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 .
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 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.
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Apr. 22, 2026 has been entered. All arguments have been fully considered.
Status of the Claims
Claims 1-5, 7-10, and 31-35 are currently pending.
Claims 1, 4, 7, and 31 are amended.
Claims 6 and 11-30 are cancelled.
Claims 32-35 are new.
Claims 1-5, 7-10, and 31-35 have been considered on the merits.
Drawing Objections
The drawing objections for color drawings are withdrawn due to Applicant’s arguments being found persuasive, see Remarks pg. 5 last para.). The Applicant notes that the drawings are specifically labeled with the colors that are described in the specification. For instance, where the specification describes a blue color the figure is labeled with the term “blue” where that color is located.
Claim Rejections - 35 USC § 112
The claim rejections under 35 USC § 112, (b) or second paragraph (pre-AIA ), are withdrawn due to amendment. New claim rejections under 35 USC § 112, (d) or fourth paragraph (pre-AIA ) have been added due to amendment.
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.
Claims 32 and 33 are 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.
In case, claim 32 depends from claim 1 which requires the synchronization to be dependent on a length of the at least one CF bridge which is the same as the synchronization being a function of a length of the at least one CF bridge. Claim 33 depends for claim 1 which recites at least two CM cell clusters oscillating at a first and a second initial beating frequency and after a synchronization time the CM clusters oscillated at the same synchronized beating frequency which is the same as the first and second CM cell clusters transition from independent oscillation to synchronized oscillation. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The claim rejections under 35 USC § 102 are revised due to amendment. New claim rejections under 35 USC § 102 have been added to address the claim amendments and new claims.
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 1, 4, 5, 7-10, and 31-35 are rejected under 35 U.S.C. 102(a) as being anticipated by Gaudesius et al. (Circulation Research, 2003) (ref. of record) as evidenced by Zorlutuna (US 2017/0069860 A1).
With respect to claims 1, 7, 9 and 10, Gaudesius teaches a heterocellular culture model which has impulse propagation where strands of cardiomyocytes are electrically coupled to fibroblasts and each other (a coupled bio-oscillating material) (abstract and pg. 424 para. 1). With respect to claims 1 and 7, Gaudesius teaches multiple strands of cardiomyocytes with cardiac fibroblasts filling in gaps between cardiomyocyte strands on an agar substrate (at least two cardiac (CM) muscle clusters and at least one cardiac fibroblast (CF) cell bridge on a substrate; and at least two biological oscillators, and at least one biological coupling element connecting the at least two biological oscillators) (Fig. 1 and Fig. 2A). With respect to claims 1 and 8, Gaudesius teaches that the fibroblasts of cardiac origin are capable of relaying electrical excitation between two separated strands of cardiomyocytes linked by the fibroblasts (the at least one CF bridge provides electrical conduction between the at least two CM cell clusters; and the at least two biologically oscillators are connected electrically, mechanically, and optically) (pg. 422 para. 1 and pg. 423 Col. 2 para. 2). With respect to claims 1 and 7, Gaudesius teaches that the linked cardiomyocyte stands have spontaneous contractions, synchronization and have impulse propagation along the strand (oscillate and synchronize at a unique phase ordering between the two CM cell clusters or two biological oscillators) (pg. 423 Col. 2 para. 2-3).
With respect to claims 1, 7 and 33, Gaudesius teaches the cardiomyocyte stands initially have contractile activity that is different and which eventually synchronize (oscillate at frequencies different from the synchronized frequency) (pg. 423 Col. 2 para. 2). Gaudesius teaches that the frequency of spontaneous contractions varied among the strands and the functional linking of the strands by fibroblasts established synchronization (first of the at least two CM cell clusters oscillating at a first initial beating frequency and a second of the at least two CM cell clusters oscillating at a second initial beating frequency) (pg. 423 Col. 2 para. 2). With respect to claims 1, 7 31, 32 and 34, Gaudesius teaches that the synchronization of the contractile activity between the linked cardiomyocyte strains occurred as soon as 8 hours after seeding of the fibroblasts in short to middle size inserts whereas it took up to 24 hours for synchronization the inserts were longer (the period of time is dependent on a length of the at least one CF bridge) (pg. 423 Col. 2 para. 2). Therefore, Gaudesius teaches that synchronization occurs as a function of the length of the insert or CF bridge, since Gaudesius teaches the time of synchronization increases as the length increases.
