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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on December 12th, 2025 is acknowledged. The traversal is on the ground(s) that there would be no serious search burden for the examiner to search all the claims. This is not found persuasive because claims 8, 10, and 12 do not positively recite the device of claim 1, i.e. the device of claim 1 is functionally recited and not a required part of the invention of claims 8, 10, and 12 and their dependents. Therefore, performing the search for four different inventions would be a serious search burden for the examiner.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 12th, 2025. However, if claims 8, 10, and 12 were amended to be system claims that explicitly recite the device of claim 1 in combination with the devices of claims 8, 10, and then rejoinder of claims 8-14 could be considered (the examiner notes that claims 8-14 may have other outstanding issues, for example claim 10 lines 2-4 have a potential issue under 35 U.S.C. 101 by positively reciting the annulus fibrosis).
Claim Objections
Claim 5 is objected to because of the following informalities: Claim 5 lines 1-2 recites …wherein it also includes a memory wire,…. The examiner will interpret this as the double-layer annulus fibrosus patch of claim 1, further comprising a memory wire. Appropriate correction is required.
Claim 7 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 1 lines 8-9 recite …at least an auxiliary connector, which is a wire buckle. Claim 7 recites …wherein the auxiliary connectors are wire buckles. Therefore, claim 7 appears to include a duplicate limitation of claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 lines 11-12 recite …limit the patch to the inner foldable patch and the outer foldable patch on the annulus fibrosus… (emphasis added by the examiner).
Claim 1 lines 12-13 recite …the folded patches are located on the medial and lateral sides of the annulus fibrosus respectively (emphasis added by the examiner).
Claim 3 lines 1-3 recite …wherein the fiber direction of the first hydrophilic layer is the same direction as the fiber direction of the inner layer of the annulus fibrosus …(emphasis added by the examiner).
Claim 3 lines 4-5 recite …the direction of fibers in the second hydrophilic layer is the same direction of fibers of the outer layer of the annulus fibrosus (emphasis added by the examiner).
Claim 5 lines 3-4 recite …after encountering the nucleus pulposus (emphasis added by the examiner).
Therefore, claims 1-7 include a human within their scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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 1-7 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 1 recites the limitation “the folded state” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the openings" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the two ends of the flexible connectors” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the inner layer patch” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 line 7 recites the limitation “the outer layer patch” in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “each end of the outer foldable patch” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation “the unfolded state” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the fiber direction of the first hydrophilic layer” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the fiber direction of the inner layer of the annulus fibrosus” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the direction of fibers in the second hydrophilic layer” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation “the direction of fibers of the outer layer of the annulus fibrosus” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the inner layer” in line 2. There is insufficient antecedent basis for this limitation in the claim.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Allowable Subject Matter
Claims 1-7 are allowable over the prior art. However, the claims are rejected under 35 U.S.C. 101 and 35 U.S.C. 112 as discussed above.
The following is an examiner’s statement of reasons for allowance:
Regarding claims 1-7:
McLeod (U.S. Publication 2008/0009878) discloses a device (for example see Figures 10a and 10b) comprising:
(claim 1) an inner patch (102) capable of being folded
(claim 1) an outer patch (110) capable of being folded
(claim 1) a pair of flexible connectors (111)
(claim 1) wherein in an unfolded state the inner patch and the outer patch are flattened (see Figures 10a and 10b) and are capable of being on the annulus fibrosus and are capable of being located on the medial and lateral sides of the annulus fibrosus respectively
McLeod fails to disclose the device wherein the pair of flexible connectors are arranged in a cross, wherein in a folded state openings on the inner foldable patch and the outer foldable patch oppose each other, the two ends of the flexible connectors connected to diagonal corners of the inner and outer layer patch, each end of the outer foldable patch contains at least an auxiliary connector, and wherein the two flexible connectors intersect to limit the patch to the inner and outer foldable patch being on the annulus fibrosus. The examiner is unable to find a reference or a combination of references that disclose and/or teach the limitations of claim 1 as presented.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775