DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 12/18/2025.
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 .
Status of the Claims
Claims 22, 25 and 36 has been amended. Claims 1-21, 28 and 29 are cancelled. Claim 37 is newly added. Accordingly, claims 22-27 and 30-37 remain pending in the application and are currently under examination.
Terminal Disclaimer
The terminal disclaimer filed on 12/18/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration dates of USPNs 10,493,107 and 11,903,976 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Objections/Rejections
Applicant’s amendment renders the objection to the specification moot. Specifically, the specification has been amended to include the generic terminology associated with the trade mark, MartigelTM. Thus, said objection has been withdrawn.
Applicant’s amendment renders the objection to claim 36 moot. Specifically, claim 36 has been amended to clarify that the “polymeric coating” is the inner polymeric coating. Thus, said objection has been withdrawn.
Applicant’s amendment renders the rejection of claims 28 and 29 under 35 USC 112(a) moot. Specifically, said claims have been canceled. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejections of claims 25, 28 and 29 under 35 USC 112(b) moot. Specifically, claim 25 has been amended to replace the trademark with the generic terminology and claims 28 and 29 have been canceled. Thus, said rejections have been withdrawn.
Applicant’s filing of the terminal disclaimer renders the double patenting rejection over USPN 10,493,107 moot. Thus, said rejection has been withdrawn.
Applicant’s filing of the terminal disclaimer renders the double patenting rejection over USPN 11, 903,976 moot. Thus, said rejection has been withdrawn.
Maintained Rejections
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 22-27, 32, 35 and 36 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al. (US 2006/0193769 A1, Aug. 31, 2006, hereafter as “Nelson”).
The claimed invention is drawn to an implantable therapeutic delivery system comprising: a gas permeable, liquid impermeable substrate; an outer hydrogel coating surrounding the substrate; and one or more therapeutic agents positioned in the outer hydrogel coating, wherein the substrate comprises an internal fluidic space configured as a hollow tube and wherein the outer hydrogel coating is a crosslinked hydrogel coating.
Regarding instant claim 22, Nelson teaches an implantable therapeutic delivery system ([a] therapeutic agent-loaded fiber is suitable for implantation in animals, or more preferably in humans... for use as therapeutic agent delivery vehicles, [0053]) comprising: a substrate (a fiber-scaffold, [0067]; an inner core, [0090]; fiber core, [0094]); an inner polymeric coating surrounding said substrate; and an outer hydrogel coating surrounding said inner polymeric coating (a biodegradable polymer fiber in a multi-layer, multi-component format, where each layer is fully contained within the next outer layer, and the inner layer is generally centered within the outer layer. These layers can be comprised of different gels or hydrogels, or different biodegradable polymers, [0084]; hydrogel exterior to the biodegradable polymer layer, [0087]; the polymer sheath surrounds an inner core, [0090]; the biodegradable polymer layers in the sheath of the fiber, [0092]; hydrogel is the exterior layer, [0094]), wherein one or more therapeutic agents is positioned in said outer hydrogel coating (the overall release of therapeutic agent(s) from the fiber is controlled by the location of the therapeutic agents, either in the gel or hydrogel exterior, [0094]). Nelson teaches a particular embodiment the fiber comprises a hollow bore (tube) ([0014], [0045] and [0087]; Examples 3 and 4). Nelson also teaches that the substrate comprises a gas permeable material and has one or more internal fluidic spaces (fibers into the weave pattern ...thereby receive oxygen, [0081]). Nelson further teaches that the polymer fiber can maintain the lumen of any tubular body such as arteries, veins, ducts, etc. (liquid carrying lumens) which implies that the fiber substrate is liquid permeable. It is further noted that Nelson teaches the same fiber substrate materials (e.g., [0097]) discussed at [0048] in the instant specification. It is also noted that a hydrogel by definition is a crosslinked network as evidenced by Nelson (“made of hydrophilic polymer molecules crosslinked either by chemical bonds or by other cohesion forces...” ([0101]).
