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 .
1. Formal Matters
Claims 15-18 and 21-32 are pending and are the subject of this Office Action.
2. Specification
The objection has been overcome in view of Applicants’ amendment.
3. Claim Objections
Applicants’ amendments are noted.
4. Claim Rejections - 35 USC § 112(a) – scope of enablement
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.
A. Claims 15-18, 21, 22, 24 and 25 remain rejected for the reasons already of record on page 4 of the Office Action dated 10/28/25. Applicants argue that the term “derivative compounds” is clearly defined and supported in the specification. This argument has been considered, but is not deemed persuasive. While the specification may define the term, it does not provide any guidance or working examples of what changes can be made and which retain the claimed binding characteristics, nor is it predictable what changes can be made. There is no limit to the number of amino acids that can be altered; therefore, the genus is excessively broad given the lack of guidance, working examples and predictability.
B. Claims 26, 29 and 30 remain rejected for the reasons already of record on page 5 of the Office Action dated 10/28/25. Applicants essentially argue that the osteosarcoma and Lyme disease are enabled. However, these two conditions, respectfully, do not define the genus of inflammatory, infectious or autoimmune diseases which can be treated by the claimed monoclonal antibody. However, if Applicants are able to support their conclusion that shifting the balance of IL-1RA/IL-1R to IL-1/IL-1R is desirable, or is expected to be desirable across many disease states, this rejection will be reconsidered. The Examiner cites Arend, who teaches the balance between IL-1 and IL-1Ra in disease; however, various diseases tend toward IL-1, whereas other toward IL-1RA. Again, clarification is requested.
C. The rejection of claim 26 on page 6 of the Office Action dated 10/28/25 has been withdrawn. Applicants do not address the issue regarding the administration of a nucleic acid encoding the antibody for the treatment of any claimed disease. However, the technique is supported, for example, as seen in Yu et al.
5. Claim Rejections - 35 USC § 112(a) – written description
A. Claims 15-18, 21, 22, 24-27 and 29-32 remain rejected for the reasons already of record on page 6 of the Office Action dated 10/28/25. Applicants argue that the specification discloses KD lower than 10-8M as well as how to screen and determining such affinity. These arguments have been considered, but are not deemed persuasive. While screen and determining such affinity is possible, the issue is that antibodies with a KD lower than those recited in the specification are not adequately described. The specification does not provide any guidance regarding the structure required to obtain affinities in the femptomolar range. While the claims are permitted to have some leeway, a lower limit which is commensurate in scope to the disclosed antibodies is required.
B. The rejection regarding “any and all monoclonal antibodies” on page 7 of the Office Action dated 10/28/25 has been withdrawn in view of Applicants’ amendment to limit the claims to all 6 CDRs.
C. The rejection regarding antibodies recognizing epitopes on page 7 of the Office Action dated 10/28/25 has been withdrawn in view of Applicants’ amendment to limit the claims to all 6 CDRs.
D. Claims 15-18, 21,22, 24 and 25 remain rejected for the reasons already of record on page 8 of the Office Action dated 10/28/25. Applicants’ arguments regarding “functional fragments” have been considered, but are not deemed persuasive for the rejection regarding “derivative compounds”, as this genus is larger than and encompasses, “functional fragments”. Applicants argue that the prior art cited by the Examiner actually supports Applicants’ claims since they, collectively, show that alterations can be made to CDRs without abolishing binding affinity. This argument has been considered, but is also not deemed persuasive. While it is clear that some changes may be made to certain CDR residues and may retain function, the issue is that there is no definition of “derivative compounds”, either regarding the number of alterations in the CDRs, or framework regions, or that the derivative has to even be an antibody. As recited, any type of alteration can be performed. This is further supported that the recitation in claim 15 that states “wherein the isolated monoclonal antibody”. This recitation does not state “wherein the isolated monoclonal antibody or derivative compound”. Therefore, this limitation does not provide any structural limitations to the derivative. Furthermore, Applicants argue that the references teach IL-1RA. Given this, it could be argued that no guidance of structure-function can be extrapolated to Applicants’ claimed derivatives. Respectfully, Applicants’ arguments appear to focus on functional fragments which, again, are different than “derivative compounds”.
E. Claims 21 and 22 remain rejected for the reasons already of record on pages 8-10 of the Office Action dated 10/28/25. Applicants’ arguments and the Examiner’s response is the same as seen for paragraph D of this section.
6. 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 15-18, 21, 22, 24 and 25 remain rejected for the reasons already of record on page 11 of the Office Action dated 10/28/25. Applicants argue that the metes and bounds of “derivative compound” is discussed under 35 USC 112(a). This argument is not deemed persuasive for the reasons provided in that section (“derivative compound” vs. “functional fragment”).
7. Conclusion
A. Claims 15-18, 21, 22, 24-27 and 29-32 are not allowable.
B. Claims 23 and 28 are objected to since they depend from rejected claims.
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 extension fee 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.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is (571)272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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, Joanne Hama, can be reached at (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
Prosecution Insights