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 .
This Office action is responsive to an amendment filed August 7, 2023. Claims 1-5, 7-9, 11-16, 18-21, 23 & 26 are pending. Claims 6, 10, 17-19, 22, 24-25 & 27-31 have been canceled.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 23, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19-21, 23 & 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dai et al. (WO 2011/0150726) (“Dai” hereinafter).
In regards to claim 19, Dai discloses an in-line cage device 1 comprising:
an elongated housing 11 comprising inner and outer walls;
a proximal opening 1110 and a distal opening 1120;
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a chamber comprising at least a first screen 121 and a second screen 122, wherein the first and second screens (121, 122) are configured such that any fluid entering the proximal opening 1110 and exiting the distal opening 1120 must pass through the first screen 121 and the second screen 122; and
a graft 5 within the chamber;
wherein the proximal opening 1110 is configured to allow a fluid to flow through the first screen 121 into the chamber, through the second screen 122, and out of the distal opening 1120 (see at least fig. 2).
In regards to claim 20, Dai discloses the in-line cage device 1 of claim 19, wherein the chamber is formed of the inner walls of the elongated housing 11, the first screen 121, and the second screen 122 (see at least fig. 2).
In regards to claim 21, Dai discloses the in-line cage device 1 of claim 19, wherein the graft 5 comprises (allogeneic) bone, or an artificial scaffold (see machine translation, which states that “the porous material 5 may be allogeneic bone, collagen, degradable artificial bone or surface-modified cell scaffold material” and fig. 2).
In regards to claim 23, Dai discloses the in-line cage device 1 of claim 22, wherein the elongated housing 11 comprises a first housing portion 111 comprising a proximal end and a distal end,
a second housing portion 112 comprising proximal end and a distal end, and
a third housing portion 12 comprising a proximal end and a distal end,
wherein the first housing portion 111 can be attached and detached (via threads as shown in fig. 2) from the second housing portion 112 and the second housing portion 112 can be attached and detached from the third housing portion 12; and
the in-line cage device 1 further comprises:
the first screen 121 at the distal end of the first housing portion 111 or at the proximal end of the second housing portion 112; and the second screen 122 at the distal end of the second housing portion 112 or the proximal end of the third housing portion 12 such that the first screen 121 and second screen 122 form a chamber when the first, second, and third housing portion (111, 112, 12) are assembled into the in-line cage device 1 (see at least fig. 2).
In regards to claim 26, Dai discloses a method of collecting stem cells comprising:
a) connecting the proximal opening 1110 of the in-line cage device 1 of claim 19 to a second device 6 for liberating cells from a tissue in a fluid (i.e., anti-coagulated bone marrow blood) (see at least figs. 1 & 3);
b) connecting the distal opening 1120 of the in-line cage device 1 to a suction or aspiration apparatus 4 (see at least figs. 1 & 3); and
c) collecting stem cells on the graft 5 (see machine translation, which reads “One of the two-way tee plate 2 is opened as a blood injection port 21, the blood injection port 21 is connected to a puncture device 6 to connect the blood bag, and the other switch is also opened as the exhaust port 22, and the anti-coagulated bone marrow blood is opened. Slowly pushing into the extension tube 3 from the injection port 21, the blood enters the filter 1 through the extension tube 3 in the direction of the arrow in FIG. 3, and the blood inlet port 21 and the row of the two-way tee plate 2 are closed after the filter 1 is filled with blood. The gas port 22 allows the blood to pass through the filter-like lid 121 located at the front end of the screening enrichment chamber of the filter cartridge 12, and is subjected to screening and enrichment of the stem cells through the porous material 5 in the screening enrichment chamber of the filter 1 and simultaneously compounding After the screening and enrichment of the bone marrow stem cells by the biological material, the switch of the two-way tee plate 2 is opened as a recovery port, and the blood after the enrichment of the stem cells is recovered through the recovery port, and finally opened. The filter 1 takes out the porous material 5 enriched for stem cells for use.”).
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) 1-5 & 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masini et al. (US 2001/0043918) (“Masini” hereinafter) in view of Diresta et al. (US 2005/0101008) (“Diresta” hereinafter).
In regards to claim 1, Masini discloses a cell collection device 10 comprising:
a container with a removable lid (28, 38) (see at least fig. 1 and par 0026);
an inlet port 12 and an outlet port 16 (see at least fig. 1 and par 0025);
a graft chamber 22 (see at least fig. 1 and par 0025),
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wherein the graft chamber 22 is configured to divide an interior of the container into a first inner compartment (i.e., facing a first side of the scaffold 20) and a second inner compartment (i.e., facing a second side of the scaffold 20) (see at least fig. 1); and
a graft material 20 (see at least fig. 1 and par 0025);
wherein the inlet port 12 is configured to allow a fluid to flow into the first inner compartment and the outlet port 16 is configured to allow a fluid to flow out of the second inner compartment (see at least fig. 1 and par 0025).
