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 .
The preliminary amendment filed on 07/30/2024 has been entered.
Amended claims 1-11 are pending in the present application, and they are examined on the merits herein.
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.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crawford et al (WO 2015/017772).
Claims 1-3 are drawn to a method for preparing cells for treating diseases comprising subjecting cells (e.g., mesenchymal stem cells) to ultrasonic treatment (e.g., wherein a frequency of the ultrasonic treatment is 30 kHz to 2.0 MHz). Claims 4-9 encompass a method for promoting a migration ability of cells or promoting a proliferation of cells, comprising subjecting cells (e.g., mesenchymal stem cells) to ultrasonic treatment (e.g., wherein a frequency of the ultrasonic treatment is 30 kHz to 2.0 MHz). Claims 10-11 are drawn to cells or mesenchymal stem cells treated with an ultrasonic wave having a frequency of 30 kHz to 2.0 MHz, respectively.
Crawford et al already disclosed a method for treating a subject having a defect, the method comprises: contacting a graft including tissue and a population of adult stem cells to the defect, wherein the stem cells do not substantially induce a T cell or natural kill (NK) cell-mediated immune response in the subject (e.g., early lineage adult (ELA) stem cells, mesenchymal stem cells (MSCs), multipotent adult progenitor cells (MAPC) and mesenchymal precursor cells (MPC); and performing ultrasound therapy on the defect using an ultrasound device, thereby stimulating healing of the skin defect; wherein the ultrasound device generates an ultrasound frequency of about 30 kHz to about 50 kHz, about 50 kHz to about 100 kHz, about 100 kHz to about 250 kHz, about 250 kHz to about 500 kHz, about 500 kHz to about 750 kHz, about 750 kHz to about 2 MHz, for examples (see at least Abstract; Summary; particularly line 11 at page 5 continues to line 17 at page 7; line 28 at page 10 continues to line 33 at page 13). Crawford et al stated clearly “The grafts and/or grafts including ELA stem cells are further treated with various types of stimuli in various embodiments to further promote or enhance tissue formation and wound healing. For example, the treated defect is stimulated with vibrational energy, biochemical agents, or by physical manipulation of the defect site or body. The vibrational energy may be ultrasonic energy……The application of ultrasonic energy may stimulate cells or cellular components, may locally apply or enhance contact or activity between the cells and nearby material, or otherwise stimulate the microstructure of the target tissue or its neighbors, without causing gross physical movement of layers that could disrupt the processes of tissue anchoring, growth or healing processes.” (page 10, line 28 continues to line 9 at page 11).
Since the method of Crawford et al has the same method step of subjecting cells, including mesenchymal stem cells, to an ultrasonic treatment that utilizes a frequency in the range of 30 kHz to 2 MHz as the claimed methods of the present application, the method of Crawford et al would necessarily result in treated cells having promoted migration ability and/or enhanced proliferation relative to cells that are not subjected to an ultrasonic treatment.
Accordingly, the teachings of Crawford et al meet every limitation of the instant claims. Therefore, the reference anticipates the instant claims.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ling et al (Cell proliferation. 2017; 50:e12383, 12 pages; IDS).
Ling et al already provided evidence for the application of low-intensity pulsed ultrasound (LIPUS) in promoting the viability and proliferation of human amnion-derived mesenchymal stem cells (hAD-MSCs); and this may benefit the use of stem cells in tissue engineering and clinical treatment (see at least Abstract; and the paragraph bridging left and right column at page 2). Specifically, Ling et al taught that hAD-MSCs were subjected to a LIPUS treatment using a LIPUS device that was set at a frequency of 0.25 MHz with a 200 μs burst width sine wave, a duty cycle of 20% and a pulse repetition frequence of 1 kHz (section titled “Optimization of LIPUS treatment protocol and dosage” on left column at page 3).
Since the method of Ling et al has the same method step of subjecting human amnion-derived mesenchymal stem cells (hAD-MSCs) to an ultrasonic treatment that utilizes a frequency in the range of 30 kHz to 2 MHz as the claimed methods of the present application, the method of Ling et al would also necessarily result in treated hAD-MSCs having promoted migration ability relative to hAD-MSCs that are not subjected to an ultrasonic treatment; particularly Ling et al already provided evidence for the application of low-intensity pulsed ultrasound (LIPUS) in promoting the viability and proliferation of human amnion-derived mesenchymal stem cells (hAD-MSCs).
Accordingly, the teachings of Ling et al meet every limitation of the instant claims. Therefore, the reference anticipates the instant claims.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Xia et al (Cell transplantation 30:1-14, 2021; IDS) disclosed that low-intensity pulsed ultrasound at a frequency of 3 MHz promotes autophagy-mediated migration of mesenchymal stem cells and cartilage repair (Abstract; and section titled “LIPUS Stimulation” at page 2).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Quang Nguyen, Ph.D., at (571) 272-0776.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s acting SPE, James Douglas (Doug) Schultz, Ph.D., may be reached at (571) 272-0763.
To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Group Art Unit 1631; Central Fax No. (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to (571) 272-0547.
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/QUANG NGUYEN/Primary Examiner, Art Unit 1631
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