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 .
DETAILED ACTION
Claim Status
The claim set of 23 Feb 2024 has been entered and reviewed.
Claims 1-17 are pending and under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10 Jun 2024 and 14 Apr 2025 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 17 is objected to because of the following informalities: “comprise” would be improved as “comprises.” 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 1-17 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 1 recites the limitation "said first secondary material" in lines 9 and 10 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 previously recites “at least one first secondary material”, which encompasses multiple first secondary materials, and it is unclear whether “said first secondary material” includes just one or more than one first secondary material. Claims 2-17 are included in this rejection as it depends directly, indirectly, or includes all the limitations of claim 2.
Claims 2 and 6 recite the limitation "said first and second secondary materials." There is insufficient antecedent basis for this limitation in the claim. Base claim 1 recites “at least one first secondary material” and “at least one second secondary material, which encompasses multiple first and second secondary materials, and it is unclear whether “said first and second secondary materials” includes just one or more than one first secondary material and second secondary material. Claim 3 is included in this rejection as it depends directly, indirectly, or includes all the limitations of claim 2.
Claims 4 and 5 recite “said delivery elements” which lack proper antecedent basis. Amending the claims to “said plurality of delivery elements” would overcome this rejection.
Claim 13 is indefinite for the recitation of “associating said tissue graft with a host.” Claim 13 introduces the step of modifying said tissue graft to create a modified tissue graft, and thus there are two types of tissue graft in the claim. It is not clear if the tissue graft that is associated with the host is the modified or the unmodified tissue graft.
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.
Claims 1, 2, 4-6, 8-10, 13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Markman (WO 2021/194817, published 30 Sep 2021).
Markman teaches modified tissue grafts that comprise a medicated graft such as by associating medicants with the surface features (abstract). Markman teaches that the invention allows for faster wound healing by promoting vascular ingrowth of the body’s tissue ([0018]). Markman teaches a method and system for associating secondary materials, such as medicants with a tissue graft ([0031]). Markman teaches one or more medicants ([0029]) rendering obvious the first and second secondary materials may be a medicant as in claim 2. Markman teaches that the medicants may be imprinted or injected into the tissue graft ([0030], [0091], [0094], see Fig 10B), rendering obvious the delivery of secondary materials. Markman teaches the delivery element in the tissue (Fig 10B) rendering obvious engaging the delivery elements with an interior portion of the tissue graft as in claim 1. Markman teaches the use of both needles and blades ([0091]), rendering obvious claims 4 and 5, and teaches an array of blades/needles on the devices ([0069], Fig 8D and 10B) rendering obvious a plurality of delivery elements. Markman teaches that the tissue graft may be pre-created with medicants or these materials such as medicants may be associated with the tissue graft at a later time ([0077]) and that multiple materials, such as a medicant and secondary tissue, might be applied in successive applications ([0096]), rendering it obvious to apply secondary materials at separate times as in claims 1 and 10. Markman teaches various medicants such as antibiotics, growth factors, chemotherapeutics, or other tissues ([0026]). Markman teaches that the blades or other contacting portions are connected to a die where the blades or other contacting portions of the die might be configured to deliver secondary material such as medicant ([00102, Fig 11B). Markman teaches the blades may include passages that lead from one or more opening in the blade, through the blade and to a delivery system whereby secondary material can be delivered to the blades and into the tissue graft ([00102]), rendering obvious delivery through delivery ports as in claim 6. Markman teaches that a press may be used to apply pressure on the template or die to press it into engagement with the graft ([0064], see Fig 11B with a double arrow indicating up and down movement of the delivery device), rendering it obvious the elements may be retracted from the graft or extended into and engaged with the graft to deliver the medicant and thereby rendering obvious the limitations of claims 8 and 9. Markman teaches that the tissue graft maybe placed on or into a jib for maintaining a position of a tissue graft for modification ([0097]). After modification, one or more medicants may be applied to the tissue ([0098]), rendering obvious association of the tissue graft with a host before the delivery steps as in claim 13. The examiner notes that the term host is broad and not defined and the jig used to maintain the position of the tissue is understood to render obvious associating with a “host.” Markman teaches that different characteristics of modification may correspond to different characteristics of an anatomical area, including features related to the anatomy and the medicant condition being treated ([0048]). Thus, it is obvious that the medicant may be associated with an anatomical area, rendering obvious selection of a secondary material based on the anatomical area as in claim 16. Regarding claim 17, Markman teaches that the graft may be cadaveric human tissue ([0089]).
