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 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) 1-3, 5, 9, 11, 15-18, 23, 25, 27, 29, 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20128/0101325 A1) in view of Keller et al. (US 2010/0003237 A1).
With regard to claim 1, Lee discloses A method for treating a subepidermal tissue in a patient, comprising:
a. visualizing the subepidermal tissue beneath a skin surface of the patient via dynamic ultrasound imaging and real time image analysis ([0183], [0182], needle includes features that allow for it to be seen under ultrasound during placement);
b. vibrating the subepidermal tissue beneath the skin surface ([0174]);
c. locating one or more entrapped nerves within the subepidermal tissue ([0137], [0147], [0149], [0187], [0188], this limitation is not linked to the other method steps nor does it provide specific details on how an entrapped is located. Thus because Lee teaches a method of treating a trapped nerve and is designed to deliver medication at the location of a trapped nerve, it necessarily teaches the method step of locating a trapped nerve. Further, the drug is designed to be delivered at the site of a trapped/pinched nerve in order to relax the tissue in the area and to reduce the pressure on the trapped nerve. Thus the location of a pinched nerve would need to be found in order to deliver the medication to the surrounding tissue of this nerve);
d. introducing a needle probe through the skin surface of the patient and into the subepidermal tissue at a site of the one or more entrapped nerves ([0137], [0147], [0149], [0187], [0188] [0189]) Drug is designed to be delivered to the tissue surrounding an entrapped/pinched nerve in order to reduce the pressure of the tissue on the nerve and reduce the pain caused by the trapped nerve. [0187] also explicitly states delivering near the spinal nerve root. Any of these locations near the trapped nerve is considered the site of the one or more entrapped nerves without further limitations that would define the boundary of what is considered a “site of the trapped nerve”);
e. manipulating the subepidermal tissue and/or the one or more entrapped nerves with the needle probe to aid in restructuring and reorganizing of the subepidermal tissue ([0189], insertion of the needle would necessarily manipulate the tissue as any puncture or movement of the tissue due to the needle insertion would be considered manipulation. Further, this aids in the restructuring and reorganizing the tissue because the needle is being inserted in order to deliver a medicament whose purpose is to restructure/reorganize the tissue [0189] states that the drug relaxes, stretches, causes dissolution or shrinkage which would all be considered restructuring or reorganizing the tissue as the tissue structure is changed), wherein the manipulating comprises sliding back and forth, vibration, or separation of the subepidermal tissue via the needle probe ([0189], separation of the subepidermal tissue would happen when a needle is inserted into the tissue); and
f. injecting a liquid composition into the subepidermal tissue via the needle probe at the site of the one or more entrapped nerves (activator is delivered by syringe 19 near the depot[0189], [0011], [0156], [0163], [0165], [0169], Lee teaches that he volume of the activator (18) can be a liquid that is delivered through the needle can be optimized or altered to fit the desired needs, thus it would be prima facie obvious to optimize the volume delivered to be between 5mL-500mL as doing so would not alter the overall function of the device);
g. repeating a through f, resulting in restructuring and reorganizing of the subepidermal tissue. ([0203] teaches repeat administrations. Repeat administrations would necessarily require locating of the entrapped nerve as the purpose of the device is to treat these entrapped nerves and therefore injection would need to be at this site and not randomly deliver, thus the steps of a-f would need to be performed for a repeat administration as taught in the prior art. [0189], [0091]).
However, Lee does not explicitly disclose injecting a volume of 20mL-500mL.
Keller teaches delivery of a depot (ADME) plus an activator that activates the therapeutic when coming into contact with the activator. The delivery device can have a volume between 20mL-500mL ([0021], [0022]) such that the activator liquid would be within the range of the volume claimed.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee with the volume injected as taught by Keller for the purpose of optimizing the therapeutic affect of the medication ([0021], [0022]).
With regard to claim 2, Lee discloses wherein the subepidermal tissue is a mesoderm- derived tissue (mesoderm tissue is developed during the emboryonic stage and forms into the muscles found in the body, thus the tissue at the wrist or other locations in the body are considered mesoderm-derived).
With regard to claim 3, Lee discloses wherein the mesoderm-derived tissue is a connective tissue, connective tissue located in the patient's neck, back, knees, hips, shoulders, elbows, feet, ankles, toes, hands, wrists, and/or fingers (Fig. 2 shows the wrist, [0187]).
