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 .
Status of the Claims
Applicant’s submission filed 08 July 2026 has been entered. Claims 23-42 are pending. No claims have been amended, cancelled without prejudice or disclaimer, or been newly added. Therefore, prosecution on the merits continues for claims 23-42. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Claim interpretation
Applicant has traversed the Examiner’s interpretation of the claims, asserting in Pages 5-6 of the Remarks filed 08 July 2026 that defining the fetal mesenchymal stem cells as “being derived from fetal liver” does not utilize product-by-process language and strips the claims of their structural and compositional significance. In response, the Examiner respectfully submits that Applicant’s arguments fail to disclose how deriving fetal mesenchymal stem cells from a fetal liver alters the structure of the final fetal mesenchymal stem cells. The Examiner also notes that the structural significance of the fetal mesenchymal stem cells is not stripped, as the fetal mesenchymal stem cells must be CD73+, CD90+, CD45-, CD31-, and HLA class II-.
Therefore, the claim interpretation is maintained.
RE: Rejection of claims 23-30 under 35 USC 101
Applicant's arguments filed 08 July 2026 have been fully considered but they are not found persuasive.
Applicant has traversed the rejection, asserting in Pages 6-7 of the Remarks filed 08 July 2026 that the claimed “in vitro population of fetal mesenchymal stem cells (FMSCs) derived from fetal liver” defines a homogenous cell population that does not exist in vivo and is obtained only through human intervention – specifically, through isolation from dissected fetal liver tissue, expansion in adherent culture without growth factors, serial passaging (which removes dead cells and non-MSC by washing such that only adherent cells remain), and harvesting. In response, the Examiner respectfully submits that maintaining the FMSCs that have been directly isolated from fetal liver in vitro does not alter the structure of the FMSCs, per se. Therefore, there are no structural differences between the instantly claimed FMSCs and those that are naturally occurring.
Applicant has further traversed the rejection, asserting in Page 7 of the Remarks filed 08 July 2026 that the instant claims are directed to a defined population of FMSCs with specific quantitative purity characteristics that can only be achieved through human intervention. In response, the Examiner respectfully submits that concentrating a population of FMSCs in vitro to have a specific percentage of FMSCs does not alter the structure of the FMSCs themselves. Therefore, there are no structural differences between the instantly claimed FMSCs and those that are naturally occurring.
Applicant has further traversed the rejection, asserting in Pages 7-8 of the Remarks filed 08 July 2026 that the population of FMSCs is considered patentable material based on the 2019 PEG, as the claimed population of FMSCs comprise cells with a specific marker profile that differs from the original mixed population of fetal liver cells. In response, the Examiner respectfully submits that maintaining the FMSCs that have been directly isolated from fetal liver in vitro does not alter the structure of the FMSCs, per se, and therefore the population of FMSCs as claimed do not exhibit a different expression profile from the naturally occurring FMSCs. The Examiner also respectfully submits that the in vitro population of cells as claimed is not required to only consist of the FMSCs, as the in vitro population of cells comprises FMSCs. Therefore, the in vitro population of cells can comprise cell types other than FMSCs. See MPEP § 2111.03.
Consequently, the rejection is maintained.
RE: Rejection of claims 23-30, 34, 36-38, and 42 under 35 USC 102(a)(1) over Gerlach et al
Applicant's arguments filed 08 July 2026 have been fully considered but they are not found persuasive.
Applicant has traversed the rejection, asserting in Pages 8-9 of the Remarks filed 08 July 2026 that the disclosure of Gerlach et al is directed to the isolation of pericytes from fetal liver and not FMSCs. In response, the Examiner respectfully submits that Gerlach et al disclose that pericytes are a source of FMSCs and are functionally equivalent to FMSCs. See, for example, Pages 3258, 3266-3268 of Gerlach et al. Therefore, the pericytes of Gerlach et al are synonymous with the FMSCs of the instant claims.
