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 .
Priority
This application was filed June 16, 2023, and is a 371 application of PCT/US2021/065694 filed on December 30, 2021,
which claims priority from provisional application 63/252,268 filed 5th of October 2021, which claims priority to provisional application 63/132,934 filed 31st of December 2020.
Election/Restrictions
Applicant’s election without traverse of Group III directed to drawn to a method for culturing cells and obtaining a single cell-derived spheroid and has elected species a: poly(L-lysine)(PLL)/poly(L-glutamic acid)(PLGA) (from group I) and species b. polyanion (from group II) in the reply filed on 27th of April 2026, is acknowledged.
Claim Status
Claims 47-66 are pending and are under consideration in this office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/16/2023; 11/16/2023; 4/15/2024; 10/8/2024; and 8/5/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Applicant is reminded that the disclosure statements filed lists Search Reports. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Furthermore, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 51-61 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 51 recites “A method for obtaining and optionally characterizing single-cell derived spheroid, the method comprising:
a) culturing a heterogeneous population of cells on a surface coated with [[the]]£!
composition of claim 32 to obtain at least one single-cell-derived spheroid disposed on the surface, and
b) analyzing the single-cell-derived spheroid to thereby obtain at least one
characteristic of the single cell, the composition comprising:
a polymer selected from the group consisting of poly(vinyl alcohol) (PV A),
poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide
(PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA),
poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl
methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives
thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and
polyelectrolyte multilayers, wherein the polymer is in direct contact with a
polycation or a polyanion of the polyelectrolyte multilayers.”
Per the 2019 Revised Patent Subject Matter Eligibility Guidance (2019 PEG) published on January 7, 2019 (84 Fed. Reg. 50), if a claim recites a limitation that can practically be performed in the human mind, the limitation falls within the mental processes grouping, and the claim recites an abstract idea. Claims recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.
The courts consider a mental process (thinking i.e. analyzing) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work' that are open to all.' " 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) ("‘[M]ental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
Regarding claim 51, the “analyzing” step is considered to embrace a mental process. See also MPEP 2106.04(a-b).
Step 1-Statutory Category: According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of matter). Claim 51 is drawn to a method for obtaining and optionally characterizing single-cell derived spheroid. Thus, the method meets the requirements for step 1 of the analysis as it is drawn to a process.
Next the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019 PEG, “directed to" is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application", requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 210 6.05 for examples of integration of practical application).
Step 2A Judicial Exception-Prong 1 (claim is directed to a judicial exception): Prong 2A asks whether the claim recites an abstract idea, law of nature, or natural phenomenon (product of nature).
Regarding claim 51, recites a judicial exception in the step of “b) analyzing the single-cell-derived spheroid to thereby obtain at least one characteristic of the single cell,”, which requires a mental step. The claim 51, “analyzing” step of the single-cell-derived spheroid to thereby obtain at least one characteristic of the single cell is an abstract idea involving mental processes because a simple observation of a single cell characteristic obtained can be performed mentally. Claims can recite a mental process even if they are described in the specification and/or claimed as being performed on a device. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 52, dependent on claim 51, and recites “herein the polymer is PVA, PEG, PEG-acrylate, PVP, PMMA or a derivative thereof.” Claim 52 just describes the composition. Therefore, claim 52 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 53, dependent on claim 51, and recites “wherein the polymer is PVA, PEG or PEG-acrylate.” Claim 53 just describes the composition. Therefore, claim 53 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 54, dependent on claim 51, and recites “wherein the polycation is a poly(amino acid)and/or the polyanion is a poly(amino acid).” Claim 54 just describes the composition. Therefore, claim 54 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 55, dependent on claim 51, and recites “wherein the polycation is selected from the group consisting of poly(L-lysine)(PLL), poly(L-arginine) (PLA), poly(L- ornithine) (PLO), poly(L-histidine)(PLH), and a combination thereof.” Claim 55 just describes the composition. Therefore, claim 55 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 56, dependent on claim 51, and recites “wherein the polyanion is poly(L-glutamic acid) (PLGA), poly(L-aspartic acid) (PLAA), or a combination thereof”. Claim 56 just describes the composition. Therefore, claim 56 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 57, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise at least one bilayer composed of a polycation and a polyanion (polycation/polyanion), wherein the bilayer is selected from the group consisting of PLL/PLGA, PLL/PLAA, PLA/PLGA, PLA/PLAA, PLO/PLGA, PLO/PLAA, PLH/PLGA, PLH/PLAA, and a combination thereof.” Claim 57 just describes the composition. Therefore, claim 57 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 58, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers are formed via layer-by-layer assembly”. Claim 58 just describes the composition. Therefore, claim 58 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 59, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise n bilayers, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polycation or a polyanion.” Claim 59 just describes the composition. Therefore, claim 59 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 60, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise n bilayers of (polycation/polyanion), and an additional layer of poly anion, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polyanion.” Claim 60 just describes the composition. Therefore, claim 60 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Regarding claim 61, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise n bilayers of (polyanion/polycation), and an additional layer of polycation, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polycation.” Claim 61 just describes the composition. Therefore, claim 61 does not remedy the deficiency of claim 51. Hence, the claim relates to an abstract idea that is related observing a natural phenomenon involving laws of nature. Thus, the claim is directed to a judicial exception.
