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/Restriction
Applicant's election to group I, drawn to claims 11-15, 17-18, and 22, in the response filed 08 Jun 2026 are acknowledged.
Claims 19-21, 23, 25-29, and 31-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed 08 Jun 2026.
Claims 11-15, 17-23, 25-29, and 31-33 are pending. Claims 11-15, 17-18, and 22 are under consideration on the merits.
Claim Objections
Claim 18 is objected to because of the following informality:
The word "and" is missing between SNC4B and KCN1 in the last line of claim 18.
Appropriate correction is required.
Claim 22 is objected to as it depends from a non-elected claim.
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 11-15, 17-18, and 22 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a multichambered cardiac organoid comprising cardiomyocytes and endothelial cells and at least two chambers beating in synchrony. This judicial exception is not integrated into a practical application because the multichambered cardiac organoid is product-by-process that is not markedly different from a mammalian heart. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I). The claims do not include additional elements sufficient to amount to significantly more than the judicial exception because the claims only recite elements found naturally in a mammalian heart.
Buijtendijk (M.F.J. Buijtendijk, et al., Am J Med Genet, 2020), Norden (J. Norden, et al., PLoS One, 2012), Aneesh Kumar (A. Aneesh Kumar, et al., Genes, 2021), Lewis-Israeli (Y.R. Lewis-Israeli, et al., Nat Commun, 2021, cited in the IDS filed 08 Sep 2025), and Sengupta (P.P. Sengupta, et al., J Am Coll Cardiol, 2006) teach all of the elements of the heart recited in the claims.
The heart is multichambered (claims 11 and 22) (Buijtendijk pp. 10-11 and Fig. 2). The heart has coordinated electrical conduction for synchronous beating and coordinated but distinct cardiomyocyte beating in the atria and ventricles (biphasic, claims 11-12 and 22) (Buijtendijk p. 12). The sinus node (pacemaker-like cell cluster) initiates cardiac pacing and expresses hyperpolarization-activated cyclic nucleotide-gated channel 4 (HCN4) and short-stature homeobox 2 (SHOX2) (HCN4 and SHOX2 positive, claim 13) (Buijtendijk p. 12).
The heart comprises an epicardium on the outer portion of the organ that expresses Wilms' tumor 1 (WT1) and T-box transcription factor 18 (TBX18) (claim 14) (Norden Introduction pp. 1-2).
The heart comprises a specialized layer of endothelial cells lining the chambers called the endocardium that express platelet endothelial cell adhesion molecule (PECAM1) (claim 15) (Aneesh Kumar Abstract).
The heart is vascularized (comprises vascular structures and capillaries within the walls of the chambers) and comprises cardiac fibroblasts that express vimentin 1 (VIM1, (vimentin positive, claim 17) (Buijtendijk pp. 11 and 16 and Lewis-Israeli p. 4). Cardiomyocytes align as elongated fibrils circumferentially around the ventricles (chambers) (claim 17) (Sengupta pp. 1989-1990). Sarcomeric patterning emerges in cardiomyocytes during the heart tubal stage of development (claim 17) (Buijtendijk p. 8).
Expression of TNNI3, MYH7, AKAP6, CASQ2, CAMK2, CAV3, SCN5A, KCNJ2 (also referred to as KIR2.1), ITPR3, and KCNJ8 is increased in fetal heart cells compared to isolated cultured cardiomyocytes (claim 18) (Lewis-Israeli Fig. 2D).
The Office published the guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published 16 Dec 2014. Step 2A was revised to include two prongs (Federal Register / Vol. 84, No. 4 / 07 Jan 2019).
Analysis is as follows:
Step 1: Are the claims drawn to one of the statutory categories of invention?
Step 1: The claims are directed to a composition of matter (a multichambered cardiac organoid).
Step 1: Yes.
Step 2A, Prong One: Are the claims drawn to a judicial exception (a law of nature, a natural product/phenomenon, or an abstract idea)?
Step 2A, Prong One: The composition of matter (a multichambered cardiac organoid) is directed to a natural product. The claims recite a composition that is not markedly different from mammalian heart.
Step 2A, Prong One: Yes.
Step 2A, Prong Two: Do the claims recite additional elements that integrate the judicial exception into practical application of the exception?
Step 2A, Prong Two: This exception is not integrated into practical application because the claims do not recite additional elements that integrate the judicial exception into practical application. The claims merely recite known features of a mammalian heart.
Step 2A, Prong Two: No.
