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 .
Claim Status
Claims 1-12 are pending.
Claims 7-12 are withdrawn.
Claims 1-6 are under examination.
Election/Restrictions
Applicant’s election with traverse of the following invention
Invention
Group I, claims 1-6, drawn to a method for producing an insulin-positive cell population, comprising culturing and differentiating a pancreatic progenitor cell population or a cell population at a later stage of differentiation in a medium containing a factor having ALK5-inhibiting activity and CDK8/19- inhibiting activity, wherein the medium contains substantially no 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine,
in the reply filed on 16th, September, 2026 is acknowledged.
Applicant’s traversal is on the grounds that “Yamamoto et al. teaches the use of ALK5 i II in the culture medium. It is well known to those skilled in the art that ALK5 i II is 2-(3-(6-methylpyridin-2-yl)-lH-pyrazol-4-yl)-l,5- naphthyridine (see paragraph [0005] of the present specification). The restriction requirement appears to not have recognized that ALK5 i II corresponds to 2-(3-(6-methylpyridin-2-yl)-lHpyrazol- 4-yl)-l,5-naphthyridine, which may have led to the above conclusion. In sum, because the special technical feature of the present invention is not disclosed in Yamamoto et al.” (pg. 1-2).
In response, this is not found persuasive because the technical features is disclosed by Sakuma et al. (Stem Cell Res Ther. 2023 Jan 5;14(1):1.; see IDS filed 30th, August, 2024; henceforth “Sakuma”) below, for the reasons set forth below (see rejection under 35 U.S.C. 102 below). Therefore, the Groups still lack Unity of Invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
The instant Application is a 371 of PCT/JP2023/016110 filed on 04/24/2023 which claims priority to Foreign Application JAPAN 2022-071507 filed on 04/25/2022. While a certified copy of the foreign priority Application has been provided, a certified English translation of the document has not been provided.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus the instant claims are being given the filing date of PCT/JP2023/016110 filed on 24th, April, 2023.
Objections to Specification
Browser Executable Code
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (“https://panglaodb.se/” para. [0174]). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
This objection would be overcome if the embedded hyperlink and/or other form of browser-executable code is removed, or the reference to the website is amended to be limited to the top-level domain name.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 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.
The purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). To satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.04.
For a claim to a genus, a generic statement that defines a genus of substances by only their functional activity does not provide an adequate written description of the genus. Reagents of the University of California v. Eli Lilly, 43 USPQ2d 1398 (CAFC 1997).
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include a disclosure of a representative number of species to describe the complete structure of the claimed genus and/or disclosure of a complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, and any combination thereof.
The specific issue is that claim 1 encompasses a single factor having ALK5-inhibiting activity and CDK8/19- inhibiting activity which Applicant does not show possession of for the reasons stated below. Claims 2-6 are also rejected by nature of their dependency on claim 1.
Breadth of the Claims
Instant claims encompass “a factor having ALK5-inhibiting activity and CDK8/19- inhibiting activity” (instant claim 1).
In light of the instant specification, the recitation of “a factor” encompasses a single inhibitor or multiple inhibitors (para. [0031] “one (or single) inhibitor having both ALK5-inhibiting activity and CDK8/19-inhibiting activity” or “combination of a plurality of factors consisting of a factor having ALK5-inhibiting activity (ALK5 inhibitor) and a factor having CDK8/19-inhibiting activity (CDK8/19 inhibitor).
Disclosure of Structure and Disclosure of Species
Concerning the single inhibitor specifically encompassed by Applicant’s claims having ALK5-inhibiting activity and CDK8/19- inhibiting activity, Applicant discloses one specific species that is 2-(3-(6-
methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine which is also known as the names RepSox, ALK5 i II, or ALK5 Inhibitor II (para. [0005, 0007, 0009-0010, 0030-0031, 0046, 0056, 00148, 0151, 0153, 0157-0158, 0161-0165, 0167-0168, 0171, 0175, 0177-0178, 0181]0. However, this specific species is excluded from the claim as “substantially no 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine” (claim 1).
The instant specification and the prior art appear to be silent to additional single specific inhibitors that include both ALK5-inhibiting activity and CDK8/19- inhibiting activity. In other words, the inhibitor of 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine which is also known as the names RepSox, ALK5 i II, or ALK5 Inhibitor II disclosed by Applicant and specifically excluded from the claims appears to be the only single specific inhibitors that include both ALK5-inhibiting activity and CDK8/19- inhibiting activity.
