DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-5,7-8,12-13,19-22,24-25 are under examination.
Response to Applicants Arguments and Amendments
The examiner considered all of applicants remarks and amendments. The examiner addressed the remarks regarding the Hariri reference below the rejection. The rejections are still appropriate for teaching “wherein the placental product is not antibiotic-treated” Therefore, most of the rejections remain with the exception of the rejection involving Young. The examiner found that applicants’ argument against the Young reference to be persuasive. The examiner agrees with applicant that one would not be likely to apply protease antigen removal process taught in Young since Hariri already employs steps to remove unwanted antigens that were successful. Therefore, the rejection with Young is removed, but the other rejections are maintained.
Response to Applicants Instant Set of Claims
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 1-5,7-8,12-13,19-21,24-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Hariri (US 20070021704) in view of Daniel (US 20080046095)
Hariri teaches a method of treating a diabetic ulcer wound which is a type of skin/dermal wound (abstract of Hariri), the method comprising applying a biofabric product comprising an amniotic membrane (Paragraph 25 of Hariri) to at least a portion of the wound (diabetic ulcer—Abstract of Hariri), wherein the placental product is selectively depleted of immunogenicity (placental material is immunoprivileged and can also be freeze dried—paragraph 234 of Hariri), wherein the product is dried which would kill remaining cells (Paragraphs 25,34,215,304-333 of Hariri), and free of viable cells (decellularization and drying would kill the cells—paragraphs 7,34, and 211 of Hariri), and wherein the amniotic membrane releases collagen, laminin, and fibronectin after being applied to the diabetic ulcer wound (the amniotic membrane product used by Hariri is the same as the amniotic membrane product taught in the specification; therefore, it would be expected to release the same factors as applicants claimed amniotic membrane). Paragraph 48 of Hariri states that antibiotics are optional.
Hariri teaches that chorion membrane material can be included (Paragraph 25). However, Hariri does not expressly state that the amnion and chorion are left in their native configuration. Daniel teaches that chorion membrane material may be included in a wound healing preparation (Abstract, Paragraphs 8-11 of Daniel). Paragraph 48 of Daniel states that the chorion and the surrounding spongy layer are only dislodged if it is desirable to have a product with no chorion. Thus, Daniel teaches preservation of the natural configuration between the amnion membrane and the chorion membrane, maintaining the spongy layer. It would have been obvious to an artisan of ordinary skill in the art to have included amnion and chorion membrane biofabric maintained in their native arranged configuration in a therapeutic treatment as taught by Daniel. An artisan would have been motivated to have included both amnion and chorion tissue in their natural configuration because Daniel teaches that amnion and chorion tissue in their natural configuration can be used successfully as a graft treatment that promotes healing (Paragraphs 5,48, and 79 of Daniel). Because Daniel teaches that amnion and chorion tissue can be maintained in their natural configuration and used in a graft successful, there would have been a high expectation for success (Paragraph 48) as in instant Claims 1 and 20.
Daniel teaches that the amnion and chorion membranes can be included together. Keeping the chorion and amnion layers together would mean that the spongy layer remains intact (Abstract and Paragraph 48). The article snoasismedical.com biology is being used to show the inherent structures of both the amnion and the chorion.
https://www.snoasismedical.com/biology
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Daniel teaches incorporating the chorion membrane (Abstract, Paragraph 11) and snoasismedical.com/biology shows that the chorion membrane inherently encompasses a basement layer, a reticular layer, and a trophoblast layer. If the amniotic and chorionic membranes are kept together as taught by Daniel (Abstract, Paragraph 11), then the spongy intermediate layer remains intact as shown by the diagram directly above as in instant Claims 1, 21.
