RESPONSE TO APPLICANT’S AMENDMENT
1. Applicant's amendment, filed 03/25/2026, is acknowledged.
2. Claims 9, 14, 17, 21, 29, 35, 38-40 are pending.
3. Claims 14, 17, 35 and 38-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
4. The claim amendment, filed 03/25/2026, is objected because the status of the claims is incorrect. For example, the status of claims 14, 17, 35 and 38-40 are not indicated as withdrawn. Correction is required.
5. Claims 9, 21 and 29 are under examination as they read on an anti-CD163 antibody and the species of the antibody comprising 1. SEQ ID NOs: 9-12 (claim 9A, clone 47 (#19), 3E11); 2. SEQ ID NOs: 1-4 (claim 9B, clone 49 (#18), VHH 3E01); 3. SEQ ID NOs: 17-20 (claim 9C, clone 48(#20), 3H11); 4. SEQ ID NOs: 83-86 (claim 21A, clone 57 (#11), 2B06); 5. SEQ ID NOs: 91-94 (claim 21B, clone 41, #12, 2C07); and 6. SEQ ID NOs: 107-110 (claim 21D, clone 29, #17, 3D03).
6. The following new ground of rejection is necessitated by the amendment submitted 03/25/2026.
7. The following is a quotation of 35 U.S.C. 112(a) (Pre-AIA 35 U.S.C. 112, first paragraph):
(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.
8. Claims 9, 21 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the anti-porcine CD163 VHH antibodies comprising the CDR1-3 of SEQ ID NO: 1-4, 9-12, 17-20, 83-86, 91-94, 107-110, does not reasonably provide enablement for intended use of the anti-porcine CD163 antibodies as suitable for a method of treatment or prevention of PRRS virus infection in a pig. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The intended use of the claimed antibodies is at issue. At issue is whether or not the claimed anti-porcine CD163 antibodies would function as “suitable for a method of treatment or prevention of PRRS virus infection in a pig”. The specification discloses the in vitro inhibition of porcine respiratory and reproductive (PRRS) virus infection of primary porcine alveolar macrophage cells by candidate CD163-specific candidate antibodies (see Example 3). The data show that VHH able to inhibit productive infection of porcine alveolar macrophage cells by both PRRS Type 1 (Fig. 1) and Type 2 (Fig. 2) isotypes. The VHH showing activity in the infection assays could be divided into those that were effective against both Type 1 and Type 2 virus infection (VHH’s 001, 002, 008, 015, 016, 018, 019, 020, and 023), and those which did not show any inhibitory activity against Type 1 PRRS virus infection, but which showed selective inhibitory activity against Type 2 PRRS virus infection (VHHs 011, 012, 014, 017). The data clearly show VHH able to inhibit productive infection of porcine alveolar macrophage cells by both PRRS Type 1 & 2 isotypes [0505]. Some VHH only showed inhibitory activity in the Type 2 virus infection (VHH’s 011, 012, 014, 017) across a concentration range up to 300 µg/mL (FIG. 2). These candidate VHH showed specificity for PRRS Type 2 virus and did not show any inhibitory activity in a Type 1 virus infection assay across a similar dose response concentration range up to 100 µg/mL (FIG. 3) [0505].
Furthermore, regarding in vivo methods which rely on generally unpredictable mechanisms, ''The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 166 USPQ 18 indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. Since no animals were used as model for treating or preventing PRRS virus infection in a pig. It is not clear that reliance on the in vitro data of inhibitory activity against Type 1 and Tye 2 PRRS virus infection accurately reflects the relative pig efficacy of the claimed therapeutic strategy. The specification does not adequately teach how to effectively treat or preventing PRRS virus infection in a pig or reach any therapeutic endpoint in mammals by administrating the therapeutic composition. The specification does not teach how to extrapolate data obtained from an in vitro assay studies to the development of effective in vivo pig therapeutic treatment, commensurate in scope with the claimed invention. Therefore, it is not clear that the skilled artisan could predict the efficacy of the therapeutic package exemplified in the specification.
