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 .
Status of the Claims
Applicant’s submission filed 03 February 2026 has been entered. Claims 1-6, 8-10, 15, 17, 24-29, and 35-36 are pending. Claims 1-2, 4-5, 10, and 17 have been amended, while claim 7 has been cancelled without prejudice or disclaimer. Therefore, prosecution on the merits continues for claims 1-6, 8-10, 15, and 17 as being drawn to the elected invention, with claims 24-29 and 35-36 withdrawn for reading on the non-elected invention(s). All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to the Specification
The substitute Specification filed 03 February 2026 is acknowledged and has been entered into the application file. Although the substitute Specification removes references to colors within the figures, the substitute Specification still contains browser-executable code that is not limited to the top-level domain. The Examiner respectfully reminds Applicant that browser-executable code limited to the top-level domain is, for example, oeis.org.
Furthermore, in response to Applicant’s traversal in Page 7 of the Remarks filed 03 February 2026, the Examiner also respectfully submits that the references to the GitHub source code still comprise browser-executable code.
Therefore, the objection is maintained.
RE: Objection to claims 10 and 17
Applicant’s amendments to each of instant claims 10 and 17 obviate the objections of record. Therefore, the objections are withdrawn.
RE: Rejection of claims 2, 4, and 7 under 35 USC 112(b)
The cancellation of claim 7 renders the rejection of that claim moot. For the remaining claims, Applicant’s amendments to each of instant claims 2 and 4 obviate the rejections of record.
Therefore, the rejections are withdrawn.
RE: Rejection of claim 5 under 35 USC 112(d)
Applicant’s amendment to instant claim 5 removing the optional limitation obviates the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1-5, 8-9, and 17 under 35 USC 102(a)(1) over Faustino Martins et al
Applicant’s amendments to independent claim 1 requiring the engineered multicellular organism to comprise passive cells that are not neurons, and have a total cell number of less than about 1,000 cells obviate the rejection of record.
Therefore, the rejection is withdrawn.
RE: Rejection of claims 1, 4-10, 15, and 17 under 35 USC 102(a)(2) over Bashir et al
Applicant’s amendments to independent claim 1 requiring the engineered multicellular organism to comprise passive cells that are not neurons, and have a total cell number of less than about
1,000 cells obviate the rejection of record.
Therefore, the rejection is withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the new rejection of record:
Applicant has traversed the rejection, asserting in Pages 8-9 of the Remarks filed 03 February 2026 that the instant disclosure states that neural cells are specifically defined as not being passive cells. See Paragraph [0053] of the Specification. In response, the Examiner respectfully submits that Applicant has failed to specifically define a “passive” cell, and that a listing of exemplary passive cells as seen in Paragraphs [0043] and [0051] of the instant Specification does not constitute a definition. Accordingly, given the broadest reasonable interpretation of the term, a “passive” cell will be considered any cell that is not involved in the contractility of the engineered multicellular organism. See MPEP § 2111.
New/Maintained Grounds of Rejection
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in Paragraphs [0128], [0195], [0197], [0208], [0223], [0228]-[0229], [0232], [0235], [0241]-[0242], [0245], [0249], [0264], [0272], [0275], [0277]-[0279], [0286], and [0288]. 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.
Appropriate correction is required.
Claim Interpretation
Under the broadest reasonable interpretation of each claim, all “optional” limitations are not required.
In addition, Applicant has defined “substantially” – as seen in instant claim 5 – to mean more than plus or minus 10% of the particular term. See Paragraph [0036] of the instant Specification.
Furthermore, instant claim 8 is directed to a products which utilizes product-by-process language. The limitations of the process of production are considered only in so far as the process of production imparts distinct structural or chemical characteristics or properties to the claimed product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e. is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP § 2113.
Claim 8 further defines the originating cell source from which the passive cells and/or contractile cells are obtained from. When defining the source of cells, the source of the cells is only considered in as far as the source defines the cell as having distinct biochemical or morphological characteristics. In the instant case, the source of the passive cells and/or contractile cells does not impart a distinction to the cells, but rather their physical and structural characteristics dictates their classification as a particular cell type.
Therefore, claim 8 will be interpreted as if passive cells and/or contractile cells from any source fulfills the limitation detailed in the instant claim.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, 8, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Devarasetty et al (Biosensors, 2017).
Devarasetty et al disclose cardiac organoids comprised of induced pluripotent stem cell-derived cardiomyocytes (iPSC CMs) and human primary cardiac fibroblasts, wherein a combined total of approximately 1,000 cells are allowed to self-assemble in a non-adherent, round-bottom 96-well plate to form the cardiac organoid (Pages 2-3). Devarasetty et al further disclose that the iPSC CMs contract both spontaneously and when actuated with a therapeutic compound (Pages 1-6).
Accordingly, Devarasetty et al anticipate the claims as follows:
Regarding claim 1: Devarasetty et al disclose cardiac organoids comprising human primary cardiac fibroblasts (passive cells) and iPSC-derived cardiomyocytes (contractile cells), wherein the cardiomyocytes contract and move when they are actuated. As the cardiac organoid is comprised of approximately 1,000 total cells, which is less than about 1,000 total cells, this therefore reads on the engineered multicellular organism of instant claim 1.
