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 .
Priority
Priority to US 62/677,307, filed 5/29/2018, is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 4/26/2024, before the mailing of a first office action. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-5, filed 1/16/2024, are pending. Claims 1-5 are under examination.
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 1, 2, 4, and 5 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 claims contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 1 is drawn to compounds of formula I wherein “R4 is a moiety that substantially inhibits cleavage of the bond between
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in mouse serum but does not substantially inhibit cleavage of the same bond by cathepsin B”.
In this case, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. (MPEP § 2163 (II.A.3.a.ii.))
According to MPEP § 2163 (II.A.3.a.ii.), a "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
MPEP § 2163 (II.A.3.a.ii.) states that “for inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’”
Even when several species are disclosed, these are not necessarily representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.”). Thus, when there is substantial variation within the genus, as here, one must describe a sufficient variety of species to reflect the variation within the genus to provide a "representative number” of species. Since each genus recited in the instant claims is large, it would be very challenging to describe sufficient species to cover the structures and phenotypes of the entire genus.
As claimed, the limitation R4 is purely functional, with no requirements for a specific length or specific core structure for R4; nor do the claims recite sufficient structural feature(s) which is(are) common to members of the genus sufficient to demonstrate possession of the genus. The instant specification teaches that “[w]e have discovered that placing a substituent R4 at a position ortho to the benzyloxycarbonyl group in a PABC moiety substantially inhibits cleavage of the bond between
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in mouse serum but yet does not substantially inhibit cleavage of the same bond by cathepsin B, as evidenced by the data presented below. Consequently the compounds disclosed herein can be conjugated to antibodies that are amenable to evaluation in mouse models. By substantially inhibiting cleavage of the aforementioned bond by mouse serum, we mean that there is 10% or less cleavage, preferably 6% or less cleavage after 24 h under the conditions described in the EXAMPLES section below. Conversely, by not substantially inhibiting cleavage of the aforementioned bond by cathepsin B, we mean that there is 90% or more cleavage after 24 h under the conditions described in the EXAMPLES section below.” (See, e.g., Tables B, C, pages 23-24 and Examples, pages 29-39).
With regards to the nature of R4, the disclosure and claims teach the following embodiments:
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a phenyl or C3-C6 cycloalkyl group being optionally substituted with F, Cl, CN, NO2, or C1-C3 alkyl, which are directed to a narrow subset of substituents that does not adequately to establish possession of the genus as a whole, which comprises a plethora of substituents.
Although the Specification teaches the substituents above under certain conditions (see Examples), the base claim does not define the R4 substituent by other means than its substantially inhibitory activity of the cleavage between
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and
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in mouse serum wherein the same substituent R4 does not substantially inhibiting cleavage of the same bond by cathepsin B.
While the general knowledge and level of skill in the art for measuring a substantially inhibitory activity of cleavage by comparison of different conditions and/or substituents is evident, this knowledge and level of skill does not supplement the omitted description because specific, not general, guidance is needed for the R4 moieties. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, and because the genus is vast and highly variant (e.g. any substituent of benzyl), the limited examples in the specification (please refer to Table B, page 23, drawn to specific compounds Ib-01, Ib-02, Ib-03, Ib-04 and Ib-05 in the Specification, which are used in the Examples 1-8, pages 29-39) is insufficient to teach the entire genus.
The specification discloses only limited examples that are not representative of the claimed genus of R4 substituents that substantially inhibit the cleavage between
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and
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in mouse serum but do not substantially inhibit cleavage of the same bond by cathepsin B; nor do the claims recite sufficient structural feature(s) which is(are) common to members of the genus sufficient to demonstrate possession of the genus.
Therefore, the teachings in the specification are general teachings relating without guidance as to the individual components of the product. In addition, there is a plethora of ortho benzyl substituents that could be employed in the invention with little direction or guidance beyond the represented genera of claims 3-4, 10-11 and 18 for one of skill in the art to practice the claimed invention. The expedient statements in the specification do not relate to an adequate disclosure or how to make and use the claimed invention.
Given the limited scope of the provided examples, the skilled artisan would not have been in possession of the treatment methods encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural and/or phenotypic attributes of a representative number of species possessed by the members of the genus of every treatment method recited by claim 1.
Regarding claims 2, 4, and 5, claim 1 is rejected as described above. Claims 2, 4, and 5 do not reduce the genus size of the R4 motif. One of skill in the art would conclude that applicant was not in possession of the structural and/or phenotypic attributes of a representative number of species possessed by the members of the genus of every treatment method recited by claim 1.
Consequently, claims 2, 4 and 5 are rejected.
Examiner Note: Claim 3 limits the genus size of R4 to the point where a person of ordinary skill in the art would conclude that the Applicant is in possession of a representative number of species of this genus. Therefore, claim 3 is not rejected under U.S.C. 112(a).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, and 5 are rejected under 35 U.S.C. 103 as being unpatentable over McDonagh et al. ( WO2007/103288, published 9/13/2007) in view of Zhang et al. (Zhang, et al. Bioconjugate chemistry 27.5: 1267-1275 (2016)).
