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
1. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above. Applicant is reminded that in the instant case the file name is incorrect. The correct information is: 101017_000016_-_Sequence_Listing.txt . (See the Electronic Filing System Acknowledgment Receipt mailed 3/31/2022 at “Information” column 6.)
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
2. Applicant’s amendment and response filed 3/9/26 is acknowledged and has been entered.
3. Applicant is reminded of Applicant's election of the following species in Applicant’s amendment and response filed 6/2/25.
T106A/A145D amino acid substituents relative to SEQ ID NO: 1 for the aglycosylated IFNa2b, the sequence of which is SEQ ID NO: 25; the antibody is specific for CD38 with the VH corresponding to SEQ ID NO: 48 and the VL corresponding to SEQ ID NO: 81; the fusion peptide comprises SEQ ID NO: 87 (which comprises the VH/VC [entire heavy chain portion of A10.21 antibody S228P/IgG4] corresponding to SEQ ID NO: 48 fused to the aglycosylated IFNa2b corresponding to SEQ ID NO: 25) and SEQ ID NO: 81 (which is the A10.21 antibody light chain).
Applicant’s amendment and response has necessitated search and examination be extended to SEQ ID NO: 3-24, 26-30, and 32-47 (the amino acid sequences of aglycosylated IFNa2b recited in instant dependent claim 9) and SEQ ID NO: 31, 61-77, and 83 (antibody heavy chain-IFNa2b fusion polypeptide), and SEQ ID NO: 82 and SEQ ID NO: 84 (antibody light chains).
Claims 4-6, 9-12 and 14-21 read upon the elected species.
Claims 4-6, 9-12 and 14-21 are presently being examined as they read upon the elected species, upon SEQ ID NO: 3-24, 26-47, 61-77, 82-84, and upon the species enunciated in the art rejection below.
4. Applicant’s amendment filed 3/9/26 has overcome the prior rejection of record of claim 21 under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism.
Applicant has amended claim 21 to recite an isolated cell.
5. Applicant’s amendment filed 3/9/26 has overcome the prior rejection of record of claims 4-6, 10-16 and 21 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.
Applicant has amended the claims to recite specific attenuating mutations relative to SEQ ID NO: 1, and has amended the claims that recite a heavy or light chain to comprise both.
6. Applicant’s amendment filed 3/9/26 has overcome the prior rejection of record of claims 12 and 13 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
Applicant has amended the claim 12 to recite both a heavy and light chain and has canceled claim 13.
7. Applicant’s amendment filed 3/9/26 has overcome the prior rejection of record of claims 5-7 and 9-21 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.
8. Applicant’s amendment and response filed 3/9/26 has overcome the prior rejection of record of claims 4-7, 9-12 and 14-21 under 35 U.S.C. 103 as being obvious over US 9,636,334 (issued from application serial no. 14/701,628 and entitled Combination of Lenalidomide and Polypeptide Construct, and Uses thereof) in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20), as evidenced by an admission in the instant specification at [0131] and at [0054].
Applicant has stated on the record that a of the earliest claimed priority date of the instant application (October 23, 2015), the instant application and the ‘334 patent were owned by, or subject to an obligation of assignment to, Teva Pharmaceuticals Australia TTY, LTD. Accordingly, an exception exists under 35 USC 102(b)(2)(C) and the ‘334 patent is not available prior art. See the said amendment and response at pages 8-9.
9. Applicant’s amendment and response filed 3/9/26 has overcome the prior rejection of record of claims 4-7, 10, 11-16, 19 and 21 under 35 U.S.C. 103 as being obvious over U.S. Patent No. 10,232,041 in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20), as evidenced by admissions in the instant specification at [0131] and at [0054].
Applicant has stated on the record that a of the earliest claimed priority date of the instant application (October 23, 2015), the instant application and the ‘041 patent were owned by, or subject to an obligation of assignment to, Teva Pharmaceuticals Australia TTY, LTD. Accordingly, an exception exists under 35 USC 102(b)(2)(C) and the ‘041 patent is not available prior art. See the said amendment and response at pages 8-9.
10. Applicant’s amendment field 3/9/26 has overcome the prior rejection of record of claim 4 under 35 U.S.C. 101 as claiming the same invention as that of claim 17 of prior U.S. Patent No. 10,544,199. This is a statutory double patenting rejection.
Applicant has presently amended instant claim 4 to recite limitations not recited by claim 17 of US 10,544,199.
11. 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.
12. The instant specification discloses at [0053] that an unexpected advantage obtained using constructs comprising [attenuated and] aglycosylated [on T106] IFNa2b as compared to constructs comprising O-glycosylated IFNa2b include an increase in on-target activity, increased target selectivity, and enhanced affinity to FcRn.
