DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 12/19/25 has been entered.
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The amendment of 12/19/25 has been entered in full. New claim 50 is added.
Claims 31-40 and 42-50 are pending and under consideration.
Information Disclosure Statement
The Information Disclosure Statement of 1/29/26 has been considered.
Withdrawn Rejections
The provisional rejection of dependent claims 38, 40, 42 and 48 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of co-pending patent application 18/715,320, filed 5/31/24, is withdrawn on further consideration that the embodiments recited in these dependent claims are not expressly recited in the pending claims of the ‘320 application.
Maintained Objections and/or Rejections
Double Patenting
The nonstatutory double (NSDP) 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 NSDP 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 (TD) in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on NSDP 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 TD must be signed in compliance with 37 CFR 1.321(b).
The filing of a TD by itself is not a complete reply to a NSDP rejection. A complete reply requires that the TD 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 TD 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 (eTD) may be filled out completely online using web-screens. An eTD that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTDs, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Note: In view of the request for continued examination (RCE), the rejections previously numbered (2)-(4) have been renumbered as (1)-(3).
(1) Claims 31-50 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,613,571, issued 3/28/23 (cited previously), and which includes the same six inventors and applicant as the instant application. This rejection was set forth previously and maintained at pages 2-5 of 10/1/25 Office action. New claim 50 is herewith added to the rejection.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of the ‘571 patent are directed to a composition comprising the same antigen binding protein (ABP) used in the methods of the instant claims. Specifically, the composition of claim 1 of ‘571 includes a “first antibody” comprising heavy chain amino acid sequence of SEQ ID NO: 1 and a light chain amino acid sequence of SEQ ID NO: 2. These are the sequences are the same as the heavy and light chain amino acid sequences of SEQ ID NO: 1 and 2 recited in instant dependent claim 42, and thus are also encompassed by independent claim 31 and dependent claims 38-40 and 47-49, as well as independent claims 43-46 and 50. The further limitation of instant dependent claim 47 that requires to composition to also include a pharmaceutically acceptable carrier corresponds to dependent claim 14 of ’571, which also requires the composition to include a pharmaceutically acceptable carrier.
Thus, the claims of the ‘571 patent are directed a product comprising the product used in the methods of the instant claims, but differ in that they claim the product per se rather than a method of use of the product. Per MPEP 804.II.B.2, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
The portion of the specification of the ‘571 patent informing the claimed invention indicates that the antibody comprising SEQ ID NO: 1 and 2, which is termed 28Y042-7F11-1 (the same name used in the instant application), is useful for treating a subject having a condition selected from a group (col 3, lines 7-14) that is identical to that recited in instant claim 31. This group includes each of the individual diseases that are also recited in independent claims 43-46 and 50, including nasal polyposis (claim 43), HES (claim 44), EGPA (claim 45), COPD (claim 46) and severe asthma (claim 50). Thus, the instant claims are directed to the disclosed utility for a product of an issued patent, analogous to the fact pattern in Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC (2003), and thus the claims of the instant application are not patentably distinct from those of the '571 patent.
(2) Claims 31-50 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 18 of co-pending patent application 18/258,588, filed 6/21/23, and which includes the same applicant as the instant application. This rejection was set forth previously and maintained at pages 2-5 of 10/1/25 Office action. New claim 50 is herewith added to the rejection.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of the ‘588 application were most recently amended on 6/21/23.
Claim 18 of ‘588 is directed to a method of treating an IL-5 mediated disease comprising administering to the subject a pharmaceutical composition comprising from about 100 to 300 mg of an antigen binding protein that binds IL-5 and comprising the HCDR1-3 of SEQ ID NO: 5-7 and the LCDR1-3 of SEQ ID NO: 8-10, and further comprising heavy chain Fc domain having a tyrosine residue at position 252, a threonine at position 254 and a glutamic acid residue at position 256, and where the composition is administered about once every 6 months. This is a narrower embodiment of instant claim 39, depending from claim 31, except that the disease is not further specified as in in the instant claims. However, the portion of the specification informing the claimed invention of ‘588 further indicates that that antibody is for treatment of disease including those recited in claim 31; see page 5, line 28 through page 6, line 2. This group includes each of the individual diseases that are also recited in independent claims 43-46 and 50, including nasal polyposis (claim 43), HES (claim 44), EGPA (claim 45), COPD (claim 46) and severe asthma (claim 50). Per MPEP 804.II.B.2, “In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).”
