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’s election without traverse of Group I, a method of treating pancreatic cancer, Species A-C, Enlimomab with a valine-citrulline linker and monomethyl auristatin E (MMAE), in the reply filed on 22 August 2025 is acknowledged (see Response to Restriction received 08/22/2025 pg. 1 last para-pg. 2, 4th para). Upon further consideration the species election set forth in the Restriction mailed 24 April 2025 of Species A (i.e., a single and specific ICAM1 antigen binding domain) and B (i.e., a single and specific drug conjugated to ICAM1) are hereby withdrawn.
Status of the Claims
Claims 1-34 were originally filed 22 February 2022. The preliminary amendment filed 1 August 2022 has been entered. Claims 9, 17, 18, 20-22, 24-26, 29, 31, and 33 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (see claims 9 and 17, i.e., non-elected linker) or group (see claims 18, 20-22, 24-26, 29, 31, and 33), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 22 August 2025.
Claims 1, 2, 4-6, 11, 13, and 15 are currently under consideration.
Withdrawn Claim Rejections
In view of Applicant amending claim 1 to clarify the subject has cancer the 35 USC 112(a) rejection is hereby withdrawn.
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.
Claim 11 is 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.
Claim 11 contains the trademark/trade name “affibody” (line 3; see Affibody™ Resource).
Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an antibody structure and, accordingly, the identification/description is indefinite.
Applicant's arguments filed 13 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant has amended the claim to recite, “®” in reference to Affibody. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). Therefore, for the reasons made of record the 35 USC 112(b) rejection is hereby maintained.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 11, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Marsha (see US Patent Publication 2020/0085972 A1).
The applied reference has a common Applicant and common inventors (i.e., Marsha Moses, Peng Guo) with the instant application. Based upon the earlier effectively filed date of the reference (i.e., 16 March 2018), it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicant's arguments filed 13 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant has argued an ICAM-1 antibody or antigen binding domain conjugated to a liposome is outside the scope of an antibody drug conjugate (ADC). Applicant specifically points to the specification’s definition of an ADC and para [0050] and [0081] (see Remarks pg. 7, middle para; see specification pg. 16, 2nd para). Applicant’s arguments are an incomplete characterization of the specification. First, the specification discloses,
“In some embodiments, the ICAM1 antibody and the drug is conjugated via a linker” (see specification pg. 2 line 6, emphasis added), and
“An ICAM1 antibody may be conjugated to a second entity either directly or via a linker. As used herein, "conjugated" or "attached" means two entities are associated, preferably with sufficient affinity that the therapeutic or diagnostic benefit of the association between the two entities is realized” (see specification pg. 16, 2nd para, emphasis added).
Thus, the specification discloses the antibody can be conjugated directly or via a linker to a second entity, not that the antibody has to be conjugated in such a manner. Furthermore, the specification specifies “conjugated” or “attached” means two entities are “associated” wherein associated is broader than requiring a physical connection (i.e., directly or indirectly linked). It is noted the specification as submitted does not have numbered paragraphs and therefore it is unclear if Applicant is pointing to alternative support.
Therefore, for the reasons made of record the 35 USC 102 rejection is hereby maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 4-6, 11, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2016/0207949 (referred to herein as Zhao as cited on the IDS received 08/01/2025, US Patent Documents 1st reference) and Caliera (as cited on the PTO-892 mailed 11/14/2025) as evidenced by Creative Biolabs (as cited on the PTO-892 mailed 11/14/2025).
Applicant's arguments filed 13 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
First, Applicant argues Zhao does not provide a reason to conjugate the Enlimomab specifically to the disclosed PBD derivatives (see Remarks pg. 8, 2nd para). Pursuant to MPEP § 2123(I), 2nd para, A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005). The reference discloses conjugating the improved PBD derivatives to Enlimomab. In addition the reference discloses using the ADCs to target cancers where the target antigen is over expressed and specifically names pancreatic cancer a type of cancer to be treated.