13. Claim interpretation:
The specification does not disclose a definition, limiting or otherwise, for the limitation “attenuate”, nor does it disclose a definition for “activity” with regard to activity of IFNa2b. Evidentiary reference Merriam-Webster Dictionary (2026, 10 pages, of record) teaches that “attenuated” means to lessen the amount, force, magnitude, or value of. The specification discloses that the IFN portion of the fusion construct can be mutated in such a way that the IFN activity on antigen-negative cells is dramatically attenuated, while the IFN activity on antigen-positive cells is only modestly, if all, attenuated ([0052]). The specification further discloses that in one embodiment, the antibody-attenuated fusion construct retains at least 30% of the maximal activity of the non-attenuated free IFN, with “maximal activity” being understood as meaning the amount of signaling activity or downstream effect thereof) at the high, plateau portion of a dose-response curve, where further increases in the agent does not further increase the amount of response ([0052]). Evidentiary reference Lukhele et al (Sem. Immunol., 2019, 43: 101277, pages 1-38, of record) teaches that IFNa2b is a type I IFN that inhibits virus replication, initiates and enhances antigen presentation (Introduction), acts directly as well as indirectly on T and B cells to trigger adaptive immune responses and regulating innate and adaptive immune cells (Abstract), and can trigger negative regulatory factors such as IL-10, IDO, PDL1 and suppressive cell types that can dampen T cell responses (see entire reference, especially adaptive resistance section at the third paragraph). In addition, the open transitional phrase “comprises” opens the limitation preceding it to include non-recited portions. Also, the recitation of an aglycosylation mutation relative to SEQ ID NO: 1 at position T106, along with one or more of the attenuation mutations recited in instant base claim 4 does not require the remainder of the sequence of the IFNa2b to be identical to that of SEQ ID NO: 1, and the open transitional phrases in the claim also allow for changes other than at the recited positions.
14. 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.
15. Claim 4. (Currently amended) A vector comprising a polynucleotide encoding a fusion
polypeptide comprising a first and a second domain, wherein the first domain comprises an
antibody, or antigen binding portion thereof, which binds to a cell surface-associated antigen and
the second domain comprises an aglycosylated interferon a 2b (IFNa2b) comprising an amino
acid sequence wherein T106 is deleted or substituted with an amino acid selected from the group
consisting of A, C, D, E, F, G, H, I, K, L, M, N, P, Q, R, S, V, W and Y, wherein T106 is relative
to SEQ ID NO: 1 and wherein the aglycosylated IFNa2b further comprises one or more amino
acid substitutions or deletions that attenuate the activity of the aglycosylated IFNa2b, and
wherein
(i) where T106 is deleted, the one or more amino acid substitutions or deletions that
attenuate the activity of the aglycosylated IFNa2b is selected from L15A, R22A, R23A, S25A,
L26A, F27A, L30A, L30V, K31A, D32A, R33A, R33K, R33Q, H34A, Q40A, D113R, L116A,
R119A, R119E, R124A, R124E, K130A, E131A, K132A, K133A, M147A, R148A, S149A,
L152A, N155A, (L30A, H57Y, E58N and Q61S), (R33A, H57Y, E58N, Q61S), (M147A,
H57Y, E58N and Q61S), (L152A, H57Y, E58N and Q61S), (R143A, H57Y, E58N and Q61S),
(N65A, L80A, Y85A and Y89A,) (N65A, L80A, Y85A. Y89A and D113A), (N65A, L80A,
Y85A, Y89A and L116A), (N65A, L80A, Y85A, Y89A and R1190A), (Y85A, Y89A and
D113A), (Y85A, Y89A, and R119A), (D113A and R119A), (L116A and R119A), (L116A,
R119A and K120A), (R119A and K120A), (R119E and K120E), replacement of R at position
143 with A, D, E, G, H, I, K, L, N, Q, S, T. V or Y, replacement of A at position 144 with D, E,
G,H,I,K, L, M, N, Q, R, S, T, V or Y, and deletion of residues L160 to E164; or
(ii) where T106 is substituted with an amino acid selected from the group consisting of A,
C, D, E,F, G, H, I, K,L,M,N,P,Q,R,S,V,W and Y, the one or more amino acid substitutions
or deletions that attenuate the activity of the aglycosylated IFNa2b is selected from L15A, R22A,
R23A, S25A. L26A, F27A, L30A, L30V, K31A, D32A, R33A, R33K, R33Q, H34A. Q40A,
D114R, L117A, R120A, R120E, R125A, R125E, K131A, E132A, K133A, K134A, M148A,
R149A, S152A, L153A, N156A, (L30A, H57Y, E58N and Q61S), (R33A, H57Y, E58N, Q61S),
(M148A, H57Y, E58N and Q61S), (L153A, H57Y, E58N and Q61S), (R144A, H57Y, E58N and
Q61S), (N65A, L80A, Y85A and Y89A), (N65A, L80A, Y85A, Y89A and D114A), (N65A,
L80A, Y85A, Y89A and L117A), (N65A, L80A, Y85A, Y89A and R120A), (Y85A, Y89A and
D114A), (Y85A, Y89A, and R120A), (D114A and R120A), (L117A and R120A), (L117A,
R120A and K121A), (R120A and K121A), (R120E and K121E), replacement of R at position
144 with A, D, E, G, H,I,K, L, N, Q, S. T. V or Y, replacement of A at position 145 with D, E,
G,H,I,K,L, M, N, Q, R, S, T, V or Y, and deletion of residues L161 to E165.
