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 .
Claim Status: Claims 21-40 are pending.
Terminal Disclaimer
The terminal disclaimer filed on January 29, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 10,907,144, US 10,202,598, US 9,999,785, and US 11,905,510 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Arguments
Applicant's arguments filed on August 14, 2025 have been fully considered but they are not persuasive.
Re Claims 21 and 33, 1) Applicant made an argument that Rudd teaches injection of prepared stem cells into or immediately adjacent to the pancreas tissue to be required, not systemically into the patient and then guided to the right location. Moreover, Rudd uses a magnetic field activation modality. In Rudd, the activation modality is a magnetic field and delivery modality is into or immediately adjacent the pancreas. 2) Paspaliaris does not disclose transcutaneously applying a homing laser beam to guide the activated repair cells specifically to the pancreas for treating Type-2 diabetes and increasing insulin sensitivity. In Paspaliaris, the activation modality is a laser and delivery modality is injection into the patient without any form of guidance. 3) Kim teaches genetically modified cells expressing photoactivable chemokine receptors that respond to light by migrating toward illuminated tissue. In Kim, the activation modality is genetic modification and delivery modality comprises light guidance. 4) Applicant argued that Examiner’s inherency position regarding the limitation “transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient’s pancreas to thereby treat the patient’s Type-2 diabetes and increase the patient’s insulin sensitivity”, is misplaced on the basis that inherency requires that the missing characteristic necessarily be present in the prior art. It is scientifically impossible to claim that when three different references teaching different modalities of activation, different resulting cells, and different forms of administration would necessarily lead to a particular therapeutic result.
These arguments have been considered but are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding argument 1), Applicant argued that Rudd teaches injection of stem cells into or immediately adjacent to the pancreas tissue only; however, this statement is incorrect.
Rudd discloses a method of preparing adult stem cells that can assist the body in repairing, replacing and regenerating tissue, particularly pancreas tissue. Rudd discloses that the cells are then injected intravenously or directly into or immediately adjacent to the pancreas tissue to be repaired allowing the body's natural system to repair and regenerate the tissue (Rudd, para. [0047]). Similar to Paspaliaris, Rudd discloses intravenously injecting the stem cells for repair of the targeted tissue. Since Paspaliarias discloses stem cell therapy to treat type II diabetes patients (Paspaliarias, para. [0162], [0164]), it would have been obvious to one of ordinary skill in the art to incorporate the teaching of Rudd of repair of pancreatic tissues for treatment of diabetes (para. [0064]), where the stem cells are injected intravenously (para. [0047]) as Paspaliarias’ delivery modality.
Regarding arguments 2) and 3), Kim was relied on to teach transcutaneously applying a homing laser beam to guide the activated repair cells to the targeted tissue (para. [0065], [0041], [0046], para. [0074], light-mediated recruitment of regulatory T cells into Diabetic Pancreas). Applicant pointed out that Kim teaches genetically modified cells expressing photoactivable chemokine receptors that respond to light by migrating toward illuminated tissue. In response to Applicant’s argument, Examiner would like to point out that the transitional phrase of claims 21 and 33 is “comprising”; therefore, the claim is open-ended and allows of additional elements. Therefore, in order to guide the activated stem cells of Paspaliarias to the pancreas, it would have been obvious to incorporate Kim’s teaching of genetic modification and homing laser beam.
Regarding argument 4), based on the above explanation, the combination of Paspaliaris, Kim, and Rudd discloses the claimed invention and the claimed step of “transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient’s pancreas”. Since the combination of Paspaliaris, Kim, and Rudd teaches each of the method steps, such steps necessarily result in the desired and recited effect that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency.
Examiner previously cited the following sections of MPEP to support the above statement:
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112 I.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). MPEP 2112 II.
In addition, Rudd discloses regeneration of pancreatic islet cells would provide an effective method of treating diabetic conditions such as Type I diabetes, Type II diabetes, diabetes induced by disturbance of insulin receptors, pancreatic diabetes and other forms of diabetes (para. [0010], [0014]), which suggests the claimed therapeutic effect.
