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 .
Status of Application, Amendments and/or Claims
The amendment and Applicant's arguments, filed 13 February 2026, have been entered in full. Claims 1-69, 71-73, 82-89 are canceled. Claim 70 is amended.
Claims 70, 74-81 are under examination.
Information Disclosure Statement
The information disclosure statement(s) (IDS) (filed 13 February 2026) was received and complies with the provisions of 37 CFR §§1.97, 1.98 and MPEP § 609. It has been placed in the application file and the information referred to therein has been considered as to the merits.
Withdrawn Objections And/Or Rejections
The rejection to claim 70 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth at page 3 of the previous Office Action (15 October 2025), is withdrawn in view of the amendment (13 February 2026).
The rejection to claims 82, 83, 87-89 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 8,734,789 in view of Demore et al. (US 2014/0294848; published October 2, 2014) and Paoluzzi et al. (Response to anti-PD1 therapy with nivolumab in metastatic sarcomas. Clin Sarcoma Res 6:24, 2016), as set forth at pages 10-16 of the previous Office Action (15 October 2025), is withdrawn in view of the amendment (13 February 2026).
The rejection to claims 82, 83, 87-89 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9,073,982 in view of Demore et al. (US 2011/0142820; published June 16, 2011) and Paoluzzi et al. (Response to anti-PD1 therapy with nivolumab in metastatic sarcomas. Clin Sarcoma Res 6:24, 2016), as set forth at pages 16-19 of the previous Office Action (15 October 2025), is withdrawn in view of the amendment (13 February 2026).
The rejection to claims 82, 83, 87-89 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,873,333 in view of Demore et al. (US 2011/0142820; published June 16, 2011) and Paoluzzi et al. (Response to anti-PD1 therapy with nivolumab in metastatic sarcomas. Clin Sarcoma Res 6:24, 2016), as set forth at pages 19-22 of the previous Office Action (15 October 2025), is withdrawn in view of the amendment (13 February 2026).
Claim Rejections - 35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), First paragraph, Written description
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 70, 74-81 remain 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
The basis for this rejection is set forth at pages 3-10 of the previous Office Action (15 October 2025).
APPLICANT’S ARGUMENTS: Applicant submits that the claims are method claims reciting a genus of known antibodies and that the genus is well known in the art. Applicant cites case law (Erfindergemeinschaft UroPep GbR v. Eli Lilly & Co. 276 F. Supp. 3d 629, 648 E.D. Tex. 2017 "UroPep" and Merck Sharp & Dohme Corp. v. Genentech, Inc., PGR2021-00039, Paper P.T.A.B. July 24, 2021 "Merck").
Applicant argues that In UroPep, the court held that a method of treatment claim reciting a genus of known compounds (PDE5 inhibitors) was not invalid based on written description because "when a genus is well understood in the art and not itself the invention but is instead a component of the claim, background knowledge may provide the necessary support for the claim" 276 F. Supp. 3d at 648. Applicant argues that in UroPep, the applicant provided documents showing that PDE5 inhibitors, including tadalafil, were known at the time of the invention. The court noted that patentees were not required to include those compounds in the disclosure, "and in fact the law makes it clear that it is preferable that they not do so." Id. at 650; see also In re Herschler, 591 F.2d 693, 701 (CCPA 1979) (finding disclosure of only a single example of steroidal agent sufficient because the claim was drawn to the method of administering the steroidal agent, and numerous active steroidal agents were known to persons of skill in the art).
Applicant argues that similarly, in Merck, the board did not invalidate claims reciting a method of treatment using two genera of compounds that each perform a particular function. In Merck, the challenged claims were directed to a method of treating cancer by administering a combination therapy comprising (i) an antagonist of TIGIT and (ii) a PD-L1 binding antagonist a PD-L2 binding antagonist, or a PD-1 binding antagonist. Id. The Petition argued that the claims lacked written description for the recited genus of TIGIT antagonists and genus of PD-1 antagonists because the specification disclosed "only a single antagonist of TIGIT activity" and "only eight species within the broad genus of PD-1 axis binding antagonists." Id., pages 14-16. Applicant maintains that the board disagreed, explaining that: "Petitioner's focus on the scope of the two compounds used in the claimed methods is incorrect. Patent Owner claims methods of treating cancer or stimulating an immune response utilizing two classes of compounds with established functionality, and is not claiming any new composition." Id., page 17.
