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
The instant claims herein are examined utilizing the accepted effective filing date of 11/6/2020 for the basis of any prior art rejections.
Claim Objections
Claim 3 is objected to because of the following informalities: “Friedrich’s ataxia” is spelled incorrectly. Appropriate correction is required.
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 3 and 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites, inter alia, “wherein the degenerative brain disease is a disease selected from the group consisting of Alzheimer's disease, Parkinson's disease, Huntington's disease, mild cognitive impairment, cerebral amyloid angiopathy, Down's syndrome, amyloidotic stroke, systematic amyloidosis, Dutch-type amyloidosis, Niemann-Pick disease, senile dementia, amyotrophic lateral sclerosis, spinocerebellar atrophy, Tourette's syndrome, Friedrich's Ataxia, Machado-Joseph's disease, Lewy body dementia, dystonia, progressive supranuclear palsy, and frontotemporal dementia”. Tourette’s syndrome, Down syndrome, amyloidotic stroke, systemic amyloidosis, dystonia, and mild cognitive impairment are not degenerative brain diseases (i.e., progressive passive break down of tissue and leading to worsening neurological function over time). There is no nexus between the scope of degenerative brain diseases embraced by the claim and these specific syndromes as claimed. The examiner notes, for example, that mild cognitive impairment embraces a range of conditions such as drug/alcohol impairment, stroke, Thus, the claim is indefinite.
Attempts to claim a process without setting forth any steps involved in the process generally raise an issue of indefiniteness under 35 U.S.C. 112(b). For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). In this regard, claim 11 recites a “use of neural precursor cells differentiated from pluripotent stem cells for preparation of a pharmaceutical composition for preventing or treating a degenerative brain disease.” However, said claim fails to set forth any active, positive steps delimiting how the neural precursor cells are actually used. Thus, the claim is indefinite.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for (i) a pharmaceutical composition for alleviating or inhibiting the progress of dementia-related memory loss comprising neural precursor cells differentiated from pluripotent stem cells, and (ii) a method of alleviating or inhibiting the progress of dementia-related memory loss does not reasonably provide enablement for (i) preventing degenerative brain disease or (ii) alleviating or inhibiting the progress of symptoms of degenerative brain diseases other than memory loss associated with dementia utilizing the instantly claimed neural precursor cells. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
While determining whether a specification is enabling, one considered whether the claimed invention provides sufficient guidance to make and use the claimed invention, if not, whether an artisan would have required undue experimentation to make and use the claimed invention and whether working examples have been provided. When determining whether a specification meets the enablement requirement, some of the factors that need to be analyzed are: the breadth of the claims, the nature of the invention, the state of the prior art, the level of one of ordinary skill, the level of predictability in the art, the amount of direction provided by the inventor, the existence of working examples, and whether the quantity of any necessary experimentation to make or use the invention based on the content of the disclosure is “undue” (In re Wands, 858 F.2d at 737, 8 USPQ2d 1400, 1404 (Fed. Cir.1988)).
Furthermore, the USPTO does not have laboratory facilities to test if an invention with function as claimed when working examples are not disclosed in the specification, therefore, enablement issues are raised and discussed based on the state of knowledge pertinent to an art at the time of the invention, therefore, skepticism raised in the enablement rejection are those raised in the art by artisans of expertise.
Nature of the invention:
A pharmaceutical composition for preventing or treating a degenerative brain disease comprising neural precursor cells differentiated from pluripotent stem cells as an active ingredient.
A use of neural precursor cells differentiated from pluripotent stem cells for preparation of a pharmaceutical composition for preventing or treating a degenerative brain disease.
A method of preventing or treating a degenerative brain disease, the method comprising: administering to an individual in need thereof an effective amount of neural precursor cells differentiated from pluripotent stem cells.
The state of the prior art:
The state of the prior art for preventing any neurodegenerative diseases was unpredictable before the effective filing date of the claimed invention. The state of the prior art for treating all neurodegenerative diseases using neural precursor cells was unpredictable before the effective filing date of the claimed invention.
