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 .
Claim Rejections - 35 USC § 112
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 are 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.
Claim 1 recites:
“a) identifying a fragmentation site in a signal-generating protein
wherein the fragment site comprises a region of sequence dissimilarity within a solvent accessible loop region of the signal-generating protein...” (see claim 1 in subsection a), emphasis added).
Examiner notes that paragraph 0046 of Applicant’s specification in the Pre-Grant Publication US 20230152329 states that “[a]s used herein, “sequence dissimilarity” may refer to a region within a protein's primary sequence that when aligned to a sequence of a closely related species that expresses a similar gene is non-homologous or different.” (Emphasis added).
It is not clear as to what “sequence dissimilarity” means. While paragraph 0046 describes what sequence dissimilarity “may” mean, there is no definition for this limitation, nor a clear description as to what is required to meet this limitation.
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 1-6 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 inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims require:
“a) identifying a fragmentation site in a signal-generating protein
wherein the fragment site comprises a region of sequence dissimilarity within a solvent accessible loop region of the signal-generating protein...” (see claim 1 in subsection a), emphasis added).
Thus, these limitations require a protein that is described by its function.
The claims also recite “c) mutating at least one residue in one or both of the protein fragments; wherein the mutation reduces binding affinity between the first protein fragment and the second protein fragment relative to the corresponding unmutated fragments” (see claim 1 in subsection c), emphasis added).
Thus, these limitations also describe the protein by another function.
Regarding the two limitations of the protein mentioned above, the specification does not describe which amino acid residues, or other molecular components are responsible for the functions claimed. Potential agents must first be screened in an assay to ascertain if the agents have the functions required by the instant claims. The specification fails to disclose the structures common to all members of the genus of peptides encompassed by the broad definition provided by applicant. The specification does not disclose the structure of all of the claimed variant agents and fails to disclose which regions of the agents are responsible for the functions claimed. In the absence of a known or disclosed correlation between structure and function, claims which encompass variants defined by their function are generally not considered described.
Applicant is directed to MPEP § 2163 for guidelines on compliance with the written description requirement. Here, applicant has not described a reasonable number of members of the genus of agents i.e. the required starting materials for the claims, but rather has presented the public with an idea of how to perform an assay that might identify some peptides that fall within the scope of the claim. Of course, depending on what agents are used in the screening assay, it may well identify none. The Court of Appeals for the Federal Circuit addressed claims of this sort in great detail in University of Rochester v. G.D. Searle and Co. (69 USPQ 2nd 1886, CAFC 2004). In Rochester, the Federal Circuit upheld the district court's ruling that patent claims which recited administration of compounds not disclosed, but rather to be identified in a screening assay, were invalid on their face.
The specification does not describe the structure of the full genus responsible for each of the functions claimed. Additionally, there is a lack of clarity as to what the function encompasses, given that there is no clear definition or description as to what is required to meet the limitation of “sequence dissimilarity” (see discussion further above regarding 35 USC 112(b)). The lack of clarity as to what the claimed function encompasses also adds to the lack of description of the structure of the full genus of the claimed limitation, and thus the instant claims do not meet the written description provision of 35 U.S.C. 112(a).
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are highly unpredictable, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a genus using functional language to define a desired result, the specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Consequently, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed protein, nor guidance as to which of the myriad of molecules would meet the limitations of the claims.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117). The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the genus of agents, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of identification. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991). Therefore, the instant claims do not meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
Response to Arguments
No claims are allowed.
Applicant's arguments have been fully considered but they are not persuasive.
Applicant has amended the claim to recite
“a) identifying a fragmentation site in a signal-generating protein
wherein the fragment site comprises a region of sequence dissimilarity within a solvent accessible loop region of the signal-generating protein;….
and c) mutating at least one residue in one or both of the protein fragments; wherein the mutation reduces binding affinity between the first protein fragment and the second protein fragment relative to the corresponding unmutated fragments” (emphasis added).
Applicant argues Gosh does not have the feature of a fragment site comprising a region of sequence dissimilarity within a solvent accessible loop region of the signal-generating protein. Applicant argues that Ghosh describes conventional, “off-the-shelf” split-protein systems. Applicant states that this disclosure is directed to the use of known split-protein constructs and does not teach or suggest identifying fragmentation sites based on sequence dissimilarity within solvent accessible loop regions of the protein.
Applicant asserts that this use of sequence dissimilarity to identify a fragmentation site is inventive as it enables the identification of novel split sites within the protein that would not have been readily apparent using conventional approaches. Additionally, these technical features advantageously provide split-protein sensors exhibiting high sensitivity, low background signal, and reduced development time.
However, these limitations are rejected for lack of clarity and lack of written description for the reasons set forth above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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