Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-13 and 18-19 are under examination.
Response to Applicants Arguments/Amendments
The examiner has carefully considered applicants’ arguments and amendments. The 102/103 rejection with Hariri are maintained for the reasons stated below.
Election by Original Presentation
Newly submitted claim 20 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 20 recites an invention that is distinct from the previously examined set of claims. For example claim 20 encompasses a skin substitute that can include viable cells, isn’t necessarily dried, is protease treated and can be immunogenic which is very different from what was previously examined.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 20 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Applicants Remarks regarding the Election by Original Presentation
The following is applicants’ arguments for the election by original presentation in which claim 20 was withdrawn in the last round of prosecution.
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Applicants argue that claim 1 and claim 20 are so similar, there would be no search burden associated with rejoining claim 20. The examiner was not persuaded by applicants’ arguments for several reasons. Claim 1 involves treating using a dried, sterile nonviable skin substitute product. However, claim 20 can encompass treating a wound with living tissue that has been protease treated prior to administration. Such differences are very important and validate the examiner’s reasons for restricting the two groups. For example, dead skin substitutes provide cover protection and can provide support; however, skin substitutes composed of dead cells do not have cells that can further integrate and/or differentiate into the wound area. Therefore, the mechanisms of healing between the two method types (Claims 1 and 20) are distinct. Furthermore, claim 20 requires that the skin substitute is protease treated, which is not required in claim 1. Protease treatment can alter the structure of the skin substitute material, thus making clams 1 and 20 distinct. If the examiner had decided to carry out searches for both inventions, the examiner would have been forced to carry out searches that were different from one another. Although claim 6 mentions that the product can be protease treated, protease treatment is not mentioned in independent claim 1 which is the independent claim compared with independent claim 20 when making the decision to restrict. The decision to restrict is based on claim 1 not claim 6.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 1-5,7-13, and 18 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Hariri (WO2007009062)
Hariri discloses a method of treating a wound/diabetic ulcer (Paragraph 3), the method comprising applying to the wound a therapeutic product comprising a skin substitute (collagen biofabric derived from amnion and/or chorion) (Abstract, Paragraphs 6,23,115, 119) to at least a portion of a debrided wound (Paragraph 17), wherein the therapeutic product: is non-immunogenic (amnion/chorion is considered non-immunogenic). Hariri teaches that the product is dried (Paragraph 125), sterile (Claims 19, 24, 168,207-208), free of viable cells(drying and decellularization taught in paragraph 120 makes the cells non-viable); and releases collagen, laminin, and fibronectin after being applied to the wound (these components are naturally present in amnion/chorion and will be released after administration into a wound). Hariri further teaches that the collagen biofabric can be laminated to provide greater stiffness (Paragraph 140). Laminates can be created by stacking multiple collagen biofabric layers (Paragraphs 140-141 of Hariri). Paragraph 141 of Hariri states specifically, “if laminated prior to the initial drying, 2 or more collagen biofabric layers may be stacked one atop the other and subsequently dried using for example a freeze-drying process.” Hariri teaches debriding the wound before applying the therapeutic product to debrided wound (Paragraph 17).” The laminates are combined by freeze drying into one single layer of skin substitute (Paragraphs 140-141). There is no mention that necrotic tissue is left, so one would assume that debridement is complete and only healthy tissue remains. The goal of debridement is to remove all dead necrotic tissue in order to improve wound healing. as in instant Claims 1-3.
