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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-8, 10, and 11 in the reply filed on 12/21/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12 and 14-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/21/2025.
Status of the Claims
Claims 1-8, 10-12, and 14-22 are currently pending.
Claims 3-8, 10-12, and 14-21 are amended.
Claims 12 and 14-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 9 and 13 are cancelled.
Claims 1-8 and 10-11 have been considered on the merits.
Information Disclosure Statement
The Information Disclosure Statement submitted on 06/25/2023 has been considered in part. All references which are not lined through have been considered. The references which have been lined through and have not currently been considered are the NPL references with citation numbers 2, 3, and 5. All three of these citations relate to video evidence and the URLs provided do not appear to be functional. When attempting to access any of the URLs a “404- not accessible” message is produced. Accessing the links using the Wayback Machine was attempted, however an archive of the videos was not taken.
Claim Objections
Claims 1-8 are objected to because of the following informalities: Claims 1-8 include numerous instances of bullet points which is improper. All instances of bullet points should be deleted. An example of appropriate correction of lines 5-16 of claim 1 would be “wherein medium 0 comprises FGF2, insulin, and TGFb and medium 0 does not comprise Activin A, BMP-4, CHIR, ACS-2-P, IWP4, and VEGF”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: “100.000 – 600.000” needs to be amended to “100,000 – 600,000”. Appropriate correction is required.
Claims 1-8 are objected to because of the following informalities: claims 1-8 contain numerous recitations of the “ ~ “ (Tilde symbol). The symbol must be replaced with the term “about” or “approximately” or similar . Appropriate correction is required.
Specification
The use of the following terms which is a trade name or a mark used in commerce, has been noted in this application:
TrueCardium™ on at least pg. 25
TeSR™-E8™ on at least pg. 25, 27, and 29
Triton X™ -100 on at least pg. 26
TriFast™ on at least pg. 26
NanoDrop™ on at least pg. 26
Direct-zol™ RNA MicroPrep kit on at least pg. 26
EcoDry™ Premix RNA to cDNA on at least pg. 26
iTaq™ Universal SYBR® Green Supermix on at least pg. 26
Biorad CFX™96 Connect Real-Time PCR system on at least pg. 27
Endothelial Cell Growth Medium™ 2 on at least pg. 27.
The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains multiple embedded hyperlinks and/or other form of browser-executable codes. 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.
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 1-8 and 10-11 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 limitation "said cells" in at least line 5, “cells” in line 99, and “the cells” in line 118. It is not clear if all instances of the recitation of the term “cells” is meant to refer to the pluripotent stem cells of line 3. There is insufficient antecedent basis for this limitation in the claim
Claim 1 recites step a) which begins with the culture of pluripotent stem cells and throughout steps a)-j) the pluripotent stem cells are referred to as “said cels” or “the cells”. A final step k) is recited which states “harvesting the cardiac tissue organoid”, which renders the claim indefinite. It is not clear at what point between steps a) and j) the cells differentiate from pluripotent stem cells into cardiac tissue or cardiac cells. Appropriate clarification is required.
Claims 1-8 contain numerous instances of listing a limitation and subsequently providing multiple subsequent limitations using the language “particularly” and “more particularly”, for example claims 1, line 3 states “providing pluripotent stem cells, particularly induced pluripotent stem cells” and claim 1, lines 5-6 states “incubating said cells for 44-52h, particularly for 46-50h, more particularly for ~48h”, which renders the claims indefinite. It is unclear, for example, if an art which employs pluripotent stem cells would still read on the limitation of claims 1, line 3 which states “providing pluripotent stem cells, particularly induced pluripotent stem cells”. It is not clear if the most preferred recitation of the limitation is required or merely an option. The same logic applies to every instance throughout claims 1-8 which list limitations in the same manner. Appropriate correction is required in at least the following claim/lines:
Claim 1 needs correction at lines: 3, 5-6, 31-32, 36-37, 40-41, 44, 52-53, 66-67, 81-82, 83, 96-97, 116-117, 119, and 122-124.
Claim 2 needs correction at lines: 2, 4, and 6.
Claim 3 needs correction at lines: 3, 5-7, and 9.
Claim 4 needs correction at lines: 3-6, and 8.
Claim 5 needs correction at lines: 3 and 5.
Claim 6 needs correction at lines: 3.
Claim 7 needs correction at lines: 3, 5, and 7.
Claim 8 needs correction at lines: 3, 5-7, and 9.
Claim 1 contains the trademark/trade name Matrigel in line 30. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe extracellular matrix or basement membrane matrix and, accordingly, the identification/description is indefinite.
Claim 1 contains the phrase “medium 1 is supplemented with a solubilized membrane preparation extracted from mammalian cells (Matrigel)”, which is indefinite. It is unclear if the term “Matrigel”, which is contained in parenthesis, is a required limitation of the claim or if it is a “preferred” embodiment of the claimed “solubilized membrane preparation extracted from mammalian cells”. Appropriate clarification is required.
Claim 1 contains the trademark/trade name “Endothelial Cell Growth Medium 2” in line 104. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a low serum culture media optimized for endothelial cells and, accordingly, the identification/description is indefinite.
Claim 1 contains the phrase “Endothelial Cell Growth Medium 2 (without FBS)”, which is indefinite. . It is unclear if the term “without FBS”, which is contained in parenthesis, is a required limitation of the claim or if it is a “preferred” embodiment of the claimed “Endothelial Cell Growth Medium 2”. Appropriate clarification is required.
Dependent claims 2-8, 10, and 11 are included in these rejections for being dependent from a rejected claim 1.
Claim Interpretation
The term “CHIR” is seen throughout the claims. The specification provides a definition of “CHIR” to be “The term CHIR in the context of the present specification relates to 6-[[2-[[4-(2,4- Dichlorophenyl)-5-(5-methyl-1 H-imidazol-2-yl)-2-pyrimidinyl]amino]ethyl]amino]-3- pyridinecarbonitrile (CAS-No: 252917-06-9)” (Specification, pg. 3, lines 26-28). This chemical name defines the commonly used CHIR molecule CHIR99021. Therefore, where CHIR is recited in the claims it is being interpreted to mean CHIR99021.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/DAVID A MONTANARI/Examiner, Art Unit 1632