Furthermore, there is nothing about claims 51-61 that include additional elements that are sufficient to amount to significantly more than the judicial exception since the invention as claimed does not introduce or recite any step of the compositions that is beyond that which is well understood, routine, and conventional.
Step 2A Judicial Exception-Prong 2 (Judicial exception is integrated into a practical application): The phrase, "integration of a practical application", requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful Iimitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application). Prong 2 asks whether a claim recites additional elements that integrate the judicial exception into a practical application.
In claim 51, there is no step after the step of “analyzing the single-cell-derived spheroid to thereby obtain at least one characteristic of the single cell, the composition comprising: a polymer selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl methacrylate) (PMMA), poly(hydroxyethyl methacrylate)(p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers”, there is no additional steps requiring a practical application (e.g. applying a treatment, action, or substance).
Thus, the instant claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 52, dependent on claim 51, and recites “herein the polymer is PVA, PEG, PEG-acrylate, PVP, PMMA or a derivative thereof.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 53, dependent on claim 51, and recites “wherein the polymer is PVA, PEG or PEG-acrylate.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 54, dependent on claim 51, and recites “wherein the polycation is a poly(amino acid)and/or the polyanion is a poly(amino acid).” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 55, dependent on claim 51, and recites “wherein the polycation is selected from the group consisting of poly(L-lysine)(PLL), poly(L-arginine) (PLA), poly(L- ornithine) (PLO), poly(L-histidine)(PLH), and a combination thereof.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 56, dependent on claim 51, and recites “wherein the polyanion is poly(L-glutamic acid) (PLGA), poly(L-aspartic acid) (PLAA), or a combination thereof”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 57, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise at least one bilayer composed of a polycation and a polyanion (polycation/polyanion), wherein the bilayer is selected from the group consisting of PLL/PLGA, PLL/PLAA, PLA/PLGA, PLA/PLAA, PLO/PLGA, PLO/PLAA, PLH/PLGA, PLH/PLAA, and a combination thereof.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 58, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers are formed via layer-by-layer assembly”. The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 59, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise n bilayers, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polycation or a polyanion.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 60, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise n bilayers of (polycation/polyanion), and an additional layer of poly anion, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polyanion.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Regarding claim 61, dependent on claim 51, and recites “wherein the polyelectrolyte multilayers comprise n bilayers of (polyanion/polycation), and an additional layer of polycation, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polycation.” The claim does not recite any additional elements or a combination thereof that integrated the judicial exception identified in prong 1 as being integrated into a practical application. Therefore, this judicial exception is not integrated into a practical application because there are no additional limitations that might integrate the mental processes and laws of nature into a practical application.
Thus, claims 51-61 meet the requirements of step 2A as being directed to a judicial exception.
Step 2B Significantly More: The "significantly more" analysis determines that a claim is patent eligible if the claims recite structures or functions that transform the natural product in a manner that make the product markedly different from the judicial exception. The nature-based product is analyzed to determine whether it has markedly different characteristics from any naturally occurring counterpart(s) in their natural state.
Claim 51 does not add significantly more than the judicial exception. The claim recites “analyzing the single-cell-derived spheroid to thereby obtain at least one characteristic of the single cell, the composition comprising: a polymer selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers.”
Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 52, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites ““herein the polymer is PVA, PEG, PEG-acrylate, PVP, PMMA or a derivative thereof.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 53, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polymer is PVA, PEG or PEG-acrylate”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 54, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polycation is a poly(amino acid)and/or the polyanion is a poly(amino acid).” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 55, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polycation is selected from the group consisting of poly(L-lysine)(PLL), poly(L-arginine) (PLA), poly(L- ornithine) (PLO), poly(L-histidine)(PLH), and a combination thereof.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 56, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polyanion is poly(L-glutamic acid) (PLGA), poly(L-aspartic acid) (PLAA), or a combination thereof”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 57, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polyelectrolyte multilayers comprise at least one bilayer composed of a polycation and a polyanion (polycation/polyanion), wherein the bilayer is selected from the group consisting of PLL/PLGA, PLL/PLAA, PLA/PLGA, PLA/PLAA, PLO/PLGA, PLO/PLAA, PLH/PLGA, PLH/PLAA, and a combination thereof.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 58, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polyelectrolyte multilayers are formed via layer-by-layer assembly”. Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 59, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polyelectrolyte multilayers comprise n bilayers, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polycation or a polyanion.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 60, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polyelectrolyte multilayers comprise n bilayers of (polycation/polyanion), and an additional layer of poly anion, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polyanion.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
Regarding claim 61, dependent on claim 51, does not add significantly more than the judicial exception. The claim recites “wherein the polyelectrolyte multilayers comprise n bilayers of (polyanion/polycation), and an additional layer of polycation, wherein n is an integer number ranging from 1 to 30, and wherein the outermost layer is a polycation.” Therefore, this step does not have an additional practical step performed in this embodiment. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements claimed. Therefore, claim 51 does not meet the requirement of step 2B and therefore does not meet patent subject matter eligibility requirements.
It is well established that data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant activity (see also MPEP 2106.05(g)).
Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. (see MPEP 2106.04(a)(2)(III).)
In conclusion, claims 51-61 recites abstract ideas which are not considered to disclose eligible subject matter under 35 U.S.C. 101, and therefore are deemed not patent eligible.
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 47-51, 54, 57-62, and 65-66 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.
Independent claims 47 and 51 recite “a composition comprising: a polymer selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof,” (see lines 3-8 of claim 47 and lines 8-13 of claim 51). In the instant case the term “derivatives thereof” are not defined by the claim and the instant specification does not provide a special definition. Thus, the polymer structure of the composition is not apparent to one of ordinary skill in the art, because one would not know what the structure is required in order to obtain the polymer composition. As such, it is unclear what “derivatives thereof” is referring to and renders the claim indefinite because the base of the claim does not state or suggest what is and what is not a “derivative”. This affects the scope of dependent claims 48-50, 54, 58-62 and 66.
Claim 50 recites "the method of claim 47, wherein the seeding comprises plating the cells at a density less than 1000 cells per cm2 on the substrate" in lines 1-2. However, there is no “substrate” recited in claim 47. Thus, it is unclear what substrate the claim is referring too. There is insufficient antecedent basis for this limitation in the claim. For compact prosecution the substrate will be interpreted as the coated surface that the cells are seeded on in claim 47.
Claim 57 and 65 recite claim limitations that are a list of polymer combinations with a slash (see e.g. PLL/PLGA). The “slash” in claims 57 and 65 encompasses “and/or” (e.g. PLL and PLGA; PLL or PLGA), which renders the claim indefinite. Thus, the polyelectrolyte multilayer comprising the polycation and/or the polyanion would not be apparent to one of ordinary skill in the art, because one would not know what structure is required in order to obtain the polyelectrolyte multilayer. Thus, it is unclear what polycation and/or the polyanion the claim is referring too. It is noted that according to the MPEP 2173.05(h), the claims may be interpreted as alternative combinations since the slash indicates an “and/or”. For compact prosecution the polymer combination will be interpretated as “or” combinations (i.e. PLL or PLGA), thus the bilayer will be any combination of polycation and polyanions listed in the 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 47-49, 62, and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schlenoff and Arias (US2016/0230136 A1, published Aug. 11, 2016, hereinafter as “Schlenoff”).
