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 .
Applicant’s reply dated 02/19/2026 has been received.
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 09/12/2025 is acknowledged. The restriction requirement is withdrawn, the groups are rejoined and claims are examined for their full breadth.
Claim Rejections - 35 USC § 112
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.
The rejection of claims 1,4,7-17,21,23,24 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is withdrawn in light of Applicant amendments (limiting the activator and inhibitor) and Remarks regarding the aggregate being an embryoid body (supported by paragraph 90 and paragraphs 107 and 71, taken together) and the wsecond activation step being optional.
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.
The rejection of claim 24 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is rendered moot by the cancelation of the claim.
Claims 1,4,7-17,21,23 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 is unclear due to the added phrase “activator comprising and glycogen synthase-3 (GSK-3) inhibitor” and “inhibitor comprising and Porcupine (PORCN) inhibitor.” It is not clear is by use of the term “comprising” Applicant is implying the activator and inhibitor are more than what is recited and only one component if the activator/inhibitor is recited. Alternatively, Applicant could intend for it to read as a “wherein” clause such as “wherein the activator is a glycogen synthase-3 (GSK-3) inhibitor”. Claims 4,7-17,21,23 are rejected based on their dependency form claim 1.
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 18-20 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a heart organoid which is claimed by characteristics possessed by a heart in nature. It is noted that the Specification does not appear to provide a definition of “organoid”. Claim 18 does recite that the organoid is derived from pluripotent stem cells. However, there is nothing in the claim that differentiates the organoid from a heart in nature. This judicial exception is not integrated into a practical application because for example, if the claim is directed to a naturally occurring organ with additional generic elements such deriving it from a pluripotent stem cell, which do not add a meaningful limitation to the product because the source of the cardiac organoid does not add a meaningful limitation is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The Office published the guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published December 16, 2014.
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Step 2A has recently been revised to include two prongs (Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019):
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Analysis is as follows:
Step 1: The claim is directed to a composition of matter (cardiac organoid that reads on a heart).
Step 2A – Prong 1: Examiners evaluate whether the claim recites a judicial exception. The composition of matter (an organoid) is directed to a natural phenomenon (Step 2A, prong 1, yes). The claim recites an organoid with characteristic features possessed by a heart in nature. MPEP §2106.04(b)(I) which shows that isolated DNA, cloned animals are considered natural phenomenon, for example.
Step 2A- Prong 2: Examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This judicial exception is not integrated into a practical application because claims 18-20 do not recite additional elements that integrate the judicial exception into a practical application.
Finally, Step 2B the claim is evaluated as to whether it provides an inventive concept. With no additional elements, there is no inventive concept (Step 2B, No).
Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product' s naturally occurring counterpart. If the claim recites a nature-based product limitation that does not exhibit markedly different characteristics, the claim is directed to a ‘‘product of nature' ' exception (a law of nature or naturally occurring phenomenon), and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception. It is concluded, here, that the claimed natural products are not markedly different from their natural counterparts as a result of an isolation process.
Based on the guidance, The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may be enough to qualify as ‘‘significantly more' ' when recited in a claim with a judicial exception include: Improvements to another technology or technical field; improvements to the functioning of the computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Limitations that were found not to be enough to qualify as ‘‘significantly more' ' when recited in a claim with a judicial exception include: Adding the words ‘‘apply it' ' (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use.
In the instant case, the limitations of the claims do not impose limits on the claim scope such that they are not markedly different in structure from a naturally occurring product. In particular, the claims are directed to a cardiac organoid defined by features possessed by a naturally occurring heart.
Accordingly, as a whole, based upon an analysis with respect to the claim as a whole, claim(s) 18-20 do not recite something significantly different than a judicial exception. Thus, based upon this analysis, the claims are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter.
Applicant has amended claim 18to recite “in vitro generated” in the preamble of the claim. This amendment to the claims does not necessarily differentiate the organoid structurally or functionally from a heart formed in nature, in vivo..
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.
The rejection of claim(s) 18-20 under 35 U.S.C. 102a1 as being anticipated by WO 2019174879 (‘879) is withdrawn in light of Applicant’s remarks. The endocardial cells in ‘879 do not define a cardiac chamber.
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 VALARIE BERTOGLIO whose telephone number is (571)272-0725. The examiner can normally be reached M-F 6AM-2:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at 571-272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632