Because any treatment/prevention using any anti-CD163 antibody that inhibit PRRRS virus infection of primary porcine alveolar macrophage cells is not yet known and has not yet been disclosed, therefore, the method is only potential because it is not currently available in practical form. Therefore, the disclosure of mechanisms inhibiting PRRRS virus infection of primary porcine alveolar macrophage cells does not provide sufficient guidance to a method of PRRS virus infection treatment or prevention in vivo.
However, in view of the lack of predictability of the art to which the invention pertains the lack of established clinical protocols for effective anti-CD163 antibody-based therapies, undue experimentation would be required to practice the claimed methods with a reasonable expectation of success, absent a specific and detailed description in applicant’s specification of how to effectively practice the claimed methods and absent working examples providing evidence which is reasonably predictive that the claimed methods are effective for treating or preventing PRRS virus infection in pigs.
Results obtained under in vitro controlled conditions often differ from the clinical response obtained in pigs.
The burden of enabling the prevention of a disease (i.e. the need for additional testing) would be greater than that of enabling a treatment due to the need to screen those pigs susceptible to such diseases and the difficulty of proof that the administration of the drug was the agent that acted to prevent the condition. Further, the specification does not provide guidance as to how one skilled in the art would go about screening those pigs susceptible to PRRS virus infection within the scope of the presently claimed invention. Nor is sufficient guidance provided as to a specific protocol to be utilized in order to prove the efficacy of the presently claimed anti-CD163 antibody in preventing PRRS virus infection state.
Reasonable correlation must exist between the scope of the claims and scope of the enablement set forth. In view on the quantity of experimentation necessary the limited working examples, the nature of the invention, the state of the prior art, the unpredictability of the art and the breadth of the claims, it would take undue trials and errors to practice the claimed invention.
9. 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.
10. Claims 9, 21 and 29 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19119956 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of `956 application are directed to anti-porcine CD163 VHH antibody of SEQ ID NO: 9/25 comprising claimed SEQ ID NOs: 9-12.
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Db 1 QVQLQESGGGLVQVGSSLRLSCVTSGRTPSRYVMGWFRQAPGQEREFVAAISWSGRAPYA 60
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Db 61 DSVKGRFTISRDNAKNTVYLQMNSLKPEDTGVYYCAGGEGAIKWTTLDAYDYWGQGTQVT 120
Qy 121 VSS 123
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Db 121 VSS 123
Anti-porcine CD163 VHH antibody of SEQ ID NO:17/33 comprising claimed SEQ ID NOs: 107-110.
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Db 1 QLQLVESGGGLVQPGGSLRLSCAASGFTLDDYTIGWFRQAPGKEREGVSCINSITSNTYY 60
Qy 61 ADSVKGRFTISRDNAKNTVYLQMNSLTAEDTAIYYCAADSGLFSGSSCLKYRAMRFGSWG 120
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Db 61 ADSVKGRFTISRDNAKNTVYLQMNSLTAEDTAIYYCAADSGLFSGSSCLKYRAMRFGSWG 120
Qy 121 QGTQVTVSS 129
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Db 121 QGTQVTVSS 129
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments, filed 03/25/2026, have been fully considered, but have not been found convincing.
Applicant submits that the office action provisionally rejects claims for alleged double patenting over co-pending application number US 19/119,956. The present application has an effective filing date of December 24, 2020, whereas the cited application has a later effective filing date of October 11, 2023. The applicant respectfully disagrees, and requests withdrawal of this rejection pursuant to MPEP § 804(I)(B)(1)(b)(i):
If a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earliest effective U.S. filing date (taking into account any benefit under 35 U.S.C. 120, 121, 365(c), or 386(c)) with respect to the conflicting claims) compared to the reference application(s), the examiner should withdraw the rejection in the application having the earliest effective U.S. filing date and permit that application to issue as a patent, thereby converting the 'provisional' nonstatutory double patenting rejection in the other application(s) into a nonstatutory double patenting rejection when the application with the earliest U.S. effective filing date issues as a patent.
The effective filing date of the present application under 35 U.S.C. §§ 120 and 365(c) is December 24, 2020, while the earliest effective filing date of the reference application is October 11, 2023, later than the effective filing date of the present application.
This is not found persuasive because the NS-ODP is not the only rejection remaining in the application. The NS-ODP rejection will be withdrawn once the enablement rejection is resolved.
