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 Application/Amendment/Claims
Applicant’s response filed 26 May 2026 has been considered. Rejections and/or objections not reiterated from the previous office action mailed 24 February 2026 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 33, 35, 36, 38, 40, 41, 43, 45, 47, 48, 52, 53, 60-71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 December 2024.
Applicant’s response of 26 May 2026 provides new claims 72-74. Claims 29, 31, 32, 56, 58, 59, and 72-74 are examined on the merits herein.
Applicant’s arguments submitted 26 May 2026 have been fully considered, but are moot in view of the new grounds of rejection set forth in the present Official action, which are necessitated by amendment to the claims.
Withdrawn Claim Rejections
The rejection of claims 29, 31, 32 and 56-59 under 35 U.S.C. 101 has been withdrawn in view of the amendment to require a cell-containing composition comprising a culture medium containing BMP4 and retinoic acid, and absent TGFβ and inhibitor thereof. A naturally occurring and developing thymus is considered to comprise TGFβ.
The rejection of claims 30 and 57 under 35 U.S.C. 112(a) for failing to comply with the written description requirement has been withdrawn in view of the cancellation of these claims.
The rejection of claims 30 and 32 under 35 U.S.C. 112(b) as being vague and/or indefinite has been withdrawn in view of the cancellation of claim 30, and the amendment to claim 32 to clarify that cells are derived from IPSCs.
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 29, 31 and 32 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. This is a new rejection, necessitated by applicant’s amendments to the claim submitted 26 May 2026.
Claim 29 has been amended to read: “[a]n in vitro, non-naturally occurring cell-containing composition consisting essentially of: a population of anterior foregut endoderm (AFE) cells and a medium containing bone morphogenetic protein 4 (BMP4), and retinoic acid (RA), wherein the medium is absent a transforming growth factor beta (TGFβ) inhibitor, and absent TGFP and the composition further comprises at least one in vitro derived third pharyngeal pouch (TPP) cell.”
Claim 31 has been amended to read: “[t]he cell-containing composition according to claim 29, wherein the at least one in vitro derived third pharyngeal pouch (TPP) cell comprises at least one of homeobox A3 positive (HOXA3+) and Eyes Absent Homolog 1 positive (EYA1+) or combination thereof of the at least one TPP cell.”
Claims 29 and 31 are rejected for mixing improper mixing of transitional phrasing. The phrase “consisting essentially of” excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931). Furthermore a claim which depends from a claim which "consists of" the recited elements or steps cannot add an element or step. See M.P.E.P. § 2111.03(II). Claim 29, due to the nominal exclusion of elements not recited in the claim due to the “consisting essentially of” transitional language, cannot thereafter recite components of the medium that are open to (i.e. “containing”) additional elements in the medium beyond the recited BMP4 and RA without running afoul of these guidelines. It may also not encompass the elements that are embraced by the recitation of “further comprising at least one in vitro derived third pharyngeal pouch (TPP) cell.” It is noted that “containing” is also considered open language that encompasses encompass unrecited elements as well. Claim 32 is included for importing these deficiencies by dependency while not being corrective.
Given the inconsistent use of transitional phrases discussed above, the remainder of the instant Official action interprets “consisting essentially of” to read as “comprising”. However, correction and/or explanation are required.
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 29, 31, 32, 56, 58, 59, and 72-74 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
This rejection is newly set forth, necessitated by applicant’s amendments to the claim submitted 26 May 2026.
Claim 29 and its dependents have been amended to require an in vitro non-naturally occurring cell containing composition “consisting essentially of” anterior foregut endoderm (AFE) cells, a medium containing BMP4 and retinoic acid (RA), absence of TGFβ and a TGFβ inhibitor, and at least one in vitro derived third pharyngeal pouch (TPP) cell.
Claim 72 recites the same with “comprising” transitional language, and further excludes exogenous or non-naturally occurring HOXA3 or FOXN1.
The subject matter of claims 29, 31, 32, 56, 58, 59, 72, 73, and 74 was not described in the specification in such a way as to reasonably convey to one of ordinary skill in the art that the inventor had possession of the claimed invention as of the filing date.
