DETAILED ACTION
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 .
Status of the Claims
Claims 1-5 were originally filed January 19, 2024.
The preliminary amendment received January 19, 2024 amended claims 1-5.
The amendment received July 1, 2026 amended claim 1.
Claims 1-5 are currently pending.
Claims 1-3 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-3) in the reply filed on July 1, 2026 is acknowledged.
Claims 4 and 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected polypeptide, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 1, 2026.
Applicant’s election without traverse of human, STC-1, liver fibrosis, no additional reagents, and no additional method steps in the reply filed on July 1, 2026 is acknowledged.
Please note: human is not in the present claims and is therefore not required for any rejection of record.
Please note: applicants elected STC-1 (subgenus), therefore, present claim 3 (i.e. SEQ ID NO: 1; species) should be withdrawn. However, in order to advance prosecution, claim 3 is under consideration.
Priority
The present application is a 371 (National Stage) of PCT/KR2022/011447 filed August 3, 2022 which claims foreign priority to Korea 10-2021-0101932 filed August 3, 2021.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome any rejection of record because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 19, 2024 is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Claim Objections
Claim 1 is objected to because of the following informalities: “subject STC-1” should read “subject a STC-1”. Appropriate correction is required.
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 and 2 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 claim(s) contains 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
With regard to the written description requirement, the attention of the Applicant is directed to The Court of Appeals for the Federal Circuit which held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1405 (1997), quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (bracketed material in original) [The claims at issue in University of California v. Eli Lilly defined the invention by function of the claimed DNA (encoding insulin)] (the case is referred to herein as “Lilly”).
Additionally, it is noted that written description is legally distinct from enablement: “Although the two concepts are entwined, they are distinct and each is evaluated under separate legal criteria. The written description requirement, a question of fact, ensures that the inventor conveys to others that he or she had possession of the claimed invention; whereas, the enablement requirement, a question of law, ensures that the inventor conveys to others how to make and use the claimed invention.” See 1242 OG 169 (January 30, 2001) citing University of California v. Eli Lilly & Co.
Although directed to DNA compounds, this Eli Lilly holding would be deemed to be applicable to any compound or a generic of compounds; which requires a representative sample of compounds and/or a showing of sufficient identifying characteristics; to demonstrate possession of the compound or generic(s). In this regard, applicant is further referred to University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997); “Guidelines for Examination of Patent Applications Under the 35 USC 112, first paragraph, ‘Written Description’ Requirement” published in 1242 OG 168-178 (January 30, 2001); and Univ. Of Rochester v G. D. Searle and Co. 249 F. Supp. 2d 216 (W.D.N.Y. 2003) affirmed by the CAFC on February 13, 2004 (03-1304) publication pending.
Additionally, Lilly sets forth a two part test for written description:
A description of a genus of cDNA’s may be achieved by means of a recitation of:
a representative number of cDNA’s, defined by nucleotide sequence, falling within the scope of the genus OR of a recitation of structural features common to the members of the genus.
See Regents of the University of California v. Eli Lilly & Co. 119 F.3d 1559 (Fed. Cir. 1997) at 1569.
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
In the present instance, the specification discloses only limited examples that are not representative of the claimed genus of a method of preventing or treating liver disease in a subject comprising administering a STC-1 or a derivative thereof; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. The instant claims do not define the STC-1 derivative. The CAFC held that a functional definition is insufficient to adequately describe a product, therefore, an adequate written description not based on a functional definition is necessary.
The Examiner further notes the present claims stated by Applicant are broader in scope that those that were held to be impermissible in Lilly because, unlike Lilly, Applicants’ claims encompass a vast number of STC-1 derivatives. The scope of these claims include a vast number of sequences because the specification and claims do not place any limit on the number of components, the type of components, or how the components are combined. Furthermore, the specification and claims do not place any limit on the number of components, the types of components, or the manner in which the components might be connected to achieve a STC-1 derivative which prevents or treats any liver disease. Therefore, Applicants are using an inadequately described STC-1 derivative to inadequately describe the claimed method.
While the general knowledge and level of skill in the art for making polypeptide derivatives is high, this knowledge and level of skill does not supplement the omitted description because specific, not general, guidance is needed for the STC-1 derivative which can prevent or treat any liver disease. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, and because the genus is vast and highly variant, the limited examples in the specification (i.e. STC-1 of SEQ ID NO: 1) are insufficient to teach the entire genus.
The specification discloses only limited examples (i.e. Example 6 which utilizes a mouse model of liver fibrosis and treatment with STC-1, presumable SEQ ID NO: 1) that are not representative of the claimed genus of a method of preventing or treating a liver disease with a STC-1 derivative; nor do the claims recite sufficient structural features which are common to members of the genus sufficient to demonstrate possession of the genus. Therefore, the teachings in the specification are general teachings relating without guidance as to the individual components of the product. In addition, there are numerous STC-1 derivatives that could be employed in the invention with little direction or guidance for one of skill in the art to practice the claimed invention. The expedient statements in the specification do not relate to an adequate disclosure or how to make and use the claimed invention. Consequently, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to adequately describe the vast genus. Thus, Applicant does not appear to be in possession of the claimed genus.
