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 of the Claims
Claims 1-4, 12-16, 23, and 24 are pending. Acknowledgment is made of the amendment of claims 1, 2, 4, 12-16, 23, and 24, and the cancellation of claims 5-11, 25, and 26, in the reply filed 01/15/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/15/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election of Species Requirement
Applicant’s elected species of AZD1236, shown below, appears allowable.
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Therefore, examination will be expanded to include the full scope of the claims. Claims 1-4, 12-16, 23, and 24 are currently under examination.
Withdrawn Objections/Rejections
Applicant’s amendment to the drawings, filed 01/15/2026, overcomes the objection to the drawings for minor informalities. The objection to the drawings has been withdrawn.
Applicant’s amendment to the claims, filed 01/15/2026, overcomes the rejection of claims 1-16 and 23-26 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 1-16 and 23-26 has been withdrawn.
Applicant’s amendment to the claims, filed 01/15/2026, overcomes the rejection of claims 1-3, 5-14, 16, and 23-26 under 35 U.S.C. 112(a) for scope of enablement. The rejection of claims 1-3, 5-14, 16, and 23-26 has been withdrawn.
Applicant’s amendment to the claims, filed 01/15/2026, overcomes the rejection of claims 1-3, 5-7, 13, 25, and 26 under 35 U.S.C. 102 (a)(1) as being anticipated by, and claims 4, 14, and 15 under 35 U.S.C. 103 as being unpatentable over, Yune et al. (KR 101129303 B1). Yune et al. fails to teach the inhibitors AZD1236 and/or AZD3342 required by the newly amended claims. The rejection of claims 1-3, 5-7, 13, 25, and 26 has been withdrawn.
Applicant’s amendment to the claims, filed 01/15/2026, overcomes the rejection of claims 8-12, 16, 23, and 24 under 35 U.S.C. 103 as being unpatentable over Yune et al. (KR 101129303 B1) in view of Chelluboina et al. (cited in previous office action). Yune et al. fails to teach the inhibitors AZD1236 and/or AZD3342, and Chelluboina et al. does not teach the treatment of spinal cord injuries using AZD1236, as required by the newly amended claims. The rejection of claims 8-12, 16, 23, and 24 has been withdrawn.
Maintained Rejections
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 4 and 15 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 4 recites the broad recitation that edema is suppressed by “25-50%”, and the claim also recites that edema is “completely suppressed” or suppressed by “30%”, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 15 recites the limitation "the orally administrable dose" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
New Rejections
Necessitated by Claim 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 15 and 24 are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 15 recites the broad recitation that the inhibitor compound is administered at 1/20th to 1/60th of the orally administrable dose, and the claim also recites the inhibitor compound is administered at 1/40th of the orally administrable dose which is the narrower statement of the range/limitation. Claim 24 recites the broad recitation that the composition is dosed at 50 to 100 mg, and the claim also recites that the composition is dosed at 75 mg, which is the narrower statement of the range/limitation. These claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 1-4 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barnwell et al. (WO 2007106022 A2), cited by Applicant in the IDS, further in view of Zhang et al. (Role of Matrix Metalloproteinases and Therapeutic Benefits of Their Inhibition in Spinal Cord Injury, Neurotherapeutics, 2011, Vol. 8(2), pages 206-220), cited by Applicant in the IDS.
Barnwell et al. teaches, on page 4 lines 16-20, compound (I), which is AZD3342 as in instant claim 1. It is taught, on page 13 lines 11-15, that “compound (I) is useful in the treatment of a disease or condition mediated by … MMP12 and/or MMP9; most especially in the treatment of a disease or condition mediated by MMP12”. Barnwell et al. teaches, on page 16 lines 1-2, that “compound (I) can also be used in the treatment of pain and connective tissue remodeling of musculoskeletal disorders due to injury [for example, sports injury]”. Barnwell et al. teaches, in claim 12, a method of treating a condition mediated by metalloproteinase activity comprising administering a pharmaceutical composition comprising compound (I).
Barnwell et al. teaches, on page 18 lines 1-5, “For the above mentioned therapeutic indications, the dose of the compound to be administered will depend on the disease being treated, the severity of the disease, the mode of administration, the age, weight and sex of the patient. Such factors may be determined by the attending physician.”
Barnwell et al. fails to teach that the injury causing the pain and connective tissue remodeling is specifically a spinal cord injury.
However, Zhang et al. teaches, on page 208 column 2, that greater stabilization of the blood-spinal cord barrier have been reported in spinal cord injured MMP-12 null mice. “MMP-12, also known as macrophage metalloelastase, is critical for the migration of blood-borne macrophages across the endothelial basement membranes into inflammatory sites. Spinal cord injured MMP-12 null animals show attenuation of blood-spinal barrier breakdown. It is likely that MMP-12 also influences the migration of macrophages into the injured cord.” It is shown in Table 2 that the elimination of MMP-12 resulted in improved function recovery.
Therefore, it would be prima facie obvious to one of ordinary skill in the art to use the method taught by Barnwell et al. which uses AZD3342 “in the treatment of pain and connective tissue remodeling of musculoskeletal disorders due to injury [for example, sports injury]” to treat a spinal cord injury, since Zhang et al. shows that MMP-12 inhibition treats spinal cord injuries, stabilizes the blood-spinal cord barrier, and results in improved function recovery.
One would have a reasonable expectation of success in using AZD3342, the MMP-12 inhibitor taught to be used in the treatment of injuries that can be treated with MMP-12 inhibition, in spinal cord injuries, which are taught by Zhang et al. to be treated by MMP-12 inhibition.
Regarding instant claims 3 and 4, the prior art is silent regarding treating oedema or neuropathic pain, and reducing oedema by 25-50%. However: treating oedema or neuropathic pain, and reducing oedema by 25-50% will inevitably flow from the teachings of the prior art (see above rejection), since the same composition (AZD3342) is being administered to the same subjects (a subject suffering from a spinal cord injury). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Regarding instant claims 13-15, Barnwell et al. teaches that the administration techniques would be determined by an attending physician. MPEP 2144.05 II. A. states: “‘[W]here 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)”. One of ordinary skill in the art would consider intrathecal administration of a composition to a spinal cord injury prima facie obvious, and the time of administration would be considered routine optimization that would generally be performed by a physician.
Advisory Notice
Claims 12, 16, and 23 appear allowable if rewritten in independent form.
Conclusion
Claims 1-4, 13-15, and 24 are rejected.
Claims 12, 16, and 23 are objected to.
THIS ACTION IS MADE FINAL. 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 RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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