Applicant has further traversed the rejection, asserting in Page 9 of the Remarks filed 08 July 2026 that Gerlach et al disclose that the pericytes unexpectedly acquire CD56 expression upon culturing. Applicant furthers this traversal by asserting that mesenchymal stem cells “generally do not express CD56”. In response, the Examiner respectfully submits that the feature upon which Applicant relies (i.e., CD56 expression) is not recited in the rejected claims. This feature is also absent from the Specification. Accordingly, Applicant’s arguments amount to a mere allegation of mesenchymal stem cell expression without any substantiated evidence and/or secondary considerations. It is of note that arguments presented by Applicant cannot take the place of evidence in the record. See MPEP § 2145(I).
Therefore, the rejection is maintained.
RE: Rejection of claims 23-30, 34-38, and 42 under 35 USC 103 over Gerlach et al
Applicant's arguments filed 08 July 2026 have been fully considered but they are not found persuasive.
Applicant has traversed the rejection, citing the same assertions in Pages 10-11 of the Remarks filed 07 July 2026 regarding the interchangeability of the pericytes of Gerlach et al with the FMSCs of the instant claims, as well as the CD56 expression, from the 35 USC 102 rejection above. In response, the Examiner respectfully directs Applicant to the discussion of these arguments presented in the 35 USC 102 rejection over Gerlach et al.
Therefore, the rejection is maintained.
RE: Rejection of claims 23-30, 34-39, and 42 under 35 USC 103 over Gerlach et al in view of Frost et al
Applicant's arguments filed 08 July 2026 have been fully considered but they are not found persuasive.
Applicant has traversed the rejection, citing the same assertions in Page 11 of the Remarks filed 07 July 2026 regarding the interchangeability of the pericytes of Gerlach et al with the FMSCs of the instant claims from the 35 USC 102 rejection above. In response, the Examiner respectfully directs Applicant to the discussion of these arguments presented in the 35 USC 102 rejection over Gerlach et al.
Therefore, the rejection is maintained.
RE: Rejection of claims 23-30, 34-38, and 40-42 under 35 USC 103 over Gerlach et al in view of Götherström et al
Applicant's arguments filed 08 July 2026 have been fully considered but they are not found persuasive.
Applicant has traversed the rejection, citing the same assertions in Pages 11-12 of the Remarks filed 07 July 2026 regarding the interchangeability of the pericytes of Gerlach et al with the FMSCs of the instant claims from the 35 USC 102 rejection above. In response, the Examiner respectfully directs Applicant to the discussion of these arguments presented in the 35 USC 102 rejection over Gerlach et al.
Therefore, the rejection is maintained.
RE: Rejection of claims 31-33 under 35 USC 103 over Götherström et al in view of Gerlach et al
Applicant's arguments filed 08 July 2026 have been fully considered but they are not found persuasive.
Applicant has traversed the rejection, citing the same assertions in Page 12 of the Remarks filed 07 July 2026 regarding the interchangeability of the pericytes of Gerlach et al with the FMSCs of the instant claims from the 35 USC 102 rejection above. In response, the Examiner respectfully directs Applicant to the discussion of these arguments presented in the 35 USC 102 rejection over Gerlach et al.
Therefore, the rejection is maintained.
Maintained Grounds of Rejection
Claim Interpretation
Instant claim 23 is directed to a product which utilizes product-by-process language. Likewise, instant claim 31 is directed to method of using a product, which utilizes product-by-process language. The limitations of the process of production are considered only in so far as the process of production
imparts distinct structural or chemical characteristics or properties to the claimed product. Therefore, if
the product, as claimed, is the same or obvious over a product of the prior art (i.e. is not structurally or
chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art
product is made by a different process. See MPEP § 2113.
In the instant case, claims 23 and 31 define the fetal mesenchymal stem cells as being derived from fetal liver. When defining the source of cells, the source of the cells is only considered in as far as the source defines the cell as having distinct biochemical or morphological characteristics. In the instant case, the source of the fetal mesenchymal stem cells does not impart a distinction to the fetal mesenchymal stem cells, other than requiring the fetal mesenchymal stem cells to be CD73+, CD90+, CD45-, CD31-, and HLA class II-.
Therefore, the claims will be interpreted as if CD73+, CD90+, CD45-, CD31-, and HLA class II- fetal mesenchymal stem cells derived from any source fulfills the limitations detailed in the instant claims.
