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 .
Assignment of Application
The location of your application in the USPTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Examiner Christina Borgeest.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1, 2, 4, 5, 7-12, 16 and 18) in the reply filed on 06/02/2026 is acknowledged. Applicant also elected the species of SEQ ID NO: 5 as the cryptic collagen epitope and a mitotic inhibitor as the at least one drug. The search for the cryptic collagen epitope was extended to include SEQ ID NO: 17 and the search for at least one drug was extended to include doxorubicin.
Claims 19, 20, 23, 29, 32, 33, 37 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/02/2026.
The examiner required restriction between product and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims will be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 1, 2, 4, 5, 7-12, 16 and 18 are under examination.
Drawings
The drawings are objected to because Figure 1 has color photographs and there has been no granted petition to include color drawings or photographs in this application. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
More specifically, 37 C.F.R. 1.84(a)(2) states:
. . . On rare occasions, color drawings may be necessary as the only practical medium by which to disclose the subject matter sought to be patented in a utility patent application. . . . The Office will accept color drawings in utility patent applications only after granting a petition filed under this paragraph explaining why the color drawings are necessary. Any such petition must include the following:
(i) The fee set forth in § 1.17(h);
(ii) One (1) set of color drawings if submitted via the Office electronic filing system, or three (3) sets of color drawings if not submitted via the Office electronic filing system; and
(iii) An amendment to the specification to insert (unless the specification contains or has been previously amended to contain) the following language as the first paragraph of the brief description of the drawings:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
(Emphases added.) MPEP 608.02, part VIII, states:
Color drawings and color photographs are not accepted in utility applications filed under 35 U.S.C. 111 unless a petition filed under 37 CFR 1.84(a)(2) or (b)(2) is granted. Color drawings and color photographs are not permitted in international applications (see PCT Rule 11.13 ).
Unless a petition is filed and granted, color drawings or color photographs will not be accepted in a utility patent application filed under 35 U.S.C. 111. The examiner must object to the color drawings or color photographs as being improper and require applicant either to cancel the drawings or to provide substitute black and white drawings.
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 1, 2, 4, 5, 7, 8, 10-1216 and 18 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. This is a written description rejection.
The claims recite an antibody-drug conjugate (ADC) comprising a monoclonal antibody conjugated to at least one drug, and wherein the antibody, or the antigen binding fragment thereof, binds to denatured collagen (type I-IV) and is internalized in a cancer cell, wherein the ADC is not directed to a receptor on the cancer cell surface and binds to any number of epitopes recited in instant claims 5 and 7. The MPEP 2163(A) states “‘[a]n invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function.’” For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. (See MPEP 2163(II)(A)(3)(a)(i)).
It is well established in the art that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin. In deciding whether the application complies with the written description requirement of 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph, it is necessary to understand what Applicant has possession of and what Applicant is claiming. The antibody portion of the ADC is claimed in terms of its functions and the epitope to which it binds. To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Applicant has possession of the antibody comprising an HUI77 monoclonal antibody deposited with ATCC accession number PTA-6551 and set forth in SEQ ID NOs: 7 and 8 (see paragraphs [0006] and [0094] and Examples). In addition, the drug portion of the ADC recited in claim 11 is broadly described in the specification (see paragraphs [0117]-[0121]). Applicant does not have possession of the genus of antibodies having the recited functions.
In the instant case, the recitation of function alone (binding denatured collagen and being internalized in a cancer cell) in the claims is little more than a wish for possession and does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing “a result that one might achieve if one made that invention”); In re Wilder, 736 F.2d 1516, 1521,222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does ‘‘little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. In summary, the single species of antibody in the ADC is not representative of the genus of antibodies required to possess the claimed functions.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Apart from the humanized HUI77 antibody set forth in SEQ ID NOs: 7 and 8, the skilled artisan cannot envision the detailed chemical structure of the encompassed antibodies, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Therefore, only isolated the anti-HUI77 antibody set forth in SEQ ID NOs: 7 and 8, but not the full breadth of the claim meets the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
Notice for all US Patent Applications filed on or after March 16, 2013: 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.
Claim Rejections - 35 USC § 102 – 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 4, 5, 7-12 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watkins et al. (US Patent 7,763,248).
