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
The election without traverse filed April 10, 2026, is acknowledged and has been entered. Applicant has elected Group VI.
The amendment filed April 28, 2026, is acknowledged and has been entered. Claims 1-3, 6, 13, 16-18, 20, 23, 24, 27, 50, 57-60, and 63-75 have been canceled. Claims 61 and 62 have been amended. Claims 76-91 have been newly added.
Claims 61-62 and 76-91 are pending. Claims 61 and 84-91 are withdrawn from further consideration, as being drawn to non-elected invention. Claims 62 and 76-83 are under consideration.
Information Disclosure Statement
The information disclosure statements have been considered.
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 62 and 76-83 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 62 and 76-83, the phrase “preferably” and “such as” occurs in claim 62 which renders the claims indefinite because it is unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d). Examples and preferences in a claim may lead to confusion over the intended scope of the claim. The description of examples or preferences is properly set forth in the specification rather than the claims.
It is noted that claim limitations which are designated as “preferably” and “such as” will not be considered required for the purposes of applying prior art under 35 U.S.C. §§ 102 and 103.
Claim Rejections - 35 USC § 112
Claims 62 and 76-83 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a NEW MATTER rejection.
Claims 62 and 76-83 have been newly amended to recite a composition that comprises “a plurality of DM4 antibody drug conjugates having an average drug-to- antibody ratio (DAR) of 3.1 to 3.7 (ii) a DM4 drug concentration of 82.0 ug/ml to 100.2 g/ml, and (iii) an aqueous carrier, wherein the composition is suitable for intravenous delivery to a human subject following dilution with an aqueous diluent and preferably wherein the composition is used in the treatment of disease, such as any condition or disorder, such as cancer and immunological disorders, that damages or interferes with the normal functioning of a cell, tissue, or organ. The other claims all depend on claim 62. New claim 76 recites that “the potency of the composition is within a therapeutic range optimized to achieve maximal therapeutic efficacy with minimal eye toxicity”.
In the response filed April 10, 2026, Applicant submits that “Support for these amendments is found in the specification and claims as originally filed, for example, in the specification at page 3, line 21 through page 4, line 4; page 15, line 36 through page 16, line 34; page 22, lines 8-17; page 23, lines 7-9; page 28, lines 21-25; page 29, lines 1-15; page 30, lines 1-10; page 30, line 23 through page 31, line 8; page 32, lines 5-9; page 36, lines 1-9; page 39, lines 20-27; page 40, lines 1-4; page 45, line 6 through page 46, line 3; and page 47, line 22 through page 48, line 3; and Figures 1-4 and 9”.
Contrary to Applicant's assertion, however, it does not appear that the specification, including the claims and figures, as originally filed, provides written support for the language of the claims.
In this case, Figure 9B discloses DM4 concentrations, DAR and antibody concentrations in table format, wherein DM4 concentrations, DAR and antibody concentrations vary such that, e.g., an antibody concentration of 5.0 mg/ml corresponds to e.g., a DAR of 3.4 and a DM4 concentration of 91.1 µg/ml, a DAR of 3.3 and a DM4 concentration of 89.2 µg/ml, etc., but the claims only recite ranges and only ranges of DAR and DM4 concentration without reciting any antibody concentration. Furthermore, while new claim 79 recites antibody concentration of 4.6 mg/ml and 5.4 mg/ml, the DAR values and DM4 concentrations in claim 62 correspond to antibody concentrations outside of these values, so a composition that comprises “a plurality of DM4 antibody drug conjugates having an average drug-to-antibody ratio (DAR) of 3.1 to 3.7 (ii) a DM4 drug concentration of 82.0 ug/ml to 100.2 g/ml, and (iii) an aqueous carrier, with an antibody protein concentration between 4.6 mg/ml and 5.4 mg/ml introduces new matter. Then with respect to the limitation “wherein the composition is suitable for intravenous delivery to a human subject following dilution with an aqueous diluent” it does not appear the specification discloses such limitations. Finally, with respect to new claim 76 support for “the potency of the composition is within a therapeutic range optimized to achieve maximal therapeutic efficacy with minimal eye toxicity” also could not be found.