Regarding claim 47, Schlenoff discloses a method for culturing cells, the method comprising: a) providing a cell culture article having a surface coated with a composition (see e.g. Examples 1-2, 9, and 15-16, claims 1-22) comprising: a polymer selected from the group consisting of poly(methyl methacrylate)(i.e. Poly(methacrylic acid), PMMA), poly(ethylene glycol)(i.e. PEG), and derivatives therefore (e.g. acrylic acid, PAA, poly(L-aspartic acid), PLAA) (see e.g. para. 60, 76-77, 87-89, 143, Table 1-2, Example 1, 15-16, claim 8). Further, Schlenoff discloses wherein the polymer is crosslinked to a surface of the cell culture article (see e.g. para. 7, 10, 76, 90-93, Example 1-2, 9, and 15-16), and polyelectrolyte multilayers (i.e. PEMUs), wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers (i.e. zwitterionic solid) (see e.g. para. 7, 10, 27-37, 76, 90-93, 118-121, Example 1-2, 9, and 15-16), b) seeding cells on the coated surface (see e.g. para. 118-121, 148, Example 1-2, 9-10), and c) culturing the cells under a suitable medium for a sufficient period of time to form one or more spheroids (i.e. quasispherical cluster)(see e.g. claim 1-22, Example 1-2, and 9-10). Furthermore, it is noted that the instant specification discloses that a derivative of the polymer are polyacrylate compositions, therefore the Poly(acrylic acid)(PAA) as taught by Schlenoff reads on a derivative thereof.
Regarding claim 48, Schlenoff discloses wherein the one or more spheroids are generated via single cell proliferation (see e.g. para. 166, Fig. 1 and 4).
Regarding claim 49, Schlenoff discloses wherein the one or more spheroids have an average diameter between 50 μM and 150 μM (see e.g. para. 80, Fig. 1)
Regarding claim 62,Schlenoff discloses wherein the polymer is a polycation or a polyanion and may be a poly(amino acid) creating a zwitterionic solid (see e.g. para. 7, 10, 27-39, 40-44, 76, 90-93, 118-121, Example 1-2, 9, and 15-16).
Regarding claim 66, Schlenoff discloses wherein the polyelectrolyte multilayers are formed via layer-by-layer assembly(see e.g. para. 7, 67, 77, and Example 1).
Therefore, Schlenoff anticipates the instant claims.
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.
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.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Schlenoff and Arias (US2016/0230136 A1, published 2016, hereinafter as “Schlenoff”), as applied to claims 47-49, 62, and 66 above, and further in view of Schlenoff et al., (US2005/0287111 A1, published 2015, hereinafter as “Schlenoff 2015”), and Kaur, et al. (Slas Discovery: Advancing the Science of Drug Discovery 26.10: 1298-1314, published online Nov. 2021), as evidence by Thermo Fisher Scientific (“Useful Numbers for Cell Culture.” Thermo Fisher Scientific - US, published n.d., accessed June 2026).
The teachings of Schlenoff apply here as disclosed above.
Regarding claim 50, Schlenoff does not explicitly disclose wherein the seeding comprises plating the cells at a density less than 1,000 cells per cm2 on the coated surface.
However, the prior art of Schlenoff 2015 discloses 1 x 104 cells/ml were plated in 6-well dishes, and grown for 30-48 hours (see e.g. para. 134, Example 1), as evidence by Thermo-Fisher which discloses that a 6-welll plate has a surface area of 9.6 cm (i.e. 10,000 cells/9.6cm2 is about 1,041 cells per cm2 ). Further, the prior art of Kaur discloses method for inoculating cells into the wells of 96-well microplates at seeding densities ranging from 2000 to 500 cells per well for obtaining spheroids (see e.g. page 1300, 1305, fig. 1-2).
Further, MPEP § 2144.05 (II) states, “Generally, differences in time, concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In reHoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.).
In the instant case, neither the specification nor Applicant have provided evidence of that the claimed number of cells per well is critical, thus the teaching of a density of less than 1,000 cells per cm2 renders the claimed time period obvious.
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Schlenoff to incorporate a density of less than a thousand cells per centimeter as taught by Kaur because both Schlenoff and Kaur disclose culturing spheroids (see e.g. abstracts, respectively). Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods to yield predictable results. Further, it would have been obvious for one of ordinary skill in the art to have considered altering the number of cells being seeded when carrying out step “(b)” because Schlenoff discloses that the morphology may be identified by microscopic examination of the cell culture (see e.g. para. 97), and Kaur discloses imaging complex and simple spheroids (see e.g. page 1305). Thus, optimizing the density at less than a thousand cells per centimeter on the surface would have been prima facie obvious at the time of filing in order to image individual spheroids.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 63-65 are rejected under 35 U.S.C. 103 as being unpatentable over Schlenoff and Arias (US2016/0230136 A1, published 2016, hereinafter as “Schlenoff”), as applied to claims 47-49, 62, and 66 above, and further in view of Richert, Ludovic, et al. ( Surface Science 570.1-2: 13-29, published 2004, hereinafter as “Richert”), Matsushita, Taku, et al. (Cytotechnology 42.2: 57-66, published 2003), and Park, Kyungtae, et al. (Journal of industrial and engineering chemistry 69: 263-268, published 2019, hereinafter as “Park”).