Claim 21 (Currently amended) An isolated transformed cell comprising the vector of claim 4.
Claims 4-6, 10-12, 14-16, 19 and 21 are rejected under 35 U.S.C. 103 as being obvious over US 11,253,591 in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20, of record), as evidenced by an admission in the specification at [0131].
This is a new ground of rejection necessitated by Applicant’s amendment and response filed 3/9/26.
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
US 11,253,591 discloses an anti-CD38 antibody-attenuated human IFNa2b construct (e.g., abstract). US 11,253,591 discloses that the C-terminus of the anti-CD38 antibody heavy chain may be fused to the N-terminus of the attenuated IFNa2b directly via a peptide bond e.g., column 3 at lines 51-57). US 11,253,591 discloses that the anti-CD38 antibody may be “A10.21” (e.g., Fig. 4). US 11,253,591 discloses that the VH may comprise SEQ ID NO: 18 and the VL may comprise SEQ ID NO: 22 or may comprise other VH/VL pairs such as SEQ ID NO: 19/21, 28/29 or 30), with a preferred embodiment being SEQ ID NO: 27/29 column 4 at lines 5-32).
The admission in the instant specification at [0131] is that anti-CD38 antibody “A10.21” (the same antibody as disclosed by the primary art reference above) has a heavy chain sequence corresponding to instantly recited SEQ ID NO: 48 and a light chain sequence corresponding to instantly recited SEQ ID NO: 81. Thus, the art anti-CD38 antibody (“A10.21”) may comprise instantly recited SEQ ID NO: 48 and SEQ ID NO: 81.
US 11,253,591 discloses that the attenuated IFNa2b may comprise the amino acid sequence of SEQ ID NO: 212 or 213 (column 4 at lines 62-66 and column 5 at lines 1-19).
SEQ ID NO: 212 of US 11,253,591 has T106A and A145D relative to instantly recited SEQ ID NO: 1 and also has a K70M amino acid substituent. SEQ ID NO: 213 of US 11,253,591 has T106A and A145G relative to instantly recited SEQ ID NO: 1 and also has a K70M mutation. Note that position 70 is not an attenuation position recited at part “(ii)” of instant base claim 4. Also note that the aglycosylated IFNa2b portion of the fusion polypeptide need not be SEQ ID NO: 1; the aglycosylation mutation and the attenuating mutation(s) must be relative to SEQ ID NO: 1. The open transitional phrases recited in instant base claim 4 open the claim to encompass other changes that are not attenuating mutations, deletions, and/or additions, i.e., “the second domain comprises an aglycosylated interferon a 2b (IFNa2b) comprising an amino acid sequence wherein T106 is deleted or substituted with an amino acid selected from the group consisting of A…., wherein T106 is relative to SEQ ID NO: 1 and wherein the aglycosylated IFNa2b further comprises one or more amino acid substitutions or deletions that attenuate the activity of the aglycosylated IFNa2b”.
Instant dependent claims 17 and 18 are included in this rejection because the art reference discloses that the anti-CD38 antibody portion of the fusion polypeptide may be antibody A10.2. Thus, based on the admission in the instant specification at [0131], the primary art reference inherently discloses that the fusion polypeptide comprises an amino acid that is a heavy chain sequence corresponding to instantly recited SEQ ID NO: 48 and a light chain sequence corresponding to instantly recited SEQ ID NO: 81.
US 11,253,591 discloses that antibodies may be recombinantly produced (i.e., using encoding nucleic acid molecules introduced into a host cell for production (e.g., column 8 at line 67, column 9 at lines 1-3, column 11 at lines 10-21). US 11,253,591 discloses using the fusion polypeptide to treat tumors in a subject (e.g., abstract). See entire reference.
US 11,253,591 does not disclose a vector comprising a polynucleotide encoding the fusion polypeptide, nor an isolated transformed cell comprising the vector.
