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 .
Acknowledgments
In the reply, filed on February 17, 2026, Applicant amended claims 1, 8-9, 11-14, 20-21, 23-26, and 28-31.
Applicant cancelled claims 7, 19, 22, and 27.
Applicant added new claims 32-37.
In the non-final rejection of October 14, 2025, Examiner noted that the listing of references in the specification is not a proper information disclosure statement. Applicant cited some of the indicated references in an information disclosure statement; however, Applicant did not cite all of the indicated references. Concern is maintained.
Examiner noted that the information disclosure statement filed April 10, 2024 (14 pages), fails to comply with 37 CFR 1.98(a)(2). Applicant submitted a copy of the indicated reference. Concern is withdrawn.
Examiner objected to the Abstract. Applicant amended the Abstract. Objection is withdrawn.
Examiner objected to claims 8-9, 13-14, 19-22, 26, and 31. Applicant amended claims 8-9, 13-14, 20-21, 26, and 31, and cancelled claims 19 and 22. Objection is withdrawn.
Examiner rejected claims 1-31 under 35 U.S.C. 112(b). Applicant amended claims 1, 11-14, and 26, and cancelled claims 7 and 22. Rejection is withdrawn.
Examiner rejected claim 26 under 35 U.S.C. 112(d). Applicant amended claim 26. Rejection is withdrawn.
Currently, claims 1-6, 8-18, 20-21, 23-26, and 28-37 are under examination.
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:
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)
Specification
The abstract of the disclosure is objected to because:
In line 5, “other therapeutic agents” should be changed to “the other therapeutic agents”
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 1, 11, 14, 28-29, and 31-33 are objected to because of the following informalities:
In regards to claim 1, line 13, “D3” should be changed to “the D3”.
In regards to claim 1, line 14, “D4” should be changed to “the D4”.
In regards to claim 1, line 14, “D3” should be changed to “the D3”.
In regards to claim 1, line 17, “the continuous lumen” should be changed to “the lumen”.
In regards to claim 11, line 1, “stem-cell derived” should be changed to “stem cell-derived”.
In regards to claim 14, line 1, “stem-cell derived” should be changed to “stem cell-derived”.
In regards to claim 28, line 1, “D3” should be changed to “the D3”.
In regards to claim 28, line 2, “D4” should be changed to “the D4”.
In regards to claim 29, line 1, “D3” should be changed to “the D3”.
In regards to claim 29, line 2, “D4” should be changed to “the D4”.
In regards to claim 31, lines 1-2, “the a), the b), the c), the d) and the e) steps” should be changed to “the a), the b), the c), the d), and the e)”.
In regards to claim 32, line 1, “D4” should be changed to “the D4”.
In regards to claim 33, line 1, “D4” should be changed to “the D4”.
Appropriate correction is required.
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.
Claims 1-6, 8-18, 20-21, 23-26, and 28-37 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.
In regards to claim 1, lines 21-22 recite “wherein at least 10% of the therapeutic in the dose is retained at the intraorgan or extravascular site for at least five days following administration”; however, such is new matter not described in the Specification. Claims 2-6, 8-18, 20-21, 23-26, and 28-37 are rejected by virtue of being dependent upon claim 1.
In regards to claim 37, lines 1-2 recite “wherein at least 15% of the therapeutic in the dose is retained at the intraorgan or extravascular site for at least five days following administration”; however, such is new matter not described in the Specification.
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 1-6, 8-10, 20-21, 23-26, and 28-37 are rejected under 35 U.S.C. 103 as being unpatentable over Holmin et al (US 8,876,792).
