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 .
DETAILED ACTION
This action is in response to papers filed on July 14, 2026. Currently claims 1, 3, 4, 6, 9-19, 31-32, and 35-37 are currently pending as per claims filed on 7/14/2026. Claims 35-37 are newly added, claims 4, 6, 9-19, and 31-32 have been amended and claims 2, 5, 7-8, 20-30 and 33-34 are canceled by Applicants’ amendment filed July 14, 2026.
Claims 1, 3, 6, 9-18 and 26-28 (claims 26-28 now canceled) were previously withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to non-elected invention, there being no allowable generic or linking claim. Claims 6, 9-18 were previously withdrawn from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to non-elected species, there being no allowable generic or linking claim.
The restriction requirement was deemed proper, maintained and previously made FINAL.
Therefore, claims 4, 19, 31-32, and 35-37 are under examination to which the following grounds of rejection are applicable. Claim 4 is an independent claim.
Priority
This application is claiming benefit under 35 U.S.C. 119(e) of prior-filed provisional application
63/352,178 filed June 14 2022, and provisional application 63/351,108 filed June 10 2022.
Thus, the earliest possible priority for the instant application is June 10 2022.
Response to Arguments
Withdrawn objections/rejections in response to Applicants’ arguments or amendments
Claim Rejections - 35 USC § 112(b)
In view of the amendments filed on July 14, 2026, the rejection of claim 32 as being unpatentable over 35 USC § 112(b) has been withdrawn.
Claim Rejections - 35 USC § 112(a)
In view of the amendments filed on July 14, 2026, the rejection of claims 4, 19 and 31-32 as being unpatentable over 35 USC § 112(a), Applicants’ have amended the claim such that it recites “three cell fate determinants” instead of “two cell fate determinants”. As such, the rejection has been withdrawn.
Claim Rejections - 35 USC § 103
In view of the amendments filed on July 14, 2026, the rejection of claims 4, 19 and 31-32 as being unpatentable over 35 USC § 103 over Toma, Yang and Okubo have been withdrawn.
A response to Applicant’s arguments about a withdrawn rejection is moot.
New Rejections Necessitated by the Amendments filed July 14, 2026
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
To the extent that newly amended claims recite the combination of at least three cell-fate determinants is interpreted as a combination comprising POU2F1, HAND1, and an additional determinant, (e.g. the genetic cocktail of POU2F1, HAND1, HAND2, and GATA4 as described in Table 9 of the Specification), the following rejection applies.
Claim(s) 4, 19, 31-32 and 35-37 are newly rejected under 35 U.S.C. 103 as being unpatentable over Gough et al. (Published: 2020. US 20200216813 A1) in view of Liu et al. (Published: 2010. Cellular and Molecular Life Sciences : CMLS, 68(11), 1969–1982.) as evidenced by NCBI database . This is a new rejection necessitated by the amendments filed July 14, 2026.
Regarding claim 4 and 19, Gough teaches a method of converting various types of cell types into cardiomyocytes (para 0002). Gough teaches that the source cell can be a mesenchymal cell, and can be reprogrammed with contacting the source cell (mesenchymal stem cell) with transcription factors (Gough, claim 38; para 0043-0046), wherein the transcription factors can be HAND2, HAND1, and GATA4 (see Table 2; para 0060 discloses that it can be a nucleic acid sequence; para 0066). Further, Gough teaches that nucleic acid can be within a viral vector (para 0069), wherein the viral vector can be an adeno-associated virus (para 0132).
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However, Gough does not teach that the transcription factors comprise POU2F1.
Liu teaches the role of OCT1, a protein encoded by the POU2F1 gene, as evidenced by the NCBI database (POU2F1 pou class 2 homeobox 1 [Homo Sapiens (human)], NCBI), plays a role in the expression of ISL1 transcription factor, which is responsible for cardiogenesis within cells (pp. 1969, col 1, abstract). Moreover, to further elucidate whether OCT1 is a crucial upstream factor of ISL1, the effects on the knock-down of OCT1, as well as cardiac transcription factors like GATA4 were examined (pp. 1977, right col, para 1). As a result of the OCT1 knockdown, the expression of GATA4 significantly decreased in comparison to the non-silencer group (Figure 6C). Moreover, Liu reveals that OCT1 knock-down leaf to a decreased differentiation efficiency compared to a control (pp. 1977, right col para 1).
