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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on 2-5-26 is acknowledged.
Claims 11-20 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2-5-26.
Claim interpretation
It is assumed the intercostal arteries in claim 1 and their numbering in claims 4-7 were well-known in the art at the time of filing.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
A) The specification lacks written description for claim 1 other than a method of making a non-human mammalian model of spinal ischemia, the method comprising: ligating an intercostal artery in a non-human mammal such that spinal ischemia occurs.
Claim 1 is drawn to: “reducing blood flow to a segment of spinal cord in a non-human vertebrate animal, the method comprising :a) dissecting a first intercostal space to expose a first group of intercostal arteries; b) keeping a second intercostal space intact; c) dissecting a third intercostal space to expose a second group of intercostal arteries; d) ligating the first group of intercostal arteries; and e) ligating the second group of intercostal arteries, thereby reducing blood flow to a segment of spinal cord, wherein the method comprises ligating five intercostal arteries.”
The 1st and 2nd “group of intercostal arteries” may be the same or different.
The dissected 1st and 3rd intercostal “spaces” may be the same or different.
The 2nd intercostal “space” left intact may be between the 1st and 3rd intercostal spaces or somewhere else.
LeMaire (J. of Thoracic and Cardiovascular Surg., 2006, Vol. 132, pg 1150-1155) made an incision through the sixth intercostal space, left some of the intercostal spaces intact, and ligated segmental arteries from T6 through L1 such that spinal ischemia was induced (pg 1151, col. 1, “Operative procedure”; pg 1152, col. 1, 2nd full para).
The specification teaches “A clinically relevant mouse model of thoracic endovascular aortic repair-induced ischemic spinal cord injury has been lacking since the procedure was first employed in 1991” (pg 16), but does not teach the procedure to which it refers or any procedures in which intercostal or segmented arteries from the aorta of a non-human vertebrate are ligated, occluded, sutured, or clamped resulting in a model of spinal ischemia. The IDS filed 4-22-24 has been reviewed which includes Xiao (Spinal Cord, 2017, Vol. 55, pg 1028-1032) who ligated bilateral lumbar arteries in mice such that a model of spinal ischemia is obtained (“Methods”); Xiao did not teach ligating intercostal arteries as claimed. The IDS includes Lang-Lazdunski (Stroke, 2000, Vol. 31, pg 208-213) who taught clamping the aortic arch, left subclavian artery, and internal mammary artery in mice such that spinal ischemia is obtained (“Methods”); Lang-Lazdunski did not teach ligating intercostal arteries as claimed. The IDS includes Fujimaki (Spine, 2006, Vol. 31, No. 21, pg E781-E789) who ligated bilateral segmental arteries at T11-T13 (3 levels), T10-T13 (4 levels), T10-L1 (5 levels), or T9-L2 (7 levels) which appears to anticipate claim 1 for reasons set forth below. The IDS does not appear to include any references from 1991 as cited on pg or any other references that teach ligating, occluding, suturing, or clamping intercostal or segmented arteries from the aorta of a non-human vertebrate resulting in a model of spinal ischemia other than Fujimaki.
The examples are limited to mice with 3, 5, or 6 double ligation; the specific arteries ligated are not disclosed (pg 17). Fig. 1 shows a schematic of the experimental design and mouse numbers without disclosing which arteries were ligated.
Pg 18 discusses the surgical procedure but fails to teach “dissecting a first intercostal space to expose a first group of intercostal arteries; b) keeping a second intercostal space intact; c) dissecting a third intercostal space to expose a second group of intercostal arteries” as required in claim 1. Pg 18 is limited to making an incision between the 8th and 9th ribs followed by making an incision in the 67th and 7th rib; however, the claims are not so limited. The paragraph bridging pg 18-19 is limited to ligating the intercostal arteries “starting with the lower-most vessel (10th intercostal pair) and ending with the 6th intercostal pair; the 8th, 9th, and 10th artery pairs were double ligated”; however, the claims are not so limited. Applicants’ discussion of the results is noted on pg 24-28, but it is unclear what phenotypes are associated with what ligation pattern.