In regards to claim 1, Holmin et al teaches a method of delivering a therapeutic to an intraorgan or extravascular site in a subject (Figures 3A-3B), the method comprising:
providing an endoluminal delivery cannula (1) comprising a dose of the therapeutic (column 15, lines 45-49: cells), wherein the endoluminal delivery cannula comprises:
an elongated proximal portion (110) having an outer diameter
a tip portion (102) arranged distally of the elongated proximal portion and extending from the elongated proximal portion to a distal tip (114) of the cannula
a lumen (113) having an inner diameter and continuously extending through the elongated proximal portion and the tip portion to the distal tip, the dose of the therapeutic being contained within the lumen (column 15, lines 45-49)
wherein the tip portion is straight (Figures 1-2) and has a proximal end with an outer diameter D3 and a distal end at the distal tip with an outer diameter D4, wherein D3 is the same as the OD of the elongated proximal portion and D4 is smaller than D3 such that the tip portion is tapered towards the distal tip (Figures 1-2)
the tip portion has a single opening at the distal tip, with no side openings, to provide communication between the continuous lumen and an exterior of the cannula (Figures 1-2)
administering the dose of the therapeutic to the intraorgan or extravascular site in the subject using the endoluminal delivery cannula (column 15, lines 45-49)
Holmin et al is silent about wherein the dose is administered in 4 minutes or less. 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 method of Holmin et al, to be in 4 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 in an unknown time, as taught by Holmin 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.
Further, Holmin et al is silent about wherein at least 10% of the therapeutic in the dose is retained at the intraorgan or extravascular site for at least five days following administration. 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 Holmin et al, wherein at least 10% of the therapeutic in the dose is retained at the intraorgan or extravascular site for at least five days following administration, as Applicant has not disclosed that such a retention of the therapeutic 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 an unknown retention of the therapeutic, as taught by Holmin et al, as a person having ordinary skill in the art would have known how to select the retention of the therapeutic 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 2, in the modified method of Holmin et al, Holmin et al is silent about wherein the dose is administered in 3 minutes or less. 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 Holmin et al, to be in 3 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 in an unknown time, as taught by Holmin 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 3, in the modified method of Holmin et al, Holmin et al is silent about wherein the dose is administered in 2 minutes or less. 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 Holmin 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 in an unknown time, as taught by Holmin 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 Holmin et al, Holmin et al is silent about wherein the dose is administered in 90 seconds or less. 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 Holmin 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 in an unknown time, as taught by Holmin 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 Holmin et al, Holmin et al is silent about wherein the dose is administered in 60 seconds or less. 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 Holmin 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 in an unknown time, as taught by Holmin 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 Holmin et al, Holmin et al teaches wherein the therapeutic comprises cells (column 15, lines 47-48); however, Holmin 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 Holmin 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 Holmin 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 8, in the modified method of Holmin et al, Holmin et al teaches wherein the intraorgan or extravascular site is within the heart (column 16, lines 1-3).
In regards to claim 9, in the modified method of Holmin et al, Holmin et al teaches wherein the intraorgan or extravascular site is within a pancreas (column 16, lines 1-3).
In regards to claim 10, in the modified method of Holmin et al, Holmin et al teaches wherein the therapeutic comprises stem cells (column 15, lines 47-48).
In regards to claim 20, in the modified method of Holmin et al, Holmin et al does not teach wherein the ID of the lumen is 140-160 micrometers, as Holmin et al instead teaches wherein the ID of the lumen is 0.104 ± 0.0127 mm (column 25, lines 46-47). 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 ID of the lumen, of the modified method of Holmin et al, to be 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 the ID of the lumen is 0.104 ± 0.0127 mm, as taught by Holmin 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 Holmin et al, Holmin et al does not teach wherein the ID of the lumen is 145-150 micrometers, as Holmin et al instead teaches wherein the ID of the lumen is 0.104 ± 0.0127 mm (column 25, lines 46-47). 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 ID of the lumen, of the modified method of Holmin et al, to be 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 the ID of the lumen is 0.104 ± 0.0127 mm, as taught by Holmin 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 23, in the modified method of Holmin et al, Holmin et al teaches wherein the OD of the elongated proximal portion is 200-300 micrometers (column 21, lines 3-4: 0.193 ± 0.0127 mm).
