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
Claims 1, 4-6, 8, 11-13, and 15 are pending.
Claims 1 and 4 are newly amended.
Claims 5, 6, 8, 11-13, and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/31/2025.
Claims 1 and 4 have been examined on their merits.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in the application. Any objections or rejections not specifically reiterated are hereby withdrawn.
The rejection of claims 1-2 and 4 under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Cytotherapy, 2017) as evidenced by Li et al. (Stem Cells Translational Medicine, 2018, on IDS 12/14/2021) are withdrawn due to the amendment of claims.
Response to Arguments
In regards to the rejections under 35 USC 112(b), in regards to the term “significantly higher”, Applicant argues that a person of ordinary skill in the art would have understood that the term referred to a statistical significance of p < 0.005 (Remarks, p10).
The rejection of the claims under 35 USC 112(b) in regards to the term “significant” has been withdrawn. Upon further consideration, a person of ordinary skill in the art would have recognized that the term would broadly refer to refer to statistical significance.
However, in regards to Applicant’s argument that the term “significant” refers to statistical significance of p < 0.005 specifically, Applicant’s argument has been fully considered but is not found persuasive.
While, statistical significance of p < 0.005 is common in the art, it is well-known that this number is arbitrary, and that any number can be set for significance (for example, p < 0.001). Furthermore, different types of statistical tests (for example, different types of T tests) will give different results. Therefore, “significant” has been broadly interpreted to any statistical difference.
Applicant argues that B27 refers to a well-known, commercially available, serum-free and chemically defined cell culture supplement, widely recognized in the field (Remarks, p11). Applicant argues that the composition of B27 supplement is well characterized and one of skill in the art would understand that it includes antioxidants, vitamins, hormones, and other nutrients (e.g., insulin, transferrin, selenium) (Remarks, p10). Continuing, Applicant argues that nonetheless, claim 4 is amended to replace the “B27” trademark name with a generic terminology of “cell culture supplement” (Remarks, p11).
Applicant’s arguments with respect to claims 1 and 4 have been considered but are moot because the claims as amended are not limited to “B27” but rather to “cell culture supplement.”
However, in as much as the generic term “cell culture supplement” necessarily refers to B27, Applicant’s arguments have been fully considered but are not found persuasive. The specification does not indicate that the term is specifically defined as B27.
Moreover, if it did, that would render the claim indefinite because it would be the same as limiting the claim to be B27 specifically because it still limits a particular trademarked product.
Furthermore, despite Applicant’s assertions, the composition of B27 is not well-known in the art. While, the specific reagents may be known, their concentrations are still proprietary.
Therefore, giving the term is broadest reasonable interpretation in view of the specification and art, the term “cell culture supplement” has been interpreted as being any cell culture supplement.
Applicant argues that the claims as amended now require that the heterogeneous cell population be obtained by the product-by-process steps as in claim 1 and therefore, requests that the rejection under 35 USC 101 be withdrawn (Remarks, p11-12).
Applicant’s arguments filed 10/08/2025 have been fully considered, but are not found persuasive.
As discussed in depth below, the claims are still drawn to a natural cell product, that is not markedly different from its natural counterpart, is not integrated in a practical application, does not include elements that amount to significantly more than the natural product itself, and as a result, does not qualify as patent eligible subject matter under 35 U.S.C. § 101.
In regards the product-by-process claims, as discussed in depth below, while the process appears to impart structural characteristics on the cells (in particular specific phenotypes), these characteristics are not markedly different from those found in nature.
In regards to the rejections under 35 USC 102, Applicant argues that the claims amended require the specific process as in claim 1 and therefore, it not anticipated by Lee (Remarks, p12-13).
Applicant’s arguments filed 10/08/2025 in respect to claims 1 and 4 have been fully considered, but are moot because the instant rejection does not rely on Li for any teaching here.
Applicant argues that compared to the prior art (the FBS system), the claimed cell population expresses significantly greater expression of MYC, KLF4, GMNN, SOX2, and NANOG and has a maintained CD146 positive rate of 50% after 7 passages (Remarks, p12; citing Figs. 1A and 1B).
Applicant’s arguments filed 10/08/2025 have been fully considered but are not found persuasive.
Specifically, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a cell population with a significantly greater expression of MYC, KLF4, GMNN, SOX2, and NANOG and has a maintained CD146 positive rate of 50% after 7 passages as compared to the prior art) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In particular, it is noted that not only does claim 1 allow for any number of passages but also only compares expression of stemness genes among subpopulations of CD146-positive cells within the claimed heterologous stem cell population.