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A person with ordinary skill in the art would have been motivated to combine the vector comprising HAND1, HAND2, and GATA4, as taught by Gough, to further comprise ISL1 and the POU2F1 gene encoding the OCT1 protein, as discussed in Liu, as OCT1 plays a role in the differentiation efficiency of cells and GATA4 and ISL1 expression. Such incorporation of POU2F1 would allow for the increased differentiation efficiency of mesenchymal stem cells into cardiomyocytes, with a reasonable expectation of success. Thus, the combined teachings of Gough and Liu render obvious the combination of CFD HAND1, HAND2, GATA4 and POU2F1 recited in claims 4 and 19.
Regarding claim 31, the combined teachings of Gough and Liu render obvious the claimed method. Moreover, Gough teaches that nucleic acids can be within a viral vector (para 0069; para 0132).
Regarding claim 32, the combined teachings of Gough and Liu render obvious the claimed method. Moreover, Gough teaches that nucleic acids can be within a viral vector (para 0069; para 0132).
Regarding claim 35, the combined teachings of Gough and Liu render obvious the claimed method. Moreover, Gough teaches that nucleic acids can be within a retroviral vector (para 0069; para 0132).
Regarding claim 36, the combined teachings of Gough and Liu render obvious the claimed method. Moreover, Gough teaches that nucleic acids can be within an adeno-associated vector (para 0069; para 0132).
Regarding claim 37, the combined teachings of Gough and Liu render obvious the claimed method. Moreover, Gough teaches that nucleic acids can be nanoparticles (para 0130).
35 U.S.C. 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 4, 19, 31-32, and 35-37 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 applicant regards as the invention. This is a new rejection necessitated by amendment of the claims in the response filed 7/14/2026.
Claim 4 is newly rejected under 35 U.S.C. 112(b) for different issues.
Claim 4 recites “at least three cell fate determinants (CFD) selected from the group consisting of [list]” and the claim also recites a series of “where the [nucleotide] encodes [specific combinations of 3–5 CFD].”
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigerwald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 4 recites the broad recitation ““at least three … selected from the group”)”, and the claim also recites specific combinations CFD which is the narrower statement of the range/limitation.
Additionally, claim 4 is indefinite because of its recitation of “a ribonucleotide, ribonucleotides, a deoxyribonucleotide or deoxyribonucleotides encoding …” because it is unclear whether a single nucleotide, a mixture, or multiple types are required and how these encode at least 3 CFD in the context of a single nucleotide.
Further, the phrase “the ribonucleotide, ribonucleotides, deoxyribonucleotide, or deoxyribonucleotides” in claim 4 is repeated in each “where” clause, but it is not clear which antecedent is being referenced, especially if more than one type is present. As such the metes and bounds of the claim are indefinite.
Claim 19 is indefinite in its recitation of “the ribonucleotide, ribonucleotides, deoxyribonucleotide, or deoxyribonucleotides encode HAND1, GATA4, and at least one of …” because it is unclear whether a single nucleotide, a mixture, or multiple types are required and how these encode HAND1, GATA4, and at least one of …. in the context of a single nucleotide.
Claim 19 is indefinite because of the phrase “the ribonucleotide, ribonucleotides, deoxyribonucleotide, or deoxyribonucleotides” is repeated in each “where” clause, but it is not clear which antecedent is being referenced, especially if more than one type is present. As such the metes and bounds of the claim are indefinite.
Claim 35 is indefinite because of its recitation of “the viral vectors”. There is no proper antecedent bases in the claim or claim 32.
Claims 31-32, and 36-37 are indefinite insofar as they depend on claim 4.
35 U.S.C. 112, (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. This is a new rejection necessitated by Applicant’s amendments to the claims. Claim 19 depends from claim 4. Claim 4 newly requires that the recites a series of “where the [nucleotide] encodes [specific combinations of 3–5 CFD]”. Claim 19 broadens the scope of the claimed combination. For example, the combination of “GATA4, HAND2, and IKZF4” in claim 4 is now broaden to “HAND2, GATA4, and at least one of PBX2, ACTN2, POU2F1, HAND1, TRIM24, PBXI, ZBTB39, IKZF4, NR0B2, NACA2, SMYDI, JUP, NEURODI, CKMT2, TSHZ2, MITF, MYOCD, and PPARGCIB” (claim 19, line 6).
Applicants may cancel the claim, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Conclusion
No claims 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Katriel B Kasayan whose telephone number is (571)272-1402. The examiner can normally be reached 10-4p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATRIEL BARCELLANO KASAYAN/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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