Markman does not expressly teach a method of delivery first and second secondary materials with a plurality of delivery elements to a tissue graft with sufficient specificity to rise to the level of anticipation.
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 have delivered medicants successively into a tissue graft through a plurality of blades/needles engaging with the tissue graft. One of ordinary skill in the art would have been motivated to do so as delivering medicants through multiple elements such as blades and needles are taught by Markman as suitable for treating modified tissue grafts. It is known from Markman that more than one medicant may be applied to the tissue grafts and that application may occur through multiple blades/needles and that the methods offer improvements such as faster wound healing by promoting vascular ingrowth of the body’s tissue. One of ordinary skill in the art would have a reasonable expectation of delivering multiple medicants (i.e. a first and second secondary material) to modified tissue grafts as taught by Markman since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Markman.
The examiner notes that claim 13 was rejected above. The claim is alternatively rejected below with a different interpretation of “host.”
Claims 3, 7, and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Markman (WO 2021/194817, published 30 Sep 2021), as applied to claims 1, 2, 4-6, 8-10, 13, 16 and 17 above, and in view of Joshi et al. (US 2009/0259171, published 15 Oct 2009).
The teachings of Markman are described supra.
The examiner notes that the blades connect to a die configured to delivery secondary material, as described in the teachings of Markman above, renders obvious the delivery elements associated with a base or a mount as in claim 7 and 11.
Markman does not teach delivery of oxygen (claim 3), a wound cover (claims 7 and 14), or a cushion (claims 11 and 12). These deficiencies are made up for in the teachings of Joshi.
Joshi teaches a method for facilitating transdermal oxygen delivery to a patient (abstract, [0002]). Joshi teaches that oxygen plays a vital role in wound healing and is necessary for cell proliferation and angiogenesis and that hypoxia prevents normal healing processes ([0006]). Joshi teaches that implanted cells or tissues are particularly prone to hypoxia due to insufficient vascularization ([0007]). Joshi teaches that direct application of oxygen to a wound such as a skin graft may impart a variety of benefits such as eliminating hypoxia, reducing clinical infection and edema and favorably influencing cytokine down regulation and growth factor up regulation ([0008]). Joshi teaches the invention for delivering oxygen transdermally to promote respiration, angiogenesis and wound healing ([0012]). Joshi teaches a supply source of oxygen connected to a delivery device for delivering oxygen transdermally and where the device has a barrier layer to substantially retain the oxygen over a localized area of skin ([0013]).
Joshi teaches a device comprising an array of hollow microneedles to aid in skin permeability and where the oxygen gas may pass through the microneedles to enter subcutaneous tissues ([0019], [0035], [0037]), and applying a patch with hollow microneedles to a patient for oxygen delivery ([0076]). For example Figure 4.
PNG
media_image1.png
383
561
media_image1.png
Greyscale
Joshi teaches the device may be a patch substantially sealed over the perimeter of the area and includes a barrier and an adhesive layer (shown in figure 4 as wrapped over the device) that both prevents oxygen from getting out of the patch and prevents outside contaminants from getting in ([0058], [0074], [0049], [0050]).
Therefore, 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 have administered a secondary material of oxygen through delivery elements associated with a die to a tissue graft wound. Oxygen is a vital component in wound healing, such as tissue grafts, for cell proliferation and angiogenesis and hypoxia prevents normal healing processes, as taught by Joshi. The devices of Markman are designed to deliver medicants to grafts and thus it would have been obvious to one of ordinary skill to delivery oxygen for the desirable benefits of wound healing that it provides. One would have a reasonable expectation of success as oxygen delivery is known from Joshi for wounds such as tissues grafts and may be delivered with systems comprising an array of microneedles, similar to a needle design taught by Markman. It would have been obvious to associate the tissue graft with a host such as a patient before the delivery steps as application of a delivery device to a patient for transdermal oxygen delivery is known from Joshi, rendering it obvious to apply oxygen during the healing process. It would be obvious to wrap the device in a barrier and adhesive layer to aid in preventing the escape of oxygen and the unwanted entry of contaminants, as taught by Joshi. Covering the device in such as way is understood to render obvious a “wound cover” as in claims 7 and 14. Such a covering is additionally understood to render obvious a “cushion” extending over the top and bottom of the mount as in claims 11 and 12.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Markman (WO 2021/194817, published 30 Sep 2021), as applied to claims 1, 2, 4-6, 8-10, 13, 16 and 17 above, and in view of Bogert (US 2004/0161362, published 19 Aug 2004
The teachings of Markman are described supra.
