarding claim 6: In Example 3 Gronthos et al administer human MEMPs to athymic mice. Thus the MEMPs are not allogeneic, but xenogeneic to the mice recipients. However the ultimate applicability of animal testing is to derive treatments for humans. It is therefore concluded that it would have been prima facie obvious to have used the treatment protocol of Gronthos et al to human patients, including autologous and allogeneic transplants of MEMPs.
Regarding claims 7 and 8: The in vivo application of Gronthos et al relied upon above in Example 3 differs from instant claims 7 and 8 in that in the Example Gronthos et al do not teach specifically how the cells are administered, they simply say “injecting” the cells. However, it is considered to have been prima facie obvious to one having ordinary skill in the art at the time the invention was made, to have injected the cells intravenously, as this would have permitted for systemic administration of the cells. As such, the method of claims 7 and 8 are considered prima facie obvious over the method of Gronthos et al.
Regarding claims 9-13: The in vivo application of Gronthos et al relied upon above in Example 3 differs from instant claims 9-13 in that Gronthos et al fail to disclose how many MEMPs are administered to the mice. However, in the claims Gronthos et al does state that the composition (to be administered) may contain 5 x 106 cells, and of this the MEMPs may be as low as 1%, meaning 5 x 105 cells (See claim 20); this is considered a “low dose”. Therefore, Gronthos et al at least providing a general concentration of cells to be administered. This concentration would be routinely optimized based on the size of the recipient and the disorder to be treated. Generally, limitations related to concentration are not considered to define patentability unless there is evidence the claimed values achieve unexpected results. As there is no evidence of unexpected results, the concentrations of claims 9-13 are considered to be prima facie obvious over the disclosure of Gronthos et al.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,301,978.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Regarding instant claims 1-3: Patented claim 1 anticipates instant claims 1-3.
Regarding instant claims 1, 2 and 4: Patented claim 2 anticipates instant claims 1, 2 and 4.
Regarding instant claims 5: Patented claim 3 anticipates instant claims 5 and 6.
Regarding instant claims 7-8: Patented claims 5 and 6 anticipate instant claims 7 and 8.
Regarding instant claims 9-13: Patented claims 7-10 anticipate instant claims 9-13.
Regarding instant claim 14: Patented claim 11 anticipates instant claim 14.
Regarding instant claim 15: Patented claim 12 anticipates instant claim 15.
Regarding instant claim 16: Patented claim 13 anticipates instant claim 16.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10105394.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate and/or render obvious the instant claims.
Regarding instant claims 1 and 2: Patented claim 1 anticipates instant claims 1 and 2 as the patent claim administers a cell population enriched for STRO-1Bright cells or multipotential cells culture-expanded from STRO-1Bright cells, which are CD34- (which read on progeny of a cell population enriched for STRO-1Bright cells) for the treatment and/or prevention of complications of GvHD.
Regarding instant claim 4: In the embodiment of patented claim 1 where the subject is undergoing bone marrow or hematopoietic stem cell transplantation, the patient is also being co-administered precursors of bone marrow lineage cells, thereby anticipating instant claim 4.
Regarding instant claim 3: In the embodiment of patented claim 1 where the subject is about to undergo bone marrow or hematopoietic stem cell transplantation, it would have been prima facie obvious to have further administered the bone marrow or hematopoietic stem cells to the patient following the patented method. This conclusion of obviousness is based on a clear suggestion in the prior art that the method is intended to precede bone marrow or hematopoietic stem cell transplantation. Thus patented claim 1 renders obvious instant claim 3
Regarding instant claims 5, 6 and 15: Following the discussion of claim 3 above, patented claim 4 further teaches the administered cells are allogenic, and patented claim 12 teaches the administration can be to a human suffering from aplastic anemia, which is a malignant disease.
Regarding instant claims 7: Following the discussion of claim 3 above, patented claim 5 anticipates instant claim 7.
Regarding instant claim 8: Following the discussion of claim 3 above, patented claim 6 anticipates instant claim 8.
Regarding instant claims 9-13: Following the discussion of claim 3 above, patented claims 7-10 anticipate instant claims 9-13.
Regarding instant claim 14: Following the discussion of claim 3 above, patented claim 11 anticipates instant claim 14.
