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 .
DETAILED ACTION
Claims 20-29 are pending in the instant application.
Claims 1-19 are canceled.
Restriction Response
Applicant’s election of Group II claims 20-29, drawn to an antibody-drug conjugate comprising an anti-hyaluronidase 2 antibody and a method of treating cancer comprising administering the antibody-drug conjugate in the reply filed on 6/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e)
or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date
under 35 U.S.C. 119(e) as follows:
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). The disclosure of the prior-filed priority applications, 63/036,206 filed 6/8/2020; and 63/037,855 filed 6/11/2020; fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim analysis of previous priority applications reveal the effective filing dates of claims are drawn to two separate applications, namely, 63/156,993 filed 3/5/2021 and the original provisional application 63/036,206 filed 6/8/2020. The priority applications 63/036,206 filed 6/8/2020; and 63/037,855 filed 6/11/2020 specifically lack priority for the specific cytotoxic agents recited in claims 21 and 23-24; wherein the specific cytotoxic agents are listed for the first time in 63/156,993 filed 3/5/2021 on pages 14-16, [0100 – 0105].
Thus, claims 20-23 and 31 contain subject matter introduced for the first time in 63/156,993 filed 3/5/2021. Claims 20, 22, and 25-29 are present in the original disclosure of the provisional application and have the priority date of 6/8/2020.
Claim Interpretation
(Use if some definition could be explained in a certain way.)
Objections to the Claims
Claim 23 is objected to because of the following informalities: camptothecin is listed twice in lines 7-8. Appropriate correction is required.
Objections to the Specification
The disclosure is objected to because of the following informalities:
The paragraph numbering is not in numerical order in the specification. For example, page 14 ends with [0050] while page 15 starts with [0100] and page 16 returns to [0051].
The third-to-last line of [0039] on Pg. 11 of the specification recites the same SEQ ID NO for successive CDRs: “CDR-H1 of SEQ ID NO: 7, CDR-H2 of SEQ ID NO 7...”. However, earlier in the same paragraph CDR-H1 is stated to correspond to SEQ ID NO: 6, which appears to be the correct CDR-H1 sequence.
Pg. 32, Example 4 references “Figure 4C”. However, there is no “Figure 4C”, neither does the content of the figures appear to match the descriptions in Example 4.
Pg. 33, Example 6 references “Figure 6C”, “Figure 6D”, and “Figure 6E” – however no such figures exist in the instant disclosure.
Appropriate correction is required.
Claim Rejections – 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 23 the claims list a genus of podophyllotoxin derivatives followed by the term “such as” then describes species of the genus. It is not clear whether the recitation of the species are an optionally preferred example—and therefore not limiting—or further limitations of the scope of the claim in line 5.
Regarding claim 23, the content of the parentheses of (DM1) or (DM4) does not define or equate to the preceding terminology of maytansinoids in lines 9-10 and thus is exemplary claim language which is unclear.
Claim 25 recites an antibody comprising “a set of 6 CDRs set forth in SEQ ID NOs: 6-11”. However, the claims do not specify which particular CDR (HCDR-1, HCDR-2, HCDR-3, LCDR-1, LCDR-2, or LCDR-3) corresponds to which SEQ ID NO, and whether all CDRs are present in a single heavy or light chain and it is therefore unclear if the antibody is intended to be encompassed by the claims.
Regarding claim 25, SEQ ID NO:10 is indefinite because it has no sequence in the sequence listing.
To promote compact prosecution, the CDR will be interpreted as comprising a heavy chain comprising HCDR1-3 of SEQ ID NO:6-8, respectively and a light chain comprising LCDR1-3 of SEQ ID NO:9, LVS, and SEQ ID NO:11, as defined at ¶0039 of the instant specification and present in the Hyal2 antibody comprising a heavy chain comprising the SEQ ID NO:4 and a light chain comprising the SEQ ID NO:2.
Claims 23 and 24 contain the trademark/trade name Taxotere®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe docetaxel and, accordingly, the identification/description is indefinite.
Claim Rejections – 35 USC § 112(a)
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 26-29 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.
Regarding claims 26-27, a Hyal2 antibody is claimed wherein only a single VH or VL is required for the antibody-drug conjugate. The formation of an intact antigen binding site in a conventional antibody typically requires the association of the complete heavy and light chain variable regions of a given antibody, each of which comprises three CDRs (or hypervariable regions) which provide the majority of the contact residues for the binding of the antibody to its target epitope;
Regarding instant claims 28-29, a method is claimed for treating cancer in a subject but the cancer is not required to express Hyal2.