Applicant maintains that like UroPep and Merck, the instant claims are directed to a method of treatment utilizing two classes of compounds with established functionality, and are not claiming any new compounds. Applicant argues that like UroPep and Merck, SFRP2 antibodies and PD-1 inhibitors were known at the time of the invention; although the combination of SFRP2 antibodies and PD-1 inhibitors for treating cancer was not. Applicant argues that the Examiner acknowledges that "[t]he instant specification teaches SFRP2 antagonists are disclosed in U.S. Pat. Nos. 8,734,789 and 9,073,982, the contents of which are hereby incorporated by reference." Office Action, p. 4. Applicant argues that these patents describe numerous SFRP2 antibodies, such as antibodies to different peptides of SFRP2 (e.g., "Antibodies to peptide AbA, AbB, AbC, and AbD" as shown in FIG. 22), antibodies with specific heavy chain variable region (SEQ ID NO: 13) and light chain variable regions (SEQ ID NO: 15), and specific isolated monoclonal antibodies produced by hybridoma cell line UNC 68-80 (deposited as ATCC Deposit NO. PTA-11672).
Applicant argues that as in UroPep, which involved claims to a method of treating a disorder (i.e., prostatic hyperplasia) by administering a functionally defined genus of "PDE5 inhibitors", but did not disclose every PDE5 inhibitor known at the time of the invention (nor did it have to); here, pending claim 70 of the subject application recites a method of treatment claim in which a humanized SFRP2 monoclonal antibody is administered, but does not disclose every humanized SFRP2 monoclonal antibody known at the time of the invention.
Applicant argues that as in Merck, where the board found claims directed to a combination therapy comprising two genera of antagonists for the treatment of cancer were not unpatentable for written description; here, pending claim 70 of the subject application is directed to a combination therapy comprising two genera of antagonists for the treatment of cancer should also be found not unpatentable. In fact, pending claim 70 is narrower than the claims in Merck because pending claim 70 recites a specific cancer (e.g., osteosarcoma) and a specific PD-1 antagonist (e.g., nivolumab).
Applicant submits that one skilled in the art would reasonably conclude that the inventors possessed the claimed methods, and requests that that the Examiner reconsider and withdraw the rejection.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. Firstly, the Examiner notes that the previous Office Action stated that the instant specification lacked written description for humanized secreted frizzled related protein 2 (SFRP2) monoclonal antibodies (not the recited PD-1 antagonist nivolumab). The Office Action stated that the claimed method required the use of undisclosed humanized SFRP2 monoclonal antibodies.
2. Regarding Applicant’s argument that the Examiner acknowledges in the previous Office Action that "the instant specification teaches SFRP2 antagonists are disclosed in U.S. Pat. Nos. 8,734,789 and 9,073,982”:
The Examiner directs Applicant’s attention to the previous Office Action at page 4-top of page 5; 10/15/2025, where it states “SFRP2 antagonists are disclosed in U.S. Pat. Nos. 8,734,789, and 9,073,982, the contents of which are hereby incorporated by reference”. “However, it is not clear which antibodies in U.S. Pat. Nos. 8,734,789 or 9,073,982, is the humanized SFRP2 monoclonal antibody (hSFRP2 mAb), that is taught in the specification to have the function of treating osteosarcoma”. “The instant claim encompasses a genus of humanized SFRP2 monoclonal antibodies based entirely on the function of treating osteosarcoma”.
3. Regarding Applicant’s arguments that SFRP2 antibodies were known at the time of the invention; that the patents describe numerous SFRP2 antibodies, such as antibodies to different peptides of SFRP2 (e.g., "Antibodies to peptide AbA, AbB, AbC, and AbD" as shown in FIG. 22), antibodies with specific heavy chain variable region (SEQ ID NO: 13) and light chain variable regions (SEQ ID NO: 15) and specific isolated monoclonal antibodies produced by hybridoma cell line UNC 68-80 (deposited as ATCC Deposit NO. PTA-11672):
Contrary to the presented arguments, U.S. Pat. Nos. 8,734,789 and 9,073,982 fail to teach numerous SFRP2 antibodies, in particular “a genus of humanized SFRP2 monoclonal antibodies” with the “associated function of treating osteosarcoma” in vivo.
