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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered:
Garbayo et al. (2016) Sci. Rep. 6:25932
Cheng, W. and Law, P. K. (2017) Cell Transplantation 26:735-751
U.S. Patent Publication 20170240964
Ochalek et al. (2016) Stem Cell Int. 2016:5838934
US Patent Publication 2021/0052776
T. E. Creighton, Proteins: Structures and Molecular Properties (W.H. Freeman and Company, 1993)
A. L. Lehninger, Biochemistry (Worth Publishers, Inc., current addition)
Sambrook, et al, Molecular Cloning: A Laboratory Manual (2nd Edition, 1989)
Methods In Enzymology (S. Colowick and N. Kaplan eds., Academic Press, Inc.)
Remington's Pharmaceutical Sciences, 18th Edition (Easton, Pa.: Mack Publishing Company, 1990)
Carey and Sundberg Advanced Organic Chemistry 3.sup.rd Ed. (Plenum Press) Vols A and B (1992)
The information disclosure statement filed April 10, 2024 (14 pages), fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered:
No copy of Nakayama et al has been provided
Specification
The abstract of the disclosure is objected to because:
In line 2, “agents” should be changed to “the other therapeutic agents”
In line 3, “the delivery site” should be changed to “a delivery site”
Line 5 recites “therapeutic agents”. Line 1 previously recites “other therapeutic agents”. It is unclear whether the two recitations are the same component or different components
In line 5, “organs” should be changed to “the organs”
In line 5, “heart” should be changed to “a heart”
In line 5, “kidney” should be changed to “a kidney”
In line 5, “pancreas” should be changed to “a pancreas”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 8-9, 13-14, 19-26, 26, and 31 are objected to because of the following informalities:
In regards to claim 8, line 1, “the intraorgan site” should be changed to “the intraorgan or extravascular site”.
In regards to claim 9, line 1, “the intraorgan site” should be changed to “the intraorgan or extravascular site”.
In regards to claim 9, line 1, “the kidney” should be changed to “a kidney”.
In regards to claim 9, line 1, “the pancreas” should be changed to “a pancreas”.
In regards to claim 9, lines 1-2, “the liver” should be changed to “a liver”.
In regards to claim 9, line 2, “the lungs” should be changed to “a lungs”.
In regards to claim 9, line 1, “the brain” should be changed to “a brain”.
In regards to claim 13, lines 1-2, “the therapeutic agent” should be changed to “the at least one therapeutic agent”.
In regards to claim 14, line 2, “the intraorgan site” should be changed to “the intraorgan or extravascular site”.
In regards to claim 19, line 9, “the exterior” should be changed to “an exterior”.
In regards to claim 20, line 1, “an ID” should be changed to “the ID”.
In regards to claim 21, line 1, “an ID” should be changed to “the ID”.
In regards to claim 22, line 1, “the outer diameter” should be changed to “an outer diameter”.
In regards to claim 26, line 1, “longitudinal length” should be changed to “the longitudinal length”.
In regards to claim 31, line 1, “steps a) through e)” should be changed to “the a), the b), the c), the d), and the e)”.
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 1-31 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.
In regards to claim 1, lines 7-8 recite: “wherein the dose is retained at the intraorgan or extravascular site at a level at least 2-fold higher than an equivalent dose administered using a 26- or 27-gauge needle”. It is unclear how to interpret said limitation as it is unclear what retention level is expected of a 26- or 27-gauge needle. Claims 2-31 are rejected by virtue of being dependent upon claim 1.
In regards to claim 7, lines 1-2 recite “a level”. Claim 7 depends upon claim 1. Claim 1, line 7 recites “a level”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 7, line 2 recites “an equivalent dose”. Claim 7 depends upon claim 1. Claim 1, line 8 recites “an equivalent dose”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 7, line 2 recites “a 26- or 27-gauge needle”. Claim 7 depends upon claim 1. Claim 1, line 8 recites “a 26- or 27-gauge needle”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 7, lines 1-2 recite: “wherein the dose is retained at the intraorgan or extravascular site at a level at least 6-fold higher than an equivalent dose administered using a 26- or 27-gauge needle”. It is unclear how to interpret said limitation as it is unclear what retention level is expected of a 26- or 27-gauge needle.
