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 .
Specification
The disclosure is objected to because of the following informalities:
The reference characters “512, 522” in paragraph 000117, line 21 and “514 and 524” in last line are both used to refer to “cell retentive layers”.
The reference character “524” has been used to refer to both “cellular open layer” in paragraph 00117, line 20 and “cell retentive layer” in paragraph 000117, last line.
Appropriate correction is required.
Claim Objections
Claim 13 is objected to because of the following informalities:
Regarding claim 13, line 2, the recitation “at least one of the inner layer the outer layer” appears to be amended to recite “at least one of the inner layer and the outer layer” to correct the grammatical error.
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 21 and 24 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.
Claim 21 recites the limitation “the at least one first configuration element” in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, the claim is unclear regarding whether “the at least one first configuration element” refers to one of “at least one configuration element” recited in claim 18, line 11 or additional. For examination purposes, examiner construes “at least one first configuration element” refers to one of “at least one configuration element” recited in claim 18.
Regarding claim 21, line 3, the recitation “at least one second configuration” renders the claim indefinite because the claim is unclear if “at least one second configuration element” refers to “at least one configuration element” recited in claim 18, line 11 or additional. For examination purposes, examiner construes that “at least one second configuration element” refers to “at least one configuration element” recited in claim 18.
Regarding claim 24, line 2, the recitation “at least one configuration element replaces the structural elements” renders the claim indefinite because the claim replaces the structural elements essentially removing the structural elements from the encapsulation device. However, claim 18 upon which claim 24 depends upon requires the structural elements located in the containment layer. Therefore, claim 24 appears to be claiming an entirely different embodiment from the embodiment claimed in claim 18 wherein claim 24 does not require all the structural details of claim 18. Thus, the scope of the claimed invention is unclear. For examination purposes, examiner construes that claim 24 recites a device eliminating the structural elements recited in claim 18.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2 and 7-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cully et al. (US 2018/0125632 A1).
Regarding claim 1, Cully teaches an implantable encapsulation device 100, 300 (figures 1, 3, while examiner has only focused on embodiment shown in figure 3, examiner also considers other embodiments of Cully that could be applied for rejecting claim 1 and would refer to other embodiments for rejecting dependent claims) comprising:
an inner layer 310;
an outer layer 320; and
a containment layer 330 positioned between the inner layer 310 and the outer layer 320 and including structural elements 340 disposed therein to maintain a separation distance between the inner layer 310 and the outer layer 320, the structural elements 340 defining a plurality of reservoir spaces 350 for the placement of at least one biological moiety (paragraph 0055, lines 15-17) therein,
wherein the structural elements 340 maintain the separation distance both under external compressive forces and under internal expansive forces (paragraphs 0088, 0089),
wherein at least one of the inner layer 310 and the outer layer 320 is a composite layer comprising a cellular open layer and cell retentive layer (paragraph 0050, lines 6-10), and
wherein the encapsulation device 100, 300 having a substantially tubular configuration (figure 3, paragraph 0087, due to use of flexible layers, encapsulation device is configured to be compressed to some extent to change the diameter from a first diameter to a second diameter) and is configurable from a first tubular configuration having a first diameter to a second tubular configuration having a second diameter.
Regarding claim 2, Cully teaches comprising a filling tube 1960 (figure 19, paragraph 0079, lines 11-14, paragraph 0086, lines 14-19) positioned between the structural elements and into at least one of the reservoir spaces for placement of the biological moiety in the reservoir spaces.
Regarding claims 7 and 8, Cully teaches wherein the inner layer (paragraph 0059, lines 1-6) is a composite layer comprising a cellular open layer and a first cell retentive layer, and wherein the outer layer is a second cell retentive layer, wherein the outer layer is a composite layer comprising a cellular open layer and a first cell retentive layer, and wherein the inner layer is a second cell retentive layer.
Regarding claim 9, Cully teaches wherein the inner layer 1410 is a first composite layer (paragraph 0078, lines 12-13) comprising a first cellular open layer and a first cell retentive layer, and wherein the outer layer 1420 is a second composite layer (paragraph 0078, lines 12-13) comprising a second cellular open layer and a second cell retentive layer.