Therefore, given the apparent difference in the claims and that of the pertinent disclosures it is submitted that this clearly illustrates that such amendments have in fact introduced new concepts, thereby violating the written description requirement set forth under 35 U.S.C. §112, first paragraph.
Otherwise, these issues might be resolved if Applicant were to point to other disclosures in the specification, including the claims, as originally filed, which are believed to provide the necessary written support for the language of the instant claims.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 62, 76-77 and 82-83 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Sanicola-Nadel, Michele (WO 2008/150530 A2) as evidenced by the instant specification.
With respect to claims 62 and 76-77, Sanicola-Nadel discloses compositions that comprise a plurality of DM4 antibody drug conjugates having an average drug-to-antibody ratio (DAR) of 3.5 with an antibody concentration of 5.0 mg/ml and an aqueous carrier, wherein the composition is suitable for intravenous delivery to a human subject following dilution with an aqueous diluent (see pages 6,76 and 92). While Sanicola-Nadel is silent as to the DM4 drug concentration of the composition, as evidenced by instant Figure 9B, compositions comprising DM4 antibody drug conjugates having an average drug-to-antibody ratio (DAR) of 3.5 with an antibody concentration of 5.0 mg/ml corresponds to a DM4 drug concentration of 92.9 µg/ml which is about 91.1 µg/ml. With respect to claim 76, which recites a property of the composition, the compositions of the prior art are materially indistinguishable from the instantly claimed composition, and Applicant is reminded that products of identical composition cannot have mutually exclusive functions. A chemical composition and its properties are inseparable. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. Therefore, while the prior art not expressly disclose the property of claim 76, the products of the prior art necessarily meet this limitation, absent a showing otherwise.
With respect to claims 82-83, these claims further recite intended use of the claimed composition and do not materially distinguish the claimed compositions from those of the prior art which are materially indistinguishable from the instantly claimed composition, so the products of the prior art also would be suitable for these uses, absent a showing otherwise. Furthermore, the compositions of the prior art are disclosed as being used in methods of treating ovarian cancer (see claims 1-10).
Furthermore, the Office does not have the facilities for examining and comparing Applicant's products with the products of the prior art in order to establish that the products of the prior art possesses the same material, structural, and functional characteristics as Applicant’s products. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the products to which the claims are directed are different than that taught by the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA, 1977) and Ex parte Gray, 10 USPQ2d 1922 1923 (PTO Board of Patent Appeals and Interferences, 1988 and 1989).
Therefore, Sanicola-Nadel is deemed to anticipate the instant claims absent a showing otherwise.
Claim Rejections - 35 USC § 103
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.
Claims 62 and 76-83 are rejected under 35 U.S.C. 103 as being unpatentable over Ab et al (US 2012/0009181 A1, IDS) and by Sanicola-Nadel, Michele (WO 2008/150530 A2) as evidenced by the instant specification.
Ab et al discloses compositions that comprise a plurality of huMov19-sulfo-SPDB-DM4 antibody drug conjugates comprising an antibody comprising a light chain comprising the amino acid sequence as shown in SEQ ID NO:13 (comprises instant SEQ ID NO:4) and a heavy chain comprising the amino acid sequence as shown in SEQ ID NO:6 (comprises instant SEQ ID NO:5) having an average drug-to-antibody ratio (DAR) of 3.4 and an aqueous carrier, wherein the composition is suitable for intravenous delivery to a human subject following dilution with an aqueous diluent (see pages 3, 21-22, 25 and 30).
