DETAILED ACTIONStatus of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14 are pending.
Claim Interpretation
Regarding claims 1-7, the claimed dressing is drawn to product claims and therefore the intended use of the dressing, “for use in treating ulceration” does not carry patentable weight over the teachings of the prior art.
Claim Objections
Claims 2-7 and 9-14 are objected to because of the following informalities:
Claims 2-7 recites “A dressing” which should read as “The dressing”.
Claim 9-14 recites “A method” which should read as “The method”.
Appropriate correction is required.
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 1-14 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 pre-AIA the applicant regards as the invention.
Regarding claims 1 and 8, the phrase "in particular" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Regarding claim 9, the phrase "preferably" renders the claims indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claims 2-7 and 10-14 are included in the rejection because they do not correct for the defect of the claim from which they depend.
Appropriate correction is required.
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 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.
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, 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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US20180117217A1) hereinafter Lee.
Regarding claims 1-14, Lee is drawn to a composition and a sheet, including a mesenchymal stem cells-hydrogel-biodegradable support or a mesenchymal stem cells-hydrogel-nondegradable support and a preparing method thereof. More specifically, in the sheet including a mesenchymal stem cells-hydrogel-biodegradable support or a mesenchymal stem cells-hydrogel-nondegradable support according to the present invention, the high-active mesenchymal stem cells may be applied to a wounded part of a patient with epidermolysis bullosa as it is without isolation using proteases, and in the culturing, an extracellular matrix such as collagen, laminin, fibronectin, and elastin secreted from the mesenchymal stem cells is wholly present on the hydrogel to have an advantageous effect that skin reproduction and re-epithelization abilities are significantly excellent as compared with conventional dressing agents used for epidermolysis bullosa (abstract and claims 1-20).
Lee discloses the human adipose-derived mesenchymal stem cells subcultured two times or more in step (a1) are treated with trypsin or dispase to make a single cell, suspended in the hydrogel, and then evenly sprayed at a concentration of about 5,000/cm2 to be attached to the biodegradable or nondegradable support fabric. Thereafter, the human adipose-derived mesenchymal stem cells are cultured for 3 to 7 days using the growth medium containing 10% FBS and EGF or bFGF. The hydrogel used in the embodiment of the present invention is a fibrin gel, but is not limited thereto, and may further include collagen, hyaluronic acid, gelatin, alginic acid, cellulose, and pectin [0072].
Lee discloses a preparing method of a sheet including high-active stem cells secreting growth factors and cytokines at a high concentration by treating hypoxic stress, mitogens or inflammatory factors in the preparing of the adipose-derived mesenchymal stem cells-hydrogel-biodegradable or nondegradable support sheet [0078].
Lee discloses the adipose-derived mesenchymal stem cells-hydrogel-biodegradable or nondegradable support sheet prepared according to the present invention has excellent therapeutic ability because the high-active stem cells may be applied to the wounded part of a patient with excellent epidermolysis bullosa as it is without isolation using protease. Also, since there is no isolation using protease, in the culturing, an extracellular matrix such as collagen, laminin, fibronectin, and elastin secreted from the mesenchymal stem cells is wholly present on the hydrogel, thereby further promoting an effect of alleviating or improving epidermolysis bullosa [0079].
Lee discloses a method of freezing the adipose-derived mesenchymal stem cells-hydrogel-biodegradable or nondegradable support sheet. The sheet is added with a freezing preservation [0082].
Lee discloses the mesenchymal stem cells subcultured two times or more in Example 1 were collected and suspended in the growth medium. Based on the results of Example 2, thrombin was added to the cell suspension to be a final 8 to 15 I.U. The fibrinogen at a concentration of about 3 to 6.5 mg/mL was applied evenly on vicryl mesh or bovine placental membrane as a biodegradable support having a square shape of about 5×5 cm or gauze, polyurethane coated with soft silicon on a single surface, and a PET film as a nondegradable support, as a support. Thereafter, the cell suspension containing thrombin was applied to the support to have about 5,000 cells per cm2, and then the cell-fibrin gel was uniformly formed and attached to the support. When the fibrin gel was completely hardened, the cells were added with a growth medium and cultured at 37° C. in a 5% CO2 incubator for 3 to 7 days [0093-0094].
Lee discloses the human adipose-derived mesenchymal stem cells-hydrogel-biodegradable or nondegradable support sheet prepared according to the present invention may be frozen for a long time at −80° C. without the damage on cells as a main active ingredient [0096-0098].
Lee discloses the support may use a biodegradable polymer support selected from the group consisting of poly-gamma-glutei acid (PGA), poly lactic acid (PLA), PGA/PLA, viral mesh, human placental membrane, bovine placental membrane, pig collagen, chitin, chatoyant, fibronectin and dextrin, or may use a nondegradable support such as sterilized no woven fabrics, polyethylene terephthalate (PET) films, polyethylene (PE) films, polypropylene (PP) films, polyurethane films, net type polyurethane films, or polyurethane coated with soft silicon on a single surface, or a combination thereof, for example, PGA/nonwoven fabric, PLA/nonwoven fabric, and PGA/PLA/nonwoven fabric [0013].
Lee discloses the concentration of fibrinogen forming fibrin glue may be 0.5 to 60 mg/mL, specifically 0.5 to 45 mg/mL, more specifically 0.5 to 30 mg/mL, much more specifically 0.5 to 20 mg/mL, and much more specifically 0.5 to 10 mg/mL [0014].
Lee does not explicitly disclose each of the components of the composition in a single embodiment.
However, 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 Lee, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Lee discloses all the required components and also discloses Lee is drawn to a composition and a sheet, including a mesenchymal stem cells-hydrogel-biodegradable support or a mesenchymal stem cells-hydrogel-nondegradable support and a preparing method thereof. More specifically, in the sheet including a mesenchymal stem cells-hydrogel-biodegradable support or a mesenchymal stem cells-hydrogel-nondegradable support according to the present invention, the high-active mesenchymal stem cells may be applied to a wounded part of a patient with epidermolysis bullosa as it is without isolation using proteases, and in the culturing, an extracellular matrix such as collagen, laminin, fibronectin, and elastin secreted from the mesenchymal stem cells is wholly present on the hydrogel to have an advantageous effect that skin reproduction and re-epithelization abilities are significantly excellent as compared with conventional dressing agents used for epidermolysis bullosa (abstract and claims 1-20). 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.
Conclusion
No claims are allowed.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615