The breadth of the claims:
The claims encompass preventing and treating all degenerative brain diseases via neural precursor cells. The specification defines “prevention” to “refer to all actions intended to inhibit or delay development of a degenerative brain disease” (p. 5, lines 20-22). The specification defines “treatment” as “all actions to alleviate, inhibit the progress of, or prevent a disease, disorder, or condition, or at least one symptom thereof” (p. 5, lines 23-24). Please note that claim 1-12 recite product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113(I)). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Degenerative brain diseases encompass Alzheimer’s, Huntington’s, dementia with Lewy bodies, Parkinson’s, multiple sclerosis, ALS, neuromyelitis optica spectrum disorder, progressive supranuclear palsy, Dutch-type amyloidosis, Niemann-Pick disease, etc. Various administration routes include direct injection, subcutaneous, intravenous, intramuscular, intrathecal, intraperitoneal, oral, topical, transdermal, inhalation, intranasal, etc.
The level of skill in the art:
The level of skill is high that requires a researcher with a PhD degree.
The working examples and guidance provided:
The specification discloses a working example in which human embryonic stem cells into neural precursor cells (example 1). The specification discloses a mouse model of amyloid-based memory loss to assess the therapeutic effects of the cells of example 1 on dementia. Mice were trained for Y-maze and NORT cognitive ability prior to procedure and behavioral evaluation was conducted post-procedures. When embryonic stem cell derived MSCs were administered, IV injection exhibited efficacy which decreased from week 3. When NPCs were delivered, IV and IH injections showed cognitive function strengthening for 2 weeks, but effects decreased. ICV injection of NPCs exhibited strengthening of cognitive function that was maintained for 4 weeks.
The specification fails to provide any working examples in which any neurodegenerative diseases were prevented. The specification fails to provide any working examples in which any neurodegenerative disease symptoms were alleviated other than memory loss related to amyloid-based dementia.
The unpredictable nature of the art:
The claims read on preventing and treating all neurodegenerative diseases via neural precursor cells.
Degenerative brain diseases such as dementia, Alzheimer’s, multiple sclerosis, cannot be prevented. This is especially true in neurodegenerative diseases having a highly causal genetic component. Neural precursor cells are not an “end-all, be-all” treatment for bran degenerative diseases.
Post-dated Chou et al (Fac Rev. 2021 Dec 1;10:81) discusses recent advances in preventing neurodegenerative diseases such as Alzheimer’s, Parkinson’s, ALS, MS, and Huntington’s via neuroprotective strategies. The reference states that neurodegenerative diseases include a broad range of disorders characterized by neuronal injury or degeneration leading to neurological impairment (Introduction para 1). The neuroprotective approach focuses on the development of strategies that prevent or arrest various types of neuronal cell death mechanisms such as oxidative stress, mitochondrial dysfunction, neuroinflammation, protein aggregation, and defective autophagy, thus limiting disease progression (same para). In cell-autonomous neurodegeneration, amyloid β (Aβ) causes hippocampal neurotoxicity by inducing oxidative stress–mediated PARP1 activation, which leads to transient receptor potential melastatin-related 2 (TRPM2) activation and Ca2+ influx and mitochondrial dysfunction. Notably, studies have shown that neurons are protected by PARP1 inhibition, which implies that PARP1 inhibition may have therapeutic value for the treatment of AD. Dysregulation of PARP1 activation and increased PAR levels contribute to the pathogenesis of various neurodegenerative diseases by promoting protein aggregation and parthanatos. Thus, neuroprotective strategies aimed to inhibit PARP1 activation may have therapeutic potential in those disorders. Many well-characterized PARP inhibitors in clinical use have yet to be tested for use in neurodegenerative disease. These should be considered for neuroprotective treatment for neurological diseases. The reference concludes that while a multifaceted approach targeting both cell-autonomous and non-cell-autonomous mechanisms may be required to prevent or slow neurodegeneration, and despite progress, therapies to prevent or decrease disease progression and restore neuronal function remain a challenge and an ongoing focus in both research and clinical practice.
Mayo Clinic (“Alzheimer’s disease: Diagnosis and treatment”, 3 March 2026; Retrieved from the Internet 4/14/2026 from https://www.mayoclinic.org/diseases-conditions/alzheimers-disease/diagnosis-treatment/drc-20350453) states that treatments for Alzheimer's disease include medicines that can help with symptoms and newer medicines that can help slow decline in thinking and functioning. These medications include cholinesterase inhibitors, which helps boost cell-to-cell communication (produces modest improvement in symptoms), memantine, Lecanemab-irmb (prevents amyloid plaque clumping in those with mild Alzheimer’s and mild cognitive impairment due to Alzheimer’s).
