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 .
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.
Claim 3 is 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 3 recites the limitation " said histochemical analysis " in line 1. There is insufficient antecedent basis for this limitation in the 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
According to the first part of the analysis, in the instant case, claims 1-20 are directed to a method. Thus, each of the claims falls within one of the four statutory categories (i.e. process, machine, manufacture, or composition of matter).
Regarding claim 1:
A method of bioprinting a three-dimensional organ comprising the steps of:
a) obtaining a computer representation of said organ;
b) identifying cellular populations comprising said organ utilizing a visualization and/or immunological visualization means;
c) utilizing a system for sequentially layer cells upon each other in order to replication said organ needed to be replicated; and
d) growing said organ in vitro and/or in vivo.
Step 2A Prong 1:
“a) obtaining a computer representation of said organ” is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“b) identifying cellular populations comprising said organ utilizing a visualization and/or immunological visualization means” is directed to math because identifying and mapping the cellular populations that make up an organ using visualization is a process entirely driven by spatial statistics, geometry, and high-dimensional algebra.
“c) utilizing a system for sequentially layer cells upon each other in order to replication said organ needed to be replicated” is directed to math because 3D bioprinting process of sequentially layering cells to replicate organs is deeply rooted in mathematics. Bioprinters move along x, y, and z axes. Math dictates the exact coordinates required to place every microscopic droplet or layer of “bio-ink” in the correct position. Before printing, a digital 3D model (like an MRI scan) must be sliced into hundreds or thousands of 2D cross-sections. This uses geometry and calculus to calculate the thickness, boundary curves, and infill patterns of each individual layer.
“d) growing said organ in vitro and/or in vivo” is directed to math because growing said organ in vitro is keeping the cells alive inside a 3D structure. Without blood vessels, oxygen and sugar must seep naturally into the tissue. Engineers use partial equations (like Fick’s Law of Diffusion) to calculate exactly how deep oxygen can penetrate a growing organoid before the center begins to suffocate. This math dictates the maximum size a lab-grown organ can achieve before needing artificial blood vessels.
Each limitation recites in the claim is a process that, under BRI covers performance of the limitation in the mind but for the recitation of a generic “measurement” which is a mere indication of the field of use. Nothing in the claim elements precludes the steps from practically being performed in the mind. Thus, the claim recites a mental process.
Further, the claim recites the step of " b) identifying cellular populations comprising said organ utilizing a visualization and/or immunological visualization means; c) utilizing a system for sequentially layer cells upon each other in order to replication said organ needed to be replicated; and d) growing said organ in vitro and/or in vivo” which as drafted, under BRI recites a mathematical calculation. The grouping of "mathematical concepts” in the 2019 PED includes "mathematical calculations" as an exemplar of an abstract idea. 2019 PEG Section |, 84 Fed. Reg. at 52. Thus, the recited limitation falls into the "mathematical concept" grouping of abstract ideas. This limitation also falls into the “mental process” group of abstract ideas, because the recited mathematical calculation is simple enough that it can be practically performed in the human mind, e.g., scientists and engineers have been solving the Arrhenius equation in their minds since it was first proposed in 1889.
Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. See October Update at Section I(C)(i) and (iii).
Additional Elements:
Step 2A Prong 2:
“A method of bioprinting a three-dimensional organ” recited in the preamble does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“a) obtaining a computer representation of said organ” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“b) identifying cellular populations comprising said organ utilizing a visualization and/or immunological visualization means” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“c) utilizing a system for sequentially layer cells upon each other in order to replication said organ needed to be replicated” does not integrate the judicial exception into a practical application. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“d) growing said organ in vitro and/or in vivo” is directed to insignificant activity and does not integrate the judicial exception into a practical application. See MPEP 2106.05(g).
The claim is merely selecting data, manipulating or analyzing the data using math and mental process.
This is similar to electric power: MPEP 2106.05(h) vi. Limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016).
Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). In contrast, a claim that purports to improve computer capabilities or to improve an existing technology may integrate a judicial exception into a practical application or provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). See MPEP §§ 2106.04(d)(1) and 2106.05(a) for a discussion of improvements to the functioning of a computer or to another technology or technical field.