Applicant further argues that the P.T.A.B. has repeatedly held that a non-statutory double patenting rejection is improper under these circumstances. A patent granted on the present application would expire before a patent granted on any of the reference applications (notwithstanding any patent term extension or patent term adjustment that such a patent may be entitled to). The Board recently issued two decisions under circumstances identical in material respects to the present case and reversed the examiner's rejections. See Ex Parte Mates et al., No. APPEAL 2025-001500, 2025 WL 3923902, at * 1 (P.T.A.B. Dec. 22, 2025) ("Mates I") and Ex Parte Mates et al., No. APPEAL 2025-001506, 2025 WL 3923952 (P.T.A.B. Dec. 22, 2025) ("Mates II").
The examiner is referred to the reasoning articulated in Mates I at *5-*8 and Mates II at
*5-*8. There, an examiner had provisionally rejected claims in applications over co-pending applications with later effective filing dates, such that a patent issuing on the application under appeal would expire before patents granted on the reference, co-pending applications (notwithstanding any possible patent term adjustment or extension). The Board therefore held that the co-pending applications were not citable for obviousness-type double patenting rejections against the application on appeal. Id. The Board, following Gilead Sciences, Inc., v. Natco Pharma Ltd, 753 F.3d 1208 (Fed. Cir. 2014), agreed that under such circumstances allowing the applications under consideration could not result in extension of patent term requiring the filing of a terminal disclaimer in the earlier-filed application.
The Board further rejected the examiner's argument that, notwithstanding the fact that the reference applications were filed after the rejected applications, obviousness-type double patent rejections were warranted to prevent "harassment" by different patent owners, stating:
(Ans. 20-21.) We do not agree. MPEP § 804.02 IV states that "jf multiple conflicting patents and/or pending applications are applied in nonstatutory double patenting rejections made in a single application, then prior to issuance of that application, it is necessary to disclaim the terminal part of any patent granted on the application which would extend beyond the expiration date of each one of the conflicting patents and/or applications." MPEP § 804.02 IV. This section of the MPEP does not contemplate what "conflicting patents and/or pending applications" are. It is true that this section of the MPEP indicates that the terminal disclaimer must include each of the commonly owned conflicting nonstatutory double patenting references to avoid the problem of dual ownership. Id. However, it should not be read to stand for the fact that preventing dual ownership alone is justification for applying a commonly owned application or patent as a reference against application claims, just that when an ODP rejection is properly made, a terminal disclaimer is only effective when it includes each of the commonly owned conflicting nonstatutory double patenting references.
Moreover, MPEP § 804.02 VI also does not provide for preventing harassment by common owners of patents or patent applications as a basis for obviousness-type double patenting. Rather, it states that harassment is one of two reasons "for insisting upon a terminal disclaimer to overcome a nonstatutory double patenting rejection. "MPEP § 804.02 VI (emphasis added). In other words, a nonstatutory double patenting rejection must have a proper reference patent applied in the first instance, and then to overcome the rejection, the terminal disclaimer for that properly applied commonly owned reference patent has to have a statement that "any patent granted on the application being examined will be enforceable only for and during the period that it and the reference patentor any patent granted on the reference application are commonly owned." I. As MPEP § 804.02 VI explains, by including such a phrase, the terminal disclaimer prevents harassment for a patent that was properly subject to nonstatutory double patenting.
The Board therefore reversed the examiner's provisional obviousness-type double patenting rejections. The exact analysis pertains in the present case, where the reference application was filed after the currently rejected application. In view of the foregoing amendments and remarks, this provisional non-statutory double patenting rejection is the only remaining rejection in the current application. Just as in Mates I and II, where the Board held that a pending application cannot be subject to a provisional double-patenting rejection over a co- pending application with a later effective filing date, the double patenting rejections should be withdrawn here.
This is not found persuasive because neither Mates I and II are not currently a precedential Board decision and is therefore not binding on USPTO Examiners. Importantly, 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.
11. No claim is allowed.
12. 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 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 date of this final action.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER M HADDAD whose telephone number is (571)272-0845. The examiner can normally be reached on Monday-Friday from7:00AM to 4:30PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu, can be reached at telephone number 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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April 8, 2026
/MAHER M HADDAD/ Primary Examiner, Art Unit 1644