The Examiner notes that the brief description for FIG. 22 from U.S. Pat. Nos. 8,734,789 and 9,073,982 teaches: “FIG. 22 shows the inhibitory activity of polyclonal antibodies raised against different epitopes of SFRP2. Sera from mice immunized against peptide sequences from SFRP2 (AbA, AbB, AbC, AbD, AbE) and control sera were used at 1:100 dilution. Antibodies to peptide AbA, AbB, AbC, and AbD all inhibited tube formation, but AbB and AbC had the greatest inhibition”.
The Examiner notes that tube formation assays are an in vitro method used to assess angiogenesis and is not an in vivo assay for osteosarcoma.
The Examiner notes also that antibody E (AbE) was not able to inhibit tube formation in the in vitro assays. This demonstrates that a skilled artisan cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus that exhibit this functional property.
The Examiner notes that only one particular SFRP2 monoclonal antibody was shown to have the function of decreasing tumor growth in an angiosarcoma xenografts animal model and a breast cancer xenografts.
The species of SFRP2 monoclonal antibodies taught in U.S. Pat. Nos. 8,734,789 and 9,073,982 is not tantamount to a “a genus of humanized SFRP2 monoclonal antibodies” with the “associated function of treating osteosarcoma” in vivo.
4. Applicant’s citation of "UroPep" and "Merck" are not applicable to the instant situation.
Numerous SFRP2 monoclonal antibodies were not known to persons of skill in the art, at the time of the invention. At the time of the invention, SFRP2 monoclonal antibodies were not a class of compounds with established functionality.
The Examiner maintains that a skilled artisan cannot visualize or recognize the identity of the members of the genus that exhibit claimed functional property. The level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of the humanized SFRP2 monoclonal antibodies have the claimed activity. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The molecule itself is required. See Fiers V. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016
The scientific reasoning and evidence as a whole indicates that the rejection should be 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.
Claims 70, 74-76 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,258,388 in view of Demore et al. (Reference of record wo 2011/119524; published Sept. 29, 2011) and Buono et al. (ADVANCED ACCELERATOR APPLICATONS, WO 2016/207732; published Dec. 29, 2016).
The basis for this rejection is set forth at pages 22-25 of the previous Office Action (15 October 2025).
APPLICANT’S ARGUMENTS: Applicant cites Ex parte Baurin, Appeal 2024-002920 (November 6, 2024) and Ex parte Mates, Appeal 2025-001500 (December 23, 2025).
Applicant submits that in In Ex parte Baurin, the Patent Trial and Appeal Board reversed an obviousness type double patenting rejection of U.S. Pat. App. No. 17/135,529 ("the '529 application", effectively filed March 28, 2011) over, inter alia, U.S. Pat. No. 10,882,922 ("the '922 patent", effectively filed on April 13, 2016) because: "The application at issue here was filed before the application leading to the '922 patent, and was published well before the earliest effective filing date of the '922 patent." Id. at *5. Applicant submits that the board noted that the '529 application "is not a second, later expiring patent for the same invention as the '922 patent, and as such does not extend a period of exclusivity on the claimed subject matter. Because we conclude that the '922 patent claims cannot serve as reference claims against the claims on appeal, we reverse the Examiner's rejection of claims 1-18 for nonstatutory double patenting as being unpatentable over claims 1-39 of the '922 patent in view of Klein." Id.
Applicant asserts that The Patent Trial and Appeal Board similarly reversed several obviousness type double patenting rejections of U.S. Pat. App. No. 16/926,552 over several later-filed, later-expiring Mates patents Appeal 2025-001500 (December 23, 2025). The PTAB held that the rejections were improper because ODP requires a proper earlier-expiring reference, and issuance of the appealed claims could not result in any unjustified timewise extension of patent term, noting that the appealed application would expire before all the asserted references, each of which had a later effective filing date, and thus a longer statutory term. Applicant argues that this reasoning aligns directly with Baurin and is equally applicable here.
Applicant argues that the present application was filed on March 25, 2021, and has a September 27, 2018, priority date. Applicant argues that the 12,258,388 patent was filed on January 12, 2024 and has a December 11, 2020, priority date. Applicant argues that the present application was filed before the application leading to the 12,258,388 patent. Applicant submits that in Baurin and Mates, the later filed patent(s) could not serve as an ODP reference against the appeal claims because the appealed claims were in an earlier filed application and not a second, later expiring patent. Applicant submits that the 12,258,388 patent is not a proper reference for the purposes of nonstatutory double patenting because the present application was filed before the ‘388 patent and is not a second, later expiring patent.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
The Examiner notes that Applicant’s reliance upon Ex parte Baurin and Ex parte Mates is not controlling in the instant application because Ex parte Baurin and Ex parte Mates have not been published or found to be precedential.
