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 .
DETAILED ACTION
This Office Action is a response to Applicant’s Amendment and Remarks filed August 28, 2025.
Claims 2-9 have been canceled. Claim 1 has been amended.
Claims 1 and 10-20 are pending in the present application.
Claims 1 and 10-20 have been examined on the merits as detailed below:
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
It is noted that Applicants have not filed an information disclosure statement under § 1.97(c). Applicant is reminded that if, in the event the present application goes to issue, there will not be references printed on the face of the issued patent.
The listing of references in the specification at pages 50-56 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 § 112
In the previous Office Action mailed February 28, 2025, claims 1-3 and 5-20 were 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 pre-AIA the applicant regards as the invention. This rejection is moot against claims 2, 3 and 5-9 in view of Applicant’s Amendment filed August 28, 2025 to cancel these claims. This rejection is withdrawn against the remaining claims in view of Applicant’s Amendment filed February 28, 2025 to spell out the term, “Hspa8”.
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In the previous Office Action mailed February 28, 2025, claims 1-3 and 5-20 were 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 a method of treating a motor neuron disease in a subject, the method comprising administering a modulator of heat shock 70 kDa protein 8 (Hspa8) to the subject, wherein the modulator is a nucleic acid molecule encoding a mutant Hspa8G470R, does not reasonably provide enablement for a method of treating a neurodegenerative disorder in a subject, the method comprising administering an effective amount of any modulator of Hspa8 to the subject. This rejection is moot against claims 2, 3 and 5-9 in view of Applicant’s Amendment filed August 28, 2025 to cancel these claims. This rejection is withdrawn against the remaining claims in view of Applicant’s Amendment to claim 1 filed February 28, 2025 and in view of the new 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejection detailed below.
Claims Rejection - Improper Markush
In the previous Office Action mailed February 28, 2025, claim 3 was rejected on the judicially-created basis that it encompasses an improper grouping of alternatives. This rejection is moot in view of Applicant’s Amendment filed August 28, 2025 to cancel claim 3.
Double Patenting
In the previous Office Action mailed February 28, 2025, claims 1-3 and 5-20 were rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11801284 B2. This rejection is moot against claims 2, 3 and 5-9 in view of Applicant’s Amendment filed August 28, 2025 to cancel these claims. This rejection is withdrawn against the remaining claims in view of Applicant’s Amendment to claim 1 filed February 28, 2025.
Applicant’s Amendment filed August 28, 2025 necessitated a new grounds of rejection as presented below:
Claim Rejections - 35 USC § 112
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 and 10-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the Specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims are drawn to a method of treating a neurodegenerative disorder in a subject, the method comprising administering an effective amount of a modulator of heat shock 70 kDa protein 8 (Hspa8) to the subject, wherein the modulator comprises a CRISPR/Cas system which introduces a G470R mutation in Hspa8.
The Specification discloses general statements such as:
The modulator may comprise a CRISPR/Cas system;
An example of sequence-specific endonucleases includes RNA-guided DNA nucleases, e.g., the CRISPR/Cas system;
The amount and/or activity of an Hsp70 family member protein (e.g., Hspa8) may be downregulated by the cluster regularly interspaced short palindromic repeat-associated nuclease (CRISPR) technology; and
The modulator is a CRISPR (clustered regularly interspaced short palindromic repeats)-Cas system specific for the heat shock protein (e.g., Hspa8).
The present Specification does not identify or describe by structure or illustration any modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8. There is not a single example of a sequence-specific endonuclease (e.g. RNA-guided DNA nuclease) which introduces a G470R mutation in Hspa8.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
“To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP § 2163. The MPEP does state that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a “sufficient number” of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad generic. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The present Specification does not identify or describe by structure or illustration a modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8. There is not a single example of a sequence-specific endonuclease (e.g. RNA-guided DNA nuclease) which introduces a G470R mutation in Hspa8.
The art of Kim et al. (Neuron 111, 1423-1439.e1-e4, May 3, 2023) teach Hspa8G470R mice were created at the Columbia University mouse core facility using CRISPR technology. However, the Examiner cannot find a single example in the prior art wherein a modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8 is exemplified or defined by structure or illustration.