Regarding claim 10, Cully teaches wherein the structural elements comprise a shape memory material (paragraph 0150).
Regarding claim 11, Cully teaches wherein the at least one biological moiety (paragraph 0051, lines 1-12) is selected from cells, viruses, viral vectors, bacteria, proteins, antibodies, genes, DNA, RNA and combinations thereof.
Regarding claim 12, Cully teaches wherein the cells (paragraph 0051, lines 1-12) are selected from prokaryotic cells, eukaryotic cells, mammalian cells, non-mammalian cells, stem cells and combinations thereof.
Regarding claim 13, Cully teaches wherein at least one of the inner layer the outer layer is a cellular open layer (paragraph 0060, lines 1-5), and wherein the at least one biological moiety is microencapsulated (paragraph 0011, lines 4-6).
Regarding claim 14, Cully teaches wherein the structural elements (paragraph 0074, lines 1-3) are adhered to at least one of the first layer and the second layer.
Regarding claim 15, Cully teaches wherein the inner layer (paragraph 0078, lines 12-13) is a first composite layer comprising a first cellular open layer and the outer layer is a second composite layer comprising a second cellular open layer,
wherein the structural elements are adhered (paragraph 0074, lines 9-12) to the first and second cellular open layers of the first and second composite layers, and
wherein the structural elements do not penetrate (paragraph 0074, lines 12-16) into pores of the first cellular open layer or the second cellular open layer.
Regarding claim 16, Cully teaches wherein the at least two reservoir spaces that are fluidly interconnected (paragraph 0086, lines 11-14).
Regarding claim 17, Cully teaches wherein the at least two reservoir spaces are discrete (paragraph 0094, lines 7-8).
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 3, 4, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 2018/0125632 A1) in view of McCullen et al. (US 2019/0000602 A1).
Regarding claims 3-5, Cully discloses the claimed invention substantially as claimed, as set forth above in claim 1. Cully is silent regarding comprising a reinforcing layer positioned between the inner layer and the containment layer or comprising a reinforcing layer positioned between the outer layer and the containment layer or comprising a reinforcing layer positioned externally to the outer layer.
However, McCullen teaches a design of an implant device (figure 4) comprising a reinforcing layer 42 positioned between a layer 41 and another layer 43 for the purpose of maintaining structural integrity of the implantable device (paragraph 0055).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the implant device of Cully to incorporate a reinforcing layer as taught by McCullen for the purpose of maintaining structural integrity of the implantable device (paragraph 0055). While McCullen does not explicitly recite to have a reinforcing layer positioned between the inner layer and the containment layer or between the outer layer and the containment layer or comprising a reinforcing layer positioned externally to the outer layer, one of ordinary skill in the art could “obvious to try” to place a reinforcing layer between the inner layer and the containment layer or between the outer layer and the containment layer or comprising a reinforcing layer positioned externally to the outer layer if the one of ordinary skill in the art wants to achieve specific structural support in the desired areas of the implantable device.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 2018/0125632 A1) in view of McCullen et al. (US 2019/0000602 A1) and further in view of Evans (US 2007/0043374 A1).
Regarding claim 6, Cully/McCullen (hereinafter referred as “modified Cully”) discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 3. Modified Cully is silent regarding wherein the reinforcing layer comprises a shape memory material.
However, Evans teaches a design of a system for repairing a vertebral disc defect wherein the reinforcing layer comprises a shape memory material (paragraph 0073, lines 31-34) for the purpose of achieving the desired shape of the implantable device as per needs to treat a medical condition (paragraph 0073, lines 33-38).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the material of the reinforcing layer of modified Cully to incorporate a shape memory material as taught by Evans for the purpose of achieving the desired shape of the implantable device as per needs to treat a medical condition (paragraph 0073, lines 33-38).
Claims 18-30 are rejected under 35 U.S.C. 103 as being unpatentable over Cully et al. (US 2018/0125632 A1) in view of Steven et al. (WO 96/32076).
