DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-7, 19, and 20, drawn to an accelerated Alzheimer’s Disease model system and kit, classified in C12N5/0619.
II. Claims 8-18, drawn to a method for deriving an accelerated Alzheimer’s Disease model system, classified in C12N2506/08.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the process as claimed can be used to make another and materially different product, including an accelerated AD model system that includes iPSCs that do not express progerin.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions have acquired a separate status in the art in view of their different classification, the inventions have acquired a separate status in the art due to their recognized divergent subject matter, and the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Carmella Stephens on 5 February 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-7, 19, and 20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 8-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-7, 19, and 20 are currently pending and under examination.
This application claims benefit of priority to U.S. Provisional Application No. 63/488475, filed March 3, 2023.
Claim Objections
Claim 1 objected to because of the following informalities: the abbreviation “iPSCs” should first be presented with the full term (e.g. “inducted pluripotent stem cells (iPSCs)”). Appropriate correction is required.
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 1-7, 19, 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.
With regard to claim 1, this claim recites:
An accelerated Alzheimer’s Disease (AD) model system comprising cultured neuronal progenitor cells, or iPSCs, that have been (i) engineered to express progerin and (ii) and subjected to cell culture conditions leading to neuronal differentiation and wherein said cultured cells develop one or more AD associated phenotypes.
This claim is indefinite, because as currently written, it is unclear what components are intended to be included in the accelerated Alzheimer’s Disease (AD) model system. This claim appears to recite components utilized to make the claimed model system, but does not appear to indicate a final cell type intended to be present in the model system.
Claims 19 is likewise rejected, as it is unclear what cell type(s) are intended to be included in the kit.
Further regarding claim 19, the limitation of “and an instruction for its use” is indefinite, because it is unclear if the instruction for “its” use is directed to the use of just the reagent, or to the use of the kit as a whole.
Claim 4 recites that the cells are “cultured in 2D/3D culture conditions.” This limitation is indefinite, because it is unclear if “2D/3D” is intended to mean cultured in either 2D or 3D culture, or instead cultured in both 2D and 3D culture.
Claim 6 contains the trademark/trade name ReNcell® VM immortalized human neural progenitor cells. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe immortalized human neural progenitor cells and, accordingly, the identification/description is indefinite.
The terms “elevated levels of Aβ42 to Aβ40 ratio” and “increased cell death and cell cycle re-entry” in claim 7 are relative terms which render the claim indefinite. The terms “elevated” and “increased” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear in relation to what starting point or baseline these determinations are intended to be made.
Further regarding claim 7, the term “elevated levels of Aβ42 to Aβ40 ratio” is indefinite, because it is unclear how elevated levels are intended to relation to a ratio here.
Claims 2-5 and 20 are included in this rejection, as these claims depend from above rejected claims and fails to remedy the noted deficiencies.
Claim Rejections - 35 USC § 102/103
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.
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.
Claims 1-7, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Studer et al. (US 2018/0230424; Published 2018).
Claims 1 and 4-7 are directed to the accelerated Alzheimer’s Disease model system, which is produced by the claimed process. "[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).
Here, Studer et al. similarly teach an accelerated Alzheimer’s Disease model system that includes cells differentiated to develop an AD-associated phenotype, including pathological aggregation of tau protein, which is Tau phosphorylation (Abs.; Para. 30, 53, 64, 86, 172). The model system is used for the same purpose as claimed: for the study of late-onset diseases, including Alzheimer’s Disease. Functionally, the accelerated Alzheimer’s Disease model system of Studer et al. is the same as the claimed system. Therefore, the model system of Studer et al. is the same as, or would have rendered obvious, the model system produced by the claimed process.
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"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).
With regard to claims 2 and 3, Studer et al. teach or render obvious the model as claimed, including the components as claimed. As the model cannot be separated from its properties, use of the model as claimed/rendered obvious would necessarily provide for observation of the AD associated phenotype(s) in less than 6 weeks, or in 3-4 weeks.
With regard to claims 19 and 20 Studer et al. teach that cell cultures derived from a patient with a late-onset disease, including AD, are utilized to construct the model system (Para. 53), wherein cells collected from a patient are necessarily collected in a container. It is further taught that Progerin and other reagents are provided to accelerate cell maturation/aging (Abs.; Para. 56). The disclosure of Studer et al. is instructions for the use of the taught components. As discussed previously, Studer et al. teach or render obvious an accelerated Alzheimer’s Disease model system that includes cells differentiated to develop an AD-associated phenotype, including pathological aggregation of tau protein, which is Tau phosphorylation (see rejection of claim 1 above). As such, Studer et al. teach or render obvious a kit that is capable of being used for diagnosing or prognosing AD in a subject, identifying a subject at risk of development of AD, or prescribing a therapeutic regimen or predicting benefit from therapy in a subject having AD.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G. Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653