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 without traverse of Group I (Claims 1-15; drawn to a production method of a myocardial cell layer) in the reply filed on July 13, 2026, is acknowledged.
Claims 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Groups II and III), there being no allowable generic or linking claim.
Applicant further elected the following species:
a. The shape as defined in claim 9
In light of the Applicant’s elected species, claims 8 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 24, 2024. Groups II (claim 37), III (claim 38), V (claim 44), VII (claim 46), and VIII (claim 51) are rejoined for examination.
DETAILED ACTION
The claims filed on April 26, 2024, have been acknowledged. In light of the Applicant’s elected invention and species, claims 8, 10, and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-7, 9, and 11-15 are pending and examined on the merits.
Priority
Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d).The applicant claims foreign priority from JP2021-176040 filed on October 28, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55, received June 11, 2024. While a certified copy of the foreign patent application JP2021-176040 is provided with the instant application, a certified English translation of said foreign patent application has not been provided.
Information Disclosure Statement
The information disclosure statements (IDS) filed on July 25, 2024, April 14, 2025, and August 27, 2025, have been considered.
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 1-7, 9, and 11-15 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 phrases “having a shape shown in the following (1-1)” and “(1-1) in a case where” are incongruous. The first phrase suggests that the shape identified in (1-1) is required; however, the second phrase suggests that the shape identified in (1-1) is only required in the specific scenario identified in (1-1). As such, it is unclear whether the shape identified in (1-1) is required or not.
Claims 2-7, 9, and 11-15 are also rejected because of their dependence on claim 1.
Claim 1 recites “a plane figure, a shape thereof is a shape obtained by hollowing out at least a part of a first plane figure”. A plane figure is a flat shape while hollowing out suggests a three dimensional shape. Therefore, the hollowing out appears incongruous with the generation of a plane figure as the process of hollowing out would create a three dimensional structure that would not be a plane. Therefore, it is unclear whether the shape is supposed to be a two dimensional plane shape or a hollowed out three dimensional shape.
Claims 2-7, 9, and 11-15 are also rejected because of their dependence on claim 1.
Regarding claim 1, the phrase "optional shape" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 1 appears to require the first and second plane figures which would have a shape. It’s not clear whether specific shapes are optional (e.g. circle or triangle) or if the plane figure itself would then be optional. As such, it is unclear whether the first and second plane figures of the optional shapes are required or not.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)). A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See, e.g., Ex parte Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). Claim 1 recites “hollowing out at least a part of a first plane figure of an optional shape having uniform spread in a second plane figure of another optional shape having uniform spread without contacting an outer periphery of the first plane figure of the optional shape”. However, the outer periphery is dependent on the shape of the plane figures and would change depending on the shape used. For example, a ring shape would have two outer peripheries and it is unclear if one or both outer periphery would have to not be in contact or fulfill the formula in claim 1.
Claims 2-7, 9, and 11-15 are also rejected because of their dependence on claim 1.
A claim may be rendered indefinite by reference to an object that is variable. (MPEP §2173.05(b)). A claim may be rendered indefinite when a limitation of the claim is defined by reference to an object and the relationship between the limitation and the object is not sufficiently defined. That is, where the elements of a claim have two or more plausible constructions such that the examiner cannot readily ascertain positional relationship of the elements, the claim may be rendered indefinite. See, e.g., Ex parte Miyazaki, 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer, 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). Claim 1 recites “in the formula, x represents the average value of the length of the outer periphery of the first plane figure and the length of the outer periphery of the second plane figure, where a unit thereof is cm, and v represents a conduction velocity of the myocardial cell induced from the pluripotent stem cell, where a unit thereof is cm·s-1”. As identified above the shape is variable as is the outer periphery. Additionally, the conduction velocity would be variable depending on the culture conditions. For example, the conduction velocity would be different between a culture that is maintained in a 37°C incubator compared to one set to 0°C or wherein the culture is placed on the sidewalk. Furthermore, day 5 of the culture may be different than day 10 of the culture leading to a culture that is only within the formula at a specific time point. Similarly, different culture conditions can change the conduction velocity, such as the addition of an inhibitor, that would make the shape no longer fit within the formula even as the shape itself has not changed. The skilled person when confronted with the myocardial cell layer as outlined in (1-1) cannot ascertain if such a cell layer fulfils the requirements of (1-1).
Claims 2-7, 9, and 11-15 are also rejected because of their dependence on claim 1.
In claim 1, the claim recites, x represents the average value of the length of the outer periphery of the first plane figure and the length of the outer periphery of the second plane figure”. As an initial matter, it is unclear how one determines the average value of the outer periphery. As stated above, the shape is undefined and the outer periphery varies depending on the shape. Similarly, if the first shape is defined by the average length of the outer periphery and the second shape is defined by the length of the outer periphery, it is unclear how these two lengths are calculated as they are treated differently within the claim even though they could be the same shape. For example, a ring shape has two outer peripheries and it is unclear whether these two would be averaged to come up with the x value or if there is some other means of determining the average. Furthermore, if the second shape is a ring, it is unclear how the length of the outer periphery is calculated if there are two outer peripheries.
Furthermore, the way the claim is currently written, (i.e. “x represents the average value of the length of the outer periphery of the first plane figure and the length of the outer periphery of the second plane figure”), this claim language appears to identify that x represents both values and not one or other leading to a lack of clarity as to whether one or the other value is used for x or if the combined value of both is used for x.
Claims 2-7, 9, and 11-15 are also rejected because of their dependence on claim 1.
In claim 1, the claim recites “circulating and proceeding at least one electrical signal or a calcium signal in the myocardial cell layer”. The claim language suggests there is an active step of externally circulating and proceeding at least one electrical signal or a calcium signal in the myocardial cell layer. However, based on what is identified in the specification of the present application it seems that when the myocardial cells are aligned properly and have been fully differentiated from pluripotent stem cells then the cell layer will exhibit a circulation wave naturally without having to add an external mechanical or electrical stimulation. Therefore, it is unclear if claim 1 subclaim (2) is meant to refer to external electrical stimulation or if it is meant to describe the resulting circulation wave that spontaneously occurs.
Claims 2-7, 9, and 11-15 are also rejected because of their dependence on claim 1.
No Art Rejection
Regarding claims 1-7, 9, and 11-15, these claims are not analyzed for prior art rejections in light of the numerous 112b issues outlined above since to do so would require considerable speculation with regards to the metes and bounds of the claimed subject matter. MPEP 2143.03 (I) states an examiner should not simply speculate about the meaning of the claim language and then enter an obviousness rejection in view of that speculative interpretation. In re Steele, 305 F.2d 859,134 USPQ 292 (CCPA 1962) (The "considerable speculation" by the examiner and the Board as to the scope of the claims did not provide a proper basis for an obviousness rejection.). A claim should not be rejected over prior art just because it is indefinite. Ionescu, 222 USPQ at 540 (citing Steele). Although a claim that is indefinite because it is susceptible to more than one interpretation may be rejected over prior art, an examiner should not base a prior art rejection on a claim interpretation that is not reasonable. As the shape identified in claim 1 as currently written is incomprehensible, any prior art rejection would require considerable speculation regarding the required shape. Therefore, these claims are not analyzed for prior art rejections and only potentially pertinent prior art is identified below.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
United States Patent Application No. 20150313704 (Thavandiran; referenced in IDS).
World Intellectual Property Organization Patent Application No. 2018124210 (Liu; referenced in IDS).
Serpooshan et al. (Biomaterials 131:47-57. 2017).
Li et al. (Communications Biology 3: 1-12. 2020; Published March 2020; referenced in IDS).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631
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