The teachings of Schlenoff et al., apply here as disclosed above.
Regarding claim 63-65, as stated supra, Schlenoff discloses wherein the polymer is a polycation or a polyanion and may be a poly(amino acid) creating a zwitterionic solid (see e.g. para. 7, 10, 27-39, 40-44, 76, 90-93, 118-121, Example 1-2, 9, and 15-16).
Schlenoff does not explicitly discloses wherein the polycation is selected from the group consisting of poly(L-lysine)(PLL) and wherein the polyanion is poly(L-glutamic acid) (PLGA), thus having the polyelectrolyte multilayers comprise at least one bilayer composed of a polyanion and a polyanion, wherein the bilayer consists of PLL or PLGA (i.e. PLL/PLGA).
However, the prior art of Richert discloses methods for a polyelectrolyte multilayer (i.e. PEM) comprising poly(L-lysine)(i.e. PLL) and poly(L-glutamic acid)(PLGA)(i.e. PGA)(see e.g. abstract, page 18, 20-27, and fig. 1, and table 3). Additionally, the prior art of Matsushita discloses spheroid formation on poly(L-lysine)(i.e. PLL) or poly(L-glutamic acid)(PLGA) coated surfaces (see e.g. abstract, page 58-63, fig. 5). Furthermore, the prior art of Park disclose that method of polyelectrolyte multilayers of poly-L-lysine (PLL) and poly-L-glutamic acid (PGA) have been known in the prior art (see e.g. abstract, page 263-264).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Schlenoff to incorporate a polyelectrolyte multilayer (i.e. PEM) with poly(L-lysine)(i.e. PLL) and poly(L-glutamic acid)(PLGA)(i.e. PGA) as taught by Richert and Matsushita, because Schlenoff and Richert disclose that polyelectrolyte multilayer compositions can be modified depending on the cell adhesion properties needed (see e.g. page 12 and 19, respectively). Additionally, the substitution of the polycation/polyanions such as those taught by Richert and Matsushita in place of the polycation/polyanions taught by Schlenoff would be considered obvious since it is prima facie obvious to substitute one known element for another to obtain predictable results. Additionally, a person of ordinary skill in the art would have motivation to do because the prior art of Park disclose that polyelectrolyte multilayers of poly-L-lysine (PLL) and poly-L-glutamic acid (PGA) have high biocompatibility in biomedical applications (see e.g. abstract, page 263-264). Moreover, Matsushita discloses that spheroid formation on poly(L-lysine)(i.e. PLL) or poly(L-glutamic acid)(PLGA) coated surfaces were both readily available and are deliverable using similar techniques. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 51-54, and 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Schlenoff and Arias (US2016/0230136 A1, published 2016, hereinafter as “Schlenoff”), in view of Huang, Yi-Ching, et al. (Biomaterials 34.2: 442-451, published 2013, hereinafter as “Huang”).
Regarding claim 51-54, Schlenoff discloses a method for obtaining one or more spheroids (i.e. quasispherical cluster)(see e.g. claim 1-22, Example 1-2, 9-10, and 15-16). Schlenoff discloses the method comprising: a) culturing a heterogeneous population of individual cells (e.g. 3T3 fibroblasts) on a surface coated with a composition to obtain at least one single-cell-derived spheroid disposed on the surface (see e.g. para. 166, Examples 1-2, 9, and 15-16, claims 1-2, Fig. 1-4) and b) the composition comprising: a polymer selected from the group consisting of poly(methyl methacrylate)(i.e. Poly(methacrylic acid), PMMA), poly(ethylene glycol)(i.e. PEG), and derivatives therefore (e.g. acrylic acid, PAA, poly(L-aspartic acid), PLAA) (see e.g. para. 60, 76-77, 87-89, 143, Table 1-2, Example 1, 15-16, claim 8). Further, Schlenoff discloses wherein the polymer is crosslinked to a surface of the cell culture article (see e.g. para. 7, 10, 76, 90-93, Example 1-2, 9, and 15-16), and polyelectrolyte multilayers (i.e. PEMUs), wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers (i.e. zwitterionic solid) (see e.g. para. 7, 10, 27-39, 76, 90-93, 118-121, Example 1-2, 9, and 15-16). Furthermore, the instant specification discloses that a derivative of the polymer are polyacrylate compositions, therefore the Poly(acrylic acid)(PAA) as taught by Schlenoff reads on a derivative thereof.