Scope of the claims
Claims 26-27 encompass an antibody drug conjugate comprising a Hyal2 antibody conjugate (ADC) conjugated to a cytotoxic agent, wherein the antibody is defined only by partial structure, reciting a VH or VL sequence, allowing for unlimited possible pairing with unspecified VH or VL sequences;
Methods of treating cancer in a subject in need thereof are claimed comprising administering an ADC comprising a Hyal2 antibody conjugated to a cytotoxic agent, but the cancer is not required to express the Hyal2 that the ADC targets.
State of the relevant art
Antibodies that bind HYAL2 and their utility in determining HYAL2 levels are known in the art (Tan J-X et al. HYAL1 overexpression is correlated with the malignant behavior of human breast cancer (Int J Cancer 2011 128(6):1303-15. doi: 10.1002/ijc.25460), wherein Tan taught Hyal2 protein levels were elevated in breast cancer cells, invasive duct cancer tissues, and metastatic lymph nodes compared to normal breast tissues (Fig. 7). However, antibodies comprising the instantly claimed sequences are not. As was well known in the antibody art, the formation of an intact antigen binding site in a conventional antibody typically requires the association of the complete heavy and light chain variable regions of a given antibody, each of which comprises three CDRs (or hypervariable regions) which provide the majority of the contact residues for the binding of the antibody to its target epitope (reviewed in Sela-Culang I et al. (Frontiers in Immunology 4 (2013): 302.). It is generally understood that all six CDRs in combination and in a specific order (HCDR1, HCDR2, HCDR3, LCDR1, LCDR2, LCDR3) are required to convey an antibody’s specificity to its target, and that neither the CDRs themselves nor individual VH and VL domains are interchangeable. For example, Julien J-P et al. (US 2017/0355756) taught an antibody specific for human TDP-43 with a heavy chain comprising 3 CDRs termed “C10-VH3” (Table A, SEQ ID NO. 4). Cassone A et al. (WO 2008/068048) taught an antibody with a heavy chain comprising the same 3 CDRs (“αSAP 2A8”; page 18, SEQ ID NO. 2). However, the antibody of Cassone is paired with a different VL and targets an entirely different protein – secreted aspartyl protease (SAP) from pathogenic yeast in the genus Candida sp. Below is an alignment between the VH domains of these unrelated antibodies; the 3 HCDRs according to Julien are highlighted (SEQ ID NOs: 16-18):
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Sela-Culang further teaches that antigens lack intrinsic properties that clearly differentiate between epitopic and non-epitopic residues, and any part of the antigen surface my become part of an epitope under some circumstances (“Ab Epitope Prediction”; page 2). Additionally, Edwards et al. 2003 (Journal of molecular biology 334.1 (2003): 103-118.) endeavored to uncover the breadth of the structural diversity of antibodies a single antigen can give rise to. Edwards employed a phage display library to screen for antibodies that bind a single protein, BLyS, and isolated over 1000 unique anti-BLyS antibodies, each comprising a different amino acid sequence (Abstract). These antibodies were structurally diverse, resulted from nearly all possible Vh, D, and Jh, germlines (page 105; “Vh and Vl germline usage”), and comprised 568 distinct Vh CDR3 sequences, ranging in length from 5 to 25 amino acid residues (Fig. 4; “Vh CDR3 sequence diversity”; page 105). Together, these works highlight that neither knowledge of the antigen sequence nor the antibody sequence is necessarily predictive of its function.
The claimed ADC would be required to target Hyal2 positive cancer cells to effectively target the cancer cells.
Description of representative species in the specification
MPEP § 2163 states that 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.
In the instant case, however, the specification discloses one structurally defined species of antibody purportedly belonging to the claimed genus comprising both a VH comprising SEQ ID NO: 4 and VL comprising SEQ ID NO: 2 – which comprise the CDRs of SEQ ID NOs 6-8 and 9-11, respectively (page 11-12 [0041]). Accordingly, one of ordinary skill in the art would not reasonably consider a single species of antibody representative of the nearly unlimited potential species comprising the claimed VH or VL.
The specification has 0 examples of effectively targeting a cancer that expressed Hyal2 with an anti-Hyal2 ADC.
