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 .
Election/Restrictions
Election of species of nucleic-based adipsin inhibitor and Jagged inhibitor in the reply filed on 03/25/2026 is acknowledged.
Claims 9, 20-21 and 25 are withdrawn from further consideration as being drawn to nonelected species.
Title
It is noted that there is a misspelling in the title of the word “adipsin” to “adispsin”. 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 1-3, 5-6, 8, 10-12, 17, 19, 24, 27 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.
Claims are broadly drawn to methods of treatment of fatty liver disease comprising administering compounds reducing adipsin activity, which can be a small molecule, an oligonucleotide, a vector or CRISPR/Cas9 system.
Instant claims encompass administration of a wide range of compounds reducing adipsin activity such as small molecules or nucleic acid-based inhibitors. Such compounds can include antibodies to adipsin, a variety of small molecule inhibitors and many others. All those compounds have very different chemical structure and mechanisms of their inhibition of adipsin activity.
Instant specification teaches that compounds reducing adipsin activity can be antisense oligonucleotides (see paragraph [0061]), ribozymes (see paragraph [0068]), interfering RNAs (see paragraphs [0073-0075]), CRISPR/Cas9 system (see paragraph [0089]) and adenoviral vectors (see paragraph [0090]). It is noted that all of those compounds are nucleic acid-based inhibitors and there is no description in specification of inhibitors of different chemical structure such as antibodies and small molecules. Further, specification provides only one working example of the method claimed which uses the only adipsin inhibitor, shRNA (see Examples 1 and 5), which is nucleic acid-based inhibitor.
Specification does not describe structure for representative species of Applicant's broadly claimed genus. Thus, their function of disease treatment is either unknown or unpredictable.
The genus of compounds reducing adipsin activity encompasses a large number of unknown structures and one of skilled in the art cannot reliably predict which member of the genus would successfully treat the disease, and which will not.
There is no description of the necessary and sufficient elements of the species encompassed by the breadth of the claims.
The only species described in specification are nucleic acid-based inhibitors. Applicant fails to describe representative members of Applicant's broadly claimed genus.
One of the skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, nucleic acid-based inhibitors are not sufficient to describe the claimed genus. Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, it is not clear that Applicant was in possession of the claimed genus at the time this application was filed.
Claims 1-3, 5-6, 8, 10-15, 17, 19, 24, 27 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 treatment of liver fibrosis by administering RNA interfering oligonucleotide targeting adipsin, does not reasonably provide enablement for treatment of fatty liver disease by administering RNA interfering oligonucleotide targeting adipsin. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The claimed invention is not supported by an enabling disclosure taking into account the Wands factors. In re Wands, 858/F.2d 731, 8 USPQ2d 1400 (Fed. Cir. 1988). In re Wands lists a number of factors for determining whether or not undue experimentation would be required by one skilled in the art to make and/or use the invention. These factors are: the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples of the invention, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability of the art, and the breadth of the claim.
The claims are broadly drawn to methods of treating of fatty liver disease comprising administering compounds reducing adipsin activity, which can be a small molecule, an oligonucleotide, a vector or CRISPR/Cas9 system.
The instantly claimed invention encompasses administrating to a subject a compound reducing adipsin activity in order to treat fatty liver disease.
Instant specification teaches that fatty liver disease is associated with obesity (see paragraph [0008]) and fibrosis (see paragraph [0011]). Working example provides evidence that shRNA targeted to adipsin and administered to animal model of the disease relieves fibrosis associated with the disease (see Example 1).
Prior art by Lucas et al (US 2003/0092620, May 2003, cited from IDS) teaches treatment of metabolic diseases such as obesity (see Abstract) by administering adipsin to a subject (see paragraph [0065, 0072]). Further, Spiegelman et al (US 2020/0093900, March 2020, cited from IDS) teach that animal models lacking adipsin gene have lower inflammation, but high degree of diabetes (see Example 2). Thus, there is unpredictability in treatment of obesity associated with fatty liver disease: instant disclosure teaches alleviation of one of the symptoms of fatty liver disease by inhibiting amount of adipsin in a subject, while prior art teaches that obesity associated with fatty liver disease can be treated by the opposite, administration of adipsin. Also, prior art teaches that decreased level of adipsin leads to diabetes, providing evidence that decreasing level of adipsin can lead to a different metabolic disorder than fatty liver disease.
Instant specification shows alleviation of one of the symptoms of fatty liver disease, but it fails to provide evidence and guidance on actual treatment of the disease as instantly claimed.
The guidance provided in the specification is too broad which fails to address the issue of actual treatment of fatty liver disease.
In the absence of guidance, undue trial and error experimentation would have been required by one skilled in the art at the time invention was made to treat fatty liver disease by administering compounds reducing adipsin activity as instantly claimed. Given the breadth of the claims, unpredictability of the art and lack of guidance of the specification, as discussed above, undue experimentation would be required by one skilled in the art to make and use the claimed invention commensurate in scope with the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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