Step 2B: Do the claims recite additional elements that individually or in combination amount to significantly more than the judicial exception (i.e., whether the additional elements provide an inventive concept)?
Step 2B: The claims merely recite known features of a mammalian heart. There are no additional elements in the claims that could amount to significantly more.
Step 2B: No.
The markedly different characteristics analysis performed in Step 2A, Prong One is a comparison of the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties. Product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See MPEP § 2106.04(b)(II). 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, and the claim will require further analysis to determine eligibility based on whether additional elements add significantly more to the exception. In accordance with this analysis, the multichambered cardiac organoid, for example, is eligible when there is a resultant change in characteristics sufficient to show a marked difference from a mammalian heart. It is concluded here that the claimed the multichambered cardiac organoid is not markedly different from its naturally occurring counterpart, a mammalian heart, as the claim does not recite structural limitations that distinguish the multichambered cardiac organoid composition from the composition of a mammalian heart.
The Supreme Court has identified several considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may 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; 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; adding insignificant extra-solution activity to the judicial exception; 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 scope of the claim such that the multichambered cardiac organoid is markedly different from a naturally occurring product. Accordingly, based on analysis of the claim as a whole, claims 11-15, 17-18, and 22 do not recite additional elements adding significantly more than the judicial exception and are thus rejected under 35 U.S.C. § 101 because the claimed invention is not directed to patent eligible subject matter.
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 11-13 and 22 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Kupfer (M.E. Kupfer, et al., Circ Res, 2020, cited in the IDS filed 08 Sep 2025).
Regarding claims 11 and 22, Kupfer discloses a cardiac organoid comprising cardiomyocytes and endothelial cells with two chambers (multichambered) that beat in synchrony (Abstract, Results p. 214, and Fig. 4D and 6). Note that the multichambered organoid of claim 22 is a product-by-process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
Regarding claim 12, contractions in the cardiac organoids disclosed by Kupfer propagate across the entire organoid (chambers beat synchronously) (Results p. 214 and Fig. 6).
Regarding claim 13, Kupfer identified a region of the organoid that was the common point of initiation for electrical activity that propagated contractions in the cardiac organoids (pacemaker-like cell cluster) (p. 218, Fig. 6E).
Claims 11-12, 14-15, 17-18, and 22 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Lewis-Israeli (Y.R. Lewis-Israeli, et al., Nat Commun, Aug 2021, cited in the IDS filed 08 Sep 2025).
Regarding claims 11 and 22, Lewis-Israeli discloses a heart (cardiac) organoid comprising cardiomyocytes and endothelial cells with two chambers (multichambered) that beat in synchrony (Abstract, Results pp. 2, 4, and 6, and Fig. 1, 2, and 6). Note that the multichambered organoid of claim 22 is a product-by-process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). See MPEP § 2113(I).
Regarding claim 12, contractions in the cardiac organoids disclosed by Lewis-Israeli propagate across the entire multichambered organoid (chambers beat synchronously) (Results p. 6 and Fig. 6D-E).
Regarding claim 14, the cardiac organoids disclosed by Lewis-Israeli comprise epicardial cells on the outer surface (outer epicardium) (Results pp. 3-4 and Fig. 1g).
Regarding claim 15, the cardiac organoids disclosed by Lewis-Israeli comprise endocardial cells on the inner surface (inner epicardium) (Results p. 4 and Fig. 3b).
Regarding claim 17, the cardiac organoids disclosed by Lewis-Israeli comprise an "interconnected network of endothelial cells... and vessel-like tube formation throughout the organoid" that form a vascular network (vascular structures and capillaries within a wall of said chambers), aligned cardiomyocytes that form myocardial tissue around the chambers with sarcomere banding (circumferentially aligned cardiomyocytes surrounding the hollow chambers, organized in a sarcomeric pattern), and fibroblasts (cardiac fibroblast-like cells) positive for VIM (vimentin) (Results pp. 2, 4, and 6 and Fig. 1B-C, 3, and 6).
Regarding claim 18, the cardiac organoids disclosed by Lewis-Israeli express increased levels of TNNT2, TNNI3, MYH7, AKAP6, GJA5, JPH2, CACNA1C, RYR2, PLN, CAMK2B SCN5A, ITPR3, HCN2, SCN1B, HCN1, KCNH2, and PRKACA relative to cultured isolated cardiomyocytes or fetal cardiac tissue (Fig. 2).
Conclusion
No claim is allowed.
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Eric B Wright, PhD
Examiner
Art Unit 1632
/Eric B Wright/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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