There is not a single species of modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8 that satisfies the genus of the present claims. See In re Gostelli 872, F.2d at 1012, 10 USPQ2d at 1618, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus.
The above position is further supported by In re Clarke, 148 USPQ 665, (CCPA 1966), which held that;
“It appears to be well settled that a single species can rarely, if ever, afford support for a generic claim. In re Soll, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38 USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.21 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of a small genus such as halogens, consisting of four species, a reduction to practice of three, or perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably large number of reductions to practice would probably be necessary.”
The genus of modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8 does not exist in the instant application. That is, adequate written description support does not exist to practice the full scope of the invention claimed. The specification nor the prior art discloses neither a representative number of species compounds nor any structure/function correlation that would enable one of skill to immediately envision the genus of modulators comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8 required to practice the full scope of the invention.
As stated above, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic claim. Given the breadth of the claims, the Specification lacks sufficient variety of species to reflect the variance in the genus.
In conclusion, the Specification and the prior art as filed does not provide sufficient descriptive support for the myriad of modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8 effective to treating a neurodegenerative disorder in a subject embraced by the claims. For the reasons discussed above, the 35 USC § 112 rejection for written description is applicable.
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Claims 1 and 10-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
There are many factors to be considered when determining whether there is sufficient evidence to support determination that a disclosure does not satisfy the enablement requirements and whether any necessary experimentation is undue. These factors have been described by the court in In re Wands, 8 USPQ2d 1400 (CA FC 1988). Wands states at page 1404,
“Factors to be considered in determining whether a disclosure would require undue experimentation have been summarized by the board in Ex parte Forman. They include:
(1) the quantity of experimentation necessary,
(2) the amount of direction or guidance presented,
(3) the presence or absence of working examples,
(4) the nature of the invention,
(5) the state of the prior art,
(6) the relative skill of those in the art,
(7) the predictability or unpredictability of the art, and
(8) the breadth of the claims.”
The nature of the invention and the breadth of the claims:
The claims are drawn to a method of treating a neurodegenerative disorder in a subject, the method comprising administering an effective amount of a modulator of heat shock 70 kDa protein 8 (Hspa8) to the subject, wherein the modulator comprises a CRISPR/Cas system which introduces a G470R mutation in Hspa8.
The amount of direction or guidance and presence/absence of working examples:
The Specification discloses general statements such as:
The modulator may comprise a CRISPR/Cas system;
An example of sequence-specific endonucleases includes RNA-guided DNA nucleases, e.g., the CRISPR/Cas system;
The amount and/or activity of an Hsp70 family member protein (e.g., Hspa8) may be downregulated by the cluster regularly interspaced short palindromic repeat-associated nuclease (CRISPR) technology; and
The modulator is a CRISPR (clustered regularly interspaced short palindromic repeats)-Cas system specific for the heat shock protein (e.g., Hspa8).
The present Specification does not identify or describe by structure or illustration any modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8. There is not a single example of a sequence-specific endonuclease (e.g. RNA-guided DNA nuclease) which introduces a G470R mutation in Hspa8.
The Specification largely prophetically considers a method of treating a neurodegenerative disorder in a subject, the method comprising administering an effective amount of a modulator of Hspa8 to the subject, wherein the modulator comprises a CRISPR/Cas system which introduces a G470R mutation in Hspa8. For example, the present application is replete with the terms, “may” and “may be”. See the following:
“The modulator may bind to a substrate binding domain of a Hsp70 family member protein (e.g., Hspa8) ... The modulator may decrease a chaperone activity of a Hsp70 family member protein (e.g., Hspa8). The modulator may increase a microautophagy activity of a Hsp70 family member protein (e.g., Hspa8) ... In one embodiment, the modulator is an inhibitor of a Hsp70 family member protein (e.g., Hspa8) ... The modulator may comprise a CRISPR/Cas system.”
However, such a disclosure would not be considered enabling since at the time of invention, CRISPR technology in neurodegenerative diseases treatment was highly unpredictable as discussed below: The Wands factors are being considered and the analysis of enablement favors undue experimentation. See MPEP §2164.01.