Markman does not teach locating the tissue graft in a hyperbaric chamber and then associating the oxygenated tissue graft with a host before the delivering steps. This deficiency is made up for in the teachings of Bogert.
Bogert teaches cleaning of tissue transplants such as medical grafts ([0002]). Bogert teaches the utilization of hyperbaric, high pressure oxygen to kill certain anaerobic bacteria, especially in their spore form, as they are very dangerous in transplants and are difficult to kill by standard techniques ([0043]). Bogert teaches that bacteria have resulted in death from tissue transplants and that pure oxygen is able to destroy anaerobic organisms ([0043]). Bogert teaches permeating tissue with high pressure pure oxygen which will destroy any anaerobic bacteria and bacterial spores present ([0043]).
Therefore, 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 have treated the tissue graft of Markman with hyperbaric oxygen prior to delivering to a host. It is known that tissue may contain bacteria which may lead to issues such as death in a patient after transplant, as taught by Bogert. Hyperbaric high pressure oxygen is known to kill bacteria, as taught by Bogert. Thus, it would have been obvious expose the tissue graft of Markman to hyperbaric high pressure oxygen t prior to delivering to a patient for the benefit of killing harmful bacteria. Hyperbaric high pressure oxygen is known from Bogert for use with tissue transplants, providing a reasonable expectation of success.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8,858,647 in view of Markman (WO 2021/194817, published 30 Sep 2021), Joshi et al. (US 2009/0259171, published 15 Oct 2009), and Bogert (US 2004/0161362, published 19 Aug 2004)).
The ‘647 patent recites a method for creating anatomically designed tissue grafts comprising steps of determining desired characteristics of the graft based on an anatomical site of a human and then modifying the tissue graft (claim 1) which may be human tissue (claim 2) and the graft is implanted at the anatomical site (claim 14) and is configured for various medicants (claim 12).
The ’647 patent does not teach applying the medicants through a plurality of delivery devices with delivery ports or multiple medicants at different times or the delivery of oxygen or association of the delivery elements with a base/mount or a wound cover or cushion or extension/retraction of the delivery elements or needles/blades or association with a host prior to delivery or selection of the medicant based on the anatomical area, or cadaveric tissue or a hyperbaric chamber. These deficiencies are made up for in the teachings of Markman, Joshi and Bogert.
The teachings of Markman, Joshi and Bogert are described supra.
Therefore, 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 have used the modified graft tissue of the ‘647 patent and to add multiple medicants such as oxygen through an array of needles/blades with delivery ports that were associated with a die (rendering obvious a base/mount) that is pressed to engage with the tissue and administered in a tissue graft wound and covered with a barrier/adhesive and the treated medicant condition is based on the anatomical area and to use cadaveric tissue and to treat the tissue in a hyperbaric chamber. Modified graft tissue, similar to those of the reference claims, are known from Markman, providing a clear link to the teachings regarding the grafts of Markman. The incorporation of each of the features listed above are described for tissue grafts by Markman. For instance, the delivery of medicants with needles/blades with delivery ports in known from Markman and thus an obvious means of administering medicants. It would be desirable to administer the medicants for the treatment of the tissue and the means of needles/blades is merely a known method of delivery and application of the tissue graft. The delivery of oxygen in particular is obvious as oxygen is necessary for tissue graft healing as it is involved in angiogenesis and may be delivered with microneedle arrays, as taught by Joshi. Further, treating tissue with hyperbaric oxygen is obvious as it is a means of killing harmful bacteria in the tissue before implantation , as taught by Bogert.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,050,177 in view of Markman (WO 2021/194817, published 30 Sep 2021), Joshi et al. (US 2009/0259171, published 15 Oct 2009), and Bogert (US 2004/0161362, published 19 Aug 2004).
