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 .
Claim Interpretation
Claims 1-18 are product claims.
The following limitations are treated as intended use limitations:
- in claim 1, “for use in a method for the treatment and/or prevention of dry macular degeneration in a subject, preferably dry age-related macular degeneration, wherein the method comprises administering PEDF and VEGF to the subject, wherein the PEDF and the VEGF are administered to the subject concurrently or sequentially”
- in claim 2, “ wherein the subject is suffering from treatment-naive quiescent choroidal neovascularization”
- in claim 3 “wherein the subject is suffering from geographic atrophy”
- in claim 4, “wherein geographic atrophy is the result of anti-VEGF therapy”
- in claim 5, “ wherein PEDF induces growth of choriocapallaris”
- in claim 6, “wherein choriocapillaris are non-leaking choriocapillaris”
- in claim 7, “ wherein PEDF inhibits growth and/or formation of geographic atrophy”
- in claim 8, “for use in a method for the treatment and/or prevention of wet macular degeneration in a subject, preferably wet age-related macular degeneration, wherein the method comprises administering PEDF and an anti-VEGF therapy to the subject, wherein the PEDF and the anti-VEGF therapy are administered to the subject concurrently or sequentially”
- in claim 9, “wherein PEDF induces growth of non-leaking choriocapillaris,”
- in claim 10, “wherein the anti-VEGF therapy comprises administration of an anti- VEGF drug to the subject”
- in claim 11, “wherein the anti-VEGF drug is selected from the group comprising pegaptanib, ranibizumab, bevacizumab and aflibercept”
- in claim 12, “for use in a method for the treatment and/or prevention of treatment-naive quiescent choroidal neovascularization in a subject, wherein the method comprises administering PEDF and VEGF to the subject, wherein the PEDF and the VEGF are administered to the subject concurrently or sequentially”
- in claim 13, “wherein the subject is suffering from dry macular degeneration, preferably dry age-related macular degeneration”
- in claim 14, “wherein the subject is suffering from geographic atrophy”
- in claim 15, “wherein geographic atrophy is the result of anti-VEGF therapy”
- in claim 16, “wherein PEDF induces growth of choriocapallaris”
- in claim 17, “wherein the choriocapillaris are non-leaking choriocapillaris”
- in claim 18, “wherein PEDF inhibits growth and/or formation of geographic atrophy”.
Therefore, BRI of claims 1-18 is a pigment epithelium-derived factor (PEDF) that is capable of performing the intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim, even if the intended use is not explicitly disclosed in the prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11, 13, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1, 8, 13, and 18, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Dependent claims 2-7 and 9-11 fail to remedy this issue and are likewise rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more. The claim(s) recite(s) pigment epithelial-derived (factor), which is a naturally-occurring human protein, as evidenced by the specification at pages 16-17. This judicial exception is not integrated into a practical application because only the protein itself is claimed. The product claims are not limited to the recited intended use but rather can be used in any and all applications of the claimed protein. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more because only the protein itself is claimed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tong et al. (US 2008/0293626 A1).
Tong et al. teach a method of treating a patient with a condition involving increased vascular permeability comprising administering to the patient a therapeutically effective amount of PEDF, PEDF 44 AA peptide, a homolog of the PEDF 44 AA peptide, a homolog of the PEDF 44 AA peptide wherein amino acid residues glutamate at the 101 amino acid position, isoleucine at the 103 amino acid position, leucine at the 112 and serine at the 115 amino acid position are unchanged, or an agent that activates the PEDF receptor. Conditions for treatment include, but are not limited to, sepsis, acute respiratory distress syndrome, nephrotic syndrome, diabetic neuropathy, preproliferative diabetic retinopathy, and the neovascular form of age-related macular degeneration (paragraph [0009]).
Tong et al. teach a pharmacological composition comprising a source of PEDF or PEDF 44 AA peptide and a suitable diluent. In addition to the source of PEDF or PEDF 44 AA peptide, the composition includes a diluent, which includes one or more pharmacologically-acceptable carriers. Pharmaceutical compositions for use in accordance with the present invention can be formulated in a conventional manner using one or more pharmacologically or physiologically acceptable carriers comprising excipients, as well as optional auxiliaries which facilitate processing of the active compounds into preparations which can be used pharmaceutically (paragraph [0062]).
Regarding the intended use limitations in claims 1-18, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, because the prior art teaches a protein with the same structure as claimed, namely PEDF, the prior art protein must be capable of performing the intended use.
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.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-16, and 19-21 of copending Application No. 17/435,162 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claim 1 recites a method for treatment and/or prevention of a disease using pigment epithelium-derived factor (PEDF), wherein the method comprises administering PEDF and an anti-vascular endothelial growth factor (VEGF) therapy to a subject, wherein the disease is an eye disease age-related macular degeneration, and wherein treatment and/or prevention of the disease comprises inhibiting labyrinth capillary formation, inducing growth of choriocapillaris, tightening choriocapillaris, inhibiting extracellular matrix formation, protecting choriocapillaris, and/or guiding vessel development.
The reference claim recites a PEDF that is capable of performing the instantly claimed intended use because it has the same structure.
Therefore, the reference claims anticipate instant claims 1-18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MARCHETTI BRADLEY whose telephone number is (571)272-9044. The examiner can normally be reached Monday-Friday, 7 am - 3 pm.
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/CHRISTINA BRADLEY/Primary Examiner, Art Unit 1654