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.
Claims 21, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), hereinafter “Paspaliaris”, in view of Kim (US 2014/0128800) and Rudd (US 2006/0193838).
Re Claim 21, Paspaliaris discloses a method of treating diabetes in a patient, the method comprising:
obtaining dormant repair cells (Fig 1, Step 1 and 2);
activating the dormant repair cells to form activated repair cells by treating the dormant repair cells with an amplitude modulated laser beam having a pre-defined wavelength and a pre-defined amplitude (Fig 1, Step 3 & Abstract, para. [0099]);
intravenously administering the activated repair cells into the patient (Fig 1, Step 4, para. [0124], intravenously).
Paspaliaris further discloses that their experiments have resulted that stem cell therapy appears to be safe and beneficial to type II diabetes patients by decreasing their resistance to insulin and decreasing diabetic cardiovascular risk factors (para. [0162], [0164]).
Paspaliaris is silent regarding transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient's pancreas.
Rudd discloses a method and composition for treating diabetes (title) and teaches injecting repair cells to the patient’s pancreas (para. [0010], [0014], Regeneration of pancreatic islet cells would provide an effective method of treating diabetic conditions such as Type I diabetes, Type II diabetes, diabetes induced by disturbance of insulin receptors, pancreatic diabetes and other forms of diabetes; para. [0047], a method is described to prepare adult stem cells that can assist the body in repairing, replacing and regenerating tissue, particularly pancreas tissue. The cells are then injected intravenously or directly into or immediately adjacent to the pancreas tissue to be repaired allowing the body's natural system to repair and regenerate the tissue; para. [0069], CD34 protein is present on the surface of hematopoietic stem cells in all states of development; para. [0077]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris, by administering the activated repair cells into the patient’s pancreas to thereby treat the patient’s Type-2 diabetes and increase the patient’s insulin sensitivity, as taught by Rudd, for the purpose of regeneration of pancreatic islet cells to treat Type II diabetes (para. [0010], [0014]).
Rudd is silent regarding transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient's pancreas.
However, Kim teaches administering repair cells into a body containing damaged biological tissue and transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient's pancreas (Kim, par. [0065], "A photoactivatable chemokine receptor can guide autologous T cells to the location of a tumor using non-invasive light stimulation to induce directional migration. ... Photoactivatable chemokine receptors can be important in guiding stem cell migration to the damaged tissues.", par. [0041], “a method of inducing cell migration comprising exposing a cell that expresses a chimetric photoactivatable polypeptide", "The visible light source can be any source that emits light in the visible light spectrum, for example, a laser an optical fiber or a light emitting diode. In the methods set forth herein, cell migration can be induced by exposing the cells to a visible light source that emits light", par. [0046], "The cell can be a T cell, a stem cell or an NK cell. For example, and not to be limiting, in tumor immunology, where adoptive cell transfer can be used for anticancer immunotherapy, the therapeutic efficiency of in vitro activated autologous T cells is dependent upon access of the T cells to the tumor sites once they are transferred to patients. A photoactivatable chemokine receptor can guide autologous T cells to the location of a tumor using non-invasive light stimulation to induce directional migration ... After the cell is administered to the subject, the cell is exposed to a visible light source to induce cell migration to the tumor site. As set forth above, the visible light source can be a laser, an optical fiber or a light emitting diode.", The cells can be delivered to a subject to treat pancreatic cancer, [0047]-[0050], para. [0051], pancreatic transplant, para. [0074], Light-Mediated Recruitment of Regulatory T Cells into Diabetic Pancreas) for the purpose of reducing or delaying one or more effects or symptoms of a disease, or reducing the underlying pathology rather than just the symptoms (Kim, par. [0044], [0045]). Kim teaches light-mediated directional cell migration using localized light stimulation. The localized light stimulation induces appearing of lamellipodial protrusions and membrane ruffles around the cell edges, thereby producing a polarized and directional migration by repeated irradiation at the cell edge, which can be used to produce prolonged cell movement by generating consistent chemotaxis signals toward the direction of light stimulation (Kim, par. [0066]-[0068]; par. [0072]-[0073]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Rudd, by adding a step of transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient's pancreas to thereby treat the patient’s Type-2 diabetes and increase the patient’s insulin sensitivity, as taught by Kim, for the purpose of promoting efficiency and specificity of stem cells in tissue repair using the laser beam in the visible light spectrum to activate a photoactivatable chemokine receptors of stem cells to induce light-mediated directional cell migration to a targeted tissue site to reduce or delay one or more effects or symptoms of a disease or to reduce the underlying pathology rather than just the symptoms (para. [0065], [0046], [0044], [0045], para. [0074], treatment of diabetic pancreas).
