DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-2,4-18, and 53 are under examination.
Response to Applicants Arguments
In the past office action, dated November 26, 2025, the examiner included a written description rejection because examiner was concerned that in the claims the recited factors released by the claimed acellular amnion membrane graft were not actually present in an amnion membrane composed of non-viable cells. Applicants provided an argument with evidence showing that at least some of the factors were preserved in acellular material. Because of the evidence and arguments presented by applicants, the examiner decided to withdraw the written description rejection.
Since these factors are inherently present in acellular amnion membrane material, they should also be present in other amnion membrane graft material created by other artisans. Therefore, the examiner is putting forth new rejections with a new reference, Tseng. The primary reference in the rejections, Tseng, discloses an acellular amniotic membrane graft which inherently releases the same factors as applicants’ acellular amniotic membrane graft material. With the exception of Tseng, the other references in the rejections are already of record.
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 1-2,4-5,10 and 53 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Tseng (US 6,326,019).
Tseng teaches a method of repairing a tendon or joint in need of repair, the method comprising applying a product comprising an amniotic membrane to at least a portion of joint or tendon, wherein the amniotic membrane comprises an epithelial cell layer, a basement layer, and a stromal layer (these layers are inherently present in amniotic membrane), wherein the product does not include a chorionic membrane, wherein the product does not contain viable cells (Abstract; Column 7, lines 1-15 of Tseng). Because the amniotic membrane of Tseng is composed of dead cells like applicants’ amniotic membrane recited in the claims, it would also inherently have the properties of: having less than 12.5 pg/cm2 endogenous TNF-alpha, and wherein the amniotic membrane releases endogenous tissue inhibitor of matrix metalloproteinase 2 (TIMP-2), hepatocyte growth factor (HGF), and transforming growth factor-beta 1 (TGF-β1) after being applied to the portion of joint or tendon (Abstract, Col 7, ln 14-15) as in instant Claim 1. An intact amniotic membrane also contains a compact layer, a fibroblast layer, and a spongy layer, releases IGF-1 after being applied to the portion of joint and tendon, is composed of extracellular matrix native to the amniotic membrane, the membrane is immunoprivileged, and the amniotic membrane comprises less than 6.25 pg/cm2 of endogenous TNF-alpha (Tseng, Abstract) as in instant Claims 2,4-5,10,53.
The reference anticipates the claim limitations.
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 1-2,4-10, and 53 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tseng (US 6,326,019) in view of Hariri (US 20070021704).
Tseng (US 6,326,019) applies as above to teach claims 1-2,4-5,10 and 53. Tseng does not teach the appropriate dimension of amniotic membrane graft material to treat wounds/injuries. However, Hariri teaches amniotic membrane graft material is less than 10 centimeter (cm) x 10 cm in size (Paragraph 200 of Hariri) as in instant Claim 6. Hariri teaches wherein the product is 2 centimeter (cm) x 2 cm to 5 cm x 5cm in size (Paragraph 200 of Hariri) as in instant Claim 7.The Hariri reference in paragraph 200 states that the amniotic membrane graft material can be cut to different dimensions as needed; therefore, it would have been obvious to have cut the material to a dimension of 5 cm to 5 cm in size as in instant Claim 8. Hariri teaches wherein the product is 0.02 millimeter (mm) to 0.5 mm thick (Paragraphs 36 and 210 of Hariri) as in instant Claim 9. Hariri teaches wherein the product is immunoprivileged (placental/amniotic membrane is considered immunoprivileged) as in instant Claim 10.
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the size dimensions taught by Hariri. An artisan would have been motivated to have used the dimensions taught by Hariri because Hariri teaches appropriate sizes of amniotic membrane graft materials that can be used to treat wounds/damaged areas (Paragraphs 36,200, and 210 of Hariri). Because amniotic membrane grafts can be successfully created with these dimensions, there would be a high expectation for success (Paragraphs 36, 200, and 210 of Hariri).
Tseng teaches a method of treating joints/tendons with amniotic membranes having non-viable cells. Hariri teaches the claimed dimensions of amniotic membrane grafts that can be successfully used to treat wounds/injured areas. Because amniotic membrane can be successfully fashioned to the sizes and types of grafts taught by Hariri, an artisan would have been motivated to have used such graft sizes to successfully treat tendons and joints as taught in Tseng. Given the teachings of the cited references and the level of skill of an ordinary skilled 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 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 without 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 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.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, cell culture, and graft repair. Therefore, the level of ordinary skill in this art is high.
Claims 1-2,4-5,10-14,16,18, and 53 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tseng (US 6,326,019) in view of Sackier (WO 8907425).
Tseng (US 6,326,019) applies as above to teach claims 1-2,4-5,10 and 53. Tseng fails to teach how the amniotic membrane is applied/administered to the joints, and tendons as recited in the claims. Sackier teaches that amniotic graft material can be used to treat tendons and joint and provides more specific methods of administering the grafts to treat tendons and joints (Pages 14,18 and 21 of Sackier).
