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 .
Claim Status
Applicant’s amendments and remarks, filed 12/23/2025, are acknowledged.
Claims 6-9, 13, 21-23, and 25-35 are canceled.
Claims 1-3, 10-12, 14, 15, and 17 are amended.
Claims 36-52 are new.
Claims 1-5, 10-12, 14-20, 24, and 36-52 are pending.
Claims 17-20 and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/23/2025.
As such, claims 1-5, 10-12, 14-16, and 36-52 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/23/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections
The drawings objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the specification on 12/23/2025.
The specification objections are withdrawn. Issues regarding minor informalities and trademarks/names have been sufficiently addressed through amendments to the specification on 12/23/2025.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 12/23/2025.
Withdrawn Rejections
Applicant’s arguments, see page 15, filed 12/23/2025, with respect to claims 6 and 13 rejected under 35 USC 112(d) as allegedly being of improper dependent form have been fully considered and are persuasive. The issue regarding improper dependent subject matter have been sufficiently addressed through amendments to the claims. Specifically, Examiner acknowledges that claims 6 and 13 are canceled thus rendering the rejection moot.
Applicant’s arguments, see page 15, filed 12/23/2025, with respect to claims 1-6 and 10-16 rejected under 35 USC 112(b) as allegedly being indefinite have been fully considered and are persuasive. The issue regarding the claims comprising indefinite language have been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claims 6 and 13 are canceled thus rendering the rejection moot. As such, the rejection under 35 USC 112(b) is withdrawn.
Applicant’s arguments, see pages 15 and 16, filed 12/23/2025, with respect to claim 13 rejected under 35 USC 112(a) as allegedly lacking enablement have been fully considered and are persuasive. The issue regarding the specification failing to reasonably provide enablement for treating all cancers with the claimed anti-MUC1 immunoconjugates has been sufficiently addressed through amendments to the claims. Further, Examiner acknowledges that claim 13 is canceled thus rendering the rejection moot.
Applicant’s remarks, see page 18, filed 12/23/2025, with respect to claims 1-6 and 10-16 rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-12, 15, and 21 of U.S. Patent No. 8,648,172 have been fully considered and are persuasive. Examiner acknowledges that claims 6 and 13 are canceled, thus rendering the rejection moot. Further, Examiner acknowledges that the ‘172 claims do not explicitly recite the species of anti-MUC1 antibodies as claimed in the present application. As such, the double patenting rejection is withdrawn.
New Objections Necessitated by Amendment
Claim Objections
Claims 1(b) and 44 are objected to because of the following informalities:
Claim 1(b) recites the term “SEQ ID NO." which is an inappropriate period. The term should read “SEQ ID NO:”. 37 CFR 1.821(c) requires that each sequence disclosed in the application appear separately in the “Sequence Listing,” with each sequence further being assigned a sequence identification number, referred to as “SEQ ID NO:” (see MPEP 2422.04).
Claim 44 is missing a period at the end of the sentence.
Appropriate correction is required.
Maintained Rejections
Claim Rejections - 35 USC § 102
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 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.
WO2006/081553 A2
Claims 1-5, 10-12, 14-16, and 36-49 are rejected under 35 U.S.C. 102(a)(1) and 35 USC 102(a)(2) as being anticipated by Rubenstein et al (WO 2006/081553 A2, publication date: 08/03/2006; previously submitted with the Office Action mailed on 07/30/2025).
With respect to instant claims 1-3, Rubinstein et al disclose of antibodies that simultaneously bind the α- and β- subunits of an intact MUC1 protein, and methods for making and using such antibodies (see Abstract). Rubinstein et al teach that the MUC1 protein is a type I transmembrane protein comprised of a heavily glycosylated extracellular domain containing a tandem-repeat-array, a transmembrane domain, and a cytoplasmic domain (MUC1/TM); MUC1/TM is proteolytically cleaved soon after its synthesis generating two subunits, α and β which specifically recognize and bind in a strong non-covalent interaction and cleavage of the MUC1 into the two subunits occurs in the SEA module (see [0004]). Thus, the claimed antibodies bind to the SEA domain. Specifically, Rubenstein et al disclose of monoclonal antibody DMC209 (see [0106]). While Rubenstein et al does not explicitly disclose of the sequence of this antibody, it shares the same name as the antibody disclosed in the present application comprising instant HCDR sequences SEQ ID NOs: 55-57 and LCDR sequences SEQ ID NOs: 58-60 and corresponding VH/VL sequences SEQ ID NOs: 23 and 24. As such, the antibodies are the same and thus inherently the antibody of Rubenstein and the present invention share the same structure and properties (see MPEP 2112.01).