Dependent Claims taught by Hariri
Hariri discloses wherein the skin substitute is natively configured (a membrane of either amnion and/or chorion can be considered a native configuration; this is mentioned in paragraph 23) as in instant Claim 4. Hariri discloses wherein the therapeutic product does not include any one of amniotic membrane, chorionic membrane, and umbilical cord (Paragraph 23 does not state that umbilical cord material is present) as in instant Claim 5. Hariri discloses wherein the skin substitute is disinfected (Paragraphs 169-170 and 207) as in instant Claim 7. Hariri discloses wherein the material used can be the following size: collagen biofabric pieces used to treat a leg ulcer, particularly a venous leg ulcer, may be approximately 1 x 1 cm, 1.5 x 1.5 cm, 2 x 2 cm, 2.5 x 2.5 cm, 3 x 3 cm, 3.5 x 3.5 cm, 4 x 4 cm, 4.5 x 4.5 cm, 5 x 5 cm, 1 x 1.5 cm, 1 x 2 cm, 1 x 2.5 cm, 1 x 3 cm, 1 x 3.5 cm, 1 x 4 cm, 1 x 4.5 cm, 1 x 5 cm, 1.5 x 2 cm, 1.5 x 2.5 cm, 1.5 x 3 cm, 1.5 x 3.5 cm, 1.5 x 4 cm, 1.5 x 4.5 cm, 2 x 2.5 cm, 2 x 3 cm, 2 x 3.5 cm, 2 x 4 cm, 2 x 4.5 cm, 2 x 5 cm, 2.5 x 3 cm, 2.5 x 3.5 cm, 2.5 x 4 cm, 2.5 x 4.5 cm, 2.5 x 5 cm, 3 x 3.5 cm, 3 x 4 cm, 3 x 4.5 cm, 3 x 5 cm, 3.5 x 4 cm, 3.5 x 4.5 cm, 3.5 x 5 cm, 4 x 4.5 cm, 4 x 5 cm, 4.5 x 5 cm in size, or up to 6 x 8 cm in size, or may be no smaller, or no larger, than 1 x 1 cm, 1.5 x 1.5 cm, 2 x 2 cm, 2.5 x 2.5 cm, 3 x 3 cm, 3.5 x 3.5 cm, 4 x 4 cm, 4.5 x 4.5 cm, 5 x 5 cm, 1 x 1.5 cm, 1 x 2 cm, 1 x 2.5 cm, 1 x 3 cm, 1 x 3.5 cm, 1 x 4 cm, 1 x 4.5 cm, 1 x 5 cm, 1.5 x 2 cm, 1.5 x 2.5 cm, 1.5 x 3 cm, 1.5 x 3.5 cm, 1.5 x 4 cm, 1.5 x 4.5 cm, 2 x 2.5 cm, 2 x 3 cm, 2 x 3.5 cm, 2 x 4 cm, 2 x 4.5 cm, 2 x 5 cm, 2.5 x 3 cm, 2.5 x 3.5 cm, 2.5 x 4 cm, 2.5 x 4.5 cm, 2.5 x 5 cm, 3 x 3.5 cm, 3 x 4 cm, 3 x 4.5 cm, 3 x 5 cm, 3.5 x 4 cm, 3.5 x 4.5 cm, 3.5 x 5 cm, 4 x 4.5 cm, 4 x 5 cm, or 4.5 x 5 cm, though the biofabric may be cut to different dimensions (Paragraph 111) as in instant Claims 8-10. Hariri discloses wherein the therapeutic product is a single-use wound dressing (Paragraph 16) as in instant Claim 11. Hariri discloses wherein the wound is an ulcer (Paragraph 3) as in instant Claim 12. Hariri teaches wherein the ulcer is diabetic ulcer (Paragraph 3) as in instant Claim 13. Hariri discloses wherein the therapeutic product is applied as an implant (Paragraph 30 of Hariri) as in instant Claim 18.
The reference teaches the claim limitations
Response to Applicants Remarks regarding Hariri
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Applicants argue that Hariri state that its collagen biofabric can constitute one layer of collogen biofabric or a layer that is composed of laminated layers of collagen biofabric. Applicants’ specification does not define what a single layer skin substitute is. Therefore, it is permissible for one skin substitute layer to be composed of multiple laminate layers that are pulled together into a single layer format by freeze drying as indicated in paragraph 141. Furthermore, the claim language does not preclude the use of lamination. The biofabric itself can be considered a single layer even if it is composed of multiple laminated layers. The freeze-drying process taught in paragraph 141 of Hariri would combine multiple layers with freeze drying into one collagen biofabric layer that could then be used for treatment purposes.
There is no definition in the specification that particularly describes what a “single layer” of skin substitute can be composed specifically of. There is nothing that rules out the single layer being composed of multiple laminates that have been fused together with freeze drying. It would be helpful to better define what the layer of skin substitute is by adding details into the claims. The term “single layer of skin substitute” is very broad and can encompass a skin substitute where laminates have been fused together with freeze drying.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-3,5-7,11-13, and18-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Niklason (US 20090028817) in view of Soto (AU 2005202256)
Niklason teaches a method of treating wounds (Paragraphs 23-29 of Niklason), the method comprising applying to the wound a previously-frozen (Paragraph 81 of Niklason) therapeutic product comprising a single layer of skin substitute to at least a portion of the wound (Paragraphs 73,77,90 of Niklason), and wherein the therapeutic product is non-immunogenic (Paragraph 44 of Niklason): is dried (Paragraphs 81 and 90), sterile (Paragraph 12), and free of viable cells (Paragraph 64---Decellularization with protease destroys living cells); and releases collagen (Paragraph 2) when applied to the wound.
Niklason teaches that multiple extracellular matrix components can be used as dermal fillers in wound healing. Niklason does disclose that collagen can be used but does not expressly state that the extracellular components, laminin and/or fibronectin can be included. Soto teaches that extracellular materials used as fillers for skin support can include but are not limited to substances such as collagen, elastin, fibrin, fibrinogen, proteases, fibronectin, laminin, fibrellins, ground substances, and other similar proteins (Pages 75-76 of Soto). Page 77 of Soto even states that an entire isolated ECM can be successfully used as a filler material (Page 77, Paragraphs 1-2 of Soto) and a single layer injection can occur (Page 79, lines 15-26 of Soto). Page 18 of Soto states that such filler/repair materials can be added subsequent to a debridement process which inherently exposes healthy tissue (Pages 18-20 of Soto).
