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 .
Claim Objections
Claims 16, 46 and 47 are objected to because of the following informalities:
Regarding claim 16, line 3, the limitation “the rigid tube for” appears to be amended to recite “the rigid tube element from” in order to refer to “a rigid tube element” recited in claim 1, last line and resolve the grammatical error.
Claim 16 recites the limitation “the distal end” in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 46 recites the limitation “the spine” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the posterior white column” in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the lateral white column” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the anterior white column” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the posterior gray horn” in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the lateral gray horn” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the posterior gray commissure” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the anterior gray commissure” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the anterior white commissure” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the central canal” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 47 recites the limitation “the ventral horn” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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 30, 31 and 53 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.
Regarding claim 30, the limitation “a portion of the distal end of the rigid tube element extends into the support tube channel at the proximal end of the support tube” because as shown in figure 6, a portion of the proximal end of the rigid tube element extends into the support tube channel at the distal end of the support tube. Therefore, one of ordinary skill in the art would not be able to understand how “a portion of the distal end of the rigid tube element extends into the support tube channel at the proximal end of the support tube”. For examination purposes, examiner construes that a portion of the proximal end of the rigid tube element extends into the support tube channel at the distal end of the support tube.
Claim 31 being dependent on claim 30 is also rejected.
Regarding claim 53, the recitation “wherein the subject has amyotrophic lateral sclerosis (ALS)” in line 2 renders the claim indefinite because the claim is unclear if the claim is positively claiming the subject suffering from amyotrophic lateral sclerosis (ALS) or the method is being applied to the subject having amyotrophic lateral sclerosis. For examination purposes, examiner construes that the claim is referring to the method being applied to the patient having amyotrophic lateral sclerosis. Claim 53 appears to overcome the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph if claim 53 is amended to clearly indicate that the method is applied to the subject having amyotrophic lateral sclerosis.
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.
Claims 1, 16, 22, 27, 30, 31, 39, 41, 42 and 48 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bankiewicz et al. (US 2006/0135945 A1).
Regarding claim 1, Bankiewicz teaches a cannula system (figure 1) comprising a proximal region (see “PR” in figure 3A below) and a distal region (see “DR” in figure 3A below), and further comprising a delivery tube 20 which extends from the proximal region (see “PR” in figure 3A below) of the cannula system (figure 1) to the distal region (see “DR” in figure 3A below) of the cannula system, wherein the distal region (see “DR” in figure 3A below) of the cannula system comprises a rigid tube element 24 (paragraph 0030, lines 1-3).
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Regarding claim 16, Bankiewicz teaches wherein the rigid tube element 24 comprises a proximal end (end of element 24 in “PR” in figure 3A above) and a distal end (end of element 24 in “DR” in figure 3A above), and further comprises a rigid tube channel (channel inside element 24) extending through the rigid tube 24 from the proximal rigid tube end to the distal rigid tube end; and wherein the delivery tube 20 extends through the rigid tube channel of the rigid tube element 24, and wherein the delivery tube 20 is longer than the rigid tube element 24 such that a portion of the distal end of the delivery tube 20 extends beyond the distal end of the rigid tube to form an exposed delivery tube element 20.
Regarding claim 22, Bankiewicz teaches wherein the distal region (see “DR” in figure 3A above) of the cannula system (figure 1) comprises a capillary tube 22 which comprises a capillary tube channel (channel extending through element 22) extending through the capillary tube 22 from a distal end (end of element 22 in “DR” in figure 3A above) of the capillary tube 22 to a proximal end (end of element 22 in “PR” in figure 3A above) of the capillary tube 22; wherein the capillary tube 22 extends through the rigid tube channel 24; and wherein the delivery tube 20 extends through the capillary tube channel (channel extending through element 22).
Regarding claim 27, Bankiewicz teaches wherein the cannula system (figure 1) comprises a support tube 30 which extends from the proximal region (see “PR” in figure 3A above) of the cannula system to the distal region (see “DR” in figure 3A above) of the cannula system; wherein the support tube 30 comprises a support tube channel (channel extending through element 30) extending through the support tube 30 from a distal end (an end of element 30 in “DR” in figure 3A above) of the support tube 30 to a proximal end (an end of element 30 in “PR” in figure 3A above) of the support tube 30; and wherein the delivery tube 20 extends through the support tube channel from the proximal region of the cannula system to the distal region of the cannula system.
