Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 6-8, 10, 12-13, 15-24, 27-33, 37, 41 and 45 were canceled.
Claim 46 was added.
Claims 1-5, 9, 11, 14, 25-26, 34-36, 38-40, 42-44 and 46 are pending and under consideration.
Withdrawn Rejections
Rejection of Claims 35 and 39-40 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claims, thereby obviating this rejection/objection.
Rejection of Claims 1-5, 9-11, 14, 25-26, 34-36, 38-40, and 44 under 35 U.S.C. 103 as being unpatentable over Jarvis et al (US4680174) in view of Shin et al (US2017/0196818) and Yan et al (Immunotherapy (2017) 9(4), 347-360) is withdrawn.
Rejection of Claims 1-5, 9-11, 14, 25-26, 34-36, 38-40, and 42-44 under 35 U.S.C. 103 as being unpatentable over Jarvis et al (US4680174) in view of Shin et al (US2017/0196818) and Yan et al (Immunotherapy (2017) 9(4), 347-360) as applied to claims 1-5, 9-11, 14, 25-26, 34-36, 38-40, and 44 above, and further in view of Toubaji et al (Vaccine 25 (2007) 5882-5891) is withdrawn.
Applicant amended claim 1 to recite specific RPE cell to overcome this rejection.
NEW - Claim Objections
(necessitated by amendments)
Claim 3 is objected to because of the following informalities: “an antibody, antibody fragment” in line 2 must be deleted because claim 1 now recite that the antigen is tumor antigen which is not antibody.
Claim 11 is objected to because of the following informalities: “IL-1a, IL-1~” in line 2 should read “IL-1α, IL-1β”. Appropriate correction is required.
Claim 42 is objected to because of the following informalities: “a third implantable element” in line 1 should read “a third implantable construct” to be consistent with “a first implantable construct” and “a second implantable construct” in claim 1. Appropriate correction is required.
Claim 43 is objected to because of the following informalities:
“produce by the second implantable construct” in line 4 should read “produced by the second implantable construct”;
“an engineered cell” in line 7 should read “an encapsulated engineered cell” to be consistent with first and second implantable construct recited before;
“and wherein the cell of the first implantable construct and the cell of the second implantable construct is a retinal pigment epithelial (RPE) cell” in line 5-6 must be deleted because same limitation is recited again in last two lines.
Appropriate correction is required.
Claim 44 is objected to because of the following informalities: period after “environment” in line 1 must be deleted. Appropriate correction is required.
NEW - Double Patenting
(based on reconsideration)
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.
Claims 1-5, 9, 11, 14, 25-26, 34-36, 38-40, 44, and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 107-128 of copending Application No. 17/633,716 (hereinafter application’716; US2022/0313599; PTO-892) in view of Jarvis et al (US4680174) and Jiang et al (Oncoimmunology 2016, vol.5, No.6, e1163462.; PTO-892) as evidenced by Yu et al (Journal of Colloid and Interface Science 539 (2019) 497-503).
Regarding claims 1, 11, 14, and 25-26, claim 1 of application’716 claims an implantable construct comprising an inner alginate layer encapsulating a plurality of retinal epithelial pigment cells expressing human IL-2.
Regarding claims 4-5, it is well known in the art that IL-2 activates immune cells and enhances immune response.
Regarding claims 35 and 38-39, as evidenced by Yu, alginate encapsulation provides sustained non-pulsatile release. Yu teaches “Alginate hydrogel particles are promising delivery systems for protein encapsulation and controlled release because of their excellent biocompatibility, biodegradability, and mild gelation process” (abstract). Yu shows that alginate encapsulation provides non-pulsatile release of ovalbumin over several days (Figure 6d).
Regarding claim 40, claim 110 of application’716 claims that the implantable construct secretes IL-2 for about 4 weeks.
Regarding claim 44, claim 115 of application’716 claims implanting the implantable construct of claim 1 into a subject.
Regarding claim 46, claim 107 of application’716 claims that the plurality of retinal epithelial pigment cells are ARPE-19 cells.
However, application’716 does not claim a combination of two implantable constructs.
Regarding claim 1-2 and 14, Jarvis teaches “Cells such as genetically modified cells, e.g., hybridoma, which secrete an antigenic substance are encapsulated within capsule membranes (corresponds to “layer” of instant claim 14) having pores of dimensions sufficient to permit efflux of the antigens secreted by the cells but insufficient to permit traverse of the cells. The capsules are injected into an experimental animal (corresponds to “first implantable construct” of claim 1) where antigen passing through the pores of the capsule membrane induces lymphocytes to produce antibodies complementary to the antigen (corresponds to “induces am immune response in a subject” of instant claim 2)” (abstract).
Regarding claim 3, Jarvis teaches that antigen secreted by encapsulated cell is a glycolipid, glycoprotein, lipoprotein, polysaccharide or protein (claim 17 and 28).
Regarding claim 9, any antigen can be considered as exogenous antigen or endogenous antigen because the antigen can be from outside of the subject or subject itself.
Regarding claim 34 and 36, Jarvis teaches “the permeability of the membrane can be controlled in part by selecting the molecular weight of the cross-linking polymer used, the duration of the cross-linking steps, and the concentration of polymer in the cross-linking solution”. Jarvis teaches “Depending on the type of semipermeable membrane formation technique employed, it is often desirable to treat the capsules so as to occupy free amino groups or the like which might otherwise impart to the capsule a tendency to clump. This can be done, for example, by immersing the capsule in a solution of sodium alginate.” Jarvis teaches “The BALB/c hybridoma (designated C25) was suspended in a 1.34% (w/v) sodium alginate (NaG-Kelco) in saline solution” (example 1). Because sustained release and duration of release are property of encapsulating alginate material and because Jarvis teaches same alginate encapsulation, the first implantable construct of Jarvis will have property claimed by instant claims 34 and 36.
Furthermore, another reference Jiang teaches rational to combine two implantable constructs to treat cancer. Jiang teaches “Interleukin-2 (IL-2) is one of the key cytokines with pleiotropic effects on immune system. It has been approved for the treatment of metastatic renal cell carcinoma and metastatic melanoma. Recent progress has been made in our understanding of IL-2 in regulating lymphocytes that has led to exciting new directions for cancer immunotherapy. While improved IL-2 formulations might be used as monotherapies, their combination with other anticancer immunotherapies, such as adoptive cell transfer regimens, antigen-specific vaccination, and blockade of immune checkpoint inhibitory molecules, for example cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) and programmed death 1 (PD-1) mono-antibodies, would hold the promise of treating metastatic cancer.” (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the first implantable construct of application’716 and the second implantable construct of Jarvis to treat cancer. Because Jiang teaches that IL-2 can be used in combination with antigen-specific vaccination, one of ordinary skill in the art would be motivated to combine implantable construct of IL-2 and second implantable construct of cancer antigen to treat cancer. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because Jiang teaches that IL-2 can be used in combination with antigen-specific vaccination. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
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