The ‘177 patent recites a method for creating anatomically designed tissue grafts comprising steps of determining desired characteristics of the graft based on an anatomical site of a human and then modifying the tissue graft (claim 1) which may be human tissue (claim 2) and the graft is implanted at the anatomical site (claim 14) and is configured for various medicants (claim 11).
The ‘177 patent does not teach applying the medicants through a plurality of delivery devices with delivery ports or multiple medicants at different times or the delivery of oxygen or association of the delivery elements with a base/mount or a wound cover or cushion or extension/retraction of the delivery elements or needles/blades or association with a host prior to delivery or selection of the medicant based on the anatomical area, or cadaveric tissue or a hyperbaric chamber. These deficiencies are made up for in the teachings of Markman, Joshi and Bogert.
The teachings of Markman, Joshi and Bogert are described supra.
Therefore, 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 have used the modified graft tissue of the ‘177 patent and to add multiple medicants such as oxygen through an array of needles/blades with delivery ports that were associated with a die (rendering obvious a base/mount) that is pressed to engage with the tissue and administered in a tissue graft wound and covered with a barrier/adhesive and the treated medicant condition is based on the anatomical area and to use cadaveric tissue and to treat the tissue in a hyperbaric chamber. Modified graft tissue, similar to those of the reference claims, are known from Markman, providing a clear link to the teachings regarding the grafts of Markman. The incorporation of each of the features listed above are described for tissue grafts by Markman. For instance, the delivery of medicants with needles/blades with delivery ports in known from Markman and thus an obvious means of administering medicants. It would be desirable to administer the medicants for the treatment of the tissue and the means of needles/blades is merely a known method of delivery and application of the tissue graft. The delivery of oxygen in particular is obvious as oxygen is necessary for tissue graft healing as it is involved in angiogenesis and may be delivered with microneedle arrays, as taught by Joshi. Further, treating tissue with hyperbaric oxygen is obvious as it is a means of killing harmful bacteria in the tissue before implantation , as taught by Bogert.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,622,845 in view of Markman (WO 2021/194817, published 30 Sep 2021), Joshi et al. (US 2009/0259171, published 15 Oct 2009), and Bogert (US 2004/0161362, published 19 Aug 2004).
The ‘845 patent recites a method for creating reconstructive tissue grafts for implantation comprising steps of determining desired characteristics of the graft based on an anatomical site of a human and then modifying the tissue graft (claim 1) which may be human tissue (claim 2) and is configured for various medicants such as antibiotics, hormones, growth factors and chemotherapeutic agents.
The ‘845 patent does not teach applying the medicants through a plurality of delivery devices with delivery ports or multiple medicants at different times or the delivery of oxygen or association of the delivery elements with a base/mount or a wound cover or cushion or extension/retraction of the delivery elements or needles/blades or association with a host prior to delivery or selection of the medicant based on the anatomical area, or cadaveric tissue or a hyperbaric chamber. These deficiencies are made up for in the teachings of Markman, Joshi and Bogert.
The teachings of Markman, Joshi and Bogert are described supra.
Therefore, 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 have used the modified graft tissue of the ‘845 patent and to add multiple medicants such as oxygen through an array of needles/blades with delivery ports that were associated with a die (rendering obvious a base/mount) that is pressed to engage with the tissue and administered in a tissue graft wound and covered with a barrier/adhesive and the treated medicant condition is based on the anatomical area and to use cadaveric tissue and to treat the tissue in a hyperbaric chamber. Modified graft tissue, similar to those of the reference claims, are known from Markman, providing a clear link to the teachings regarding the grafts of Markman. The incorporation of each of the features listed above are described for tissue grafts by Markman. For instance, the delivery of medicants with needles/blades with delivery ports in known from Markman and thus an obvious means of administering medicants. It would be desirable to administer the medicants for the treatment of the tissue and the means of needles/blades is merely a known method of delivery and application of the tissue graft. The delivery of oxygen in particular is obvious as oxygen is necessary for tissue graft healing as it is involved in angiogenesis and may be delivered with microneedle arrays, as taught by Joshi. Further, treating tissue with hyperbaric oxygen is obvious as it is a means of killing harmful bacteria in the tissue before implantation, as taught by Bogert.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,246,697 in view of Markman (WO 2021/194817, published 30 Sep 2021), Joshi et al. (US 2009/0259171, published 15 Oct 2009), and Bogert (US 2004/0161362, published 19 Aug 2004).
