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 .
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.
Claim Status
Applicant’s arguments and amendments dated 3/23/26 have been received and entered in the application.
Claims 1-2, 4-12, 14, 17-18, 20-22, 25-39 are currently pending and examined on the merits.
Claims 1-2, 5, 21, 25, 33 are currently amended.
Withdrawn Objections & Rejections
The objections and rejections presented herein represent the full set of objections and rejections currently pending in this application. Any objections rejections not specifically reiterated are hereby withdrawn.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), or 386(c) or under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No. 16/268,959 (hereinafter ‘959) and Application No. 15/400,392 (hereinafter ‘392), fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘959 and ‘392 applications disclose that a composition comprising micronized nucleus pulposus (NP) may be injected using a syringe or suitable injection delivery device through a cannula (‘959: [0009], [0069] [0075], ‘392: [0009], [0066], [0069]). Neither application discloses “the damaged viable disc comprises a void resulting from a tissue biopsy”. The earliest appearance of these limitations occurs in the present application. Therefore, claim 1, and its dependents claims 2-12, 14, 17-18, 20-22, 25-39 are all accorded an earliest priority date of 9/28/21.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-12, 14, 17-18, 20-22, 25-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beall et al., (2020) VAST clinical trial: Safely supplementing tissue lost to degenerative disc disease. Int J Spine Surg, 14(2) pp. 239-253 (hereinafter Beall) in view of Temple et al., US Publication No. 2019/0191694 (hereinafter Temple), Lopez, R.M., US Publication No. 2019/0008526 (hereinafter Lopez) and Peh, WCG., (2006) CT-guided percutaneous biopsy of spinal lesions. Biomed Imaging Interv J, 2(3); e25 (hereinafter Peh).
Regarding claims 1, 6, Beall discloses methods of treating intervertebral disc (IVD) degeneration using an allograft material (Abstract). Beall discloses inserting a 22-gauge needle through Kambin’s triangle (Study interventions). A viable allograft material prepared from human NP (VIA Disc Matrix) is then injected into the affected disc tissue to repair the damaged disc (Study interventions).
Regarding claim 4, Beall explains that the disclosed methods result in improved disc morphology, height, and patient indices of pain and functional improvement with no adverse events (Discussion).
Beall does not explicitly disclose that the allograft material is prepared by certain means or has certain characteristics. However, methods of making, and characteristics of the Via Disc allograft are disclosed in Temple (paragraph [0090] of Temple indicates that the disclosed product is named “Via Disc”). As Beall discloses that the allograft material utilized is the same is Via Disc of Temple, it would be obvious to one of ordinary skill in the art that the allograft material of Beall is produced by the same methods and has the same characteristics of the allograft material of Temple.
Temple discloses viable disc regenerative compositions comprising micronized NP and methods of making thereof (Abstract]).
Regarding claim 1, Temple discloses that the composition may be administered using a syringe through a small cannula, or any suitable injection delivery device ([0009]-[0010], [0075]).
Regarding claim 5, Temple discloses injecting a fibrin glue after administration of the graft material to seal any pre-existing cracks or fissures ([0010], [0069]).
Regarding claims 7-8, 28-30, Temple discloses freeze-drying the NP and micronizing into a very fine powder, wherein the particles have a size of less than 400 microns ([0069]). When ready for administration, the powder may be rehydrated with an appropriate solution ([0069]).
Regarding claims 9-11, Temple discloses that the allograft material is composed of a mixture of mechanically selected allogeneic biologic material derived from bone marrow, including non-whole cellular components, vesicular components, active and inactive components of biological activity, cell fragments, cell excretions, cellular derivatives, and extracellular components ([0011]).
Regarding claim 12, preferably, the composition includes non-expanded whole cells derived from bone marrow ([0012]).
Regarding claim 14, Temple discloses that the non-expanded cells may include differentiated, committed cells, non-differentiated cells, and non-committed cells ([0013]).
Regarding claim 16, Temple discloses that “the biological composition extends regenerative resonance that compliments or mimics disc tissue complexity” ([0014]).
Regarding claim 17-18, 20, the mixture may be treated in a protectant or cryoprotectant and cryopreserved ([0014]). Preferably, the protectant or cryoprotectant is a polyampholyte ([0015]). Temple further discloses that the protectant “creates a physical or electrical or chemical gradient or combination thereof for disc tissue regeneration” ([0014]).
Regarding claims 21-22, Temple discloses that cryopreservation preferably occurs at a temperature from 0°C to -200°C ([0015]).
Regarding claims 25-27, Temple discloses that the composition may be prepared by “collecting, recovering and processing bone marrow from a cadaver donor; mechanically separating cellular and non-cellular components of bone marrow from cadaverous bone; concentrating by centrifugation and filtering; separation by density gradient centrifugation; collecting cells or non-cellular components or combinations thereof of predetermined density; washing the cells or non-cellular components or combinations thereof to create a mixture; quantifying cell concentration not to exclude zero; suspending to a predetermined concentration in a polyampholyte cryoprotectant; freezing the mixture at a predetermined controlled rate; and packaging micronized nucleus pulposus having particles in the size range of less than 300 µm separate” ([0017]). The method may further include thawing the mixture in a warm water bath for two to three minutes at 37°C, diluting the thawed mixture in saline without spinning, combining the mixture with the micronized nucleus pulposus, and implanting via injection ([0017]).