The specification does not correlate non-human mammals to any fish, amphibian, reptile, or bird as broadly encompassed by claim 1. Accordingly, the specification lacks written description for claim 1 other than a method of making a non-human mammalian model of spinal ischemia.
B) The specification lacks written description for causing brain ischemia by ligating intercostal arteries as required in claim 9. The claim encompasses ligating any intercostal artery such that brain injury occurs. The specification contemplates the concept throughout pages 1-15, but the Examples do not teach how to ligate any intercostal arteries such that brain ischemia occurs. The art is of no help in this regard (see above). Since the intercostal arteries are not supplying blood to the brain, then there is no way to create brain ischemia by ligating intercostal arteries. Accordingly, the concept lacks written description.
Enablement
Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of making a non-human mammalian model of spinal ischemia, the method comprising: ligating an intercostal artery in a non-human mammal such that spinal ischemia occurs, does not reasonably provide enablement for performing the method in any non-human vertebrate other than a non-human mammal. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
A) The specification does not enable performing the method of claim 1 in any non-human vertebrate or for any purpose other than a method of making a non-human mammalian model of spinal ischemia, the method comprising: ligating an intercostal artery in a non-human mammal such that spinal ischemia occurs.
Claim 1 and its scope are discussed above.
The art at the time of filing is discussed above.
The specification and examples are discussed above.
The specification does not correlate non-human mammals to any fish, amphibian, reptile, or bird as broadly encompassed by claim 1. Accordingly, the specification lacks written description for claim 1 other than a method of making a non-human mammalian model of spinal ischemia.
B) The specification does not enable causing brain ischemia by ligating intercostal arteries as required in claim 9. The claim encompasses ligating any intercostal artery such that brain injury occurs. The specification contemplates the concept throughout pages 1-15, but the Examples do not teach how to ligate any intercostal arteries such that brain ischemia occurs. The art is of no help in this regard (see above). Since the intercostal arteries are not supplying blood to the brain, then there is no way to create brain ischemia by ligating intercostal arteries. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to perform the method of claim 9.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
A) Claims 1, 4, 5, 7-10 are rejected under 35 U.S.C. 102a1 as being anticipated by LeMaire (J. of Thoracic and Cardiovascular Surg., 2006, Vol. 132, pg 1150-1155).
LeMaire made an incision through the sixth intercostal space which is equivalent to “a) dissecting a 1st intercostal space to expose a 1st group of intercostal arteries” and “c) dissecting a 3rd intercostal space to expose a 2nd group of intercostal arteries” as required in claim 1. LeMaire left some of the intercostal spaces intact which is equivalent to: “b) keeping a second intercostal space intact”. LeMaire ligated segmental arteries from T6 through L1 such that spinal ischemia was induced which is equivalent to “d) ligating the first group of intercostal arteries; and e) ligating the second group of intercostal arteries, thereby reducing blood flow to a segment of spinal cord, wherein the method comprises ligating five intercostal arteries” (pg 1151, col. 1, “Operative procedure”; pg 1152, col. 1, 2nd full para).
Claims 4 and 5 have been included because LeMaire ligated segmental arteries from T6 through L1 which includes the 6th-10th intercostal arteries.
Claim 7 has been included because LeMaire ligated the arteries once (pg 1151, col. 2, 1st full para).
LeMaire induced spinal ischemia as required in claim 8.
Claim 9 has been included because the arteries ligated by LeMaire are those described as being part of the invention.
Claim 10 has been included because it does not further limit claim 1; all intercostal arteries branch from the descending aorta.
B) Claims 1, 4, 5, 7-10 are rejected under 35 U.S.C. 102a1 as being anticipated by Fujimaki (Spine, 2006, Vol. 31, No. 21, pg E781-E789).
