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 Claims
Applicant's response dated 10/01/2025 has been received and entered into the application file.
Claims 9-10, 17, 22, and 24-29 are pending. Claims 24-29 are new.
Claims 9-10 are currently amended and are examined on the merits.
Claims 17, 22, and 24-29 are withdrawn from consideration. Applicants previously elected Group 4, drawn to claims 9-10, without traverse.
Election/Restrictions – Election by Original Presentation
Newly submitted claims 24-29 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Independent claim 24 is directed to “A method of preparing the mammalian chondrocyte progenitor cell population of claim 9, comprising the following items (i) to (v): (i) inducing a mammalian primitive streak cell from a mammalian iPS cell, (ii) inducing a mammalian lateral plate mesoderm cell from the mammalian primitive streak cell, (iii) inducing a mammalian limb bud mesenchymal cell population consisting of single-peak cell population satisfying PRRXl positivity, CD44 positivity, CD140B positivity, and CD49f negativity from the mammalian lateral plate mesoderm cell, (iv) inducing the mammalian chondrocyte progenitor cell population from the mammalian limb bud mesenchymal cell population, and (v) determining whether the mammalian chondrocyte progenitor cell population satisfies conditions of CD90 positivity and CD140B positivity.”
Independent claim 25 is directed to “A method of preparing a mammalian chondrocyte or a mammalian cartilage tissue, comprising a step of inducing the mammalian chondrocyte or the mammalian cartilage tissue from the mammalian chondrocyte progenitor cell population of claim 9.”
Independent claim 26 is directed to “A method of preparing a mammalian chondrocyte or a mammalian cartilage tissue, comprising the following items (i) and (ii): (i) preparing a mammalian chondrocyte progenitor cell population induced from a mammalian iPS cell, having the same karyotype as the mammalian iPS cell, and consisting of single-peak cell population satisfying conditions of PRRXl positivity, CD90 positivity, and CD140B positivity by the method according to claim 24, and (ii) inducing the mammalian chondrocyte or the mammalian cartilage tissue from the mammalian chondrocyte progenitor cell population.”
The instant application is a 371. The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The shared technical feature among the claims is a mammalian chondrocyte progenitor cell population of claim 9. This technical feature is not a special technical feature as it does not make a contribution over the prior art over Lu (Journal of Bone and Mineral Research, 2011, 26(1): 209-219), as evidenced by GeneCards (PRRX1), Tang (PNAS, 2004, 101(26): 9607-9611), and Roson-Burgo (BMC Genomics, 2016, 17: 944) (see Claim Rejections - 35 USC § 102, below).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 24-29 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Interpretation
Claim 9 is drawn to a mammalian chondrocyte progenitor cell population. Absent a specific definition in the specification, the term “chondrocyte progenitor cell population” is given its broadest reasonable interpretation in the art, which is a cell population that exhibits differentiation capacity into chondrocytes.
Claim 9 is a product-by-process claim. Product-by-process claims are not limited to the
manipulations of the recited steps, only the structure implied by the steps. See MPEP 2113. In the instant
case, the method step of claim 9 (induced from a mammalian iPS cell, line 2) does not clearly impart additional structural limitations to the claimed mammalian chondrocyte progenitor cell population.
Claim 9 recites the limitation “having the same karyotype as the mammalian iPS cell” (lines 2-3). It is noted that a mammalian iPS cell may have a wild-type karyotype or display chromosomal aberrations.
Claim 9 recites the limitation “consisting of a single-peak cell population” (line 3). The specification does not define how a single-peak cell population is measured. Therefore, the broadest reasonable interpretation of the phrase single-peak cell population includes a population of two cells exhibiting a similar measured characteristic.
Therefore, claim 9 is interpreted as “A mammalian chondrocyte progenitor cell population, wherein in at least two cells satisfy the conditions of PRRX1 positivity, CD09 positivity, and CD140B positivity.”
Claim Rejections - 35 USC § 112(b)
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 9-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9, as amended, recites the phrase “consisting of a single-peak cell population satisfying conditions of PRRX1 positivity, CD90 positivity, and CD140B positivity” (lines 3-4). It is unclear whether this “single-peak cell population” refers to “a mammalian chondrocyte progenitor cell population” of lines 1-2, or whether “single-peak cell population” refers to a sub-population of cells within the mammalian chondrocyte progenitor cell population of lines 1-2.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(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.
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu (Journal of Bone and Mineral Research, 2011, 26(1): 209-219), as evidenced by GeneCards (PRRX1), Tang (PNAS, 2004, 101(26): 9607-9611), and Roson-Burgo (BMC Genomics, 2016, 17: 944).