As such, claim 18 of ‘588 is properly construed in view of the disclosure as having disclosed utility in treatment of such diseases, and as such, instant claims 31 and 39, as well as instant claims 32-37, 43-46 and 50 (each reciting specific diseases), are not patentably distinct from claim 18 of ‘588.
The further limitations of instant claims 38, 40, 42 and 47 also correspond to preferred embodiments of the administered antigen binding protein of the claims of ‘588, as evidenced by claims 1, 3, 5 and 6 of ‘588, which include these limitations. Thus, claim 18 of ‘588 properly construed as encompassing these further dependent limitations, and thus instant claims 38, 40, 42 and 47 are not patentably distinct from claim 18 of ‘588.
Instant claim 48 further limits the method to subcutaneous or intravenous administration. Claim 18 of ‘588 does not specify a route of administration, but such is a preferred embodiment of the method of treatment of the claims of ‘588, as evidenced by claim 7 of ‘588, which indicates that the composition is formulated for subcutaneous administration. As such, claim 18 is properly construed, as part of the disclosed utility, as encompassing such administration, and claim 48 is also not patentably distinct from claim 18 of ‘588.
Instant claim 49 further encompasses administration once every 6 months, which is also part of claim 18 of ‘588, and thus instant claim 49 is also not patentably distinct.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
(3) Claims 31, 34-36, 39, 43-45, 47 and 49 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21-29 of co-pending patent application 18/715,320, filed 5/31/24, and which includes the same applicant as the instant application. This rejection was set forth previously and maintained at pages 2-5 of 10/1/25 Office action. The cited claim numbers (claims 21-28) of ‘320 are herewith corrected.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
The claims of the ‘320 application were most recently amended on 5/31/24.
Claims 21 and 28 of ‘320 are directed to a method of treating an IL-5 mediated disease selected from EGPA (eosinophilic granulomatosis with polyangiitis), HES (hypereosinophilic syndrome), CRSsNP or CRSwNP (nasal polyposis) comprising administering to the subject a pharmaceutical composition comprising from about 100 to 300 mg of an antigen binding protein that binds IL-5 and comprising the HCDR1-3 of SEQ ID NO: 5-7 and the LCDR1-3 of SEQ ID NO: 8-10, and further comprising heavy chain Fc domain having a tyrosine residue at position 252, a threonine at position 254 and a glutamic acid residue at position 256, and where the composition is administered about once every 6 months. This is a narrower embodiment of instant claim 39, which depends from claim 31. It also meets the limitations of dependent claims 34-36, and independent claims 43-45, directed to treatment of EGPA, HES, or NP. As such, instant claims 31, 34-36, 39, and 43-45 are not patentably distinct from the claims of ‘320.
Instant claim 47 further encompasses a method of claim 31 wherein the antigen binding protein is in a pharmaceutical composition comprising the antigen binding protein and a pharmaceutically acceptable carrier. In ‘320, claim 29 is directed to a product claim comprising same product administered in claim 21, but also includes a pharmaceutically acceptable excipient, which is encompassed by the term carrier as recited in instant claim 47. As such, it would have been obvious, when practicing the method of claim 21 of ‘320, to include further include the antigen binding protein with such an excipient, which would meet the further limitations of claim 47.
Instant claim 49 further encompasses administration once every 6 months, which is also part of claim 1 of ‘320, and thus instant claim 49 is also not patentably distinct.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claim 48 is provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21-29 of co-pending patent application 18/715,320, filed 5/31/24, and which includes the same applicant as the instant application, and further in view of “Mepolizumab”, ADIS R&D Profile, Drugs R D 2008, 9(2):125-130, no author listed.
Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons.
Claim 48 encompasses a method of claim 31 wherein the antigen binding protein is administered subcutaneously or intravenously. The claims of ‘320, while meeting the limitations of parent claim 31 for the reasons set forth above, do not expressly recite a route of administration for the administered antigen binding protein binding to IL-5.