Examiner notes: Paspaliaris as modified by Rudd and Kim discloses “transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient’s pancreas”. The claim states that step of “transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient’s pancreas” is required to yield the results of “treat[ing] the patient’s Type-2 diabetes and increas[ing] the patient’s insulin sensitivity”. Since prior art reference discloses the claimed step of “transcutaneously applying a homing laser beam along at least one axis such that the laser beam guides the activated repair cells to the patient’s pancreas”, it is inherent that the prior art’s methods would yield the same results of treating the patient’s Type-2 diabetes and increasing the patient’s insulin sensitivity, as recited.
Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112 I.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). MPEP 2112 II.
Re Claim 25, Paspaliaris discloses that the dormant repair cells are harvested from at least one of peripheral blood, bone marrow, or fat of the patient (para. [0037], bone marrow, [0039], adipose-derived stem cells, para. [0080], [0040], peripheral blood).
Re Claim 27, Paspaliaris discloses that the pre-defined wavelength is in a range of 405 to 980 nanometers (para. [0067], 575-595 nm (5-20 mW) (yellow; this can also be considered to be an “orange” range of wavelengths as well), and 630-635 nm or 660-670 nm (10-100 mW) (red) and/or 510-540 nm (10-60 mW) (green) for 30-60 mins; para. [0030], [0031], [0033], [0099], [0108]).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), as modified by Kim (US 2014/0128800) and Rudd (US 2006/0193838), and further in view of McCarthy (US 2011/0144011).
Re Claims 22 and 23, Paspaliaris as modified by Kim and Rudd discloses the claimed invention substantially as set forth in claim 21.
Paspaliaris further discloses that the activated stem cell may be applied in combination with insulin (para. [0125]) to treat diabetes type II (fig. 1).
Paspaliaris is silent regarding infusing insulin calibrated to the patient's body weight and administering pulsed intravenous insulin therapy to the patient.
However, McCarthy discloses pulsed intravenous insulin therapy for diabetic patient (abstract, para. [0003], [0016], administer insulin intravenously to reduce the blood sugar level) and teaches infusing insulin calibrated to the patient's body weight (para. [0019], individuals having a longer history of diabetes, those having a larger body mass index (BMI), older individuals, and those having greater incidence of diabetic complications will need to be given higher doses of insulin to achieve the desired swings in blood sugar contemplated by Cellular Activation Insulin Therapy; para. [0033], Be aware that as these patients now can lose weight, the doses of insulin needed early in treatment may need to be lowered. Insulin doses and oral agents will almost always need to be reduced as the patient continues on regular CAIT treatments BMI (Body Mass Index) is calculated using weight and height and can be done in English or Metric units.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim and Rudd, by adding steps of administering pulsed intravenous insulin therapy to the patient and infusing insulin calibrated to the patient's body weight, as taught by McCarthy, for the purpose of treating diabetes and determining appropriate dose for a patient (para. [0033], abstract).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), as modified by Kim (US 2014/0128800) and Rudd (US 2006/0193838), and further in view of Warburton et al. (US 2002/0164790).
Re Claim 24, Paspaliaris as modified by Kim and Rudd discloses the claimed invention substantially as set forth in claim 21.