Schlenoff does not explicitly discloses characterizing and obtaining a single-cell derived spheroid and discloses wherein the surface is coated with the polymer poly(vinyl alcohol)(PVA).
However, the prior art of Huang discloses characterizing (e.g. polymerase chain reaction (PCR)-based analysis, see Spec. para. 136) and obtaining a single-cell derived spheroids (see e.g. abstract, page 443-445, and fig. 2). Further Huang discloses that the cells were seeded into a PVA coated surface (see e.g. page 443).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Schlenoff and incorporate characterizing and obtaining a single-cell derived spheroid and the use a surface that is coated with the polymer poly(vinyl alcohol)(PVA) as taught by Huang because both Huang and Schlenoff disclose methods of using polymers for obtaining spheroids (see e.g. abstracts). Further, Huang discloses that the PVA-coated array of PCT tubes preserved the cell phenotype and cause the cells to cells quickly aggregated into one single spheroidal microtissue after 1 day in culture (see e.g. page 445). Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Regarding claim 58, Schlenoff discloses wherein the polyelectrolyte multilayers are formed via layer-by-layer assembly(see e.g. para. 7, 67, 77, and Example 1).
Regarding claim 59-61, Schlenoff discloses wherein the polyelectrolyte multilayers comprise “n” bilayers, wherein “n” is an integer number ranging from 1 to 30 (see e.g. 20 layers in Example 1). Schlenoff discloses wherein the terminated layer (i.e. outermost layer) is a polyanion (i.e. poly(styrenesulfonic acid)(PSS)(see e.g. para. 10, 34, 116, 144, 163, Examples 1, 9-10, 15, and fig. 3). Further, Schlenoff discloses wherein the terminated layer (i.e. outermost layer) is a polycation (i.e. Poly(diallyldimethylammonium)(PDADMA)(see e.g. para. 10, 34, 116, 144, 163, Examples 1, 9-10, 15, and fig. 3). Additionally, Schlenoff discloses the polyelectrolyte multilayers complex (i.e. PECTF) may have additional treatment with polyelectrolytes (i.e. having an additional layer of a polycation or a polyanion) in order to create a charged surface having a preferred net fixed surface charge (see e.g. para. 101-117, page 12).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claims 55-57 are rejected under 35 U.S.C. 103 as being unpatentable over Schlenoff and Arias (US2016/0230136 A1, published 2016, hereinafter as “Schlenoff”), and Huang, Yi-Ching, et al. (Biomaterials 34.2: 442-451, published 2013, hereinafter as “Huang”), as applied to claims 51-54, and 58-61 above, and further in view of Richert, Ludovic, et al. ( Surface Science 570.1-2: 13-29, published 2004, hereinafter as “Richert”), Matsushita, Taku, et al. (Cytotechnology 42.2: 57-66, published 2003), and Park, Kyungtae, et al. (Journal of industrial and engineering chemistry 69: 263-268, published 2019, hereinafter as “Park”).
The teachings of Schlenoff et al. apply here as indicated above.
Regarding claim 55-57, as stated supra, Schlenoff discloses wherein the polymer is crosslinked to a surface of the cell culture article (see e.g. para. 7, 10, 76, 90-93, Example 1-2, 9, and 15-16), and polyelectrolyte multilayers (i.e. PEMUs), wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers (i.e. zwitterionic solid) (see e.g. para. 7, 10, 27-39, 76, 90-93, 118-121, Example 1-2, 9, and 15-16).
Schlenoff does not explicitly discloses wherein the polycation is selected from the group consisting of poly(L-lysine)(PLL) and wherein the polyanion is poly(L-glutamic acid) (PLGA), thus having the polyelectrolyte multilayers comprise PLL or PLGA (i.e. PLL/PLGA).