In regards to claim 24, in the modified method of Holmin et al, Holmin et al does not teach wherein the OD of the elongated proximal portion is 250 micrometers, as Holmin et al instead teaches wherein the OD of the elongated proximal portion is 0.193 ± 0.0127 mm (column 21, lines 3-4). 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 OD of the elongated proximal portion, of the modified method of Holmin 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 elongated proximal portion is 0.193 ± 0.0127 mm, as taught by Holmin 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 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 Holmin et al, Holmin et al does not teach wherein the tip portion has a longitudinal length within a range of 5 mm to 300 mm, as Holmin et al instead teaches wherein the tip portion has a longitudinal length of approximately 3x the outer diameter (Table 1), wherein the outer diameter is 0.193 ± 0.0127 mm (column 21, lines 3-4), thus the longitudinal length of the tip portion would be approximately 0.579 ± 0.0381 mm (3 x (0.193 ± 0.0127 mm)). 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 tip portion having a longitudinal length, of the modified method of Holmin 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 of approximately 0.579 ± 0.0381 mm, as taught by Holmin 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 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 Holmin et al, Holmin et al does not teach wherein the longitudinal length of the tip portion is between 100 mm to 300 mm, as Holmin et al instead teaches wherein the longitudinal length of the tip portion is approximately 3x the outer diameter (Table 1), wherein the outer diameter is 0.193 ± 0.0127 mm (column 21, lines 3-4), thus the longitudinal length of the tip portion would be approximately 0.579 ± 0.0381 mm (3 x (0.193 ± 0.0127 mm)). 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 longitudinal length of the tip portion, of the modified method of Holmin et al, to be between 100 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 the longitudinal length of the tip portion being approximately 0.579 ± 0.0381 mm, as taught by Holmin 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 of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 28, in the modified method of Holmin et al, Holmin et al does not specifically teach wherein D3 is 225-275 micrometers and D4 is 175-200 micrometers, as Holmin et al instead teaches wherein D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3 (Figures 1-2). 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 Holmin et al, wherein D3 is 225-275 micrometers and 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 D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3, as taught by Holmin 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 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 Holmin et al, Holmin et al does not specifically teach wherein D3 is 250 micrometers and D4 is 194 micrometers, as Holmin et al instead teaches wherein D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3 (Figures 1-2). 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 Holmin et al, wherein D3 is 250 micrometers and 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 D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3, as taught by Holmin 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 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 Holmin et al, Holmin 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 15, lines 14-18)
directing the distal tip toward a vessel wall in a general direction of the intraorgan or extravascular site (column 15, lines 22-24)
advancing the distal tip such that the distal tip penetrates the vessel wall and reaches the intraorgan or extravascular site (column 15, lines 24-26)
injecting the dose into the intraorgan or extravascular site (column 15, lines 45-47)
retracting the distal tip of the cannula from the intraorgan or extravascular site of the subject (column 22, line 21)
In regards to claim 31, in the modified method of Holmin et al, Holmin et al is silent about repeating the a), the b), the c), the d) and the e) steps 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 Holmin et al, with repeating the a), the b), the c), the d) and the e) steps with a second dose of the therapeutic, as such will allow for continued treatment of the patient as needed.
