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
Claims 43, 45-46, 48-49 remain withdrawn.
Claims 29, 32-33, 36-38, 40-42, 51, and new claims 53-55 are now under consideration in the instant Office Action.
Modified Rejections Necessitated by Amendment
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 29, 32-33, 36-38, 40-41, 51, and new claims 53-55 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 a fusion protein as described in SEQ ID NOs: 25, 27, and 29, does not reasonably provide enablement for the generic fusion protein comprising a single polypeptide chain comprising a first human IL-10 monomer, a human second IL-10 monomer and a heterologous transmembrane-intracellular stretch, wherein said first IL-10 monomer and said second IL-10 monomer are identical, and wherein the heterologous transmembrane-intracellular stretch is derived from a heavy chain of a human MHC class I molecule; a human CD28: or a human IL- 10R β chain. 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.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term “undue experimentation,” it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include but are not limited to:
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The breadth of the claims;
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The nature of the invention;
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The state of the prior art;
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The level of one of ordinary skill;
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The level of predictability in the art;
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The amount of direction provided by the inventor;
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The existence of working examples; and
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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). The factors most relevant to this rejection are 1) the amount of direction provided by the inventor, 2) the existence of working examples, and 3) undue experimentation. In the instant case, the amount of direction provided by the inventor, undue experimentation, and existence of working examples disclosed in the specification, as filed, would not be sufficient to enable the skilled artisan to make and/or use the claimed invention at the time the application was filed without undue experimentation.
(1) The amount of direction provided by the inventor - The amount of guidance or direction needed to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). Due to the high level of unpredictability in creating fusion proteins which several interchangeable and customizable parts, the skilled artisan would need significant guidance in preparing a fusion protein with a targeted function. The skilled artisan recognizes that creating a fusion protein designed to reside in the membrane is a wildly unpredictable endeavor that requires specificity in structure. Without a proper structure provided by the Applicant for a complete embodiment of the = invention(s), it is nearly impossible to envision and recognize all the potential structures amongst all potential possibilities of homodimeric proteins, flexible linkers, heterologous transmembrane-intracellular stretch proteins, and connecting peptides that would be conducive to a structure possessing the functionality needed to access it. As currently recited, the claims are not listed in a manner that clearly elucidates a complete structure for the fusion protein as the dependencies branch off after listing one or two of the necessary limitations for a complete structure. Instead, the instant claims list potential options for the sequences of structures such as the flexible linkers or connecting peptides in a series of dependent claims. As such, a complete embodiment is not described in the instant claims.
(2) The existence of working examples - As stated above the specification reasonably provides enablement for a fusion protein as described in SEQ ID NOs: 25, 27, and 29; however, there is no showing in the specification of any means by which one skilled in the art could prepare a generic fusion protein comprising a single polypeptide chain comprising a first human IL-10 monomer, a human second IL-10 monomer and a heterologous transmembrane-intracellular stretch, wherein said first IL-10 monomer and said second IL-10 monomer are identical, and wherein the heterologous transmembrane-intracellular stretch is derived from a heavy chain of a human MHC class I molecule; a human CD28; or a human IL- 10R β chain. Applicant provides examples on page 6 of the instant specification of a “complete mem-IL10” fusion protein requiring all of the necessary structural components in SEQ ID NOs: 25, 27, and 29. Applicant also fully describes the structures required in Examples 1 and 2 of the instant specification. However, the instant claims fall short of the disclosure as they recite a large number of fusion proteins that contained undefined variability that are required to achieve the same function despite the fact that their structures have not been defined. Therefore, one skilled in the art would be subject to undue experimentation to practice each embodiment of the instant invention as it is currently claimed.
