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 Status
Claims 1-20 are pending.
Claims 1-9 and 13-19 are withdrawn.
Claims 10-12 and 20 are under examination.
Election/Restrictions
Applicant’s election without traverse of the following invention
Invention
Group III, claims 10-20, drawn to a method for screening a neurological disease therapeutic drug, comprising: introducing a differentiation factor into a pluripotent stem cell derived from a neurological disease patient and differentiating the cell into a neural cell; applying a candidate drug to a cell during differentiation of the pluripotent stem cell into the neural cell or to the differentiated neural cell; and screening the candidate drug on the basis of the neural cell,
in the reply filed on 30th, September, 2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without traverse of the following species
Species
survival rate of the neural cell or the number of the neural cell (claim 12)
in the reply filed on 30th, September, 2025 is acknowledged. Claims 10, 12 and 20 encompass the elected species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11 and 13-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Species Rejoinder
The species election requirement between “candidate drug is screened based on type,” as set forth in the Restriction/Election Requirement mailed on 1st, August, 2025 has been reconsidered in view of the prior art. The species of “differentiation efficiency of the neural cell,” encompassed by claim 11, directed to previously a non-elected species is no longer withdrawn from consideration.
In view of the above noted withdrawal of the species election requirement, Applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a species election requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 10-12 and 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea (mental process) without significantly more.
Applicant is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on 1/07/2019, which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf; and the October 2019 Update: Subject Matter Eligibility, which is found at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf.
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
Step 1
Regarding step 1, the claims are directed to a method for screening a neurological disease therapeutic drug, which is a process and is a statutory class of invention. Accordingly, the requirements of step 1 are met.
Step 2A Prong One
In regard to Step 2A prong one, claim 10 is directed to a method for screening a neurological disease therapeutic drug comprising the step of “screening the candidate drug on the basis of the neural
cell” which is a mental process and is therefore is the judicial exception of an abstract idea.
Claim 11 is directed to the method comprising the mental step of “the candidate drug is screened based on the differentiation efficiency of the neural cell” which is a mental process and is therefore is the judicial exception of an abstract idea.
Claim 12 is directed to the method comprising the step “the candidate drug is screened based on the survival rate of the neural cell or the number of the neural cell” which is a mental process and is therefore is the judicial exception of an abstract idea.
Applicant is directed to MPEP 2106.04(a)(2) (III) which states that the courts consider a mental process (thinking) 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).
In the instant case, regarding claim 10, “screening the candidate drug on the basis of the neural cell” can be performed merely by looking at the cell and therefore the recited step is a mental process.
Regarding claim 11, the step of “the candidate drug is screened based on the differentiation efficiency of the neural cell” can be performed in the human mind by looking at the cells, observing whether they have differentiated or not and calculating the efficiency at a given time and therefore the recited step is a mental process.
Regarding claim 12, the step of “the candidate drug is screened based on the survival rate of the neural cell or the number of the neural cell” can be performed in the human mind by looking at the cells and counting the cells and therefore the recited step is a mental process.
Since the claims recite a judicial exception, the additional elements of the claims are analyses to determine whether the judicial exception is integrated into a practical application (Step 2A prong two), and whether the claim as a whole amounts to significantly more than the judicial exception (Step 2B).
Step 2A Prong Two
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application.
Claim 10 recites the following additional elements:
“introducing a differentiation factor into a pluripotent stem cell derived from a neurological disease patient and differentiating the cell into a neural cell”
“applying a candidate drug to a cell during differentiation of the pluripotent stem cell into the neural cell or to the differentiated neural cell”
The steps of introducing a differentiation factor and applying a candidate drug as recited above do not integrate the mental process into a practical application because they are merely insignificant extra solution activity of necessary data gathering and outputting. All uses of the recited judicial exception require such data gathering or data output because screening a drug requires analyzing some basis of data upon which to screen the drug. The specific recited steps are merely specific well-known ways to perform such data gathering or data output and therefore these recites steps do not integrate the judicial exception into a practical application (see MPEP 2106.05(g)).
Regarding claims 11-12, these claim does not recite additional elements other than the mental steps discussed above and therefore these claims cannot integrate into a practical Application.
Regarding claim 20, the claim recites the additional element of the step of “further comprising removing an undifferentiated cell”
Clearly, simply removing an undifferentiated cell does nothing to improve a technology, effect a particular treatment, or implement with a particular device to provide a meaningful limitation on the judicial exception and therefore does not integrate into a practical application.