Sanicola-Nadel discloses compositions that comprise a plurality of DM4 antibody drug conjugates having an average drug-to-antibody ratio (DAR) of 3.5 with an antibody concentration between 1-10 mg.ml, with preferred antibody concentration of 5.0 mg/ml and an aqueous carrier, wherein the composition is suitable for intravenous delivery to a human subject following dilution with an aqueous diluent (see pages 6, 76 and 91-92). While Sanicola-Nadel is silent as to the DM4 drug concentration of the composition, as evidenced by instant Figure 9B, compositions comprising DM4 antibody drug conjugates having an average drug-to-antibody ratio (DAR) of 3.5 with an antibody concentration of 5.0 mg/ml corresponds to a DM4 drug concentration of 92.9 µg/ml which is about 91.1 µg/ml, while compositions comprising DM4 antibody drug conjugates having an average drug-to-antibody ratio (DAR) of 3.4 with an antibody concentration of 5.0 mg/ml corresponds to a DM4 drug concentration of 91.1 µg/ml.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to formulate a composition comprising huMov19-sulfo-SPDB-DM4 antibody drug conjugates comprising an antibody comprising a light chain comprising the amino acid sequence as shown in SEQ ID NO:13 (comprises instant SEQ ID NO:4) and a heavy chain comprising the amino acid sequence as shown in SEQ ID NO:6 (comprises instant SEQ ID NO:5) having an average drug-to-antibody ratio (DAR) of 3.4 and an aqueous carrier at an antibody concentration of 5.0 mg/ml which corresponds to a DM4 drug concentration of 91.1 µg/ml because the prior art recognized that antibody drug conjugates are commonly formulated between 1-10 mg/ml with a preferred concentration of 5 mg/ml. Notably, Sanicola-Nadel provides motivation to formulate the Ab et al antibody at a concentration of 5.0 mg/ml because that is a preferred concentration. Furthermore, one of skill in the art would see such a combination as combining prior art elements according to known methods to yield predictable results because 5 mg/ml is a known concentration of antibody drug conjugate and it was clear that concentration of the antibody could be varied to achieve a desired result, i.e., a stable and effective therapeutic composition.
In this case, with respect to the antibody concentration of 5.0 mg/ml, the art taught that the skilled artisan can readily vary and make different antibody concentrations, so a composition comprising huMov19-sulfo-SPDB-DM4 antibody drug conjugates comprising an antibody comprising a light chain comprising the amino acid sequence as shown in SEQ ID NO:13 (comprises instant SEQ ID NO:4) and a heavy chain comprising the amino acid sequence as shown in SEQ ID NO:6 (comprises instant SEQ ID NO:5) having an average drug-to-antibody ratio (DAR) of 3.4 and an aqueous carrier at an antibody concentration of 5.0 mg/ml would have been considered obvious, absent a showing otherwise. Notably, as evidenced by the references, different antibody concentrations were recognized as variables which achieve a recognized result and as set forth in MPEP 2144.05: “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977).
It is a common objective in the art to optimize result effective variables, so as achieve optimal effect and maximal benefit. See In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” (citations omitted)). Therefore, the optimization of the antibody concentration of Ab et al using the teaching of Sanicola-Nadel would be seen as routine optimization, absent a showing otherwise, because one would see these limitations as combining prior art elements according to known methods to yield predictable results and simple substitution of one known element for another to obtain predictable results. Furthermore, one of skill in the art would have expected success in making such compositions as the prior art of Sanicola-Nadel discloses that such an antibody concentration can be made.
With respect to claim 76, which recites a property of the composition, the compositions suggested by the prior art are materially indistinguishable from the instantly claimed composition, and Applicant is reminded that products of identical composition cannot have mutually exclusive functions. A chemical composition and its properties are inseparable. In re Spada 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. Therefore, while the prior art not expressly disclose the property of claim 76, the products suggested by the prior art necessarily meet this limitation, absent a showing otherwise.
With respect to claims 82-83, these claims further recite intended use of the claimed composition and do not materially distinguish the claimed compositions from those of the prior art which are materially indistinguishable from the instantly claimed composition, so the products suggested by the prior art also would be suitable for these uses, absent a showing otherwise. Furthermore, the compositions of the prior art of Ab et al are disclosed as being used in methods of treating ovarian cancer (see page 29).
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The Examiner works a flexible schedule and can normally be reached Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
September 25, 2026
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