Regarding claims 31-32, 38, Temple discloses aseptically recovering human cadaver spine segments from T9 to L5, removing discs by cutting between the cancellous bone and vertebral endplate junction, removing normal NP, freeze drying the NP from multiple disc segments, placing the freeze dried material into a cryomill, and placing the micronized disc material into a sterile container for later use ([0069]).
Regarding claim 33, Temple explains that the disclosed methods contains proteoglycans ([0008], [0023]-[0024], [0073])
Regarding claim 34, Temple discloses that the micronized material is dehydrated and aseptically packaged in a container ([0093]).
Regarding claims 35-36, 39, Temple discloses that the micronized material when rehydrated has a “high viscosity” at which the rehydrated material is flowable as injectable through a small bore cannula ([0009]). The flowable mixture may then be injected using any suitable injection delivery device through a cannula to treat the disc ([0010]).
Regarding claim 37, Temple discloses the rehydrated material is stored in a syringe or other injectable device for insertion into a damaged disc to be treated ([0009]).
The combination of Beall and Temple also does not disclose that degenerative tissue is removed from the disc to create a void.
Lopez discloses methods and apparatuses for minimally invasive insertion of intervertebral implants (Abstract). Lopez discloses introducing a first dilator tube through Kambin’s triangle towards the IVD (claim 1). In some embodiments, the first dilator tube may be a trocar ([0107]-[0108], Fig. 10). An access cannula may be introduced over the first dilator tube (Abstract, [0016]-[0017], See MPEP §2144.04 regarding sequence of process steps). Surgical instruments may pass through the access cannula to operate on the IVD or to insert an IVD implant (Abstract, [0094], [0099]). In some embodiments, disc material may be removed from the IVD space with an instrument inserted through the access cannula ([0204], claim 33). After the implant site is prepared, an implant may be inserted into the disc cavity and adjusted to appropriate dimensions ([0207]).
As each of the references is directed to methods of treating intervertebral disc degeneration, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to use the methods of Lopez in the method of the combination as it would be simple combining of prior art elements according to known methods to yield the predictable result of IVD repair. Further, Temple indicates that any suitable injection means may be used in the treatment methods. Therefore, there is a suggestion present in Temple that known methods and instruments may be successfully utilized in the methods of the combination.
The combination of Beall, Temple, and Lopez do not disclose that a tissue biopsy is removed from the NP.
Peh explains that accurate diagnosis of spinal lesions is essential for accurate diagnosis and enables appropriate ongoing treatment (Abstract, General principles and preparation, Indications). Peh explains that a large variety of equipment may be utilized to obtain a biopsy specimen from an IVD and will depend on the subject and the surgeon’s preferences (Technique and equipment). In some embodiments, a biopsy may be procured using an ostycut trephine needle which includes a cannula and a trocar point stylet (Technique and equipment). Peh discloses that the biopsy may be evaluated to confirm or exclude diagnosis (Indications)
A skilled artisan would be motivated to incorporate Peh into the methods of the combination as Peh stresses the importance of biopsies for continued treatment of subjects with spinal conditions, including IVD degeneration. Further, Peh indicates that the same equipment may be utilized to obtain a biopsy as that used in the combination for treatment of the damaged disc.
Response to Arguments
Applicant's arguments dated 3/23/26 have been fully considered but are not persuasive as explained in detail below.
Claim 1, and its dependents claims 2-12, 14, 17-18, 20-22, 25-39 have been accorded an earliest priority date of 9/28/21.
Applicant argues that the ‘959 application and the ‘392 application disclose that disc degeneration causes tears or cracks of the annulus fibrosus through which may cause the NP to bulge, rupture, or break into fragments (Response p8-9). Applicant concludes that based on this disclosure a skilled artisan would understand that a biopsy may also cause the NP to be forced out of the disc and leave a void, such that the claims are entitled to an earliest priority date of 1/6/17 (Response p8-9).
Priority date is not based upon what a skilled artisan might reasonably extrapolate from a disclosure (i.e., enablement), but what applicants actually disclosed at the time of filing (i.e., written description). See MPEP § 211.05. In the present case, it is not clear that at the time of filing the ‘959 or ‘392 applications, applicants contemplated treating a void caused by a biopsy. It appears that applicants had only contemplated treating damage arising from natural causes (i.e., disc degeneration). Therefore, applicants arguments are not considered persuasive and the present claims are afforded an earliest priority date of 9/28/21.
Claim(s) 1-12, 14, 17-18, 20-22, 25-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beall in view of Temple, Lopez and Peh.
Applicant argues that the art rejections are moot in view of the amendments to the claims resulting in an earliest priority date of 1/6/17, before the priority date of each of Beall, Temple, and Lopez (Response p9-10).
As discussed supra, the examiner disagrees that the present claims are afforded the earlier priority date. Therefore, the cited art is still deemed to obviate the claims as presented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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, Peter Paras can be reached on (571) 272-4517. 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.
/KARA D JOHNSON/Primary Examiner, Art Unit 1632
Prosecution Insights