Masini discloses a cell collection device 10, as described above, that fails to explicitly teach a cell collection device 12 with the graft chamber comprising at least two panels, wherein a first panel comprises a first opening and a second panel comprises a second opening; a connector that holds the at least two panels together; and the graft material positioned between the first and second panels 13 and at least partially covering the first and second openings.
However, Diresta teaches that it is known to provide a cell collection device with graft chamber (i.e., cell growing chamber) comprising at least two panels (13, 21, 24), wherein a first panel 13 comprises a first opening (see fig. 2) and a second panel (13, 21, 24) (second panel is mirror image of first panel, see par 0015) comprises a second
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opening (see fig. 2); a connector (i.e., hinge) that holds the at least two panels (13, 21, 24) together (see at least fig. 2 and par 0015 & 0033); and the graft material (i.e., cell membrane) positioned between the first and second panels (13, 21, 24) and at least partially covering the first and second openings (shown in fig. 2) (see at least par 0030, 0032-0033, 0039-0048 & 0054-0055).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the cell collection device of Masini with the graft chamber comprising at least two panels, wherein a first panel comprises a first opening and a second panel comprises a second opening; a connector that holds the at least two panels together; and the graft material positioned between the first and second panels 13 and at least partially covering the first and second openings as taught by Diresta since such a modification would amount to a simple substitution of one known element (i.e., as taught by Masini) for another (i.e., as taught by Diresta) to obtain predictable results such as culturing a variety of single cell organisms in a cassette under typical pressurized media culture conditions including elevated and pulsatile interstitial pressure without significant changes in the cassette’s internal volume (see at least par 0144-0148 of Diresta)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 2, Masini discloses the cell collection device 10 of claim 1, wherein the graft chamber 22 is configured to allow a fluid to flow from the first inner compartment to the second inner compartment through the first and second openings (see at least fig. 1 and par 0025).
In regards to claim 3, Masini discloses the cell collection device 10 of claim 2, that fails to explicitly teach a cell collection device wherein the first and second openings are at least partially aligned to allow fluid to flow from the first inner compartment through the first and second openings and into the second inner compartment. However, Diresta teaches that it is known to provide a cell collection device 12 wherein the first and second openings are at least partially aligned to allow fluid to flow from the first inner compartment through the first and second openings and into the second inner compartment (first and second panels (13, 21, 24) are mirror images of each other, see par 0015 & 0033) . Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the cell collection device of Masini wherein the first and second openings are at least partially aligned to allow fluid to flow from the first inner compartment through the first and second openings and into the second inner compartment as taught by Diresta since such a modification would amount to a simple substitution of one known element (i.e., as taught by Masini) for another (i.e., as taught by Diresta) to obtain predictable results such as culturing a variety of single cell organisms in a cassette under typical pressurized media culture conditions including elevated and pulsatile interstitial pressure without significant changes in the cassette’s internal volume (see at least par 0144-0148 of Diresta)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 4, Masini discloses the cell collection device 10 of claim 1, wherein the graft material 20 comprises a bone, cartilage, tendon, ligament, or an artificial scaffold (such as porous glass, sol, gel, aerogel, porous ceramic, nylon or other biocompatible polymers) (see at least par 0027-0028).
In regards to claim 5, Masini discloses the cell collection device 10 of claim 1, that fails to explicitly teach a cell collection device wherein the first opening, the second opening, or both the first and second openings comprise a screen or filter. However, Diresta teaches that it is known to provide cell collection device wherein the first opening, the second opening, or both the first and second openings comprise a screen (i.e., rigid support of frame (13, 21, 24) contains mesh 22) (see at least par 0033 & 0039). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the cell collection device of Masini wherein the first opening, the second opening, or both the first and second openings comprise a screen as taught by Diresta since such a modification would amount to a simple substitution of one known element (i.e., as taught by Masini) for another (i.e., as taught by Diresta) to obtain predictable results such as culturing a variety of single cell organisms in a cassette under typical pressurized media culture conditions including elevated and pulsatile interstitial pressure without significant changes in the cassette’s internal volume (see at least par 0144-0148 of Diresta)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 11, Masini discloses the cell collection device 10 of claim 1, that fails to explicitly teach a cell collection device wherein the graft chamber comprises two panels and a hinged connector, wherein the hinged connector is configured so that the two panels can open while remaining connected. However, Diresta teaches that it is known to provide a cell collection device wherein the graft chamber comprises two panels (13, 21, 24) and a hinged connector, wherein the hinged connector is configured so that the two panels (13, 21, 24) can open while remaining connected (see at least fig. 2 and par 0015 & 0033). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the cell collection device of Masini wherein the graft chamber comprises two panels and a hinged connector, wherein the hinged connector is configured so that the two panels can open while remaining connected as taught by Diresta since such a modification would amount to a simple substitution of one known element (i.e., as taught by Masini) for another (i.e., as taught by Diresta) to obtain predictable results such as culturing a variety of single cell organisms in a cassette under typical pressurized media culture conditions including elevated and pulsatile interstitial pressure without significant changes in the cassette’s internal volume (see at least par 0144-0148 of Diresta)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masini et al. (US 2001/0043918) (“Masini” hereinafter) in view of Diresta et al. (US 2005/0101008) (“Diresta” hereinafter) further in view of Parton (US 5,690,825).
