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 election of Group I (claims 1, 3, 4 and 6-16, wherein the ACAT inhibitor is a small molecule) in the reply filed on 6/25/2025 is acknowledged.
Applicants’ following species elections in the reply filed on 6/25/2025 are acknowledged:
a) In claim 4, the applicant elected HBV genotype C.
b) In claims 7 and 8, the applicant elected claim 7a), exhibits direct anti-viral activity.
c) In claims 9-11, the applicant elected claim 9 and that the ACAT inhibitor reduces the HBV load.
d) In claim 13, the applicant elected avasimibe.
e) In claims 15 and 16, the applicant elected claim 15 and that at least one further pharmaceutically active agent is TCR-gene-engineered cells.
Furthermore, Applicants amendment of claims 1, 3, 6, 9 and 14-16 is acknowledged.
Applicant’s withdrawing of claims 10-11 is acknowledged.
There are no new claims. Claims 1-25 are cancelled.
Claims 1, 3, 4 and 6, 8, 9 and 12-16 are under consideration in this office action and will be examined on the merits.
Status of Claims
Claims 1, 3, 4 and 6, 8, 9 and 12-16 are pending. Applicants amended claims 1, 3, 6, 9 and 14-16. Claims 2, 5, 7 and 17-25 are cancelled. Claims 10 and 11 are withdrawn.
Claims 1, 3, 4, 6, 8, 9, and 12-16 are under consideration in the instant office action.
Claim Rejections - 35 USC § 112(b)
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, 3, 4, 6, 8, 9 and 12-16 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.
Claims 1 and 3 are indefinite, because they are unclear and confusing. The claims recite that the mode of action is that the ACAT inhibitor, avasimibe, inhibits the HBV by direct anti-viral activity. The reference, Schmidt et al. (Oral Presentation PS-115, "Rescuing hepatitis- B-specific T cell responses by modulating cholesterol metabolism," Journal of Hepatology 68: S62, 2018) discloses that avasimibe improves the effector function of T cells (CD8+ T cells) in vivo and in vitro by promoting plasma membrane and lipid raft cholesterol accumulation, which results in improved TCR (T cell receptor) clustering and signaling. In this increased effector function, the binding to HBV dextramers is increased. See p. S62, left col.
The reference discloses claim 8, part (c), that the T cell immunity (immune system function) against HBV is increased. As a result, it is unclear and cannot be determined how the mode of action is that avasimibe has direct anti-viral activity against HBV. Clarification and appropriate corrections are required.
Furthermore, regarding claim 1 (line 3) and in claim 3 (line 2) the phrase "effective amount" renders the claim indefinite, because PHOSITA could not determine specific values for the amount based on the disclosure. See MPEP § 2173.05(c)(III). There is no guidance in the specification as to which dose(s) would be appropriate for which hepatitis B infection genotype. Consequently, what is an “effective amount” in the context of the claimed method is ambiguous and cannot be ascertained reasonably by PHOSITA.
The remaining claims are rejected for depending on a rejected claim and not resolving the aforementioned ambiguity.
Claim Rejections - 35 USC § 112(d)
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 8 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 8 recites “c) enhances T cell immunity to HBV” and therefore it does not further limit claim 1. Applicants 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.
Response to Arguments
The Remarks of August 1, 2025, have been fully considered but are not fully persuasive for the reasons below.
Applicants’ Argument:
Applicant argues in substance that
A) the special technical feature which links the claimed subject-matter is treating chronic HBV infection and not ACAT inhibitor, and
B) claim 7 (now incorporated into claim 1 is not indefinite as the term “direct antiviral activity” is clear.
Examiner’s Response:
In response to A, the examiner respectfully disagrees.
The requirement of unity of invention is not fulfilled because there is no technical relationship among these inventions involving one or more of the same or corresponding special technical features. Specifically, the technical feature cannot be applicant’s asserted treatment of chronic HBV. Although claim 1 is directed towards chronic HBV, independent claim 3 is not directed towards chronic HBV. Other, withdrawn and subsequently canceled claims are directed towards a therapeutic HBV vaccine composition (claim 17) that do not make mention of chronic HBV. Thus, the basis of applicant’s arguments is not accurate because it would cause lack of unity within restricted groups as well as between the restricted groups. Examiner therefore maintains the position of that the special technical feature that links the 8 groups of inventions is a composition comprising a compound/molecule/structure that inhibits ACAT. With respect to applicant’s assertion of Schmidt not teaching each and every one of the many recited features, examiner maintains that the ACAT inhibitor avasimibe does disclose the special technical feature and is thus not novel regardless of the delivery mechanism of the claims. Therefore, the restriction requirement was deemed and remains proper and is made FINAL.
In response to B, the examiner respectfully disagrees.
In support of their assertions, applicant further state that the term “direct antiviral activity” has a well-known meaning in the art. Applicants then provide an excerpt from paragraph 0082 of the instant specification. It should be noted that this excerpt does not provide a definition of the term direct. The term direct coupled with a generic term such as activity is unreasonably broad and indefinite. In addition, the examiner maintains that the term “direct antiviral activity” is inconsistent with the original position that the mode of action for avasimibe, which applicant elected, is unclear and cannot be determined. Therefore, the rejection is maintained. It should also be noted that although applicants have canceled claim 7, they have incorporated it into claim 1 in the alternate language. With applicant’s election of claim 7a (see page 8 of applicant’s remarks on 6/25/2025), claim 8 fails to further narrow independent claim 1 as now presented.
Conclusion
Claims 1, 3, 4, 6, 8, 9, and 12-16 are rejected.
No claims are allowed. 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 SAHAR INAM whose telephone number is (571)272-0821. The examiner can normally be reached 7:30 am-5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAHAR INAM/
Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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