Jager et al teach production of antibody fusion proteins in host cells comprising transforming said host cells with a vector encoding the fusion protein (see entire reference).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide sequence encoding the fusion polypeptide disclosed by the primary art reference and to have transformed an isolated host cell as per the teaching of Jager et al.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to produce the fusion polypeptide for use in the method of treating tumors disclosed by US 11,253,591.
As is stated above, it bears repeating that SEQ ID NO: 212 has T106A and A145D while SEQ ID NO: 213 of the art reference has T106A and A145G amino acid substituents, but also comprises a K70M amino acid substituent (and because of the K70M mutation these art sequences are not identical to Applicant’s elected species of instantly recited SEQ ID NO: 25). Note that position 70 is not a position for attenuation that is recited in instant base claim 4 at part (ii), and instant base claim 4 recites “the second domain comprises an aglycosylated interferon a 2b (IFNa2b) comprising an amino acid sequence wherein T016…is substituted with an amino acid selected from the group consisting of A… and wherein the aglycosylated IFNa2b further comprises one or more amino acid substitutions or deletions that attenuate the activity of the aglycosylated IFNa2b….”; that is, the claim recites the open transitional phrase “comprises”. Therefore the instant claim language encompasses a non-attenuating mutation at position 70.
16. 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.
17. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
18. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
The instant application is a CON of parent application serial no. 16/710,574 which is a DIV of grandparent application serial no. 14/921,420 (US Patent No. 10,544,199). Note that in 14/921,420, Invention III (a method of generating a polypeptide ligand- attenuated IFNa2b fusion polypeptide in mammalian cells comprising culturing a recombinant mammalian cell comprising a polynucleotide encoding the said polypeptide) was rejoined with elected Invention I (the fusion polypeptide). Accordingly, the instant rejection is set forth below.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 9-12 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 and 18-20 of U.S. Patent No. 10,544,199. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
Claims 1-16, 18 and 19 of US 10,544,199 are drawn to a fusion polypeptide/pharmaceutical composition thereof comprising a first and a second domain, wherein the first domain comprises an antibody or antigen binding portion thereof that binds to a cell surface-associated antigen and the second domain comprises an aglycosylated IFNa2b in which T106 is deleted or substituted with an amino acid selected from those that are recited in claim 1 of ‘199 and further comprising attenuating mutations that are recited in claims 5 and 6 of ‘199, including A145D when T106A is substituted, or including A144D when T106 is deleted (as is recited in instant dependent claim 19). Note that T106A, Applicant’s elected species is recited in claim 1 of ‘199 as well as the others recited in instant base claim 4. Also note that the attenuating mutations are the same as are recited in instant base claim 4. The amino acid sequence of the aglycosylated IFNa2b is selected from the group consisting of SEQ ID NO: 3 to 30 and 32 to 47 (claim 7 of ‘199) which are identical to those recited in the instant dependent claim 9), wherein the cell surface-associated antigen is selected from the same alternatives as are recited in the instant dependent claim 10 (claim 8 of ‘199), including wherein the fusion polypeptide in which the antibody binds to CD38 comprises the same VH and VL (claims 9-11 of ‘199, SEQ ID NO: 48 to 56 and 58, and SEQ ID NO: 81, 82 and 84, respectively, that are identical to those instantly recited SEQ ID NO: 48, 81, 87 (claims 12 and 18). The limitations recited in claims 11-14 of ‘199 are the same as are recited in instant dependent claims 14-16. The limitations recited in claim 18 of ‘199 are the same as those recited in instant dependent claim 17, and those recited in claim 19 of ‘199 are identical to those recited in claim 18 of ‘199. Note that SEQ ID NO: 87 of either of the instant claims or of the claims of ‘199 comprises instantly recited SEQ ID NO: 25 (an aglycosylated IFNa2b recited in instant dependent claim 21).
Claim 20 of US 10,544, 199 is drawn to a method of generating a polypeptide ligand-attenuated IFNa2b fusion polypeptide comprising culturing a recombinant mammalian cell comprising one or more polynucleotides encoding the fusion polypeptide of claim 1.
It would have been prima facie obvious to one of ordinary skill in the art to have made a vector comprising a polynucleotide sequence that encodes any of the aglycosylated (claim 1 of ‘199) and attenuated IFNa2b fusion polypeptides (dependent claims of ‘199) recited in the product claims of ‘199, rather than just the aglycosylated polypeptide of claim 1 of ‘199, and to have transformed the mammalian host cell recited in claim 20 of ‘199 with it. One of ordinary skill in the art would have been motivated to do this in order to make the said fusion polypeptides, and with a reasonable expectation of success in doing so, as methods of making encoding polynucleotide sequences was known in the art before the filing date of the claimed invention.
19. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Note that as the instant application is a CON of 16/710,574 that issued as US 11,319,356, the instant rejection has been set forth below.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 9-12 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,319,356. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The claims of US 11,319,356 are drawn to a method of treating a tumor in a subject comprising administering a fusion polypeptide (the same as is encoded by the vector comprising the polynucleotide recited in the instant claims) having the same T106 substitution or deletion (claim 1 of ‘356) and further comprising attenuating mutations in the IFNa2b second domain of the fusion polypeptide (claims 5-7 of ‘356). The antibody specificity of the first domain portion of the fusion polypeptide has the same antigen specificity as recited in the instant claims, and the claims of ‘356 recite VH of the antibody domain portion as one of SEQ ID NOs: 48-56 and 58, and the VL as one of SEQ ID NOs: 81, 82, and 84, or wherein the fusion polypeptide comprises the amino acid sequence of SEQ ID NO: 87 and 81 (claim 18 of ‘356 and instant dependent claim 18). Claim 8 of ‘356 recites that the sequence of the aglycosylated IFNa2b portion is selected from the group consisting of SEQ ID NOs: 3 to 30 and SQE ID NOs: 32 to 47 (instant claim 9). Claim 16 of ‘356 recites that the sequence of the aglycosylated IFNa2b is SEQ ID NO: 25 (as is also recited in instant dependent claim 20). The SEQ ID NOs recited in the claims of ‘356 are identical to their instantly recited counterparts.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide that encodes the fusion polypeptide administered in the method recited in the claims of US 11,319,356 and to have transformed an isolated host cell with it.
One of ordinary skill in the art would have been motivated to do this in order to make a construct for production of the fusion polypeptide, and with a reasonable expectation of success in doing so, as transforming host cells was an art known for recombinant production of polypeptides, as evidenced for example by the teachings of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20, of record).
20. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 16/317,077 case that issued as US 11,618,784 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 9-12 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,618,784 in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20, of record).
The claims of US 11,618,784 are drawn to a method of treating a tumor in a subject comprising administering a combination therapy comprising (i) a polypeptide construct comprising an attenuated Type I IFNa2b fused to an anti-CD38 antibody and having a T106A aglycosylation mutation (claims 6, 7, 9 of ‘784) as well as a 145D attenuating mutation, and (ii) a CD47 antagonist. The said polypeptide comprises an IFNa2b with the said mutations relative to SEQ ID NO: 3 (identical to instantly recited SEQ ID NO: 1 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 1 versus 077 ID 3, of record). Note that this aglycosylated T106A/145D IFNa2b is identical to instantly recited SEQ ID NO: 25. The fusion polypeptide may correspond to SEQ ID NO: 508 (identical to instantly recited SEQ ID NO: 87 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 87 versus 077 ID 508, of record) and SEQ ID NO: 507 (identical to instantly recited SEQ ID NO: 81 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 81 versus 077 ID 507, of record). Instant claim 12 that recites SEQ ID NO: 48 is included in this rejection because SEQ ID NO: 48 is comprised within instantly recited SEQ ID NO: 87. Also note that dependent claim 5 of ‘784 recites the same attenuating substitutions that are recited at part (ii) of instant base claim 4 in the attenuated IFNa2b portion of the fusion polypeptide. The antigen specificities of the antibody portion of the fusion polypeptide includes those recited in dependent claim 10 of ‘784 (and all of the specificities recited in instant dependent claim 10 are recited therein). The attenuated IFNa2b is linked to the antibody via a peptide bond (claim 2 of ‘784, instant claims 14 and 15), and the attenuated IFNa1b is linked to the C-terminus of the light or heavy chain constant region of the antibody (claim 4 of ‘784, instant claim 16).
The claims of US 11,618,784 do not recite a vector comprising a polynucleotide encoding the fusion polypeptide, nor a transformed cell comprising the vector.
Jager et al teach production of antibody fusion proteins in host cells comprising transforming said host cells with a vector encoding the fusion protein (see entire reference).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide sequence encoding the fusion polypeptide recited in the method claims of US 11,618,784 and to have transformed a host cell with it as per the teaching of Jager et al.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to produce the fusion polypeptide for use in the method of treating tumors disclosed recited in the method claims of US 11,618,784.
Claims 4-6, 9-12 and 14-21 are directed to an invention not patentably distinct from claims 1-21 of US commonly assigned US 11,618,784, as enunciated above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned US 11,618,784, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
21. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 17/733,378 case that issued as US 12,258,401 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 9-12 and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,128,401 (of record) in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20, of record).