Although Gaudesius teaches the method by which the cardiomyocyte strands or clusters are produced as claims 1, 7 and 31 are being interpreted, these limitations are interpreted as product by process type limitations. It is noted that the patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
With respect to claim 4, Gaudesius teaches the cardiac fibroblasts (CF bridge) delay the activation and the activation delay increases as the length of the fibroblast insert increases (the CF bridge is equivalent to a Resistor-Capacitor (RC) filter) (pg. 424 Col. 1 para. 2).
Although, Gaudesius is silent with respect to synchronized frequency that the cardiomyocyte strands synchronize at and does not teach that the CM cell clusters synchronize at a frequency in the range from 0.01 to 10 Hz as recited in claim 5, this would inherently have occurred or be present in the composition of Gaudesius, since Gaudesius teaches the same composition containing at least two cardiac muscle cell clusters and at least one cardiac fibroblast cell bridge (abstract, pg. 424 para. 1, Fig. 1 and Fig. 2A). Additionally, Zorlutuna reports cultured cardiomyocytes which beat at a rate of 0.5 to 1.5 Hz (0111).
With respect to claim 35, Gaudesius teaches the cardiac fibroblasts (CF cell bridge) delay the activation and the activation delay increases as the length of the fibroblast insert increases (the CF cell bridge provides RC-type coupling) (pg. 424 Col. 1 para. 2). Gaudesius teaches that the synchronization of the contractile activity between the linked cardiomyocyte strains occurred as soon as 8 hours after seeding of the fibroblasts in short to middle size inserts whereas it took up to 24 hours for synchronization the inserts were longer (the period of time is dependent on a length of the at least one CF bridge) (pg. 423 Col. 2 para. 2). Therefore, Gaudesius teaches a CF cell bridge that provides RC-type coupling that determines the synchronization time, since Gaudesius teaches a CF cell bridge with RC-type coupling between two cardiac muscle cell clusters and synchronization time that depends on the length of the CF cell bridges.
Therefore, the reference anticipates the claimed subject matter.
Claim Rejections - 35 USC § 103
The claim rejections under 35 USC § 103 are revised due to amendment. New claim rejections under 35 USC § 103 have been added to address the claim amendments and new claims.
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 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.
Claims 1-5, 7-10 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Gaudesius et al. (Circulation Research, 2003) (ref. of record) as evidenced by Zorlutuna (US 2017/0069860 A1) in view of Zorlutuna (US 2017/0069860 A1).
With respect to claims 1, 7, 9 and 10, Gaudesius teaches a heterocellular culture model which has impulse propagation where strands of cardiomyocytes are electrically coupled to fibroblasts and each other (a coupled bio-oscillating material) (abstract and pg. 424 para. 1). With respect to claims 1 and 7, Gaudesius teaches multiple strands of cardiomyocytes with cardiac fibroblasts filling in gaps between cardiomyocyte strands on an agar substrate (at least two cardiac (CM) muscle clusters and at least one cardiac fibroblast (CF) cell bridge on a substrate; and at least two biological oscillators, and at least one biological coupling element connecting the at least two biological oscillators) (Fig. 1 and Fig. 2A). With respect to claims 1 and 8, Gaudesius teaches that the fibroblasts of cardiac origin are capable of relaying electrical excitation between two separated strands of cardiomyocytes linked by the fibroblasts (the at least one CF bridge provides electrical conduction between the at least two CM cell clusters; and the at least two biologically oscillators are connected electrically, mechanically, and optically) (pg. 422 para. 1 and pg. 423 Col. 2 para. 2). With respect to claims 1 and 7, Gaudesius teaches that the linked cardiomyocyte stands have spontaneous contractions, synchronization and have impulse propagation along the strand (oscillate and synchronize at a unique phase ordering between the two CM cell clusters or two biological oscillators) (pg. 423 Col. 2 para. 2-3).
