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. Claim 63 was inadvertently omitted from the Restriction requirement dated 11/06/2025. To clarify, claim 63, together with claims 53 and 55, is part of Group IV; the corrected Group IV reads as follows:
IV. Claims 53, 55 and 63, drawn to a method of ex vivo killing or depleting CD45- expressing target cells in a tissue or organ for treating or preventing GVHD, comprising contacting said tissue or organ with an antibody of Group I.
3. Applicant’s election of the invention of Group I (claims 1-10, drawn to an antibody comprising at least two different paratopes, each being specific for a different epitope of CD45) in the reply filed on 12/30/2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 16-19, 24-36, 42-45, 50-53, 55 and 57-66 are withdrawn from further consideration by the Examiner under 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1-10 are presently under consideration.
4. 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.
5. Claims 4 and 6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
(i) Claim 4 is indefinite in the use of the term “preferably,” because it is unclear whether or not the preferred embodiments constitute claim limitations. Description of examples or preferences is properly set forth in the specification rather than the claims.
(ii) Claim 6 is indefinite in the recitation of the phrases “for example” and “such as,” because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
In view of the above, a person of ordinary skill in the art cannot unequivocally interpret the metes and bounds of the claims so as to understand how to avoid infringement. Applicant is reminded that any amendment must point to a basis in the specification so as not to add New Matter. See MPEP 714.02 and 2163.06.
6. 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)(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.
7. Claims 1-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Boitano et al. (US 20220267441; see entire document).
Boitano at [0019] teaches an isolated anti-CD45 antibody, or antigen-binding portion thereof specifically binds to:
(a) an epitope of human CD45 located within CD45 Fragment 2, and an epitope of human CD45 located within Fragment 4; or
(b) an epitope of human CD45 located within CD45 Fragment 1, and an epitope of human CD45 located within CD45 Fragment 3.
Accordingly, Boitano teaches an antibody which comprises two different paratopes, each being specific for a different epitope of CD45, which is within the scope of instant claims 1-3.
Since Boitano’s antibody is structurally the same as instantly claimed, it inherently possesses the same functional properties, including those recited in claim 4.
Boitano teaches modifying Fc region (e.g. [0226]), diabody format (e.g. [0221]), humanized antibody (e.g. [0241]), and pharmaceutical compositions (e.g. [0023]), thereby anticipating claims 5-7 and 10. Nucleic acids and vectors encoding an antibody are inherent in teachings of a recombinantly produced antibody, i.e. claims 8 and 9 are anticipated. Accordingly, Boitano teaches all of the limitations of claims 1-10, and as such anticipates the claimed invention.
8. The following prior art references cited of record but not presently relied upon teach biparatopic anti-CD45 antibodies:
US 20220249683 (e.g. [0502]) (cited in the previous office action), and
US 20220202967 (e.g. [0043]).
9. Conclusion: no claim is allowed.
10. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ILIA I OUSPENSKI/ Primary Examiner, Art Unit 1644
Prosecution Insights