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 .
DETAILED ACTION
Claims 1-6 are currently pending and a preliminary amendment to the claims filed on 02/23/2024 is acknowledged.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The three (3) information disclosure statement (IDS) submitted on 11/20/2024; 06/12/2024; 02/23/2024 were filed before the mailing date of the instant first action on the merits. The submissions thereof are in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statements have been considered by the examiner, and signed and initialed copies are enclosed herewith.
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 1-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ajou University Industry-Academic Cooperation Foundation, “Development of Intracorporeal Differentiation of Stem Cells to Induce One-Step Mastoid Bone Reconstruction during Otitis Media Surgeries,” Research Report of Ministry of Science and ICT, 2019-October 19, pp. 1-20 (IDS of 02/23/2024, citation is obtained from its corresponding English non-patent literature “Polymers”, February 2022, Vol. 14, thesis no. 877, pp. 1-13 (IDS of 02/23/2024)).
Please note that as the original is a Korean research paper that was laid-open in 2019, the citation provided corresponds to its English version published in Polymers (2022). The content, title, and inventors remain consistent across both publications. If the applicant disagrees with this assertion, a certified English translation of the 2019 paper is required.
Applicant claims the below claim 1 filed on 02/23/2024:
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Prior Art
Ajou University discloses mastoidectomy is a surgical procedure for the treatment of chronic otitis media, and reconstruction of the mastoid bone defect is caused by mastoidectomy (see e.g., abstract on page 1); in the animal study, twenty male Sprague Dawley rats were randomly divided according to the obliteration materials: (1) control, (2) 3D PCL scaffold only, (3) rSVFs (rat stronmal vascular fraction cells) + 3D PCL, (4) rSVFs + 3D PCL + platelet-rich plasma, and (5) rSVFs + 3D PCL + whole plasma (WP)(abstract on page 1); for mastoid bulla defects, the anterior midline neck skin was incised using a scalpel to expose both sides of the bulla (anterior approach), and 3 × 3 mm holes were made using a straight pick, and then, 3D PCL scaffold was placed in the mastoid cavity in the PCL group, and fat (50 mg) was transplanted directly into the 5 mm diameter of the PCL scaffolds with 50 µL of normal saline and placed in the bulla cavity in the PCL + fat (PF) group which reads on the claimed treating a composition containing a 3D scaffold and adipose tissue, and the remaining groups were transplanted with 50 µL of blood product components such as PRP (plate-rich plasma) and WP (whole plasma) (see e.g., section 2.7 on page 4 and Fig. 1 on page 4) wherein the rSVF is isolated from rat adipose tissue (see e.g., section 2.2 on page 3 and Fig. 2 on page 6) which reads on the claimed adipose tissue, and the PCL scaffold reads on the claimed porous scaffold, and at 7 months after transplantation, the rSVFs + PCL + WP group showed remarkable new bone formation in the mastoid, and these results indicate that autologous rSVFs, PCL scaffolds, and blood products such as autologous WP accelerate bone regeneration for mastoid reconstruction (see e.g., abstract on page 1 and Fig. 2 on page 6). In summary, the results of this study demonstrated that the combination of autologous rSVFs, PCL scaffold and autologous WP can remarkably accelerate osteogenesis in a rat mastoid bone defect model (See e.g., Conclusion on page 10) (instant claims 1-6).
In light of the foregoing, instant claims 1-6 are anticipated by Ajou University.
Claim Rejections - 35 USC § 103
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 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Jang et al., “A MSCs-laden polycaprolactone/collagen scaffold for bone tissue regeneration”, RSC Advances, 2016, vol. 6, pp. 6259-6265.
