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 .
Status
Claims 1, 4-6, 15, 16, 18, 19, 24-26, 28, 31-33, 35-37, 40 and 41 are pending. Claims 6, 15, 24, 25, 28, withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (Claim 6, 15, 24, 25, 28, and 31-33) and invention (Claims 35-37, 40 and 41).
Therefore, Claims 1, 4-5, 16, 18, 19, and 26 are presented for examination
Election/Restrictions
Applicant’s election of the following without traverse in the reply filed on 1/16/2026 is acknowledged:
Group I (reducing post-injury scar, reducing neuroinflammation or treating neurodegeneration - Claims 1, 4-6, 15, 16, 18, 19, 24-26, 28, and 31-33),
reducing post-injury scar formation, where the specific condition is spinal cord injury and the site of injury is the spinal cord; and
Proteinase inhibitor: specifically, combination of E64 and serpina3n.
(Applicant states elected species include claims 1, 4-5, 16, 18, 19, 26, and 31-33).
Claims 6, 15, 24, 25, 28, 31-33, 35-37, 40 and 41 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (Claim 6, 15, 24, 25, 28, and 31-33) and invention (Claims 35-37, 40 and 41), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/16/2026.
Therefore, Claims 1, 4-5, 16, 18, 19, and 26 are presented for examination.
Priority
This application is a 371 of PCT/US2021/044680 filed 08/05/2021, which claims priority to PRO 63/062,088 filed 08/06/2020.
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, 4-5, 16, 18, 19, and 26 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 “contacting a site of injury with a proteinase inhibitor and/or phospholipase A2 inhibitor and/or a microglial cell or microglial-like cell contacted with a proteinase inhibitor and/or phospholipase A2 inhibitor.” The scope of the claim is unclear because it is not clear whether the method requires contacting the site of injury with the inhibitor, contacting the site of injury with the microglial/microglial-like cell, contacting the microglial/microglial-like cell with the inhibitor prior to administration, or some combination thereof. The repeated “and/or” language and placement of “contacted with” renders the required method step unclear.
Claim 26 recites the limitation "said administration" in line 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-5, 16, 18, 19, and 26 are rejected under 35 U.S.C. 102a1 as being anticipated by Haile et al. (“Granzyme B-inhibitor serpina3n induces neuroprotection in vitro and in vivo.” Journal of Neuroinflammation (2015) 12:157 DOI 10.1186/s12974-015-0376-7.)
Claimed invention
Claim 1 is drawn to a method for reducing post-injury scar formation in the central nervous system of a subject comprising contacting a site of injury with a proteinase inhibitor (e.g., serpina3n), thereby reducing post-injury scar formation.
Prior art
Haile teaches the use of the granzyme B-inhibitor, serpina3n, for neuroprotection in vitro and in vivo of spinal cord injury. (Haile, title.). Haile states “Granzyme B-inhibitor serpina3n induces neuroprotection in vitro and in vivo.” (Haile, p. 4, 2nd column.)
In assessing whether the improvement of neurological disability in the serpina3n-treated mice was due to a reduction of axonal injury, quantification of SMI32-positive axons in the contra-lateral columns in the lumbar section of the spinal cord revealed that 50 mg serpina3n significantly reduced (by about 50 %) the number of injured axons in the treated mice compared to control animals (Fig 4a, e, i; P <0.05). (Haile, p. 4, 2nd column; see also p. 5)
Claim 4-5 limit the invention, wherein the proteinase inhibitor is a serine protease inhibitor – particularly serpina3n. Haile teaches serpina3n.
Claim 16 limits claim 1, wherein the site of injury is the spinal cord. Haile teaches spinal cord.
Claim 18 limits claim 1, wherein the method promotes axon regeneration or regrowth. Claim 26 limits claim 1, wherein said administration or contacting reduces the number of CD68+ cells, fibroblasts, reactive astrocytes, collagen I, fibronectin, CSPG and/or laminin present at the site of injury relative to an untreated site of injury. Claims 18 and 26 merely recite the result or intended biological effects of the method of Claim 1, namely that the method promotes axon regeneration/regrowth or administration/contacting reduces the number of CD68+ cells, fibroblasts, reactive astrocytes, collagen I, fibronectin, CSPG and/or laminin present at the site of injury relative to an untreated site of injury. Because the prior art teaches the same administration/contacting method for reducing post-injury scar formation in the CNS/spinal cord, and because reduced scar formation would reasonably be expected to facilitate or promote axon regeneration/regrowth and reduce the number of the recited cells and other factors at the site of injury.
Claim 19 limits claim 1, wherein the proteinase inhibitor and/or phospholipase A2 inhibitor and the microglial cell or microglial-like cell treated with a proteinase inhibitor and/or phospholipase A2 inhibitor are administered concurrently or sequentially. Serpina3n was administered multiple times a day for 7 days, which is sequential administration of the proteinase inhibitor. (Haile, abstract.)
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRIS E SIMMONS whose telephone number is (571)272-9065. The examiner can normally be reached M-F: 9:30-6:00p.
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CHRIS E. SIMMONS
Examiner
Art Unit 1622
/CHRIS E SIMMONS/Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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