Masini as modified by Diresta discloses the cell collection device 10 of claim 1, that fails to explicitly teach a cell collection device wherein the graft is attached to the first panel, the second panel, or both the first and second panels by a clip or pin.
However, Parton teaches that it is known to provide a collection device wherein the graft 36 is attached to the first panel 28, the second panel 30, or both the first and second panels 28, 30) by a pin 32 (see at least abstract, figs. 1-2, col. 2, lines 38-47 & 62-65 and col. 4, lines 2-27).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the cell collection device of Masini as modified by Diresta wherein the graft is attached to the first panel, the second panel, or both the first and second panels by a pin as taught by Howard since such a modification would amount to applying a known technique (i.e., as taught by Parton) to a known device (i.e., as taught by Masini) ready for improvement to achieve a predictable result such as facilitating adjustment of the degree of compression applied to the graft or foam to provide an effective pore size sufficiently small to trap the desired particles (see at least col., 2, lines 62--65 of Parton)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Claim(s) 8-9, 12-16 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masini et al. (US 2001/0043918) (“Masini” hereinafter) in view of Diresta et al. (US 2005/0101008) (“Diresta” hereinafter) further in view of Howard et al. (US 2008/0243029) (“Howard” hereinafter).
In regards to claim 8, Masini as modified by Diresta discloses the cell collection device 10 of claim 1, that fails to explicitly teach a cell collection device further comprising a second device for liberating cells from a tissue connected to the inlet port, wherein the second device is an endoscopic shaver, an endoscopic bone cutter, an endoscopic burr, or an endoscopic drill. However, Howard teaches that it is known to provide a cell collection device 40 further comprising a second device 10 for liberating cells from a tissue connected to the inlet port 44b, wherein the second device 10 is an endoscopic shaver or an endoscopic bone cutter (see at least fig. 1 and par 0082-0084). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the cell collection device of Masini as modified by Diresta further comprising a second device for liberating cells from a tissue connected to the inlet port, wherein the second device is an endoscopic shaver or an endoscopic bone cutter as taught by Howard since such a modification would amount to applying a known technique (i.e., as taught by Howard) to a known device (i.e., as taught by Masini) ready for improvement to achieve a predictable result such as minimizing intervention from the surgeon; and harvesting tissue, loading tissue onto a scaffold in an expedient manner, and implanting the scaffold for tissue repair in a sterile manner in a single surgical procedure (see at least par 0026 of Howard)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 9, Masini as modified by Diresta discloses the cell collection device 10 of claim 1, that fails to explicitly teach a cell collection device further comprising a device for aspiration or suction at the outlet port. However, Howard teaches that it is known to provide a cell collection device further comprising a device 70 for aspiration or suction at the outlet port (i.e., through outlet cap 48) (see fig. 1 and par 0088). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the cell collection device of Masini as modified by Diresta further comprising a device for aspiration or suction at the outlet port as taught by Howard since such a modification would amount to applying a known technique (i.e., as taught by Howard) to a known device (i.e., as taught by Masini) ready for improvement to achieve a predictable result such as minimizing intervention from the surgeon; and harvesting tissue, loading tissue onto a scaffold in an expedient manner, and implanting the scaffold for tissue repair in a sterile manner in a single surgical procedure (see at least par 0026 of Howard)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 12, Masini discloses a method of collecting stem cells comprising:
a) connecting the inlet port 12 of the cell collection device 10 of claim 1 to cells from a tissue in a fluid (see at least par 0025);
b) connecting the outlet port 16 of the cell collection device 10 (i.e., by actuating outlet control 18); and
c) collecting stem cells on the graft material 20 (see at least abstract and par 0028 & 0031).