Fujimaki ligated bilateral segmental arteries at T11-T13 (3 levels), T10-T13 (4 levels), T10-L1 (5 levels), or T9-L2 (7 levels) (Materials and Methods) which is equivalent to “a) dissecting a 1st intercostal space to expose a 1st group of intercostal arteries” and “c) dissecting a 3rd intercostal space to expose a 2nd group of intercostal arteries” as required in claim 1. Fujimaki left some of the intercostal spaces intact which is equivalent to: “b) keeping a second intercostal space intact”. Fujimaki ligated segmental arteries from T10-L1 or T9-L2 such that spinal ischemia was induced which is equivalent to “d) ligating the first group of intercostal arteries; and e) ligating the second group of intercostal arteries, thereby reducing blood flow to a segment of spinal cord, wherein the method comprises ligating five intercostal arteries” (Materials and Methods).
Claims 4 and 5 have been included because Fujimaki ligated T10-L1 or T9-L2 which includes the 6th-10th intercostal arteries.
Claim 7 has been included because Fujimaki ligated the arteries once (Materials and Methods).
Fujimaki induced spinal ischemia as required in claim 8.
Claim 9 has been included because the arteries ligated by Fujimaki are those described as being part of the invention.
Claim 10 has been included because it does not further limit claim 1; all intercostal arteries branch from the descending aorta.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
A) Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over LeMaire (J. of Thoracic and Cardiovascular Surg., 2006, Vol. 132, pg 1150-1155).
Claim 1 was taught by LeMarie for reasons set forth above.
LeMarie failed to teach dissecting 1st and 3rd intercostal spaces that were non-adjacent to one another as required in claim 2 or that the 2nd intercostal space left intact was between the 1st and 3rd intercostal space as required in claim 3 as obvious variants. However, it was well within the purview of the ordinary artisan dissect an intercostal space, skip the one below it, and dissect an intercostal space below that. Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make the model of spinal ischemia as taught by LeMarie and dissect non-adjacent intercostal spaces leaving one intact in between as required in claims 2 and 3. Those of ordinary skill in the art at the time of filing would have been motivated to do so to decrease the severity of injury and create a model that has mild spinal ischemia.
LeMarie did not teach ligating the arteries twice as required in claim 6. However, it was well within the purview of the ordinary artisan ligate an intercostal artery twice as an obvious variant. Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make the model of spinal ischemia as taught by LeMarie and ligate each intercostal artery twice as required in claims 2 and 3. Those of ordinary skill in the art at the time of filing would have been motivated to do so to ensure blood flow to the spine is completely stopped.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
B) Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fujimaki (Spine, 2006, Vol. 31, No. 21, pg E781-E789).
Claim 1 was taught by Fujimaki for reasons set forth above.
Fujimaki failed to teach dissecting 1st and 3rd intercostal spaces that were non-adjacent to one another as required in claim 2 or that the 2nd intercostal space left intact was between the 1st and 3rd intercostal space as required in claim 3 as obvious variants. However, it was well within the purview of the ordinary artisan dissect an intercostal space, skip the one below it, and dissect an intercostal space below that. Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make the model of spinal ischemia as taught by Fujimaki and dissect non-adjacent intercostal spaces leaving one intact in between as required in claims 2 and 3. Those of ordinary skill in the art at the time of filing would have been motivated to do so to decrease the severity of injury and create a model that has mild spinal ischemia.
Fujimaki did not teach ligating the arteries twice as required in claim 6. However, it was well within the purview of the ordinary artisan ligate an intercostal artery twice as an obvious variant. Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to make the model of spinal ischemia as taught by Fujimaki and ligate each intercostal artery twice as required in claims 2 and 3. Those of ordinary skill in the art at the time of filing would have been motivated to do so to ensure blood flow to the spine is completely stopped.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
Prosecution Insights