Teachings of the Prior Art and How it is Anticipatory
Watkins et al. teach an antibody that binds specifically to a cryptic (i.e., denatured) collagen type I or IV (see claim 1; column 2, lines 6-15; column, 7, lines 58-67). Watkins et al. disclose the antibody may be the monoclonal antibody HUI77 (see column 9, lines 1-38; column 31, lines 53-67 through column 32, lines 1-50). The PGPUB (US2007/0048325) by Van Epps et al. is presented as evidence that HUI77 has the accession number PTA-6551 (see paragraph [0132]). Watkins et al. also teach that the antibodies may be administered conjugated with a separate “therapeutic agent” or “moiety” (see column 32, lines 51-67 through column 33, lines 1-41), i.e., an antibody-drug conjugate:
In the case of a therapeutic moiety, the moiety can be a drug such as a chemotherapeutic agent, cytotoxic agent, toxin, or anti angiogenic agent, which refers to a molecule that reduces or inhibits angiogenesis…In addition, a moiety can be a drug delivery vehicle such as a chambered microdevice, a cell, a liposome or a virus, which can contain an agent such as a drug or a nucleic acid.
Exemplary therapeutic agents include, for example, the anthracyclin, doxorubicin, which has been linked to antibodies and the antibody/doxorubicin conjugates have been therapeutically effective in treating tumors…Similarly, other anthracyclins, including idarubicin and daunorubicin, have been chemically conjugated to antibodies, which have delivered effective doses of the agents to tumors…
In addition to the anthracyclins, alkylating agents such as melphalan and chlorambucil have been linked to antibodies to produce therapeutically effective conjugates…as have vinca alkaloids such as vindesine and vinblastine…Similarly, conjugates of antibodies and antimetabolites such as 5-fluorouracil, 5 fluorouridine and derivatives thereof have been effective in treating tumors…Other chemotherapeutic agents, including cis-platinum…methotrexate…also are therapeutically effective when administered as conjugates with various different antibodies. A therapeutic agent can also be a toxin such as ricin. (Citations omitted by examiner).
Watkins teaches that the composition is formulated in a pharmaceutically acceptable carrier (see column 31, lines 34-56). Since Watkins et al. teach the antibody binds to a denatured collagen epitope and the contemplated conjugates encompass chemotherapeutic agents, it flows therefrom that it not directed to a receptor on the cancer cell surface.
Regarding the epitopes listed in claims 5 and 7, the HUI77 antibody binds to the cryptic collagen epitope set forth in SEQ ID NO: 17, as evidenced by Freimark et al. (Molecular Immunology 44 (2007) 3741–3750 at p. 3745, right column, middle paragraph). Regarding both Van Epps et al. and Freimark et al., MPEP 2131.01 addresses the use of more than one reference when making rejections under 35 USC 102. Specifically, rejections under 35 USC 102 over multiple references have been held to be proper when the extra references are cited to show that a characteristic not explicitly disclosed in the primary reference is inherent. Thus, Watkins teaches the limitations of claims 1, 2, 4, 5, 7-12 and 18.
Finally, regarding the limitation that the antibody is internalized in a cancer cell, Watkins teaches the same antibody-drug conjugate, which therefore must be capable of the same functions because “[f]rom the standpoint of patent law, a compound and all its properties are inseparable”. See In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963); also In re Swinehart and Sfiligoj, 169 USPQ 226 (CCPA 1971); In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978). Additionally, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable (In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)).
How the Prior Art Renders the Claims Obvious
Claims 1, 2, 4, 5, 7-12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Watkins et al. (7,763,248) in view of Van Epps et al. (US2007/0048325) and Freimark et al. (Molecular Immunology 44 (2007) 3741-3750). The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. Watkins et al. teach an antibody that binds specifically to a cryptic (i.e., denatured) collagen type I or IV (see claim 1; column 2, lines 6-15; column, 7, lines 58-67). Watkins et al. disclose the antibody may be the monoclonal antibody HUI77 (see column 9, lines 1-38; column 31, lines 53-67 through column 32, lines 1-50). The PGPUB by Van Epps et al. provides guidance that HUI77 has the accession number PTA-6551 (see paragraph [0132]). Watkins teaches that the composition is formulated in a pharmaceutically acceptable carrier (see column 31, lines 34-56). Since Watkins et al. teach the antibody binds to a denatured collagen epitope and the contemplated conjugates encompass chemotherapeutic agents, it flows therefrom that it not directed to a receptor on the cancer cell surface. Regarding the epitopes listed in claims 5 and 7, Freimark et al. (at p. 3745, right column, middle paragraph) provide guidance that the HUI77 antibody inherently binds to the cryptic collagen epitope set forth in SEQ ID NO: 17.
The second factor to consider is to ascertain the differences between the prior art and the instant claims. While Watkins et al. teach that the antibodies may be administered conjugated with a separate “therapeutic agent” or “moiety” (see column 32, lines 51-67 through column 33, lines 1-41), they do not explicitly disclose an antibody-drug conjugate. Nevertheless, the cited passage strongly teaches that the anti-cryptic collagen antibody may be conjugated to another therapeutic moiety, including doxorubicin:
In the case of a therapeutic moiety, the moiety can be a drug such as a chemotherapeutic agent, cytotoxic agent, toxin, or anti angiogenic agent, which refers to a molecule that reduces or inhibits angiogenesis…In addition, a moiety can be a drug delivery vehicle such as a chambered microdevice, a cell, a liposome or a virus, which can contain an agent such as a drug or a nucleic acid.