With respect to claims 1, 7 and 33, Gaudesius teaches the cardiomyocyte stands initially have contractile activity that is different and which eventually synchronize (oscillate at frequencies different from the synchronized frequency) (pg. 423 Col. 2 para. 2). Gaudesius teaches that the frequency of spontaneous contractions varied among the strands and the functional linking of the strands by fibroblasts established synchronization (first of the at least two CM cell clusters oscillating at a first initial beating frequency and a second of the at least two CM cell clusters oscillating at a second initial beating frequency) (pg. 423 Col. 2 para. 2). With respect to claims 1, 7 31, 32 and 34, Gaudesius teaches that the synchronization of the contractile activity between the linked cardiomyocyte strains occurred as soon as 8 hours after seeding of the fibroblasts in short to middle size inserts whereas it took up to 24 hours for synchronization the inserts were longer (the period of time is dependent on a length of the at least one CF bridge) (pg. 423 Col. 2 para. 2). Therefore, Gaudesius teaches that synchronization occurs as a function of the length of the insert or CF bridge, since Gaudesius teaches the time of synchronization increases as the length increases.
Although Gaudesius teaches the method by which the cardiomyocyte strands or clusters are produced as claims 1, 7 and 31 are being interpreted, these limitations are interpreted as product by process type limitations. It is noted that the patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113)
With respect to claim 4, Gaudesius teaches the cardiac fibroblasts (CF bridge) delay the activation and the activation delay increases as the length of the fibroblast insert increases (the CF bridge is equivalent to a Resistor-Capacitor (RC) filter) (pg. 424 Col. 1 para. 2).
Although, Gaudesius is silent with respect to synchronized frequency that the cardiomyocyte strands synchronize at and does not teach that the CM cell clusters synchronize at a frequency in the range from 0.01 to 10 Hz as recited in claim 5, this would inherently have occurred or be present in the composition of Gaudesius, since Gaudesius teaches the same composition containing at least two cardiac muscle cell clusters and at least one cardiac fibroblast cell bridge (abstract, pg. 424 para. 1, Fig. 1 and Fig. 2A). Additionally, Zorlutuna reports cultured cardiomyocytes which beat at a rate of 0.5 to 1.5 Hz (0111).
With respect to claim 35, Gaudesius teaches the cardiac fibroblasts (CF cell bridge) delay the activation and the activation delay increases as the length of the fibroblast insert increases (the CF cell bridge provides RC-type coupling) (pg. 424 Col. 1 para. 2). Gaudesius teaches that the synchronization of the contractile activity between the linked cardiomyocyte strains occurred as soon as 8 hours after seeding of the fibroblasts in short to middle size inserts whereas it took up to 24 hours for synchronization the inserts were longer (the period of time is dependent on a length of the at least one CF bridge) (pg. 423 Col. 2 para. 2). Therefore, Gaudesius teaches a CF cell bridge that provides RC-type coupling that determines the synchronization time, since Gaudesius teaches a cardiac fibroblast bridge with RC-type coupling between two cardiac muscle cell clusters and synchronization time that depends on the length of the cardiac fibroblast bridges.
Gaudesius does not teach the coupled bio-oscillating material where the substrate is embedded with a microelectrode array (MEA) and where the MEA is configured to measure a field potential of the at least two CM cell clusters as recited in claims 2 and 3.
However, Zorlutuna teaches similar a coupled bio-oscillating material which is cell-based diode where the cells are cardiomyocytes that spontaneously beat (0004, 0008, 0058 and 0110-0111). Zorlutuna teaches the material containing a chain of cardiomyocytes or a patch of cardiomyocytes connected to a patch of cardiac fibroblasts (0100 and 0116). Zorlutuna teaches the coupled bio-oscillating material where the substrate is embedded with a microelectrode array (MEA) and where the MEA is configured to measure a the electrical response of the micropatterned cells (field potential of the at least two CM cell clusters) (0106). Zorlutuna further teaches the MEA allows for simultaneous stimulation and recording of electrical channels and is capable of assigning recording and stimulation functions to individual channels (0106).