Lu discloses that murine primary stromal cells and C3H10T1/2 cells express Prx1 (Abstract; Fig 2). GeneCards shows that Prx1 is an alias for PRRX1.
Lu discloses that primary marrow stromal cultures were obtained from young-adult C57BL/6 male mice (Materials and Methods, Cell Culture). Roson-Burgo shows that bone-marrow mesenchymal stromal/stem cells are positive for CD90 and CD140B (p 8, Table 1). Therefore, the PRRX1-positive primary bone-marrow stromal cells disclosed in Lu are also positive for CD90 and CD140B.
Tang shows that C3H10T1/2 cells are pluripotent stem cells, which are derived from mouse embryos and are functionally similar to mesenchymal stem cells (Abstract; p 9607, col 1, para 3). Roson-Burgo shows that CD90 and CD140b are molecular markers for MSCs and other stem cells (p 19, col 1, para 1). Therefore, the PRRX1-positive C3H10T1/2 cells disclosed in Lu are also positive for CD90 and CD140B.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lu (Journal of Bone and Mineral Research, 2011, 26(1): 209-219), as evidenced by GeneCards (PRRX1), Tang (PNAS, 2004, 101(26): 9607-9611), and Roson-Burgo (BMC Genomics, 2016, 17: 944), in view of Collins (US 2009/0029463 A1).
The teachings of Lu, as wells as the evidence of GeneCards, Tang, and Roson-Burgo, are set forth above. Lu anticipates claim 9.
Lu does not teach cryopreserving the mammalian chondrocyte progenitor cell population according to claim 9.
Collins teaches that chondrocyte progenitor cells can be cryopreserved to allow for long-term storage of the cells for therapeutic use (para 2, 18, 46).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mammalian chondrocyte progenitor cell population, as taught in Lu, by cryopreserving them, as taught in Collins. One of ordinary skill in the art would have been motivated to make this modification because Collin teaches that cryopreservation allows for long-term storage of the cells for therapeutic use. One of ordinary skill in the art would have had a reasonable expectation of successfully making this modification because Collins teaches that chondrocyte progenitor cells can be cryopreserved.
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 9-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (specifically, a natural phenomenon) without significantly more.
The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. Claim 9 is interpreted as “A mammalian chondrocyte progenitor cell population, wherein at least two cells satisfy the conditions of PRRX1 positivity, CD09 positivity, and CD140B positivity.”
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category. MPEP 2106.03. Here, the claims recite a mammalian chondrocyte progenitor cell population. Because a mammalian chondrocyte progenitor cell population is a composition of matter, the claims 9-10 fall within a statutory category. (Step 1: YES)
Step 2A, Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Because claims 9-10 recite a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception. MPEP 2106.04(c)(I). MPEP 2106.04(c)(I)(A). The markedly different characteristics analysis is performed by comparing the nature-based product limitation in the claim to its naturally occurring counterpart to determine if it has markedly different characteristics from the counterpart. MPEP 2106.04(c)(II).
Here, the closest natural counterpart to mammalian chondrocyte progenitor cell populations of claims 9-10 is a naturally occurring PRRX1+, CD90+, and CD140B+ mammalian chondrocyte progenitor cell population, per se. The art, as exemplified in Lu (Journal of Bone and Mineral Research, 2011, 26(1): 209-219), teaches that murine primary stromal cells and embryonic stem cells are positive for PRRX1 (Abstract; Fig 2). Roson-Burgo (BMC Genomics, 2016, 17: 944) shows that the cells taught in Lu are also positive for CD90 and CD140B (Table 1; p 19, col 1, para 1). The claimed mammalian chondrocyte progenitor cell population is identical to a naturally occurring mammalian chondrocyte progenitor cell population, thus there is no marked difference between the claim and product of nature. Accordingly, the claims recite a judicial exception, and the analysis must therefore proceed to Step 2A, Prong Two.
Step 2A, Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55.
Claim 9 does not integrate the product into a practical application because the claims are to a mammalian chondrocyte progenitor cell population, per se, and do not recite additional elements beyond the judicial exception. (Step 2A: NO)
Claim 10 is drawn to a mammalian chondrocyte progenitor cell population, which is cryopreserved. The additional element of a cryoprotectant does not integrate into the mammalian chondrocyte progenitor cell population, and therefore does not add a meaningful limitation to the claim. The cryoprotectant is merely a nominal or token extra-solution component of the claim and is nothing more than an attempt to generally link the product of nature to a particular technological environment. Therefore, the claim does not integrate the product into a practical application (Step 2A: NO).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05.
