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/Restrictions
Applicant’s election without traverse of Group I, presently claims 1-13, in the reply filed on 8/05/2025 is acknowledged.
Applicant’s species election without traverse of autism and fibroblasts in the reply filed on 8/05/2025 is acknowledged.
Claims 14-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/05/2025.
Claims 1-6 and 9-13 are under consideration on the merits and are considered to the extent they read on the elected species.
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.
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 1-6 and 9-13 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 the combination of mammalian subjects, autism or autism spectrum disorder, and non-modified fibroblasts, does not reasonably provide enablement for generic pervasive developmental disorders across generic subjects and does not provide enablement for treatment thereof with modified fibroblasts, fibroblast apoptotic bodies, and/or fibroblast conditioned media. 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 use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized in In re Wands, 858 F.2d 731, 737, 8 USPQd 1400, 1404 (Fed. Cir. 1988) (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. While all of these factors are considered, a sufficient number are discussed below so as to create a prima facie case.
Before and after the invention was filed, treating pervasive developmental disorder with fibroblasts, fibroblast apoptotic bodies, and/or fibroblast conditioned media was unpredictable as set forth in claims 1, 12, and 13. Preclinical treatment of animal models and clinical treatment of humans was limited to stem cells and exosomes/vesicles obtained from stem cells and either animal models or humans suffering from autism spectrum disorder. See Nabetani et al. (Cell Transplantation (2023), 32, 1-14; Reference U) at Tables 2 and 3 and the pre- and post-filed references contained therein.
Noggle et al. (US 2015/0166964; provided in the IDS dated 12/20/2021) does not teach methods of treating any pervasive developmental disorder with any therapeutically effective dosage of fibroblasts, as Noggle only contemplates autism in the context of “cell panels” derived from a population of autistic individuals for screening biomolecule libraries (¶0090-0093) and then separately teaches treatment of a variety of diseases with induced pluripotent stem cells (iPSCs) differentiated into other stem cells or differentiated cells but not does not teach treatment of any species of pervasive developmental disorder such as autism with fibroblasts, modified fibroblasts, fibroblast apoptotic bodies, and/or fibroblast conditioned media (¶0222).
In the unpredictable arts, more guidance is needed to satisfy the enablement requirement, see M.P.E.P. § 2164.03 and In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991). Also see M.P.E.P. § 2164.03. In this case, treatment of generic subjects for pervasive developmental disorder with fibroblasts, fibroblast apoptotic bodies, and/or fibroblast conditioned media was unknown before the effective filing date of the Application, and therefore unpredictable and so more guidance is required in this case to satisfy the enablement requirement.
Applicants presents two working embodiments in the specification. Example 1 is the prophetic treatment of human subjects suffering from autism spectrum disorder with an unspecified effective dosage of generic fibroblasts. Given the unpredictability of the art as set forth above and lack of actual data, Example 1 is insufficient to satisfy the enablement requirement for the full scope of the claims. There would necessarily be an undue burden on a person skilled in this art to make and use the claimed methods to their full scope as that person would be left to empirically test every conceivable dosage of fibroblasts, generic modified fibroblasts, fibroblast apoptotic bodies, and/or fibroblast conditioned media against the generic subjects suffering from pervasive developmental disorder of claim 1 or the subjects suffering from autism, autism spectrum disorder, Rett syndrome, childhood disintegrative disorder, Asperger’s syndrome, and/or pervasive developmental disorder otherwise not specified as set forth in claim 2 for operability (i.e. an actual therapeutic effect and distinguishing between operable and inoperable treatment conditions).
Example 2 is directed towards treating a rodent subjects as an animal model of autism (i.e. valproic acid-treated rats) with generic fibroblasts. While the valproic acid model of autism would be reasonably enabling for a method of treating autism or autism spectrum disorder in mammalian subjects with a therapeutically effective dosage non-modified fibroblasts (for the valproic acid-induced rodent model of autism, see Nicolini et al. (Experimental Neurology (epub May 2nd, 2017), 299, 217-227; Reference V), a singular, narrow working embodiment cannot be a sole factor in determining enablement, its limited showing, in light of the unpredictable nature of the art and the lack of direction applicants present, provides additional weight to the lack of enablement in consideration of the Wands factors as a whole. There would necessarily be an undue burden on a person skilled in this art to make and use the claimed methods to their full scope as that person would be left to empirically test every conceivable dosage of, generic genetically modified fibroblasts, fibroblast apoptotic bodies, and/or fibroblast conditioned media against the generic subjects suffering from pervasive developmental disorder of claim 1 or the subjects suffering from, Rett syndrome, childhood disintegrative disorder, Asperger’s syndrome, and/or pervasive developmental disorder otherwise not specified as set forth in claim 2 for operability (i.e. an actual therapeutic effect and distinguishing between operable and inoperable treatment conditions). Particularly, neither Example 2 nor the prior art provide any predictable guidance to the embodiments set forth above that might otherwise provide a basis to extrapolate the limited showing the specification to the generic claimed methods.
Claims 2-6 and 9-11 depend from claim 1 but only recite statements of intended outcome (see M.P.E.P. § 2111.02 and 2111.04), and so are afforded no patentable weight and do not meaningfully limit the scope of claim 1 to enabled subject matter for the reasons given above.
Thus, one of ordinary skill in the art would not have a reasonable expectation of success in using the claimed invention to the full scope of the claims.
Claims 1-6 and 9-13 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.
The term “modified” in claim 1 is a relative term which renders the claim indefinite. The term “modified” is 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. Particularly, there is no standard in this art for recognizing what degree of modification of the fibroblasts and what type of modifications would and would not be encompassed by the term “modified”.
In so much that claims 2-6 and 9-13 depend from claim 1 and do not resolve the point of confusion, these claims must be rejected with claim 1 as indefinite.
Conclusion
No claims are allowed.
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/Sean C. Barron/Primary Examiner, Art Unit 1653