With regard to independent claims 29 and 72, the specification describes a stepwise differentiation protocol and related cell populations at different developmental stages, rather than the presently claimed single, unified composition comprising all of the recited elements in the claimed configuration. The disclosure is directed to the generation of AFE cells, TPP cells, TEP cells, and TECs through successive culture stages, and does not clearly describe a single composition containing, in the same composition, the exact combination of:
anterior foregut endoderm (AFE) cells,
a medium containing BMP4 and retinoic acid (RA),
absence of TGFβ and a TGFβ inhibitor,
at least one in vitro derived third pharyngeal pouch (TPP) cell, and
the further negative exclusion of exogenously provided HOXA3 and FOXN1 (pertinent to claim 72).
Although the claims employ open-ended language such as “comprising” or “consisting essentially of,” the written description requirement is not satisfied merely because additional unrecited elements may be present. Rather, the specification must convey possession of the claimed combination itself. Here, the disclosure does not reasonably describe the claimed combination as a single, unified composition having the presently claimed boundaries. In particular, the requirement for a singular composition to comprise 2 different cell types that the specification appears to disclose are generated through stepwise derivation. Should applicant disagree, applicant is invited to show with particularly by page and line number were support exists for a singular composition comprising or consisting essentially of these 2 cell types with the claimed medium for reconsideration.
Further, the specification appears to disclose embodiments in which exogenous recombinant HOXA3 and/or FOXN1 are affirmatively added to certain differentiation conditions. For example, the disclosure describes culture conditions including recombinant FOXN1 and recombinant HOXA3 to enhance thymic differentiation. Accordingly, the specification does not clearly support a claim directed to a composition that is affirmatively recited as being absent non-naturally occurring or exogenously provided HOXA3 and FOXN1, while still comprising both AFE and TPP cells in a singular composition because the disclosure teaches those factors in at least some embodiments as added components.
Accordingly, the elements are not expressly and unambiguously disclosed as a single composition in the application as filed. The specification instead describes separate stages and separate culture conditions, while failing to disclose AFE cells and TPP cells in a single composition. Thus, the presently claimed composition represents an impermissible extraction and recombination of features from disparate portions of the disclosure. As it is, the claimed invention appears to require impermissible picking and choosing to identify a combination that is not readily envisaged from the instant disclosure. Accordingly, claims 29 and 72 are rejected as containing new matter.
Dependent claims 31, 32, 56, 58, 59, 73, and 74 fall with claim 29 or claim 72, as appropriate, because they depend therefrom and recite additional limitations that do not cure the deficiency in written description.
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.
Claim(s) 29, 31, 32, 56, 58, 59, 73 and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Su et al., M., Hu, R., Jin, J. et al. Efficient in vitro generation of functional thymic epithelial progenitors from human embryonic stem cells. Sci Rep 5, 9882 (2015), of record. This is a new rejection necessitated by amendment to the claims provided 26 May 2026. Any aspect of Applicant’s traversal as it relates to the rejection is newly set forth is provided below.
This rejection is predicated on the following findings. First, it if it is reiterated from above that “consisting essentially of” has been interpreted as “comprising” in view of the improper mixed use of transitional phrases as discussed further in the rejection under 35 U.S.C. 112(b) above. M.P.E.P. § 2111.03(II) states that for the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355. Second, to the extent that it may be argued that the instant disclosure necessarily teaches a combination of AFE cells and TPP cells with a differentiation medium in a single unified composition, the instant rejection is considered proper insofar as Su teaches the same stepwise differentiation process using the same cells and differentiating medium, and would thus contain the same composition as claimed presently.
Regarding claim 29, Su teaches a differentiation protocol that results in the generation of cell-containing compositions comprising 3rd pharyngeal pouch cells. Figure 1 of Su presents a schematic of their differentiation protocol. hESCs were induced to generate DE that further developed into TEPs in the presence of BMP4 + FGF7 + FGF10 + EGF + RA (BFFER), rFOXN1 (100 ng/ml) and rHOXA3 (200 ng/ml).