Functional Characteristics and Structure/Function Correlation
Applicant’s specification teaches ALK5iII is a commercially available ALK5 inhibitor and is a derivative of naphthyridine (Figure 1) (para. [0157]) and also discloses a single structural analog of ALK5iII (2-(3-(pyridin-3-yl)-1H- pyrazol-4-yl)quinoxaline) (para. [0157]). However, Applicant discloses the structural analog of ALK5iII (2-(3-(pyridin-3-yl)-1H- pyrazol-4-yl)quinoxaline exhibited no ALK5-inhibiting activity.
Applicant’s specification teaches ALK5iII has ALK5-inhibiting activity and CDK8/19- inhibiting activity (para. [0005, 0007, 0009-0010, 0030-0031, 0046, 0056, 00148, 0151, 0153, 0157-0158, 0161-0165, 0167-0168, 0171, 0175, 0177-0178, 0181]0). However, as stated above, this species is excluded from the claims.
Written Description - Conclusion
Therefore, because the only single inhibitor disclosed by Applicant is excluded by the claims, the specification further evidences that analogs of the inhibitors do not possess the expected function, and further the art is silent to additional single inhibitors that meet this function, Applicant cannot have possession of single inhibitors that inhibit both Alk5 and CDK8/19. Applicant has disclosed 0 species of this genus, and Applicant fails to disclose required structural features or a structure/function correlation that would show possession of this genus. The state of the art does not remedy these issues.
Therefore, the examiner concludes there is insufficient written description support for the instantly claimed genera. Specifically, there is no support for single inhibitors of both Alk5 and CDK8/19. For the reasons set forth above. Further, the specification fails to provide a nexus between the structure of the claimed single factor and the required function of inhibiting both Alk5 and CDK8/19. This is not remedied by the state of the art. Thus, in the face of an unpredictable art, one of ordinary skill in the art could not envision the requisite structural elements and the elements that could be modified from the disclosures of the application or art at the time of filing.
Therefore, in view of the above, while Applicant does not have possession of single inhibitors. Only methods wherein the factor having ALK5-inhibiting activity and CDK8/19-inhibiting activity comprises an ALK5 inhibitor and a CDK8/19 inhibitor, and not the full breadth of the claims is supported by Applicant’s specification.
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 1-6 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 1 recites the subjective terminology “substantially” which renders the metes and bounds of the claim unclear and makes the scope of the claim indefinite. A claim may be rendered indefinite by reference to subjective term or phrase (see MPEP 2173.05(b), IV). In the instant case, the specification does provide a definition of the subjective phrase as ‘“Contain substantially no ALK5iII" described about the medium of the present invention means that the medium does not contain ALK5iII in a form that exerts arbitrary activity including ALK5-inhibiting activity, and does not necessarily mean that the medium does not contain any ALK5iII”’ (para. [0032]), which is not sufficient to make the scope of the phrase clear. Specifically, the definition includes terminology this is also subjective including “arbitrary activity” which are not specifically defined and make the scope of the definition unclear. Therefore, because the term “substantially” is not defined by the claim, and the specification does not provide a clear standard for measuring the scope of the term, the term renders the claim indefinite and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Furthermore, the definition provided in the specification creates additional clarity because it states that “the medium does not contain ALK5iII in a form that exerts arbitrary activity including ALK5-inhibiting activity” which appears to encompass mediums that contain ALK5iII that exerts activity in amount other than arbitrary activity, and would include ALK5iII in a medium exerting normal or expected activity. However, because the claim appears to attempt exclude ALK5iII, this disparity in possible interpretation creates a clarity issue that renders the claim indefinite.
By nature of their ultimate dependency on claim 1, claims 2-6 are also rejected.
Generally, when the claims are indefinite, vague or unclear, they cannot be construed without speculation or conjecture; therefore, the indefinite claims are not treated on the merits with respect to prior art. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.); see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably definite meaning can be ascribed to certain terms in the claim, the subject matter does not become obvious-the claim becomes indefinite."). Notwithstanding Steele, the Office has made every attempt to construe the claims in what the Office believes is the intent of the Applicants in the interest of compact prosecution.
Claim Interpretation
Claim 1 recites “a factor having ALK5-inhibiting activity and CDK8/19- inhibiting activity.” From para. [0031] that this may encompass “one (or single) inhibitor having both ALK5-inhibiting activity and CDK8/19-inhibiting activity” or “combination of a plurality of factors consisting of a factor having ALK5-inhibiting activity (ALK5 inhibitor) and a factor having CDK8/19-inhibiting activity (CDK8/19 inhibitor)” (instant specification para. [0031]).
Therefore, in light of the specification, the claimed term “ a factor” is interpreted to encompass one inhibitor factor or a combination of a plurality of factors.