Regarding claim 2: Following the discussion of claim 1, Devarasetty et al further disclose that the cardiac organoids are only comprised of the cardiac fibroblasts and cardiomyocytes, and do not comprise an inorganic material (Page 2). This therefore reads on the engineered multicellular organism of the instant claim.
Regarding claim 4: Following the discussion of claim 1, Devarasetty et al further disclose that the cardiac fibroblasts and cardiomyocytes self-assemble into the cardiac organoids. This therefore reads on the engineered multicellular organism of the instant claim.
Regarding claim 8: The instant claim comprises product-by-process language. The effect of the product-by-process language is discussed above – see Claim Interpretation – and is incorporated herein in its entirety.
Accordingly, since Devarasetty et al disclose cardiac organoids comprising cardiac fibroblasts (passive cells) and iPSC-derived cardiomyocytes (contractile cells), this therefore reads on the engineered multicellular organism of the instant claim.
Regarding claim 17: Following the discussion of claim 1, Devarasetty et al further disclose that the cardiac fibroblasts are human primary cardiac fibroblasts. As a human is inherently a vertebrate, this therefore reads on the engineered multicellular organism of the instant claim.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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, 3-6, 8-10, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bashir et al (US 10906169 B1, of record).
Bashir et al is considered prior art under 35 USC 102(a)(2), with an effective filing date of 26 October 2016.
Regarding claim 1: Bashir et al, however, disclose biological machines – termed “bio-bots” –
comprising a skeleton that comprises at least one bioactuator, wherein the bioactuator is a muscle ring comprised of mammalian cardiac muscle cells and endothelial cells, and hydrogel pillars – or protrusions – that aid in the locomotion of the bio-bot (Abstract; Columns 16-20, 23-25; Figures 1, 21).
Bashir et al further disclose that the cells are present in the muscle ring at a concentration of about 100 cells/mL (Column 18).
Bashir et al do not disclose that the total number of cells within the muscle ring is less than about 1,000 cells, as required by instant claim 1.
However, Bashir et al do disclose that the ring molds may be made into any shape or size (Columns 19-20, 22).
Therefore, it would have been prima facie obvious to have modified the bio-bot of Bashir et al such that the muscle ring comprises less than about 1,000 total cells. One of ordinary skill in the art before the effective filing date of the invention would have recognized that the muscle ring can be tailored to comprise less than about 1,000 total cells, as Bashir et al disclose that the muscle ring can be any shape or size with a cell concentration of about 100 cells/mL, and would have had a reasonable expectation of success given that Bashir et al reasonably suggest muscle ring molds that hold 60, 80, and 90 μL of cell suspension within embodiments of the invention (Column 49). See MPEP § 2143(I)(G) and 2144.05(II).
Consequently, Bashir et al render obvious a bio-bot comprising a skeleton that comprises at
least one bioactuator, wherein the bioactuator is a muscle ring comprising mammalian cardiac muscle cells (contractile cells) and endothelial cells (passive cells) having a total cell count of less than about 1,000 cells. As the cardiac muscle cells contract and move when they are actuated, this therefore renders obvious the engineered multicellular organism of the instant claim.
Regarding claims 3 and 9-10: Following the discussion of claim 1, Bashir et al further disclose that the muscle cells within the bio-bot are genetically modified to express a light-sensitive heterologous protein (claim 9), wherein the genetically-modified cells are stimulated and allow the bio-bot to move via the contraction of the muscle cells upon receiving the light signal (claims 3, 10) (Columns 8, 24-25). Bahir et al further disclose that the bio-bots can alternatively be fabricated such that the cells comprise one or more chemoreceptors, wherein the bio-bots are stimulated to move towards the chemoreceptor ligand (Column 25). This therefore reads on the engineered multicellular organism of the instant claims.
Regarding claim 4: Following the discussion of claim 1, Bashir et al further disclose that the cells self-assemble to form the muscle ring (Column 19). This therefore reads on the engineered multicellular organism of the instant claim.
Regarding claims 5-6: Following the discussion of claim 1, Bashir et al further disclose that the bio-bot moves at a linear (claim 5) locomotive rate of 24 mm/minute (Columns 22-26). As this value is greater than 1 mm/minute, this therefore reads on the engineered multicellular organism of instant claim 6.
Regarding claim 8: The instant claim comprises product-by-process language. The effect of the product-by-process language is discussed above – see Claim Interpretation – and is incorporated herein in its entirety.
Accordingly, since Bashir et al disclose bio-bots comprising endothelial cells (passive cells) and cardiac muscle cells (contractile cells), this therefore reads on the engineered multicellular organism of the instant claim.
Regarding claim 15: Following the discussion of claim 1, Bashir et al further disclose that the bio-bot has protrusions extending from the skeleton that facilitate movement of the bio-bot (Abstract; Columns 23-25). This therefore reads on the engineered multicellular organism of the instant claim.
Regarding claim 17: Following the discussion of claim 1, Bashir et al further disclose that the endothelial cells and cardiac muscle cells are mammalian cells (Columns 16, 27, 35-36). As mammals are inherently vertebrates, this therefore reads on the engineered multicellular organism of the instant claim.
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 ALYSSA G WESTON whose telephone number is (571)272-0337. The examiner can normally be reached Monday-Thursday 8AM - 4PM (CT); Friday 8AM - 11AM (CT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA G WESTON/Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633
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