Exemplary therapeutic agents include, for example, the anthracyclin, doxorubicin, which has been linked to antibodies and the antibody/doxorubicin conjugates have been therapeutically effective in treating tumors…Similarly, other anthracyclins, including idarubicin and daunorubicin, have been chemically conjugated to antibodies, which have delivered effective doses of the agents to tumors…
In addition to the anthracyclins, alkylating agents such as melphalan and chlorambucil have been linked to antibodies to produce therapeutically effective conjugates…as have vinca alkaloids such as vindesine and vinblastine…Similarly, conjugates of antibodies and antimetabolites such as 5-fluorouracil, 5 fluorouridine and derivatives thereof have been effective in treating tumors…Other chemotherapeutic agents, including cis-platinum…methotrexate…also are therapeutically effective when administered as conjugates with various different antibodies. A therapeutic agent can also be a toxin such as ricin. (Citations omitted by examiner).
The person of ordinary skill in the art at the time of the filing of the invention would have been motivated to formulate an antibody-drug conjugate because Watkins and colleagues teach antibody-doxorubicin conjugates have been therapeutically effective in treating tumors (see column 32, lines 64-67). For this reason, as well, the person of ordinary skill in the art could have reasonably expected success.
Finally, the effect of the antibody-drug conjugate being internalized in a cancer cell would have been inherent to the teachings of Watkins and colleagues since they strongly suggest the antibody-drug conjugate, which therefore must be capable of the same functions because “[f]rom the standpoint of patent law, a compound and all its properties are inseparable”. See In re Papesch, 315 F.2d 381, 391, 137 USPQ 43, 51 (CCPA 1963). Moreover, Watkins and colleagues suggest treating cancer with an antibody-doxorubicin conjugate. Further, for the record, the express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 103. “The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness.” In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). See also MPEP 2112.
Claims 11, 12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Watkins et al., Van Epps et al. and Freimark et al. as applied to claims 1, 2, 4, 5, 7-12 and 18 above, and further in view of Su et al. (Acta Pharmaceutica Sinica B 2021;11(12):3889-3907). For the purpose of this rejection, claims 11 and 12 are interpreted as reading upon the elected species of mitotic inhibitor. The first factor to consider when making a rejection under 35 U.S.C. 103(a) is to determine the scope and contents of the prior art. The combined teachings of Watkins et al., Van Epps et al. and Freimark et al. and how they meet the limitations of claims 1, 2, 4, 5, 7-12 and 18 are outlined above in the preceding rejection and are hereby incorporated.
The second factor to consider is to ascertain the differences between the prior art and the instant claims. The combined teachings of Watkins et al., Van Epps et al. and Freimark et al. do not teach the linker used in conjugating the drug to the antibody is a cleavable or a non-cleavable linker. Su et al. teach antibody-drug conjugates may be fused by either cleavable or non-cleavable linkers (see p. 3890, left column, 2nd paragraph):
The linker connects the antibody and the cytotoxic payload and is a key component in the function of ADCs. The linker imparts the following characteristics to ADCs: (1) high stability in the circulation, and (2) specific release of payload in the target tissue…To achieve the above requirement, various linkers have been developed and can be divided into two types according to their cleavage method. The first type is the cleavable linker, which has a chemical trigger in its structure that can be efficiently cleaved to release the cytotoxic payload in the tumor. More than 80% of the clinically approved ADCs employ cleavable linkers…The other type of linker is non-cleavable. In contrast to the cleavable linker, there are no chemical triggers in this structure, and the linker is part of the payload. (Citations omitted by examiner).
Further, Su et al. teach ADCs may comprise payloads such as doxorubicin and mitotic inhibitors such as MMAE (see Table 1 at p. 3891). It would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention to conjugate the antibody and drug via either a cleavable or non-cleavable linker because these represent the two choices in designing ADCs. Similarly, it would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention to conjugate either doxorubicin or MMAE to the HUI77 antibody because they are both indicated in treating cancer (see the table at p. 3891 of Su and colleagues). In choosing either cleavable or non-cleavable linkers and either doxorubicin or MMAE when designing an ADC, the person of ordinary skill in the art would be choosing from a finite number of identified, predictable solutions with a reasonable expectation of success. In the case of the type of linker, there are only two choices. Furthermore, the person of ordinary skill in the art could have reasonably expected success because the therapeutic properties of both drugs were known and widely used to treat cancer.
Thus, the claims do not contribute anything non-obvious over the prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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