Regarding claim 18, Cully discloses an encapsulation device 100, 300, 1400 (figures 1, 3, 14, while examiner has only focused on embodiment shown in figures 3 and 14, examiner also considers other embodiments of Cully that could be applied for rejecting claim 18 and would refer to other embodiments for rejecting dependent claims) comprising: a first composite layer 310, 1410 including a first cellular open layer and a first cell retentive layer (paragraph 0078, lines 12-13); a second composite layer 320, 1420 including a second cellular open layer and a second cell retentive layer (paragraph 0078, lines 12-13); a containment layer 330 (layer formed by element 1430) positioned between the first composite layer 310, 1410 and the second composite layer 320, 1420, the containment layer 330 (layer formed by element 1430) including structural elements 340 (structures extending within element 1430) disposed therein to maintain a separate distance between the first composite layer 310, 1410 and the second composite layer 320, 1420, the structural elements 340 defining a plurality of reservoir spaces 350 for placement of at least one biological moiety (paragraph 0055, lines 15-17) therein, wherein the encapsulation device 100, 300, 1400 is configurable (figure 3, paragraph 0087, element 100, 300, 1400 can be configured to be pressed to a little extent to form a first geometric configuration and released to return element 100, 300, 1400 to the original shape thereby reaching second geometric configuration) between a first geometric configuration and a second geometric configuration. Cully is silent regarding at least one configuration element comprising a shape memory material.
However, Steven teaches a design of an apparatus (figure 37) for implanting cells comprising at least one configuration element 228, 230 for the purpose of providing proper support to the device as needed (page 30, lines 33-35).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the encapsulation device of Cully to incorporate at least one configuration element as taught by Steven for the purpose of providing proper support to the device as needed (page 30, lines 33-35).
Cully in view of Steven is silent regarding at least one configuration element comprising a shape memory material.
However, Cully already teaches the use of the support element comprising a shape memory material (paragraph 0074, lines 16-18). Therefore, it would have been prima facie obvious to use the material for at least one configuration element comprising a shape memory material as taught by Cully (paragraph 0074, lines 16-18) because Cully already discloses the use of material in support element which is equivalent to spacers of Cully.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the material of at least one configuration element of Steven to incorporate a shape memory material as taught by Cully for the purpose of using a well-known material known for designing spacers (paragraph 0074, lines 16-18).
Regarding claim 19, Cully is silent regarding wherein the at least one configuration element is positioned between the first cellular open layer and the first cell retentive layer.
However, Steven teaches a placement of at least one configuration element 228, 230 between two layers 222, 250 or 224, 252 for the purpose of providing proper support to the device as needed (page 30, lines 33-35).
Therefore, it would be obvious to modify the encapsulation device of Cully to incorporate at least one configuration element placed somewhere between two layers as taught by Steven for the purpose of providing proper support to the device as needed (page 30, lines 33-35). While Steven does not explicitly recite to have a placement of the at least one configuration between the first cellular open layer and the first cell retentive layer, it would be obvious to one of ordinary skill in the art “to try” and place the at least one configuration element between the first cellular open layer and the first cell retentive layer if one of ordinary skill desires to achieve proper support in the device between the first cellular open layer and the first cell retentive layer.
Regarding claim 20, Cully is silent regarding wherein the at least one configuration element is positioned between the second cellular open layer and the second cell retentive layer.
However, Steven teaches a placement of at least one configuration element 228, 230 between two layers 222, 250 or 224, 252 for the purpose of providing proper support to the device as needed (page 30, lines 33-35).
Therefore, it would be obvious to modify the encapsulation device of Cully to incorporate at least one configuration element placed somewhere between two layers as taught by Steven for the purpose of providing proper support to the device as needed (page 30, lines 33-35). While Steven does not explicitly recite to have a placement of the at least one configuration between the second cellular open layer and the second cell retentive layer, it would be obvious to one of ordinary skill in the art “to try” and place the at least one configuration element between the second cellular open layer and the second cell retentive layer if one of ordinary skill desires to achieve proper support in the device between the second cellular open layer and the second cell retentive layer.