Post-dated Buil et al (Brain. 2023 Mar 1;146(3):823-841) discusses cell therapy across the blood-brain barrier. Uncertainty remains regarding the optimal route for cell delivery to the injured brain. Local intracerebral injections are effective in precisely delivering cells into stroke cavities but carry the risk of damaging adjacent healthy tissue. Systemic endovascular injections, meanwhile, are minimally invasive, but most injected cells do not cross CNS barriers and become mechanically trapped in peripheral organs. Although the blood–brain barrier and the blood–CSF barrier tightly limit the entrance of cells and molecules into the brain parenchyma, immune cells can cross these barriers especially under pathological conditions, such as stroke. Deciphering the cell surface signature and the molecular mechanisms underlying this pathophysiological process holds promise for improving the targeted delivery of systemic injected cells to the injured brain. There are several feasible routes for delivering a cellular graft to the recipient of a cell therapy. The most commonly used routes for cell delivery in animal models and in humans are the intracerebral (IC), intracerebroventricular (ICV), intrathecal (IT), intra-arterial (IA), intravenous (IV) and intranasal (IN) deliveries (Fig. 1). Although intraperitoneal and subcutaneous injections are the preferred routes for drug administration in rodent models, their use for cell delivery is not effective enough and is even less so in humans. IC administration has precise graft placement and high level of cells at the lesion site, however there is poor cell distribution throughout the lesion (table 2). IV injection causes cell entrapment in the lungs, live, and spleen (table 2).
The extremely broad scope of the claims and lack of guidance in the specification exacerbates a highly unpredictable art regarding using neural precursor cells to prevent or treat all degenerative brain disease. While the results presented in the art do not necessarily preclude Applicant’s hypothesis, they certainly fail to support it in its totality that neural precursor cells can treat or prevent the above disorders via various administration routes. Consequently, the prior and post-filling art, when combined with the lack of any disclosed direct experimental test of Applicant’s hypothesis, shows that one of ordinary skill would have no basis to reasonably predict or conclude that the cells could be used alone in the claimed method preventing or treating all degenerative brain diseases. It is noted that, though not controlling, the lack of working examples is a factor to be considered in a case involving both physiological activity and an underdeveloped art. When a patent applicant chooses to forego exemplification and bases utility on broad terminology and general allegations, they run the risk that unless one of skill in the art would accept the allegations as obviously valid and correct, the PTO may, properly, ask for evidence to substantiate them (Ex parte Sudilosky, 21 USPQ2d 1702, 1705 (BPAI 1991); In re Novak, 134 USPA 335 (CCPA 1962); In re Fouche, 169 USPQ 429 (CCPA 1971)).
In essence, the specification merely presents an idea of, and leaves it entirely up to the
practitioner to determine whether the cells would produce a therapeutically relevant effect in a subject having or at risk of developing various degenerative brain diseases, and if so, how to carry out the invention. It has been established by legal decision that a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion. Tossing out the germ of an idea does not constitute an enabling disclosure. While every aspect of a generic claim need not have been carried out by an inventor or exemplified in the specification, reasonable detail must be provided in order to enable one of ordinary skill to understand and carry out the invention. It is true that a specification need not disclose what is well known in the art. However, that general, oft-repeated statement is merely a rule of supplementation, not a substitute for a basic enabling disclosure. It means that the omission of minor details does not cause a specification to fail to meet the enablement requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph.
Absent specific guidance, one skilled in the art before the effective filing date of the claimed invention would not know how to practice the claimed invention and would require undue experimentation to practice over the full scope of the invention claimed.
The amount of experimentation necessary:
The specification only describes alleviating memory loss in dementia in a mouse model utilizing the instantly claimed cell with efficacy via ICV route of administration. One of ordinary skill in the art could not reasonably take these working examples and readily or immediately apply these cells to prevent or treat degenerative brain diseases as broadly embraced by the claims. These teachings do not reasonably support these cells as a potential treatment or preventative for the broad scope embraced by the claims. One of ordinary skill in the art before the effective filing date of the claimed invention would be required to trial and error identify and select a subject from the broad genus of potential degenerative brain disease population (or those at risk of developing them as such) populations, as well as from subpopulations of disease progression for treatment, administration of the cells to a subject via various routes, trial and error experimentation to determine whether sufficient cells reach the target sites in vivo, and trial and error experimentation to determine whether therapeutic effect can be provided to ameliorate various pathological symptoms of the various degenerative brain diseases.