With regard to claim 5, Lee discloses wherein the liquid composition comprises one or more regenerative proteins or cells, and a buffer ([0156], [0157], [0163], enzymes including lysosomal enzymes (which are made up of proteins) and a buffer).
With regard to claim 9, Lee discloses wherein the vibrating is an acoustic radiation force impulse, a shear wave, or a palpitation [0174], ultrasound is considered an acoustic radiation force).
With regard to claim 11, Lee discloses needle probe includes one or more fenestrated holes to allow for delivery of the liquid composition ([0189], needles delivers a medication and thus would have at least one fenestrated hole).
With regard to claim 15, Lee discloses wherein the visualizing includes real-time image analysis to locate the one or more entrapped nerves and abnormal tissue ([0183], [00182], needle can include structure that allow it to be viewed under ultrasound during placement and because the needle is used to deliver to an entrapped nerve site the ultrasound visualization would necessarily be used to locate an entrapped nerve).
With regard to claim 16, Lee discloses further comprising dissipating the liquid composition within the subepidermal tissue via one or more of manual manipulation, percussion massaging, application of a sound wave, and application of a pulsed electromagnetic field (Fig. 2 shows a manual syringe being used to dissipate the liquid composition 18 into the suepidermal tissue, the user pushing the plunger to deliver the liquid can be considered a manual manipulation. Further [0174] teaches use of ultrasound or sound waves to help deliver the liquid and rupture the drug depot 16).
With regard to claim 17, Lee discloses A method for treating a mesoderm-derived tissue (mesoderm tissue is developed during the emboryonic stage and forms into the muscles found in the body, thus the tissue at the wrist or other locations in the body are considered mesoderm-derived) in a patient, comprising:
a. visualizing the mesoderm-derived tissue beneath a skin surface of the patient via dynamic ultrasound imaging and real time image analysis ([0183], [0182], needle includes features that allow for it to be seen under ultrasound during placement);
b. vibrating the mesoderm-derived tissue beneath the skin surface ([0174]);
c. locating one or more entrapped nerves within the mesoderm-derived tissue ([0137], [0147], [0149], [0187], [0188], this limitation is not linked to the other method steps nor does it provide specific details on how an entrapped is located. Thus because Lee teaches a method of treating a trapped nerve and is designed to deliver medication at the location of a trapped nerve, it necessarily teaches the method step of locating a trapped nerve. Further, the drug is designed to be delivered at the site of a trapped/pinched nerve in order to relax the tissue in the area and to reduce the pressure on the trapped nerve. Thus the location of a pinched nerve would need to be found in order to deliver the medication to the surrounding tissue of this nerve);
d. introducing a needle probe through the skin surface of the patient and into the mesoderm-derived tissue at a site of the one or more entrapped nerves ([0137], [0147], [0149], [0187], [0188] [0189]) Drug is designed to be delivered to the tissue surrounding an entrapped/pinched nerve in order to reduce the pressure of the tissue on the nerve and reduce the pain caused by the trapped nerve. [0187] also explicitly states delivering near the spinal nerve root. Any of these locations near the trapped nerve is considered the site of the one or more entrapped nerves without further limitations that would define the boundary of what is considered a “site of the trapped nerve”);
e. manipulating the subepidermal tissue and/or the one or more entrapped nerves with the needle probe to aid in restructuring and reorganizing of the subepidermal tissue ([0189], insertion of the needle would necessarily manipulate the tissue as any puncture or movement of the tissue due to the needle insertion would be considered manipulation. Further, the aids in the restructuring and reorganizing the tissue because the needle is being inserted in order to deliver a medicament whose purpose is to restructure/reorganize the tissue [0189] states that the drug relaxes, stretches, causes dissolution or shrinkage which would all be considered restructuring or reorganizing the tissue as the tissue structure is changed), wherein the manipulating comprises sliding back and forth, vibration, or separation of the subepidermal tissue via the needle probe ([0189], separation of the subepidermal tissue would happen when a needle is inserted into the tissue); and
f. injecting a liquid composition into the mesoderm-derived tissue via the needle probe at the site of the one or more entrapped nerves ([0189], [0011], [0156], [0163], [0165], [0169], Lee teaches that he volume of the activator 18 can be a liquid that is delivered through the needle can be optimized or altered to fit the desired needs, thus it would be prima facie obvious to optimize the volume delivered to be between 5mL-500mL as doing so would not alter the overall function of the device);
g. repeating a through f, resulting in restructuring and reorganizing of the subepidermal tissue. ([0203] teaches repeat administrations. Repeat administrations would necessarily require locating of the entrapped nerve as the purpose of the device is to treat these entrapped nerves and therefore injection would need to be at this site and not randomly deliver, thus the steps of a-f would need to be performed for a repeat administration as taught in the prior art. [0189], [0091]).
