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 .
Status of the Claims
Claims 1-20 are pending.
Information Disclosure Statement
The IDS’s dated 4/1/2025 and 4/2/2025 has been considered. Signed copies are enclosed herewith.
Priority
This application repeats a substantial portion of prior Application No. 16/780,596, filed 2/3/2020, and adds disclosure not presented in the prior application. For example, “For example, the drug partition may be in the range of from about 50% of the incorporated drug to about 98% of the incorporated drug, and may include any values therebetween” in [00124] of the instant specification is not found in comparable [00118] of the prior application. Additionally, [0036]-[0038] and [0149] are new. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/780,596, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Instant claims 1, 7 and 13 recite, “release up to 94.78% of the S1P1 agonist within the first 24 hours following implantation” (emphasis added). Paragraph [0118] of the parent application states,
According to one embodiment, the nanofiber scaffold releases (from the portion of drug released in the first 75 hours) a predetermined drug portion during the first 24 hours (e.g., following implantation). In at least one embodiment, the predetermined drug portion is about 97.08-98.02%. In one or more embodiments, after about 75 hours, the nanofiber scaffold releases about 96.7% of incorporated drug. In at least one embodiment, after about 75 hours, about 0.061-0.069 μg of drug remains in the nanofiber scaffold.
Using Applicant's rationale from parent application 16/780,596 (page 11 of Remarks dated
3/15/2022), the S1P1 agonist releases 93.87%-94.78% (98.02*96.7) within the first 24 hours of implantation. The phrase "up to" is not supported by the disclosure of the previous filed application. Values below 93.87% and values above 94.78% are not disclosed (explicitly or implicitly). Thus, the phrase, "up to 94.78%" does not meet the description requirement because the phase "up to" has no lower limit and the claims, as they are currently written, allow for embodiments outside of the 93.87% to 94.78% range.
Accordingly, the instant application is afforded a priority date of April 7, 2025.
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goudy et al. (US 2021/0001010 A1, Jan. 7, 2021, hereafter as “Goudy”).
Claim 1 is drawn to a method of treating an oral cavity wound comprising: implanting an implantable scaffold in an oral cavity wound in a subject, wherein the implantable scaffold comprises a plurality of nanofibers forming a flat portion having a diameter between 1 mm and 23 mm; wherein the nanofibers within the plurality of nanofibers are uniaxially aligned; wherein the plurality of nanofibers comprises polycaprolactone (PCL), poly(lactic-co-glycolic-acid) (PLGA), and an S1P1 agonist; wherein the S1P1 agonist is differentially released for controlled release with an initial burst release in an initial period, followed by a delay, and a second phase of release occurring between 3 and 5 days following implantation; wherein the plurality of nanofibers is configured to release up to 94.78% of the S1P1 agonist within 24 hours following implantation; and wherein the plurality of nanofibers is configured to release about 96.7% of the S1P1 agonist after about 75 hours following implantation; and wherein the S1P1 agonist is FTY720.
Regarding claim 1, Goudy teaches a method for treating an oral wound cavity, comprising implanting a scaffold at an oral cavity wound site of a patient, wherein: the scaffold comprises a plurality of nanofibers forming a substantially flat portion; and each of the plurality of nanofibers comprises polycaprolactone (PCL), poly(lactic-co-glycolic-acid) PLGA, and S1P1 agonist (claim 7), wherein the plurality of nanofibers are uniaxially aligned (claim 8), wherein: the S1P1 agonist is FTY720 (claim 9). Goudy teaches the nanofiber scaffold includes a substantially disk-like or cylindrical shape of a predetermined diameter as well as diameters about 1 to about 23 mm ([0116]). Goudy teaches FTY720 is released with an initial burst in the first hours of incubation in vitro, followed by a delay and a second phase of release between 3 and 5 days ([0068]). Goudy teaches after about 75 hours, the nanofiber scaffold releases about 96.7% of incorporated drug ([0118]). Goudy at [0118] teaches,
According to one embodiment, the nanofiber scaffold releases (from the portion of drug released in the first 75 hours) a predetermined drug portion during the first 24 hours (e.g., following implantation). In at least one embodiment, the predetermined drug portion is about 97.08-98.02%. In one or more embodiments, after about 75 hours, the nanofiber scaffold releases about 96.7% of incorporated drug. In at least one embodiment, after about 75 hours, about 0.061-0.069 μg of drug remains in the nanofiber scaffold.