“Mepolizumab” teaches that “Mepolizumab is an anti-interleukin-5 monoclonal antibody that is in clinical trials with GlaxoSmithKline (GSK) for the treatment of severe asthma, nasal polyposis and hypereosinophilic syndrome and eosinophilic esophagitis” (page 125). “Mepolizumab” further teaches that the antibody can be administered intravenously (page 126).
It would have been obvious to the person of ordinary skill in the art to take the method of claims 21-28 of ‘320 and to modify it to administer the antibody that binds to IL-5 intravenously as taught by “Mepolizumab”. The person of ordinary skill in the art would have been motivated to make such a change because the claims of ‘320 indicate administration of the antibody, but do not specify a route of administration, and “Mepolizumab” provides the missing information on how to administer an antibody. The person of ordinary skill in the art would have had a reasonable expectation of success because the teachings of “Mepolizumab” are directed to administration of the same structural type of molecule (antibody) directed to the same target protein (IL-5) for use in treatment of the same type of diseases (e.g., hypereosinophilic syndrome). This rationale supports a prima facie conclusion of obviousness in accord with KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (2007).
Applicants’ arguments (12/19/25; pages 6-11) as they pertain to the above rejections have been fully considered but are not deemed to be persuasive for the following reasons.
At pages 6-9, Applicants respond to the rejection of the claims over the claims of the ‘517 patent. Applicants first point to two Federal Circuit case decisions, Allergan (2024) and Cellect (2023), providing a quote from each. These quotations are acknowledged, but Applicants merely present them without advancing any arguments as to why the quoted subject matter overcomes the NSDP rejection, and as such they are not sufficient to overcome the rejection.
Applicants then point to Ex parte Baurin, a PTAB Decision issued on Nov 6. 2024, as holding that “a later-filed, later expiring patent cannot serve as a reference patent to an earlier-filed earlier expiring patent that is not in the same family” in a NSDP rejection (page 6). Applicants further point to the decision being affirmed by the PTAB in 2025 following a request for rehearing. With respect to the instant application, Applicants then assert that (1) the “patent term filing date” (as defined in MPEP 804), or PTFD, of the instant application is 5/24/18, whereas the PTFD of ‘571 is 5/21/19; and (2) the two patents are in different patent families as neither claims priority to each other (page 8). Relying on the decision in Ex parte Baurin, Applicants then argue that “the ‘571 patent is not a proper ODP reference at least because the ‘571 patent expires later than the patent that would issue from the current application, and because the instant application is not later-filed compared to the ‘571 patent” (page 8).
These arguments have been fully considered but are not found persuasive. While it is acknowledged that the PTFD of the ‘571 application is later than that of the instant application, and that the two patents are in different families, these facts are not sufficient to overcome the NSDP rejection. The PTAB decision of Ex Parte Baurin has not been made precedential, and is not the only PTAB decision addressing this fact pattern. Ex parte Baumeister, Appeal No. 2026-000193 (11/21/25), relies on In re Fallaux, 564, F.3d 1313, 1316 (Fed Cir. 2009), and comes to a different conclusion, affirming the NSDP rejections of an application with an earlier PTFD over reference patents with later PTFDs. Specifically, in Baumeister, the decision at pages 7-8 states:
“In Fallaux, the examiner rejected the pending claims in the Fallaux
application for obviousness-type double patenting over certain claims of two
reference patents. 564 F.3d at 1314-15. The Fallaux family of applications
originated in a PCT application filed in June 1995. Id. at 1315. The first U.S.
application in the family was filed in March 1997. Id. The Fallaux
application was the fifth continuation application, claiming priority to
the 1997 application. Id. The reference patents were filed in June 1998 and
July 1999, respectively, and issued in July 2002 and January 2002,
respectively. Id. Our predecessor, The Board of Patent Appeals and
Interferences, affirmed the examiner's rejection. Id. at 1314-15. And the
Federal Circuit affirmed the Board's decision. Id. at 1319.