However, Lee does not explicitly disclose injecting a volume of 5mL-500mL.
Keller teaches delivery of a depot (ADME) plus an activator that activates the therapeutic when coming into contact with the activator. The delivery device can have a volume between 20mL-500mL ([0021], [0022]) such that the activator liquid would be within the range of the volume claimed.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee with the volume injected as taught by Keller for the purpose of optimizing the therapeutic affect of the medication ([0021], [0022]).
With regard to claim 18, Lee discloses wherein the mesoderm-derived tissue is a connective tissue, connective tissue located in the patient's neck, back, knees, hips, shoulders, elbows, feet, ankles, toes, hands, wrists, and/or fingers (Fig. 2 shows the wrist, [0187]).
With regard to claim 23, Lee discloses wherein the vibrating is an acoustic radiation force impulse, a shear wave, or a palpitation [0174], ultrasound is considered an acoustic radiation force).
With regard to claim 25, Lee discloses needle probe includes one or more fenestrated holes to allow for delivery of the liquid composition
With regard to claim 27, Lee discloses further comprising dissipating the liquid composition within the subepidermal tissue via one or more of manual manipulation, percussion massaging, application of a sound wave, and application of a pulsed electromagnetic field (Fig. 2 shows a manual syringe being used to dissipate the liquid composition 18 into the suepidermal tissue, the user pushing the plunger to deliver the liquid can be considered a manual manipulation. Further [0174] teaches use of ultrasound or sound waves to help deliver the liquid and rupture the drug depot 16).
With regard to claim 29, Lee discloses further comprising re-injecting the liquid composition comprising the one or more regenerative proteins and the buffer to the mesoderm-derived tissue after the initial injecting ([0203], multiple depots can be used which would necessarily require multiple liquid injections from the composition to activate, further [0203], teaches repeat administration to lengthen delivery timeframe.). While not necessarily teaches 14-90 days this range is quite large and it would be prima facie obvious to optimize the deliver timeframe as doing so would not alter the overall function of the device and because the time frame does not appear to have a significance over the method as a whole).
With regard to claim 34 and 35, Lee discloses injecting a liquid activator (18) and that the volume can be altered to optimize the effectiveness of the therapeutic in the depot ([0189], [0011], [0156], [0163], [0165], [0169], Lee teaches that he volume of the activator 18 can be a liquid that is delivered through the needle can be optimized or altered to fit the desired needs, thus it would be prima facie obvious to optimize the volume delivered to be between 50mL-200mL as doing so would not alter the overall function of the device).
However, Lee does not explicitly disclose injecting a volume of 50mL-200mL.
Keller teaches delivery of a depot (ADME) plus an activator that activates the therapeutic when coming into contact with the activator. The delivery device can have a volume between 50mL-200mL ([0021], [0022]) such that the activator liquid would be within the range of the volume claimed.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee with the volume injected as taught by Keller for the purpose of optimizing the therapeutic affect of the medication ([0021], [0022]).
Claim(s) 6, 14, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20128/0101325 A1) in view of Keller et al. (US 2010/0003237 A1) and in further view of Blaivas et al. (US 2011/0166451 A1).
With regard to claim 6 and 21, Lee/Keller discloses the use of ultrasound visualization but fails to disclose the specific frequency.
Blaivas teaches the use of dynamic real-time ultrasound visualization for locating vessels in the body ([0029]) and further teaches a frequency of about 4-100 MHz ([0030], [0038]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee/Keller with the frequency as taught by Blaivas for the purpose of being able to obtain 2D and 3D images of the blood vessels ([0038]).