For the reasons set forth above, one skilled in the art before the effective filing date of the claimed invention would have to engage in undue experimentation to practice over the full scope of the invention claimed, This is particularly true given the nature of the invention, the state of the prior art, the breadth of the claims, the amount of experimentation necessary, the level of skill which is high, the working examples provided and scarcity of guidance in the specification, and the unpredictable nature of
the art.
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.
Non-Statutory Subject Matter
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 129 USPQ227, 228 (CCPA 1961) (“one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. 101”). In this case, claim 11 recites “A use of neural precursor cells differentiated from pluripotent stem cells for preparation of a pharmaceutical composition for preventing or treating a degenerative brain disease,” however, said claim fails to recite at least one of the four categories of patent eligible subject matter.
Product of Nature
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (natural product) without significantly more. This judicial exception is not integrated into a practical application and does not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below:
Claim interpretation: Under the broadest reasonable interpretation (BRI), the terms of the claims are presumed to have their plain meaning consistent with the specification as it would be interpreted by one of ordinary skill in the art (see MPEP 2111). The specification states that the term “neural precursor cell” is a cell having capacity for self-renewal and the ability to differentiate into cells of the nervous system. The neural precursor cell is also referred to as neural progenitor cell and neural stem cell and can be differentiated into neurons, astrocytes, or oligodendrocytes and express SOX1 (see p. 3 of the instant specification. Claims 1 and 5-10 (which depend on independent claim 1) recite product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113(I)). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. Here, the claims recite a pharmaceutical composition for preventing or treating a degenerative brain disease comprising neural precursor cells differentiated from pluripotent stem cells as an active ingredient. This is a composition of matter; therefore, the claims fall within a statutory category. [Step 1: YES]
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. A claim “recites” a judicial exception when the exception is “set forth” or “described” in the claim (see MPEP 2106.04(II)). Because the claims recite nature-based product limitations, the markedly different characteristics analysis is used to determine if the nature-based product limitations are a product of nature exception (see MPEP 2106.04(c)(I)). This analysis is performed by comparing the nature-based product limitations in the claims to its naturally occurring counterparts to determine if it has markedly different characteristics (see MPEP 2106.04(c)(II).
The appropriate natural counterpart to the claimed *** is *** as found in its natural state. The second step in the analysis requires identifying appropriate characteristics to compare. In this case, the appropriate characteristics pertain to ability to differentiate into various CNS cells and SOX1 expression.
Science Insights (“What are neural progenitor cells and how do they work?” 2 Nov 2025; Retrieved from the internet 4/6/2026 from https://scienceinsights.org/what-are-neural-progenitor-cells-and-how-do-they-work/) states Neural Progenitor Cell (NPC) is a multipotent cell restricted to generating only nervous system cell types (Defining the neural progenitor cell, para 1). In the adult mammalian brain, NPCs primarily reside within two specific microenvironments, often called neurogenic niches (Defining the NPC, para 2). These are the Subventricular Zone (SVZ), which lines the lateral ventricles of the cerebral cortex, and the Subgranular Zone (SGZ) within the dentate gyrus of the hippocampus (same para). These specific locations provide the necessary molecular and cellular cues to maintain the progenitor cell population. NPCs are the cells actively dividing and preparing to differentiate into the mature components of the CNS. The primary mature cell types that NPCs generate are neurons, which are responsible for rapid communication, and glial cells, which provide structural and metabolic support (Process of Differentiation and Cell Fate, para 1). Glial cells include astrocytes, which maintain the blood-brain barrier, and oligodendrocytes, which form the insulating myelin sheath around axons (same para).