In regards to claim 11, lines 1-2 recite “mesenchymal stem cells (MSCs)”. Claim 11 depends upon claim 10. Claim 10, line 1 recites “stem cells”. It is unclear whether the two recitations are the same component or different components. Claims 12-13 are rejected by virtue of being dependent upon claim 11.
In regards to claim 12, lines 1-2 recite “at least one therapeutic agent”. Claim 12 depends upon claim 11, which depends upon claim 10, which depends upon claim 1. Claim 1, line 1 recites “a therapeutic”. It is unclear whether the two recitations are the same component or different components. Claim 13 is rejected by virtue of being dependent upon claim 12. Claim 13, lines 1-2 also recite the unclear recitation “the therapeutic agent”.
In regards to claim 14, lines 1-2 recite “human ventricular progenitor cells (HVPs)”. Claim 14 depends upon claim 10. Claim 10, lines 1-2 recite “stem cell-derived progenitor cells”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 22, lines 1-2 recite “a 26-gauge or 27-gauge needle”. Claim 22 depends upon claim 19, which depends upon claim 1. Claim 1, line 8 recites “a 26- or 27-gauge needle”. It is unclear whether the two recitations are the same component or different components.
In regards to claim 26, lines 1-2 recite: wherein longitudinal length (L3) of the tip portion is “less than 100 mm”. Claim 26 depends upon claim 25. Claim 25, lines 1-2 recite: wherein the tip portion has a longitudinal length (L3) within a range of “5 mm to 300 mm”. The term “less than 100 mm” means 0 mm to 100 mm, but not including 100 mm. It is unclear how the longitudinal length already limited by “5 mm to 300 mm” in claim 25, can also be 0 mm to 100 mm, but not including 100 mm, of claim 26, as “5 mm to 300 mm” of claim 25 does not include the range 0 mm to 5 mm expected in “less than 100 mm” of claim 26.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 26 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
In regards to claim 26, lines 1-2 recite: wherein longitudinal length (L3) of the tip portion is “less than 100 mm”. Claim 26 depends upon claim 25. Claim 25, lines 1-2 recite: wherein the tip portion has a longitudinal length (L3) within a range of “5 mm to 300 mm”. The term “less than 100 mm” means 0 mm to 100 mm, but not including 100 mm. However, claim 26 fails to include all the limitations of claim 25 upon which it depends, as claim 25 does not include the range 0 mm to 5 mm expected in “less than 100 mm” of claim 26.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-10, 15, and 19-30 are rejected under 35 U.S.C. 103 as being unpatentable over Latere Dwan’isa et al (US 9,345,857).
In regards to claim 1, Latere Dwan’isa et al teaches a method of delivering a therapeutic to an intraorgan or extravascular site in a subject, the method comprising:
providing an endoluminal delivery cannula (2) comprising a dose of the therapeutic (Abstract: injection catheter for delivering a therapeutic agent)
administering the dose of the therapeutic to the intraorgan or extravascular site in the subject using the endoluminal delivery cannula (Abstract: injection catheter for delivering a therapeutic agent into a substrate)(column 10, line 42: substrate may be an organ)
wherein the dose is administered in 4 minutes or less (column 8, lines 51-53: the therapeutic agent is delivered over a period of between 20 seconds and 3 minutes)
wherein the dose is retained at the intraorgan or extravascular site at a level (column 11, lines 55-56: retention of microspheres at the site where they are injected into the heart)
Latere Dwan’isa et al does not explicitly disclose wherein the dose is retained at the intraorgan or extravascular site at a level “at least 2-fold higher than an equivalent dose administered using a 26- or 27-gauge needle”, as Latere Dwan’isa et al instead only teaches that the dose is retained at the intraorgan or extravascular site at a capacity of retention of 100 microspheres (/103) retained per gram of the intraorgan or extravascular site (column 12, lines 6-9)(Figure 8), and the endoluminal delivery cannula is between 20 gauge and 34 gauge, preferably between 25 gauge and 32 gauge (column 6, lines 58-60). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the dose is retained at the intraorgan or extravascular site at a level, of the method of Latere Dwan’isa et al, to be at least 2-fold higher than an equivalent dose administered using a 26- or 27-gauge needle, as Applicant has not disclosed that such a level provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the dose is retained at the intraorgan or extravascular site at a capacity of retention of 100 microspheres (/103) retained per gram of the intraorgan or extravascular site, and the endoluminal delivery cannula is between 20 gauge and 34 gauge, preferably between 25 gauge and 32 gauge, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select an appropriately sized endoluminal delivery cannula in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 2, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the dose is administered in 3 minutes or less (column 8, lines 51-53: the therapeutic agent is delivered over a period of between 20 seconds and 3 minutes).
