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 .
Request for Continued Examination (RCE)
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/24/26 has been entered.
Priority
This application is a CIP of 16/948,235 (09/09/2020, US11654134)
16/948,235 has PRO 63/002,179 (03/30/2020)
16/948,235 is a CIP of 16/719,723 (12/18/2019, US10859573)
16/719,723 is a CIP of 16/252,402 (01/18/2019, US10895572)
16/719,723 has PRO 62/686,184 (06/18/2018)
16/252,402 has PRO 62/686,184 (06/18/2018).
Status
Rejections not reiterated in this action are withdrawn.
Claims 1-17, and 20 were cancelled. New claims 21-40 are pending.
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 21-25, 27-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elgebaly et al. (US8288350).
Elgebaly teaches prevention of damage to the function of nerve tissue in surgical patients subjected to ischemia (col 7, line 20: “the present invention involves a system that provides for a three-stage treatment of (i) prevention, (ii) immediate therapy during ischemia, and (iii) post-ischemia rehabilitation to preserve, restore, and sustain the function of nerve tissue in surgical and non-surgical patients subjected to ischemia and reperfusion”; col 19, line 22: “The present invention can be used for mammalian patients who will undergo nerve-related Surgery, such as aneurysms, tumor, intracerebral hemorrhage Surgery, and other similar procedures (e.g., neuromuscular diseases)”) by administration of cyclocreatine and/or cyclocreatine phosphate (Abstract, claim 1, cols 19-20). Elgebaly teaches “methods of the present invention have applicability in treatment of many tissue injuries … . … non-limiting examples include: … brain ischemia and trauma, spinal cord ischemia and trauma, aortic cross clamping leading to spinal cord ischemia” (Col 14, line 63). Thus, claims 21-25 are anticipated.
Regarding claim 27, Elgebaly teaches administration by injection (col 8, line 45; claim 8).
Regarding claim 28 specifying the effect of administration, such a limitation would be inherent in the administration of the same composition to the same patient. MPEP 2112.
Regarding claim 29, Elgebaly teaches “methods of the present invention have applicability in treatment of many tissue injuries … . … non-limiting examples include: … brain ischemia and trauma, spinal cord ischemia and trauma, aortic cross clamping leading to spinal cord ischemia” (Col 14, line 63).
Regarding claim 30, Elgebaly teaches administration before ischemia to preserve nerve function (col 7, line 11-25).
Regarding claim 31, Elgebaly teaches administration three days before surgery (Col 20, line 5-20).
Regarding claim 32, Elgebaly teaches “methods of the present invention have applicability in treatment of many tissue injuries … . … non-limiting examples include: … aortic cross clamping leading to spinal cord ischemia” (Col 14, line 63) and Example 6 (col 24) which one of skill in the art would at once envisage as surgical repair of the descending thoracic aorta. MPEP 2131.02.
Regarding claim 33, Elgebaly teaches administration by injection (col 8, line 45; claim 8).
Regarding claim 34, Elgebaly teaches administration by injection with a sterile saline solution (col 8, line 43-55).
Regarding claim 35, Elgebaly teaches administration before ischemia to preserve nerve function (col 7, line 11-25).
Regarding claim 36-37 specifying the effect of administration, such a limitation would be inherent in the administration of the same composition to the same patient. MPEP 2112.
Regarding claim 38, Elgebaly teaches prevention of damage to the function of nerve tissue in surgical patients subjected to ischemia (col 7, line 20: “the present invention involves a system that provides for a three-stage treatment of (i) prevention, (ii) immediate therapy during ischemia, and (iii) post-ischemia rehabilitation to preserve, restore, and sustain the function of nerve tissue in surgical and non-surgical patients subjected to ischemia and reperfusion”; col 19, line 22: “The present invention can be used for mammalian patients who will undergo nerve-related Surgery, such as aneurysms, tumor, intracerebral hemorrhage Surgery, and other similar procedures (e.g., neuromuscular diseases)”) by administration of cyclocreatine and/or cyclocreatine phosphate (Abstract, claim 1, cols 19-20). Elgebaly teaches “methods of the present invention have applicability in treatment of many tissue injuries … . … non-limiting examples include: … brain ischemia and trauma, spinal cord ischemia and trauma, aortic cross clamping leading to spinal cord ischemia” (Col 14, line 63).