Accordingly, at the effective time of filing of the claimed invention, one of ordinary skill in the art would have been motivated to modify the coupled bio-oscillating material of Gaudesius to include a MEA for the benefit of measuring the electrical response of the cells on the substrate as taught by Zorlutuna. It would have been obvious to one of ordinary skill in art to include other known electrical measuring devices such as the MEA taught by Zorlutuna in the coupled bio-oscillating material of Gaudesius for the purpose of recording the electrical activity of the cardiomyocytes. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification to the coupled bio-oscillating material of Gaudesius, since Zorlutuna teaches a similar coupled bio-oscillating material with a MEA and Gaudesius teaches measuring the electrical activity of the material (pg. 423 Col. 1 para. 3 and Fig. 2).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed Apr. 22, 2026 have been fully considered but they are not persuasive.
With respect to the rejections under 35 U.S.C. § 112, Applicant argues that the elements (where the clusters initially oscillate at different frequencies, subsequently converge to a synchronized frequency and the synchronization time depends on the length of the CF cell bridge) are properties of the claimed system and tied directly to the physical structure (Remarks pg. 6 para. 2). However, this argument is not found to be persuasive, since these elements are time dependent and the claims are to a composition, specifically a coupled bio-oscillating material containing at least two cardiac muscle cell clusters and at least one cardiac fibroblast cell bridge that provides electrical conduction between the two cardiac muscle cell clusters and where the cardiac cell cluster have the same synchronized beating frequency.
With respect to the rejections under 35 U.S.C. § 102, Applicant argues that Gaudesius does not teach that two CM cell clusters initially oscillate at different beating frequencies and subsequentially converge to a synchronized frequency that is different from the initial frequencies and instead only describes electrical coupling and synchronization phenomena without characterizing the initial conditions and frequency evolution (Remarks pg. 7 para. 3). However, this argument was not found to be persuasive, since Gaudesius clearly teaches cardiomyocyte stands or CM cell clusters that initially have contractile activity that is different and which eventually synchronize (oscillate at frequencies different from the synchronized frequency) (pg. 423 Col. 2 para. 2). Furthermore, Gaudesius teaches the claimed final composition, a coupled bio-oscillating material containing at least two cardiac muscle cell clusters and at least one cardiac fibroblast cell bridge that provides electrical conduction between the two cardiac muscle cell clusters and where the cardiac cell cluster have the same synchronized beating frequency (abstract, pg. 424 para. 1, and Fig. 1 and Fig. 2A).
Applicant argues that Gaudesius does not teach that the synchronization time is dependent on the length of the CF cell bridge and that observations of synchronization time occurring over different time periods for different insert lengths do not establish the claimed functional relationship between synchronization time and bridge length which is a property required by the claims (Remarks pg. 7-8 bridging para.). However, this argument was not found to be persuasive, since Gaudesius clearly does teach that the synchronization time is dependent on the length of the CF cell bridge from these observations. As stated in the rejection, Gaudesius teaches that the synchronization of the contractile activity between the linked cardiomyocyte strains occurred as soon as 8 hours after seeding of the fibroblasts in short to middle size inserts whereas it took up to 24 hours for synchronization the inserts were longer (the period of time is dependent on a length of the at least on CF bridge) (pg. 423 Col. 2 para. 2).