Sackier teaches wrapping tendons with amnion graft material (Page 21 of Sackier) as in instant Claim 11. Sackier teaches that such a wrapping process taught in Page 21 would inherently envelop at least a portion of the tendon in the amnion (Page 21 of Sackier) as in instant Claim 12. Sackier teaches that sheets of amnion graft material have been sutured in damaged regions (Page 18, In 27-30) as in instant Claim 13. Sackier teaches that this composition can be used in order to repair a ruptured/torn tendon (Page 14, 1st paragraph) as in instant Claim 14. Sackier teaches where the tendon is an Achilles tendon (Page 13, bottom paragraph) as in instant Claim 16. Sackier teaches wherein the method of repairing is a surgical procedure selected from knee surgery (Page 13, bottom paragraph ) as in instant Claim 18.
Tseng teaches that its amniotic membrane can be successfully used to treat tendon injury/damage. An artisan would have been motivated to have used such methods of application/administration taught by Sackier because Sackier teaches that amniotic membrane can be successfully applied to tendons in those manners as recited in the instant claims. Because Sackier teaches that such methods of administrations to tendons can be used to successfully treat damage in those regions, there would be a high expectation for success. Given the teachings of the cited references and the level of skill of an ordinary skilled 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 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 without 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 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.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, cell culture, and graft repair. Therefore, the level of ordinary skill in this art is high.
Claims 1-2,4-5,10,15, and 53 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tseng (US 6,326,019) in view of Papadaki “Promises and Challenges in Tissue Engineering” Cellular/Tissue Engineering IIEE Engineering in Medicine and Biology Jan/February 2001.
Tseng (US 6,326,019) applies as above to teach claims 1-2,4-5,10 and 53. Tseng teaches that its acellular amniotic membrane graft material can be used to treat tendons and joints. Tseng fails to teach that acellular amniotic membrane grafts can treat an anterior cruciate ligament. However, Papadaki teaches that anterior cruciate ligaments can be successfully treated using acellular graft materials (Page 117, right side of Papadaki). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the product of Tseng to treat anterior cruciate ligaments. An artisan would have been motivated to have used Tseng’s acellular graft material to treat anterior cruciate ligaments since Papadaki teaches that anterior cruciate ligament can be treated using acellular graft material (Page 117, right side of Papadaki). Because acellular graft material can be used to treat anterior cruciate ligament and Tseng’s amniotic membrane is an acellular graft product, there would have been a high expectation for success. (Page 117, right side of Papadaki) as in instant Claim 15.
Tseng teaches a method of treating joints/tendons with amniotic membranes having non-viable cells (acellular grafts). Although Tseng does not state that its amniotic membrane can be used successfully to treat anterior cruciate ligament, an artisan would have been strongly motivated to have used Tseng’s acellular amniotic membrane graft to treat anterior cruciate ligaments since Papadaki teaches that acellular graft material can be used to treat anterior cruciate ligaments. Given the teachings of the cited references and the level of skill of an ordinary skilled 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 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 without 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 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.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, cell culture, and graft repair. Therefore, the level of ordinary skill in this art is high.
Claims 1-2,4-5,10-14, and 16-18 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tseng (US 6,326,019) in view of Sackier (WO 8907425) and Michalow (US 20060111778)
Tseng (US 6,326,019) and Sackier apply as above to teach claims 1-2,4-5,10-14,16,18, and 53. The graft material of Tseng is acellular. Tseng does not teach that its acellular graft material can be used to treat cartilage and/or femoral condyle cartilage specifically. Sackier teaches that amnion graft material can treat cartilage (Abstract of Sackier), and Michalow teaches that femoral condyle cartilage can be successfully treated using graft material (Paragraph 67 of Michalow).
It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used Tseng’s acellular graft material to treat femoral condyle cartilage. An artisan would have been motivated to have treated the femoral condyle cartilage region with the product taught by Tseng because treatment of such a region by graft material was known in the art as taught by Michalow (Paragraph 67 of Michalow) and Sackier teaches that amnion graft material can treat cartilage (Abstract of Sackier). Because Michalow teaches that femoral condyle cartilage can be treated with grafts, there would have been a high expectation for success (Paragraph 67 of Michalow) as in instant Claim 17.
Tseng teaches acellular amniotic membrane graft material that can be used to treat damaged areas. It would have been obvious to an artisan of ordinary skill in the art to have applied the acellular amniotic membrane of Tseng to cartilage. Sackier teaches that amnion graft material can be applied to treat cartilage. Michalow further states that a more specific region of cartilage (the femoral condyle cartilage region) can be successfully treated/repaired with graft material. Given the teachings of the cited references and the level of skill of an ordinary skilled 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 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 without 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 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.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, cell culture, and graft repair. Therefore, the level of ordinary skill in this art is high.
Conclusion
All claims stand rejected.
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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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
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