DETAILED ACTION
Status of the Claims
Claims 29 and 39-41 are currently pending and are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The following Office Action is in response to Applicant’s communication dated 07/09/2025. Rejection(s) and/or objection(s) not reiterated from previous office actions are hereby withdrawn. The following rejection(s) and/or objection(s) are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Terminal Disclaimer
The terminal disclaimer filed on 07/09/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. 10,976,306 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Restriction Requirement
Applicant’s election without traverse of Group IV (claims 29 and 39-41) in the reply filed on 12/12/2024 is acknowledged.
Applicant has canceled all other claims in the reply filed on 12/12/2024.
Claim Rejections - 35 USC § 112(a) – Written Description
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 29 and 39-41 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 claims contain 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.
As per MPEP 2163.03(V), while there is a presumption that an adequate written description of the claimed invention is present in the specification as filed, In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976), a question as to whether a specification provides an adequate written description may arise in the context of an original claim. As per MPEP 2163(I), "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. A specification may describe an actual reduction to practice by showing that the inventor constructed an embodiment or performed a process that met all the limitations of the claim and determined that the invention would work for its intended purpose. Cooper v. Goldfarb, 154 F.3d 1321, 1327, 47 USPQ2d 1896, 1901 (Fed. Cir. 1998). See also UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987) ("[T]here cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim."); Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997) ("[A] reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose."); Mahurkar v. C.R. Bard, Inc., 79 F.3d 1572, 1578, 38 USPQ2d 1288, 1291 (Fed. Cir. 1996) (determining that the invention will work for its intended purpose may require testing depending on the character of the invention and the problem it solves).
Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that applicant had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention. See, e.g., Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323, 56 USPQ2d 1481, 1483 (Fed. Cir. 2000) (the written description "inquiry is a factual one and must be assessed on a case-by-case basis"); see also Pfaff v. Wells Elec., Inc., 55 U.S. at 66, 119 S.Ct. at 311, 48 USPQ2d at 1646 ("The word ‘invention’ must refer to a concept that is complete, rather than merely one that is ‘substantially complete.’ ").
Finally, MPEP 2163.04 describes the burden on the examiner with regard to the Written Description requirement, stating that in rejecting a claim, the examiner must set forth express findings of fact which support the lack of written description conclusion. These findings should:
(A) Identify the claim limitation(s) at issue; and
(B) Establish a prima facie case by providing reasons why a person skilled in the art at the time the application was filed would not have recognized that the inventor was in possession of the invention as claimed in view of the disclosure of the application as filed.
In the present case, the claim limitation at issue is the “protein-degradation inducing tag” and specifically the breadth of this generic term.
The term “protein-degradation inducing tag” is recited in the claim as being “capable of binding to the target molecule and in a molecule having affinity with the 26S proteasome, without inhibiting degradation of the target protein by the 26S proteasome.” As per MPEP § 2111 and § 2111.01, “[d]uring patent examination, the pending claims must be ‘given their broadest reasonable interpretation consistent with the specification’" and the words of a claim must be given their ‘plain meaning’ unless such meaning is inconsistent with the specification, wherein ‘plain meaning’ of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art.
Consistent with the instant claims, the specification describes, in several places, a protein-degradation inducing tag in terms of its affinity for both the target protein a particular protease or protease complex (e.g., a proteasome), such affinity leading to the proteolytic degradation of said target protein. Further, the specification at page 17 (corresponding to [0074] of the published application) explicitly states “[t]here is no particular limitation for the structure of the protein-degradation inducing tag as long as the protein degradation inducing tag has an affinity with a protease without inhibiting degradation of a protein by the protease.”
Therefore, the broadest reasonable interpretation (BRI) of the term “protein-degradation inducing tag” encompasses any tag “capable of binding to the target molecule and in a molecule having affinity with the 26S proteasome, without inhibiting degradation of the target protein by the 26S proteasome.” Given the lack of structural limitations for the tag, it is essentially defined only by its function. In other words, the BRI of the term encompasses a genus of all tags that meet the claimed functions.