Paspaliaris and Kim are silent regarding wherein the activated repair cells have increased telomerase activity relative to the dormant repair cells.
However, Warburton discloses lung stem cell and lung regeneration (abstract) and teaches that the activated repair cells have increased telomerase activity relative to the dormant repair cells (para. [0069], activation of telomerase expression may coincide with proliferation and activation of a stem or progenitor cell population, which participates in re-population of the damaged lung epithelium during recovery from injury).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim and Rudd, by observing that the activated repair cells have increased telomerase activity relative to the dormant repair cells, as taught by Warburton, for the purpose of detecting proliferation and activation of a stem or progenitor cell population (para. [0069]).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), hereinafter “Paspaliaris”, as modified by Kim (US 2014/0128800) and Rudd (US 2006/0193838), and further in view of Christopherson (US 2008/0118477).
Re Claim 26, Paspaliaris as modified by Kim and Rudd discloses the claimed invention substantially as set forth in claim 21.
Paspaliaris is silent regarding the dormant repair cells are obtained from a stem cell donor who is genetically matched to the patient.
However, Christopherson discloses stem cell therapy (abstract) and teaches stem cells being sourced from a stem cell donor who is genetically matched to the patient (para. [0012], umbilical cord mesenchymal stem cells can be obtained from the same donor as cord blood hematopoietic stem cells and thereby allow the possibility of genetically matched transplant of both hematopoietic and mesenchymal stem cells as a cellular therapy).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim and Rudd, by obtaining the dormant repair cells from a stem cell donor who is genetically matched to the patient, as taught by Christopherson, for the purpose of preventing different immunological effects from occurring.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), hereinafter “Paspaliaris”, as modified by Kim (US 2014/0128800) and Rudd (US 2006/0193838), and further in view of Kurtz et al. (EP 1292134 A2).
Re Claim 29, Paspaliaris as modified by Kim and Rudd discloses the claimed invention substantially as set forth in claim 21.
Paspaliaris is silent regarding prior to treating the dormant repair cells, the amplitude modulated laser beam being expanded in a range varying between two times to seven times by passing the amplitude modulated laser beam through a beam expander.
However, Kurtz et al. teaches use of beam expansion optics by an afocal pair of lenses or a three element zooming Galilean or Keplerian beam expander for the purpose of expanding the laser beam into a collimated beam with the necessary diameter (Kurtz et al., paragraph 16).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim and Rudd, by expanding the amplitude modulated laser beam by passing the amplitude modulated laser beam through a beam expander prior to treating the unactivated stem cells, as taught by Kurtz, for the purpose of adjusting the laser beam size to a necessary diameter.
Further, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim, Rudd, and Kurtz, by expanding the amplitude modulated laser beam in a range varying between two times to seven times, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Claims 28, 30, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), as modified by Kim (US 2014/0128800) and Rudd (US 2006/0193838), and further in view of Ovokaitys et al. (US 2004/0204746).
Re Claims 28 and 30, Paspaliaris as modified by Kim and Rudd discloses the claimed invention substantially as set forth in claim 21.
Paspaliaris and Kim are silent regarding the amplitude modulated laser beam comprising a string of short duration pulses of sub-femto second duration and a phase cancellation of the amplitude modulated laser beam being adjusted to achieve a predetermined power output before treating the dormant repair cells.