The state of the prior art and the predictability or unpredictability of the art:
The claimed invention is a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). The following is cited and discussed herein to illustrate the state of the art of CRISPR technology in neurodegenerative diseases treatment.
The following is cited herein to illustrate the state of the art of CRISPR in neurodegenerative diseases treatment at the time of invention: The unpredictability in using CRISPR in neurodegenerative diseases treatment was discussed in a very recent review article by Akbar et al. (Genes 2025, 16, 850, pages 1-28). For example, Akbar explicitly disclose:
Although CRISPR/Cas9 represents a promising and innovative approach to AD treatment, several critical challenges must be addressed before its clinical application. These include ensuring safety and efficacy through additional preclinical studies in appropriate models, developing efficient delivery systems capable of transporting CRISPR components across the blood-brain barrier and into target cells, and addressing ethical concerns related to genome editing, particularly regarding potential unintended consequences and long-term effects…Significant limitations persist. These include challenges in achieving precise, safe, and efficient delivery across the blood–brain barrier, potential off-target effects, and the need for long-term efficacy and safety validation in vivo.
Akbar teach that compared to CRISPR/Cas9-based genome editing, which is still largely in the preclinical or early clinical trial phase, ASOs represent a more established and rapidly deployable therapeutic platform.
Regarding the unpredictability of CRISPR in neurodegenerative diseases treatment, Google AI Overview downloaded from is it unpredictable to use CRISPR to treat neurodegenerative disease? - Google Search on October 24, 2025 disclose:
Using CRISPR to treat neurodegenerative diseases is unpredictable due to significant challenges like off-target edits, the difficulty of delivering the therapy to the right cells in the brain, and the complexity of the diseases themselves. While CRISPR shows great promise, it is not yet a reliable or precise tool for treating these conditions in humans.
Google AI Overview teach key challenges and reasons for unpredictability include off-target edits and effects; delivery to the central nervous system; efficiency and specificity; cellular and disease complexity; delivery methods; and ethical considerations.
Li et al. (Signal Transduction and Targeted Therapy (2023) 8:36, pages 1-23) (submitted with the Office Action filed February 28, 2025) teach that there are still many potential challenges identified when targeting delivery of CRISPR/Cas9 technology for disease treatment. For example, Li et al. discuss the limitations and challenges of using CRISPR/Cas9 technology for disease treatment, including off target effects; validity; applicability; biocompatibility; limitations in targeted delivery; and efficiency and safety to name a few.
The level of skill in the art:
The relative skill of those in the art is considered to be high, being a graduate student or post-doctoral fellow in a biological science.
The quantity of experimentation necessary:
A review of the instant application prophetically considers a method of treating a neurodegenerative disorder in a subject, the method comprising administering an effective amount of a modulator of Hspa8 to the subject, wherein the modulator comprises a CRISPR/Cas system which introduces a G470R mutation in Hspa8. The present Specification does not identify or describe by structure or illustration any modulator comprising a CRISPR/Cas system which introduces a G470R mutation in Hspa8. There is not a single example of a sequence-specific endonuclease (e.g. RNA-guided DNA nuclease) which introduces a G470R mutation in Hspa8.
The prior art of Turturici et al. (Biochemistry Research International, 2011 Vol. 2011:1-18) (submitted with the Office Action filed February 28, 2025) teaches the role of Hsp70 in nervous system diseases is contradictory and further studies will be required to describe the apparently contradictory roles of Hsp70 in nervous system diseases.
Applicants do not exemplify administering an effective amount of a modulator of Hspa8 to the subject, wherein the modulator comprises a CRISPR/Cas system which introduces a G470R mutation in Hspa8. As the art indicates, using CRISPR to treat neurodegenerative diseases is unpredictable due to challenges like off-target edits and effects, difficulty delivering the therapy to the brain, and the need for more long-term safety and efficacy studies. Accordingly, one skilled in the art, being unable to use the prior art for such guidance, must necessarily find such guidance from the Specification. However, one of skill would not find the prophetic disclosures in the Specification enough to overcome the uncertainty in using CRISPR technology for neurodegenerative treatment.