Using the information from [0118], calculations of the amount of S1P1 agonist released within the first 24 hours can be determined, i.e., the S1P1 agonist releases 93.87% (97.08*0.967) -94.78% (98.02*0.967) within the first 24 hours of implantation.
Regarding instant claim 2, Goudy also teaches wherein each of the plurality of nanofibers includes PCL and PLGA at a predetermined weight ratio between about 20:80 and 80:20 wt./wt ([0016]).
Regarding instant claim 3, Goudy also teaches wherein: A) the predetermined weight ratio of PCL and PLGA is about 1:1 wt./wt.; and B) each of the plurality of nanofibers includes FTY720 at about a 1:200 drug to polymer weight ratio ([0017]).
Regarding instant claim 4, Goudy also teaches wherein the substantially flat portion includes a disk-like shape ([0018]).
Regarding instant claim 5, Goudy also teaches wherein the plurality of nanofibers includes inter-fiber distances of about 50 μm ([0019]).
Regarding instant claim 6, Goudy also teaches recruitment of pro-regenerative cells, LY6Clo monocytes and M2 macrophages to oronasal wounds ([0130]).
Regarding instant claim 7, Goudy also teaches the elements discussed above. Goudy also teaches drug release of about 1.65-2.18 μg ([0118]).
Regarding instant claim 8, Goudy also teaches wherein each of the plurality of nanofibers includes PCL and PLGA at a predetermined weight ratio between about 20:80 and 80:20 wt./wt ([0016]).
Regarding instant claim 9, Goudy also teaches wherein: A) the predetermined weight ratio of PCL and PLGA is about 1:1 wt./wt.; and B) each of the plurality of nanofibers includes FTY720 at about a 1:200 drug to polymer weight ratio ([0017]).
Regarding instant claim 10, Goudy also teaches recruitment of pro-regenerative cells, LY6Clo monocytes and M2 macrophages to oronasal wounds ([0130]).
Regarding instant claim 11, Goudy, at [0011] also teaches,
In one or more embodiments, by day 3 (e.g., post-ONF formation), flow cytometry analysis for the FTY720 group shows an increase in LY6Clo Monocytes and M2 Macrophages when compared to the blank group (LY6Clo% of total cells=5.7%±0.6 for FTY720 vs. 3.7%±0.9 for Blank) (LY6Clo% of total CD11B+ cells =22.5±5.6 for FTY720 vs. 12.7±5.7 for blank) (M2 Macrophages % of total cells=3.7±0.5% for FTY720 vs. 1.4±0.2% for blank) (M2 Macrophages % of Macrophages=63.6±3.9 for FTY vs. 34.7±6.4% for blank). Emphasis added.
Using the information from [0011], calculations of the amount of LY6Clo monocytes within 3 days of implantation compared to an identical scaffold without the S1P1 agonist can be determined, i.e., 10.87% (5.7 – 0.6) – (3.7 + 0.9)) / (3.7 + 0.9) to 125% (5.7 + 0.6) – (3.7 - 0.9)) / (3.7 - 0.9).
Regarding instant claim 12, Goudy, at [0011] also teaches,
In one or more embodiments, by day 3 (e.g., post-ONF formation), flow cytometry analysis for the FTY720 group shows an increase in LY6Clo Monocytes and M2 Macrophages when compared to the blank group (LY6Clo% of total cells=5.7%±0.6 for FTY720 vs. 3.7%±0.9 for Blank) (LY6Clo% of total CD11B+ cells =22.5±5.6 for FTY720 vs. 12.7±5.7 for blank) (M2 Macrophages % of total cells=3.7±0.5% for FTY720 vs. 1.4±0.2% for blank) (M2 Macrophages % of Macrophages=63.6±3.9 for FTY vs. 34.7±6.4% for blank). Emphasis added.
