DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's amendment and remarks filed on 07/13/2026 are acknowledged.
Claims 1-2, 6, 16, 19, 21-23, 29, 31, 34, 39 and 41-45 are pending
Claims 34 and 41 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected Inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction requirement in the reply filed on 01/12/2026.
Claims 1-2, 6, 16, 19, 21-23, 29, 31, 39 and 42-45 are presently under consideration.
3. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1-2, 19, 21-23, 31, 39, 42 and 44 stand rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Morris et al. (US 20160368980, of record).
The grounds of rejection presented in section 9 of the previous Office action are maintained for the reasons of record as they apply to the amended claims.
Applicant’s arguments have been fully considered but have not been found convincing.
Applicant argues that “[t]he mere reference to the term "CSL324" is not an enabling disclosure of the claimed antibody as there is no sequence information or other identifying information provided. Notwithstanding the above, there is still no disclosure in Morris of an anti-G-CSFR antibody with the VH and VL regions defined by the amended claims, or a formulation comprising the same with the claimed combination of excipients.”
This is unpersuasive, because the amino acid sequences of the VH and VL regions are inherent properties of antibody CSL324, regardless of whether these sequences are disclosed in the prior art reference.
Therefore, the rejection is maintained, and is incorporated by reference herein as if reiterated in full.
5. Copending application USSN 17/299590 (published as US 20220220209) shares a coinventor and/or an assignee with the present application, and claims a method of treatment comprising administering the same anti-G-CSFR antibody as recited in the present claims, but does not contain currently pending claims which would anticipate or make obvious the presently claimed formulation.
6. Claims 6, 16, 29, 43 and 45 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all relevant limitations of the base claim and any intervening claims.
7. 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.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ILIA I OUSPENSKI whose telephone number is (571)272-2920. The examiner can normally be reached 9 AM - 5:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
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