The claims of US 12,128,401 are drawn to a composition comprising (i) a fusion of an anti-CD38 antibody with an aglycosylated T106A and attenuated A145D IFNa2b, the latter relative to SEQ ID NO: 3, and (ii) a CD47 antagonist.
Note that as 17/733,378 is a continuing application of 16/317,077 (the latter is now US Patent No 11,648,784), the sequence identifiers are identical with those in said parent application, and Applicant is directed to the evidentiary references noted above in the rejection pertaining to said parent application, i.e., SEQ ID NO: 3 is identical to instantly recited SEQ ID NO: 1 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 1 versus 077 ID 3, of record); said aglycosylated T106A/145D IFNa2b is identical to instantly recited SEQ ID NO: 25. The fusion polypeptide may correspond to SEQ ID NO: 508 (identical to instantly recited SEQ ID NO: 87 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 87 versus 077 ID 508, of record) and SEQ ID NO: 507 (identical to instantly recited SEQ ID NO: 81 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 81 versus 077 ID 507, of record). Instant claim 12 that recites SEQ ID NO: 48 is included in this rejection because SEQ ID NO: 48 is comprised within instantly recited SEQ ID NO: 87. Note that the attenuation substitutions recited in dependent claim 5 of ‘401 are the same as are recited in instant base claim 4 at part (ii), the attenuated IFNa2b is linked to the antibody via a peptide bond (claim 2 of ‘401, instant claims 14 and 15), the attenuated IFNa2b is linked to the C-terminus of the light or heavy chain constant region of the antibody (claim 4 of ‘401, instant claim 16). The call surface antigen specificity of the antibody portion of the fusion polypeptide recited in claim 10 of ‘401 comprises some of the species recited in instant claim 10.
The claims of US 12,128,401 do not recite a vector comprising a polynucleotide encoding the fusion polypeptide, nor a transformed cell comprising the vector.
Jager et al teach production of antibody fusion proteins in host cells comprising transforming said host cells with a vector encoding the fusion protein (see entire reference).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide sequence encoding the fusion polypeptide recited in the method claims of US 12,128,401 and to have transformed an isolated host cell as per the teaching of Jager et al.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to produce the fusion polypeptide for use in the method of treating tumors disclosed recited in the method claims of US 12,258,401.
Claims 4-6, 9-12 and 14-21 are directed to an invention not patentably distinct from claims 1-21 of US commonly assigned US 12,258,401, as enunciated above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned 12,258,401, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
22. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 18/866,286 case as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 9-12 and 14-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9, 11, 12, 21, 22, 24, 25, 27, 31, 34, 35, 37, 40, 41, 48, 49 and 52 of copending Application No. 18/866,286 in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 9, 11, 12, 21, 22, 24, 25, 27, 31, 34, 35, 37, 40 and 41 of application serial no. 18/866,286 are drawn to a composition comprising a CD38-binding fusion protein, wherein the anti-CD38 is fused to an aglycosylated T106A, attenuated A145D IFNa2b, including one comprising the amino acid sequence of SEQ ID NO: 12 (that has T106A and A156D substituent amino acid residues), and wherein said aglycosylated and attenuated IFNa2b is fused to the C-terminus of the heavy chain. The anti-CD38 portion may comprise a heavy chain comprising the amino acid sequence of SEQ ID NO: 9 and a light chain comprising the amino acid sequence of SEQ ID NO: 10. The IFNa2b portion may comprise the amino acid sequence of SEQ ID NO: 12 but with the substitutions of T106A and A145D.
Note that the said aglycosylated T106A/attenuated A145D IFNa2b relative to SEQ ID NO: 12 is the same sequence as is instantly recited SEQ ID NO: 25, as is evidenced by evidentiary reference EMBOSS Needle 510 ID 25 versus 286 ID 11 (2026, pages 1-4, of record). Note that SEQ ID NO: 9 of the claims of ‘286 is identical to instantly recited SEQ ID NO: 48 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 48 versus 286 ID 9 (2026, pages 1-5, of record). Note that SEQ ID NO: 10 of the claims of ‘286 is identical to instantly recited SEQ ID NO: 81 as is evidenced by evidentiary reference EMBOSS Needle 510 ID 81 versus 286 ID 10 (2026, pages 1-4, of record). In addition, claim 11 of 18/866,286 recites that the CD38-binding fusion protein comprises a heavy chain comprising the amino acid sequence of SEQ ID NO: 13 and a light chain comprising the amino acid sequence of SEQ ID NO: 10 (identical to instantly recited SEQ ID NO: 87 and SEQ ID NO: 81, respectively) with the IFNa2b portion comprising the sequence of SEQ ID NO: 12 (identical to instantly recited SEQ ID NO: 25).