Second, Applicant argues elevated ICAM-1 mRNA does not correlate with increased cell surface expression of ICAM-1 and therefore does not provide motivation to target ICAM using an ADC (see Remarks pg. 8, last 2 para). However, Caliera discloses ICAM-1 is a cell surface glycoprotein important for cell-to-cell and cell-to extracellular matrix interactions (see Caliera Abstract, Background and Objectives). Caliera in addition to mRNA levels used immunohistochemistry to identify changes in ICAM-1 expression in normal versus pancreatic cancer (see Caliera pg. 95 para spanning cols 1-2). In normal pancreas, acinar cells, ductal cells, and Langerhans islet exhibited no immunoreactivity for ICAM-1 (see Caliera pg. 96, 1st col. last para, pg. 97 Fig. 2A). While most pancreatic cancer cells exhibited intense immunoreactivity for ICAM-1 (see Caliera pg. 96, 2nd col, 1st full para, pg. 97 Figure 2B). Caliera specifically discloses,
“Our present data demonstrate that many pancreatic adenocarcinomas show enhanced expression of ICAM-1 and VCAM-1 mRNA but not of ELAM-1 mRNA. Enhanced expression at the protein level was confirmed by increased ICAM-1 and VCAM-1 immunoreactivity in the cancer samples compared with the normal controls” (see Caliera pg. 98, 1st col. 4th para).
The ordinary artisan would know ICAM-1 could be sufficiently targeted in pancreatic cancer given Caliera discloses ICAM-1 is a known cell surface molecule an exhibits an increase in both mRNA and protein expression in pancreatic cancer versus normal tissue.
Therefore, the 35 USC 103 rejection set forth above is hereby maintained.
Claims 1, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (see PTO-892 mailed 11/14/2025) and Brooks (see Brooks et al. as cited on the IDS received 22 January 2024) as evidenced by Abcam (see PTO-892 mailed 11/14/2025) and Coleman (see PTO-892 mailed 11/14/2025).
Applicant's arguments filed 13 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
First, Applicant is arguing PMO nanoparticle conjugated to an ICAM1 antibody is not within the scope of claim one because the PMA nanoparticles are not attached directly or indirectly via a linker to the ICAM1 antibody. However, Wang teaches the ICAM-1 antibody is “attached” to the PMO nanoparticles; therefore, is within the scope of two entities that are associated preferably with sufficient affinity that the therapeutic benefit of the association between the two entities is realized (see specification pg. 16, 2nd para). Wang does disclose an ICAM-1 antibody “conjugated” to a therapeutic drug.
Therefore, for the reasons set forth above the 35 USC 103 rejection above is hereby maintained.
Claims 2, 4-6, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wang and Brooks in further view of Newman and Cragg (see PTO-892 mailed 11/14/2025) as evidenced by Abcam and Coleman.
Applicant's arguments filed 13 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant refers to argument made regarding the independent claims (see Remarks pg. 11, 1st full para).
Thus, for the reasons set forth above the 35 USC 103 rejection is hereby maintained.
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.
Claim 1, 11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S. Patent No. 11260132 B2 (referred to herein as ‘132 patent) in view of Brooks as evidenced by Cohenuram and Saif (see Cohenuram and Saif (2007) Epidermal growth factor receptor inhibition strategies in pancreatic cancer: past, present and the future. JOP. J Pancreas; 8(1): 4-15).
Applicant's arguments filed 13 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
First, Applicant argues the ‘132 patent is drawn to a structure not within the scope of the instant claims (i.e., a liposome conjugated to an ICAM-1 antibody) (see Remarks pg. 10, 2nd para). Second, Applicant argues the remaining references (i.e., Brooks, Cohenuram, and Saif) do not overcome this deficiency (see Remarks pg. 10, 3rd para). However, for the reasons stated above a liposome conjugated to an ICAM-1 antibody is within the scope of the instant claims (see above (i.e., 35 USC 102 rejection)).
The ‘132 patent claims an EGFR and ICAM1 antibody conjugated to a liposome comprising a therapeutic agent (see ‘132 claim 1) and a method of treating TNBC by administering said product (see ‘132 claim 15).
Therefore, the above non-statutory double patenting rejection above is hereby maintained.
Claims 1, 2, 4-6, 11, 13, and 15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10, 12, 14, and 25 of copending Application No. 18/278394 (referred to herein as ‘394 application) in view of Brooks.
Applicant's arguments filed 13 February 2026 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant has argued this is the only remaining rejection and therefore should be withdrawn pursuant to MPEP § 804(I)(B)(1)(b)(i) (see Remarks pg. 10, last para). However, this is not the only outstanding rejection and therefore is hereby maintained.
Conclusion
No claim allowed.
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 HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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/H.A.P./Examiner, Art Unit 1644
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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