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
Applicant’s election without traverse of Group II, claims 14-26, in the reply filed on 10/30/2025 is acknowledged. Election of species of casein kinase I isoform delta is acknowledged.
Claims 1, 3-7, 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
Claim Objections
Claim 14 is objected to because of the following informalities: Claims recites “A method for the treatment of hepatitis B or hepatitis D infection comprising administering to a subject in need of treatment an effective amount of a pharmaceutically acceptable small molecule inhibiting the activity of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1.” Such wording implies that one small molecule targets all three of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1. Instant disclosure does not teach such small molecule, while teaching small molecules targeting each of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1 separately: see, for example, Abstract. 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 14-15, 17, 21-22, 24-26 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 hepatitis B or D by administering small molecules inhibiting the activity of one of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1.
Instant claims encompass a broad genus of small molecules inhibiting activity of any of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1.
Instant specification does not provide a clear definition of small molecules inhibiting activity of any of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1. The only examples of such small molecules are antisense oligonucleotides, siRNAs or guide RNAs (see paragraphs [0016-0018]). There are no other examples of what such small molecule can be and there is no definition of how small the molecule has to be.
Specification does not describe structure for representative species of Applicant’s broadly claimed genus. Thus their function of inhibiting casein kinase 1 isoform delta, DNAJB12, or microtubule-actin crosslinking factor 1 is either unknown or unpredictable.
The genus encompasses a large number of unknown structures and one of skilled in the art cannot reliably predict which member of the genus would successfully inhibit casein kinase 1 isoform delta, DNAJB12, or microtubule-actin crosslinking factor 1, 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 antisense oligonucleotides, siRNAs or guide RNAs. 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, antisense oligonucleotides, siRNAs or guide RNAs 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 14-18 and 20-26 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 hepatitis B and D by administering siRNAs of SEQ ID NOs: 5, 6, 10, 12, 13, 17, does not reasonably provide enablement for treatment of hepatitis B and D by administering any other possible small molecules. 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.
Claims are broadly drawn to methods of treatment hepatitis B or D by administering small molecules inhibiting the activity of one of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1, such small molecules can be siRNAs of SEQ ID NOs: 5, 6, 10, 12, 13, 17.
Instant claims encompass treatment of hepatitis B and D by administering wide genus of possible small molecules inhibiting activity of one of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1.
Instant specification, however, provides evidence of hepatitis treatment using only one type of small molecule, siRNA, with specific sequences (see Figure 3, Example II). There is no evidence of using any other small molecules for inhibition of casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1 for treatment of hepatitis B and D. Specification does not provide any examples of using any small molecules in vivo.
It is well known in the art that different inhibitors use very different mechanisms for carrying out their effects. Thus, it is not known that even structurally similar antisense oligonucleotides of the same sequence as antisense strand of siRNAs will be effective in inhibiting the same target, because antisense oligonucleotides and siRNAs use different mechanisms for their activity. Further, there is evidence in the art that siRNAs can be effective in vivo, while antisense oligonucleotides are not: see, for example, Abstract of Bertrand et al (Biochemical and Biophysical Research Communications, 2002, vol.296, issue 4, pages 1000-1004).
The guidance provided in the specification (see paragraphs [0044-0046]) is too vague describing only structures of possible small molecules, which fails to address the issue of actual activity of such inhibitors in hepatitis treatment.
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 administer any possible small molecule targeting casein kinase 1 isoform delta, DNAJB12, and microtubule-actin crosslinking factor 1 for treatment of hepatitis B and D 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.
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 16-17, 21 and 24-25 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 16 recites the limitation "the oligonucleotide" in the first line. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination it will be considered that claim 16 depends on claim 15, but appropriate correction is required.
Claim 17 recites the limitation "said composition" in the first line. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "said oligonucleotide" in the first line. There is insufficient antecedent basis for this limitation in the claim.
Claim 24 recites the limitation "said oligonucleotide" in the first line. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "said oligonucleotide" in the first line. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 16 originally depends on claim 14 and adds limitation that the oligonucleotide is complementary to mRNA of casein kinase 1 isoform delta, DnaJB12, casein kinase 1 isoform alpha, coatomer subunit epsilon, transducin beta-like protein 2, or microtubule-actin crosslinking factor 1. Such limitation recites targets from claim 14, but also targets not present in claim 14 such as casein kinase 1 isoform alpha, coatomer subunit epsilon, transducin beta-like protein 2. Therefore, claim 16 widens scope of claim 14 instead of limiting it.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claim 19 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 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