Applicant argues that the claimed synchronization behavior is not necessarily present in or inherent to the system taught by Gaudesius. Applicant further argues Gaudesius only reports variable and condition dependent outcomes and does not teach distinct initial beating frequencies, convergence to a synchronized frequency different from the initial frequencies and a functional dependency between synchronization time and CF bridge length is silent with respect to synchronized frequences (Remarks pg. 8 para. 2). However, this argument was not found to be persuasive, since Gaudesius teaches the claimed coupled bio-oscillating material and teaches the synchronization behavior as explained above. Furthermore, it is maintained that these limitations are product by process type limitations. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113) In this case, the coupled bio-oscillating material of Gaudesius is made by a similar method where the cardiomyocyte stands initially have contractile activity that is different and which eventually synchronize (oscillate at frequencies different from the synchronized frequency) (pg. 423 Col. 2 para. 2), the frequency of spontaneous contractions varied among the strands, and the functional linking of the strands by fibroblasts established synchronization (first of the at least two CM cell clusters oscillating at a first initial beating frequency and a second of the at least two CM cell clusters oscillating at a second initial beating frequency) (pg. 423 Col. 2 para. 2). More importantly, the final product taught by Gaudesius is the same as the claimed final product. Furthermore, no evidence has been provided that the claimed product-by-process steps provide a different composition than that taught by Gaudesius. Instead the applicant appears to be arguing that these elements are intrinsic characteristics of the coupled bio-oscillating material, however these elements appear to be the steps that occur when forming the final coupled bio-oscillating material and which are taught by Gaudesius.
With respect to the rejections under 35 U.S.C. § 102 and § 103, Applicant argues that the claim 7 contains these similar limitations to claim 1 which are not taught by Gaudesius and likewise the dependent claims (Remarks pg. 8 para. 3-5). For the same reasons the arguments with respect to claim 1 were not found to be persuasive, this argument was not found to persuasive.
Applicant argues that Gaudesius is directed to observational electrophysiological studies and does not teach clusters that begin at different frequencies, converge to a new synchronized frequency and/or exhibit a synchronization time that depends on CF bridge length. Applicant further argues that Gaudesius does not teach that synchronization time should be treated as a function of bridge length and that this relationship should be controlled or utilized (Remarks pg. 9 para. 3). However, these arguments were not found to be persuasive, since the claims are to a coupled bio-oscillating material which Gaudesius teaches. Additionally, the observation that synchronization time increases with bridge length taught by Gaudesius clearly demonstrates that the synchronization time is a function of bridge length. Even if this observation was not made in Gaudesius, it does not appear to alter the final composition, the coupled bio-oscillating material. Additionally, the claim is not controlling or utilizing this apparent inherent characteristic of bridge length and synchronization time, since the claim is directed to a composition.
Applicant argues that the relationship of synchronization time with bridge length would have to be based on hindsight reasoning using the Applicant’s disclosure and Gaudesius does not provide a motivation to derive or exploit the claimed dependency (Remarks pg. 9 para. 3). This argument was not found to be persuasive, since the relationship between bridge length and synchronization time is clearly taught in Gaudesius. Furthermore, there is no need to provide motivation or to exploit this claimed dependency of bridge length and synchronization time, since the claim is to a composition and not to a method. There is no requirement for the coupled bio-oscillating material of the claims to have a particular length or particular synchronization time. Additionally, these formation steps do not appear to structurally change the coupled bio-oscillating material and no evidence showing this has been presented.
Applicant argues that Zorlutuna does not remedy the deficiencies of Gaudesius (Remarks pg. 9 para. 3). However, this argument was not found to be persuasive, since the arguments with respect to the rejections over Gaudesius were not found to be persuasive as explained above.
Applicant argues that the pending claims recite a specific dynamic behavior not disclosed by Gaudesius (Remarks pg. 9-10 bridging para.). However, this argument was not found to persuasive, since the specific dynamic behavior is describing the formation of the coupled bio-oscillating material and not the final characteristics of the claimed composition or material. Additionally, it is maintained that Gaudesius teaches these formation steps and claimed coupled bio-oscillating material.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY ANN CORDAS whose telephone number is (571)272-2905. The examiner can normally be reached on M-F 9:00-5:30 EST.
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/EMILY A CORDAS/Primary Examiner, Art Unit 1632
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