Claim 9 does not recite any elements in addition to the judicial exception of a mammalian chondrocyte progenitor cell population, so there are no additional elements that add significantly more to the judicial exception. (Step 2B: NO)
Claim 10 is drawn to a mammalian chondrocyte progenitor cell population, which is cryopreserved. The presence of a cryoprotectant does not alter the mammalian chondrocyte progenitor cell population. Luetzkendorf (Cryotherapy, 2015, 17: 186-198) teaches that cryopreservation does not alter the main characteristics, including viability, of human multipotent mesenchymal stromal cells (Abstract). The addition of a cryoprotectant to a cell population is a well-understood, routine, and conventional activity in the art. Therefore, the claim does not include additional elements that are sufficient to amount to significantly more (also known as an “inventive concept”) than the judicial exception of a mammalian chondrocyte progenitor cell population. (Step 2B: NO).
The claims are not patent eligible.
Response to Arguments
RE: Rejection of claims 9-10 under 35 U.S.C. 101
Applicant argues that “Michelis et al. does not disclose a mammalian chondrocyte progenitor cell population satisfying the condition of PRRXl positivity” (Remarks, p 6, para 5).
In response, Applicant's argument is persuasive. The updated rejection, as set forth above, uses a mammalian chondrocyte progenitor cell population satisfying the condition of PRRXl, CD90, and CD140B positivity, as taught in Lu. It is noted, however, that the thrust of the rejection remains the same.
Applicant argues that “the mammalian chondrocyte progenitor cell population of amended claim 9 is induced from a mammalian iPS cell, which is different from a naturally occurring counterpart” (Remarks, p 6, para 5).
In response, Applicant's arguments have been fully considered but are not persuasive. Claim 9 is drawn to a mammalian chondrocyte progenitor population, per se, not a method of producing said cell population. Therefore, the amendment to claim 9 to recite “induced from a mammalian iPS cell” (line 2) amounts to a product-by-process limitation, which does not carry patentable weight. See MPEP 2113.
Applicant argues that “because human cartilage progenitor cells (hCPCs) coexist with other cell types in the human body, the human body has no naturally occurring mammalian chondrocyte progenitor cell population "consisting of single-peak cell population satisfying conditions of PRRXl positivity, CD90 positivity, and CD140B positivity," as required by the pending claims” (Remarks, p 7, para 2).
In response, Applicant's arguments have been fully considered but are not persuasive. The specification does not define how a single-peak cell population is measured. Therefore, the broadest reasonable interpretation of the phrase single-peak cell population includes a population of two cells exhibiting a similar measured characteristic. Furthermore, the claim does not recite a human chondrocyte progenitor cell population, but a mammalian chondrocyte progenitor cell population (line 1). Therefore, two cells in a mammalian body that satisfy conditions of PRRXl positivity, CD90 positivity, and CD140B positivity read on the limitation of claim 9.
RE: Rejection of claims 9-10 under 35 U.S.C. 102
The rejection of claims 9-10 under 35 U.S.C. 102(a)(1) as being anticipated by Collins (US 2009/0029463 A1), as evidenced by NCBI (PDGFRB, Gene ID: 5159), is withdrawn in light of the amendment to claim 9, which requires that the cell population satisfies the condition of PRRX1 positivity.
The rejection of claims 9-10 under 35 U.S.C. 102(a)(1) as being anticipated by Michelis (Stem Cell Reports, 2018), as evidenced by NCBI (PDGCD140B FRB, Gene ID: 5159), is withdrawn in light of the amendment to claim 9, which requires that the cell population satisfies the condition of PRRX1 positivity.
The rejection of claim 9 under 35 U.S.C. 102(a)(1) as being anticipated by Braun (Am J Vet Res, 2010), is withdrawn in light of the amendment to claim 9, which requires that the cell population satisfies the condition of PRRX1 positivity.
RE: Rejection of claims 9-10 under 35 U.S.C. 103
The rejection of claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Michelis (Stem Cell Reports, 2018), as evidenced by NCBI (PDGFRB, Gene ID: 5159), in view of Collins (US 2009/0029463 A1), is withdrawn in light of the amendment to claim 9, which requires that the cell population satisfies the condition of PRRX1 positivity.
The rejection of claims 9-10 under 35 U.S.C. 103 as being unpatentable over Braun (Am J Vet Res, 2010), in view of Collins (US 2009/0029463 A1), is withdrawn in light of the amendment to claim 9, which requires that the cell population satisfies the condition of PRRX1 positivity.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Risa Takenaka whose telephone number is (571)272-0149. The examiner can normally be reached M-F, 12-7 EST.
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/RISA TAKENAKA/Examiner, Art Unit 1632
/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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