Regarding claim 21, Cully is silent regarding wherein the at least one configuration element is positioned between the first cellular open layer and the first cell retentive layer and at least one second configuration is positioned between the second cellular open layer and the second cell retentive layer.
However, Steven teaches a placement of at least one first configuration element 228 between two layers 222, 250 and at least one second configuration 230 between other two layers 224, 252 for the purpose of providing proper support to the device as needed (page 30, lines 33-35).
Therefore, it would be obvious to modify the encapsulation device of Cully to incorporate at least one configuration element placed somewhere between two layers as taught by Steven for the purpose of providing proper support to the device as needed (page 30, lines 33-35). While Steven does not explicitly recite to have a placement of the at least one configuration between the first cellular open layer and the first cell retentive layer and at least one second configuration is positioned between the second cellular open layer and the second cell retentive layer, it would be obvious to one of ordinary skill in the art “to try” and place the at least one first configuration element between the first cellular open layer and the first cell retentive layer and at least one second configuration element between the second cellular open layer and the second cell retentive layer if one of ordinary skill desires to achieve proper support in the device between the first cellular open layer and the first cell retentive layer and the second cellular open layer and the second cell retentive layer.
Regarding claims 22 and 23, Cully discloses the first cellular open layer and the second cellular open layer forming an exterior surface of the encapsulation device (paragraph 0057, lines 1-7) but is silent regarding wherein the at least one configuration element is exteriorly positioned on the first cellular open layer or on the second cellular open layer.
However, Steven teaches a placement of at least one configuration element 228, 230 exterior of the layer 222, 224 for the purpose of providing proper support to the device as needed (page 30, lines 33-35).
Therefore, it would be obvious to modify the encapsulation device of Cully to incorporate at least one configuration element placed exterior of a layer as taught by Steven for the purpose of providing proper support to the device as needed (page 30, lines 33-35). While Steven does not explicitly recite to have a placement of the at least one configuration exteriorly on the first cellular open layer or the second cellular open layer, it would be obvious to one of ordinary skill in the art “to try” and place the at least one configuration element exteriorly on the first cellular open layer or the second cellular open layer if one of ordinary skill desires to achieve proper support in the device from exterior of the first cellular open layer or the second cellular open layer.
Regarding claim 24, Cully discloses wherein at least one configuration element 340 (as explained in the rejection of claim 24 under 35 USC 112, examiner construes elimination of the structural elements therefore, examiner can construe element 340 as claimed configuration element) replaces the structural elements and is positioned between the first composite layer 310 and the second composite layer 320.
Regarding claim 25, Cully discloses wherein the at least one biological moiety (paragraph 0051, lines 1-12) is selected from cells, viruses, viral vectors, bacteria, proteins, antibodies, genes, DNA, RNA and combinations thereof.
Regarding claim 26, Cully discloses wherein the cells (paragraph 0051, lines 1-12) are selected from prokaryotic cells, eukaryotic cells, mammalian cells, non-mammalian cells, stem cells and combinations thereof.
Regarding claim 27, Cully discloses wherein the structural elements are adhered (paragraph 0074, lines 9-12) to the first cellular open layer of the first composite layer and the second cellular open layers of the second composite layer, and
wherein the structural elements do not penetrate (paragraph 0074, lines 12-16) into pores of the first cellular open layer or the second cellular open layer.
Regarding claim 28, Cully discloses wherein the plurality of reservoir spaces in the cell containment layers are interconnected (paragraph 0086, lines 11-14).
Regarding claim 29, Cully discloses wherein the plurality of reservoir spaces in the cell containment layer are discrete (paragraph 0094, lines 7-8).
Regarding claim 30, Cully discloses wherein the structural elements 340 maintain the separation distance both under external compressive forces and under internal expansive forces (paragraphs 0088, 0089).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Neuenfeldt et al. (US 5,545,223): discloses a design of an implant assembly for a host tissue comprising a chamber to hold cells for implantation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHELSEA STINSON can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783
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