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Su teaches that they first induced the differentiation of hESCs into DE that was further induced to develop into TEPs. Su teaches: “[a]lthough our protocol does not include separate steps that direct the differentiation of DE into the third PPE, or anterior foregut endoderm (AFE) and ventral pharyngeal endoderm (VPE) [references omitted], our kinetic analysis of the expression genes related to PPE and TEPs indicates that on days 9–11 the DE developed into the third PPE or VPE which then further developed into TEPs on day 14. (1st ¶ of discussion). Su does not teach the use of TGFβ or an inhibitor thereof.
Regarding claims 31 and 56, Su evidences that TPP cells express HOXA3, FOXN1 and EYA1. See image above provided in the rejection of claim 29, right column.
Regarding claims 32, 58, 59, 73 and 74, it is noted that these limitations include method steps by which the AFE cells are “derived from…IPSCs”. The “derived from” language in these claims describes a process step (i.e. “derived”) that defines a composition (i.e. “AFE cell”). Furthermore, since the process step is recited in the past tense, it is not required to be performed in the present claims. Thus, in the context of the claimed requirement for the AFE cell to be “derived from” an IPSC, the “product” AFE cell (derived from the “process” of derivation from an IPSC) is limiting only to the extent that such a process confers a structural or functional difference to the recited AFE cell. Since an AFE cell derived from the ESC of Su is not distinguishable from the AFE cell recited presently, the AFE cells derived from the ESC of Su is considered to meet the limitation of the presently recited AFE cell that is “derived from” an iPSC.
Response to Traversal
Applicant’s response to the rejection over Sun as previously set forth has been fully considered. To the extent that such arguments may applied to the rejection over Sun as newly set forth, such arguments are not persuasive for the reasons set forth below.
Regarding claim 29, Applicant argues that Su fails to teach the presently claimed cell-containing composition because Su is directed to a differentiation protocol rather than a composition, and because Su uses additional factors such as FGF7, FGF10, EGF, rFOXN1, and rHOXA3.
These arguments are unpersuasive. As explained in the rejection, the claimed “consisting essentially of” language is construed as “comprising” in view of the improper mixed use of transitional phrases and the absence of a clear indication of the basic and novel characteristics in the claim language. Accordingly, claim 29 is not limited to a closed composition excluding additional ingredients or steps.
Further, Su expressly teaches a cell-containing composition resulting from the same stepwise differentiation pathway, beginning with hESCs and proceeding through DE, third PPE, and TEPC/TPP-like cells. Su states that: “…on days 9–11 the DE developed into the third PPE or VPE which then further developed into TEPs on day 14.”
Thus, Su discloses the claimed composition containing a population of anterior foregut endoderm/third pharyngeal pouch lineage cells and a differentiation medium used to generate those cells. The fact that Su additionally discloses other factors does not remove the disclosure from the scope of the present claim, particularly where the claim is construed broadly as a composition comprising the recited components.
Applicant’s argument that Su does not teach the claimed absence of TGFβ or a TGFβ inhibitor is also not persuasive. Su’s protocol does not require TGFβ or a TGFβ inhibitor as an operative component of the disclosed differentiation scheme. The claim is therefore met by Su’s disclosed composition and culture conditions.
Regarding claims 31 and 56, Applicant contends that Su does not teach the recited HOXA3, FOXN1, and EYA1 features. This is not persuasive.
Su expressly teaches that the third PPE / TEP-like cells express these markers. In particular, Su’s Figure 1 and associated text show expression of HOXA3, EYA1, FOXN1. Accordingly, Su discloses the very TPP/TEP marker profile recited in claims 31 and 56. The fact that these are developmental markers associated with a staged differentiation protocol does not negate anticipation where the disclosed cells are the same cell population recited in the claims.
Regarding claims 32, 58, 59, 72, and 73, Applicant argues that the recitations relating to AFE cells “derived from” iPSCs are limiting and that Su does not teach iPSC-derived AFE cells. This argument is not persuasive. As set forth in the rejection, the “derived from” language is a product-by-process limitation. Under well-settled law, patentability of a product claim is based on the product itself, not the process by which it is made, unless the recited process imparts a structural or functional difference to the product. Applicant has not shown, and the present disclosure does not establish, that an AFE cell derived from an iPSC is structurally or functionally distinct from an AFE cell otherwise obtained by the same differentiation lineage disclosed in Su.