Claim 1 recites the phrase “pancreatic progenitor cell population or a cell population at a later stage of differentiation” which is specifically defined by the specification as follows:
“pancreatic progenitor cell population or cell population at a later stage of differentiation" means a pancreatic progenitor cell population, an endocrine progenitor cell population, or an insulin-positive cell population, or two or more cell populations selected from a pancreatic progenitor cell population, an endocrine progenitor cell population, and an insulin-positive cell population” (para. [0057]).
Instant claims are interpreted accordingly.
Therefore, the claims have been given the their broadest reasonable interpretation consistent with the specification (see MPEP 2111).
Due to the 112b issues above, in claim 1, for the sake of compact prosecution, the phrase “substantially no 2-(3-(6-methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine” is interpreted to exclude 2-(3-(6-methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine from the medium recited in the claimed method.
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.
Claims 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakuma et al. (Stem Cell Res Ther. 2023 Jan 5;14(1):1.; see IDS filed 30th, August, 2024; henceforth “Sakuma”).
Regarding claim 1, Sakuma discloses a method for producing an insulin-positive cell
population, comprising culturing and differentiating a cell population at a later stage of differentiation (pancreatic islet cell and “iPICs that were exposed to… a combination of SB431542 and senexin B (SB/Sen-cells)” pg. 7 col. 2) in a medium containing a factor having ALK5-inhibiting activity and CDK8/19- inhibiting activity (“at Stages 5-7 is replaced with ALK5 inhibitors, CDK8/19 inhibitors, and their combination, as alternatives to ALK5iII” pg. 2 col. 2; Methods “Cell culture and in vitro differentiation of hiPSCs”; Figures 2-5), wherein the medium contains substantially no 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine (“in the absence of ALKSill” abstract; results).
Regarding claim 2, further to the discussion of claim 1 above, as stated above (see claim 1 rejection above), Sakuma discloses the factor having ALK5-inhibiting activity and CDK8/19-inhibiting
activity comprises an ALK5 inhibitor and a CDK8/19 inhibitor (ALK5 inhibitors, CDK8/19 inhibitors, and their combination, as alternatives to ALK5iII” pg. 2 col. 2; Methods “Cell culture and in vitro differentiation of hiPSCs”; Figures 2-5; and specifically “a combination of SB431542 and senexin B (SB/Sen-cells)” pg. 7 col. 2).
Regarding claims 3 and 5, further to the discussion of claims 1-2 above, as stated above (see claims 1-2 rejection above), Sakuma discloses the CDK8/19 inhibitor is senexin B (“a combination of SB431542 and senexin B (SB/Sen-cells)” pg. 7 col. 2)), which is the same as 4-((2-(6-4- methylpiperazine-1-carbonyl)naphthalen-2- yl)ethyl)amino)quinazoline-6-carbonitrile.
Regarding claim 4, further to the discussion of claims 1-2, above, as stated above (see claims 1-2 rejection above), Sakuma discloses the ALK5 inhibitor is SB431542 (pg. 7 col. 2) which is the same as 4-[4-(l,3-benzodioxol-5-yl)-5-(2-pyridinyl)-lH-imidazol-2-yl]-benzamide.
Regarding claim 6, further to the discussion of claim 1 above, Sakuma discloses the cell
population at a later stage of differentiation (pancreatic islet cel) is a cell population produced by the induction of differentiation from pluripotent stem cells (Methods “Cell culture and in vitro differentiation of hiPSCs” pg. 3 col. 1- pg. 3 col 1).
Accordingly, Sakuma anticipates instant claims.
Pertinent Art
Osafune
The prior art of Osafune et al. (US-2019/0390169-A1; see IDS filed 30th, August, 2024; henceforth “Osafune”) is considered pertinent to Applicant’s disclosure.
Regarding claims 1-2, Osafune discloses a method for producing pancreatic progenitor cells comprising culturing and differentiating NKX6.1-negative cells in a medium containing a factor having CDK8/19-inhibiting activity (“method for producing pancreatic progenitor cells, comprising causing the action of a factor having the inhibitory activity for cyclin-dependent kinase 8 and/or cyclin-dependent kinase 19 (hereinafter, also abbreviated to CDKS/19)”; abstract; see also “culturing NKX6.1-negative cells in the presence of a factor having CDK8/19-inhibiting activity” para. [0009]; see also para. [0054, 0103]; Figure 1). Osafune discloses the NKX6.1-positive and PDX-1-positive cells differentiate into βcells which may produce insulin (para. [0142).
