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 .
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.
DETAILED ACTION
This action is in response to claim amendments filed 6/2/26. Claims 1, 3, 6, 8, 11, 14-18, 20, 24, and 27-30 are pending.
Previously, all elements of the Restriction requirement had been withdrawn except for the species requirement of the therapeutic as TrkB and the VNAR as VNAR-txp1. As noted below, all prior art rejections have been withdrawn and any pending species have been examined. The withdrawal of the remaining species election arrives at the whole of the Restriction requirement mailed 6/3/25 being withdrawn.
All pending claims are under examination.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
All instant claims now require certain sequences of the VNAR-txp1 construct. These sequences—those of SEQ ID NO: 6—were not disclosed or supported by priority document 62939522 and the priority document does not name VNAR-txp-1. For example, the instant specification references WO2019/089395 and WO2020/056327 at paragraph 16 for certain VNARs; these documents were not referenced in 62/939522 and so these disclosures are not supported in the priority document. The same is true of 63/112314, referenced in paragraph 16, which was filed after the priority document 62/939522 and so could not be supported by ‘522. Applicant is reminded that adding subject matter which was not supported by the priority documents will not afford the claimed priority.
Therefore, all pending claims have an effective filing date of 11/20/2020, which is the PCT where this subject matter was newly added.
Withdrawn Rejections
The claim objections are withdrawn in light of the amendments.
The §112b rejection is withdrawn. Claim 2 has been canceled. Claim 3 no longer recites “variants”. Claim 16 no longer recites “preferably”. Claims 17 and 18 clearly list the options and establish clear antecedent basis.
The §112d rejection is withdrawn; claim 14 now included an additional limitation.
The §112a rejection regarding the structure of the antibody is withdrawn. Applicant has amended the claims to require 100% identity to the disclosed first and third CDRs of a specific VNAR. Applicant also provided evidence (see IDS and arguments) establishing that, unlike traditional antibodies, a VNAR’s specificity is defined only by the first and third CDR. Also, unlike traditional antibodies, the Examiner is not in possession of any objective evidence to the contrary.
The §103 rejection is withdrawn. As noted in the previous action, SEQ ID NO: 6 is allowable over the prior art. All claims are now limited to VNARs comprising the first and third CDR of SEQ ID NO: 6, which shares the same facts as set forth in the “Allowable subject matter” section of the previous office action mailed 2/2/26.
The double patenting rejection over US12351642 is withdrawn; the claimed amino acid sequences are not the same as those instantly claimed. For example, reference sequences 18, 7, 22, or 34 do not contain the Val-Val dipeptide sequence present in the instantly claimed CDR3.
The double patenting rejection over US11097010 is withdrawn; the claimed amino acid sequences are not the same as those instantly claimed. Reference claim 1 includes the CDR1 having the sequence DSNCALS (SEQ ID NO: 104), which is identical to the instant residues excepting that the instant sequence contains an additional S. However, reference claim 1 also claims that CDR1 is immediately followed by FW2. As such, the specification may be inspected to determine what support the reference document contains for this claim element. Table 1 teaches the first residue of FW2 is S; see #4 which is the first entry containing reference SEQ ID NO: 104 and is immediately followed by a serine residue. Thus, while not referring to this “S” as part of CDR1, it nevertheless discloses a sequence which is structurally identical and so must have the same properties. However, the same is not true of CDR3. The reference claims certain sequences for CDR3 but the instant sequence does not fall within those claimed sequences either explicitly or inherently.
The double patenting rejection over US 11766482 is withdrawn; the claimed sequences of ‘482 are the same as those of ‘010 above and so do not encompass the instant sequences for the same reasons.
The double patenting rejection over co-pending application 18684463 is withdrawn. The reference application has an effective filing date of 11/9/2021, which is later filed than the instant 11/20/20. As a provisional nonstatutory double patenting rejection is the only remaining rejection, the rejection over the later filed application is withdrawn (MPEP §804).
The double patenting rejection over co-pending application 18977734 is withdrawn. The reference application has an effective filing date of 11/9/2021, which is later filed than the instant 11/20/20. As a provisional nonstatutory double patenting rejection is the only remaining rejection, the rejection over the later filed application is withdrawn (MPEP §804).
Maintained Rejections and New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
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 15-17 and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The 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.
Claim 15 recites the genus of “a condition which responds to activation of a neurotrophin receptor”. This is not an established or well-known genus of conditions. Other than the name of the genus, there is no disclosed shared characteristic which would define which conditions are members of this genus and the specification does not appear to disclose any species to represent this genus. Given the evidence of record and taking the disclosure into account, the skilled artisan could not immediately envisage which conditions are members of the claimed genus and which are not.
Therefore, claims 15-17 and 20 do not meet the written description requirement. Note that claim 18 is not included in this rejection as the disease being treated is a neurodegenerative disease or condition, which are well-established in the art.
