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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/22/2026 has been entered.
Claims 35 and 43-49 remain withdrawn.
Claims 29, 31-33, 36-38, 40-42, and new claims 51-52 are now under consideration in the instant Office Action.
Withdrawn Rejections
Rejections of claims 29-33, 36-38, 40-42, and 50 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to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, are hereby withdrawn in view of amendments to the claims.
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, 31-33, 36-38, 40-41, and new claims 51-52 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: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 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 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.
(2) The existence of working examples - As stated above the specification reasonably provides enablement for a fusion protein as described in SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 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 in the instant specification of a “complete” fusion protein requiring all of the necessary structural components in SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 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 undefined fusion proteins that are required to achieve the same function despite the fact that their structures have not been defined. Additionally, the broadest reasonable interpretation of the dependent claims are missing important structural information. The dependent claims all depend from the generic claim 29, which some claims reciting the need for only a flexible hinge region (see claims 30 ad 31) and some reciting the need for only a connecting peptide between the second IL-10 monomer and heterologous transmembrane-intracellular stretch (see claim 36). As such, the dependent claims recite a component that is required for the fusion protein (e.g., the connecting peptide or heterologous transmembrane-intracellular stretch) but their dependencies are written in a way that indicates the claims are not all a part of a complete embodiment. This creates several incomplete embodiments of the fusion protein due to the structure of the claim dependency; none of which are fully enabled by the disclosure. 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 property (inhibiting a certain pathway), 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: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and 29.
Response to Arguments
Applicant's arguments filed 01/22/2026 have been fully considered but they are not persuasive.
Applicant argues “the Office Action states that only SEQ ID NO: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, and 29 are exemplified and that undue experimentation is required to produce the full scope of claim 29… A skilled artisan can certainly produce an IL-10 monomer and can certainly produce the transmembrane-intracellular stretch derived from MHC, CD28, or IL-10R β”. This is not found persuasive.
The Examiner acknowledges that the specification teaches the component parts of the IL-10 homologous protein, from the linkers to the transmembrane stretches, However, the claim construction and claim dependencies do not reflect this in the instant claims. The independent claim 29 reads on a broad category of potential structures at the various points of the IL-10 protein. While the dependent claims later provide the necessary structural details, the independent claim still reads as extremely broad and encompasses more structures than Applicant has provided disclosure for. Additionally, the claims have been constructed in a manner so that the dependencies of the claims do not “compound” upon one another and instead provide structural limitations that only paint a part of the picture, creating several incomplete embodiments of the invention. As such, the claims would require undue experimentation to arrive at the instant invention because the disclosure does not provide support for the full scope of all the incomplete embodiments that are claimed. Given that multiple components are required to construct the protein, there is undue experimentation in ascertaining which of the disclosed elements could be present at each part of the embodiment of the instant claims.
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675