Regarding claim 30, Bankiewicz teaches wherein a portion of the proximal end of the rigid tube element 24 extends into the support tube channel (channel extending through element 30) at the distal end of the support tube 30.
Regarding claim 31, Bankiewicz teaches wherein the cannula system comprises a collar tube 32 which extends over a portion of the distal end of the support tube 30 and extends over a portion of the proximal end of the rigid tube element 24.
Regarding claim 39, Bankiewicz teaches a kit (figure 1) comprising (i) the cannula system (figure 1) and (ii) an adhesive (paragraph 0045).
Regarding claim 41, Bankiewicz teaches a method of delivering a therapeutic agent to a therapeutic target tissue in a subject, comprising: providing the cannula system (figure 1),
inserting a portion of the delivery tube 20 of the cannula system into a delivery target tissue (paragraph 0031, lines 2-7), wherein the delivery target tissue (paragraph 0031, lines 2-7) is the therapeutic target tissue or corresponding tissue which facilitates the delivery of the therapeutic agent to the therapeutic target tissue; and delivering a therapeutically effective amount (paragraph 0062) of the therapeutic agent through the delivery tube 20 of the cannula system into the delivery target tissue.
Regarding claim 42, Bankiewicz teaches wherein the delivery target tissue is parenchymal tissue in the brain (paragraph 0070, lines 1-10, paragraph 0112, lines 1-6, neurons are targeted for delivery, paragraph 0117, “brain”), eye, heart or spine of the subject.
Regarding claim 48, Bankiewicz teaches wherein the therapeutic agent comprises a small molecule compound, a naturally-occurring pharmaceutical compound, a synthetic pharmaceutical compound, a polypeptide, a protein (paragraph 0015, lines 1-4), a polynucleotide, a viral vector, a biological progenitor cells, a stem cell, a biological transplant cell, a macrophage, a T cell, or a combination thereof.
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.
Claim(s) 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over Bankiewicz et al. (US 2006/0135945 A1) in view of Schulte et al. (US 2005/0182425 A1).
Regarding claim 32, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claim 1. Bankiewicz is silent regarding wherein the cannula system comprises a cannula positioning guide, said CPG comprising: a guide base comprising an upper surface, a lower surface, and at least one edge surface, said guide base comprising suitable for connecting, appending or adhering the CPG directly or indirectly to a target tissue; and at least one comb projection extending from the edge surface of the guide base.
However, Schulte teaches a design of an apparatus for securing a therapy delivery device within a burr hole comprising comprises a cannula positioning guide (figure 22), said CPG (figure 22) comprising: a guide base 600 comprising an upper surface (surface of element 604 not comprising element 606), a lower surface (surface of element 604 comprising element 606), and at least one edge surface (surface comprising “C” in figure 22 below), said guide base comprising suitable for connecting, appending or adhering the CPG directly or indirectly to a target tissue (see figure 1); and at least one comb projection (see “C” in figure 22 below) extending from the edge surface of the guide base for the purpose of using a low profile structure to securely hold the cannula/tube closer to cranial surface for delivering therapeutic agent into the patient’s head (paragraph 0085).
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the cannula system of Bankiewicz to incorporate a cannula positioning guide, said CPG comprising: a guide base comprising an upper surface, a lower surface, and at least one edge surface, said guide base comprising suitable for connecting, appending or adhering the CPG directly or indirectly to a target tissue; and at least one comb projection extending from the edge surface of the guide base as taught by Schulte for the purpose of using a low profile structure to securely hold the cannula/tube closer to cranial surface for delivering therapeutic agent into the patient’s head (paragraph 0085).
Regarding claim 33, Bankiewicz is silent regarding further comprising a first pedicle and a second pedicle, with both pedicles being positioned on the upper or lower surface of the base.