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 1, 3, 6, 8, 11, 14-18, 20, 24, and 27-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12187805 in view of Lerner and Mi. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Instant claim 1 is a conjugate of a VNAR which passes the BBB and a TrkB agonist antibody defined by a particular formula and two CDRs of SEQ ID NO: 6. The reference document claims the VNAR has the sequence of SEQ ID NO: 5 (claim 4), which is 100% identical to instant SEQ ID NO: 6 (newly added instant claim 30). The reference document claims such conjugated variants, e.g., claim 1, 2, 5, 8, 9, 10, including the same formula and the same sequences for the CDRs (claim 1) but differs in that the reference claims do not specify the therapeutic is a TrkB agonist antibody nor specifically 29D7. Nevertheless, this would have been an obvious variation. The reference claims explicitly state that the VNAR transports across the BBB and may be operably linked to a heterologous molecule such as a therapeutic. Reference claim 16 claims treatment of a CNS disease. One of ordinary skill in the art would have found it obvious to choose a particular therapeutic for transport within this generic genus. Lerner provides the teachings and motivations to select a TrkB agonist antibody as the therapeutic and Mi teaches 29D7 is such an antibody. Lerner teaches the TrkB agonist antibody to treat Alzheimer’s disease (paragraph 79), which is a CNS disease. It would have been obvious to use the conjugate as described above to treat Alzheimer’s because the therapeutic of Lerner is a known therapeutic for Alzheimer’s that needs to reach the brain and the VNAR of the reference claims delivers that therapeutic to the brain. As Alzheimer’s disease is listed in instant claim 18, which depends from claim 15, Alzheimer’s disease must also meet the limitations of the treated disease in claim 15.
While Lerner would have made obvious a TrkB agonist antibody, Lerner does not teach that this antibody is 29d7.
Nevertheless, selecting 29d7 as the antibody would have been obvious. Given the teachings above, one would have found it obvious to select a known TrkB agonist antibody, in particular one which demonstrates benefits to CNS neurons and is taught as treating Alzheimer’s disease for the reasons described above. Mi teaches 29D7 is a TrkB agonist antibody (paragraph 142) and teaches administering the antibody to a subject with Alzheimer’s disease (claim 106) to promote neuronal survival (claim 6). This provides a reasonable expectation that the specific TrkB agonist antibody 29D7 will accomplish the therapeutic effects desired by administering a TrkB agonist antibody as described by Lerner.
Note that this rejection has been modified solely due to Applicant’s amendments. The information regarding Lerner and Mi, previously incorporated from the previous rejections, has been added due to those rejections being withdrawn. However, the art and reasoning remain the same except where deviating based on Applicant’s amendments.
Claims 1, 3, 6, 8, 11, 14-18, 20, 24, and 27-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-12, 20-27, and 34-36 of copending Application No. 18684463 in view of Lerner and Mi.
Instant claim 1 is a conjugate of a VNAR which passes the BBB and a TrkB agonist antibody, defined by a particular formula and two CDRs of SEQ ID NO: 6. The reference document claims such sequence. Claim 27 claims the same formula, while the claims also disclose the same CDRs (reference claim 20. While the identity of CDR3 is not claimed, the reference specification may be inspected to determine support for the genus of possible CDR3 sequences supporting this claim element. The specification discloses, e.g., SEQ ID NO: 7, which is 100% identical to instant SEQ ID NO: 6 and contains the same CDRs. Notably, the sequence of reference claim 34 and 20 (which depends on claim 34) also arrive at a sequence which is the same as instant SEQ ID NO: 6 but for the lack of an explicit claiming of the CDR3 sequence, supporting the use of the specification to determine the obvious variants within the scope of the reference claims.
“The specification can be used as a dictionary to learn the meaning of a term in the patent claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999)(‘[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning.’); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) (‘Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings.’). See also MPEP § 2111.01. Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
The reference claims differ in that the reference claims do not specify the therapeutic is a TrkB agonist antibody nor specifically 29D7. Nevertheless, this would have been an obvious variation.
While the reference claims do not claim a method of treatment, where the reference claims are to a composition (such as claim 34), the specification may be reviewed for the disclosed uses of that composition. See the decisions in Sun Pharmaceuticals v Eli Lily Fed Cir July 28, 2010; Geneva v GlaxoSmithKline 349, F.3d 1373; and Pfizer v Teva 518 F3d 1353 supporting the Office’s use of disclosed utilities of compositions when applying double patenting rejections to method claims. Further, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1)
The VNAR polypeptide conjugated to a therapeutic antibody (reference claim 10) is disclosed as passing the blood brain barrier to deliver a therapeutic to the brain (abstract). The specification also supports that the claimed sequences in, e.g., reference claim 34, meet the limitations of the instantly amended claim. One of ordinary skill in the art would have found it obvious to choose a particular therapeutic for transport within this genus. Lerner provides the teachings and motivations to select a TrkB agonist antibody as the therapeutic and Mi teaches 29D7 is such an antibody as described above and incorporated herein.
