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 .
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.
DETAILED ACTION
This action is in response to claim amendments filed 5/8/26. Claims 46-48, 53, 55-58, and 62-64 are pending.
All pending claims are no longer rejected by prior art. All pending species have been searched according to MPEP §803.02 and the species requirement set forth in the Restriction mailed 6/10/22 is withdrawn.
Applicant’s elected group is allowable over the prior art. All claims to the non-elected group (Group I) have been canceled. MPEP 821.04(b) states “if Applicant cancels all the claims directed to a nonelected process invention before rejoinder occurs, the examiner should not withdraw the restriction requirement. This will preserve applicant’s rights under 35 USC 121”. In keeping with this requirement, the Group Restriction has not been withdrawn.
Withdrawn Rejections
The claim objection is withdrawn in light of the amendments.
The §103 rejection is withdrawn. Applicant persuasively argues that the reference cited for the sequence is not valid as prior art. All pending claims now require one of SEQ ID NOs: 15, 16, or 17. A search of these three sequences did not discover any prior art document that discloses these sequences. As set forth previously, it would have been obvious to a person of ordinary skill in the art at the time of filing to utilize the nucleic acid and amino acid sequences of any known FVIII-BDD sequence. However, it would not have been obvious to use an unknown sequence because that protein had yet to be discovered, Applicant being the first to discover these molecules. It is also readily understood that the FVIII-BDD used in the art by, e.g., Kitchen, inherently has a sequence. However, the Office is not equipped to make and test prior art products to determine if the FVIII-BDD therapeutic of the prior art inherently meets the requirements of the instant claims. The evidence of record currently supports the conclusion that the instant SEQ IDs were both unknown and not inherently the sequences of the FVIII already in use and therefore the evidence supports a conclusion that the claims are non-obvious.
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 46-48, 53, 55-58, and 62-64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12161760 (reference patent) in view of Kitchen and Little (WO2018213886). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 46, the reference claims a first compartment comprising a cell or plurality of cells (claims 1, 6), where the cell is an RPE cell (claim 8) and the cell expresses a therapeutic agent (claim 10). The therapeutic agent is Factor VIII (claim 11). The cell (first compartment) is surrounded (enclosed) by a second compartment (claim 1, 6), which meets the limitations of an “enclosing component”. The second compartment—the enclosing component—comprises an alginate polymer (claim 1), which is “an alginate” and is modified in the same way (claim 1); compare both instant and reference compound 101 as well as reference claim 18 compared to instant claim 53. There is nothing in reference claim 1 to suggest the particle is not implantable and so meets the limitations of “an implantable element”. Thus, instant claim 46 differs from reference claim 1 only in that the reference claim does not specify the FVIII is an FVIII-BDD.
Nevertheless, it would have been obvious to incorporate FVIII-BDD into the reference particle/element. First, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). In this case, in support of the explicitly claimed “variant” of Factor VIII in claim 11, the reference document discloses the preferred FVIII-BDD (figure 2A; figure 17A+; C4-6). Further, Kitchen teaches that B-domain deleted recombinant FVIII is an effective FVIII replacement (page 332). It would have been obvious to substitute FVIII with FVIII-BDD because the art explicitly teaches this is an effective substitution.
The claims also differ in that the instant claim specifies the RPE cell is human. However, the reference specification may be used as a dictionary to learn the meaning of a term in a patent claim; see also Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999), Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998), and MPEP 2111.01. The reference specification explicitly defines “RPE cell” to be “from a human or other mammal” (C18), making a human cell an obvious variation.
Reference claim 22 claims SEQ ID NO: 17 and exemplifies SEQ ID NO: 1 for the FVIII-BDD. Reference claim 22 also claims the cell is from ARPE-19 and comprises an exogenous nucleotide.
Thus, the instant claims are an obvious variation of the reference claims.
Regarding claim 47, reference claim 22 claims the cell is from ARPE-19.
Regarding claim 48, reference claim 22 claims SEQ ID NO: 23
Regarding claim 53, this modification would have been obvious as above, e.g., reference claim 18.
Regarding claim 55, ARPE-19 cells would have been obvious as above. Reference claim 21 claims a minimum of 50 million cells/mL as well as other concentrations. Where the number of cells is recognized as a result-effective variable, such as it is in reference claim 21, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05(II).
Regarding claim 56, the first compartment comprises an alginate polymer separate from the alginate encapsulating the cell (claim 1), i.e., a pharmaceutically acceptable carrier.
Regarding claim 57, Little would have made obvious the poly A sequence as described in the §103 rejection above and incorporated herein.
Regarding claim 58, these limitations would have been obvious as above.
Regarding claim 62, the first compartment comprises an alginate polymer separate from the alginate encapsulating the cell (claim 1), e.g., a matrix or microcarrier. The cells are also disclosed as being “attached to a microcarrier”, which meets the definition of “disposed on”.
Regarding claim 63, the reference claims the particle (i.e., the implantable element) has a diameter (largest linear dimension) of 1.5-2mm (claim 4).
Regarding claim 64, this compound would have been obvious as above.
Therefore, claims 46-48, 53, 55-58, and 62-64 would have been obvious.