Osafune does not disclose the cell population culture is a pancreatic progenitor cell population or a cell population at a later stage of differentiation (the NKX6.1-negative cells disclosed by Osafune are an earlier stage of differentiation). Osafune does not disclose the medium includes a factor having ALK5-inhibiting activity. Osafune does not disclose the medium contains substantially no 2-(3-(6-methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine.
Yamazoe
The prior art of Yamazoe et al. (CA-3097962-A1; published 31st, October, 2019; henceforth “Yamazoe”), made of record but not relied upon, is considered pertinent to Applicant’s disclosure.
Yamazoe discloses a method for producing an insulin-positive cell population (“method for producing an insulin-producing cell population or a pancreas β cell population”; abstract), comprising culturing and differentiating posterior foregut cells in a medium containing a factor having CDK8/19- inhibiting activity (“factor having CDKS/19-inhibiting activity" para. [0031]; see “step 4” para. [0058, 0078-0079]), wherein the medium contains substantially no 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine (“ALK5 inhibitor II” the step 4 medium disclosed by Yamazoe does not include this but it is included in a different medium in step 5; see para. [0089]).
Yamazoe does not disclose the cells cultured and differentiated in the medium are a pancreatic progenitor cell population or a cell population at a later stage of differentiation. Yamazoe does not disclose the medium contains a factor having ALK5-inhibiting activity.
Rezania
The prior art of Rezania et al. (US-9234178-B2; Published 12th, January, 2016; henceforth “Rezania”) made of record but not relied upon, is considered pertinent to Applicant’s disclosure.
Regarding claims 1-2, Rezania discloses a method for producing a an insulin-positive (See Figure 4I, 6-8 and “in insulin-producing cells, produced by the methods” col. 4) cell population (“method for increasing the expression of MAFA in cells expressing markers characteristic of the pancreatic endocrine lineage”; abstract), comprising culturing and differentiating a pancreatic progenitor cell population or a cell population at a later stage of differentiation (“pancreatic endocrine linage” or “pancreatic endocrine progenitor cells”; col. 3-6, 11-12, 15-18, 20; claim 1; see also “Differentiating the cells expressing markers characteristic of the pancreatic endoderm lineage into cells expressing markers characteristic of the pancreatic endocrine lineage” col 11) in a medium containing a factor having CDK inhibiting activity (“cyclin dependent kinase inhibitor” col. 19; see specifically “1 μm of CDK inhibitor III (Catalog#217714, Calbiochem, Ca) for 10 days (Stage 7)” wherein the medium contains substantially no 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine (μM ALK5 inhibitor II (Catalog#616452) is in the medium in stage 4 and 5, but not stage 7 which has the CDK inhibitor; see Example 6; col. 24).
Rezania does disclose including a factor having ALK5-inhibiting activity in the specific step that includes a CDK inhibitor.
Bryce
The prior art of Bryce (US-20220233646-A1; published 28th, July, 2022 with benefit to 25th, June, 2019).
Bryce discloses a method for producing an insulin-positive cell population (“methods of manufacturing β cells; abstract), comprising culturing and differentiating a pancreatic progenitor cell population or a cell population at a later stage of differentiation (“NKX6.1-positive pancreatic
progenitor cells” para. [0402]) in a medium containing a factor having ALK5-inhibiting activity (Alk5i (SB505124) para. [0003, 0005, 0022, 0137, 0332, 00336, 0402, 0406, 0450, 0472]; claim 285), wherein the medium contains substantially no 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine (Bryce does not disclose including this in the medium).
Bryce does not disclose the medium contains a factor having CDK8/19-inhibiting activity.
Pertinent Co-Pending Applications
U.S. Co-pending Application 18/033,961 (claim set filed on 29th, May, 2026) is made of record but not relied upon is considered pertinent to Applicant’s disclosure.
Co-pending App ‘961 claims a method for producing an insulin-positive cell population, comprising culturing and differentiating a pancreatic progenitor cell population or a cell population at a later stage of differentiation in a medium containing a factor having CDK8/19- inhibiting activity (“differentiating, in a medium comprising a CDK8/19 inhibitor, (i) a pancreatic progenitor cell population in a step of inducing a differentiation of pancreatic progenitor cells into endocrine progenitor cells and/or an endocrine progenitor cell population in a step of inducing a differentiation of endocrine progenitor cells into insulin-positive cells”) (claim 1).
Co-pending App ‘961 does not claim the factor has ALK5-inhibiting activity, and Co-pending App ‘961 does not claim the medium contains substantially no 2-(3-(6- methylpyridin-2-yl)-lH-pyrazol-4-yl)-1,5-naphthyridine.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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