Regarding instant claim 23, Nelson teaches the implantable therapeutic delivery system according to claim 1, wherein the substrate comprises a gas permeable material and has one or more internal fluidic spaces (fibers into the weave pattern ...thereby receive oxygen, [0081]).
Regarding instant claim 24, Nelson teaches the outer hydrogel coating can be homopolymeric, copolymeric, or multipolymeric in composition ([0105] and [0107]).
Regarding instant claims 25 and 26, Nelson teaches the particular hydrogel materials, alginate, collagen, hyaluronic acid, fibrin, agarose, chitosan, keratin… and mixtures thereof ([0063] and [0105]).
Regarding instant claim 27, Nelson teaches the particular hydrogel materials polyethylene glycol, poly(acrylates) poly(ethylene oxide), polyvinyl alcohol, polyphosphazene… and derivatives thereof… and copolymers thereof ([0105]).
Regarding instant claim 32, Nelson teaches that the therapeutic agent can be released from the outer hydrogel coating ([0094]). Nelson further teaches that the therapeutic agent includes cells ([0059]).
Regarding instant claims 35 and 36, Nelson teaches multiple layer embodiments ([0084] and [0091]; Fig. 4B) including an embodiment wherein said polymeric coating is porous (the polymer sheath surrounds an inner core, [0090]: the biodegradable polymer layers in the sheath of the fiber, [0092]; the polymer becomes more porous, [0074])..
Thus, the teachings of Nelson render the instant claims anticipated.
Response to Arguments
Applicant's arguments, filed 12/18/2025, regarding the 102 rejection over Nelson have been fully considered but they are not persuasive.
Applicant argues that Nelson does not teach or suggest that the outer hydrogel coating is a crosslinked hydrogel coating. Remarks, pages 5-6.
In response, it is respectfully submitted that Nelson teaches an outer hydrogel coating ([0087]). Additionally, a hydrogel by definition is a crosslinked network as evidenced by Nelson (“made of hydrophilic polymer molecules crosslinked either by chemical bonds or by other cohesion forces...” ([0101]). Thus, the outer hydrogel coating of Nelson would be understood by one of ordinary skill in the art as a crosslinked hydrogel coating. Applicant’s argument is unpersuasive.
Thus, said rejection is maintained.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 34 stands rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2006/0193769 A1, Aug. 31, 2006, hereafter as “Nelson”),
The claimed invention is described above.
Nelson teaches the elements discussed above.
Regarding instant claim 34, Nelson teaches the elements discussed above including that the therapeutic agent can be released from the outer hydrogel coating ([0094]) and that the therapeutic agent includes cells ([0059]). Nelson, in a particular embodiment, additionally teaches the inclusion of stem cells ([0162]).
Nelson is silent to a particular embodiment comprising stem cells within the outer hydrogel.
However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the elements taught in Nelson with a reasonable expectation of success because Nelson generally teaches that the therapeutic can be released from the outer hydrogel coating, the therapeutic agent can be cells, and the particular cells, stem cells.
Thus, the teachings of Nelson render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 12/18/2025, regarding the 103 rejection over Nelson have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 102 rejection over Nelson. No further arguments regarding claim 34 are presented. Remarks, pages 5-6.
For the same reasons as discussed above, Applicant’s arguments are not persuasive.
Thus, said rejection is maintained.
Claim 31 stands rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2006/0193769 A1, Aug. 31, 2006, hereafter as “Nelson”), as applied to claim 22 above, in view of Hossainy et al. (US 2013/0103138 A1, Apr. 25, 2013, hereafter as “Hossainy”).
The claimed invention is described above.
Nelson teaches the elements discussed above. Nelson also teaches therapeutic agents include glycoproteins ([0059] and [0078]).
Nelson is silent to the particular therapeutic agent, fibrinogen or Factor VIII.