Claims 46-48, 53, 55-58, and 62-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8-10, 12, 28, and 31 of copending Application No. 17280802 (reference application) in view of Little and Vegas. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 46, the reference claims a hydrogel comprising a “cell-containing compartment” which comprises a plurality of engineered RPE cells where the RPE produces or releases a therapeutic agent (claim 1). The cell is surrounded (enclosed) by a barrier compartment (claim 1), which meets the limitations of an “enclosing component”. The second compartment—the barrier component—comprises a modified alginate (claim 1), which is “an alginate” and is modified in the same way (claims 1; 8); compare both instant and reference compound 101 as well as reference claim 8 compared to instant claim 53. There is nothing in reference claim 1 to suggest the hydrogel is not implantable and so meets the limitations of “an implantable element”.
The claims differ in that the instant claim specifies the RPE cell is human. However, the reference specification may be used as a dictionary to learn the meaning of a term in a patent claim; see also Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999), Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998), and MPEP 2111.01. The reference specification explicitly defines “RPE cell” to be “from a human or other mammal” (paragraph 129), making a human cell an obvious variation.
The claims further differ in that reference claim 1 RPE comprises “an exogenous nucleotide sequence encoding a therapeutic polypeptide” while the instant therapeutic is FVIII-BDD of a specific sequence.
In addition to using the specification as a dictionary, those portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent. In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized ‘that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,’ but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first ‘determine how much of the patent disclosure pertains to the invention claimed in the patent’ because only ‘[t]his portion of the specification supports the patent claims and may be considered.’ The court pointed out that ‘this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.’’’ MPEP §804(II)(B)(1).
Reference claim 1 encompasses the genus of all “exogenous nucleotide sequence encoding a therapeutic polypeptide”. Those portions of the spec that provide support—such as §112 written description support—for this genus may therefore be examined to determine how Applicant has supported this genus. On page 3 L24-25, the reference specification discloses the specific embodiment of the RPE-19 cells comprising “an exogenous coding sequence…for a FVIII BDD protein, e.g., SEQ ID NO: 15”. This SEQ 15 is the same as the instant SEQ 15. Thus, within the genus of the claimed exogenous nucleotide sequences encompassed by the reference claims, the instant sequence is explicitly exemplified in support of said nucleotides. In support of t FVIII-BDD, SEQ ID NO: 1 is also disclosed (paragraph 45). As such, this represents an obvious variation of the reference claims.
Regarding claim 47, reference claim 10 claims the cell is from ARPE-19 and claim 1 states the cells comprise an exogenous nucleotide.
Regarding claim 48, reference claim 14 claims a promoter sequence. In looking to the specification for support (Vogel), paragraph 313 discloses only two: SEQ ID NO: 23 and 26. This would have made SEQ ID NO: 23 an obvious variation.
Regarding claim 53, this modification would have been obvious as above, e.g., reference claim 8.
Regarding claim 55, ARPE-19 cells would have been obvious as above. Reference claim 32 claims a minimum of 35 million cells/mL as well as other concentrations. Where the number of cells is recognized as a result-effective variable, such as it is in reference claim 32, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP §2144.05(II).
Regarding claim 56, the first compartment comprises an alginate polymer separate from the alginate encapsulating the cell (claim 1), i.e., a pharmaceutically acceptable carrier.
Regarding claim 57, reference claim 14 claims the polyA sequence. Little would have made obvious the specific poly A sequence as described in the §103 rejection above and incorporated herein.
Regarding claim 58, these limitations would have been obvious as above.
Regarding claim 62, the first compartment comprises an alginate polymer separate from the alginate encapsulating the cell (claim 1), e.g., a matrix or microcarrier. The cells are also claimed as in the same compartment as a cell-binding peptide as well as in a hydrogel, meeting the limitations of “disposed on”.
Regarding claim 63, the reference does not claim a size of the hydrogel. Vegas also teaches encapsulation in a hydrogel matrix and specifies size ranges of said elements which encompass the 1 mm to 2 mm.
Regarding claim 64, this compound would have been obvious as above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Note that, as of the time of writing, a notice of allowance has been mailed in the reference application but the issue fee has not been paid and the application has not issued as a patent.
Response to Arguments
Applicant's arguments filed 5/8/26 have been fully considered but they are not persuasive.
Regarding the double patenting rejections, Applicant states “Applicant concurrently submits a terminal disclaimer to the ‘760 patent”. This is not persuasive because Applicant submitted no such terminal disclaimer.
Applicant further argues that the instant claims are limited to the therapeutic being FVIII-BDD and no longer recite FIX. Applicant also notes that the ‘802 application was amended to remove claims to a FVIII-BDD. While Applicant is correct that—due to amendment—no claim explicitly recites FVIII-BDD being the therapeutic, the co-pending claim still encompasses FVIII-BDD by the recitation in claim 1 of any exogenous nucleic acid. While simply encompassing the species is insufficient on its own to make FVIII-BDD obvious, the rejection has been modified as necessitated by amendments to articulate the finding that FVIII-BDD is an obvious variation/species of the first reference claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM M WEIDNER whose telephone number is (571)272-3045. The examiner can normally be reached M-T 9-18; W-R 9-15.
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/Adam Weidner/Primary Examiner, Art Unit 1675
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