However, Schulte teaches further comprising a first pedicle (one of three elements 606) and a second pedicle (another of three elements 606), with both pedicles being position on the upper or lower surface (surface of element 604 comprising element 606) of the base 600 for the purpose of coupling two parts of the base together (paragraph 0150) thereby forming a low profile structure to securely hold the cannula/tube closer to cranial surface for delivering therapeutic agent into the patient’s head (paragraph 0085).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the cannula system of Bankiewicz to incorporate a first pedicle and a second pedicle, with both pedicles being positioned on the upper or lower surface of the base as taught by Schulte for the purpose of coupling two parts of the base together (paragraph 0150) thereby forming a low profile structure to securely hold the cannula/tube closer to cranial surface for delivering therapeutic agent into the patient’s head (paragraph 0085).
Regarding claim 34, Bankiewicz is silent regarding wherein the CPG further comprises an alignment fence juxtaposed between the first pedicle and the second pedicle.
However, Schulte teaches wherein the CPG further comprises an alignment fence 616 juxtaposed between the first pedicle (one of three elements 606) and the second pedicle (other of the three elements 606) for the purpose of forming an interference fit with the delivery tube (paragraph 0148) thereby forming a low profile structure to securely hold the cannula/tube closer to cranial surface for delivering therapeutic agent into the patient’s head (paragraph 0085).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the cannula system of Bankiewicz to incorporate an alignment fence juxtaposed between the first pedicle and the second pedicle as taught by Schulte for the purpose of forming an interference fit with the delivery tube (paragraph 0148) thereby forming a low profile structure to securely hold the cannula/tube closer to cranial surface for delivering therapeutic agent into the patient’s head (paragraph 0085).
Claim(s) 45 is rejected under 35 U.S.C. 103 as being unpatentable over Bankiewicz et al. (US 2006/0135945 A1) in view of Mammana et al. (“The Role of Macrophages in Neuroinflammatory and Neurodegenerative Pathways of Alzheimer’s disease, Amyotrophic Lateral Sclerosis, and Multiple Sclerosis: Pathogenetic Cellular Effectors and Potential Therapeutic Targets.”, 2018).
Regarding claim 45, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 41. Bankiewicz is silent regarding wherein the delivery target tissue is non-parenchymal tissue in the spine of the subject.
However, Mammana teaches the role of macrophages in neural diseases and potential drug targets wherein the delivery target tissue is non-parenchymal tissue (page 1, first paragraph under “Introduction”, “Under steady-state conditions, the central myeloid cell population … non-parenchymal macrophages”, page 11, section “Conclusions”) in the spine of the subject for the purpose of regulating CNS hemostasis and potentially control the pathophysiology of CNS diseases (page 11, section “Conclusions”).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of Bankiewicz to incorporate wherein the delivery target tissue is non-parenchymal tissue in the spine of the subject as taught by Mammana for the purpose of regulating CNS hemostasis and potentially control the pathophysiology of CNS diseases (page 11, section “Conclusions”).
Claims 46 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Bankiewicz et al. (US 2006/0135945 A1) in view of Bates (US 2006/0093641 A1).
Regarding claim 46, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 41. Bankiewicz is silent regarding wherein the therapeutic target tissue is parenchymal tissue in the spine of the subject; and wherein the delivery target tissue is non-parenchymal tissue in the spine which is adjacent to or corresponds with the parenchymal tissue, and which facilitates the delivery of the therapeutic agent to the parenchymal tissue in the spine.
Bates teaches a method for treating an injured nerve pathway wherein the therapeutic target tissue (figures 5D, 6C, paragraph 0006, the site is in center of spinal which can be construed as parenchymal tissue, in addition, glial basal lamina region can also be construed as parenchymal) is parenchymal tissue in the spine of the subject; and wherein the delivery target tissue (figures 5D, 6C, tissues on exterior or outside but near spine) is non-parenchymal tissue in the spine which is adjacent to or corresponds with the parenchymal tissue, and which facilitates the delivery of the therapeutic agent to the parenchymal tissue in the spine for the purpose of treating the spinal cord injury (paragraph 0006).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of Bankiewicz to incorporate wherein the therapeutic target tissue is parenchymal tissue in the spine of the subject; and wherein the delivery target tissue is non-parenchymal tissue in the spine which is adjacent to or corresponds with the parenchymal tissue, and which facilitates the delivery of the therapeutic agent to the parenchymal tissue in the spine as taught by Bates for the purpose of treating the spinal cord injury (paragraph 0006).