The claim as a whole does not meet any of the following criteria to integrate the judicial exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Step 2B:
“A method of bioprinting a three-dimensional organ” recited in the preamble does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“a) obtaining a computer representation of said organ” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“b) identifying cellular populations comprising said organ utilizing a visualization and/or immunological visualization means” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“c) utilizing a system for sequentially layer cells upon each other in order to replication said organ needed to be replicated” does not amount to significantly more than the judicial exception in the claim. This additional element is merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(h)).
“d) growing said organ in vitro and/or in vivo” is directed to insignificant activity and does not amount to significantly more than the judicial exception in the claim. See MPEP 2106.05(g) and 2106.05(d)(ii), third list, (iv).
The claim is therefore ineligible under 35 USC 101.
Dependent claims 2-20 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea, as detailed below: there is no additional element(s) in the dependent claims that adds a meaningful limitation to the abstract idea to make the claim significantly more than the judicial exception (abstract idea).
Hence the claims 1-20 are treated as ineligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 6, 7, 10, and 12-15 is/are rejected under 35 U.S.C. 103 as being obvious over Mathew (CN 115052738 A).
Regarding claim 1, Mathew discloses a method of bioprinting a three-dimensional organ ([n0039]) comprising the steps of:
a) obtaining a computer representation of said organ ([n0041]: the 3D lymphoid organoids are selected from B-cell germinal centers, thymic microhabitats, lymph nodes, Langerhans islands, hair follicles, tumors, tumor spheroids, nerve bundles or supporting cells, nephrons, liver organoids, intestinal crypts, primary lymphoid organs, and secondary lymphoid organs);
b) identifying cellular populations ([n0040]: provides a method for generating a population of human immune proteins… (c) subjecting the at least one layer of the medium to an energy source to form at least a portion of the 3D lymphoid organoid comprising (i) at least a subpopulation of the plurality of cells) comprising said organ utilizing a visualization and/or immunological visualization means ([0303]: Printed lymph nodes can be used to generate or evaluate antibodies, T-cell receptors, immunological products, or immune responses);
c) utilizing a system for sequentially layer cells upon each other in order to replication said organ needed to be replicated ([n0246]); and
d) growing said organ in vitro and/or in vivo ([n0280], [n0416]).
Regarding claim 2, Pompano et al. disclose wherein said identification of said cellular populations is performed by histological analysis ([n0074]: microscopic study).
Regarding claim 3, Mathew discloses wherein said histochemical analysis is performed using a computer assisted visualization means which incorporates principal component analysis ([n0232]).
Regarding claim 6, Mathew discloses wherein cells to be seeded into said organ are identified based on cell surface markers ([n0298]).
Regarding claim 7, Mathew discloses wherein cells to be seeded into said organ are identified based on molecular pathway analysis ([n0364]).
Regarding claim 10, Mathew discloses wherein said bioprinting is performed in a media capable of sustaining cellular viability and activity ([n0011], [n0013]).
Regarding claim 12, Mathew discloses wherein bioprinting comprises three-dimensional printing of a biological organ, organoid, and/or tissue through the layering of living cells using a bioprinter ([n0024], [n0040]).
Regarding claim 13, Mathew discloses wherein said bioprinter is a three-axis mechanical platform that controls the movements of extruders that deposit layers of living cells in a desired shape ([n0158], [n0171]).
Regarding claim 14, Mathew discloses wherein said desired shape is acquired by scanning the surface of a desired organ, organoid and/or tissue to generate a surface map for guidance with cell deposition ([n0042], [n0166],[n0170]).
Regarding claim 15, Mathew discloses wherein scanning the surface of a desired organ, organoid and/or tissue is achieved using a laser, electron beam, magnetic resonance imaging, microwave, x-ray, computed tomography, or a combination thereof ([n0170]).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN H LE whose telephone number is (571)272-2275. The examiner can normally be reached on Monday-Friday from 7:00am – 3:30pm Eastern Time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shelby A. Turner can be reached on (571) 272-6334. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN H LE/Primary Examiner, Art Unit 2857
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