With regard to claim 14, Lee/Keller discloses the claimed method except for also movement by the patient.
Blaivas teaches during the visualization step the patient is positioned which would require movement of the tissue ([0094]). The positioning of the patient is considered part of the visualization step as it allows for the user to be moved to a position that can be viewed with the ultrasound. Further limitations regarding the visualization the movement of the patient would be needed to overcome this limitation.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee/Keller with the movement of the patient as taught by Blaivas for the purpose of positioning the user in a position to allow for optimal viewing ([0094]).
Claim(s) 20, 36 and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US 20128/0101325 A1) in view of Keller et al. (US 2010/0003237 A1) and in further view of Werber et al. (US 2016/0199417 A1).
With regard to claim 20, Lee disclose the claimed invention including the use of a buffer and dextrose and a protein as part of the activator ([0163]).
However, Lee/Keller does not explicitly teach one of the placental proteins.
Werber teaches a composition that may include a placental protein including: basic fibroplast growth factor, epidermal growth factor, and platelet-derived growth factor ([0026]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee/Keller with the delivery of one of the placental proteins as taught by Weber for the purpose of aiding in the restructuring and healing of the tissue ([0014], [0049]).
With regard to claim 36 and 37, Lee the use of hyaluronic acid and collagen in the depot for immediate release from the depot but not in the delivered liquid composition delivered by the needle probe.
Werber teaches a liquid composition for the purpose of skin regeneration and wound healing ([0049]) that may be used for delivery to specific nerves in the nervous system ([0048]) similar to that of Lee. Werber teaches a syringe with a needle probe (Fig. 9, element 10) that delivers a liquid composition that includes a hyaluronic acid ([0040]), one or more collagens I, III, IV, V, VI, VII ([0024], [0007]) and one or more placental proteins ([0014]). This composition is delivered directly to the target treatment site without the use of a depot.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Lee/Keller with the delivery of hyaluronic acid, collagen and one of the placental proteins as taught by Weber for the purpose of aiding in the restructuring and healing of the tissue directly without need for an intermediary device such as a depot ([0014], [0049]).
Affidavit
The affidavit under 37 CFR 1.132 filed 8/21/25 is insufficient to overcome the rejection of claims 1-3, 5-6, 9, 11, 14-18, 20-21, 23, 25, 27, 29, 34-37 based upon 35 U.S.C. 103 as set forth in the last Office action because: Applicant has not provided sufficient evidence to support the claims made in the Affidavit. Affidavit summarizes the Office Action of Lee in view of Keller and argues in paragraph 14 that the depot would be washed away if the claimed range of 20mL-500mL of activator were to be delivered. However, Affidavit does not provide supporting evidence that this would necessarily happen with a volume delivery in this range. Further in paragraph 16 Affidavit claims that the 20mL-500mL would not be able to delivered to the human radius and ulna like in Lee as this area would not accommodate such a volume. Applicant again does not provide support for the claim indicating a specific size of the ulna or radius that would preclude such a delivery. MPEP 716.01(c) requires that evidence needs to be provided to support and an argument and simply having opinion evidence is insufficient to overcome the 103 rejection.
Further, while the Affidavit seeks to indicate that a volume range of 20mL-500mL would be an unreasonable amount of fluid to deliver to the wrist (as taught in Lee), Applicant’s own specification and claims state that the liquid composition of 20mL-500mL is delivered into the subepidermal tissue which in claim 3 can be located at the patient’s wrist. Therefore, Applicant’s own invention appears to be teaching that this particular volume could be and is delivered to the wrist which is the same location as that in Lee. Thus, Applicant contradicts its own invention by now stating in the Affidavit that this volume of liquid could not be delivered to the wrist. Thus, The Affidavit does not appear to be persuasive as it has not provided factual evidence supporting its claims and appears to teach against its own invention.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Arguments
Applicant's arguments filed 8/21/25 have been fully considered but they are not persuasive. Applicant’s remarks appear to reference and state similar arguments as that found in the Affidavit. Thus similar arguments apply as stated above in the response to Affidavit section.
As stated in the previous Office Action further defining the method steps may help to overcome the current rejection. For example, the term manipulate could be further defined or the needle probe itself could be provided with further structures to differentiate it from the prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Lauren P Farrar/Primary Examiner, Art Unit 3783