Identifying characteristics and structure/function correlation
In the absence of a representative number of species, the written description requirement for a claimed genus may be satisfied 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 applicant was in possession of the claimed genus. To meet this requirement in the instant case, the specification must describe structural features that the skilled artisan as of the effective filing date would have expected to convey the claimed binding activity.
However, the specification discloses no structure/function relationship between the claimed sequences and their ability to bind HYAL2, and there is no discussion of which residues are important for said interaction or whether the VH or VL are alone sufficient to confer the required HYAL2 binding activity. Further, each of the examples appear to make use of commercially available polyclonal HYAL2 antibody (page 28, [0080]), and there is no direct showing that an antibody comprising the claimed sequences binds to HYAL2.
The specification has 0 examples of effectively targeting a cancer that expressed Hyal2 with an anti-Hyal2 ADC.
Summary
A genus of species is not present in the instant specification or prior art that would demonstrate a structure activity relationship would be known for an antibody to effectively bind Hyal2 in the absence of 3 defined CDRs of a heavy and light chain antibody. One of skill in the art would reasonably conclude that applicant was not in possession of an Hyal2 antibody wherein the heavy and light chain are not both defined.
A genus of species is not present in the instant specification or prior art that would demonstrate a Hyal2 targeted ADC can effectively target a cancer that does not express Hyal2.
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.
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.
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.
Claims 20-23 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Asundi J et al. (Clin Cancer Res 2015 21(14) 3252–3262), Tan J-X et al. (Int J Cancer 2011 128(6):1303-15. doi: 10.1002/ijc.25460.), Andre B et al. (BBRC 2011 411(1) 175-179), and Bourguignon LYW et al. (JBC 2004 279(26) 26991-27007, IDS reference)
Asundi taught a method of effective breast cancer treatment comprising administration of a pharmaceutical composition comprising a pharmaceutically acceptable excipient and an antibody-drug conjugate that targeted the GPI anchored protein LY6E (Fig. 5), wherein the ADC comprised a conjugated MMAE drug (page 3253, right column, first paragraph).
Asundi did not teach: 1) an Hyal2 ADC conjugated to a cytotoxic agent but this is obvious in view of Tan, Andre, and Bourguignon.
Tan taught Hyal2 protein levels were elevated in breast cancer cells, invasive duct cancer tissues, and metastatic lymph nodes compared to normal breast tissues (Fig. 7).
Andre taught Hyal2 is highly expressed in MDA-MB-231 breast cancer cells (page 175, right column, first paragraph). Andre taught Hyal2 is expressed in breast cancer cells and linked to the cell membrane via a GPI anchor (Fig. 3) and the GPI anchor drives Hyal2 to the plasma membrane (page 177, right column, section 3.5).
Bourguignon taught down-regulation of Hyal-2 expression via Hyal-2-specific siRNAs impairs tumor cell invasion (abstract and Table V). Bourguignon taught breast cancer cells express Hyal-2 mRNA and protein (Fig. 5).
Regarding instant claims 20-23 and 28-29, it would have been obvious for a person having ordinary skill in the art to modify the method of Asundi of a method of effectively treating breast cancer that expressed Ly6E in a subject in need thereof comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and an antibody-drug conjugate that targeted the GPI anchored protein LY6E, wherein the ADC comprised an anti-Hyal2 antibody conjugated MMAE drug – by:
Exchanging the LY6E targeting antibody for an antibody that targeted Hyal2 in Hyal2 expressing cancer in view of Tan, Andre, and Bourguignon.
This is obvious because Asundi taught effective targeting of GPI anchored proteins with an ADC is effective and:
1a) Tan taught Hyal2 protein levels were elevated in breast cancer cells, invasive duct cancer tissues, and metastatic lymph nodes compared to normal breast tissues;
1b) Andre taught Hyal2 is highly expressed in breast cancer cells and linked to the plasma membrane via a GPI anchor; and
1c) Bourguignon taught breast cancer cells express Hyal-2 mRNA and protein and down-regulation of Hyal-2 expression via Hyal-2-specific siRNAs impairs tumor cell invasion. Thus, Hyal2 is expression is elevated in breast cancer cells, is present at the cell membrane via a GPI anchor, and promotes tumor cell invasion.
There is a reasonable expectation of success because Asundi taught effective targeting of GPI anchored proteins with an ADC is effective for breast cancer treatment and:
1a) Tan taught Hyal2 protein levels were elevated in breast cancer cells, invasive duct cancer tissues, and metastatic lymph nodes compared to normal breast tissues;
1b) Andre taught Hyal2 is highly expressed in breast cancer cells and linked to the plasma membrane via a GPI anchor; and
1c) Bourguignon taught breast cancer cells express Hyal-2 mRNA and protein and down-regulation of Hyal-2 expression via Hyal-2-specific siRNAs impairs tumor cell invasion.