The ‘697 patent recites a method for creating modified tissue grafts comprising steps of determining desired characteristics of the graft based on an anatomical site of a human and then modifying the tissue graft (claim 1) which may be human tissue (claim 2) and the graft is implanted at the anatomical site (claim 14) and is configured for various medicants such as antibiotics (claim 3).
The ‘697 patent does not teach applying the medicants through a plurality of delivery devices with delivery ports or multiple medicants at different times or the delivery of oxygen or association of the delivery elements with a base/mount or a wound cover or cushion or extension/retraction of the delivery elements or needles/blades or association with a host prior to delivery or selection of the medicant based on the anatomical area, or cadaveric tissue or a hyperbaric chamber. These deficiencies are made up for in the teachings of Markman, Joshi and Bogert.
The teachings of Markman, Joshi and Bogert are described supra.
Therefore, 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 have used the modified graft tissue of the ‘697 patent and to add multiple medicants such as oxygen through an array of needles/blades with delivery ports that were associated with a die (rendering obvious a base/mount) that is pressed to engage with the tissue and administered in a tissue graft wound and covered with a barrier/adhesive and the treated medicant condition is based on the anatomical area and to use cadaveric tissue and to treat the tissue in a hyperbaric chamber. Modified graft tissue, similar to those of the reference claims, are known from Markman, providing a clear link to the teachings regarding the grafts of Markman. The incorporation of each of the features listed above are described for tissue grafts by Markman. For instance, the delivery of medicants with needles/blades with delivery ports in known from Markman and thus an obvious means of administering medicants. It would be desirable to administer the medicants for the treatment of the tissue and the means of needles/blades is merely a known method of delivery and application of the tissue graft. The delivery of oxygen in particular is obvious as oxygen is necessary for tissue graft healing as it is involved in angiogenesis and may be delivered with microneedle arrays, as taught by Joshi. Further, treating tissue with hyperbaric oxygen is obvious as it is a means of killing harmful bacteria in the tissue before implantation , as taught by Bogert.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,701,213 in view of Markman (WO 2021/194817, published 30 Sep 2021), Joshi et al. (US 2009/0259171, published 15 Oct 2009), and Bogert (US 2004/0161362, published 19 Aug 2004).
The ‘213 patent recites a method for creating anatomically designed tissue grafts comprising steps of determining desired characteristics of the graft based on an anatomical site of a human and then modifying the tissue graft (claim 1) which may be cadaveric tissue (claim 15) and the graft is is configured for various medicants such as antibiotics (claim 6).
The ‘213 patent does not teach applying the medicants through a plurality of delivery devices with delivery ports or multiple medicants at different times or the delivery of oxygen or association of the delivery elements with a base/mount or a wound cover or cushion or extension/retraction of the delivery elements or needles/blades or association with a host prior to delivery or selection of the medicant based on the anatomical area, or a hyperbaric chamber. These deficiencies are made up for in the teachings of Markman, Joshi and Bogert.
The teachings of Markman, Joshi and Bogert are described supra.
Therefore, 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 have used the modified graft tissue of the ‘213 patent and to add multiple medicants such as oxygen through an array of needles/blades with delivery ports that were associated with a die (rendering obvious a base/mount) that is pressed to engage with the tissue and administered in a tissue graft wound and covered with a barrier/adhesive and the treated medicant condition is based on the anatomical area and to treat the tissue in a hyperbaric chamber. Modified graft tissue, similar to those of the reference claims, are known from Markman, providing a clear link to the teachings regarding the grafts of Markman. The incorporation of each of the features listed above are described for tissue grafts by Markman. For instance, the delivery of medicants with needles/blades with delivery ports in known from Markman and thus an obvious means of administering medicants. It would be desirable to administer the medicants for the treatment of the tissue and the means of needles/blades is merely a known method of delivery and application of the tissue graft. The delivery of oxygen in particular is obvious as oxygen is necessary for tissue graft healing as it is involved in angiogenesis and may be delivered with microneedle arrays, as taught by Joshi. Further, treating tissue with hyperbaric oxygen is obvious as it is a means of killing harmful bacteria in the tissue before implantation , as taught by Bogert.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,048,617 in view of Markman (WO 2021/194817, published 30 Sep 2021), Joshi et al. (US 2009/0259171, published 15 Oct 2009), and Bogert (US 2004/0161362, published 19 Aug 2004).