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have also included laminin and fibronectin in the extracellular matrix material used as extracellular matrix components. An artisan would have been motivated to have used such materials (laminin and fibronectin) because they provide additional support in filler material as taught by Soto (Pages 75-77). These materials (laminin and fibronectin) can be released into the wound site. There would be a high expectation for success since Soto teaches that extracellular matrix material can be used as filler material in various augmentation or repair procedures (Page 77, Paragraphs 1-2) as in instant Claims 1-3.
Dependent Claim taught by Niklason
Niklason teaches wherein the therapeutic product does not include any one of amniotic membrane, chorionic membrane, and umbilical cord (Abstract and Paragraphs 2-3) as in instant Claim 5. Niklason teaches wherein the skin substitute is protease treated prior to administration of the therapeutic product to the wound or portion thereof (Paragraph 64 of Niklason) as in instant Claim 6. Niklason teaches wherein the skin substitute is disinfected (Paragraph 81) as in instant Claim 7. Niklason teaches wherein the therapeutic product is a single-use wound dressing (Paragraphs 11 and 26 of Niklason) as in instant Claim 11.
Dependent Claims taught by Soto
Soto teaches wherein the therapeutic product is a single-use wound dressing (Pages 18-20 of Soto) as in instant Claim 11. Soto teaches the treatment of diabetic or pressure ulcers (Page 18) as in instant Claims 12-13. Soto teaches wherein the therapeutic product is applied as an implant (Page 56, lines 19-23) as in instant Claim 18. Soto teaches applying an additional one of the therapeutic products to at least a portion of the wound (Soto teaches that multiple administrations can occur—Page 79, lines 15-26) as in instant Claim 19.
Niklason teaches a method of treating a wound using a non-immunogenic, dried, sterile, free of viable cells product. Niklason does not teach that such a product can be protease treated and release laminin or fibronectin. However, Soto teaches that such a product can be decellularized using a protease; such a decellularization process with a protease produces a product that can serve as an adequate dermal support. Soto also teaches the inclusion of laminin and/or fibronectin (extracellular matrix components) in such a product to provide additional support. An artisan would have been motivated to have added such components since they provide additional support. Given the teachings of the cited references and the level of skill of an ordinarily skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinarily skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All the claimed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals, possessing advanced degrees, including M.D.s and Ph.Ds. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in wound care and biology. Therefore, the level of ordinary skill in this art is high.
Response to Arguments for Niklason and Soto
Applicants again argue that the references fail to teach the concept of a single-layer skin substitute. As argued above, the specification does not specify what a single layer skin substitute constitutes. A single layer skin substitute is not defined in the specification and there are no additional limitations that narrowly define what the single layer can or cannot be composed of.
Both the abstract and paragraph 2 of Niklason (US 20090028817) state that the composition can include isolated human collagen and elastin with a pharmaceutically acceptably carrier. The isolated human collagen and elastin can be considered single layer substitute. Nothing precludes the use of a carrier. The term single layer substitute is still very broad because there is no real definition in the specification defines what a single layer encompasses. There, the term can be broadly interpreted. Adding additional limitations could be used to distinguish it from the prior art.
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 1-5,7-13, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,5,8,12-13 of copending Application No.18/584,350 in view of Hariri (WO 2007009062).
Claim 1 of 18/584,350 is actually a species of instant Claim 1 because it is a type of non-immunogenic material (amniotic membrane, a spongy layer, and a chorionic layer) that is dried, and free of viable cells. Claim 1 of 18/584,350 mentions the presence of an amniotic membrane and a chorionic membrane which possess a native configuration; this corresponds to instant claim 4. Claim 1 of 18/584,350 also corresponds to instant claim 18 since it is implant material. Claim 2 of 18/584,350 does not require the presence of an umbilical cord which corresponds to instant claim 5. Claim 8 of 18/584,350 corresponds to instant claims 8-10. Claim 12 of 18/584,350 corresponds to instant claim 11. Claim 13 of 18/584,350 corresponds to instant claims 12 and 13.
The claims of 18/584,350 do not address the issue of debriding before treatment. However, Hariri teaches that ulcers can be debrided before treatment (Paragraph 17) as in instant Claims 1-3 and wherein the skin substitute is disinfected (Paragraphs 169-170 and 207) as in instant Claim 7. This is a provisional nonstatutory double patenting rejection.
Response to Applicants Remarks
Applicants argue that the double patenting rejection cannot be maintained because Hariri is not a valid reference. The validity of Hariri was explained above. Therefore, the double patenting rejection is not defective.
Conclusion
All claims stand rejected.
Applicants’ 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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