Regarding claim 47, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 41. Bankiewicz is silent regarding wherein the delivery target tissue is selected from: the posterior white column, the lateral white column, the anterior white column, the posterior gray horn, the lateral gray horn, the posterior gray commissure, the anterior gray commissure, the anterior white commissure, the central canal, the ventral horn, and combinations thereof.
However, Bates teaches wherein the delivery target tissue (figure 5D and 6C, the target site will be one of the claimed areas) is selected from: the posterior white column, the lateral white column, the anterior white column, the posterior gray horn, the lateral gray horn, the posterior gray commissure, the anterior gray commissure, the anterior white commissure, the central canal, the ventral horn, and combinations thereof for the purpose of treating the spinal cord injury (paragraph 0006).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the method of Bankiewicz to incorporate wherein the delivery target tissue is selected from: the posterior white column, the lateral white column, the anterior white column, the posterior gray horn, the lateral gray horn, the posterior gray commissure, the anterior gray commissure, the anterior white commissure, the central canal, the ventral horn, and combinations thereof as taught by Bates for the purpose of treating the spinal cord injury (paragraph 0006).
Claims 50-53 are rejected under 35 U.S.C. 103 as being unpatentable over Bankiewicz et al. (US 2006/0135945 A1) in view of Xu et al. (US 2005/0288243 A1).
Regarding claim 50, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 41. Bankiewicz further discloses wherein the therapeutic agent comprises an AAV vector particle (paragraph 0015, lines 1-4, “AAV vectors”, paragraph 0071, lines 1-7) which comprises an AAV capsid and an AAV vector genome but is silent regarding wherein the AAV vector genome comprises a nucleotide sequence encoding an RNAi molecule.
However, Xu teaches a method of treating gain of function disorder comprising AAV vector genome wherein the AAV vector genome comprises a nucleotide sequence encoding an RNAi molecule (paragraph 0013) for the purpose of treating a subject suffering from a disease such as amyotrophic lateral sclerosis (paragraph 0016).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the AAV vector genome of Bankiewicz to incorporate wherein the AAV vector genome comprises a nucleotide sequence encoding an RNAi molecule as taught by Xu for the purpose of treating a subject suffering from a disease such as amyotrophic lateral sclerosis (paragraph 0016).
Regarding claim 51, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 41. Bankiewicz is silent regarding wherein the RNAi molecule is an siRNA strand or an siRNA duplex.
However, Xu teaches wherein the RNAi molecule is an siRNA strand or an siRNA duplex (paragraph 0013) for the purpose of treating a subject suffering from a disease such as amyotrophic lateral sclerosis (paragraph 0016).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the AAV vector genome of Bankiewicz to incorporate wherein the RNAi molecule is an siRNA strand or an siRNA duplex as taught by Xu for the purpose of treating a subject suffering from a disease such as amyotrophic lateral sclerosis (paragraph 0016).
Regarding claim 52, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 41. Bankiewicz is silent regarding wherein the RNAi molecule is an SOD1 targeting polynucleotide.
However, Xu teaches wherein the RNAi molecule is an SOD1 targeting polynucleotide (paragraph 0009) for the purpose of treating a subject suffering from a disease such as amyotrophic lateral sclerosis (paragraph 0016).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the AAV vector genome of Bankiewicz to incorporate wherein the RNAi molecule is an SOD1 targeting polynucleotide as taught by Xu for the purpose of treating a subject suffering from a disease such as amyotrophic lateral sclerosis (paragraph 0016).
Regarding claim 53, Bankiewicz discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 41. Bankiewicz is silent regarding wherein the subject has amyotrophic lateral sclerosis. However, one can construe that the method disclosed by Bankiewicz could be applied to the subject having amyotrophic lateral sclerosis.
Additionally, Xu teaches a method of treating a subject wherein the subject has amyotrophic lateral sclerosis (paragraph 0016) for the purpose of treating the patient’s medical condition (paragraph 0016).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the method of Bankiewicz to incorporate wherein the subject has amyotrophic lateral sclerosis as taught by Xu for the purpose of treating the patient’s medical condition (paragraph 0016).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gupta (US 5,718,693): discloses a design of a catheter system comprising a rigid tube in the distal portion of the catheter system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached on 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/ Primary Examiner, Art Unit 3783
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