Thus, the embodiments of the claims encompass naturally occurring neural precursor/progenitor cells. Thus, the claims recite a judicial exception, a natural product. [Step 2A, Prong 1: YES]
Therefore, the analysis proceeds to Step 2A Prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application. The neural precursor cells is a product of nature, and the additional elements (differentiated from pluripotent stem cells) do not impose a practical use or application of the claimed natural products. In this regard, the claims fail to recite additional elements that integrate the judicial exception natural products into a practical application. [Step 2A, Prong 2: NO]
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05). The claims themselves are drawn to the neural precursor cells, and not a method of producing the cells. However, claims 1-2 and 5-10 recite product by process limitations (differentiated from pluripotent stem cells, 2D and 3D culturing to produce the NPCs, etc.). However, this was well-known, routine, and conventional in the prior art.
The claims fail to recite any additional elements that are sufficient to amount to significantly more than the judicial exception. As such, none of these limitations impose a practical use or application of the claimed natural products as stated in Step 2A2, and thus do not add significantly more to the exception. [Step 2B: NO]
The claims fail to recite additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the claims do not qualify as eligible subject matter under 35 USC 101.
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.
Claim(s) 1-2 and 5-11 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Rodrigues et al (Stem Cell Rev and Rep 10, 151–161 (2014). Epub 13 Nov 2013).
Rodrigues teaches an integrated platform for production and purification of human pluripotent stem-cell derived neural precursors. Rodrigues validated a neural commitment protocol that was found to rapidly and efficiently convert hPSCs into neural precursors (NPs) under adherent culture conditions by the synergistic action of two SMAD signaling inhibitors (Introduction). Simultaneous inhibition of both Activin/Nodal and BMP pathways with small molecules, SB431542 and LDN193189, respectively, promotes rapid and complete neural conversion of >80 % of hPSCs because the pathways responsible for the induction into mesoderm, endoderm and trophoblast lineages are blocked, allowing neuroectoderm specification (Introduction) (“A pharmaceutical composition . . . comprising neural precursor cells differentiated from pluripotent stem cells” as in instant claim 1). hiPSCs were used to produce the cells (Materials and methods, para 1) (“wherein the pluripotent stem cells are selected from the group consisting of . . . induced pluripotent stem cells” as in instant claim 2).
Claims 5-10 (which depend on independent claim 1) recite product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113(I)). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Instant claim 11 recites “use of neural precursor cells differentiated from pluripotent stem cells for preparation of a pharmaceutical composition for preventing or treating a degenerative brain disease.” Absent evidence to the contrary, the cells produced by Rodrigues can be used for the claimed purpose as it is an intended use claim.
Accordingly, absent evidence to the contrary, Rodrigues anticipates the instant invention of claim 1-2 and 5-11.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as anticipated by Goldman (US 10,279,051 B2, 2/10/2017; published 5/7/2019).
Goldman teaches a method of treating frontotemporal dementia, said method comprising selecting a subject having frontotemporal dementia; and administering to the selected subject a preparation of CD44+ astrocyte-biased glial progenitor cells at a dosage effective to treat the frontotemporal dementia in the subject (see claim 1 of Goldman) (as in instant claims 3 and 12; the cells utilized in the method read on/anticipate instant claim 1). The glial progenitor cells are derived from fetal tissue, embryonic stem cells, or induced pluripotent stem cells (see claim 8 of Goldman) (as in instant claim 1 and 2). The cells can be administered via any standard route of administration known in the art, including, but not limited to, parenteral (e.g., intravenous, intraarterial, intramuscular, subcutaneous injection, intrathecal), oral (e.g., dietary), topical, transmucosal, or by inhalation (e.g., intrabronchial, intranasal or oral inhalation, intranasal drops) (as in instant claim 4).
Claims 5-10 (which depend on independent claim 1) recite product-by-process limitations. Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113(I)). "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Instant claim 11 recites “use of neural precursor cells differentiated from pluripotent stem cells for preparation of a pharmaceutical composition for preventing or treating a degenerative brain disease.” Absent evidence to the contrary, the cells of Goldman can be used for the claimed purpose as it is an intended use claim.
Accordingly, absent evidence to the contrary, Goldman anticipate instant claims 1-12.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kim et al (WO2016209057 A2, 6/27/2016; Published 12/29/2016), which describes a composition for treating ischemic diseases or neurogenic inflammatory disorders, containing secretomes of neural progenitor cells (NPCs) as an active ingredient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 7-3.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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