However, Ovokaitys discloses a method for improving the bioavailability of a bioactive substance including subjecting the bioactive substance to laser radiation, and the laser radiation modifies the bioactive substance to thereby modify reactions relating thereto in the body (abstract, para. [0169]). Ovokaitys teaches the amplitude modulated laser beam comprising a string of short duration pulses of sub-femtosecond duration (para. [0018], "sparse nodes of constructive interference of electromagnetic waves generated as rapidly as sub-femtosecond duration can be configured to overcome much of the limitations of scatter pathways through organic and other molecular media to selectively stimulat specific molecular resonances far more efficiently than ordinary laser EM stimulation", [0019], [0020], [0155]) and a phase cancellation of the amplitude modulated laser beam being adjusted to achieve a predetermined power output before treating the dormant repair cells (para. [0191], [0196], [0294], Two GaAs diode lasers were used with primary powers of 4.6 mW and 3.0 mW phase cancelled to 2.3 mW and 1.5 mW, respectively).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing to modify Paspaliaris as modified by Kim and Rudd, by adjusting a phase cancellation of the amplitude modulated laser beam to achieve a predetermined power output before treating the unactivated stem cells, as taught by Ovokaitys, for the purpose of adjusting the power to a predetermined power output; by configuring the amplitude modulated laser beam to comprise a string of short duration pulses of sub-femto second duration, as taught by Ovokaitys, for the purpose of selectively stimulating specific molecular resonances more efficiently (para. [0018]).
Re Claims 31 and 32, Paspaliaris as modified by Kim and Rudd discloses the claimed invention substantially as set forth in claim 21, including treating the dormant repair cells comprises applying the amplitude modulated laser beam having a wavelength lying in a range of 405 to 980 nanometers to a container containing the dormant repair cells (Paspaliaris et al., Abstract, para. [0099], [0108]).
Paspaliaris, Rudd, and Kim are silent regarding treating the dormant repair cells comprising applying the amplitude modulated laser beam to a container containing the dormant repair cells such that the container is moved up and down in a vertical direction during an activation process and treating the dormant repair cells comprising applying the amplitude modulated laser beam to a container containing the dormant repair cells such that the container is rotated during an activation process.
However, Ovokaitys teaches a container of bioactive substance treated with laser irradiation while the container is rotating in a gyroscopic device through three axes for the purpose of treating the bioactive substance homogeneously with the laser irradiation (para. [0294], Each container was treated with dual laser irradiation with the container rotating in a gyroscopic device for 12 minutes per container; para. [0357]). The gyroscopic device rotating the container through three axes for 12 minutes (para. [0294], [0357]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim and Rudd, by treating the dormant repair cells comprising applying the amplitude modulated laser beam to a container containing the dormant repair cells such that the container is moved up and down in a vertical direction during an activation process and by treating the dormant repair cells comprising applying the amplitude modulated laser beam to a container containing the dormant repair cells such that the container is rotated during an activation process, as taught by Ovokaitys, for the purpose of treating the stem cells homogeneously with the laser irradiation (para. [0294], [0357]).
Claims 33 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), hereinafter “Paspaliaris”, in view of Kim (US 2014/0128800), Rudd (US 2006/0193838), and Daley (US 2010/0209396).
Re Claim 33, Paspaliaris disclose a method of treating Type-2 diabetes in a patient, comprising:
obtaining dormant repair cells (Fig 1, Step 1 and 2);
activating the dormant repair cells to form activated repair cells by treating the dormant repair cells with an amplitude modulated laser beam having a pre-defined wavelength and a pre-defined amplitude (Fig 1, Step 3 & Abstract, para. [0099]), and
intravenously administering the activated repair cells into the patient (Fig 1, Step 4, para. [0124], intravenously).
Paspaliaris further discloses that their experiments have resulted that stem cell therapy appears to be safe and beneficial to type II diabetes patients by decreasing their resistance to insulin and decreasing diabetic cardiovascular risk factors (para. [0162], [0164]).
Paspaliaris is silent regarding using a homing laser beam to direct the activated repair cells toward pancreatic tissue, wherein, relative to the dormant repair cells, the activated repair cells comprise at least one of an increased expression of an alpha or beta integrin or an increase in CD34.
