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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/02/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/02/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 11/03/2025. As directed by the amendment: claims 1, 5, 6, 8, 10, 11, 13 have been amended. Claims 9 and 17 have been cancelled.
Thus, claims 1-8, 10-16 and 18-25 are pending in this application.
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 6-7 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 6 recites the limitation "the endoscopic tubular retractor" in 3. There is insufficient antecedent basis for this limitation in the claim.
By virtue of dependency, claim 7 is also rejected.
Claim Rejections - 35 USC § 103
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 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 1-3, 6, 7, 10, 14, 16, 18 and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Milbocker et al (US 20080221628 A1) in view of Lau et al (US 20210030789 A1).
Regarding claim 1, Milbocker et al disclose a method for treating or repairing a damaged spinal disc of a patient (abstract, para 0024-25), comprising: inserting, using medical imaging (para 0137), a hollow shaft (fig 2, 612) with a lumen extending from an exterior of the patient to the damaged spinal disc (para 0135 and 0209); surgically treating an annular tear (650) in the damaged spinal disc through the lumen of the hollow shaft (para 0074, 0135 and 0209); providing a tool comprising a syringe (615) with a barrel and a plunger (see fig 2), the barrel containing particles in one of a dry powder, a liquid solution, and a gel suspension (para 0081-82 and 0100, 0135, 0209 and claim 22); dispensing the particles from the barrel and through the lumen of the hollow shaft to the damaged spinal disc by actuating the plunger (para 0135, 0190 and 0209); and removing the hollow shaft from the patient (para 0187 and 0197 and 0218).
Milbocker et al fail to disclose wherein the particles are silver particles but teach the invention further comprises improved methods for use of an adhesive to repair defects in a disc, including repair of the annulus (see para 0081) and the material of the present invention may be mixed with any of a number of materials to create a tissue bonding solid mass in-situ, including without limitation bone and bone particles, metallic particulate (para 0228).
However, Lau et al disclose methods for treating or repairing a damaged spinal disc of a patient include using silver particles (figs 4-5, abstract and 0010 and 0034).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Milbocker et al and incorporate the teaching of Lau et al to dispense silver particles through said syringe barrel to the annulus fibrosus to reduce or prevent inflammation and aid in healing and recovery of function and/or regeneration (para 0010 and 0034).
Regarding claim 2, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al fail to expressly teach wherein the hollow shaft is within a range from 1 mm to 12 mm in diameter.
However, Milbocker et al disclose a hollow shaft (612).
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the hollow shaft of Milbocker et al by making the diameter of the hollow shaft within a range from 1 mm to 12 mm as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955.
Regarding claim 3, Milbocker et al in view of Lau et al disclose the method of claim 2,
Milbocker et al further teach wherein the inserting the shaft includes inserting a hypodermic needle (610), using the medical imaging, to the damaged spinal disc (see fig 2 and para 0135).
Regarding claim 6, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al further teach wherein the syringe (615) includes a needle (614), and the needle is advanced into the lumen of the endoscopic tubular retractor to dispense the silver particles to the damaged spinal disc through the needle (para 0135 and 0209).
Regarding claim 7, Milbocker et al in view of Lau et al disclose the method of claim 6,
Milbocker et al further teach wherein the needle includes a hypodermic needle or a flexible dispensing needle (para 0136).
Regarding claim 10, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al teach said method further comprising using an endoscopic camera to visualize a distribution of the silver particles on a surface of the damaged spinal disc (para 0095 and 0135, 0137).
Regarding claim 14, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al further teach wherein the inserting the shaft using medical imaging includes using at least one of X-ray guided imaging, stereotactic techniques, or robotic navigation to insert the shaft (para 0137 and 0173).
Regarding claim 16, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al teach said method further comprising advancing the hollow shaft to enter an anterior side of the damaged spinal disc to a damaged on a posterior side of the damaged spinal disc (para 0144).
Regarding claim 18, Milbocker et al in view of Lau et al disclose the method of claim 1,
Lau et al further teach wherein the silver particles have dimensions within a range between 1 nm and 1000 nm (para 0011 and 0030).
Regarding claim 20, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al teach said method further comprising endoscopically debriding the damaged spinal disc before distributing the silver particles (para 0146-47).
Regarding claim 21, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al further teach wherein surgically treating includes removing a portion of a nucleus pulposus that has pushed through the annular tear (para 0165 and 0186, fig 11).
Regarding claim 22, Milbocker et al in view of Lau et al disclose the method of claim 1,
Milbocker et al further teach wherein surgically treating includes debriding the annular tear (para 0165 and 0186, fig 11).
Claims 4, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Milbocker et al (US 20080221628 A1) in view of Lau et al (US 20210030789 A1) and further in view of Cragg (US 20030229353 A1).