Using the information from [0011], calculations of the amount of M2 macrophages within 3 days of implantation compared to an identical scaffold without the S1P1 agonist can be determined, i.e., 45.3% (63.6 - 3.9) – (34.7 + 6.4)) / (34.07 + 6.4) to 138.5%. (63.6 + 3.9) – (34.7 – 6.4)) / (34.07 – 6.4).
Regarding instant claim 13, Goudy also teaches the elements discussed above. Goudy also teaches recruitment of pro-regenerative cells, LY6Clo monocytes and M2 macrophages to oronasal wounds ([0130]).
Regarding instant claim 14, Goudy, at [0011] also teaches,
In one or more embodiments, by day 3 (e.g., post-ONF formation), flow cytometry analysis for the FTY720 group shows an increase in LY6Clo Monocytes and M2 Macrophages when compared to the blank group (LY6Clo% of total cells=5.7%±0.6 for FTY720 vs. 3.7%±0.9 for Blank) (LY6Clo% of total CD11B+ cells =22.5±5.6 for FTY720 vs. 12.7±5.7 for blank) (M2 Macrophages % of total cells=3.7±0.5% for FTY720 vs. 1.4±0.2% for blank) (M2 Macrophages % of Macrophages=63.6±3.9 for FTY vs. 34.7±6.4% for blank). Emphasis added.
Using the information from [0011], calculations of the amount of LY6Clo monocytes within 3 days of implantation compared to an identical scaffold without the S1P1 agonist can be determined, i.e., 10.87% (5.7 – 0.6) – (3.7 + 0.9)) / (3.7 + 0.9) to 125% (5.7 + 0.6) – (3.7 - 0.9)) / (3.7 - 0.9).
Regarding instant claim 15, Goudy, at [0011] also teaches,
In one or more embodiments, by day 3 (e.g., post-ONF formation), flow cytometry analysis for the FTY720 group shows an increase in LY6Clo Monocytes and M2 Macrophages when compared to the blank group (LY6Clo% of total cells=5.7%±0.6 for FTY720 vs. 3.7%±0.9 for Blank) (LY6Clo% of total CD11B+ cells =22.5±5.6 for FTY720 vs. 12.7±5.7 for blank) (M2 Macrophages % of total cells=3.7±0.5% for FTY720 vs. 1.4±0.2% for blank) (M2 Macrophages % of Macrophages=63.6±3.9 for FTY vs. 34.7±6.4% for blank). Emphasis added.
Using the information from [0011], calculations of the amount of M2 macrophages within 3 days of implantation compared to an identical scaffold without the S1P1 agonist can be determined, i.e., 45.3% (63.6 - 3.9) – (34.7 + 6.4)) / (34.07 + 6.4) to 138.5%. (63.6 + 3.9) – (34.7 – 6.4)) / (34.07 – 6.4).
Regarding instant claims 16-20, Goudy also teaches oral cavity healing with drastic reduction of oronasal fistula (ONF) at day 3 and closure of the ONF at day 5 (abstract; [0137]).
Thus, the teachings of Goudy render the instant claims anticipated.
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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,263,277. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the patented claims are significantly overlapping.
The claimed invention is described above.
