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 .
Status of Claims
Applicant’s amendment filed on /30/2025 is acknowledged. Following the amendment, claims 1 and 7 are currently amended. Claims 13-17 are canceled. Claims 1-12 are currently pending and under examination.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see pg. 4, filed 11/21/2025, with respect to claims 1-17 have been fully considered and are persuasive. The rejection of 05/21/2025 is withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s amendment filed 11/21/2025.
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 1-12 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention. This is a written description rejection for the introduction of NEW MATTER into the claims.
The specification and the claims as originally filed do not provide support for the method of claims 1 and 7 including the step of “…analyzing phosphorylation of CD6 receptor of the CD6-ALCAM complex in the host cell, thereby showing a reduction of phosphorylation of CD6 receptor of the CD6-ALCAM complex…”. Applicant cites page 13, lines 20-21 of the specification in support of the new limitations.
Page 13, lines 20-21 disclose:
“…Phosphorylation of receptors is controlled by expression of phosphatases. SHP1 and SHP2 are key phosphatases known to be associated with receptor proteins and control their phosphorylation thereby modulating signal transduction. The association and phosphorylation of these proteins with immunoprecipitated CD6 was investigated in itolizumab-mediated inhibition.…”.
The specification originally filed has support for phosphorylation detection using Western blot with two antibodies. However, analyzing phosphorylation is broader than the phosphorylation detection using Western blot disclosed in the specification. Analyzing phosphorylation can be done with other methods such as Elisa, Mass Spectroscopy, and FACS as discussed in Dephoure et al.
Therefore, newly added limitation “analyzing” is considered f NEW MATTER.
Priority
For the purposes of claim priority, amended claims 1 and 7 are given priority filing date of 06/15/2023, the effective filing date of the current application, due to the introduction of NEW MATTER that does not have support in its parent application.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pg. 5, filed 11/21/2025, with respect to the rejection of claims 1-17 under 35 U.S.C. 102(a)(1) as being anticipated by Rodriguez et al have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s amendment of claims 1 and 7.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rodriguez et al. (2012, cited on pg. 23 of IDS filed 12/18/2023) in view of U.S. Patent Application Publication 20190345247 (2019, cited on pg. 3 of IDS filed 12/18/2023).
Rodriguez et al. teach the administration of itolizumab to human subjects (see particularly, page 205, 2.1 Study design and endpoints). Itolizumab is the antibody of SEQ ID NOs:1 and 2. Note that the claims recite only a method of “contacting a host cell” with the antibody of the claims; administration of the antibody of the claims to a patient meets said limitation. The mechanisms of action recited in the claims are inherent properties to the antibody of the claims and add no patentable weight to the claimed method.
The reference differs from the claimed invention only in that it does not teach:
“…analyzing phosphorylation of CD6 receptor of the CD6-ALCAM complex in the host cell, thereby showing a reduction of phosphorylation of CD6 receptor of the CD6-ALCAM complex.”
The ‘247 application teaches that CD6 is hyperphosphorylated during T cell activation (see particularly paragraph [0008].
Given the combined teachings of the references it would have been prima facie obvious to the ordinarily skilled artisan at the time of filing to analyze the phosphorylation of CD6 in the subjects of Rodriguez et al. by simply observing their progress. That is if the subject improves then T cells were not activated and T cell CD6 was obviously not hyperphosphorylated as taught by the ‘247 application. Regarding claim 7, the same logic applies; the analysis is performed by observing the subject.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Applicant’s arguments, see pgs. 5-6, filed 11/21/2025, with respect to the rejection of claims 1-17 on the ground of nonstatutory double patenting over listed patent publications have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Applicant’s amendment of claims 1 and 7.
1. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-12, 15, 17-20, and 22-25 of U.S. Patent No. 11981743 (’743). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims encompass the administration of the antibody of the claims, e.g., itolizumab, to a subject thereby “contacting a host cell” with the antibody of the claims. Regarding the new “analyzing” limitations, the ‘247 application (cited above) teaches that CD6 is hyperphosphorylated during T cell activation (see particularly paragraph [0008]. Accordingly, it would have been prima facie obvious to the ordinarily skilled artisan at the time of filing to analyze the phosphorylation of CD6 in the subjects of ‘743 patent by simply observing their progress. That is if the subject improves then T cells were not activated and T cell CD6 was obviously not hyperphosphorylated as taught by the ‘247 application.
2. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11028168 for the same reasons listed above.
3. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9670285 for the same reasons listed above.
4. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10189899 for the same reasons listed above.
5. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 8524233 for the same reasons listed above.
6. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10000573 for the same reasons listed above.
7. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 9217037 (‘737) in view of Rodriguez et al. (cited above). Patent ‘737 teaches a pharmaceutical composition comprising itolizumab that effectively treats a disorder selected from a group consisting of multiple sclerosis, transplant rejection, rheumatoid arthritis, and psoriasis. This composition is also capable of eliciting an anti-inflammatory immune response selected from a group comprising Glutamic acid decarboxylase (GAD) and Heat Shock Protein 60 (HSP60), Myelin Basic Protein (MBP) and Myelin oligodendrocyte glycoprotein (MOG). However, patent ‘737 does not teach the method of “contacting a host cell” as recited in claim 1 of instant application. Rodriguez, as discussed above, addresses this deficiency by teaching the administration of itolizumab to human subjects and thereby meeting limitation of contacting host cell (see particularly, page 205, 2.1 Study design and endpoints). In addition, the ‘247 application teaches that CD6 is hyperphosphorylated during T cell activation (see particularly paragraph [0008]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the itlolizumab composition known from patent ‘737 and combine it with the teachings of Rodriguez to administer said composition to human subjects for the treatment of various disorders and analyze the phosphorylation of CD6 in the subjects of Rodriguez et al. by simply observing their progress. That is if the subject improves then T cells were not activated and T cell CD6 was obviously not hyperphosphorylated as taught by the ‘247 application. Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
8. Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10669346 in view of Rodriguez et al. (cited above) for the same reasons discussed above.
9. Claim 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 15-22 of copending Application No. 17/559,382 (reference application) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
10. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/630,519 (reference application) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
11. Claims 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17, and 22-24 of copending Application No. 17/916,910 (reference application) for the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/MISOOK YU/ Supervisory Patent Examiner, Art Unit 1641
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