Regarding claim 4, Milbocker et al in view of Lau et al disclose the limitations of claims 1 and 2 as discussed above and further teach wherein the shaft is an endoscopic tubular retractor (para 0035 and 0135) and wherein the endoscopic tubular retractor includes the lumen used to dispense silver particles to the annular tear (para 0209) but fail to teach the method further including inserting a guidewire, using a guidewire introducer needle and the medical imaging, to the damaged spinal disc, inserting at least one hollow dilator over the guidewire to the damaged spinal disc, inserting the endoscopic tubular retractor over the at least one hollow dilator to the damaged spinal disc, and removing the guidewire and the at least one hollow dilator from the endoscopic tubular retractor.
However, Cragg discloses a method for treating or repairing a damaged spinal disc of a patient (para 0026, see fig 30) comprising a shaft (196) wherein the shaft is an endoscopic tubular retractor (para 0075, see fig 30), the method further including inserting a guidewire (80), using a guidewire introducer needle (70) and the medical imaging (para 0078), to the damaged spinal disc (para 0108), inserting at least one hollow dilator (340) over the guidewire to the damaged spinal disc (para 0112 and 0114, see fig 30), inserting the endoscopic tubular retractor (196) over the at least one hollow dilator to the damaged spinal disc (para 0116, see fig 30), and removing the guidewire and the at least one hollow dilator from the endoscopic tubular retractor (para 0117, see fig 31).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Milbocker et al in view of Lau et al and incorporate the teaching of Cragg to have said method further including inserting a guidewire, using a guidewire introducer needle and the medical imaging, to the damaged spinal disc, inserting at least one hollow dilator over the guidewire to the damaged spinal disc, inserting the endoscopic tubular retractor over the at least one hollow dilator to the damaged spinal disc, and removing the guidewire and the at least one hollow dilator from the endoscopic tubular retractor. This would provide the benefit of having a guidewire that can be inserted to assist in creating a surgical pathway and a dilator can also be used to expand/enlarge the surgical pathway by dilating surrounding muscle or tissue (para 0034-35).
Regarding claim 5, Milbocker et al in view of Lau et al and Cragg disclose the method of claim 4,
Milbocker et al disclose the method further comprising inserting the tool into the endoscopic tubular retractor to dispense the silver particles to the damaged spinal disc (para 0135 and 0209).
Regarding claim 8, Milbocker et al in view of Lau et al and Cragg disclose the method of claim 5,
Milbocker et al further disclose the method wherein the tool further comprises a steerable catheter (614), and the dispensing includes feeding a distal end of the steerable catheter through the lumen of the endoscopic tubular retractor (612) and steering the distal end to dispense the silver particles through a lumen in the steerable catheter to the damaged spinal disc (para 0135, 0136 and 0209).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Milbocker et al (US 20080221628 A1) in view of Lau et al (US 20210030789 A1) and further in view of Riebman et al (US 20160114112 A1).
Regarding claim 11, Milbocker et al in view of Lau et al disclose the limitations of claim 1 as discussed above but fail to teach said method, further comprising atomizing the silver particles into an aerosol or small droplets into a gas phase to coat a surface region of the damaged spinal disc, wherein the silver particles are contained in the barrel in the dry powder form.
However, Riebman et al teach a method for spraying the medicant onto the tissue surface (abstract) comprising atomizing a tissue treatment medicant into gas phase to coat a surface region of the tissue (para 0005 and 0042), wherein the tissue treatment medicants are contained in the barrel in the dry powder form (para 0001 and 0005).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Milbocker et al in view of Lau et al and incorporate the teachings of Riebman et al to have said method further comprising atomizing the silver particles into an aerosol or small droplets into a gas phase to coat a surface region of the damaged spinal disc, wherein the silver particles are contained in the barrel in the dry powder form. The modification would provide the benefit of atomizing said silver particles which is useful for a precise control over the amount of silver particles and the ability to create uniform coating by spraying the silver particles directly at the intended site, helping targeted delivery, atomization, and ease of application (see para 0005).
Regarding claim 12, Milbocker et al in view of Lau et al and Riebman et al disclose the method of claim 11,
Riebman et al further disclose using sterile compressed air to atomize the silver particles to coat the surface region, wherein the sterile compressed air is appropriately sterile for introduction into a surgical field (para 0005).
Regarding claim 13, Milbocker et al in view of Lau et al and Riebman et al disclose the method of claim 11,
Riebman et al further disclose using air in the syringe to atomize the silver particles to coat the surface region of the damaged spinal disc (para 0005).
Claims 15 and 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Milbocker et al (US 20080221628 A1) in view of Lau et al (US 20210030789 A1) and further in view of To (US 20130317296 A1).