The patented invention is drawn to an implantable scaffold comprising: a plurality of nanofibers forming a flat portion having a diameter between 1 mm and 23 mm; wherein all of the nanofibers within the plurality of nanofibers are uniaxially aligned; and wherein each of the plurality of nanofibers comprises polycaprolactone (PCL), poly (lactic-co-glycolic-acid) (PLGA), and an S1P1 agonist; wherein the S1P1 agonist is differentially released for controlled release with an initial burst release in the first hours, followed by a delay, and a second phase of release occurring between 3 and 5 days following implantation; wherein the plurality of nanofibers is configured to release between 93.87% and 94.78% of the S1P1 agonist within the first 24 hours following implantation; wherein the plurality of nanofibers is configured to release about 96.7% of the S1P1 agonist after about 75 hours following implantation; and wherein the S1P1 agonist is FTY720. The patent further recites, wherein each of the plurality of nanofibers comprises PCL and PLGA at a predetermined weight ratio between about 20:80 and 80:20 wt./wt; wherein: the predetermined weight ratio of PCL and PLGA is about 1:1 wt./wt.; and each of the plurality of nanofibers comprises FTY720 at about a 1:200 drug: polymer weight ratio; wherein the flat portion comprises a disk-like shape; wherein the plurality of nanofibers comprises inter-fiber distances of about 50 μm; wherein the implantable scaffold is configured to selectively recruit LY6Clo monocytes and M2 macrophages to oral cavity wounds when implanted therein; between 1.7 and 2.2 μg of an S1P1 agonist; wherein 3 days after implantation of the implantable scaffold in a wound site, the LY6Clo monocytes are recruited in an amount between 11% and 125% greater than an amount recruited upon implantation of an identical implantable scaffold without the S1P1 agonist; and wherein 3 days after implantation of the implantable scaffold in a wound site, the M2 macrophages are recruited in an amount between 45.3% and 138.5% greater than an amount recruited upon implantation of an identical implantable scaffold without the S1P1 agonist.
While the patent does not explicitly recite, “A method of treating an oral cavity wound”, the patent recites, “wherein the implantable scaffold is configured to selectively recruit LY6Clo monocytes and M2 macrophages to oral cavity wounds when implanted therein” (claim 6) which implies that the implantable scaffold is implanted in the oral cavity to treat an oral cavity wound.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a method of treating an oral wound by implanting the implantable scaffold of the patent in an oral cavity wound in a subject with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the patent recites implantation in an oral cavity wound and recruiting monocytes/macrophages known for healing.
The subject matter of the instant claims is unpatentable over the subject matter of the patented claims.
Claims 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,263,277, as applied to claim 13 above, in view of Goudy et al. (US 2021/0001010 A1, Jan. 7, 2021, hereafter as “Goudy”).
The claimed invention is described above.
The patent teaches the elements discussed above.
The patent does not explicitly teach “healing of the oral cavity wound”, “healing of oral cavity wound within about seven (7) days”, “wherein the subject has been diagnosed with an oronasal fistula (ONF) formation”, “wherein treatment comprises a reduction in the ONF”, and “wherein treatment comprises healing of the ONF”.
Goudy teaches a method for treating an oral wound cavity, comprising implanting a scaffold at an oral cavity wound site of a patient, wherein: the scaffold comprises a plurality of nanofibers forming a substantially flat portion; and each of the plurality of nanofibers comprises polycaprolactone (PCL), poly(lactic-co-glycolic-acid) PLGA, and S1P1 agonist, wherein the S1P1 agonist is FTY720 (clams 7 and 9). Goudy also teaches that said method yielded oral cavity healing with drastic reduction of oronasal fistula (ONF) at day 3 and closure of the ONF at day 5 (abstract; [0137]).
Both the patent and Goudy teach treating an oral cavity wound comprising implanting a scaffold at an oral cavity wound site of a patient, wherein the scaffold comprises a plurality of nanofibers forming a substantially flat portion; and each of the plurality of nanofibers comprises polycaprolactone (PCL), poly(lactic-co-glycolic-acid) PLGA, and S1P1 agonist, wherein the S1P1 agonist is FTY720, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include “healing of the oral cavity wound”, “healing of oral cavity wound within about seven (7) days”, “wherein the subject has been diagnosed with an oronasal fistula (ONF) formation”, “wherein treatment comprises a reduction in the ONF”, and “wherein treatment comprises healing of the ONF” into the patent, as suggested by Goudy, with a reasonable expectation of success. A skilled artisan would have been motivated to d so because Goudy teaches a comparable implantable scaffold that yielded oral cavity healing with drastic reduction of oronasal fistula (ONF) at day 3 and closure of the ONF at day 5.
The subject matter of the instant claims is unpatentable over the subject matter of the patented claims in view of Goudy.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