In regards to claim 3, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the dose is administered in 2 minutes or less, as Latere Dwan’isa instead teaches wherein the dose is administered over a period of between 20 seconds and 3 minutes (column 8, lines 51-53). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the dose is administered, of the modified method of Latere Dwan’isa et al, to be in 2 minutes or less, as Applicant has not disclosed that such a time provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the dose is administered over a period of between 20 seconds and 3 minutes, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the time that the dose is administered in order to allow for optimal distribution of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 4, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the dose is administered in 90 seconds or less, as Latere Dwan’isa instead teaches wherein the dose is administered over a period of between 20 seconds and 3 minutes (column 8, lines 51-53). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the dose is administered, of the modified method of Latere Dwan’isa et al, to be in 90 seconds or less, as Applicant has not disclosed that such a time provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the dose is administered over a period of between 20 seconds and 3 minutes, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the time that the dose is administered in order to allow for optimal distribution of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 5, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the dose is administered in 60 seconds or less, as Latere Dwan’isa instead teaches wherein the dose is administered over a period of between 20 seconds and 3 minutes (column 8, lines 51-53). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the dose is administered, of the modified method of Latere Dwan’isa et al, to be in 60 seconds or less, as Applicant has not disclosed that such a time provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the dose is administered over a period of between 20 seconds and 3 minutes, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the time that the dose is administered in order to allow for optimal distribution of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 6, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the therapeutic comprises cells (column 10, lines 48-49); however, Latere Dwan’isa et al is silent about wherein the therapeutic comprises cells specifically “at a concentration in the dose of 100,000-300,000 cells/µl”. But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the therapeutic comprises cells, of the modified method of Latere Dwan’isa et al, to be at a concentration in the dose of 100,000-300,000 cells/µl, as Applicant has not disclosed that such a concentration provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the therapeutic comprises cells to be at an unknown concentration, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the concentration of the cells in order to allow for optimal distribution of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 7, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not explicitly disclose wherein the dose is retained at the intraorgan or extravascular site at a level “at least 6-fold higher than an equivalent dose administered using a 26- or 27-gauge needle”, as Latere Dwan’isa et al instead only teaches that the dose is retained at the intraorgan or extravascular site at a capacity of retention of 100 microspheres (/103) retained per gram of the intraorgan or extravascular site (column 12, lines 6-9)(Figure 8), and the endoluminal delivery cannula is between 20 gauge and 34 gauge, preferably between 25 gauge and 32 gauge (column 6, lines 58-60). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the dose is retained at the intraorgan or extravascular site at a level, of the modified method of Latere Dwan’isa et al, to be at least 6-fold higher than an equivalent dose administered using a 26- or 27-gauge needle, as Applicant has not disclosed that such a level provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the dose is retained at the intraorgan or extravascular site at a capacity of retention of 100 microspheres (/103) retained per gram of the intraorgan or extravascular site, and the endoluminal delivery cannula is between 20 gauge and 34 gauge, preferably between 25 gauge and 32 gauge, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select an appropriately sized endoluminal delivery cannula in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 8, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the intraorgan site is within the heart (column 11, line 56).