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 23-30 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a nature-based product without significantly more.
Independent claim 23 is directed to an in vitro population of cells comprising fetal mesenchymal stem cells (FMSCs) derived from fetal liver, wherein the FMSCs are CD73+, CD90+, CD45-, CD31-, and HLA class II-, wherein at least 85% of the population of cells are CD73+ and CD90+.
The test for 101 eligibility of judicial exceptions can be found at MPEP § 2106:
“First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter.”
“Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013).”
“The Supreme Court in Mayo laid out a framework for determining whether an applicant is seeking to patent a judicial exception itself, or a patent-eligible application of the judicial exception. See Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. 66, 101 USPQ2d 1961). This framework, which is referred to as the Mayo test or the Alice/Mayo test, is discussed in further detail in subsection III, below. The first part of the Mayo test is to determine whether the claims are directed to an abstract idea, a law of nature or a natural phenomenon (i.e., a judicial exception). Id. If the claims are directed to a judicial exception, the second part of the Mayo test is to determine whether the claim recites additional elements that amount to significantly more than the judicial exception. Id. citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966). The Supreme Court has described the second part of the test as the "search for an 'inventive concept'". Alice Corp., 573 U.S. at 217-18, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966).”
Examiners should determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the following steps outlined in a flow chart at MPEP 2106(III) and 2106.04(II)(A):
Step 1: is the Claim to a process, machine, manufacture or composition of matter? If Yes, proceed to Step 2A;
Step 2A, prong one: Is the Claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea? If Yes, proceed to Step 2A, prong two;
Step 2A, prong two: Does the claim recite additional elements that integrate the judicial exception into a practical application? If No, proceed to Step 2B;
Step 2B: Does the claim recite additional elements that amount to significantly more (an inventive concept) than the judicial exception? If No, the claim is not eligible subject matter under 35 USC 101.
With regard to Step 1: YES, the claims are directed to a composition of matter, or product.
With regard to Step 2A, prong one: YES, instant claim 23 is directed to a population of FMSCs, which are nature-based products. Accordingly, the claimed FMSCs are compared to the closest naturally occurring counterpart, which are FMSCs, per se. Thus, there is no marked difference between the claim and product of nature. See, for example, Pages 3258-3259, 3266 and Figure 7 in Gerlach et al (Stem Cells and Development, 2012, of record on IDS filed 26 March 2024), wherein FMSCs derived from fetal liver are CD73+, CD90+, CD45-, CD31-, and HLA class II-.
With regard to Step 2A, prong two: No, the claims do not include any additional elements that integrate the judicial exceptions into a practical application. Integration into a practical application requires additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception.
The claims do not modify or transform the naturally occurring FMSCs, nor apply the FMSCs for a particular treatment or medical condition, nor imposes a meaningful limit on the FMSCs recited therein.
With regard to Step 2B: No, the claims do not provide any additional elements that amount to significantly more (an inventive concept) than the judicial exception. It is of note that the percentages of FMSCs having a specific surface expression within the population does not alter the FMSCs, per se.
Taken together, the claims encompass natural products. The judicial exceptions are not integrated into practical applications as iterated above. The claims do not include additional elements
that are sufficient to amount to significantly more than the judicial exception as iterated above.
Claim Rejections - 35 USC § 102
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 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 23-30, 34, 36-38, and 42 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gerlach et al (Stem Cells and Development, 2012, of record on IDS filed 26 March 2024).
Gerlach et al disclose a population of FMSCs derived from fetal livers that are CD73+, CD90+, CD45-, CD31-, and HLA class II-, wherein 100% of the population analyzed via flow cytometry express CD73 and CD90 and are negative for HLA class II (Pages 3258-3259, 3266; Table 1; Figure 7).
Gerlach et al further disclose that the adherent FMSCs are passaged at about 70% confluence for 13 passages (Pages 3262, 3266; Figures 2-3).
Gerlach et al further disclose that the FMSCs undergo immunocytochemical analysis (Pages 3261, 3265-3266; Figure 5).