1. Regarding Ex parte Baurin, the Patent Trial and Appeal Board (PTAB) decision, Ex Parte Baurin reversed an Examiner’s rejection for obviousness-type double patenting (ODP) in U.S. Application No. 17/135,529 over the later-filed, later-expiring unrelated U.S. Patent No. 10,882,922. The Appellant argued the later-filed, later-expiring unrelated ’922 patent is not the proper reference patent because it has a later filing date, and expires later. In doing so, the Appellant pointed to the In re Cellect decision which noted that “claims are entitled to their full term, including … duly granted PTA, unless they are found to be later-filed obvious variations of earlier-filed … claims.” Ex parte Mates aligns with Ex parte Baurin,
In the instant case, the later filed claims (i.e. in US Patent 12,258,388) are a clear obvious variation of the earlier-filed claims from the instant application.
2. The Examiner points out that in In Ex parte Baumeister (Appeal 2026‑000193), the PTAB declined to follow the Baurin PTAB’s earlier decision, noting that Baurin is nonprecedential and, at the time, remained subject to a pending rehearing request with no final resolution. The Baumeister PTAB expressly refused to consider Baurin when evaluating whether later‑filed, later‑expiring patents could serve as ODP references. Instead, the Baumeister PTAB applied In re Fallaux, 564 F.3d 1313 (Fed. Cir. 2009) and reaffirmed that ODP rejections may rely on commonly owned patents even when those patents have later effective filing dates and later expiration dates. This approach contrasts with the reasoning in Baurin, where the PTAB treated Fallaux as not controlling and instead, as discussed above, relied on the Federal Circuit’s modern ODP framework, concluding that later‑filed, later‑expiring patents claiming patentably distinct inventions cannot serve as proper ODP references. An appeal to the Federal Circuit was recently filed in Baumeister.
3. Lastly, the Examiner acknowledges that the instant application has an actual filing date of 25 March 2021, with an effective filing date of 27 September 2018.
However, even if the instant application under examination has the earlier patent term filing date, only a one-way determination of distinctness is needed to support a double patenting rejection in the absence of a finding: (A) that "the PTO is solely responsible for any delays" in prosecution of that application (In re Hubbell, 709 F.3d 1140, 1150, 106 USPQ2d 1032, 1039 (Fed. Cir. 2013); and (B) that the applicant could not have filed the conflicting claims in a single (i.e., the earlier-filed) application (In re Kaplan, 789 F.2d 1574, 229 USPQ 678 (Fed. Cir. 1986)). Both specifications of the instant application and ‘388 disclose overlapping teachings and Applicant has not provided evidence that both embodiments could not have been filed together. Therefore, a one-way determination of distinctness is appropriate.
The Examiner directs Applicant’s attention to MPEP 804 II. REQUIREMENTS OF A DOUBLE PATENTING REJECTION (INCLUDING PROVISIONAL REJECTIONS) B. Nonstatutory Double Patenting: section 4 and 5.
A double patenting rejection is to be made in the absence of a finding: (A) that "the PTO is solely responsible for any delays" in prosecution of that application (In re Hubbell, 709 F.3d 1140, 1150, 106 USPQ2d 1032, 1039 (Fed. Cir. 2013)); and (B) that the applicant could not have filed the conflicting claims in a single (i.e., the earlier-filed) application ( In re Kaplan, 789 F.2d 1574, 229 USPQ 678 (Fed. Cir. 1986)). In Kaplan, a generic invention (use of solvents) was invented by Kaplan, and a species thereof (i.e., use of a specific combination of solvents) was invented by Kaplan and Walker. Multiple applications were necessary to claim both the broad and narrow inventions because at the time the applications were filed, 35 U.S.C. 116 did not expressly authorize filing a patent application in the name of joint inventors who did not make a contribution to the invention defined in each claim in the patent. Compare In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998), wherein the genus and species claims could have been filed in the same application.