Applicant argues that the claimed cells have superior functional properties in terms of differentiation potential, etc. (as in Examples 3-9) (Remarks, p13).
Applicant’s arguments filed 10/08/2025 have been fully considered but are not found persuasive.
As above, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., superior properties of the claimed cells, etc.) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Therefore, Applicant’s allegation of unexpected results are not commensurate in scope with the claims (see MPEP 716.02(d)).
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 1 and 4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural product without significantly more.
Applicant is directed to MPEP 2106 for guidance on subject matter eligibility.
Briefly summarized here, the new guidance cites a two part test (see Flowchart, MPEP 2106): is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
Analysis on View of the Interim Guidance
In regards to Step 1, regarding claim 1, the claim is directed to a “A heterogeneous stem cell population” which is a product, and thus a statutory class of invention (Step 1: YES).
In regards to Step 2A, prong one, claims 1-2 and 4 are drawn to a nature-based product which is not markedly different from its naturally occurring counterpart.
Specifically, claim 1 is drawn to “A heterogeneous stem cell population, characterized in that the stem cells in the heterogeneous stem cell population express stemness genes MYC, KLF4, GMNN, SOX2 and NANOG.”
The heterologous stem cell population is obtained by subculturing a stem cell population in by the process claims as in claim 1. Thus, claim 1 is a product-by-process claim.
As a result of these process steps, 1-50% of the stem cells in the heterologous stem cell population express CD146, and among those CD146-expressing stem cells (which are divided into CD146+ and CD146++ subpopulations), the percentage of cells expressing MYC, KLF4, GMNN, SOX2 and NANOG is “significantly” higher in the CD146+ subpopulation than the CD146++ subpopulation.
Additionally, as a result of the process steps, the proportion of the CD146+ subpopulation is 1% to less than 50% of the cells, while the proportion of CD146+++ cells is 50-100%.
In regards to product-by-process claims, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113).
However, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding "interbonded by interfusion" to limit structure of the claimed composite and noting that terms such as "welded," "intermixed," "ground in place," "press fitted," and "etched" are capable of construction as structural limitations). See also In re Nordt Dev. Co., 881 F.3d 1371,1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir. 2018)(holding "the specification demonstrates that ‘injected molded’ connotes an integral structure," and discussing several cases since Garnero that held "limitations to convey structure even when they also describe a process of manufacture").
In the instant case, the process steps appear to provide structure to the claims.
Specifically, the method steps provide structure characteristics to the final product in that 1-50% of the stem cells in the heterogeneous stem cell population express CD146 and the expression level of stemness genes CD146+ cells is significantly greater than CD146++ cells.
However, as discussed in depth below, the structure does not appear to be markedly different from those that appear in nature as discussed below.
Turning to the art, heterogeneous expression of CD146 (also referred to as MCAM in the art) is known in the art to exist in mesenchymal stem cell (MSC) populations derived from differing natural tissues.
As evidenced by Lee et al. (Cytotherapy, 2017), adipose-derived (AD) MSCs isolated from donor tissues heterogeneously express CD146 (Figure 3, p175). As further evidenced by Lee, CD146 is a known marker for bone marrow (BM) and umbilical cord (UC) MSCs as well (Introduction, p170-171).
This is confirmed by Espagnolle et al. (J Cell Mol Med, 2014), who demonstrates that not only do BM-MSCs express CD146 heterogeneously (Abstract, p104; Fig. 4, p111), but that heterogeneity depends on the tissue and molecular environment (Introduction, p104).
In other MSC populations, Paduano et al. (Stem Cell Rev and Rep, 2016, on IDS 12/14/2021, previously cited), evidences that MSCs derived from dental tissues also heterogeneously express CD146 (Abstract, p593; Fig. 2, p595; Sup. Fig. 1).
In regards to the specific percentages of CD146 cells, it is noted that the claims only require that 1-50% of the stem cells to express CD146. As evidenced by Lee, fewer than 50% of AD-MSCs express CD146 from all tissue sources (Fig. 3A).
In regards to the different subpopulations of CD146, as evidenced by Tormin et al. (Blood, 2011), primary samples of BM-MSCs demonstrate subpopulation of CD146-expressing cells, “CD146-/low” cells (which includes both CD146-negative and the “CD146+” cells as referred to in the instant claims) and “CD146+” cells (which are the CD146+++ as referred to in the instant claims).
In regards to the percentages of these cells, as evidenced by Tormin this is dependent on niche (Introduction, p5067). For example, subendothelial sinusoidal tissues are mainly “CD146++” (Introduction, p5067).
