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
Responsive to communication entered 05/02/2024.
Priority
This application, filed 05/02/2024, Pub. No. US 2024/0353396 A1, published 10/24/2024, is a division of application No. 17/236,790, filed 04/21/2021, Pub. No. US 2021/0349078 A1, published 11/11/2021, now abandoned, and claims priority to provisional application No. 63/013,344, filed 04/21/2020.
Status of Claims
Claims 1-8 are currently pending. Claims 1-8 are examined.
Information Disclosure Statement
The information disclosure statement, submitted on 05/02/2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Please note that the following reference has been corrected by the Examiner:
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Claim Objections
Claims 3, 4, 6 and 7 are objected to because of the following informalities: reciting “S100B-GFP” and/or “S1003-GFP” instead of “S100β-GFP”.
Claim 7 is further objected to because of the following informalities: reciting “NG2-dsRedt”. Does it mean to be “NG2-dsRed+”?
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 112 that form the basis for the rejections under this section made in this Office action.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 1-8 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 (“new matter”).
The claims, as recited in independent Claim 1, are drawn to:
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With regard to Claim 1 and Claims 2-8 depend thereon, there appears to be no support for the broad recitation “obtaining isolated Schwann cells, wherein the Schwann cells coexpress two different fluorescence proteins, wherein the message for each of the two different fluorescence proteins is expressed using a different promoter; and wherein the promoters are an NG2 promoter and an S100β promoter”, because the instant disclosure is limited to obtaining the isolated perisynaptic Schwann cells coexpressing two different fluorescence proteins:
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Specification filed 05/02/2024; Emphasis added.
With regard to Claim 2, there appears to be no support for the recitation “muscle repair following exercise” because the term “exercise” is not found in the application as filed.
With regard to Claim 3 and Claim 5 depends thereon, there appears to be no support for the recitation “producing isolated Schwann cells, wherein the isolated Schwann cells are produced by a transgenic cell line crossing of two or more transgenic lines in which either the NG2 promoter, which drives expression of dsRed; or the S100β promoter,” because the instant disclosure is limited to producing a transgenic mouse line (called S100β-GFP; NG2-dsRed) by crossing two transgenic mouse lines:
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Specification filed 05/02/2024; Emphasis added.
With regard to Claim 7, there appears to be no support for the recitation “wherein a deleterious effect is defined as a cell death,” because the term “cell death” is not found in the application as filed.
Applicant is reminded that it is their burden to show where the specification supports any amendments to the disclosure. See MPEP 714.02, paragraph 5, last sentence and also MPEP 2163.06 I. MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” MPEP 2163.02 teaches that “Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. ... If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. This conclusion will result in the rejection of the claims affected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C.112, first paragraph - description requirement, or denial of the benefit of the filing date of a previously filed application, as appropriate”. MPEP 2163.06 further notes “When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure.” Emphasis added.
Claims 1-8 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.
According to “Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.,” https://www.federalregister.gov/documents/2024/01/10/2024-00259/guidelines-for-assessing-enablement-in-utility-applications-and-patents-in-view-of-the-supreme-court, USPTO personnel will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.
These factors can include, but are not limited to:
(1) the breadth of the claims;
(2) the nature of the invention;
(3) the state of the prior art;
(4) the relative skill of those in the art;
(5) the level of predictability in the art;
(6) the amount of direction provided by the inventor;
(7) the existence of working examples; and
(8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
(1 and 2) The breadth of the claims and the nature of the invention: The present invention is exploiting the scientific discovery that perisynaptic Schwann cells( PSCs) can be identified by the combined expression of two protein markers, S100β and neuron-glia antigen-2 (NG2) protein, and double transgenic mice generated by crossing a NG2-dsRED mouse with a S100β -GFP mouse enabled the selective isolation of PSCs by FACS (Fluorescence-Activated Cell Sorting) from collagenase-digested skeletal muscles, as taught by a prior art reference Castro et al., “Identification of a molecular fingerprint for synaptic glia,” bioRxiv, March 14, 2020,19 pages (IDS submitted 05/02/2024).
The instant application reproduces the teachings of Castro et al., and discloses that, coupled with RNA sequencing, this approach led to the first cell-specific transcriptome of PSCs. The analysis revealed that PSCs express a battery of genes involved in the regulation of synaptic activity, synaptic pruning, and synaptic maintenance, a unique gene expression signature that distinguishes PSCs from all other Schwann cells (SCs).