In contrast, Applicant shows possession of a much narrower scope of protein-degradation inducing tags as per the disclosure as originally filed, and none specific for the 26S proteasome and administered to a living body. For example, the specification at page 18 shows compounds of formula (I):
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134
122
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Greyscale
wherein “R1 and R2 each independently represent a hydrocarbon group having 1 to 20 carbon atoms, an alkoxy group having 1 to 20 carbon atoms, an aryloxy group having 6 to 20 carbon atoms, a hydroxy group, a carboxy group, an amino group, or a halogeno [sic] group.”
The specification recites in Tables 1-10 many known proteasome inhibitors, indicating for at least some of these, that one could substitute the functional group that covalently binds to the protease active site with some other functional group. Notably, these are only indicated as being inhibitors for the 20S proteasome, 19S proteasome, 20S immunoproteasome, and one labeled as “for a constituent factor other than 20S/19S”. The 26S proteasome is not named. Further Tables 11-79 recite inhibitors for specific proteases, and Tables 80-82 recite activators of the 20S or 19S/11S proteasomes.
Specific examples of protein-degradation inducing tags (including their exact structure) are recited in the Examples, and include the following five compounds:
TMP-CiKD_Bortezomib
TMP-CiKD_ALLN
TMP-CiKD_MLN
MTX-CiKD_MLN
TMP-CiKD_DMT
These five compounds were synthesized, their activity was evaluated by FACS and thermal shift analysis, their inhibitory activity and affinity for the 20S proteasome were assayed, and the IC50 values were determined. Only a single compound, MTX-CiKD_MLN, was parenterally administered to a living body (mouse) as required by the claims, and none were assayed against the 26S proteasome. In fact, the 26S proteasome is only mentioned on page 15, stating “Examples of the proteasome include 26S proteasome, an immunoproteasome, and a thymus proteasome. 26S proteasome is composed of 20S proteasome and two units of 19S proteasome, the two units of 195 proteasome being attached to the 20S proteasome.” While the 26S proteasome is a combination of the 20S and 19S proteasomes, there is no indication that affinity and/or inhibitory activity one or more of the various proteasomes can be used to predict that for any other.
As per MPEP § 2163, citing UMC Elecs. Co. v. United States, 816 F.2d 647, 652, 2 USPQ2d 1465, 1468 (Fed. Cir. 1987), "there cannot be a reduction to practice of the invention ... without a physical embodiment which includes all limitations of the claim", and citing Estee Lauder Inc. v. L’Oreal, S.A., 129 F.3d 588, 593, 44 USPQ2d 1610, 1614 (Fed. Cir. 1997), "a reduction to practice does not occur until the inventor has determined that the invention will work for its intended purpose."
Therefore, Applicant has not shown an actual reduction to practice for the invention as claimed.
Alternatively, as per MPEP § 2163.02, possession may be evidenced by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
However, MPEP § 2163(II)(A) states that “describing a composition by its function alone typically will not suffice to sufficiently describe the composition”, citing Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene’s function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)), which states “[a]n adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed” (emphasis added). See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described.").
Finally, it should be noted that when a claim is drawn to a genus, that the written description requirement may be satisfied through sufficient disclosure of a representative number of species. See MPEP 2163. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). As detailed above, Applicant has presented a generic formula (I), a list of inhibitors/activators with a suggestion to modify them to function as part of a protein-degradation inducing tag, and five specific example compounds, noting that none of these were presented as being specific for the method of the present claims.
In conclusion, Applicant has not presented an actual reduction to practice for the invention as claimed, there is no indication that the claimed methods were “ready for patenting” as outlined in MPEP 2163, and there is no indication of a representative number of species to show possession of the genus as claimed. Therefore, the disclosure as originally filed lacks sufficient written description support for the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEREMY FLINDERS whose telephone number is (571)270-1022. The examiner can normally be reached M-F 10-6:00 EST.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684