DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. Formal Matters
A. In the response filed 9/4/26, Applicants elected HLA-B57. However, upon further review, all species have been considered.
B. Claims 1-16 are pending and are the subject of this Office Action.
2. Information Disclosure Statement
A. Reference 1 on the 1449 filed 9/15/26 had an incomplete publication year. The Examiner corrected this.
B. Reference 3 on the 1449 filed 9/15/26 recited “year”. The Examiner amended this.
3. Specification
A. The specification is objected to since the Brief Description of the Figures (e.g. Figures) should be amended to initially reflect the panels. In other words, “Figure 1 shows” should be amended to, for example, “Figures 1A-1D show” or “Figures 1A-D. Figure A shows”. The use of “A” through “D” later in the description may be retained.
B. The listing of references on page 34 of the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
C. The use of at least the term Incucyte® (page 30, lines 25 and 34), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. The Examiner performed a cursory review, but Applicants are urged to perform a more thorough review of the specification. Furthermore. it is noted that page 30, line 2 should recite “Red96e”.
D. The specification has not been checked to the extent necessary to determine the presence of all possible minor errors, embedded hyperlinks, or improperly referenced trademarks. Applicants’ cooperation is requested in correcting any errors of which Applicants may become aware.
4. Claim Objections
A. Though not incorrect, it is noted that the specification recites “b2m”, whereas the claims recite “B2m”.
B. Claim 6b is objected to since the “F” should be amended to “Fc”.
C. Clim 14 is objected to since it recites an “a.” after the period
5. 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.
Regarding at least claims 1a, 3, 6b, 6c, 6d, 9, 12, 13 and 15, the phrases "particularly” and “more particularly” render the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
6. Claim Rejections - 35 USC § 112(a) – written description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 13 is rejected under 35 U.S.C. 112(a) as containing 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(s), at the time the application was filed, had possession of the claimed invention. The claim does not provide a lower limit for the KD value. Therefore, the claim reads on “superbinders”, which can have affinity values in the femptomolar range, or lower (i.e. higher affinity), for which neither the specification, nor claims has described.
7. Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Claims 1-3 and 5-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,369,660 (16/083,508) in view of Bernabeu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating cancer by administering an HLA-B57-Fc fusion.
Regarding claims 1, 2 and 9, the only essential difference is that the patent does not teach the administration of B2m. However, Bernabeu teaches that these two molecules nocovalently associate and that B2m is required for HLA heavy chain expression (first two sentences). Given this, it would have been obvious to have expressed B2m along with B57 in order to maximize its effectiveness.
Regarding claim 3, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 454, 105 USPQ 223,235, (CCPA 1955). Furthermore, "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and, therefore, obvious) and E.I. DuPont de Nemours & Co. v. Synvina C.V., 904 F.3d 996, 1006 (Fed. Cir. 2018) (“it is not inventive to discover the optimum or workable ranges by routine experimentation.”).
Regarding claims 5, 6 and 8, SEQ ID NO:7 of the patent is identical to instant SEQ ID NO:1. The fusion of the patent is recited as instant SEQ ID NO:5, which comprises a linker.
Regarding claim 7, determining the best orientation given a small number of possibilities would have been obvious.
Regarding claim 10, patent claim 1 recites an “open conformer”.
Claims 11-14 are met, or rendered obvious, by patent claims 5-7.
B. Claims 1-3, 6, 7 and 9-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7 and 10-12 of U.S. Patent No. 11,279,747 (16/323,902) in view of Bernabeu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating cancer by administering an HLA-Fc fusion.
Regarding claims 1, 2, 9 and 10, the only essential difference is that the patent does not teach the administration of B2m. However, Bernabeu teaches that these two molecules nocovalently associate and that B2m is required for HLA heavy chain expression (first two sentences). Given this, it would have been obvious to have expressed B2m along with B57 in order to maximize its effectiveness.
Regarding claim 3, this is not inventive (In re Aller; In re Boesch; Merck & Co. v. Biocraft Labs. Inc.; E.I. DuPont de Nemours & Co. v. Synvina C.V.)
Claim 6 is further met by patent claim 6.
Regarding claim 7, determining the best orientation given a small number of possibilities would have been obvious.
Claims 11-14 are met, or rendered obvious, by patent claims 10-12.
C. Claims 1-3, 6, 7 and 9-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 6, 7, 11, 13 and 14 of U.S. Patent No. 11,807,676 (17/687,732) in view of Bernabeu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to treating cancer by administering the HLA-Fc fusion of the patent.
Regarding claims 1, 2, 9 and 10, the only essential differences are that the patent does not teach methods of treating cancer, or the administration of B2m. However, the HLA system was well-known at the time to be involved in cancer antigen presentation to T cells; therefore, using the HLA composition for treatment would have been obvious. Furthermore, Bernabeu teaches that these two molecules nocovalently associate and that B2m is required for HLA heavy chain expression (first two sentences). Given this, it would have been obvious to have expressed B2m along with B57 in order to maximize its effectiveness.
Regarding claim 3, this is not inventive (In re Aller; In re Boesch; Merck & Co. v. Biocraft Labs. Inc.; E.I. DuPont de Nemours & Co. v. Synvina C.V.)
Claim 6 is further met by patent claim 6.
Regarding claim 7, determining the best orientation given a small number of possibilities would have been obvious.