In regards to claim 9, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the intraorgan site is within the kidney, the pancreas, the liver, or the brain (column 10, lines 42-44).
In regards to claim 10, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the therapeutic comprises stem cells (column 10, lines 54-55).
In regards to claim 15, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the therapeutic comprises a protein-based agent (column 10, lines 47-51).
In regards to claim 19, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the endoluminal delivery cannula comprises:
an elongated proximal portion having an outer diameter (OD) (Figure 1A)
a tip portion (4) arranged distally of the proximal portion and extending from the proximal portion to a distal tip of the cannula (Figure 1A)
a lumen having an inner diameter (ID) and continuously extending through the proximal portion and the tip portion to the distal tip, the therapeutic being contained within the lumen (Figure 1B)(column 8, lines 32-33)
wherein the tip portion has an opening (22) at the distal tip to provide communication between the continuous lumen and the exterior of the cannula
the tip portion is tapered towards the distal tip (Figures 2-7)
In regards to claim 20, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the lumen has an ID of 140-160 micrometers, as Latere Dwan’isa et al instead teaches wherein the lumen has an ID of between 0.0826 mm and 0.603 mm, preferably between 0.108 mm and 0.260 mm (column 6, lines 64-66). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the lumen has an ID, of the modified method of Latere Dwan’isa et al, to be of 140-160 micrometers, as Applicant has not disclosed that such an inner diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the lumen has an ID of between 0.0826 mm and 0.603 mm, preferably between 0.108 mm and 0.260 mm, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the inner diameter of the lumen in order to allow for optimal distribution of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 21, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the lumen has an ID of 145-150 micrometers, as Latere Dwan’isa et al instead teaches wherein the lumen has an ID of between 0.0826 mm and 0.603 mm, preferably between 0.108 mm and 0.260 mm (column 6, lines 64-66). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the lumen has an ID, of the modified method of Latere Dwan’isa et al, to be of 145-150 micrometers, as Applicant has not disclosed that such an inner diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the lumen has an ID of between 0.0826 mm and 0.603 mm, preferably between 0.108 mm and 0.260 mm, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the inner diameter of the lumen in order to allow for optimal distribution of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 22, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the OD is smaller than the outer diameter of a 26-gauge or 27-gauge needle, as Latere Dwan’isa et al instead teaches wherein the OD between 20 gauge and 34 gauge, preferably between 25 gauge and 32 gauge (column 6, lines 58-60). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the OD, of the modified method of Latere Dwan’isa et al, to be smaller than the outer diameter of a 26-gauge or 27-gauge needle, as Applicant has not disclosed that such an outer diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the OD between 20 gauge and 34 gauge, preferably between 25 gauge and 32 gauge, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the outer diameter of the endoluminal delivery cannula in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 23, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the OD of the proximal portion is 200-300 micrometers, as Latere Dwan’isa et al instead teaches wherein the OD of the proximal portion is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm (column 6, lines 60-63). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the OD of the proximal portion, of the modified method of Latere Dwan’isa et al, to be 200-300 micrometers, as Applicant has not disclosed that such an outer diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the OD of the proximal portion is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the outer diameter of the endoluminal delivery cannula in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 24, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the OD of the proximal portion is 250 micrometers, as Latere Dwan’isa et al instead teaches wherein the OD of the proximal portion is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm (column 6, lines 60-63). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the OD of the proximal portion, of the modified method of Latere Dwan’isa et al, to be 250 micrometers, as Applicant has not disclosed that such an outer diameter provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the OD of the proximal portion is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the outer diameter of the endoluminal delivery cannula in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 25, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the tip portion has a longitudinal length (L3) within a range of 5 mm to 300 mm, as Latere Dwan’isa et al instead teaches wherein the tip portion has a longitudinal length (L3) of about 4 mm (column 11, line 45). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify wherein the tip portion has a longitudinal length (L3), of the modified method of Latere Dwan’isa et al, to be within a range of 5 mm to 300 mm, as Applicant has not disclosed that such a longitudinal length provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the tip portion has a longitudinal length (L3) of about 4 mm, as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the longitudinal length of the tip portion in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 26, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein longitudinal length (L3) of the tip portion is less than 100 mm (about 4 mm) (column 11, line 45).