Dependent Claims taught by Hariri
Hariri teaches that the amniotic membrane can be included so this would also include the extracellular matrix that is native to the amniotic membrane (Paragraph 25, 5.2 Example 2, Paragraphs 339-350 of Hariri) as in instant Claim 3. Hariri teaches the product is less than 10 centimeters (cm) x 10 cm in size, 2 centimeters (cm) x 2 cm to 5 cm x 5 cm in size, or 5 centimeters (cm) x 5 cm in size and is 0.02 millimeters (mm) to 0.5 mm thick (Paragraph 200 of Hariri) as in instant Claim 8. Hariri teaches the product of Hariri is capable of being used once (Abstract of Hariri) as in instant Claim 12. Hariri teaches that the wound is a diabetic ulcer (Abstract of Hariri) as in instant Claim 13. Hariri teaches wherein the amniotic membrane comprises an epithelial cell layer, a basement layer, a compact layer, and a fibroblast layer (the entire amnion is used which would include all these layers) as in instant Claim 19. Hariri’s amniotic membrane (Paragraph 25) is the same product as taught in applicants’ specification; therefore, it would be expected to release the same factors as applicants claimed placental product as in instant Claim 20. Hariri teaches wherein the amniotic membrane undergoes a rinsing procedure which conveniently removes blood that is present (Paragraphs 293-294 of Hariri) as in instant Claim 24. Hariri teaches the extracellular matrix native to the amniotic membrane comprises platelet-derived growth factor (Paragraphs 8, 26, and 54 of Hariri) as in instant Claim 25.
Dependent Claims taught by Daniel
Daniel’s placental product does not include an umbilical cord (entire reference) as in instant Claim 2. Daniel teaches that a chorionic membrane can be included which would also include extracellular matrix native to the chorionic membrane (Paragraph 48) as in instant Claims 4. Daniel further teaches that a sterile decontamination/disinfection procedure may be performed (Paragraph 51-55 of Daniel) as in instant Claim 5. Daniel teaches wherein the placental product does not include residual blood (Paragraph 17 of Daniel) as in instant Claim 7.
Hariri teaches using collagen biofabric derived from placental material (amnion and chorion) to treat wounds such as ulcers. Although Hariri does state that amniotic membrane and chorion membrane material can be used in a collagen biofabric, Hariri does not expressly establish the configuration of the amnion and chorion in which the amniotic membrane and the chorionic membrane are in native configuration with the spongy layer positioned between the amniotic membrane and the chorionic membrane. However, an artisan would have been motivated to have used such a natural configuration because Daniel teaches that the amnion and chorion structures can be used together in their natural configuration to make a therapeutic graft material. Given the teachings of the cited references and the level of skill of an artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of 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 combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA 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.D.'s. 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 molecular biology, graft treatments, and placental implant material.
Response to Applicants Arguments
Applicants argue that the references previously cited in the rejections do not teach a placental product that is “not antibiotic treated.” Paragraph 48 of Hariri states that antibiotics are optional which means that antibiotics do not have to be present. Paragraph 48 of Hariri specifically states, “The collagen biofabric, or composite comprising collagen biofabric, may comprise an antibiotic…..” Therefore, paragraph 48 states that antibiotic use is optional and not required.
Applicants further argue that, “Hariri discloses a placental-derived collagen biofabric that is necessarily exposed to sodium deoxycholate, a compound with well-established bacterial-killing properties, and does not teach or suggest a placental product that is not antibiotic treated.” Applicants then provide evidence that sodium deoxycholate is indeed an antibiotic. Applicants then argue that sodium deoxycholate is present in the decellularization solutions.
The examiner does not find this argument persuasive because paragraph 210 of Hariri recites, “Preferably, the decellularization of the amniotic membrane comprises use of a detergent-containing solution, such as nonionic detergents, Triton X-100, anionic detergents, sodium dodecyl sulfate (sodium deoxycholate), any mild anionic detergent, i.e. non-caustic detergent with a pH of 6 to 8, and low foaming, can be used to decellularize the amniotic membrane. In a specific embodiment, 0.01-1% deoxycholic acid sodium salt monohydrate is used in the decellularization of the amniotic membrane.” The sodium dodecyl sulfate (sodium deoxycholate) is one option of several detergents that can be used in the decellularization solutions. Additional detergent options are listed above.