McDonagh teaches ligand drug conjugates for targeted delivery of drugs. The ligand drug conjugates have potent cytotoxic activity against antigen-specific targets, as compared with intact antibody drug conjugates (e.g., abstract). Drug moieties include those of pages 62-74.
McDonagh discloses Example 6:
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which reads upon the instantly claimed
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wherein R1 =
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; X is a spacer group [(CH2)5-C(O)]; R2 corresponds to the residues Val-Cit; R3 is N-CH3 (N-(C1-alkyl), L is the residue of a bioactive molecule of the formula L-R3-H (MMAE) except that it does not disclose an R4 substituent in the benzyl group of PABA (p-aminobenzoic acid).
Many other embodiments are presented, including in pages 1-15 and Figures. Further, McDonagh (see, e.g., pages 58-60) teaches that the benzyl ring of PABA may be substituted by Qm (corresponding to the instantly claimed R4) wherein Q is C1-C10 alkyl, -O-C1-C10 alkyl, -halogen, -nitro, -cyano, m is an integer from 0-4, n is 0 or 1 and includes the ortho position corresponding to R4 and/or the meta positions:
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According to McDonagh, a conjugate containing a self-immolative spacer unit can release -D. As used by McDonagh, the term “self-immolative spacer refers to a bifunctional chemical moiety that is capable of covalently linking together two spaced chemical moieties into a stable tripartite molecule. It will spontaneously separate from the second chemical moiety if its bond to the first moiety is cleaved.
Further, the compounds may be conjugated to L, which includes an antibody, e.g., comprising the VH or VL region of a humanized antibody AC10, BR96, 1F6, or 2F2 (e.g., claims, Figures, pages 46-47), which reads upon the limitations of claims 8, 9, 12, 14, 15, 16, 17, 20 including conjugates with antibodies and methods of making thereof (e.g., pages 8-9):
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Regarding the Qm motif of McDonagh, Zhang further teaches the addition of an -O-C1-C10 alkyl motif to PABA in this context:
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(Zhang et al., page 1268, Fig. 1).
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(Zhang et al., page 1268, Fig. 2).
Zhang discloses that this motif is useful for the addition of PEG molecules or any addition via click chemistry:
Zhang also discloses that the 3 position would be more likely to not sterically interfere with the trigger region than the 2 position:
“While self-immolative linkers involved in prodrug design are becoming increasingly common in recent years, the development of multifunctional linkers is quite limited. (12−14) Though some successful multifunctional prodrugs have been reported, (15) they always involve tough synthetic chemistry. Click chemistry is proven to be a powerful tool in drug development and diverse chemical biology applications. (16,17) We designed a multifunctional linker with a potential click chemistry fragment, which was expected to solve several drawbacks simultaneously. An alkynyl moiety was introduced into the 2-position of PABA (Figure 1). Compared with 3-position of PABA, the 2-substituted analog might have less influence when the trigger is sterically bulky.” (Zhang et al., page 1267, col. 2, para. 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to utilize a 3-position Qm substituted benzyl in the formula of Example 6 of McDonagh to make immolative delivery molecules because Zhang teaches the utility of a click chemistry motif in that position.
A person of ordinary skill in the art would have been motivated to do so because substitution would still provide immolative cleavage as taught in pages 58-59. Furthermore, the modification taught by Zhang provides a moiety that allows for PEGylation which in turn increases solubility of the conjugate. Lastly, substitution at the 3 position is taught to be less likely to cause steric interference with the trigger moiety.
One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that such modifications were available via synthetic modifications as disclosed by Zhang. Furthermore, Zhang employs the same Val-Cit motif and therefore the 3 position modification disclosed by Zhang can reasonably be expected to work with the conjugate of McDonagh.
Regarding the functional limitation, The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ comprising e.g., the embodiment of Example 6 further modified by ortho (position 3) Qm wherein Q is C1-C10 alkyl, -O-C1-C10 alkyl, -halogen, -nitro, -cyano, m is an integer from 0-4, substantially inhibits the cleavage of the bond between
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in mouse serum but with does not substantially inhibit of the cleavage of the same bond by cathepsin B under the conditions of the Examples in the instant application (within the claimed compositions) and if they differ, and if so, to what extent, from that of the discussed reference.
Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Consequently, claim 1 is obvious over McDonagh et al. in view of Zhang et al. and rejected.
Regarding claim 2, claim 1 is obvious as described above. McDonagh and Zhang both use the Val-Cit motif as the primary trigger motif.
Consequently, claim 2 is obvious over McDonagh et al. in view of Zhang et al. and rejected.
Regarding claim 5, claim 1 is obvious as described above. The R1 motif of McDonagh Example 6 is
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.
Consequently, claim 5 is obvious over McDonagh et al. in view of Zhang et al. and rejected.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over McDonagh et al. ( WO2007/103288, published 9/13/2007) in view of Zhang et al. (Zhang, et al. Bioconjugate chemistry 27.5: 1267-1275 (2016)) as applied to claim 1 above, further in view of Mandal et al. (Mandal, et al. The Journal of organic chemistry 72.17: 6599-6601 (2007)).