Claims 48, 49 and 52 of application serial no. 18/866,286 are drawn to a method of treating a CD38-expressing cancer comprising administering an effective amount of the said composition.
The claims of 18/866,286 do not recite a vector comprising a polynucleotide encoding the fusion polypeptide, nor a transformed cell comprising the vector.
Jager et al teach production of antibody fusion proteins in host cells comprising transforming said host cells with a vector encoding the fusion protein (see entire reference).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide sequence encoding the fusion polypeptide recited in claims of 18/866,286 and to have transformed an isolated host cell with it as per the teaching of Jager et al.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to produce the fusion polypeptide for use in the method of treating CD38-expressing tumors disclosed recited in the method claims of 18/866,286. Instant claims 14 and 15 are included in this rejection because a fusion protein has the recited features therein. Instant claims 17 and 18 are included in this rejection because instantly recited SEQ ID NO: 87 comprises SEQ ID NO: 48 (Ab heavy chain sequence) fused to SEQ ID NO: 25 (aglycosylated, attenuated IFNa2b) and SEQ ID NO: 81 represents the antibody light chain sequence (see claim 40 of ‘286 along with the evidentiary references pertaining to SEQ ID NO: 9, 10 and 12 of ‘286 noted above in this rejection).
Claims 4-6, 9-12 and 14-21 are directed to an invention not patentably distinct from claims 1-3, 9, 11, 12, 21, 22, 24, 25, 27, 31, 34, 35, 37, 40, 41, 48, 49 and 52 of commonly assigned 18/866,286, as enunciated above.
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between applications or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned US 18/866,286, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualifies as prior art under 35 U.S.C. 102(a)(2) and the patentably indistinct inventions were not commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case. Alternatively, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
23. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 15/420,152 case that issued as US 10,232,041 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 10, 11, 14-16, 19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,232,041 in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20).
The claims of US 10,232,041 are drawn to a method for treating a CD38-expressing tumor of the recited types tumor in a subject comprising administering a combination therapy comprising (i) lenalidomide or pomalidomide and (ii) a fusion polypeptide of an antibody that specifically binds to CD38 and a human, attenuated IFNa2b having a T106A aglycosylation mutation (such as SEQ ID NO: 212 which has T106A and A145D, and which is identical to instantly recited SEQ ID NO: 25, but for a difference at position 70). Note that position 70 is not a position for attenuation that is recited in instant base claim 4 at part (ii), and instant base claim 4 recites “the second domain comprises an aglycosylated interferon a 2b (IFNa2b) comprising an amino acid sequence wherein T016…is substituted with an amino acid selected from the group consisting of A… and wherein the aglycosylated IFNa2b further comprises one or more amino acid substitutions or deletions that attenuate the activity of the aglycosylated IFNa2b….”; that is, the claim recites the open transitional phrase “comprises”. Therefore the instant claim language encompasses a non-attenuating mutation at position 70.
The claims of US 10,232,041 do not recite a vector comprising a polynucleotide encoding the fusion polypeptide, nor a transformed cell comprising the vector.
Jager et al teach production of antibody fusion proteins in host cells comprising transforming said host cells with a vector encoding the fusion protein (see entire reference).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide sequence encoding the fusion polypeptide recited in the method claims of US 10,232,041 as per the teaching of Jager et al.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to produce the fusion polypeptide for use in the method of treating tumors disclosed recited in the method claims of US 10,232,041.
24. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 14/701,628 case that issued as US 9,636,334 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 10, 11, 14-16, 19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,636,334 in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20).
The claims of US 9,636,334 are drawn to a method for treating a CD38-expressing tumor of the recited tumor types in a subject comprising administering a fusion polypeptide of an antibody that specifically binds to CD38 and a human, attenuated IFNa2b having a T106A aglycosylation mutation (such as SEQ ID NO: 212 which has T106A and A145D, and which is identical to instantly recited SEQ ID NO: 25, but for a difference at position 70). (Note that the sequences are the same as those in US 10,232,041 which is rejected above, as the application from which ‘041 issued is a continuing application of ‘628 from which US 9,636,334 issued. Thus, the evidentiary reference cited in the rejection of ‘041 also apply hereto and will not be repeated.)
Note that position 70 is not a position for attenuation that is recited in instant base claim 4 at part (ii), and instant base claim 4 recites “the second domain comprises an aglycosylated interferon a 2b (IFNa2b) comprising an amino acid sequence wherein T016…is substituted with an amino acid selected from the group consisting of A… and wherein the aglycosylated IFNa2b further comprises one or more amino acid substitutions or deletions that attenuate the activity of the aglycosylated IFNa2b….”; that is, the claim recites the open transitional phrase “comprises”. Therefore the instant claim language encompasses a non-attenuating mutation at position 70.