Claims 1-5,7-8,12-13,19-22,24-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Hariri (US 20070021704) in view of Daniel (US 20080046095) and Wang (US 20060228339)
Hariri and Daniel apply as above to teach claims 1-5,7-8,12-13,19-21, and 24-25. Neither Hariri or Daniel teach that the trophoblast layer is removed. Wang teaches removal of trophoblast layer (Paragraphs 86-87). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have removed the trophoblast layer as taught by Wang. An artisan would have been motivated to have removed the trophoblast layer because removing such a layer then allows the chorion membrane to be better able to seed and culture skin cells which are placed on the graft structure (Paragraph 86 of Wang). Because the removal of the trophoblast layer allows the graft to be better used for cell seeding, there would be a high expectation for success (Paragraph 86 of Wang) as in instant Claim 22.
Hariri teaches using collagen biofabric derived from placental material to treat wounds such as ulcers. Although Hariri does state that amniotic membrane and chorion membrane material can be used in a collagen biofabric, Hariri does not expressly establish the configuration of the amnion and chorion in which the amniotic membrane and the chorionic membrane are in native configuration with the spongy layer positioned between the amniotic membrane and the chorionic membrane. However, an artisan would have been motivated to have used such a natural configuration because Daniel teaches that the amnion and chorion structures can be used together in their natural configuration to make a therapeutic graft material. An artisan would have been further motivated to have removed the trophoblast layer from the chorion as taught by Wang in order to allow therapeutic cells to be seeded onto a surface of the graft material. Given the teachings of the cited references and the level of skill of an artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of 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 combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA 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.D.'s. 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 molecular biology, graft treatments, and placental implant material.
Arguments Against Wang
Applicants further argue that Wang fails to cure the deficiencies of Hariri and Daniel. Because Hariri and Daniel are not deficient as argued above, Wang is not defective.
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 1-4,8,12-13,19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,5,8-9,11-17 of copending Application No. 18/584,293 in view of Hariri (US 20070021704) and Daniel (US 20080046095)
Claim 1 of 18/584,293 states, “A method for treating a wound, the method comprising applying to the wound a therapeutic product comprising a skin substitute to at least a portion of a debrided wound, wherein the therapeutic product is immunoprivileged; is dried, sterile, and free of viable cells; and releases collagen, laminin, and fibronectin after being applied to the wound.” Claim 1 does not specifically state that the materials used to construct such graft material can be placental materials (amnion/chorion) materials as required by instant claims 1 and 19. However, Daniel and Hariri does state that graft membrane material can be constructed from decellularized amnion and/or chorion membrane material (Hariri Paragraph 25) and (Paragraphs 8-11 of Daniel) The amnion and chorion portions are not necessarily severed (Paragraph 48 of Daniel). Hariri further teaches that placental membrane material can be depleted of immunogenicity/immune cells, dried, free of viable cells, able to release important factors, cytokines, etc. Hariri teaches that antibiotics are optional. Therefore, the instant claims 1,3-4,19-22 limitations are taught by the combined teachings of claim 1 of Application 18/584,293 and the Hariri and Daniel references. Instant claim 2 corresponds to claim 5 of application 18/584,293. Instant claim 8 corresponds to claims 8-9 of Application 18/584,293. Instant claim 12 corresponds to claim 11 of Application 18/584,293. Instant claims 13 corresponds to claims 12-17 of Application 18/584,293. This is a provisional nonstatutory double patenting rejection.
Response to Argument Against the Double Patenting Rejection
Hariri and Daniel are used as secondary references. Applicant feels that the double patenting rejection is invalid because these references are defective. The double patenting rejection still remains because these references are not deficient in teaching the claim limitations. No terminal disclaimer has been received for 18/584,293. Therefore, the Double Patenting Rejection is maintained.
Conclusion
All claims stand rejected.
THIS ACTION IS MADE FINAL. 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
Prosecution Insights