Su discloses the same developmental lineage and the same resulting intermediate cell types. Thus, to the extent claims 32, 58, 72, and 73 recite cells “derived from” iPSCs, that recitation does not impart a patentable distinction absent evidence of structural or functional difference. None has been shown.
With respect to claim 59, Su’s disclosed protocol likewise meets the limitation that the medium is absent a TGFβ activator. Su does not disclose the inclusion of a TGFβ activator in the differentiation medium. The fact that Su teaches a different set of signaling factors does not exclude anticipation where the claimed absence limitation is satisfied by the disclosed medium composition.
For at least the foregoing reasons, Applicant’s traversal is not persuasive. Su teaches or inherently discloses the presently claimed cell-containing composition, including the recited developmental lineage, marker expression, and medium conditions. The claims remain anticipated under 35 U.S.C. 102(a)(1) by Su.
Claims 29, 31, 32, 56, 58, 59, 72, 73, and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al., Cell Stem Cell 13, 230-236 (2013), of record. This is a new rejection necessitated by amendment to the claims provided 26 May 2026. Any aspect of Applicant’s traversal as it relates to the rejection is newly set forth is provided below.
As above, this rejection is predicated on the finding that, to the extent that it may be argued that the instant disclosure necessarily teaches a combination of AFE cells and TPP cells with a differentiation medium in a single unified composition, the instant rejection is considered proper insofar as Sun teaches the same stepwise differentiation process using the same cells and differentiating medium, and would thus contain the same composition as claimed presently.
Furthermore the present rejection is made in view of the claim interpretation set forth above, including the determination that:
the transitional phrase “consisting essentially of” in claim 29 is construed, for purposes of the present record, as “comprising” in light of the mixed and inconsistent use of transitional phrases and the absence of a clear indication of the basic and novel characteristics of the composition; and
the recitations relating to cells “derived from” iPSCs are treated as product-by-process limitations that do not further limit the composition absent a showing of a structural or functional distinction imparted by the recited derivation.
Accordingly, the presently pending claims are properly read on a cell-containing composition comprising AFE cells and a medium containing BMP4 and RA, and further comprising at least one in vitro derived TPP cell, with the additional limitations of the dependent claims likewise satisfied, as explained below.
Claim 29 recites an in vitro, non-naturally occurring cell-containing composition comprising a population of anterior foregut endoderm (AFE) cells and a medium containing BMP4 and retinoic acid (RA), wherein the medium is absent a TGFβ inhibitor and absent TGFβ, and further comprising at least one in vitro derived third pharyngeal pouch (TPP) cell.
Sun teaches a stepwise differentiation protocol that generates thymic epithelial progenitor-like cells from hESCs by sequential exposure to developmental signaling cues, including Activin A, RA, BMP4, and WNT3a, and discloses that the DE cells further develop into the third PPE and then into TEPCs/TEPLCs. Sun expressly states in the Discussion subsection, immediately after the Results section describing the differentiation protocol: “on days 9-11 the DE developed into the third PPE or VPE which then further developed into TEPCs on day 14.”
Sun further discloses the use of RA and BMP4 in the directed differentiation scheme, and the claim, as construed, does not require exclusion of additional factors beyond those expressly recited. To the extent the claim recites absence of TGFβ and TGFβ inhibitor, Sun does not require those materials in the disclosed differentiation composition. Accordingly, Sun anticipates claim 29.
Claim 31 depends from claim 29 and recites that the at least one in vitro derived TPP cell comprises at least one of HOXA3+ and EYA1+, or a combination thereof.
Sun expressly teaches that the third PPE / TEPC-like cells express HOXA3 and EYA1. In particular, Sun’s Figures 1 and 2 and associated text show that these markers are induced during the stepwise differentiation process and are associated with the third PPE/TEPC population. Thus, Sun discloses the recited marker profile and anticipates claim 31.
