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 .
Election/Restrictions
Applicant’s election without traverse of group I and species in the reply filed on June 19, 2026 is acknowledged.
Claims filed June 16, 2026 is entered.
Claims 1-15, 28, 30-33 are pending. Claims 16-27, 29 are canceled. Claims 15, 28, 30-33 are withdrawn. Claims 1-14 are examined
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.
Claim 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recite 99% which is confusing and ambiguous because it is a relative term which does not indicate what the percentage is compared to. Claims 1-8, 10-14 encompass claim 9.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-9, 12-13 is/are rejected under 35 U.S.C. 102A1 as being anticipated by Verma et al. (WO 2021/184022).
` Verma disclose extracellular vesicles (EV) comprising BMP2 (paragraph 203, 212). BMP2 is a TGF-beta superfamily member that inherently bind cell surface receptor for signaling and inherently is contained within the lumen of the EV. Verma disclose exosome and nanovesicles from macrophage (para 100-107, 151). BMP is inherently osteogenic. Verma teach the enhancement of 99% of molecules in the vesicles (para 152). Verma disclose EV comprising more than one payload (para 292). Verma disclose EV composition comprising two or more populations of EVs (para 341).
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.
Claim(s) 1-10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verma et al. (WO 2021/184022) in view of Crasto et al. (WO 2016/109892).
Verma disclose extracellular vesicles (EV) comprising BMP2 (paragraph 203, 212). BMP2 is a TGF-beta superfamily member that inherently bind cell surface receptor for signaling and inherently is contained within the lumen of the EV. Verma disclose exosome and nanovesicles from macrophage (para 100-107, 151). BMP is inherently osteogenic. Verma teach the enhancement of 99% of molecules in the vesicles (para 152). Verma disclose EV comprising more than one payload (para 292). Verma disclose EV composition comprising two or more populations of EVs (para 341). Verma does not disclose the specific amount of claim 10.
Crasto teach the estimation of encapsulation efficiency from total protein loaded in the vesicle (paragraph 76). Crasto disclose formulation of gelatin capsule estimated to contain about 35-40 ug of BMP-2 protein encapsulated in the liposome formulation (para 125).
It would have been obvious to one of ordinary skill in the art at the time of the filing to determine the protein loaded into vesicle of Verma using the teaching of Crasto. One of ordinary skill in the art would be motivated to combine the teachings in order to improve the specific administration amount for treatment of diseases.
Claim(s) 1-9, 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verma et al. (WO 2021/184022) in view of Bhattacharyya et al. (US 2018/0303616).
Verma disclose extracellular vesicles (EV) comprising BMP2 (paragraph 203, 212). BMP2 is a TGF-beta superfamily member that inherently bind cell surface receptor for signaling and inherently is contained within the lumen of the EV. Verma disclose exosome and nanovesicles from macrophage (para 100-107, 151). BMP is inherently osteogenic. Verma teach the enhancement of 99% of molecules in the vesicles (para 152). Verma disclose EV comprising more than one payload (para 292). Verma disclose EV composition comprising two or more populations of EVs (para 341). Verma does not disclose the printer cartridge of claim 14.
Bhattacharyya et al. teach the microparticles and/or nanoparticles in the 3-D printer as composite ink (paragraph 205, 211). Bhattacharyya disclose formulation with BMP-2 for bone graft (para 52,128, 146).
It would have been obvious to one of ordinary skill in the art at the time of the filing to incorporate the 3D printer of Bhattacharyya using vesicle of Verma. One of ordinary skill in the art would be motivated to combine the teachings in order to improve the bone graft treatment of diseases.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Verma et al. (WO 2021/184022) in view of Crasto et al. (WO 2016/109892) as applied to claims 1-10, 12-13 above, and further in view of He (US 2021/0268121).
The teaching of Verma et al. (WO 2021/184022) in view of Crasto et al. (WO 2016/109892) is discussed above. They do not teach the stripped vesicle of claim 11.
He teach the stripping step of sonication of engineered extracellular vesicle. He disclose engineered extracellular vesicle as a carrier for delivering a therapeutic or active agent (paragraph 9). He discloses sonication as an alternative approach for membrane permeabilization (para 97). He disclose the washing to separate the stripped extracellular vesicle (para 101).
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate the stripping of vesicles of He et al. into the disclosures of Verma et al. and Crasto et al. One of ordinary skill in the art would have been motivated to combine the teachings in order to improve and increase the permeability of the extracellular vesicles.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL D PAK/Primary Examiner, Art Unit 1674
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