With respect to instant claims 4 and 5, Rubinstein et al disclose that the antibodies can be polyclonal, chimeric, humanized, or fully human (see [0075]). Additionally, Rubinstein et al disclose that the antibodies can be single chain Fv fragments (scFv), Fab, F(ab)2, etc. (see [0038]).
With respect to instant claims 10-12 and 36-49, Rubinstein et al disclose that the claimed antibodies can be conjugates to various compounds such as radiodiagnostic compounds, radiotherapeutic compounds, drugs, and toxins (see [0090]). Additionally, Rubinstein et al disclose that the claimed antibodies can be conjugated to pseudomonas toxin (see [0075]). Rubinstein et al disclose that the claimed antibodies can be used in methods of diagnosing or providing a prognosis of a cancer of a tissue that overexpresses MUC1 (see [0072] and [0111]-[0114]).
With respect instant claim 14, Rubinstein et al disclose that the claimed antibodies can be bispecific antibodies (see [0038]).
With respect to instant claims 15 and 16, Rubinstein et al disclose that the claimed antibodies can be formulated into pharmaceutical compositions comprising a physiologically compatible carrier and can be combined with other therapeutic agents (see [0082]).
As such, the teachings of Rubenstein et al anticipate the present invention.
Rubenstein et al
Claims 1-5, 10-12, and 49 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubenstein et al (Int. J. Cancer: 124, 46–54 (2009); previously submitted with the Office Action mailed on 10/01/2025).
With respect to instant claims 1-5, Rubenstein et al disclose of monoclonal antibody DMC209 and demonstrated that the antibody showed significant in vivo tumor-suppressive activity (see Abstract and Fig. 6). While Rubenstein et al does not explicitly disclose of the sequence of this antibody, it shares the same name as the antibody disclosed in the present application comprising instant HCDR sequences SEQ ID Nos: 55-57 and LCDR sequences SEQ ID Nos: 58-60 and corresponding VH/VL sequences SEQ ID Nos: 23 and 24. As such, the antibodies are the same and thus inherently the antibody of Rubenstein and the present invention share the same structure and properties (see MPEP 2112.01).
With respect to instant claims 10-12 and 49, Rubenstein et al disclose of Pseudomonas toxin PE38 linked to polyclonal anti-MUC1 α/β junction Abs both bound and killed MUC1-positive malignant cells (see Abstract and Figure 4).
As such, the teachings of Rubenstein et al anticipate the present inventions.
Pichinuk et al
Claims 1-5, 10-12, and 49-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pichinuk et al (Cancer Res; 72(13); 3324–36; publication date: 07/01/2012); previously submitted with the Office Action mailed on 10/01/2025).
With respect to claims 1-5, Pichinuk et al generated a set of MUC1 monoclonal antibodies that target a region termed the SEA domain that remains tethered to the cell surface after MUC1 cleavage (see Abstract). In particular, Pichinuk et al disclose of DMB4B4, DMB4F4, DMB5F3, DMB7F3, DMB10F10, DMB10B7, DMB13D11, and DMC209 (see Fig. 1). While Pichinuk et al does not explicitly disclose of the sequences of these antibodies, the antibodies disclosed in Fig. 1 share the same name as the antibodies disclosed in the present application comprising the claimed CDR sequences and corresponding VH/VL sequences. As such, the antibodies disclosed by Pichinuk et al are the same as the antibodies of the present invention, thus they inherently share the same structure and properties (see MPEP 2112.01).
Additionally, Pichinuk et al disclose of preparing DMB5F3, a partially humanized antibody, IgG1 Fab fragments (see Abstract and pg. 3326, right col.).
With respect to claims 10-12 and 49, Pichinuk et al disclose of fusing a chimeric DMB5F3 with a ZZ-PE38 fusion protein to form an immunotoxin conjugate (see pg. 3326, left col.). Pichinuk et al disclose that the immunotoxin conjugate was potently cytocidal to T47D human breast cancer cells (see pg. 3331, right col.).
As such, the teachings of Pichinuk et al anticipate the present application.
Guillaume et al
Claims 1-5, 10-12, 43, and 50-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guillaume et al (Experimental Hematology Feb 2019;70:97−108); previously submitted with the Office Action mailed on 10/01/2025).