Claim 32 depends from claim 29 and recites that the population of AFE cells are derived from a population of iPSCs comprising and wherein the iPSCs are derived from a population of HSCs, lymphocytes, PBMCs, cells isolated from cord blood, or somatic cells or a combination thereof.
As set forth above, the “derived from” language is treated as a product-by-process limitation. Sun teaches the same developmental lineage and the same intermediate cell populations arising through directed differentiation. The source of the pluripotent cell, standing alone, does not impart a structural distinction to the recited AFE cell population absent evidence of a patentably distinct product. No such distinction is shown on this record. Accordingly, the claim is anticipated by Sun.
Claim 56 depends from claim 31 and recites that the at least one TPP cell comprises at least one FOXN1+ TPP cell.
Sun expressly teaches FOXN1 expression in the thymic epithelial progenitor-like cells generated by the disclosed protocol. The reference describes FOXN1 as a key thymic marker induced during the differentiation process and further identifies FOXN1 as part of the thymic epithelial progenitor phenotype. Therefore, Sun anticipates claim 56.
Claim 58 depends from claim 32 and recites that the iPSCs are generated from a population of CD34+ HSCs, lymphocytes, PBMCs, cells isolated from cord blood, or somatic cells or a combination thereof.
As with claim 32, the recitation of derivation from iPSCs is treated as a product-by-process limitation that does not further distinguish the claimed composition absent a structural difference. Sun discloses the same type of thymic developmental progression and resulting cell-containing composition. The additional source limitation does not patentably distinguish the claimed composition on this record. Claim 58 is therefore anticipated.
Claim 59 depends from claim 29 and recites that the medium is absent a TGFB activator.
Sun does not disclose a TGFB activator as part of its differentiation medium. The reference teaches a culture scheme directed to generating third PPE / TEPC-like cells using the recited developmental factors, and does not require TGFB activation. Accordingly, Sun anticipates claim 59.
Claim 72 recites an in vitro, non-naturally occurring cell-containing composition comprising AFE cells and a medium containing BMP4 and RA, wherein the medium is absent a TGFβ inhibitor and absent TGFβ, and further comprises at least one in vitro derived TPP cell, and wherein the composition is absent non-naturally occurring or exogenously provided HOXA3 and FOXN1.
Sun discloses the same developmental pathway and the same cell populations generated without the addition of exogenous HOXA3 or FOXN1 as required by the claim. Sun’s protocol relies on endogenous developmental progression to third PPE / TEPC-like cells rather than a composition that requires exogenous HOXA3 or FOXN1 to define the resulting cell population. Sun therefore anticipates claim 72.
Claim 73 depends from claim 58 and recites that the population of iPSCs comprises a population of iPSCs obtained from a subject to be treated. Claim 74 depends from claim 73 and recites that the iPSCs are derived from one or more of the subject’s skin, uterus, kidney, liver, muscle, adrenal glands, and blood.
These source limitations are likewise treated as product-by-process limitations with no demonstrated structural distinction in the claimed cell-containing composition. Sun teaches the same directed differentiation of pluripotent stem cells into thymic epithelial progenitor-like cells and resultant thymic lineage composition. The recited source of the pluripotent cells does not impart patentable distinction absent evidence of a structurally different product. Claims 73 and 74 are therefore anticipated by Sun.
For the reasons set forth above, claims 29, 31, 32, 56, 58, 59, 72, 73, and 74 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Sun et al.
Response to Traversal
Applicant’s response to the rejection over Sun as previously set forth has been fully considered. To the extent that such arguments may applied to the rejection over Sun as newly set forth, such arguments are not persuasive for the reasons set forth below.
Applicant argues that Sun fails to teach or render obvious the amended composition of claim 29 because, inter alia, Sun allegedly requires additional factors such as FGF7, FGF10, EGF, rFOXN1, and rHOXA3, and therefore does not disclose the presently claimed composition comprising AFE cells, BMP4, RA, and at least one in vitro derived TPP cell.