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, 6, 8, 11, 14-18, 20, 24, and 27-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18977734 in view of Lerner and Mi.
Instant claim 1 is a conjugate of a VNAR which passes the BBB and a TrkB agonist antibody, defined by a particular formula and two CDRs of SEQ ID NO: 6. The reference document claims the same formula and sequences. The reference document claims the VNAR has the sequence of SEQ ID NO: 5 (claim 4), which is 100% identical to instant SEQ ID NO: 6 (newly added instant claim 30). The reference differs in that the reference claims do not specify the therapeutic is a TrkB agonist antibody nor specifically 29D7. Nevertheless, this would have been an obvious variation.
The VNAR polypeptide conjugated to a therapeutic antibody (reference claim 1) is claimed as passing the blood brain barrier to deliver a therapeutic to the brain (reference claim 6). One of ordinary skill in the art would have found it obvious to choose a particular therapeutic for transport within this genus. Lerner provides the teachings and motivations to select a TrkB agonist antibody as the therapeutic and Mi teaches 29D7 is such an antibody as described above and incorporated herein.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
See previous office action mailed 2/2/26. As noted in the specification, the first disclosure of SEQ ID NO: 6 appears to be the unpublished US application 63/112314, which is not a valid prior art document. This sequence is disclosed in US 20250122298, WO2024107749, and WO2022103769, but these documents also do not qualify as prior art under either §102a1 or §102a2 in light of the effective filing date of 11/20/2020. As noted previously, the VNAR is an antibody, where it is well-established that the sequence of such an antibody is unpredictable. A search of the specific sequences now claimed did not discover any art which predates the instant effective filing date of 11/20/2020.
Response to Arguments
Applicant's arguments filed 6/2/26 have been fully considered but they are not persuasive.
Regarding the written description rejection, Applicant argues that incorporation of two of the sequences of the allowable construct overcome the written description rejection. While this is true of the rejection regarding the structure of the VNAR, this does not address the portion of the rejection regarding the genus of “a condition which responds to activation of a neurotrophin receptor”. The structure of the VNAR does not inform the artisan of which conditions are within this genus and so does not point to any specific deficiency in the rejection. It is appreciated that Applicant has amended claims 15-17 to recite “said neurodegenerative disease or condition”, similar to claim 18. However, claim 18 makes clear that the neurodegenerative disease is one of a few specific choices, all of which are known in the art and fall under “neurodegenerative disease” or “neurodegenerative condition”. Claim 15 recites two choices: 1) a neurodegenerative disease or 2) a condition which responds to activation of a neurotrophin receptor, where option 2 may or may not be neurodegenerative. The amendments to claim 17 further emphasize that the neurodegenerative disease is separate from “said condition” in claim 15.
The examiner suggests that removing “which responds to activation of a neurotrophin receptor” from claim 15 would overcome this rejection. In that case, a “neurodegenerative disease or condition” would clearly be referring to either 1) a neurodegenerative disease or 2) a neurodegenerative condition, both of which are well characterized in the art and meet the written description requirement. This would also bring the language in claim 15 in concordance with the language used in claims 17 and 18.
Regarding the provisional double patenting rejections over 18/684463 and 18/977734, Applicant argues the rejections should be withdrawn because there is allowable subject matter in the instant application and the prosecution in these co-pending applications is ongoing. Applicant does not cite any portion of the statutes or MPEP which supports the practice that Applicant is proposing and so the argument is not persuasive. One situation in which a provisional non-statutory double patenting rejection is simply withdrawn is when the provisional rejections are the only remaining rejections and the reference applications are later filed (MPEP §804). The examiner notes that this latter fact is true: both ‘463 and ‘734 have an effective filing date of 11/09/2021, which is later than the instant effective filing date of 11/20/2020. However, the first condition has not been met as there are rejections other than provisional nonstatutory double patenting rejections.
Regarding the double patenting rejection over US12187805, Applicant argues that since the presently claimed subject matter has been deemed allowable, the rejection should be withdrawn. The rejections of record clearly indicate why the subject matter is not allowable due to the included double patenting rejections. Applicant also argues that the instant application would result in an earlier expiring patent and the rejection should be withdrawn because there would be no extension of patent term. This is not persuasive. First, the Examiner is not in a position to determine any potential patent term adjustment and so cannot definitively determine the expiration of a “potential” patent. Second, as noted above and previously, improper timewise extension is only one of the reasons for nonstatutory double patenting. The practice also exists to “prevent possible harassment by multiple assignees”. Without a terminal disclaimer, Applicant could assign these patentably indistinct inventions to different parties and so either a terminal disclaimer must be submitted and accepted or else there must be a showing that the claims subject to the rejection are patentably distinct from the reference claims. While Applicant includes a footnote stating that Applicant submits the claimed subject matter is patentably distinct, this is merely a statement of patentability that does not specifically or distinctly point to any deficiency in the rejection of record.
Conclusion
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 ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Weidner/Primary Examiner, Art Unit 1675
Prosecution Insights