Applicant claims the below claim 1 filed on 02/23/2024:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “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). The level of skill is that of a medical/pharmaceutical bone regeneration/tissue engineering research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01);
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Jang discloses a mesenchymal stem cell (MSC)-laden scaffold for use in mastoid bone regeneration where the scaffold comprises a MSC, a 3D-polycaprolactone (PCL), collagen and alginate, and the MSC is derived from adipose tissue which reads on the claimed adipose tissue and MSC therapy has been shown to promote bone regeneration by increasing the formation of new bone and increasing bone mineral density (see e.g., abstract, right column, second para. on page 6259 and left column, third para. on page 6264) and the MSC is laden within 3D-PCL structure (see e.g., abstract on page 6259) and therefore, the PCL reads on the claimed 3D porous scaffold; when a mastoid cavity was treated with different types of scaffolds, the PCAMSC scaffold having MSC-laden PCL/collagen/alginate showed a significant amount of new bone formation as compared to the PCA scaffold having PCL/collagen/alginate, with viewpoint of mastoid bone formation (see abstract on page 6259 and Fig. 7 on page 6263). Therefore, Jang teaches the combination of PCL and adipose tissue-derived MSC involves regenerating mastoid bone formation (instant claims 1 and 2); Jang further discloses autografts using autologous transplantations are better than allografts because autografts are histocompatible, non-immunogenic and they provide all of the properties of bone graft materials (see e.g., 4. Discussion - right column on page 6263), and Jang does not expressly teach the MSC is autologous adipose tissue derived cell. However, Jang discloses the benefits of autografts (e.g., reduce immune rejection in case of a composition for implantation in the body) and thus it would be obvious to select autologous MSC instead of allogeneic MSC (instant claim 3); Jang discloses that in their previous study, 3D PCL scaffold coated with umbilical cord serum enhanced osteogenesis (right column, third para. on page 6264) wherein the umbilical cord serum reads on the claimed plasma (instant claim 4). Although Jang does not expressly teach autologous serum, choosing that serum would be obvious due to the advantages of autologous serum (e.g., less immune rejection) (instant claim 5).
In light of the foregoing, instant claims 1-5 are obvious over Jang.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Jang et al., “A MSCs-laden polycaprolactone/collagen scaffold for bone tissue regeneration”, RSC Advances, 2016, vol. 6, pp. 6259-6265, in view of by Ajou University Industry-Academic Cooperation Foundation, “Development of Intracorporeal Differentiation of Stem Cells to Induce One-Step Mastoid Bone Reconstruction during Otitis Media Surgeries,” Research Report of Ministry of Science and ICT, 2019-October 19, pp. 1-20 (IDS of 02/23/2024, citation is obtained from its corresponding English non-patent literature “Polymers”, February 2022, Vol. 14, thesis no. 877, pp. 1-13 (IDS of 02/23/2024)).
Jang was discussed above with respect to instant claims 1-5.
However, Jang does not teach the plasma is whole plasma of instant claim 6. The deficiency is cured by Ajou University.
Ajou University discloses mastoidectomy is a surgical procedure for the treatment of chronic otitis media, and reconstruction of the mastoid bone defect is caused by mastoidectomy (abstract); in the animal study, twenty male Sprague Dawley rats were treated with rSVFs (rat stronmal vascular fraction cells) + 3D PCL + whole plasma (WP)(abstract on page 1) wherein the rSVF is isolated from rat adipose tissue (see e.g., 2.2 on page 3 and Fig. 2 on page 6), and at 7 months after transplantation, the rSVFs + 3D PCL + WP group showed remarkable new bone formation in the mastoid, and these results indicate that the combination of autologous rSVFs, PCL scaffolds, and blood products such as autologous WP accelerate bone regeneration for mastoid reconstruction (see e.g., abstract and Fig. 2). In summary, the results of this study demonstrated that the combination of autologous rSVFs with PCL scaffold and autologous WP can remarkably accelerate osteogenesis in a rat mastoid bone defect model (see e.g., Conclusion on page 10)
It would have been obvious to modify the teachings of Jang with whole plasma of Ajou University in order to enhance the mastoid bone formation, as taught Ajou University.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined 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 combined references, especially in the absence of evidence to the contrary.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613