Regarding claim 4, claim 1 is obvious as described above. Zhang discloses the usage of the Cbz (benzyl carbamate) as a conjugation motif located on the N-terminal side of the Val-Cit motif.
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Mandal et al. discloses that when unprotected, the Cbz motif becomes an amino group:
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It would have been obvious to a person of ordinary skill in the art to use a Cbz motif as disclosed by Zhang in the R1 position of the McDonagh construct and then deprotect the Cbz motif to arrive at the claimed invention because Mandal discloses that Cbz motifs result in amino groups when deprotected.
A person of ordinary skill in the art would be motivated to use a Cbz motif and then deprotect in order to generate an amino group to perform further conjugation chemistry and have a reasonable expectation of success because Zhang shows the usage of Cbz on the N-terminal end of the canonical Val-Cit motif.
Consequently, claim 4 is obvious over McDonagh et al. in view of Zhang et al. as applied to claim 1 above, further in view of Mandal et al. and rejected.
Free of the Prior Art
Regarding claim 3, the R4 motifs disclosed by claim 3 are not taught or suggested by the available prior art.
The closest prior art would be any prior art that discloses a substituent in that position with a different structure. For example, Zhang discloses and ether-alkyne motif at that position:
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(Zhang et al., page 1268, Fig. 2).
Therefore, the concept of a position 3 of the PABA moiety that is central to this self-immolating moiety is known, but these particular substituents are not known, nor taught or suggested by the available prior 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 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 10,898,578.
Regarding claim 1, the ‘578 patent discloses the following conjugate in claims 7 and 8:
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The ‘578 patent also discloses the following compound in claims 1 and 2:
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It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to create the conjugate of Applicant claim 1 by conjugating an antibody to the compound disclosed by claim of the ‘578 patent because the ‘578 patent shows a compound that reads on Applicant claim 1 both separate (claims 1 and 2) and conjugated to an antibody (claims 7 and 8).
A person of ordinary skill in the art would be motivated to conjugate an antibody in order to target the compound to a target of interest and would have a reasonable expectation of success because the ‘578 shows that such a conjugate can be created.
Consequently, claim 1 is obvious over the ‘578 patent and rejected.
Regarding claim 2, claim 1 is obvious as described above. Claim 2 of the ‘578 patent discloses:
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Consequently, claim 2 is obvious over the ‘578 patent and rejected.
Regarding claim 3, claim 1 is obvious as described above. The ‘578 patent discloses the follow R4 moieties in claim 1:
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Consequently, claim 3 is obvious over the ‘578 patent and rejected.
Regarding claim 4, claim 1 is obvious as described above. Claim 1 of the ‘578 patent discloses the following R1 moieties:
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Any of these moieties would be obvious to try and there this claim reads on Applicant claim 4.
Consequently, claim 4 is obvious over the ‘578 patent and rejected.
Regarding claim 5, claim 1 is obvious as described above. Claim 1 of the ‘578 patent discloses the following R1 moieties:
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Any of these moieties would be obvious to try and there this claim reads on Applicant claim 5.
Consequently, claim 5 is obvious over the ‘578 patent and rejected.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,911,483 in view of Dal Corso et al. (Dal Corso, et al. Journal of Controlled Release 264: 211-218 (2017)).
Regarding claim 1, the ‘483 patent discloses the following compound in claims 1-6:
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Dal Corso discloses conjugating an antibody to the same Val-Cit motif:
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(Dal Corso, et al., page 213, Fig. 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to conjugate an antibody as disclosed by Dal Corso to the compound of the ‘483 patent to arrive at Applicant claim 1 because Dal Corso shows antibody conjugation to the exact motif disclosed by the ‘483 patent and Applicant claim 1.
A person of ordinary skill in the art would be motivated to conjugate an antibody in order to target the compound of the ‘483 patent to a target of interest and have a reasonable expectation of success because Dal Corso teaches antibody conjugation to the exact motif disclosed by the ‘483 patent and Applicant claim 1.
Consequently, claim 1 is obvious over the ‘483 patent and Dal Corso and rejected.
Regarding claim 2, claim 1 is obvious as described above. Claim 2 of the ‘483 patent discloses:
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Consequently, claim 2 is obvious over the ‘483 patent and Dal Corso and rejected.
Regarding claim 3, claim 1 is obvious as described above. Claim 5 and 6 of the ‘483 patent disclose:
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Consequently, claim 3 is obvious over the ‘483 patent and Dal Corso and rejected.
Regarding claim 4, claim 1 is obvious as described above. Claim 3 of the ‘483 patent discloses:
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Consequently, claim 4 is obvious over the ‘483 patent and Dal Corso and rejected.
Regarding claim 5, claim 1 is obvious as described above. Claim 3 of the ‘483 patent discloses:
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Consequently, claim 5 is obvious over the ‘483 patent and Dal Corso and rejected.
Conclusion
No claim is allowed.
Claims 1-5 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Paul Bowles whose telephone number is (571)272-0919. The examiner can normally be reached Monday-Friday 8:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID PAUL BOWLES/ Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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