Gerlach et al further disclose that the FMSCs exhibit migratory activity and osteogenic differentiation potential in vitro (Page 3260-3261, 3266; Figure 6).
Accordingly, Gerlach et al anticipate the claims as follows:
Regarding claim 23: Gerlach et al disclose a population of FMSCs derived from fetal livers that are CD73+, CD90+, CD45-, CD31-, and HLA class II-. This therefore reads on the in vitro population of cells of the instant claim.
Regarding claim 24: Following the discussion of claim 23, the CD73+, CD90+, CD45-, CD31-, and HLA class II- FMSCs of Gerlach et al will inherently comprise the same properties and/or perform the same functions as recited in the instant claims, as the FMSCs of Gerlach et al are identical to the FMSCs within the in vitro cell population of instant claim 23. See MPEP § 2112.01. Accordingly, the FMSCs of Gerlach will inherently have the ability to expand and to differentiate into osteoblasts, and will inherently be non-tumorigenic and adherent without growth factors. This therefore reads on the in vitro population of cells of the instant claim.
Regarding claim 25: Following the discussion of claim 23, the CD73+, CD90+, CD45-, CD31-, and HLA class II- FMSCs of Gerlach et al will inherently comprise the same properties and/or perform the same functions as recited in the instant claims, as the FMSCs of Gerlach et al are identical to the FMSCs within the in vitro cell population of instant claim 23. See MPEP § 2112.01. Accordingly, the FMSCs of Gerlach will inherently be bone forming, produce healthy collagen, and secrete paracrine factors. This therefore reads on the in vitro population of cells of the instant claim.
Regarding claim 26: Following the discussion of claim 23, the CD73+, CD90+, CD45-, CD31-, and HLA class II- FMSCs of Gerlach et al will inherently comprise the same properties and/or perform the same functions as recited in the instant claims, as the FMSCs of Gerlach et al are identical to the FMSCs within the in vitro cell population of instant claim 23. See MPEP § 2112.01. Accordingly, the FMSCs of Gerlach will inherently differentiate into bone in an at least two-fold differentiation increase over a negative control. This therefore reads on the in vitro population of cells of the instant claim.
Regarding claims 27 and 29: Following the discussion of claim 23, Gerlach et al further disclose that the adherent FMSCs are passaged at about 70% confluence for 13 passages (claim 27). As the FMSCs at 70% confluence will inherently have a viability of at least 70% based on the adherent nature of the FMSCs, this therefore reads on the in vitro population of cells of instant claim 29. See Page 12 of the instant disclosure and MPEP § 2112.01.
Regarding claim 28: Following the discussion of claim 23, the CD73+, CD90+, CD45-, CD31-, and HLA class II- FMSCs of Gerlach et al will inherently comprise the same properties and/or perform the same functions as recited in the instant claims, as the FMSCs of Gerlach et al are identical to the FMSCs within the in vitro cell population of instant claim 23. See MPEP § 2112.01. Accordingly, the FMSCs of Gerlach will inherently have a Hayflick limit. This therefore reads on the in vitro population of cells of the instant claim.
Regarding claim 30: Following the discussion of claim 23, Gerlach et al further disclose that 100% of the cells in population are HLA class II-. This therefore reads on the in vitro population of cells of the instant claim, as 0% of the cells will be CD45+, CD31+, HLA class II+.
Regarding claims 34 and 36-38: Gerlach et al disclose the analysis of a population of FMSCs via flow cytometry (claims 36-37) and immunocytochemistry (claim 38), wherein the analyses show that the FMSCs are CD73+, CD90+, CD45-, CD31-, and HLA class II-. This therefore reads on the method of instant claim 34.
Regarding claim 42: Following the discussion of claim 34, Gerlach et al further disclose that the FMSCs are expanded for 13 passages. This therefore reads on the method of the instant claim.
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.
Claims 23-30, 34-38, and 42 remain rejected under 35 U.S.C. 103 as being unpatentable over Gerlach et al (Stem Cells and Development, 2012, of record on IDS filed 26 March 2024).
The discussion of Gerlach et al regarding claim 34 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Gerlach et al anticipate claims 23-30, 34, 36-38, and 42.