Thus, it is determined that the prior art before the effective filing date of the claimed invention would not enable the disclosure of the methods as claimed. This is particularly true based on at least the teachings of Akbar et al., Li et al., and Turturici et al.
In order to practice the invention using the Specification and the state of the prior art as outlined above, the quantity of experimentation required to practice the invention as claimed in vivo would require the de novo determination of how to overcome the unpredictability of using CRISPR technology to treat neurodegenerative diseases such that an effective amount of a CRISPR/Cas system introduces a G470R mutation in Hspa8 in a subject. As supported by Google AI Overview, Akbar et al., Li et al., and Turturici et al., such analysis is replete with trial and error experimentation. Such experimentation represents an inventive and unpredictable undertaking in itself, with each of the many intervening steps, not providing any guarantee of success. Given the art recognized unpredictability discussed above, this determination would not be routine and would require undue trial and error experimentation.
Due to the scope of the claims, one of skill in the art would be required to further undertake extensive trial and error experimentation with a large number of subjects and controls, to use CRISPR technology to treat neurodegenerative diseases. Since the specification fails to provide any real guidance for the methods as claimed, and since resolution of the various complications in regards to off-target effects; delivery to the central nervous system; efficiency and specificity; cellular and disease complexity; delivery methods; and ethical considerations is highly unpredictable, one of skill in the art would have been unable to practice the invention, without engaging in undue trial and error experimentation.
Thus, in view of the breadth of the claims, the lack of guidance, and the lack of working examples, the instant specification is not found to be enabling. Without further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention. Therefore, it is appropriate to reject the claims under 35 USC 112(a) for not being enabled.
In view of the foregoing, one of ordinary skill in the art would not be able to make and use the claimed invention. The Wands factors have been weighed and favor undue experimentation.
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Claims 1 and 10-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended and is now drawn to a method of treating a neurodegenerative disorder in a subject, the method comprising administering an effective amount of a modulator of heat shock 70 kDa protein 8 (Hspa8) to the subject, wherein the modulator comprises a CRISPR/Cas system which introduces a G470R mutation in Hspa8. In Applicant’s Response filed August 28, 2025, Applicants indicate that support for the amendments can be found at least in the original claims, and at page 4, line 3; page 6, line 23; page 7, line 13; page 13, lines 15-18; page 17, lines 22-23; page 20, lines 26-31; page 43, line 34 to page 44, line 2; and page 45, lines 4-5 of the specification as filed. The following are the explicit disclosures that Applicant rely upon for support of amended claim 1:
The modulator may comprise a CRISPR/Cas system;
In one embodiment, the mutant Hsp70 family member protein is Hspa8G470R;
The amount and/or activity of an Hsp70 family member protein (e.g., Hspa8) may be downregulated by the cluster regularly interspaced short palindromic repeat-associated nuclease (CRISPR) technology;
In one embodiment, the modulator is a CRISPR (clustered regularly interspaced short palindromic repeats)-Cas system specific for the heat shock protein (e.g., Hspa8);
An example of sequence-specific endonucleases includes RNA-guided DNA nucleases, e.g., the CRISPR/Cas system (Geurts et al., Science 325, 433 (2009); Mashimo et al., PLoS ONE 5, e8870 (2010); Carbery et al., Genetics 186, 451-459 (2010); Tesson et al., Nat. Biotech. 29, 695-696 (2011). Wiedenheft et al. Nature 482,331-338 (2012); Jinek et al. Science 337,816-821 (2012); Mali et al. Science 339,823-826 (2013); Cong et al. Science 339,819-823 (2013));
The second, a G470R mutation in the Hspa8 gene, was further investigated by introducing it onto the typically affected SMA background using standard knock-in technology; and
Accordingly, each of these attributes will be investigated in the mutants with or without the G470R mutation.
These disclosures do not support, “a CRISPR/Cas system which introduces a G470R mutation in Hspa8”. This newly amended limitation is new matter.
If Applicants believe the Specification supports ““a CRISPR/Cas system which introduces a G470R mutation in Hspa8”, the Examiner urges Applicant to point to, with particularity, where support can be found for the claims as now filed. Otherwise, Applicant is required to cancel the new matter in reply to this Office Action.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The Examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/Primary Examiner, Art Unit 1635