In regards to claim 27, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the tip portion has a proximal end with an outer diameter (D3) and a distal end at the distal tip with an outer diameter (D4), wherein the outer diameter (D3) is the same as the OD of the elongated proximal portion and the outer diameter (D4) is smaller than the outer diameter (D3) (Figures 2-7).
In regards to claim 28, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the outer diameter (D3) is 225-275 micrometers and the outer diameter (D4) is 175-200 micrometers, as Latere Dwan’isa et al instead teaches wherein the outer diameter (D3) is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm (column 6, lines 60-63), and the outer diameter (D4) is smaller than the outer diameter (D3) (Figures 2-7). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified method, of Latere Dwan’isa et al, wherein the outer diameter (D3) is 225-275 micrometers and the outer diameter (D4) is 175-200 micrometers, as Applicant has not disclosed that such outer diameters provide an advantage, are used for a particular purpose, or solve a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the outer diameter (D3) is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm (column 6, lines 60-63), and the outer diameter (D4) is smaller than the outer diameter (D3), as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the outer diameters of the tip portion of the endoluminal delivery cannula in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 29, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al does not specifically teach wherein the outer diameter (D3) is 250 micrometers and the outer diameter (D4) is 194 micrometers, as Latere Dwan’isa et al instead teaches wherein the outer diameter (D3) is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm (column 6, lines 60-63), and the outer diameter (D4) is smaller than the outer diameter (D3) (Figures 2-7). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify the modified method, of Latere Dwan’isa et al, wherein the outer diameter (D3) is 250 micrometers and the outer diameter (D4) is 194 micrometers, as Applicant has not disclosed that such outer diameters provide an advantage, are used for a particular purpose, or solve a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with wherein the outer diameter (D3) is 0.184 mm and 0.908 mm, preferably, between 0.235 mm and 0.514 mm (column 6, lines 60-63), and the outer diameter (D4) is smaller than the outer diameter (D3), as taught by Latere Dwan’isa et al, as a person having ordinary skill in the art would have known how to select the outer diameters of the tip portion of the endoluminal delivery cannula in order to allow for optimal distribution and retention of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 30, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches wherein the dose is administered to the intraorgan or extravascular site in the subject by:
navigating the distal tip of the cannula to a location near the intraorgan or extravascular site in the subject (column 14, lines 52-55)
directing the distal tip toward a vessel wall in a general direction of the intraorgan or extravascular site (column 14, lines 52-55)
advancing the distal tip such that the distal tip penetrates the vessel wall and reaches the intraorgan or extravascular site (column 4, lines 3-6)(Figure 1A)
injecting the dose into the intraorgan or extravascular site (Abstract: injection catheter for delivering a therapeutic agent into a substrate)(column 10, line 42: substrate may be an organ)
retracting the distal tip of the cannula from the intraorgan or extravascular site of the subject (column 6, lines 52-55)
In regards to claim 31, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al is silent about repeating steps a) through e) with a second dose of the therapeutic. But it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method, of Latere Dwan’isa et al, with repeating steps a) through e) with a second dose of the therapeutic, as such will allow for continued treatment of the patient as needed.
Claims 11-13 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Latere Dwan’isa et al, as applied to claims 1, 10, and 15 above, and further in view of Moomiaie et al (US 2023/0241213)
In regards to claim 11, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al is silent about wherein the therapeutic comprises mesenchymal stem cells (MSCs). Moomiaie et al teaches a method, wherein a therapeutic comprises mesenchymal stem cells (MSCs) (paragraph [0470]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic, of the modified method of Latere Dwan’isa et al, to comprise mesenchymal stem cells (MSCs), as taught by Moomiaie et al, as such will be therapeutically effective to treat cancer by decreasing tumor mass and biomarker levels (paragraph [0468]).