This argument is not persuasive. As set forth in the newly set forth rejection, claim 29 is construed in light of the mixed and inconsistent transitional language and, for purposes of examination, the “consisting essentially of” language is treated as not excluding additional material where the basic and novel characteristics are not clearly delineated. Accordingly, the presence in Sun of additional factors does not preclude anticipation where Sun otherwise teaches the claimed cell-containing composition and the same developmental lineage.
Sun expressly teaches a stepwise differentiation protocol that proceeds from hESCs through DE and the third PPE toward thymic epithelial progenitor-like cells, and further teaches that: “on days 9-11 the DE developed into the third PPE or VPE which then further developed into TEPCs on day 14.” See Discussion subsection, immediately after the Results section describing the differentiation protocol.
Sun also expressly teaches the use of RA and BMP4 in the directed differentiation of thymic epithelial progenitor-like cells. The fact that Sun includes additional signaling factors in the broader protocol does not remove the disclosed composition from the scope of the presently claimed invention, particularly where the claim is not limited to a closed composition excluding such additional factors. Applicant’s position therefore does not overcome the rejection.
Applicant further contends that Sun does not teach the absence of TGFβ or a TGFβ inhibitor. This argument is likewise unpersuasive. Sun does not require TGFβ or a TGFβ inhibitor as part of the disclosed differentiation composition. The claim recites the absence of such materials, and Sun is not inconsistent with that limitation. Therefore, the claimed composition remains anticipated.
Applicant argues that Sun does not teach the recited HOXA3, EYA1, and FOXN1 features. This argument is not persuasive.
Sun expressly teaches that the third PPE / TEPC-like cells express the same thymic developmental markers recited in the claims. In particular, Sun’s Figures 1 and 2 and associated text show induction and/or expression of HOXA3, EYA1, and FOXN1 during the stepwise differentiation process. Applicant’s attempt to distinguish the claims based on the developmental context of those markers does not overcome the fact that Sun teaches the recited marker-positive thymic progenitor-like cell population.
Applicant argues that the recitations relating to AFE cells derived from iPSCs are not taught by Sun because Sun is directed to hESC-derived cells. This argument is not persuasive.
As explained in the rejection, the “derived from” language is treated as a product-by-process limitation. The patentability of a product does not depend on its source or method of derivation unless the recited derivation imparts a structural or functional difference to the product. Applicant has not shown such a distinction. Sun teaches the same thymic developmental lineage and the same resulting thymic progenitor-like cell population. The fact that Sun uses hESCs rather than iPSCs does not, by itself, avoid anticipation where the claimed product is otherwise met and no patentably distinct structure is recited.
Applicant argues that Sun fails to teach a medium absent a TGFB activator.
This argument is not persuasive. Sun does not disclose a TGFB activator as a required component of the disclosed differentiation medium. The claimed absence limitation is therefore not sufficient to distinguish over Sun.
Applicant’s arguments with respect to claims 72, 73, and 74 are likewise unpersuasive for the same reasons set forth above.
Claim 72 recites the same basic cell-containing composition as claim 29, with the additional exclusion of exogenous HOXA3 and FOXN1. Sun teaches endogenous expression of the relevant thymic lineage markers during differentiation and does not require the composition to include exogenous HOXA3 or FOXN1 as a structural limitation of the resulting cell-containing composition.
Claims 73 and 74 recite additional source limitations regarding the iPSCs. As explained previously, these are treated as product-by-process limitations and do not impart a patentable distinction absent evidence of a structural difference in the claimed composition. Applicant has not shown that the source of the iPSCs changes the claimed cell-containing composition in a way that distinguishes over Sun.
For the reasons set forth above, Applicant’s traversal is not persuasive. Sun discloses the presently claimed cell-containing compositions and the recited thymic lineage progression, including the relevant marker-positive cell populations and culture conditions. The rejection of claims 29, 31, 32, 56, 58, 59, 72, 73, and 74 under 35 U.S.C. 102(a)(1) as anticipated by Sun et al. is therefore considered proper.
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.
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J. Douglas SCHULTZ
Supervisory Patent Examiner
Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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