Therefore, a population of heterogeneous cells, where greater than 50% of the CD146-expressing cells are CD146++ is known to exist in natural tissues.
Additionally, MYC, KLF4, GMNN, SOX2, or NANOG area all also known naturally expressed in MSCs as well.
As evidenced by Li et al. (Stem Cells Translational Medicine, 2018, on IDS 12/14/2021), natural AD-MSCs express the genes MYC, KLF4, GMNN, SOX2, and NANOG (Abstract, p792; Results, p795; Fig. 1, p795).
As evidenced by Heo et al. (International Journal of Molecular Medicine, 2016), BM-MSCs express at least MYC, KLF4, SOX2, and NANOG (Abstract, p115; Fig. 1, p118), and evidenced by Zhang et al. (Europe PMC, 2022), the gene GMNN is expressed by BM-MSCs (Abstract, p3; Discussion, p12).
Furthermore, as evidenced by Paduano, in addition to CD146-pexpression, dental MSCs express at least KL4F, OCT4, NANOG, SOX2, MYC as well (p599).
In regards to CD146+ cells showing significant expression of stemness factors compared to CD146++ cells significance is not defined in the claims and therefore, could be a random difference in sampling.
Additionally, as above, whether MSCs exhibit CD146+ or CD146+++ expression is a function of tissue niche. Additionally, as evidenced by Tormin, CD146 expression is regulated by oxygen levels (Abstract, p5067). Thus, significant expression of stemness factors could not only be random but would be dependent on the number of CD146+ and CD146+++ cells in the population.
Therefore, there is no difference between the claimed heterogeneous stem cell population and naturally occurring cells, the process steps to not appear to impart markedly different characteristics, and thus the cells are a “product of nature” exception.
Accordingly, the claim is directed to an exception (Step 2A, prong one: YES).
With respect to Step 2A, prong two, limitations that may be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Improvements to another technology or technical field.
Improvements to the functioning of the computer itself.
Applying the judicial exception with, or by use of, a particular machine.
Effecting a transformation or reduction of a particular article to a different state or thing
Adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application.
Other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
With respect to Step 2A, prong two, limitations that were found not to be enough to qualify as additional elements that integrate the judicial exception into a practical application include:
Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer
Simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well understood, routine and conventional activities previously known to the industry
Adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea
Generally linking the use of the judicial exception to a particular technological environment or field of use.
In regards to Step 2A, prong two, the instant claim 1 does not recite additional elements or a combination of elements other than the natural product itself.
Accordingly, the claim is directed to an exception (Step 2A, prong two: NO).
In regards to Step 2B, the claim does not recite additional elements that amount to significantly more than the judicial exception. In instant case, as above, the instant claim does not recite additional elements or a combination of elements in the claims other than the natural product itself. As discussed above, the heterogeneous stem cell population could be cells from a tissue sample.
While claim 4 describes possible steps of differentiating cells into reticular vascular endothelial cells, this claim only describes characteristics that “will be induced” if process steps occur, but does not require these steps, and is therefore, optional.
Therefore, claims 1 and 4 are directed to a natural cell product, that is not markedly different from its natural counterpart, is not integrated in a practical application, and does not include elements that amount to significantly more than the natural product itself (accordingly, Step 2B: NO).
As a result, claims 1 and 4 do not qualify as patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102 – necessitated by amendment
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.
Claims 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhao et al. (CN102048756A, 2011, on IDS 12/14/2021).
In regards to claim 1, the claim is drawn to a heterogeneous stem cell population” comprising stem cells that express stemness genes MYC, KLF4, GMNN, SOX2, and NANOG.
This heterogeneous stem cell population obtained by the process steps of subculturing a stem cell population in a culture medium comprising 50%-99% DMEM/F12, 0.1-30 ng/mL EGF, 0.1-2% “cell culture supplement” (which is undefined and has been interpreted as allowing for any supplement), and 0.1-10% FBS.
Thus, the heterogeneous stem cell population is produced by the product-by-process step in claim 1.
In regards to product-by-process claims, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (see MPEP 2113).
However, the structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art, especially where the product can only be defined by the process steps by which the product is made, or where the manufacturing process steps would be expected to impart distinctive structural characteristics to the final product. See, e.g., In re Garnero, 412 F.2d 276, 279, 162 USPQ 221, 223 (CCPA 1979) (holding "interbonded by interfusion" to limit structure of the claimed composite and noting that terms such as "welded," "intermixed," "ground in place," "press fitted," and "etched" are capable of construction as structural limitations). See also In re Nordt Dev. Co., 881 F.3d 1371,1375-76, 125 USPQ2d 1817, 1820 (Fed. Cir. 2018)(holding "the specification demonstrates that ‘injected molded’ connotes an integral structure," and discussing several cases since Garnero that held "limitations to convey structure even when they also describe a process of manufacture").