Thus, Hyal2 is expression is elevated in breast cancer cells, is present at the cell membrane via a GPI anchor, and promotes tumor cell invasion.
This would produce a method of Asundi, Tan, Andre, and Bourguignon of effectively treating breast cancer (claim 29) that expressed Hyal2 in a subject in need thereof comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and an antibody-drug conjugate that targeted Hyal2, wherein the ADC comprised an anti-Hyal2 antibody conjugated to MMAE, which is a cytotoxic dolastatin chemotherapeutic agent (claims 20-23 and 28).
Claims 20-24 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Asundi J et al. (Clin Cancer Res 2015 21(14) 3252–3262), Tan J-X et al. (Int J Cancer 2011 128(6):1303-15. doi: 10.1002/ijc.25460.), Andre B et al. (BBRC 2011 411(1) 175-179), Bourguignon LYW et al. (JBC 2004 279(26) 26991-27007, IDS reference) as applied to claims 20-23 and 28-29 above, and further in view of Trail PA et al. (Science 1993 261(5118):212-5.).
Asundi, Tan, Andre, and Bourguignon are described above.
Asundi does not teach an anti-Ly6e doxorubicin ADC, but this is obvious in view of Trail.
Trail taught an ADC comprising doxorubicin effectively treated a subject with breast cancer (abstract).
Regarding instant claims 24, it would have been obvious for a person having ordinary skill in the art to modify the method of Asundi, Tan, Andre, and Bourguignon of effectively treating breast cancer that expressed Hyal2 in a subject in need thereof comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and an antibody-drug conjugate that targeted Hyal2, wherein the ADC comprised an anti-Hyal2 antibody conjugated MMAE drug, which is a cytotoxic dolastatin chemotherapeutic agent– by:
Exchanging the MMAE with doxorubicin in view of Trail.
This is obvious because:
1a) Trail taught an ADC comprising doxorubicin effectively treated a subject with breast cancer. Thus, exchange of one effective cytotoxin for another would be expected to be effective in subjects that expressed a Hyal2 expressing cancer.
There is a reasonable expectation of success because:
1a) Trail taught an ADC comprising doxorubicin effectively treated a subject with breast cancer. Thus, exchange of one effective cytotoxin for another would be expected to be effective in subjects that expressed a Hyal2 expressing cancer.
This would produce a method of Asundi, Tan, Andre, Bourguignon, and Trail of effectively treating breast cancer that expressed Hyal2 in a subject in need thereof comprising administering a pharmaceutical composition comprising a pharmaceutically acceptable excipient and an antibody-drug conjugate that targeted Hyal2, wherein the ADC comprised an anti-Hyal2 antibody conjugated to doxorubicin (claim 24).
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 20-24 and 28-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/675,014. Although the claims at issue are not identical, they are not patentably distinct from each other because:
‘014 taught compositions of Hyal2 antibodies and methods of treatment of cancer with antibody drug conjugates comprising Hyal2 antibodies in copending claims 1-21.
Regarding instant claims 20-24 and 28-29, ‘014 taught an antibody or antigen binding fragment that binds Hyal2 comprising 6 CDRs set forth in ‘019 SEQ ID NO:2-7 in copending claim 1, wherein an antibody drug conjugate comprises the antibody above conjugated to a cytotoxic agent in copending claim 14 (instant claims 20), wherein the cytotoxic agent is cytotoxic agent is a DNA intercalator in copending claim 15 (instant claims 21), wherein the cytotoxic agent is a chemotherapeutic agent in copending claim 16 (instant claims 22), wherein the cytotoxic agent is MMAE in copending claim 17 (instant claims 23), wherein the cytotoxic agent is doxorubicin in copending claim 18 (instant claims 24). ‘014 taught the Hyla2 antibody-drug conjugate of copending claim 14 in a method of treating cancer in a subject in need thereof comprising administering the ADC to the subject in copending claim 20, wherein the cancer is breast cancer in copending claim 21 (instant claims 28-29).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN J SKOKO III whose telephone number is (571)272-1107. The examiner can normally be reached M-F 8:30 - 5:00.
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/J.J.S./Examiner, Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
Prosecution Insights