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 in response to applicant’s communication of 8/18/2023. Currently claims 1-15 are pending and rejected below.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aebischer et al. (US 5,182,111).
Aebischer discloses a device (as in figures 1-4) for implantation into a mammalian host, comprising:a) a dialysis tube (22) with a lumen and a dialysis membrane (12/14) enclosing the lumen, wherein: i) the dialysis tube has an outer diameter, and ii) the dialysis membrane has a molecular weight cutoff of from 25 kDa to 150 kDa (see col 4 lines 51-63) and comprises at least one material selected from the group consisting of polyethersulfone, polyarylethersulfone, polyethylene, polytetrafluoroethylene, polyvinylidene fluoride, and polypropylene (again see col 4 lines 51-63); and b) a therapeutic composition (in compartment 16 of device) disposed within the lumen and comprising a plurality of cells (25, 27) configured for secreting a therapeutic compound, and a matrix material embedding said cells, wherein the matrix material is selected from the group consisting of alginate, collagen, fibrin, extracellular matrix material, synthetic hydrogel, and acrylate (see hydrogel or alginate gel sphere to encapsulate cells as discussed in col 9 lines 25-30).
Aebischer discloses the claimed invention except for explicitly stating that the dialysis tube has an outer diameter of from 20 pm to 600 pm. It would have been obvious to one having ordinary skill in the art at the time the invention was made have the dialysis tube has an outer diameter of from 20 pm to 600 pm since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). If not inherent in the disclosure of Aebisher it is examiner position that a PHOSITA would form the dialysis tube has an outer diameter of from 20 pm to 600 pm in order to effectively treat a be located at particular anatomical sites for treatement of the device while being small enough to minimize pain and tissue damage in a patient and provide ease of application.
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Concerning claim 2 and the dialysis tube has an outer diameter of from 400 pm to 500 pm.
Aebischer discloses the claimed invention except for exspicitly stating that the dialysis tube has an outer diameter of from 400 pm to 500 pm. It would have been obvious to one having ordinary skill in the art at the time the invention was made have the dialysis tube has an outer diameter of from 400 pm to 500 pm since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). If not inherent in the disclosure of Aebisher it is examiner position that a PHOSITA would form the dialysis tube has an outer diameter of from 400 pm to 500 pm in order to effectively treat a be located at particular anatomical sites for treatement of the device while being small enough to minimize pain and tissue damage in a patient and provide ease of application.
Concerning claim 3 and the dialysis membrane has a molecular weight cutoff of from 80 kDa to 100 kDa (as discussed in col 9 lines 7-24). Aebisher discloses the claimed invention except for explicitly stating the range from 80 kDa to 100 kDa. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have a range from 80 kDa to 100 kDa, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955). The prior art discusses a range from 25 kD to about 300kD, it is examiners position that a PHOSITA would know to have a range from 80 kDa to 100 kDa in order to optimize an explicit size for a particular permeation parameter.
Concerning claim 4 and an implantable first guiding system configured for at least partially guiding the dialysis tube through a subcutaneous tissue (see figure 4 and 62 with 40).
Concerning claim 5 and a port providing access to the dialysis tubing from a body surface of the mammalian host and/or from a subcutaneous access element (see port 62).
Concerning claim 6 and the port is configured for transcutaneous implantation (see figure 4 and note location via patents anatomy).
Concerning claim 7 and the port comprises a fixing element configured to fix the port within or under the skin of the mammalian host (note sides of cap port 62 that fixes to the patients anatomy as in figure 4).
Concerning claim 8 and the dialysis tube is configured to be at least partially implanted intraperitoneally, subcutaneously, intraarterially, or intravenously (see implant placement as shown in figure 4 for one example).
Concerning claim 9 and the device is configured for in situ replacement of the dialysis tube and/or for in situ replacement of the content of the dialysis tube (see para at col 8 lines 61-68).
Concerning claim 10 and the therapeutic compound is selected from the group consisting of insulin, glucagon, Factor IX, human growth hormone (huGH), Calcitonin, Glucagon-like peptide (GLP-1) and agonists, Amylin, levodopa, somatostatin, alphal-antitrypsin (AAT), interleukins, and interferons (see column 3 lines 15-62).
Concerning claim 11 and the therapeutic compound is insulin or an insulin analog, wherein the plurality of cells is adapted to secrete an amount of insulin related to the concentration of glucose present in the matrix material. (again see column 3 lines 15-62).
Concerning claim 12 and a method of producing the device for implantation according to claim 1 (see rejection of elements of claim 1 as discussed above), comprising:a) filling the dialysis tube with a plurality of cells secreting a therapeutic compound and a matrix material (as shown in figures 1-4); b) at least temporarily sealing at least one end of the dialysis tube (as shown in figures 1-3); and c) thereby producing the device for implantation (see figure 4 delivery).
Concerning claim 13 and a port system, comprising:a device for implantation comprising a port according to claim 5 (see discussion of port 62) ; and an extracorporeal connecting head (see element 44 tether).
Concerning claim 14 and d cell secreting a therapeutic compound for use in treating disease by implantation of said cells in a device for implantation according to claim 1. (see column 3 lines 15-62).
Concerning claim 15 and a cell secreting a therapeutic compound for use in treating diabetes, Hemophilia B, huGH deficiency, osteoporosis, Parkinson's disease, acromegaly, an endocrine tumor, alphal-antitrypsin -deficiency, an infectious disease, an autoimmune disease, cancer, or chronic virus infection by implantation of said cells in a device for implantation according to claim 1 (see discussion of claim 1 above and column 3 lines 15-62).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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