Regarding claim 35: Following the discussion of claim 34 above, Gerlach et al further disclose that 100% of the FMSC-comprising cell population analyzed via flow cytometry express CD73 and CD90 and are negative for HLA class II (Pages 3258-3259, 3266; Table 1; Figure 7).
Gerlach et al further disclose that the cultured FMSCs express CD45 and CD31 at significantly lower levels – or almost negligible levels – when compared to whole fetal liver tissue (Table 1).
Gerlach et al further disclose that the cultured FMSCs are passaged at about 70% confluence (Pages 3262, 3266; Figures 2-3).
Gerlach et al do not disclose that no more than 5% of the population comprising FMSCs expresses CD45 or CD31, as required by instant claim 35.
However, it would have been prima facie obvious to have modified the method of Gerlach et al such that the cultured population of cells comprising FMSCs has no more than 5% of cells that express CD45 or CD31. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to ensure the population comprised those percentages, as it would indicate that the cultured population is a substantially pure population of FMSCs. Furthermore, the ordinary artisan would have had a reasonable expectation of success given that Gerlach et al disclose that the FMSCs inherently comprise an almost negligible amount of CD45 and CD31, and it would not have been outside the skillset of the ordinary artisan to modify the proportion of CD45- and CD31- cells within the population using well-known sorting and/or isolation techniques. See MPEP § 2143(I)(G) and MPEP § 2144.05.
Consequently, Gerlach et al render obvious a method of analyzing a population of cells comprising FMSCs, wherein the population is determined to have at least 70% viable cells, and wherein 100% of the cells express CD73, 100% of the cells express CD90, 0% of the cells express HLA class II, and no more than 5% of the cells express CD45 or CD31. This therefore renders obvious the method of the instant claim. See Page 12 of the instant disclosure and MPEP § 2112.01.
Claims 23-30, 34-39, and 42 remain rejected under 35 U.S.C. 103 as being unpatentable over Gerlach et al (Stem Cells and Development, 2012, of record on IDS filed 26 March 2024) in view of Frost et al (Epigenetics, 2011, of record).
The discussion of Gerlach et al regarding claim 34 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Gerlach et al anticipate claims 23-30, 34, 36-38, and 42. Gerlach et al render obvious claims 23-30, 34-38, and 42. Frost et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 39: Following the discussion of claim 34 above, Gerlach et al further disclose that the population of FMSCs are capable of expanding and exhibit osteogenic differentiation potential in vitro (Page 3260-3262, 3266; Figures 2, 6).
Gerlach et al do not disclose that the population of FMSCs are non-tumorigenic, as required by instant claim 39.
Frost et al, however, disclose that fetal mesenchymal stem cells derived from fetal livers are non-tumorigenic (Pages 52-53, 59-60). Frost et al further disclose that the FMSCs are capable of differentiating into osteoblasts (Pages 53-55, 59).
Therefore, it would have been prima facie obvious to have modified the method of Gerlach et al such that the tumorigenicity of the population is analyzed, as detailed in Frost et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to ensure that the population of FMSCs does not have tumorigenic potential, and would have had a reasonable expectation of success given that the disclosures of Gerlach et al and Frost et al are each concerned with the analysis of FMSCs derived from fetal livers. See MPEP § 2143(I)(G).
Consequently, Gerlach et al as modified by Frost et al render obvious a method of analyzing a population of cells comprising FMSCs, wherein the population is determined to be non-tumorigenic and capable of expanding and differentiating along the osteogenic lineage – including into osteoblasts. This therefore renders obvious the method of the instant claim.
Claims 23-30, 34-38, and 40-42 remain rejected under 35 U.S.C. 103 as being unpatentable over Gerlach et al (Stem Cells and Development, 2012, of record on IDS filed 26 March 2024) in view of Götherström et al (Stem Cells Translational Medicine, 2013, of record on IDS filed 26 March 2024).
The discussion of Gerlach et al regarding claim 34 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Gerlach et al anticipate claims 23-30, 34, 36-38, and 42. Gerlach et al render obvious claims 23-30, 34-38, and 42. Götherström et al is considered prior art under 35 USC 102(a)(1), with an electronic publication date of 16 December 2013.