If a reference patent has a later patent term filing date than the application under examination, the question of whether the timewise extension of the right to exclude granted by a patent is justified or unjustified must be addressed. A two-way test is to be applied only when the applicant could not have filed the claims in a single application and the Office is solely responsible for any delays. In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998) ("The two-way exception can only apply when the applicant could not avoid separate filings, and even then, only if the PTO controlled the rates of prosecution to cause the later filed species claims to issue before the claims for a genus in an earlier application . . . . In Berg’s case, the two applications could have been filed as one, so it is irrelevant to our disposition who actually controlled the respective rates of prosecution." 140 F.3d at 1435, 46 USPQ2d at 1232); In re Hubbell, 709 F.3d 1140, 106 USPQ2d 1032 (Fed. Cir. 2013) ("[P]rosecution choices resulted in the foreseeable consequence that the ′685 patent issued before the application claims on appeal. Given these circumstances, and because it is undisputed that the PTO was not solely responsible for the delay, Hubbell is not entitled to a two-way obviousness analysis." 709 F.3d at 1150, 106 USPQ2d at 1039.); see also In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993) (in a situation where delayed issuance equated to later expiration, applicant’s voluntary decision to obtain early issuance of claims directed to a species and to pursue prosecution of previously rejected genus claims in a continuation is a considered election to postpone by the applicant and not administrative delay). Unless the record clearly shows administrative delay caused solely by the Office and that applicant could not have avoided filing separate applications, the examiner may use the one-way distinctness determination and shift the burden to applicant to show why a two-way distinctness determination is required.
Although a delay in the processing of applications before the Office that causes patents to issue in an order different from the order in which the applications were filed is a factor to be considered in determining whether a one-way or two-way distinctness determination is necessary to support a double patenting rejection, it may be very difficult to assess whether the administrative process is solely responsible for a delay in the issuance of a patent. On the one hand, it is applicant who presents claims for examination and pays the issue fee. On the other hand, the resolution of legitimate differences of opinion in an appeal process or the time spent in an interference proceeding can significantly delay the issuance of a patent. Nevertheless, the reasons for the delay in issuing a patent have been considered in assessing the propriety of a double patenting rejection. Thus, in Pierce v. Allen B. DuMont Laboratories, Inc., 297 F.2d 323, 131 USPQ 340 (3d. Cir. 1961), the court found that administrative delay may justify the extension of patent rights beyond 17 years but "a considered election to postpone acquisition of the broader [patent after the issuance of the later filed application] should not be tolerated." In Pierce, the patentee elected to participate in an interference proceeding [after all claims in the application had been determined to be patentable] whereby the issuance of the broader patent was delayed by more than 7 years after the issuance of the narrower patent. The court determined that the second issued patent was invalid on the ground of double patenting. Similarly, in In re Emert, 124 F.3d 1458, 44 USPQ2d 1149 (Fed. Cir. 1997), the court found that the one-way test is appropriate where applicants, rather than the Office, had significant control over the rate of prosecution of the application at issue. In support of its finding that the applicants were responsible for delaying prosecution of the application during the critical period, the court noted that the applicants had requested and received numerous time extensions in various filings. More importantly, the court noted, after initially receiving an obviousness rejection of all claims, applicants had waited the maximum period to reply (6 months), then abandoned the application in favor of a substantially identical continuation application, then received another obviousness rejection of all claims, again waited the maximum period to reply, and then again abandoned the application in favor of a second continuation application substantially identical to the original filing. On the other hand, in General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 23 USPQ2d 1839 (Fed. Cir. 1992), the court did not hold the patentee accountable for a delay in issuing the first-filed application until after the second-filed application issued as a patent, even where the patentee had intentionally refiled the first-filed application as a continuation-in-part after receiving a Notice of Allowance indicating that all claims presented were patentable. Where, through no fault of the applicant, the claims in a later-filed application issue first, a nonstatutory double patenting rejection is improper, in the absence of a two-way distinctness determination, because the applicant does not have complete control over the rate of progress of a patent application through the Office. In re Braat, 937 F.2d 589, 19 USPQ2d 1289 (Fed. Cir. 1991). While acknowledging that allowance of the claims in the earlier-filed application would result in the timewise extension of an invention claimed in the patent, the court in Braat was of the view that the extension was justified under the circumstances, indicating that a nonstatutory double patenting rejection would be proper only if the claimed inventions were obvious over each other — a two-way distinctness determination.
See, however, In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998), wherein the claims at issue could have been filed in the same application. The Berg court explained, "Braat was an unusual case; moreover, its factual situation is not likely to be repeated since the 1984 Act [amending 35 U.S.C. 116, and permitting joint inventorship even though not all inventors contributed to each claim] went into effect." 140 F.3d at 1433-34, 46 USPQ2d at 1230.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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/R.M.D/Examiner, Art Unit 1647 6/3/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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