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 and 2 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. One of skill in the art would not be able to determine the scope of the present claim. For example, it is unclear what “derivative thereof” would be capable of preventing or treating liver disease.
Claim 3 is 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. One of skill in the art would not be able to determine the scope of the present claim. For example, it is unclear what represented by encompasses (e.g. open, closed, etc.). This is particularly relevant since the claim utilizes both closed “consists of” claim language and the indefinite “represented by” claim language.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olsen et al. WO 01/30969 published May 3, 2001.
For present claims 1-3, Olsen et al. teach methods of administering human stanniocalcin (STC; SEQ ID NO: 2) to human subjects to treat liver diseases including liver neoplasms, liver cancer, cirrhosis, liver injury, hepatitis, liver disease, liver failure, liver damage (please refer to the entire specification particularly the abstract; pages 1, 3, 9-34, 122-125, 134, 150, 155-158, 161). While Olsen et al. do teach fibrosis, liver fibrosis is not taught.
Therefore, the present claims are anticipated by the teachings of Olsen et al.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen et al. WO 01/30969 published May 3, 2001; Manka et al., 2019, Fibrosis in Chronic Liver Disease: An Update on Diagnostic and Treatment Modalities, Drugs, 79: 903-927; and Olsen et al. U.S. Patent Application Publication 2002/0102634 published August 1, 2002.
For present claims 1-3, Olsen et al. teach methods of administering human stanniocalcin (STC; SEQ ID NO: 2) to human subjects to treat liver diseases including liver neoplasms, liver cancer, cirrhosis, liver injury, hepatitis, liver disease, liver failure, liver damage (please refer to the entire specification particularly the abstract; pages 1, 3, 9-34, 122-125, 134, 150, 155-158, 161). While Olsen et al. do teach fibrosis, liver fibrosis is not taught.
For present claims 1-3, Manka et al. teach that individuals with progressive liver fibrosis develop cirrhosis and are at risk of developing liver cancer and liver failure (please refer to the entire reference particularly the abstract; Introduction; “Liver Fibrosis Suring Chronic Liver Injury”).
For present claims 1-3, Olsen et al. teach stanniocalcin-alpha SEQ ID NO: 10 (100% identity and the same length as present SEQ ID NO: 1).
All the claimed elements were known in the prior art (present SEQ ID NO: 1; treatment of liver disease; liver fibrosis as a liver disease) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (STC treatment of liver disease including fibrosis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (STC; genus of liver disease) for another (present SEQ ID NO: 1; liver fibrosis) would have yielded predictable results (STC treatment of liver disease including liver fibrosis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (utilizing STC to treat liver disease) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen et al. WO 01/30969 published May 3, 2001; Manka et al., 2019, Fibrosis in Chronic Liver Disease: An Update on Diagnostic and Treatment Modalities, Drugs, 79: 903-927; and Olsen et al. U.S. Patent 5,837,498 issued November 17, 1998.
For present claims 1-3, Olsen et al. teach methods of administering human stanniocalcin (STC; SEQ ID NO: 2) to human subjects to treat liver diseases including liver neoplasms, liver cancer, cirrhosis, liver injury, hepatitis, liver disease, liver failure, liver damage (please refer to the entire specification particularly the abstract; pages 1, 3, 9-34, 122-125, 134, 150, 155-158, 161). While Olsen et al. do teach fibrosis, liver fibrosis is not taught.
For present claims 1-3, Manka et al. teach that individuals with progressive liver fibrosis develop cirrhosis and are at risk of developing liver cancer and liver failure (please refer to the entire reference particularly the abstract; Introduction; “Liver Fibrosis Suring Chronic Liver Injury”).
For present claims 1-3, Olsen et al. teach stanniocalcin-alpha SEQ ID NO: 2 (100% identity and the same length as present SEQ ID NO: 1).
All the claimed elements were known in the prior art (present SEQ ID NO: 1; treatment of liver disease; liver fibrosis as a liver disease) and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (STC treatment of liver disease including fibrosis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (STC; genus of liver disease) for another (present SEQ ID NO: 1; liver fibrosis) would have yielded predictable results (STC treatment of liver disease including liver fibrosis) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (utilizing STC to treat liver disease) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO 2005067650 – SEQ ID NO: 39 (100% to present SEQ ID NO: 1; longer)
WO 2007076465 – SEQ ID NO: 8 (100% to present SEQ ID NO: 1; longer)
WO 2005059179 – SEQ ID NO: 6 (97.3% to present SEQ ID NO: 1)
U.S. Patent 6,812,339 – SEQ ID NO: 11426 (100% to present SEQ ID NO: 1; longer).
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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