Rudd discloses a method and composition for treating diabetes (title) and teaches injecting repair cells to the patient’s pancreas (para. [0010], [0014], Regeneration of pancreatic islet cells would provide an effective method of treating diabetic conditions such as Type I diabetes, Type II diabetes, diabetes induced by disturbance of insulin receptors, pancreatic diabetes and other forms of diabetes; para. [0047], a method is described to prepare adult stem cells that can assist the body in repairing, replacing and regenerating tissue, particularly pancreas tissue. The cells are then injected intravenously or directly into or immediately adjacent to the pancreas tissue to be repaired allowing the body's natural system to repair and regenerate the tissue; para. [0069], CD34 protein is present on the surface of hematopoietic stem cells in all states of development; para. [0077]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris, by administering the activated repair cells into the patient’s pancreas to thereby treat the patient’s Type-2 diabetes and increase the patient’s insulin sensitivity, as taught by Rudd, for the purpose of regeneration of pancreatic islet cells to treat Type II diabetes (para. [0010], [0014]).
Rudd is silent regarding using a homing laser beam to direct the activated repair cells toward pancreatic tissue.
However, Kim teaches administering repair cells into a body containing damaged biological tissue and using a homing laser beam to direct the activated repair cells toward pancreatic tissue (Kim, par. [0065], "A photoactivatable chemokine receptor can guide autologous T cells to the location of a tumor using non-invasive light stimulation to induce directional migration. ... Photoactivatable chemokine receptors can be important in guiding stem cell migration to the damaged tissues.", par. [0041], “a method of inducing cell migration comprising exposing a cell that expresses a chimetric photoactivatable polypeptide", "The visible light source can be any source that emits light in the visible light spectrum, for example, a laser an optical fiber or a light emitting diode. In the methods set forth herein, cell migration can be induced by exposing the cells to a visible light source that emits light", par. [0046], "The cell can be a T cell, a stem cell or an NK cell. For example, and not to be limiting, in tumor immunology, where adoptive cell transfer can be used for anticancer immunotherapy, the therapeutic efficiency of in vitro activated autologous T cells is dependent upon access of the T cells to the tumor sites once they are transferred to patients. A photoactivatable chemokine receptor can guide autologous T cells to the location of a tumor using non-invasive light stimulation to induce directional migration ... After the cell is administered to the subject, the cell is exposed to a visible light source to induce cell migration to the tumor site. As set forth above, the visible light source can be a laser, an optical fiber or a light emitting diode.", The cells can be delivered to a subject to treat pancreatic cancer, [0047]-[0050], para. [0051], pancreatic transplant, para. [0074], Light-Mediated Recruitment of Regulatory T Cells into Diabetic Pancreas) for the purpose of reducing or delaying one or more effects or symptoms of a disease, or reducing the underlying pathology rather than just the symptoms (Kim, par. [0044], [0045]). Kim teaches light-mediated directional cell migration using localized light stimulation. The localized light stimulation induces appearing of lamellipodial protrusions and membrane ruffles around the cell edges, thereby producing a polarized and directional migration by repeated irradiation at the cell edge, which can be used to produce prolonged cell movement by generating consistent chemotaxis signals toward the direction of light stimulation (Kim, par. [0066]-[0068]; par. [0072]-[0073]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris, by using a homing laser beam to direct the activated repair cells toward pancreatic tissue to thereby treat the patient’s Type-2 diabetes and increase the patient’s insulin sensitivity, as taught by Kim, for the purpose of promoting efficiency and specificity of stem cells in tissue repair using the laser beam in the visible light spectrum to activate a photoactivatable chemokine receptors of stem cells to induce light-mediated directional cell migration to a targeted tissue site to reduce or delay one or more effects or symptoms of a disease or to reduce the underlying pathology rather than just the symptoms (para. [0065], [0046], [0044], [0045], para. [0074], treatment of diabetic pancreas).
Examiner notes: Paspaliaris as modified by Rudd and Kim discloses “using a homing laser beam to direct the activated repair cells toward pancreatic tissue”. The claim states that step of “using a homing laser beam to direct the activated repair cells toward pancreatic tissue” is required to yield the results of “treat[ing] the patient’s Type-2 diabetes and increas[ing] the patient’s insulin sensitivity”. Since prior art reference discloses the claimed step of “using a homing laser beam to direct the activated repair cells toward pancreatic tissue”, it is inherent that the prior art’s methods would yield the same results of treating the patient’s Type-2 diabetes and increasing the patient’s insulin sensitivity, as recited.
Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, that the reference does not describe the recited effect in haec verba is of no significance as the reference meets the claim under the doctrine of inherency.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112 I.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). MPEP 2112 II.
Kim is silent regarding wherein, relative to the dormant repair cells, the activated repair cells comprise at least one of an increased expression of an alpha or beta integrin or an increase in CD34.
However, Daley discloses method of enhancing proliferation and/or hematopoietic differentiation of stem cells (abstract) and teaches that relative to the dormant repair cells, the activated repair cells comprise at least one of an increased expression of an alpha or beta integrin or an increase in CD34 (para. [0107], CD34 is developmentally and functionally regulated, and its expression is influenced by the activation-state of stem cells. Higher expression of CD34+ in Cdx4 expanded cells suggested these cells were at actively cycling state undergoing proliferation and differentiation).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim, by selecting the stem cell, wherein relative to the dormant repair cells, the activated repair cells comprise at least one of an increased expression of an alpha or beta integrin or an increase in CD34, as taught by Daley, for the purpose of inducing differentiation of a stem cell (para. [0107]).
Re Claim 35, Paspaliaris discloses that the pre-defined wavelength is in a range of 405 to 980 nanometers (para. [0067], 575-595 nm (5-20 mW) (yellow; this can also be considered to be an “orange” range of wavelengths as well), and 630-635 nm or 660-670 nm (10-100 mW) (red) and/or 510-540 nm (10-60 mW) (green) for 30-60 mins; para. [0030], [0031], [0033], [0099], [0108]).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), hereinafter “Paspaliaris”, as modified by Kim (US 2014/0128800), Rudd (US 2006/0193838), and Daley (US 2010/0209396), and further in view of Kurtz et al. (EP 1292134 A2).
Re Claim 36, Paspaliaris as modified by Kim, Rudd, and Daley discloses the claimed invention substantially as set forth in claim 33.
Paspaliaris is silent regarding prior to treating the dormant repair cells, the amplitude modulated laser beam being expanded in a range varying between two times to seven times by passing the amplitude modulated laser beam through a beam expander.
However, Kurtz et al. teaches use of beam expansion optics by an afocal pair of lenses or a three element zooming Galilean or Keplerian beam expander for the purpose of expanding the laser beam into a collimated beam with the necessary diameter (Kurtz et al., paragraph 16).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim, Rudd, and Daley, by expanding the amplitude modulated laser beam by passing the amplitude modulated laser beam through a beam expander prior to treating the unactivated stem cells, as taught by Kurtz, for the purpose of adjusting the laser beam size to a necessary diameter.
Further, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim, Rudd, and Kurtz, by expanding the amplitude modulated laser beam in a range varying between two times to seven times, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. MPEP 2144.05.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), hereinafter “Paspaliaris”, as modified by Kim (US 2014/0128800), Rudd (US 2006/0193838), and Daley (US 2010/0209396), and further in view of Christopherson (US 2008/0118477).
Re Claim 37, Paspaliaris as modified by Kim, Rudd, and Daley discloses the claimed invention substantially as set forth in claim 33.
Paspaliaris is silent regarding the dormant repair cells are obtained from the patient or a stem cell donor who is genetically matched to the patient.
However, Christopherson discloses stem cell therapy (abstract) and teaches stem cells being sourced from a stem cell donor who is genetically matched to the patient (para. [0012], umbilical cord mesenchymal stem cells can be obtained from the same donor as cord blood hematopoietic stem cells and thereby allow the possibility of genetically matched transplant of both hematopoietic and mesenchymal stem cells as a cellular therapy).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim, Rudd, and Daley, by obtaining the dormant repair cells from the patient or a stem cell donor who is genetically matched to the patient, as taught by Christopherson, for the purpose of preventing different immunological effects from occurring.