Regarding claim 15, Milbocker et al in view of Lau et al disclose the limitations of claim 1 as discussed above but silent about said method, further comprising using the medical imaging to advance the hollow shaft through a foramen in a spine to access the damaged spinal disc.
However, To discloses a method for treating or repairing a damaged spinal disc of a patient (see fig 25, para 0011) comprising using medical imaging to advance a hollow shaft through a foramen in a spine to access the damaged spinal disc (para 0125 and 0164).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Milbocker et al in view of Lau et al and incorporate the teachings of To to have said method further comprising using the medical imaging to advance the hollow shaft through a foramen in a spine to access the damaged spinal disc. This would provide the benefit of passing instruments through a naturally occurring hole in the disc causing less disruption to surrounding muscles and tissue (see para 0125 and 0164).
Regarding claim 23, Milbocker et al in view of Lau et al disclose the limitations of claims 1, 21 and 22 as discussed above but fail to teach wherein surgically treating an annular tear in the damaged spinal disc comprises using a laser.
However, To discloses a method for treating or repairing a damaged spinal disc of a patient (see fig 25, para 0011) comprising surgically treating an annular tear in the damaged spinal disc comprises using a laser (para 0103, 0105).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Milbocker et al in view of Lau et al and incorporate the teachings of To to have said method further comprising wherein surgically treating an annular tear in the damaged spinal disc comprises using a laser. This would provide the benefit of effectively vaporizing the targeted tissue and applying energy to surrounding tissue for debriding (para 0103 and 0105).
Regarding claim 24, Milbocker et al in view of Lau et al disclose the limitations of claim 1 as discussed above but fail to teach wherein surgically treating an annular tear in the damaged spinal disc comprises using a laser.
However, To discloses a method for treating or repairing a damaged spinal disc of a patient (see fig 25, para 0011) comprising surgically treating an annular tear in the damaged spinal disc comprises using a laser (para 0103, 0105).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Milbocker et al in view of Lau et al and incorporate the teachings of To to have said method further comprising wherein surgically treating an annular tear in the damaged spinal disc comprises using a laser. This would provide the benefit of effectively vaporizing the targeted tissue and applying energy to surrounding tissue for debriding (para 0103 and 0105).
Regarding claim 25, Milbocker et al in view of Lau et al disclose the limitations of claims 1, 21 and 22 as discussed above but fail to teach wherein surgically treating an annular tear in the damaged spinal disc comprises using a radio frequency probe.
However, To discloses a method for treating or repairing a damaged spinal disc of a patient (see fig 25, para 0011) comprising surgically treating an annular tear in the damaged spinal disc comprises using a radio frequency probe (para 0103, 0105).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Milbocker et al in view of Lau et al and incorporate the teachings of To to have said method further comprising wherein surgically treating an annular tear in the damaged spinal disc comprises using a radio frequency probe. This would provide the benefit of using a tissue removal probe by delivering high-frequency electrical currents that generate localized heat (para 0103 and 0157).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Milbocker et al (US 20080221628 A1) in view of Lau et al (US 20210030789 A1) and further in view of Shukla et al (US 20190094679 A1).
Regarding claim 19, Milbocker et al in view of Lau et al disclose the limitations of claim 1 as discussed above but fail to teach wherein the silver particles are coated with hydroxyethyl cellulose.
However, Shukla et al disclose silver particles coated with hydroxyethyl cellulose (para 0043).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the disclosure of Milbocker et al in view of Lau et al and incorporate the teachings of Shukla et al to have said method wherein the silver particles are coated with hydroxyethyl cellulose. This would enhance antimicrobial activity, potentially due to the synergistic effect of the silver and the increased surface area of the nanoparticles and can act as a carrier or matrix for silver particles, allowing for controlled release of silver nanoparticles in damaged spinal disc (para 0045 and 0067).
Response to Arguments
Applicant’s arguments, see Remarks, filed on 11/03/2025, with respect to the rejections of claims 1-25 have been fully considered and are persuasive. The rejections of claims 1-25 have been withdrawn.
Lutz (US 20220105316 A1) in view of Loboa et al (US20150290354 A1) fail to teach a tool comprising a syringe with a barrel and a plunger, the barrel containing silver particles in one of a dry powder, a liquid solution, and a gel suspension; dispensing the silver particles from the barrel and through the lumen of the hollow shaft to the damaged spinal disc by actuating the plunger.
However, upon further consideration, a new ground(s) of rejection is made in view of Milbocker et al (US 20080221628 A1) and Lau et al (US 20210030789 A1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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, Bhisma Mehta can be reached at 571-272-3383. 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.
/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783 /DUNG T ULSH/Examiner, Art Unit 3783