Hossainy teaches surface modification of implantable medical devices to enhance endothelial adhesion and coverage in order to promote accelerated, controlled healing and functionally competent tissue integration on medical implants (abstract; [0019]). Hossainy teaches endothelial cell-conductive coating materials including fibrinogen, hyaluronic acid, collagen, elastin, etc. ([0029]).
Nelson and Hossainy are both drawn to implantable medical devices, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable therapeutic delivery system of Nelson to include the particular glycoprotein, fibrinogen, as taught by Hossainy with a reasonable expectation of success. A skilled artisan would have been motivated to do so because 1) Nelson teaches other endothelial cell-conductive coating materials such as hyaluronic acid, collagen, and elastin and it is prima facie obvious to substitute equivalents known for the same purpose (MPEP 2144.06(II)) and 2) Hossainy teaches that the inclusion of fibrinogen on an implantable medical device effectively promotes accelerated, controlled healing and functionally competent tissue integration of medical implants.
Thus, the combined teachings of Nelson and Hossainy render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 12/18/2025, regarding the 103 rejection over Nelson in view of Hossainy have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 102 rejection over Nelson. No further arguments regarding claim 31 are presented. Remarks, pages 5-6.
For the same reasons as discussed above, Applicant’s arguments are not persuasive.
Thus, said rejection is maintained.
Claims 30, 32 and 33 stand rejected under 35 U.S.C. 103 as being unpatentable over Nelson et al. (US 2006/0193769 A1, Aug. 31, 2006, hereafter as “Nelson”), as applied to claims 22 and 32 above, in view of Beck et al. (WO 2008/079997 A2, Jul. 3, 2008, hereafter as “Beck”).
The claimed invention is described above.
Nelson teaches the elements discussed above.
Nelson is silent to “wherein the cells are islet cells”.
Beck is in the field of implantable therapeutic delivery devices (the present invention relates to therapeutic implantable medical devices, [0002]) and teaches a therapeutic agent is released from a preparation of cells positioned within a hydrogel, wherein the cells are islet cells (an implantable device for providing therapy to a living body is provided that includes a permeable container and therapeutic living cells carried by the container. The living cells are capable of generating cell products that are emitted from the permeable container to the living body, [0010]; formation of underhydrated encapsulated therapeutic living cells is provided that includes a mass of underhydrated hydrogel and a plurality of islet cells within the underhydrated hydrogel, [0019]; a formation of hydrogel encapsulated therapeutic cells disposed on the hydrogel carrier, [0020]; the implanted device 10, in embodiments in which islet cells are subsequently loaded to treat Type I diabetes, provides surfaces across which insulin moves out of the device and into blood vessels, and connections to routes for circulation of insulin throughout the body, [00141]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable therapeutic delivery system of Nelson to include islet cells for the delivery of insulin as taught by Beck with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Beck teaches loading an implant comprising insulin secreting islet cells are effective in treating Type I diabetes (Beck, [00141]).
Thus, the combined teachings of Nelson and Beck render the instant claim prima facie obvious.
Response to Arguments
Applicant's arguments, filed 12/18/2025, regarding the 103 rejection over Nelson in view of Beck have been fully considered but they are not persuasive.
Applicant relies on the same arguments as presented for the 102 rejection over Nelson. No further arguments regarding claims 30, 32 and 33 are presented. Remarks, pages 5-7.
For the same reasons as discussed above, Applicant’s arguments are not persuasive.
Thus, said rejection is maintained.
Allowable Subject Matter
Claim 37 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art does not teach or suggest an implantable therapeutic delivery system comprising: a gas permeable, liquid impermeable substrate; an outer hydrogel coating surrounding the substrate; and one or more therapeutic agents positioned in the outer hydrogel coating, wherein the substrate comprises an internal fluidic space configured as a hollow tube and wherein the outer hydrogel coating is a crosslinked hydrogel coating, further comprising an inner polymeric coating, wherein the inner polymeric coating is crosslinked to the outer hydrogel coating.
Conclusion
All claims have been rejected or objected to; no claims are allowed.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617