Regarding claims 40-41: Following the discussion of claim 34 above, Gerlach et al further disclose that the population of FMSCs is cleared of cell debris during the performed analysis (Pages 3260-3261; Figure 1).
Gerlach et al do not disclose that the population of cells is characterized as being one or more of: sterile, virus-free, mycoplasma-free, exhibiting chromosome stability, being free of known mutations causing skeletal dysplasia, and being a colorless cell suspension free of visible particulate matter, as required by instant claim 40.
Götherström et al, however, disclose a population of FMSCs derived from fetal liver that are CD73+, CD45-, CD31-, and HLA class II- (Abstract; Page 258). Götherström et al further disclose that the population of FMSCs are assayed for sterility, mycoplasma, and cell characteristics – including the surface expression of proteins, trilineage differentiation ability, and karyotype – and are then administered to subjects suffering from osteogenesis imperfecta once characterized as being sterile, negative for mycoplasma, and having a normal karyotype (Pages 256-259).
Therefore, it would have been prima facie obvious to have modified the method of Gerlach et al such that the population of FMSCs are further assayed for sterility, mycoplasma, and karyotype, as detailed in Götherström et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to verify that the population is uncontaminated and chromosomally stable prior to utilizing the cells as a therapeutic, and would have had a reasonable expectation of success given that the disclosures of Gerlach et al and Götherström et al are each concerned with the analysis of FMSCs derived from fetal livers. See MPEP § 2143(I)(G).
Consequently, Gerlach et al as modified by Götherström et al render obvious a method of analyzing a population of cells comprising FMSCs, wherein the population is characterized as being sterile, mycoplasma-free, and exhibiting chromosomal stability via karyotyping (claim 40). As this characterization is performed prior to utilizing the cell population as a therapeutic for osteogenesis imperfecta, this therefore renders obvious the method of instant claim 41.
Claims 31-33 remain rejected under 35 U.S.C. 103 as being unpatentable over Götherström et al (Stem Cells Translational Medicine, 2013, of record on IDS filed 26 March 2024) in view of Gerlach et al (Stem Cells and Development, 2012, of record on IDS filed 26 March 2024).
Götherström et al is considered prior art under 35 USC 102(a)(1), with an electronic publication date of 16 December 2013. Gerlach et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 31: Götherström et al disclose the transplantation of FMSCs derived from fetal liver for the treatment of osteogenesis imperfecta (Abstract; Pages 255-261).
Götherström et al further disclose that the FMSCs are CD73+, CD45-, CD31-, and HLA class II- (Page 258). Götherström et al further disclose that the FMSCs are capable of differentiating along the osteogenic lineage (Page 258).
Götherström et al do not disclose that the FMSCs are CD90+, as required by instant claim 31.
Gerlach et al, however, disclose FMSCs that are CD73+, CD90+, CD45-, CD31-, and HLA class II- (Pages 3258-3259, 3266; Figure 7). Gerlach et al further disclose that the FMSCs exhibit migratory activity and osteogenic differentiation potential in vitro (Page 3260-3261, 3266; Figure 6).
Therefore, it would have been prima facie obvious to have substituted the FMSCs of Götherström et al with the FMSCs of Gerlach et al, as doing so would have been a simple substitution of one population of FMSCs for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the two populations of FMSCs are functionally comparable, as they are both CD73+, CD45-, CD31-, HLA class II-, and have osteogenic differentiation potential, and thereby would have been able to substitute the FMSCs with predictable results.
Consequently, Götherström et al as modified by Gerlach et al render obvious a method of treating osteogenesis imperfecta, wherein the FMSCs derived from fetal liver are CD73+, CD90+, CD45-, CD31-, and HLA class II-. This therefore renders obvious the method of the instant claim.
Regarding claims 32-33: Following the discussion of claim 31, Götherström et al further disclose that the FMSCs are administered prenatally (claim 33) and postnatally (claim 32) (Pages 255-258; Table 1). This therefore reads on the method of the instant claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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 at (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.
/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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