In regards to claim 32, in the modified method of Holmin et al, Holmin et al is silent about wherein D4 is between 0.10 mm and 0.25 mm, as Holmin et al instead teaches wherein D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3 (Figures 1-2). 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 D4, of the modified method of Holmin et al, to be between 0.10 mm and 0.25 mm, 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 D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3, as taught by Holmin 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 of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 33, in the modified method of Holmin et al, Holmin et al is silent about wherein D4 is between 0.15 mm and 0.22 mm, as Holmin et al instead teaches wherein D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3 (Figures 1-2). 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 D4, of the modified method of Holmin et al, to be between 0.15 mm and 0.22 mm, 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 D3 is 0.193 ± 0.0127 mm (column 21, lines 3-4), and D4 is smaller than D3, as taught by Holmin 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 of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
In regards to claim 34, in the modified method of Holmin et al, Holmin et al teaches wherein the therapeutic comprises cells (column 15, lines 47-48); however, Holmin et al is silent about wherein the therapeutic comprises cells specifically “at a concentration in the dose of 10,000-1,000,000 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 Holmin et al, to be at a concentration in the dose of 10,000-1,000,000 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 Holmin 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 35, in the modified method of Holmin et al, Holmin et al teaches wherein the therapeutic comprises cells (column 15, lines 47-48); however, Holmin et al is silent about wherein the therapeutic comprises cells specifically “at a concentration in the dose of 25,000-500,000 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 Holmin et al, to be at a concentration in the dose of 25,000-500,000 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 Holmin 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 36, in the modified method of Holmin et al, Holmin et al is silent about wherein the dose is delivered at a flow rate in a range of 20-2,000 µl/minute. 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 Holmin et al, wherein the dose is delivered at a flow rate in a range of 20-2,000 µl/minute, as Applicant has not disclosed that such a flow rate 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 delivered at an unknown flow rate, as taught by Holmin et al, as a person having ordinary skill in the art would have known how to select the flow rate that the dose is delivered 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 37, in the modified method of Holmin et al, Holmin et al is silent about wherein at least 15% of the therapeutic in the dose is retained at the intraorgan or extravascular site for at least five days following administration. 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 Holmin et al, wherein at least 15% of the therapeutic in the dose is retained at the intraorgan or extravascular site for at least five days following administration, as Applicant has not disclosed that such a retention of the therapeutic 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 an unknown retention of the therapeutic, as taught by Holmin et al, as a person having ordinary skill in the art would have known how to select the retention of the therapeutic in order to allow for optimal distribution of the therapeutic within the intraorgan or extravascular site to allow for treatment of the patient.
Claims 11-13 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Holmin et al, as applied to claims 1 and 10 above, and further in view of Moomiaie et al (US 2023/0241213)
In regards to claim 11, in the modified method of Holmin et al, Holmin et al is silent about wherein the stem cells or stem-cell derived progenitor cells are mesenchymal stem cells. Moomiaie et al teaches a method, wherein stem cells are mesenchymal stem cells (MSC) (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 stem cells, of the modified method of Holmin et al, to be mesenchymal stem cells, 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 Holmin et al and Moomiaie et al, Holmin et al is silent about wherein the MSCs are modified to express at least one agent. Moomiaie et al teaches wherein the MSCs are modified to express at least one 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 Holmin et al and Moomiaie et al, to be modified to express at least one 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 Holmin et al and Moomiaie et al, Holmin et al is silent about wherein the MSCs are modified with mRNA encoding the at least one agent. Moomiaie et al teaches wherein the MSCs are modified with mRNA encoding the at least one 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 Holmin et al and Moomiaie et al, to be modified with mRNA encoding the at least one 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 15, in the modified method of Holmin et al, Holmin et al is silent about wherein the therapeutic comprises a protein-based agent. Moomiaie et al teaches a method, wherein a therapeutic comprises a protein-based agent (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 therapeutic, of the modified method of Holmin et al, to comprise a protein-based agent, 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 16, in the modified method of Holmin et al and Moomiaie et al, Holmin et al is silent about wherein the protein-based agent is a nanobody. Moomiaie et al teaches wherein the 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 Holmin 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 Holmin et al, Holmin 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 Holmin 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 Holmin et al and Moomiaie et al, Holmin 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 Holmin 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 Holmin 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 Holmin et al, Holmin et al teaches the intraorgan or extravascular site is within a heart (column 16, lines 1-3); however, Holmin et al is silent about wherein the stem cells or stem-cell derived progenitor cells are human ventricular progenitor cells. Chien et al teaches a method, wherein stem cells or stem-cell derived progenitor cells are 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 stem cells or stem-cell derived progenitor cells, of the modified method of Holmin et al, to be human ventricular progenitor cells (HVPs), as taught by Chien et al, as such will allow for cardiac repair or to improve cardiac function (Abstract).
Response to Arguments
Applicant’s arguments with respect to claims 1-6, 8-18, 20-21, 23-26, and 28-37 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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