In regards to claim 12, in the modified method of Latere Dwan’isa et al and Moomiaie et al, Latere Dwan’isa et al is silent about wherein the MSCs are modified to express at least one therapeutic agent. Moomiaie et al teaches wherein the MSCs are modified to express at least one therapeutic agent (paragraph [0470]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the MSCs, of the modified method of Latere Dwan’isa et al and Moomiaie et al, to be modified to express at least one therapeutic agent, as taught by Moomiaie et al, as such will be therapeutically effective to treat cancer by decreasing tumor mass and biomarker levels (paragraph [0468]).
In regards to claim 13, in the modified method of Latere Dwan’isa et al and Moomiaie et al, Latere Dwan’isa et al is silent about wherein the MSCs are modified with mRNA encoding the therapeutic agent. Moomiaie et al teaches wherein the MSCs are modified with mRNA encoding the therapeutic agent (paragraph [0470]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the MSCs, of the modified method of Latere Dwan’isa et al and Moomiaie et al, to be modified with mRNA encoding the therapeutic agent, as taught by Moomiaie et al, as such will be therapeutically effective to treat cancer by decreasing tumor mass and biomarker levels (paragraph [0468]).
In regards to claim 16, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al is silent about wherein the protein-based agent is a nanobody. Moomiaie et al teaches a method, wherein a protein-based agent is a nanobody (paragraph [0113]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the protein-based agent, of the modified method of Latere Dwan’isa et al, to be a nanobody, as taught by Moomiaie et al, as the utility and advantages include, but are not limited to, their smaller size, larger number of accessible epitopes, relatively low production costs and improved robustness (paragraph [0103][0113]).
In regards to claim 17, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al is silent about wherein the therapeutic comprises an oligonucleotide-based agent. Moomiaie et al teaches a method, wherein a therapeutic comprises an oligonucleotide-based agent (paragraph [0070]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic, of the modified method of Latere Dwan’isa et al, to comprise an oligonucleotide-based agent, as taught by Moomiaie et al, as such will encode antibody or antigen-binding fragments thereof, such as a single-domain antibody for which the utility and advantages include, but are not limited to, their smaller size, larger number of accessible epitopes, relatively low production costs and improved robustness (paragraphs [0103][0246]).
In regards to claim 18, in the modified method of Latere Dwan’isa et al and Moomiaie et al, Latere Dwan’isa et al is silent about wherein the oligonucleotide-based agent is an mRNA agent. Moomiaie et al teaches wherein the oligonucleotide-based agent is an mRNA agent (paragraph [0246]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the oligonucleotide-based agent, of the modified method of Latere Dwan’isa et al and Moomiaie et al, to be an mRNA agent, as taught by Moomiaie et al, as such will encode the anti-PD-1 antibody or single-domain antibody expressible to be therapeutically effective to treat cancer by decreasing tumor mass and biomarker levels (paragraph [0468][0470]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Latere Dwan’isa et al, as applied to claim 10 above, and further in view of Chien et al (US 2016/0053229).
In regards to claim 14, in the modified method of Latere Dwan’isa et al, Latere Dwan’isa et al teaches the intraorgan site is within the heart (column 11, line 56); however, Latere Dwan’isa et al is silent about wherein the therapeutic comprises human ventricular progenitor cells (HVPs). Chien et al teaches a method, wherein a therapeutic comprises human ventricular progenitor cells (HVPs) (Abstract). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the therapeutic, of the modified method of Latere Dwan’isa et al, to comprise human ventricular progenitor cells (HVPs), as taught by Chien et al, as such will allow for cardiac repair or to improve cardiac function (Abstract).
Conclusion
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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