Regarding instant claim 16: Following the discussion of claim 3 above, patented claim 13 anticipates instant claim 16.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10849932.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate and/or render obvious the instant claims.
Regarding instant claims 1 and 2: STRO-1+/TNAP+ cells are a subset of STRO-1Bright cells. Thus patented claim 1 anticipates instant claims 1 and 2 as the patent claim administers STRO-1Bright cells for the treatment and/or prevention of complications of GvHD.
Regarding instant claim 4: In the embodiment of patented claim 1 where the subject is undergoing bone marrow or hematopoietic stem cell transplantation, the patient is also being co-administered precursors of bone marrow lineage cells, thereby anticipating instant claim 4.
Regarding instant claim 3: In the embodiment of patented claim 1 where the subject is about to undergo bone marrow or hematopoietic stem cell transplantation, it would have been prima facie obvious to have further administered the bone marrow or hematopoietic stem cells to the patient following the patented method. This conclusion of obviousness is based on a clear suggestion in the prior art that the method is intended to precede bone marrow or hematopoietic stem cell transplantation. Thus patented claim 1 renders obvious instant claim 3
Regarding instant claims 5, 6 and 15: Following the discussion of claim 3 above, patented claim 12 further teaches the administered STRO-1+/TNAP+ cells are allogenic and administered to treat a malignant disease, including aplastic anemia.
Regarding instant claims 7: Following the discussion of claim 3 above, patented claim 5 anticipates instant claim 7.
Regarding instant claim 8: Following the discussion of claim 3 above, patented claim 6 anticipates instant claim 8.
Regarding instant claims 9-13: Following the discussion of claim 3 above, patented claims 7-10 anticipate instant claims 9-13.
Regarding instant claim 14: Following the discussion of claim 3 above, patented claim 11 anticipates instant claim 14.
Regarding instant claim 16: Following the discussion of claim 3 above, patented claim 13 anticipates instant claim 16.
Claims 1, 2, 4-6 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 15 of U.S. Patent No. 8,828,375.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims. Specifically patented claim 1 recites a method of transplanting hematopoietic precursor cells into a subject in need thereof, wherein the hematopoietic precursor cells have been previously expanded in vitro in the presence of STRO-1bright cells.
Regarding instant claims 1, 2 and 4: Patented claim 1 recites administering the hematopoietic cells which have been expanded in the presence of STRO-1bright cells. While the patented claim does not specify that the STRO-1bright cell are administered along with the expanded hematopoietic cells, the claim does not require a step of separation or isolation of the hematopoietic cells, and it is thus considered at least prima facie obvious to have administered the entire cell culture. The STRO-1bright cells read on 'a cell population enriched for STRO-1bright cells" and the hematopoietic precursor cells read on ‘precursors of bone marrow lineage cells'. Administration of the complete expanded culture would involve co-administration of the two cell types. The method is inherently effective to both prevent and treat complications of GvHD, given that the same cells are administered to the same patient population as required by the instant claims.
Regarding claims 5 and 15: Patented claim 15 defines the subject as one having various malignant blood disorders, including aplastic anemia.
Regarding claim 6: Patented claim 2 defines the population of cells enriched for STRO-1bright as being allogeneic.
Claims 1, 2, 4-6 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 15 of U.S. Patent No. 9,415,072.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims. Specifically, patented claim 1 recites a method of reducing the risk of developing GvHD by culturing hematopoietic precursors in the presence of cells enriched for STRO-1bright cells, and then administering the combination of hematopoietic precursors and STRO-1bright cells to the subject.
Regarding instant claims 1, 2 and 4: Patented claim 1 prevents development of GvHD complications. The method of patented claim 1 involves co-administering a cell population enriched for STRO-1bright cells and hematopoietic precursor cells (which read on precursors of bone marrow lineage cells).
Regarding claims 5 and 15: Patented claim 15 defines the subject as one having various malignant blood disorders, including aplastic anemia.
Regarding claim 6: Patented claim 2 defines the population of cells enriched for STRO-1bright as being allogeneic.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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, Christopher Babic can be reached on 571-272-8507. 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.
/ALLISON M FOX/Primary Examiner, Art Unit 1633
Prosecution Insights