With respect to claims 1-5 and 50-52, Guillaume et al disclose of DMB-5F3, a partially humanized single chain murine anti-MUC1 SEA domain monoclonal antibody, used to examine MUC1 expression in acute myeloid leukemia (AML) and was found to bind acute myelomonocytic and monocytic leukemia (AML-M4 and AML-M5) cell lines (see Abstract). While Guillaume et al does not explicitly disclose of the sequences of DMB5F3, the antibody shares the same name as the antibody disclosed in the present application comprising the claimed CDR sequences SEQ ID Nos: 25-30 (see Table 3) and corresponding VH/VL sequences SEQ ID Nos: 13 and 14 (see Table 2). As such, DMB5F3 disclosed by Guillaume et al are the same as the DMB5F3 of the present invention, thus they inherently share the same structure and properties (see MPEP 2112.01).
With respect to claims 10-12 and 43, Guillaume et al disclose of a construct consisting of a humanized, dimeric single-chain antibody of DMB-5F3 fused to gelonin, a type I ribosome-inactivating toxin, thereby generating a 5F3-VHVL-gelonin immunotoxin (see pgs. 98 and 99). Guillaume et al disclose that the immunotoxin was highly cytotoxic to MUC1+ monocytic lineage AML cell lines (see pg. 99, left col.).
As such, the teachings of Guillaume et al anticipate the present invention.
Applicant’s Arguments
Applicant requests withdrawal of all rejections under 35 USC 102(a)(1) (see pages 16 and 17 of the Remarks filed 12/23/2025).
While all of the cited references disclose anti-MUC1 antibodies, none of the cited art discloses the sequence of the anti-MUC1 antibodies therein. As the cited art does not provide the sequence of an anti-MUC 1 antibody, claims directed to particular anti-MUC 1 antibody sequences are not anticipated… In contrast, Applicant discloses the CDR sequences of several anti-MUC1 monoclonal antibodies (DMB5F3, DMB7F3, DMB4B4, DMB10F10, DMB4F4, DMB10B7, DMB13D11 and DMC209) that target the MUC1 SEA-a-3 region (SEQ domain) of the receptor. Without specific amino acid sequences of at least the CDR residues, it would not have been possible for one of skill in the art to make the anti-MUC1 antibodies claimed by Applicant, which are defined by the CDR sequences. Even though the cited art provides methods of making anti-MUC 1 antibodies, one of skill in the art could not have expected to isolate anti-MUC1 antibodies which bind the MUC1 SEQ domain having the exact CDR sequences of the antibodies presently claimed. In order for a reference to be enabling for making such an antibody, the reference must provide either the structural (sequence) information, or a clear method for producing the antibody without undue experimentation. The chance of isolating anti-MUC1 antibodies with the same CDR sequences as those claimed based on teachings provided in the cited art is infinitesimally small. Accordingly, it would require undue experimentation for one of skill in the art to produce an antibody having the CDR sequences of the claimed antibodies based on the disclosures in the cited art. The requirement for a reference cited in a novelty rejection to be enabling is discussed in MPEP 2121.01.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Examiner acknowledges that the cited art do not explicitly recite the sequences of anti-MUC1 therein, however MPEP 2112 addresses rejections based on inherency. MPEP 2112(III) states: “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.”
In this case, the art teaches of anti-MUC1 antibodies; specifically, the art names specific anti-MUC1 antibodies. The names of the anti-MUC1 antibodies recited in the art are the same as those disclosed in the instant application. Furthermore, the art shares common inventors as the instant application. As such, it would be inherent that the named antibodies recited in the art would have the same sequences as the antibodies with the same name disclosed in the instant application.
Further, with respect to Applicant’s argument that it would require undue experimentation for one of skill in the art to produce an antibody having the CDR sequences of the claimed antibodies based on the disclosures in the cited art, Applicant is reminded that MPEP 2121.01 also states a reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the effective filing date of the claimed invention for applications or patents subject to the first inventor to file provisions of the AIA or at the time the invention was made for applications or patents subject to pre-AIA law. Further, MPEP 2121.01(I) states: “It is possible to make a 35 U.S.C. 102 rejection even if the reference does not itself teach one of ordinary skill how to practice the invention, i.e., how to make the article disclosed or use the method disclosed. If the reference teaches every claimed element of the article or every claimed step of the method, secondary evidence, such as other patents or publications, can be cited to show public possession of the method of making the article or using the method. In re Donohue, 766 F.2d at 533, 226 USPQ at 621." The references used in the rejections: (1) were published before the effective filing date of the claimed invention; (2) provided methods of producing the antibodies; (3) disclosed that the antibodies demonstrated antitumor properties; and, (4) as stated previously, share common inventors and possess the same name as the present application. Therefore, producing the antibodies would not require undue experimentation based on the disclosures of the cited art.
As such, the 102 rejections are maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674