Masini as modified by Diresta discloses a method, as described above, that fails to explicitly teach a method comprising connecting the inlet port of the cell collection device to a second device for liberating cells from a tissue in a fluid; and connecting the outlet port of the cell collection device to a suction or aspiration apparatus.
However, Howard teaches that it is known to provide a method (see par 0022-0023) comprising connecting the inlet port 44b of the cell collection device 40 to a second device 10 for liberating cells from a tissue in a fluid (see at least fig. 1 and par 0082-0084); and connecting the outlet port of the cell collection device 10 to a suction or aspiration apparatus 70 (see at least fig. 1 and par 0088).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Masini as modified Diresta comprising connecting the inlet port of the cell collection device to a second device for liberating cells from a tissue in a fluid; and connecting the outlet port of the cell collection device to a suction or aspiration apparatus as taught by Howard since such a modification would amount to applying a known technique (i.e., as taught by Howard) to a known device (i.e., as taught by Masini) ready for improvement to achieve a predictable result such as minimizing intervention from the surgeon; and harvesting tissue, loading tissue onto a scaffold in an expedient manner, and implanting the scaffold for tissue repair in a sterile manner in a single surgical procedure (see at least par 0026 of Howard)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 13, Masini discloses the method of claim 12, wherein the graft is bone, soft tissue, or an artificial scaffold (such as porous glass, sol, gel, aerogel, porous ceramic, nylon or other biocompatible polymers) (see at least par 0027-0028).
In regards to claim 14, Masini as modified by Diresta discloses the method of claim 12, that fails to explicitly teach a method wherein the second device for liberating cells is an arthroscopic shaver, an arthroscopic bone cutter, an arthroscopic burr, or an arthroscopic drill. However, Howard teaches that it is known to provide a method wherein the second device 10 for liberating cells is an endoscopic shaver or an endoscopic bone cutter (see at least fig. 1 and par 0022-0023 & 0082-0084). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Masini as modified by Diresta wherein the second device for liberating cells is an endoscopic shaver or an endoscopic bone cutter as taught by Howard since such a modification would amount to applying a known technique (i.e., as taught by Howard) to a known device (i.e., as taught by Masini) ready for improvement to achieve a predictable result such as minimizing intervention from the surgeon; and harvesting tissue, loading tissue onto a scaffold in an expedient manner, and implanting the scaffold for tissue repair in a sterile manner in a single surgical procedure (see at least par 0026 of Howard)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 15, Masini as modified by Diresta discloses the method of claim 12, that fails to explicitly teach a method further comprising connecting a filter device to the cell collection device to remove tissue fragments from the fluid. However, Howard teaches that it is known to provide a method further comprising connecting a filter device 30 to the cell collection device 40 to remove tissue fragments from the fluid (see at least fig. 1 and par 0022-0023 & 0084). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Masini as modified by Diresta further comprising connecting a filter device to the cell collection device to remove tissue fragments from the fluid as taught by Howard since such a modification would amount to applying a known technique (i.e., as taught by Howard) to a known device (i.e., as taught by Masini) ready for improvement to achieve a predictable result such as minimizing intervention from the surgeon; and harvesting tissue, loading tissue onto a scaffold in an expedient manner, and implanting the scaffold for tissue repair in a sterile manner in a single surgical procedure (see at least par 0026 of Howard)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 16, Masini as modified by Diresta discloses the method of claim 15, that fails to explicitly teach a method wherein the filter device is connected in series between the second device for liberating cells from a tissue and the cell collection device. However, Howard teaches that it is known to provide a method wherein the filter device 30 is connected in series between the second device 10 for liberating cells from a tissue and the cell collection device 40 (see at least fig. 1 and par 0022-0023 & 0082-0084). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the method of Masini as modified by Diresta wherein the filter device is connected in series between the second device for liberating cells from a tissue and the cell collection device as taught by Howard since such a modification would amount to applying a known technique (i.e., as taught by Howard) to a known device (i.e., as taught by Masini) ready for improvement to achieve a predictable result such as minimizing intervention from the surgeon; and harvesting tissue, loading tissue onto a scaffold in an expedient manner, and implanting the scaffold for tissue repair in a sterile manner in a single surgical procedure (see at least par 0026 of Howard)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 18, Masini discloses the method of claim 13, wherein the soft tissue is tendon, ligament, or cartilage (see at least par 0027-0028).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6139757 to Ohmura et al. discloses a method of separating cells from blood using a filter having changeable porosity.
US 2021/0113351 to Lambarth et al. discloses a bone fragment collector and processor.
US 2019/0118125 to Banju et al. discloses a filtration filter device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE T TOWA whose telephone number is (313)446-/6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/Primary Examiner, Art Unit 3791
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