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 Application
The claim set filed on 12/20/2024 is acknowledged.
Claims 1-8 are included in the prosecution.
Claim Rejections - 35 USC § 103
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 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Griswold (US 2011/0038936) in view of Shalaby (of US 2001/0051814).
Griswold teaches biodegradable resorbable drug delivery systems characterized by an electrospun biodegradable resorbable polymeric fiber matrix with at least one therapeutic agent incorporated into the fibers of the matrix (see, e.g., abstract).
Regarding claims 1-4 and 8, Griswold discloses a biodegradable controlled release implant of electrospun biodegradable polymeric fibers [0093], wherein the drug delivery system comprises EFS (L-PLA) at a crystallinity percentage (37%) (see [0115]) and at least one API released from the EFS (see, e.g., [0018]).
Griswold does not explicitly disclose teach the crystallinity recited in claim 1.
However, Shalaby teaches yarns made of a crystalline copolymer which is a copolymer of l-lactide and at least one cyclic monomer which is a liquid at or above about 40 degrees C and exhibits a crystallinity of at least about 20% (see, e.g., [0003]). Shalaby explains that the disclosed yarns (1) support high loads; (2) experience cyclic stresses; (3) display minimum or average stretchability; (4) display a high degree of toughness; (5) display optimum hydrolytic stability; and (6) possess a prolonged strength profile, particularly during the initial post-operative period, as braided multifilament or monofilament sutures (see [0002]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Griswold, wherein the fiber is made of a crystalline copolymer, as previously disclosed by Shalaby, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Griswold and Shalaby are both in the field of electrospun fibers, and Shalaby discloses crystalline copolymer which is a copolymer of l-lactide and at least one cyclic monomer which is a liquid at or above about 40 degrees C and exhibits a crystallinity of at least about 20% (see, e.g., [0003]) and Shalaby explains that the disclosed yarns (1) support high loads; (2) experience cyclic stresses; (3) display minimum or average stretchability; (4) display a high degree of toughness; (5) display optimum hydrolytic stability; and (6) possess a prolonged strength profile, particularly during the initial post-operative period, as braided multifilament or monofilament sutures (see [0002]). Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
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 in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Griswold (US 2011/0038936) in view of Shalaby (of US 2001/0051814) as applied to claims 1-4 and 8 and further in view of CN 104711759 (“Cao”).
Regarding the process recited in claim 5, the patentability of product-by-process claims is based on the product itself. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In any event, Cao teaches a poly L-lactic acid electrospun film having a stable micro/nanofiber oriented structure (see abstract of English translation). Cao explains that since the fiber membrane has been subjected to a heat treatment process, it has stable fiber orientation and good thermal stability (see abstract of English translation).
Regarding claim 5, the electrospun fiber is placed at a temperature of 70 to 140 degrees C for 5 minutes to 12 hours (see page 4 of the English translation).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Griswold (US 2011/0038936) in view of Shalaby (of US 2001/0051814) as applied to claims 1-4 and 8 above and further in view of US 2012/0136090 (“Kasuga”).
Regarding the process recited in claim 6, the patentability of product-by-process claims is based on the product itself. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In any event, Kasuga teaches bioactive materials prepared using electrospinning techniques (see, e.g., [0031]). To prepare the materials, stearic structures were cut into pieces and soaked in 4ml of cell culture medium (i.e. 100% humidity), held at a temperature of 37 degrees C in an incubator in an atmosphere of 5% carbon dioxide gas (see [0060]). Kasuga explains that the disclosed material is beneficial in that it may have a sustained release system to guide bone reconstruction ability effectively and has a three-dimensional structure having such flexibility as to fit in an affected area satisfactorily (see [0010]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Griswold (US 2011/0038936) in view of Shalaby (of US 2001/0051814) as applied to claims 1-4 and 8 above and further in view of WO 200245720 (“Martin”).
Regarding claim 7, while Griswold teaches treatment of cancerous tissue (see, e.g., [0099]), it does not teach the 6AN. However, 6AN is known in the art as an anticancer agent, as explained by Martin (see, e.g., page 9, line 18). As such, it would have been obvious to a person of ordinary skill in the art at the time the invention was made to use an anticancer agent such as 6AN in the EFS system disclosed by Griswold.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of prior U.S. Patent No. 11,793,877.
The instant claims differ from the claims of U.S. Patent No. 11,793,877 because claim 1 of the ‘877 patent recites wherein the electrospun fiber scaffold is poly-L-lactic acid (PLLA) fiber wherein the first PLLA EFS is heat treated at a first temperature and the second PLLA EFS is heat treated at a second temperature, and wherein the first temperature is between about 50° C. and about 60° C. and the second temperature is at least 80° C, which instant claim 1 does not require.
However, instant claims 4-5 recite wherein the EFS includes poly-L-lactic acid (PLLA) fibers and wherein the EFS includes poly-L-lactic acid (PLLA) electrospun fibers that have been heated to between 50°C and 80°C for about one hour.
Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose a drug delivery system comprising an electrospun fiber scaffold (EFS) having a polymer crystallinity percentage greater than zero; and at least one active pharmaceutical ingredient (API), wherein the at least one API is released from the EFS upon administration of the drug delivery system to an individual.
This is a nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00am-5:00pm.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
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