Claims 11-14 are met, or rendered obvious, by patent claims 10-12.
D. Claims 1-3 and 5-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,383,602 (17/849,643) in view of Bernabeu et al. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to treating cancer by administering the HLA-Fc fusion of the patent.
Regarding claims 1, 2, 9 and 10, the only essential differences are that the patent does not teach methods of treating cancer, or the administration of B2m. However, the HLA system was well-known at the time to be involved in cancer antigen presentation to T cells; therefore, using the HLA composition for treatment would have been obvious. Furthermore, Bernabeu teaches that these two molecules nocovalently associate and that B2m is required for HLA heavy chain expression (first two sentences). Given this, it would have been obvious to have expressed B2m along with B57 in order to maximize its effectiveness.
Regarding claim 3, this is not inventive (In re Aller; In re Boesch; Merck & Co. v. Biocraft Labs. Inc.; E.I. DuPont de Nemours & Co. v. Synvina C.V.)
Claim 6 is further met by patent claim 6.
Regarding claim 7, determining the best orientation given a small number of possibilities would have been obvious.
E. Claims 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,383,602 (17/849,643) in view of Bernabeu et al. further in view of either (1) U.S. Patent No. 11,369,660 (16/083,508) or (2) U.S. Patent No. 11,279,747. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons discussed in paragraph D above.
The ‘602 patent does not teach the instantly claimed checkpoint inhibitors or cancers. However, each of ‘660 and ‘747 do.
F. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 6, 7, 10-15, 25-28 and 30-32 of copending Application No. 19/154,406 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are drawn to treating cancer by administering the HLA-Fc fusion of the patent. However, the copending application also claims this intended use in claim 32.
Generally, both sets of claims require a B2m fused to an HLA-B57 (or A25) linked to an Fc. The only essential difference is that the copending claims require SIRPa. However, the instant claims recite the open language “comprising”, which encompass SIRPa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
G. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 and 17-21 of copending Application No. 18/681,074 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. Both the instant claims and copending claims 17-21 are drawn to methods of treating cancer using the same HLA-B57 variant, whereas claims 1-12 are drawn to the variant, itself. The only essential difference is that the copending claims require SIRPa. However, the instant claims recite the open language “comprising”, which encompass SIRPa.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
H. Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8, 10 and 14-24 of copending Application No. 18/681,072 (reference application) in view of either (1) Bernabeu et al., (2) copending Application 19,154,506, or (3) copending Application 18/681,074. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and ‘072 are drawn to essentially the same subject matter. Both the instant claims and ‘072 claims 14-18, 23 and 24 are drawn to methods of treating cancer using the same HLA-B57 variant, whereas claims 5-8, 10 and 19-22 are drawn to the variant, itself. Instant SEQ ID NO:5 is identical to copending SEQ ID NO:15, except for A46E.
The ‘072 claims do not recite B2m. However, as discussed above, (1) Bernabeu et al., (2) 19/154,506 and (3) 18/681,074 do.
Regarding claim 3, this is not inventive (In re Aller; In re Boesch; Merck & Co. v. Biocraft Labs. Inc.; E.I. DuPont de Nemours & Co. v. Synvina C.V.)
Regarding claim 7, determining the best orientation given a small number of possibilities would have been obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
I. Claims 1-16 are rejected are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over each of (1) U.S. Patent No. 11,369,660, (2) U.S. Patent No. 11,279,747, (3) U.S. Patent No. 11,807,676 and (4) U.S. Patent No. 12,383,602, each in view of copending Application 19/154,406.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57, including the claimed variant, as discussed in the individual rejections.
J. Claims 1-3 and 5-16 are rejected are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,369,660 in view of copending Application 18/681,074.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57 as discussed in the individual rejections.
K. Claims 1-3, 6, 7 and 9-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,279,747 in view of copending Application 18/681,074.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57 as discussed in the individual rejections.
L. Claims 1-3, 6, 7 and 9-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 6, 7, 11, 13 and 14 of U.S. Patent No. 11,807,676 in view of copending Application 18/681,074.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57 as discussed in the individual rejections.
M. Claims 1-3 and 5-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 12,383,602 in view of copending Application 18/681,074.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57 as discussed in the individual rejections.
N. Claim 4 is rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,369,660 in view of Bernabeu et al. further in view of 18/681,072.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57, including the claimed variant, as discussed in the individual rejections.
O. Claims 4, 5 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,279,747 in view of Bernabeu et al. further in view of 18/681,072.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57, including the claimed variant, as discussed in the individual rejections.
P. Claims 4, 5 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,807,676 in view of Bernabeu et al. further in view of 18/681,072.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57, including the claimed variant, as discussed in the individual rejections.
Q. Claims 4, 5, 8 and 11-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,383,602 in view of Bernabeu et al. further in view of 18/681,072.
Each is discussed above. It would have been obvious to have combined B2M with HLA-B57, including the claimed variant, as discussed in the individual rejections, as well as to have used checkpoint inhibitors for treating cancer.
8. Conclusion
A. Other than in the copending applications, the 46E and R97R mutations appear to be novel.
B. No claim is allowable.
Advisory information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT S LANDSMAN whose telephone number is 571-272-0888. The examiner can normally be reached M-F 8 AM – 6 PM (eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at 571-272-2911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT S LANDSMAN/Primary Examiner, Art Unit 1647