The instant application further discloses the use of the S100β-GFP; NG2-dsRed mouse model for:
to study PSCs and their functions at neuromuscular junctions and discloses that in healthy young adult muscle the same number of PSCs at neuromuscular junctions in the extensor digitorum longus muscle of S100β-GFP and S100β-GFP; NG2-dsRed mice is observed;
to study PSCs at degenerating and regenerating neuromuscular junctions in young adult mice and discloses that similar to healthy uninjured extensor digitorum longus muscles, NG2-dsRed and S100β-GFP coexpressed exclusively in PSCs at 4-day and 7-day post-injury;
to examine the expression pattern of NG2-dsRed and S100β-GFP in the extensor digitorum longus during the symptomatic stage (P120) by crossing the SOD1G93A mouse line, which is a model of Amyotrophic Lateral Sclerosis (ALS) shown to exhibit significant degeneration of neuromuscular junctions, with S100β-GFP; NG2-dsRed mice and discloses that S100β-GFP coexpressed only in PSCs in the extensor digitorum longus of P120 SOD1G93A; S100β-GFP; NG2-dsRed mice.
Although addressing a method wherein PSCs are the only cells expressing both S100β-GFP and NG2-dsRed in muscles (see Claim 6), the claims are broadly drawn to obtaining any isolated SCs, wherein the SCs coexpress two different fluorescence proteins, wherein the message for each of the two different fluorescence proteins is expressed using a different promoter; and wherein the promoters are an NG2 promoter and an S100β promoter. Accordingly, the claim scope is unduly broad with respect to the encompassed isolated SCs.
(3 and 5) The state of the prior art and the level of predictability in the art:
The art is highly unpredictable. As evidenced by Hastings et al., “Origin, identity, and function of terminal Schwann cells,” Trends Neurosci., 2024, Volume 47, Issue 6, pp. 432-446, although current evidence suggests that terminal Schwann cells (TSCs), also referred to as PSCs, in young adult mice, are derived from the same progenitors as SCs along the nerve, many questions remain, such as, what factors, if any, do axon terminals and other end-organ structures produce to promote TSC differentiation and maturation? Moreover, although TSCs have been found to be altered in aging and various diseases, it is still unknown, which of the cellular and molecular changes to TSCs in these conditions are beneficial or detrimental to the sustained physiology of their associated axon terminal. (see Outstanding questions at page 443).
Furthermore, as evidenced, for example, by Negro et al., “Models and methods to study Schwann cells,” J. Anatomy, 2022, vol. 241, issue 5, pp. 1235-1258, at the time of filing the instant application, although primary cultures represented an established method and have long been used for the study of basic cellular mechanisms of SCs also thanks to a progressive refinement of isolation and culturing protocols, unfortunately, no methods have been available to culture PSCs:
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Emphasis added.
(4) The level of one or ordinary skill: The level of skill in the art would be high, most likely at the Ph.D. level. However, such persons of ordinary skill in this art, given its unpredictability, would have to engage in undue (non-routine) experimentation to carry out the invention as claimed.
(6-7) The amount of direction provided by the inventor and the existence of working examples: Here, there is no actual reduction to practice of the instantly claimed method. The specification as filed is limited to the following statements:
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Emphasis added.
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Emphasis in the original.
(8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure:
In light of the unpredictability surrounding the claimed subject matter, the undue breadth of the claimed invention’s intended use, and the lack of adequate guidance, one wishing to practice the presently claimed invention would be unable to do so without engaging in undue experimentation. One wishing to practice the presently claimed invention would have to develop in vitro cell culture assays to discover and test agents that cause SCs to stop proliferating and differentiate into PSCs, with no direction provided from the specification regarding the cell culture to start with. Noteworthy, as evidenced by Hastings et al., see above, factors promoting PSCs differentiation and maturation are still needed to be found out.
Therefore, it is deemed that further research of an unpredictable nature would be necessary to make or use the invention as claimed. Thus, due to the inadequacies of the instant disclosure, undue experimentation would be required of one of ordinary skill in the art to practice the full scope of the claimed invention.
Accordingly, Claims 1-8 do not meet the enablement provision of 35 U.S.C. §112(a) or 35 U.S.C. §112 (pre-AIA ), first paragraph.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GALINA M YAKOVLEVA whose telephone number is (571)270-3282. The examiner can normally be reached on M-F 8:30 AM-5:00 PM.
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, GREGORY S EMCH can be reached on (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GALINA M. YAKOVLEVA/Primary Examiner, Art Unit 1678