Regarding claim 39, Elgebaly teaches in Example 6 iv administration 1 hour before aortic cross claimping (col 24).
Claim Rejections - 35 USC § 103
Claims 21-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Elgebaly et al. (US8288350) in view of Teicher et al. (Cancer Chemother Pharmacol (1995) 35: 411-416).
Regarding claims 21-25, 27-29, Elgebaly teaches as detailed in the 35 USC 102 rejection supra and one of ordinary skill in the art following the teaching of the prior art would reasonably consider following the guidance therein and arrive at the claimed invention with a reasonable expectation of success.
Regarding claims 26 and 40 specifying a 0.3 g/kg/day dose, Elgebaly teaches “greater than about 5 g/70 kg” but does not specifically teach the dose as claimed.
Teicher teaches a therapeutic dose of 0.5 – 1 g/kg of cyclocreatine in cancer patients (Abstract).
One of ordinary skill in the art following the teaching of Elgebaly would have considered varying the dose of the composition because it is a well-known results-effective variable that is routinely optimized for therapeutic effect. In addition, one of ordinary skill in the art would have known that a dose of 0.5g/kg was known to be safe and would have readily considered testing a similar dose in Elgebaly’s technique with a reasonable expectation of success.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Response to Remarks - 35 USC § 103
Applicant argues that “Elgebaly describes general metabolic support during ischemia” and not the claimed invention. This argument is not persuasive as the Elgebaly specifically teaches prevention of damage to the function of nerve tissue in surgical patients subjected to ischemia (col 7, line 20: “the present invention involves a system that provides for a three-stage treatment of (i) prevention, (ii) immediate therapy during ischemia, and (iii) post-ischemia rehabilitation to preserve, restore, and sustain the function of nerve tissue in surgical and non-surgical patients subjected to ischemia and reperfusion”; col 19, line 22: “The present invention can be used for mammalian patients who will undergo nerve-related Surgery, such as aneurysms, tumor, intracerebral hemorrhage Surgery, and other similar procedures (e.g., neuromuscular diseases)”) by administration of cyclocreatine and/or cyclocreatine phosphate (Abstract, claim 1, cols 19-20). Elgebaly teaches “methods of the present invention have applicability in treatment of many tissue injuries … . … non-limiting examples include: … brain ischemia and trauma, spinal cord ischemia and trauma, aortic cross clamping leading to spinal cord ischemia” (Col 14, line 63).
Applicant argues that Elgebaly does not teach a neurologic surgical procedure context. This is not persuasive because Elgebaly teaches “The present invention can be used for mammalian patients who will undergo nerve-related Surgery, such as aneurysms, tumor, intracerebral hemorrhage Surgery” (col 19).
New Double Patenting
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8288350 in view of Teicher et al. (Cancer Chemother Pharmacol (1995) 35: 411-416). Although the claims at issue are not identical, they are not patentably distinct from each other as detailed in the 35 USC 103 rejection supra and incorporated herein.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11654134 in view of US8288350 and Teicher et al. (Cancer Chemother Pharmacol (1995) 35: 411-416). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are to a method of treatment of ischemic diseases by administering cyclocreatine and as detailed in the 35 USC 103 rejection supra and incorporated herein renders the instant claims obvious.
Response to Remarks - Double Patenting
Applicant argues similarly as with the 35 USC 103 rejection. These arguments are not persuasive for the reasons provided above.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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, Kortney Klinkel can be reached at (571) 270-5293. 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.
/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
Prosecution Insights