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 .
Summary
Claims 30-48 are pending in this office action. Claims 30-48 are new. Claims 1-29 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on September 8, 2023 is a 371 of PCT/US2022/024632 filed on April 13, 2022, which in turn claims domestic priority to provisional patent application 63/177,613 filed April 21, 2021.
Information Disclosure Statement
Receipt of the Information Disclosure Statement filed on May 18, 2026 is acknowledged. A signed copy of the document is attached to this office action.
Specification
The specification is confusing to the Examiner particularly as it pertains to the first polymer:
"The disclosed electrospun core-shell fibers include (i) a central core that is electrically conductive having an exterior surface, wherein the core comprises a first polymer and an electroconductive material; (ii) a shell adjacent to the exterior surface of the core, the shell comprising a second polymer; and (iii) one or more bioactive agents in the shell (see instant specification page 1); and conversely
"The shell of the core-fiber includes an electroconductive material in addition to the first polymer. An electroconductive material is any material capable of conducting electricity (see instant specification page 7).
Is the first polymer associated with the shell or core?
Claim Objections
Claim 48 is objected to because of the following informalities: claim 48 has acronyms. Please describe these in-full.
Appropriate correction is required.
Claim Rejections- 35 USC § 112-Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30-48 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: "To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Costello, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include "level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient." MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claim 1 recites an ex vivo method for delivering a bioactive cargo to cells, comprising (a) contacting the cells and the bioactive cargo with electrospun fibers comprising a first polymer and an electroconductive material, wherein the electrospun fibers do not include a shell layer; and (b) applying an electric field to the cells, the bioactive cargo, and the electrospun fibers to deliver the bioactive cargo to the cells.
(1) Level of skill and knowledge in the art:
The level of skill and knowledge in the art is replete with regards to providing electrospun fibers comprising a core-shell structure. However, there is little motivation to halt production of the fiber at just a core. "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR International Co. v. Teleflex Inc., 127 S.Ct. 1727, 167 LEd2d 705, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. At 1396, 82 USPQ2d at 1396. The "hypothetical person having ordinary skill in the art' to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art." Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988).
(2) Partial structure:
The specification teaches core-shell electrospun fibers [see page 1 (Summary) and page 6 (Core-Shell Fibers and Methods of Making)]. The core is always associated with the corresponding shell.
However, the specification does not suggest or have an example of the core electrospun fiber without a shell.
There is no guidance for the synthesis of a core electrospun fiber. For this reason, the pending claims lack a written description.
(3) Physical and/or chemical properties and (4) Functional characteristics:
The physical and/or chemical properties of the core-shell electrospun fibers are described in-full within the instant specification.
The physical and/or chemical properties of the core electrospun fibers are not described within the instant specification. There is not a structure with function correlation for the core electrospun fibers.
(5) Method of making the claimed invention:
It is deemed that the specification fails to provide adequate written description for the functional property of claim 1 and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. Written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967) (“If n-propylamine had been used in making the compound instead of n-butylamine, the compound of claim 13 would have resulted. Appellants submit to us, as they did to the board, an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the present specification. The trouble is that there is no such disclosure, easy though it is to imagine it.” (emphasis in original)); Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1328, 56 USPQ2d 1481, 1487 (Fed. Cir. 2000) (“[T]he specification does not clearly disclose to the skilled artisan that the inventors ... considered the ratio... to be part of their invention .... There is therefore no force to Purdue’s argument that the written description requirement was satisfied because the disclosure revealed a broad invention from which the [later-filed] claims carved out a patentable portion”).
A written description requirement generally involves the question of whether the subject matter of a claim is supported by the disclosure of the specification. The subject matter of the claims imply that a core electrospun fiber is preferred over a core-shell electrospun fiber, however the claimed subject matter is not supported in the specification. Although the claims may recite some structural characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond the electrospun core-shell fibers disclosed in the instant specification.
Accordingly, it is deemed that the specification fails to provide adequate written description for the core electrospun fiber and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 33-38 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.
Claim 33 depends from claim 1, which has been cancelled. It is therefore unclear and indefinite.
Dependent claims 34-38 are included here because they fail to cure the defect of claim 33.
Allowable Subject Matter
Claims 30-48 are allowable over the prior art of record. The Applicant is required to address all the above non-prior art rejections.
Response to Arguments
Applicant's arguments filed May 18, 2026 have been fully considered but they are not persuasive.
The instant claim amendments were sufficient to address the duplicate claim warning and the claim objections. Therefore, they are all withdrawn from the non-final office action dated February 23, 2026.
The amendments did not necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that new instant claim 30 is not taught by the prior art of record, specifically the two clauses in italics and boldfaced below.
“An ex vivo method for delivering a bioactive cargo to cells, comprising (a) contacting the cells and the bioactive cargo with electrospun fibers comprising a first polymer and an electroconductive material, wherein the electrospun fibers do not include a shell layer; and (b) applying an electric field to the cells, the bioactive cargo, and the electrospun fibers to deliver the bioactive cargo to the cells.
Examiner’s Rebuttal: All prior art rejections have been withdrawn from the record. The clause, “wherein the electrospun fibers do not include a shell layer” defeated the references of from the non-final office action. All of the prior art of record supported a core-shell electrospun fiber.
Regarding part (b) of instant claim 30. Yu discloses that the interconnected porous network of fibers prepared by this method is an ideal channel for drug, gene and cell delivery, an ideal biomedical support for tissue regeneration, and a good fixation site for enzymes and catalysts (see paragraph [0005] within Yu). Furthermore, Serrano-Garcia et al. disclose that FIG. 1 illustrates (a) a core/shell structure and (b) electrode locations for different electrical characterizations and applications (i.e., diode, sensor, field effect transistor) (see paragraph [0011] within Serrano-Garcia et al.). Indicating the electric field usage to force a cascade of events, such as drug delivery. Therefore, making it obvious to a skilled artisan (POSITA; person having ordinary skill in the art) regarding the delivery of bioactive cargo to cells.
Conclusion
No claims are allowed.
Please address all non-prior art rejections.
THIS ACTION IS MADE FINAL. 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.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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