(3) Undue experimentation – The instant claims cover all possible fusion proteins comprising homodimeric IL-10 proteins, a heterologous transmembrane-intracellular stretch, flexible linkers, and a connecting peptide as long as they are generically related to each of these components. Further, these claimed fusion proteins encompass any possible future discoveries of any factors and substances with the claimed functions. When claims depend on a recited function (binding to a particular protein), a fact situation comparable to Hyatt is possible, where the claim covers every conceivable structure (means) for achieving the stated property (result) while the specification discloses at most only those known to the inventor. See also Fiers v. Sugano, 984 F.2d 164, 25 USPQ2d 1601 (Fed. Cir. 1993) and MPEP §2164.08(a). Therefore, the specification fails to provide enough guidance for one skilled in the art on how to produce the instant product except for the instant Examples, thereby requiring trial and error experimentation to identify compounds meeting the functional limitations of the claims.
As set forth above, inadequate guidance is presented in the specification to overcome the obstacles in practicing the claimed invention in its full scope. The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. Given the tremendous breath of scope involving the instant claims, it would require undue experimentation for one of skill in the art to practice the claimed invention in its full scope. Therefore, the specification fails to provide enough guidance for one skilled in the art on how to produce the instantly claimed protein, thereby requiring trial and error experimentation to identify fusion proteins meeting the functional limitations of the claims. The general knowledge and level of skill in the art do not supplement the omitted description because specific, not general, guidance is what is needed.
In conclusion upon careful consideration of the Wands factors that are used to determine whether undue experimentation is required to practice an invention, the amount of direction provided by the inventor, undue experimentation, and the working examples provided, as filed, is not deemed sufficient to enable the skilled artisan to make and/or use the invention commensurate in scope with the instant claims at the time the application was filed without undue experimentation. Applicant is enabled for the complete embodiment of the fusion protein as described in Examples 1 and 2 of the instant specification and SEQ ID NOs: 25, 27, and 29.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive.
Applicant argues that they “fail to understand what undue experimentation is needed in order to perform the claims over their full scope”. This is not persuasive.
As currently recited, the amendments to instant claim 29 improves the clarity and description of the fusion protein in the claims by reciting each structure that is required to complete the embodiment. New claims 53-55 have been added to the claim set and provide structural information regarding the transmembrane intracellular stretches and human IL-10R β chain. The element that remains missing from the claims is the “complete mem-IL10” fusion protein sequences of SEQ ID NOs: 25, 27, and 29. According to page 6 of the instant specification, these sequences contain the identity of the monomers of the fusion protein and thus define the invention in greater detail. The instant claims have been amended to recite limitations that would require more of the generic structures of the fusion protein, such as reciting the IL-10 monomers, flexible linkers, heterologous transmembrane-intracellular stretch, flexible hinge regions and connecting peptides, but fail to narrow the scope of the invention to embodiments which the Applicant has provided support for in the disclosure. The language of the instant claim limitations as written follows the same fact pattern that is discussed in Hyatt, where the claim covers every conceivable structure (means) for achieving the stated property (result) while the specification discloses at most only those known to the inventor. See also Fiers v. Sugano, 984 F.2d 164, 25 USPQ2d 1601 (Fed. Cir. 1993) and MPEP §2164.08(a). Therefore, the specification fails to provide enough guidance for one skilled in the art on how to produce the instant product except for the instant Examples, thereby requiring trial and error experimentation to identify compounds meeting the functional limitations of the claims.
Applicant argues “if the issue of undue experimentation instead is with respect to the selection of the transmembrane-intracellular stretch, then it is unclear why instant claim 37 was rejected.” This is not found persuasive.
As discussed above, instant claim 37 fails to define the monomeric portions of the protein and instead describes the fusion protein on a functional basis. The other components of the proteins, such as the transmembrane-intracellular stretch, have some description in regards to their structures and identities but as Applicant corroborates on page 8 of the Remarks, these are not the inventive concepts of the fusion protein. Instant claim 37 depends from a claim which does not resolve previous enablement issues by providing a structure for which the Applicant is enabled for, and as such remains rejected for the same reasons of undue experimentation as one of ordinary skill in the art would need to perform undue experimentation to arrive at the identity of the fusion protein that is instantly claimed.
Therefore, the claims remain rejected as not being fully enabled.
Allowable Subject Matter
Claim 42 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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