The ‘617 patent recites a method for creating medicated tissue grafts comprising steps of determining desired characteristics of the graft based on an anatomical site of a human and then modifying the tissue graft (claim 1) which may be human tissue (claim 10).
The ‘617 patent does not teach applying the medicants through a plurality of delivery devices with delivery ports or multiple medicants at different times or the delivery of oxygen or association of the delivery elements with a base/mount or a wound cover or cushion or extension/retraction of the delivery elements or needles/blades or association with a host prior to delivery or selection of the medicant based on the anatomical area, or cadaveric tissue or a hyperbaric chamber. These deficiencies are made up for in the teachings of Markman, Joshi and Bogert.
The teachings of Markman, Joshi and Bogert are described supra.
Therefore, 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 have used the modified graft tissue of the ‘617 patent and to add multiple medicants such as oxygen through an array of needles/blades with delivery ports that were associated with a die (rendering obvious a base/mount) that is pressed to engage with the tissue and administered in a tissue graft wound and covered with a barrier/adhesive and the treated medicant condition is based on the anatomical area and to use cadaveric tissue and to treat the tissue in a hyperbaric chamber. Modified graft tissue, similar to those of the reference claims, are known from Markman, providing a clear link to the teachings regarding the grafts of Markman. The incorporation of each of the features listed above are described for tissue grafts by Markman. For instance, the delivery of medicants with needles/blades with delivery ports in known from Markman and thus an obvious means of administering medicants. It would be desirable to administer the medicants for the treatment of the tissue and the means of needles/blades is merely a known method of delivery and application of the tissue graft. The delivery of oxygen in particular is obvious as oxygen is necessary for tissue graft healing as it is involved in angiogenesis and may be delivered with microneedle arrays, as taught by Joshi. Further, treating tissue with hyperbaric oxygen is obvious as it is a means of killing harmful bacteria in the tissue before implantation , as taught by Bogert.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 1-17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-16 of copending Application No. 18/826,107 in view of Markman (WO 2021/194817, published 30 Sep 2021), Joshi et al. (US 2009/0259171, published 15 Oct 2009), and Bogert (US 2004/0161362, published 19 Aug 2004).
The ‘107 application recites a method for medicating tissue grafts comprising steps using punches with tissue and associating secondary material with the tissue engaged with the punches (claim 8). The secondary material may be a medicant (claim 11) and oxygen (claim 12) and the tissue may be cadaveric tissue (claim 13).
The ‘107 application does not teach applying the medicants through a plurality of delivery devices with delivery ports or multiple medicants at different times or association of the delivery elements with a base/mount or a wound cover or cushion or extension/retraction of the delivery elements or needles/blades or association with a host prior to delivery or selection of the medicant based on the anatomical area, or a hyperbaric chamber. These deficiencies are made up for in the teachings of Markman, Joshi and Bogert.
The teachings of Markman, Joshi and Bogert are described supra.
Therefore, 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 have used the modified graft tissue of the ‘107 application and to add multiple medicants through an array of needles/blades with delivery ports that were associated with a die (rendering obvious a base/mount) that is pressed to engage with the tissue and administered in a tissue graft wound and covered with a barrier/adhesive and the treated medicant condition is based on the anatomical area and to use cadaveric tissue and to treat the tissue in a hyperbaric chamber. Modified graft tissue, similar to those of the reference claims, are known from Markman, providing a clear link to the teachings regarding the grafts of Markman. The incorporation of each of the features listed above are described for tissue grafts by Markman. For instance, the delivery of medicants with needles/blades with delivery ports in known from Markman and thus an obvious means of administering medicants. It would be desirable to administer the medicants for the treatment of the tissue and the means of needles/blades is merely a known method of delivery and application of the tissue graft. Further, treating tissue with hyperbaric oxygen is obvious as it is a means of killing harmful bacteria in the tissue before implantation , as taught by Bogert.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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, David Blanchard can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600