Step 2B
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As stated above (see Step 2A prong one above), the additional elements recited are necessary data gathering and outputting which do not integrate the claims into a practice Application and therefore also do not amount to significantly more. The recited specific steps of introducing a differentiation factor and applying a candidate drug also do not amount to significantly more because they recited steps are well-understood routine and conventional. The steps of “introducing a differentiation factor into a pluripotent stem cell derived from a neurological disease patient and differentiating the cell into a neural cell” and “applying a candidate drug to a cell during differentiation of the pluripotent stem cell into the neural cell or to the differentiated neural cell” are well known in the art.
Regarding claim 10, Applicant is directed to the art of Wernig et al. (US-20170369840-A1; see IDS filed 27th, December, 2022; henceforth “Wernig”) which evidences the steps of “introducing a differentiation factor” ((“three or more factors selected from an Asel agent, a Ngn agent, a Brn agent, a NeuroD agent, a Mytl agent, an Olig agent or a Zic agent” para. [0007]; see also “one or more neuron reprogramming (NR) factors” para. [0008] and para. [0009-0011, 0014, 0018-0020, 0025, 0028-0029, 0045, 0047-0052, 0056-0062, 0065-0066, 0070, 0073-0075, 0082-0085, 0087, 0098-0099, 0114, 0116, 0126, 0136-0139, 0144-0151, 0158, 0160-0174, 0180, 0187, 0190, 0196, 0198-0199, 0208-0211, 0213, 0215-0216, 0218, 0222, 0225, 0229, 0242-0249, 0251]; Figures 5-7, 12, 15-16; Table 1; claims 1 and 4) and “applying a candidate drug to a cell during differentiation” (“candidate agent”; abstract; para. [0006, 0010, 0037, 0106, 0108-0111, 0179-0184]) are well-known in the art. Therefore, because these steps are well-known, routine and conventional, they cannot amount to insignificantly more than the mental process judicial exception.
Regarding claims 11-12, these claim does not recite additional elements other than the mental steps discussed above and therefore these claims cannot amount to significantly more.
Regarding claim 20, as discussed above, the claim recites the additional element of the step of “further comprising removing an undifferentiated cell.” The step of removing an undifferentiated cell is well-understood routine and conventional.
Applicant is directed to the art of Sachdeva et al. (Proc Natl Acad Sci U S A. 2010 Jun 22;107(25):11602-7. Epub 2010 Jun 7.; henceforth “Sachdeva”) which evidences removing the undifferentiated cells (pg. 11606 col. 1 3rd para.) is well-known in the art and therefore because the step is well-known, routine and conventional, it cannot amount to insignificantly more than the mental process judicial exception.
Judicial Exception – Conclusion
Therefore, the claims are directed to an abstract idea (mental process of screening the candidate drug on the basis of the neural cell) that is not integrated into a practical application, does not include elements that amount to significantly more than the abstract idea, and does not qualify as patent eligible subject matter under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 112(b)
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 10-11 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 10 recites the step of “screening the candidate drug on the basis of the neural cell,” without reciting a structure as to what “on the basis of the neural cell” is. The instant specification does not teach the metes and bounds what the full breadth of “on the basis of the neural cell” encompasses and therefore it is unclear on what basis the candidate drug is screened on. Therefore, it is unclear what the step encompasses and the metes and bounds of the claim is unclear.
By nature of its dependency on claim 10, claim 20 is also rejected because it does not clarify the issue.
Claim 11 recites “screened based on the differentiation efficiency of the neural cell.” However, because neural cells are already differentiated, it is unclear how the differentiation efficiency can be used as a metric.
Claim Interpretation
Due to the 112b issues above, claim 11 is interpreted as they cells are screened based on the differentiation efficiency of the pluripotent stem cell.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wernig et al. (US-20170369840-A1; see IDS filed 27th, December, 2022; henceforth “Wernig”).