The claims of US 9,636,334 do not recite a vector comprising a polynucleotide encoding the fusion polypeptide, nor a transformed cell comprising the vector.
Jager et al teach production of antibody fusion proteins in host cells comprising transforming said host cells with a vector encoding the fusion protein (see entire reference).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide sequence encoding the fusion polypeptide recited in the method claims of US 9,636,334 and to have transformed an isolated host cell as per the teaching of Jager et al.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to produce the fusion polypeptide for use in the method of treating tumors disclosed recited in the method claims of US 9,636,334.
25. Court rulings have been quite clear that ONLY DIVISIONAL applications are entitled to the shield from double patenting under 35 USC 121. Indeed, in AMGEN INC v. HOFFMANN LA ROCHE LTD GMBH LA (Nos. 2009-1020, 2009-1096) the court discusses this issue at length and states:
Turning to the legislative history, the court observed that a House Report also referred specifically to “divisional application[s].” Id. Notably absent from the legislative history, in the court's view, was a suggestion “that the safe-harbor provision was, or needed to be, directed at anything but divisional applications.” Id. at 1361. From there, the court “conclude^] that the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Id. at 1362. Accordingly, the court decided that the § 121 safe harbor did not apply to the patent before it, which issued from a continuation-in-part application. Id.
We are persuaded by the reasoning in Pfizer that the § 121 safe harbor provision does not protect continuation applications or patents descending from only continuation applications. The statute on its face applies only to divisional applications, and a continuation application, like a continuation-in-part application, is not a divisional application.
Given that Applicant chose to file the 16/263,611 case that issued as US 11,253,591 as a separate unrelated application, not as a DIV of the instant application, the instant rejection has been set forth.
This is a new ground of rejection necessitated by Applicant’s amendment filed 3/19/26. Applicant has amended instant base claim 4 and its dependent claims and has canceled claims 7, 8 and 13.
Claims 4-6, 10, 11, 14-16, 19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,256,591 in view of Jager et al (BMC Biotechn., 2013, 13: 52, pages 1-20).
The claims of US 11,253,591 are drawn to a method for treating a CD38-expressing cancers comprising administering an anti-CD38 antibody-attenuated IFNa2b fusion protein, wherein the anti-CD38 antibody comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 27 and a light chain variable region comprising the amino acid sequence of SEQ ID NO: 29, wherein the attenuated IFNa2b comprises the amino acid sequence of SEQ ID NO: 212 or 213.
SEQ ID NO: 212 of the claims of US 11,253,591 has T106A and A145D relative to instantly recited SEQ ID NO: 1 and also has a K70M amino acid substituent. SEQ ID NO: 213 of the claims of US 11,253,591 has T106A and A145G relative to instantly recited SEQ ID NO: 1 and also has a K70M mutation. Note that position 70 is not an attenuation position recited at part “(ii)” of instant base claim 4. Also note that the aglycosylated IFNa2b portion of the fusion polypeptide need not be SEQ ID NO: 1; the aglycosylation mutation and the attenuating mutation(s) must be relative to SEQ ID NO: 1. The open phrases recited in instant base claim 4 open the claim to encompass other changes that are not attenuating mutations, deletions, and/or additions, i.e., “the second domain comprises an aglycosylated interferon a 2b (IFNa2b) comprising an amino acid sequence wherein T106 is deleted or substituted with an amino acid selected from the group consisting of A…., wherein T106 is relative to SEQ ID NO: 1 and wherein the aglycosylated IFNa2b further comprises one or more amino acid substitutions or deletions that attenuate the activity of the aglycosylated IFNa2b”.
The claims of US 11,253,591 do not recite a vector comprising a polynucleotide encoding the fusion polypeptide used in the claimed method, nor an isolated host cell comprising the said vector.
Jager et al teach production of antibody fusion proteins in host cells comprising transforming said host cells with a vector encoding the fusion protein (see entire reference).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to have made a vector comprising a polynucleotide sequence encoding the fusion polypeptide recited in the method claims of US 11,253,591 and to have transformed an isolated host cell as per the teaching of Jager et al.
One of ordinary skill in the art would have been motivated to do this, and with a reasonable expectation of success in doing so, in order to produce the fusion polypeptide for use in the method of treating CD38 expressing cancers disclosed recited in the method claims of US11,253,591.
26. No claim is allowed.
27. 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.
28. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE DIBRINO whose telephone number is (571)272-0842. The examiner can normally be reached on M, T, Th, F.
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/Marianne DiBrino/
Marianne DiBrino, Ph.D.
Patent Examiner
Group 1640
Technology Center 1600
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
Prosecution Insights