However, the prior art of Richert discloses methods for a polyelectrolyte multilayer (i.e. PEM) comprising poly(L-lysine)(i.e. PLL) and poly(L-glutamic acid)(PLGA)(i.e. PGA)(see e.g. abstract, page 18, 20-27, and fig. 1, and table 3). Additionally, the prior art of Matsushita discloses spheroid formation on poly(L-lysine)(i.e. PLL) or poly(L-glutamic acid)(PLGA) coated surfaces (see e.g. abstract, page 58-63, fig. 5). Furthermore, the prior art of Park disclose that method of polyelectrolyte multilayers of poly-L-lysine (PLL) and poly-L-glutamic acid (PGA) have been known in the prior art (see e.g. abstract, page 263-264).
Accordingly, it would have been obvious for a person of ordinary skill in the art to have modified the methods of Schlenoff to incorporate a polyelectrolyte multilayer (i.e. PEM) with poly(L-lysine)(i.e. PLL) and poly(L-glutamic acid)(PLGA)(i.e. PGA) as taught by Richert and Matsushita, because Schlenoff and Richert disclose that polyelectrolyte multilayer compositions can be modified depending on the cell adhesion properties needed (see e.g. page 12 and 19, respectively). Additionally, the substitution of the polycation/polyanions such as those taught by Richert and Matsushita in place of the polycation/polyanions taught by Schlenoff would be considered obvious since it is prima facie obvious to substitute one known element for another to obtain predictable results. Additionally, a person of ordinary skill in the art would have motivation to do because the prior art of Park disclose that polyelectrolyte multilayers of poly-L-lysine (PLL) and poly-L-glutamic acid (PGA) have high biocompatibility in biomedical applications (see e.g. abstract, page 263-264). Moreover, Matsushita discloses that spheroid formation on poly(L-lysine)(i.e. PLL) or poly(L-glutamic acid)(PLGA) coated surfaces were both readily available and are deliverable using similar techniques. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 47-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-16 and 27-30 of U.S. Patent No. US11492598B2 (hereinafter as the ‘598 patent).
The instant claims are directed to a method of a method for culturing cells, the method comprising: a) providing a cell culture article having a surface coated with a composition of comprising: a polymer selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers, b) seeding cells on the coated surface, and c) culturing the cells under a suitable medium for a sufficient period of time to form one or more spheroids (claim 47) and a method for obtaining and optionally characterizing single-cell derived spheroid, the method comprising: a) culturing a heterogeneous population of cells on a surface coated with a composition of claim to obtain at least one single-cell-derived spheroid disposed on the surface (claim 51).
The ‘598 patented claims are direct to: A substrate for cell culture, the substrate comprising an elastomer membrane having a surface coating comprising a) an absorbent polymer, wherein the absorbent polymer is deposited on a surface of the elastomer membrane, and b) polyelectrolyte multilayers, wherein the absorbent polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers, wherein the elastomer membrane comprises polydimethylsiloxane (PDMS) (claim 1), and the substrate of claim 1, wherein the absorbent polymer is selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), polyethyleneimine (PEI), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA), and derivatives thereof (claim 2).
Both claims are directed to methods or compositions comprising a single cell derived spheroid with the exact same group of polymers selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.” In the instant case, although instant claims 47-66 and claims 1-16 and 27-30 of the ‘598 patent are not identical they are not patentable distinct because the claims of both inventions are drawn to methods or a composition for culturing a single cell derived spheroid with the exact same group of polymers, as discussed above.
Thus, it would not be possible to use the instant claims without the compositions of the patented claims.
Claims 47-66 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21, and 24-35 of copending Application Number 17/966,281 (the ‘281 application).
The instant claims are directed to a method of a method for culturing cells, the method comprising: a) providing a cell culture article having a surface coated with a composition of comprising: a polymer selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers, b) seeding cells on the coated surface, and c) culturing the cells under a suitable medium for a sufficient period of time to form one or more spheroids (claim 47) and a method for obtaining and optionally characterizing single-cell derived spheroid, the method comprising: a) culturing a heterogeneous population of cells on a surface coated with a composition of claim to obtain at least one single-cell-derived spheroid disposed on the surface (claim 51).
The co-pending ‘281 application’s claims are directed to “a substrate, comprising an elastomer membrane having a surface coated with: a) an absorbent polymer, wherein the absorbent polymer is deposited on the surface of the elastomer membrane, and b) polyelectrolyte multilayers, wherein the absorbent polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers, wherein the absorbent polymer is selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), polyL-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA), and derivatives thereof (claims 21, and 24-35).