Regarding claim 10, Wernig discloses a method for screening candidate agents for activity in converting cells into neuronal cells (“methods are for screening candidate agents for activity modulating the direct conversion of somatic cells into induced neuronal cells (iNs)” para. [0010]); see also abstract; para. [0006-0007, 0014, 0019-0020, 0037, 0108, 0111, 0179-0184, 0196, 0201, 0215, 0247-0248, 0253]; Figures 1, 6-7; Example 2) comprising:
introducing a differentiation factor (“three or more factors selected from an Asel agent, a Ngn agent, a Brn agent, a NeuroD agent, a Mytl agent, an Olig agent or a Zic agent” para. [0007]; see also “one or more neuron reprogramming (NR) factors” para. [0008] and para. [0009-0011, 0014, 0018-0020, 0025, 0028-0029, 0045, 0047-0052, 0056-0062, 0065-0066, 0070, 0073-0075, 0082-0085, 0087, 0098-0099, 0114, 0116, 0126, 0136-0139, 0144-0151, 0158, 0160-0174, 0180, 0187, 0190, 0196, 0198-0199, 0208-0211, 0213, 0215-0216, 0218, 0222, 0225, 0229, 0242-0249, 0251]; Figures 5-7, 12, 15-16; Table 1; claims 1 and 4) into a pluripotent stem cell (“ “non-neuronal cells may be somatic cells or may be pluripotent cells” para. [0049]:see also para. [0007, 0012, 0037, 0043, 0049, 0056-0057, 0087, 00141, 0144, 0153, 0155, 0177, 0242, 0251]; claims 1-6, 10-13) (see also “NR factors are provided to somatic or pluripotent cells in the context of a NR system” para. [0057]) and differentiating the cell into a neural cell (neurons; abstract);
applying a candidate drug (“candidate agent”; abstract; para. [0006, 0010, 0037, 0106, 0108-0111, 0179-0184]) to a cell during differentiation of the pluripotent stem cell into the neural cell or to the differentiated neural cell ; and
screening the candidate drug on the basis of the neural cell (“the effect of the candidate agent assessed by monitoring output parameters such as iN survival” para. [0106]; see also para. [0049-0051, 0068, 0076, 0079-0080, 0085, 0139-0140, 0151-0152, 0174-0175, 0182, 0226]; Figure 1).
Regarding claim 10, as stated above, Wernig teaches the method in pluripotent stem cells. Instant claims require “a pluripotent stem cell derived from a neurological disease patient,” which is a product-by-process limitation with respect to the pluripotent stem cells. Since not all neurological diseases are genetic (such as those caused by trauma or injury), the pluripotent stem cells disclosed by Wernig are structurally indistinguishable from “a pluripotent stem cell derived from a neurological disease patient,” where the patient has a neurological disease from a trauma or injury that is not genetic. Therefore, the pluripotent stem cells of Wernig meet the limitations of instant claims.
Regarding the preamble of claim 10, the preamble merely states the purpose or intended use of the invention (“screening a neurological disease therapeutic drug”), rather than any distinct definition of any of the claimed invention’s limitations and therefore the preamble is not considered a limitation and is of no significance to claim construction (see MPEP 2111.02) See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). In the instant case, Wernig discloses the active method steps above and therefore the method disclosed by Wernig is capable of meeting the intended use of screening a neurological disease therapeutic drug.
Regarding claim 11, further to the discussion of claim 1 above, Wernig discloses the candidate drug is screened based on the differentiation efficiency of the cells (“efficiency of reprogramming may be determined” para. [0088];see also para. [0008, 0016, 0024, 0029, 0053, 0192, 0202-0203, 0208, 0226, 0248]; Figures 3, 11, 16; claims 1 and 3).
Regarding claim 12, further to the discussion of claim 10 above, Wernig discloses the candidate drug (“candidate agent”) is screened based on the survival rate of the neural cell (“the effect of the candidate agent assessed by monitoring output parameters such as iN survival” para. [0106]; see also para. [0049-0051, 0068, 0076, 0079-0080, 0085, 0139-0140, 0151-0152, 0174-0175, 0182, 0226])).
Accordingly, Wernig anticipates 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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Wernig et al. (US-20170369840-A1; see IDS filed 27th, December, 2022; henceforth “Wernig”) in view of Sachdeva et al. (Proc Natl Acad Sci U S A. 2010 Jun 22;107(25):11602-7. Epub 2010 Jun 7.; henceforth “Sachdeva”).
The teachings of Wernig above are hereby incorporated in their entirety.
Regarding claim 20, further to the discussion of claim 10 above, although Wernig teaches the neurons produced can be used for transplantation (abstract; para. [0006, 0011, 0037, 0089, 0102-0104, 0142, 0178]) Wernig does not disclose a step of removing an undifferentiated cell.
Nevertheless, regarding claim 20, Sachdeva teaches a method comprising differentiating neural cells from pluripotent stem cells for use in transplant comprising a step of removing the undifferentiated cells to reduce the formation of tumors and lead to neuron-rich transplants displaying mature neuronal morphologies (pg. 11606 col. 1 3rd para.).
Therefore, regarding claim 20, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice the method of Wernig, and combine the known prior art element of the step of removing undifferentiated cells of Sachdeva to obtain the predictable result of cells for use in transplant. One of ordinary skill would have been motivated to do so as taught by Sachdeva to reduce the formation of tumors and lead to neuron-rich transplants displaying mature neuronal morphologies (pg. 11606 col. 1 3rd para.). Regarding the reasonable expectation of success, Sachdeva evidences removing undifferentiated cells (pg. 11606 col. 1 3rd para.).
Hence the claimed invention as a whole was prima facie obvious.
Conclusion
No claims are allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632
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