Like this case, the reference patents in Fallaux, have later patent term
filing dates compared to the application under examination. Because they are
post-URAA patents, they would expire twenty years from the patent term
filing dates. See Allergan, 111 F.4th at 1367 (explaining that post-URAA, "a
patent's term is now measured from its effective filing, or priority, date").
The application under examination was also filed post-URAA, and thus, any
patent issued from the application would expire before the reference patents
expired. Yet, the Federal Circuit upheld the Board's decision, affirming the
NSDP rejection of the pending claims over the reference patents with later
patent term filing dates and later expiration dates because "there is a second
justification for obviousness-type double patenting-harassment by multiple
assignees." Fallaux:, 564 F.3d at 1318. As explained below, that justification
remains relevant to the instant facts.
Fallaux remains good law. Indeed, the Federal Circuit cited Fallaux
as recent as in Allergan. See Allergan, 111 F.4th at 1367 (citing Fallaux,
564 F.3d at 1318). Thus, under Fallaux, which is binding on us, we are not
persuaded by Appellant's argument that the reference patents do not qualify
as NSDP references because they each have a later patent term filing date
compared to the instant application and expires later than any patent issuing
from the instant application.”
Thus, for the same reasons as given in Baumeister, citing Fallaux, Applicant’s argument here that the “‘571 patent is not a proper ODP reference” is not found to be persuasive.
At pages 8-9, Applicants further dispute that the rejection is proper due to the instant applicant having the same six inventors and applicant as the instant application, pointing to Ex Parte Baurin Appeal Decision at page 23 as holding that “[w]hile there may a policy concern of risk of separate ownership underlying the non-alienation provision for terminal disclaimers, no court has held that risk of common ownership is a sole justification for upholding an ODP rejection that is not based on a proper reference patent”.
This argument has been fully considered but are not found persuasive. First, it is maintained that the reference is a proper reference patent for the reasons set forth above. Again, Baumeister addresses this issue and comes to a different conclusion, as stated in the excerpts quoted above. Baumeister further addressed this at page 16:
“In Fallaux, the Federal Circuit relied on a different 'justification for
obviousness-type double patenting-harassment by multiple assignees" in
upholding the Board's decision affirming the NSDP rejection.
564 F.3d at 1319. The court later applied the multiple-assignee-harassment
rationale again. See Hubbell, 709 F.3d 1147-48 ("Because it is undisputed
that an infringer of the [reference] patent would also infringe the ...
application [under examination], the multiple assignee harassment
justification adopted in Van Ornum and reaffirmed in Fallaux applies
here."); see also Cellect, 81 F.4th at 1230 (concluding "the Board did not err
in determining that a risk of separate ownership existed and, even in the
absence of separate ownership, that a terminal disclaimer would have been
required to ensure common ownership" and stating "[w]hile [the patent
owner] has not engaged in actions that resulted in divided ownership in the
past, and it has promised that it will not do so in the future, neither fact
suffices to abrogate the potential future risk of multiple owners or
assignees").
Under the Federal Circuit precedent, the Examiner did not err in
stating that under the guidance under MPEP § 804.02(VI), "it is appropriate
for an examiner to require a terminal disclaimer that will address the risk of
separate ownership even where it is possible that there would be no
unjustified timewise extension of the right to exclude." Ans. 18.
Thus, for the same reasons given in Baumeister, Applicant’s argument here that the NSDP patent rejection is not proper based on common ownership is not found to be persuasive.
At pages 9-10 and 10-11, Applicants provide arguments against the provisional’ NSDP rejections of the claims over the claims of each of the ‘588 (pages 9-10) and ‘320 (pages 10-11) applications. These arguments are the same as those advanced against the rejection of the claims over the claims of the ‘571 patent. While it is acknowledged that the ‘558 and ‘320 applications have patent term filing dates that are later than that of the instant application, and belong to different patent families, the argument that each is not a proper reference for a NSDP rejection is not found to be persuasive for the same reasons as set forth above for the ‘571 patent.
Notes
No prior art has been identified that teaches or suggests the administered antigen binding protein of the claimed methods, which comprises a heavy chain variable region having CDHR1-3 of SEQ ID NO: 5-7 and a light chain variable region having CDLR1-3 of SEQ ID NO: 8-10.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674