Both claims are directed to methods or compositions comprising a single cell derived spheroid with the exact same group of polymers selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.” In the instant case, although instant claims 47-66 and claims 21, and 24-35 of the ‘281 application are not identical they are not patentable distinct because the claims of both inventions are drawn to methods or a composition for culturing a single cell derived spheroid with the exact same group of polymers, as discussed above. Therefore, the instant claims would have been obvious in view of the copending claims. In addition, it would not be possible to use the instant claims without the compositions of the copending claims.
This is a provisional nonstatutory double patenting rejection.
Claims 47-66 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4, 15-16, and 21 of copending Application Number 18/697,799 (the ‘799 application).
The instant claims are directed to a method of a method for culturing cells, the method comprising: a) providing a cell culture article having a surface coated with a composition of comprising: a polymer selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers, b) seeding cells on the coated surface, and c) culturing the cells under a suitable medium for a sufficient period of time to form one or more spheroids (claim 47) and a method for obtaining and optionally characterizing single-cell derived spheroid, the method comprising: a) culturing a heterogeneous population of cells on a surface coated with a composition of claim to obtain at least one single-cell-derived spheroid disposed on the surface (claim 51).
The copending ‘799 application’s claims are directed to “a method of preparing cell cultures, comprising: (a) providing a cell culture article having a surface coated with polyelectrolyte multilayers and optionally an absorbent polymer, wherein the polyelectrolyte multilayers comprise n bilayers of polycation/polyanion, n is an integer number ranging from 12 to 20, and the polyanion/polycation is selected from poly(L-glutamic acid) (PLGA)/ poly(L-lysine) (PLL), poly(L-aspartic acid) (PLAA)/PLL, PLGA/ poly(L-arginine) (PLA), PLAA/PLA, PLGA/ poly(L-ornithine) (PLO), PLAA/PLO, PLGA/ poly(L- histidine) (PLH) and PLAA/PLH; (b)seeding a plurality of cancer cells on the surface, wherein the plurality of cancer cells is obtained from a fluid sample of a cancer patient, and the plurality of cancer cells comprises circulating tumor cells (CTCs); and (c) culturing the cancer cells under a suitable medium for a time sufficient to produce cell cultures, wherein the cell cultures comprise three-dimensional (3D) cell cultures comprising a plurality of tumor spheroids adhered to the coated surface (claim 1, 4, 15- 16, and 21).
Both claims are directed to methods or compositions comprising a single cell derived spheroid with the exact same group of polymers selected from the group consisting of poly(vinyl alcohol) (PVA), poly(ethylene glycol) (PEG), PEG-acrylate, polyvinylpyrrolidone (PVP), poly-L-lactide (PLLA), poly-D-lactide (PDLA), poly(L-lactide-co-D,L-lactide) (PLDLLA), poly(glycolic acid) (PGA), poly(lactic-co-glycolic acid) (PL-co-GA), poly(methyl-methacrylate) (PMMA), poly(hydroxyethyl methacrylate) (p-HEMA) and derivatives thereof, wherein the polymer is crosslinked to a surface of the cell culture article, and polyelectrolyte multilayers, wherein the polymer is in direct contact with a polycation or a polyanion of the polyelectrolyte multilayers.
Providing guidance on instances where the method steps of the prior art and instant claims are the same, Ex parte Marhold, 231 USPQ 904, 905 (Bd. Pat. App. & Int. 1986) relying on In re Sussman, 141 F.2d 267, 269-70, 60 USPQ 538, 540-41 (CCPA 1944) states “[T]hat since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims.” In the instant case, although instant claims 47-66 and claims 1, 4, 15- 16, and 21 of the ‘799 application are not identical they are not patentable distinct because the claims of both inventions are drawn to methods or a composition for culturing a single cell derived spheroid with the exact same group of polymers, as discussed above. Therefore, the instant claims would have been obvious in view of the copending claims. In addition, it would not be possible to use the instant claims without the compositions of the copending claims.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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JOSEPHINE GONZALES
Examiner
Art Unit 1631
/JOSEPHINE GONZALES/Examiner, Art Unit 1631
/JAMES D SCHULTZ/Supervisory Patent Examiner, Art Unit 1631
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