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 .
DETAILED ACTION
The Amendments filed on 4/2/2026 has been received and entered.
Claims 1-16 are pending. Claims 1-11 and 14-16 are examined on the merits. Claims 12-13 are withdrawn.
There is no 101 rejection because the decellularized nuclear pulposus of the intervertebral disc of the fetus of a vertebrate animal has markedly different characteristic different from a cell that has a nucleus.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-11 and 14-16), the species hydrogel, in the reply filed on June 16, 2025 is acknowledged.
Claims 12-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 16, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/9/22 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
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.
Claims 6, 10, and 11 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.
Claims 6, 10, and 11 contains “further comprising” language, which is indefinite because the language of Claim 1 is “consisting of”. Claims 6, 10, and 11 depends from Claim 1, which precludes other ingredients from being added to the composition. Please amend.
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.
Claim(s) 1-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fernandez et al. (from IDS) in view of Delgado et al. (2017, Biomed.Mater.12: 065009, pages 1-11). This is a new rejection with modification.
Fernandez et al. teaches a biomaterial with a decellularized intervertebral disc tissue, the decellularized intervertebral disc tissue being substantially free of cell nuclei, the decellularized intervertebral disc tissue comprising nucleus pulposus tissue, the nucleus pulposus tissue having a glycosaminoglycan (GAG) content of about 200 (Claim 1). The fresh bovine nucleus pulposus [0012]. The biomaterials can retain significant amounts of GAG as well as collagen type II from the source tissue. For instance, treated tissue can retain a hydroxyproline (HYP) content (as measure of type II collagen content) such that the treated tissue has a GAG: HYP ratio of about 15: 1 or higher, for instance from about 10:1 to about 25:1 in some embodiments. The biomaterials can retain significant levels of other collagens (e.g., collagen type IX, collagen type XI, etc.) that can improve the function of the biomaterials [0031]. The same collagen would inherently have the same characteristics of Claims 2 and 3. The decellularization solution further comprising one or more of an ionic surfactant, a salt, a buffer, an antibiotic, or an antimycotic (Claim 16); thus, limitation of 6 is met. The decellularized biomaterial that can be utilized in one embodiment as an implantable graft material and can be particularly suited for use as a intervertebral graft material [0025]. The biomaterial scaffolds investigated include pre-formed and injectable hydrogels [0054]; thus, limitation of Claims 8-9 are met. The same biomaterial for IVD regeneration would inherently contain COL12A1 and/or COL14A1 in Claim 11. Claims 14-16 are intended uses that do not affect the scope of the claims.
However, Fernandez et al. does not teach fetal source, pepsin, acetic acid and saline.
Delgado et al. teaches a process of collagen extraction with acetic acid, pepsin, and salt (Fig 1, AASP) results in high yield, high purity, low in innate cross-linking density and low in secretion of IL-1β and TNF-α collagen can be extracted using pepsin in acetic acid (page 8, Conclusion, last sentence).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use fetal sources because fetal cells are economic waste products from the slaughterhouse. One would have been motivated to make a nucleus pulposus from cheaper fetal source for the expected benefit of a nucleus pulposus. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use add pepsin, acetic acid, and saline to the collagen extract because Delgado et al. teaches a process of collagen extraction with acetic acid, pepsin, and salt (Fig 1, AASP) results in high yield, high purity, low in innate cross-linking density and low in secretion of IL-1β and TNF-α collagen can be extracted using pepsin in acetic acid (page 8, Conclusion, last sentence). One would have been motivated to make a nucleus pulposus with the extraction method of Delgado et al. for the expected benefit of high yield, high purity, low in innate cross-linking density and low in secretion of inflammatory factors. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Response to Arguments
Applicant argues that hydrogel is only mentioned once.
In response to Applicant’s argument, as long as the claimed element is taught, then the reference teaches the limitation of the invention.
Applicant argues that Fernandez only teaches crossed-linked alginate.
In response to Applicant’s argument, Fernandez et al. teaches a biomaterial with a decellularized intervertebral disc tissue, the decellularized intervertebral disc tissue being substantially free of cell nuclei, the decellularized intervertebral disc tissue comprising nucleus pulposus tissue, the nucleus pulposus tissue having a glycosaminoglycan (GAG) content of about 200 (Claim 1). This meets the limitation of the claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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