Claims 34, 38, 39, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Paspaliaris et al. (US 2012/0101479), as modified by Kim (US 2014/0128800), Rudd (US 2006/0193838), and Daley (US 2010/0209396), and further in view of Ovokaitys et al. (US 2004/0204746).
Re Claims 34, 38, and 39, Paspaliaris as modified by Kim, Rudd, and Daley discloses the claimed invention substantially as set forth in claim 33.
Paspaliaris, Rudd, and Kim are silent regarding the homing laser beam being generated using a 20% to 90% phase cancellation, wherein the amplitude modulated laser beam comprises a string of short duration pulses of sub-femto second duration, wherein a phase cancellation of the amplitude modulated laser beam is adjusted to achieve a predetermined power output before treating the dormant repair cells.
However, Ovokaitys discloses a method for improving the bioavailability of a bioactive substance including subjecting the bioactive substance to laser radiation, and the laser radiation modifies the bioactive substance to thereby modify reactions relating thereto in the body (abstract, para. [0169]). Ovokaitys teaches the amplitude modulated laser beam comprising a string of short duration pulses of sub-femtosecond duration (para. [0018], "sparse nodes of constructive interference of electromagnetic waves generated as rapidly as sub-femtosecond duration can be configured to overcome much of the limitations of scatter pathways through organic and other molecular media to selectively stimulat specific molecular resonances far more efficiently than ordinary laser EM stimulation", [0019], [0020], [0155]) and a phase cancellation of the amplitude modulated laser beam being adjusted to achieve a predetermined power output before treating the dormant repair cells (para. [0191], [0196], [0294], Two GaAs diode lasers were used with primary powers of 4.6 mW and 3.0 mW phase cancelled to 2.3 mW and 1.5 mW, respectively). Ovokaitys teaches a laser beam being generated using a 20% to 90% phase cancellation (para. [0191], [0196], [0294], Two GaAs diode lasers were used with primary powers of 4.6 mW and 3.0 mW phase cancelled to 2.3 mW and 1.5 mW, respectively).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing to modify Paspaliaris as modified by Kim, Rudd, and Daley, by adjusting a phase cancellation of the amplitude modulated laser beam to achieve a predetermined power output before treating the unactivated stem cells and generating the homing laser beam using a 20% to 90% phase cancellation, as taught by Ovokaitys, for the purpose of adjusting the power to a predetermined power output and improving the beam quality (para. [0191], [0196], [0294]); by configuring the amplitude modulated laser beam to comprise a string of short duration pulses of sub-femto second duration, as taught by Ovokaitys, for the purpose of selectively stimulating specific molecular resonances more efficiently (para. [0018]).
Re Claim 40, Paspaliaris as modified by Kim, Rudd, and Daley discloses the claimed invention substantially as set forth in claim 33, including treating the dormant repair cells comprises applying the amplitude modulated laser beam having a wavelength lying in a range of 405 to 980 nanometers to a container containing the dormant repair cells (Paspaliaris et al., Abstract, para. [0099], [0108]).
Paspaliaris, Rudd, and Kim are silent regarding treating the dormant repair cells comprising applying the amplitude modulated laser beam to a container containing the dormant repair cells such that the container is rotated during an activation process.
However, Ovokaitys teaches a container of bioactive substance treated with laser irradiation while the container is rotating in a gyroscopic device through three axes for the purpose of treating the bioactive substance homogeneously with the laser irradiation (para. [0294], Each container was treated with dual laser irradiation with the container rotating in a gyroscopic device for 12 minutes per container; para. [0357]). The gyroscopic device rotating the container through three axes for 12 minutes (para. [0294], [0357]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Paspaliaris as modified by Kim, Rudd, and Daley, by treating the dormant repair cells comprising applying the amplitude modulated laser beam to a container containing the dormant repair cells such that the container is rotated during an activation process, as taught by Ovokaitys, for the purpose of treating the stem cells homogeneously with the laser irradiation (para. [0294], [0357]).
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, September 27, 2025
Examiner, Art Unit 3792