In the instant case, the process steps appear to provide structure to the claims.
Specifically, the method steps provide structure characteristics to the final product in that 1-50% of the stem cells in the heterogeneous stem cell population express CD146 and the expression level of stemness genes CD146+ cells is significantly greater than CD146++ cells.
However, the process steps for culturing stem cells were known in the art before the effective filing date.
In particular, Zhao discloses a mesenchymal stem cell (MSC) population (Abstract, paragraphs [0001, 0009, 0012]).
Zhao discloses that this population is cultured in a medium comprising 58% DMEM/F12, 2% fetal calf serum (FCS, which is the same as fetal bovine serum (FBS), 10 ng/mL EGF (1.1. Culture and expansion of human adipose-derived MSCs), and 1X (1%) insulin-transferrin-selenous acid (ITS, a “cell culture supplement”) (paragraph [0039]). Zhao discloses that the cells were passaged (paragraph [0039]), and therefore are subcultured stem cells. The concentrations as disclosed by Zhao overlap with the claimed ranges as in claim 1. Thus, Zhao discloses the process steps as in claim 1.
In regards to expression of 1-50% expression of CD146 (which is noted is also referred to as MCAM or MUC18 in the art) in the stem cells, it is noted that this has been interpreted as referring to the phenotype of stem cells in the heterologous population after the process steps.
This interpretation is supported by the claims as amended (responsive to communications on 03/31/2025) which originally stated “in the heterologous stem cell population, the ratio of stem cells expressing CD146 is 1-50%.”
Thus, whether the stem cells in the heterologous population express CD146 is a property of the stem cells that arises as a result of the method steps.
While Zhao is silent as to whether 1-50% of the resulting stem cells express CD146, “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of an unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Additionally, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
In the instant case, the claims indicate that culturing stem cells according to the process steps of claim 1 are sufficient to provide a heterologous stem cell population comprising 1-50% of stem cells expressing CD146. Therefore, since Zhao discloses the claimed process steps as discussed above, 1-50% of the resulting population of stem cells would express CD146.
In fact, this is indicated in the instant specification which demonstrates that in the prior art (“MSC-FBS) express CD146 (see Fig. 1B).
The reasoning is the same for whether the resulting population of cells (which is noted would necessarily be heterogeneous since at least cells vary in regards to expression of CD146, but also because a person of ordinary skill in the art would have recognized that cell populations exhibit heterogeneity unless there is clonal isolation) express stemness markers MYC, KLF4, GMNN, SOX2, and NANOG, and indeed, the instant specification demonstrates that prior art method express these markers (see Fig. 1A).
In regards to the limitation “wherein the expression level of the stemness genes MYC, KLF4, GMNN, SOX2, and NANOG in the stem cells with CD146+ expression are significantly higher than those of the stem cells with CD146+++ expression; and wherein CD146+ specifies the ratio of stem cells expressing CD146 as being 1-50%, excluding 50%, and the CD146+++ specifies the ratio of stem cells expressing CD146 and being 50-100%, it is noted that, as above, this has been interpreted as referring to the properties of the stem cells in the heterologous population after the process steps.
The limitation “wherein CD146+ specifies the ratio of stem cells expressing CD146 as being 1-50%, excluding 50%, and the CD146+++ specifies the ratio of stem cells expressing CD146 and being 50-100%” has been interpreted as 1-50%, excluding 50% (thus, less than 50%) of the resulting stem cells expressing CD146 having a CD146+ phenotype and 50-100% of the resulting stem cells expressing CD146 as having a CD146++ phenotype. It is noted that in the art, it is known that CD146 is expressed in high and low amounts in CD146-positive stem cells.
As discussed above, since Zhang discloses the process steps as claimed, this specific ratio of CD146+ and CD146++ stem cells within the resulting population would be the natural consequence of the method of Zhang, and the expected result, absent evidence to the contrary.
In regards to claim 4, the claim only states that the heterogeneous stem cells “will be induced to differentiate” according to the method steps as in claim 1, but does not require a specific active step of differentiating cells. Thus, the claim has been interpreted as optional.
Therefore, Zhang anticipates the invention as claimed.
Conclusion
No claims are allowed.
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.
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/JOSEPH PAUL MIANO/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631