DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The preliminary amendment of 11/4/2022 has been received and entered into the application file. Claims 21-27 are pending in the instant application, all of which have been considered on the merits.
Priority
Acknowledgement is made of the priority claims made in the 2/17/2023 ADS.
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21, 22 and 25 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Hariri et al (US 2004/0048796).
Hariri et al disclose collagen biofabrics made from amniotic membranes (See Hariri et al, ¶0037). The collagen biofabrics are produced by: processing placental membranes to separate the amnion from the chorion (See Hariri, ¶0080); decellularizing the amniotic membrane to remove substantially all cells (See Hariri et al, ¶0083); washing the decellularized amniotic membrane (See Hariri et al, ¶0093); drying the decellularized amniotic membrane, wherein the drying involves placing the amniotic membrane, fetal side down, onto a drying frame (See Hariri et al, ¶0104), and heat drying the amniotic membrane under vacuum (See Hariri et al, ¶0107). The result is a dehydrated amniotic membrane (See Hariri et al, ¶0107). The dehydrated collagen biofabric can then be placed in a sterile container, such as a peel pouch, and is sealed (See Hariri et al, ¶0100).
Hariri et al teach that laminates can be created by performing the above described method, but layering at least two of the decellularized amniotic membranes on each other, and then drying them together, to thereby form the laminate (See Hariri et al, ¶0115).
Hariri et al also teach that chorionic membrane may be used in the same manner as amniotic membrane (See Hariri et al, ¶0055, 0112). Thus Hariri et al teach use of chorionic membranes to form multi-layered laminates of chorionic membranes.
Regarding claim 21: The method of making multi-layered laminates of chorionic membranes is relied upon for this rejection. The multi-layered laminates of chorionic membranes are dehydrated tissue grafts.
The step of placing a first decellularized chorionic membrane on the drying frame reads on a) placing a first chorion tissue layer on a drying frame.
The step of layering at least one additional decellularized chorionic membrane on top of the first decellularized chorionic membrane reads on b) adding at least one additional chorion tissue layer to the first chorion tissue layer.
The step of drying the decellularized chorion tissue layers under vacuum reads on c) dehydrating the chorions so as to produce a dehydrated tissue graft.
The step of placing the dehydrated multi-layered laminate of chorionic membranes into a peel pouch reads on d) placing the dehydrated tissue graft in a package.
The step of sealing the peel pouch reads on e) sealing the package.
Regarding claim 22: At ¶0059, in discussing production of multi-layered laminates, Hariri et al teach that at least 6, at least 8, at least 10… at least 1000 amniotic membranes can be layered upon one another. This teaching is extendable to the production of multi-layered chorionic membranes. This is considered to read on wherein at least two or more additional layers of chorion are added during step b).
Regarding claim 25: Following the discussion of claim 21 above, the peel pouch reads on a pouch.
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 negatived by the manner in which the invention was made.
Claims 21-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hariri et al (US 2004/0048796).
The teachings of Hariri et al are set forth above. Hariri et al anticipates claims 21, 22 and 25. Regarding claims 23-34: Hariri et al teaches that the collagen biofabrics can be impregnated with one or more compounds or substances that are not part of the collagen matrix of the biofabric, including, inter alia, antibiotics, e.g. gentamycin. Hariri et al teach the compounds can be impregnated during production or during preparation for surgery (See Hariri et al, ¶0062).
Hariri et al differs from the instant claims in that they do not disclose with specificity that the antibiotic gentamycin can be impregnated to the collagen biofabric specifically prior to dehydration. However, selection of this timing for the impregnation step would have been at least prima facie obvious. The conclusion of obviousness is based on the obvious to try rationale. There are a finite number of steps during the processing of the collagen biofabrics. Contacting the biofabric with the antibiotic at any point in time during the production would have been expected to impregnate the antibiotic into the collagen biofabric. It would therefore have been obvious to contact the biofabric with the antibiotic prior to the dehydrating step, with a reasonable expectation that the contact would result in at least some level of impregnation of the antibiotic into the collagen biofabric. It has been held that "a person with ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." See KSR International Co. v Teleflex, Inc. 82 USPQ2d 1385 at 1390.
Claims 21-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hariri et al (US 2004/0048796), and further in view of Schankereli (US Patent 5782914).
The teachings of Hariri et al are set forth above. Hariri et al anticipates claims 21, 22 and 25 and renders obvious claims 23-24. Regarding claims 26-27: The sealed pouch of Hariri et al differs from the instant claims in that Hariri et al is silent as to whether the peel pouch contains an inner pouch, and wherein, following sealing the inner pouch, the sealed pouch is placed in an outer pouch, which is subsequently sealed.
Schankereli is cited for disclosure of moisture-proof sterilizing pouches which actually contain an inner and outer pouch, said inner pouch being nested within the outer pouch. The nested format facilitates sterile handling in an operating room (See Schankereli, col. 4, ln 33-41). Schankereli’s pouches are specifically designed for use with dehydrated transplantable tissue . The pouches are evacuated of oxygen (replaced with argon or nitrogen) to limit free radical formation (oxidation) of the tissue during sterilization process, thus inhibiting chemical and physical changes to the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22).
Given that both Hariri et al and Schankereli teach sealed containers for storage of dehydrated tissue grafts at room temperature, it would have been prima facie obvious to have substituted the double pouch of Schankereli for the peel pouch of Klen. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395. The double pouch of Schankereli reads on wherein the package is a pouch, wherein the pouch is an inner pouch, and then following sealing the dehydrated tissue in the inner pouch, the sealed pouch is placed in an outer pouch, which is subsequently sealed.
Claims 21-22 and 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klen (International Congress on Research in Burns, 1970), in view of Sulner et al (US 2007/0038298).
Klen teach preparation of placental tissue grafts for use on burns. Klen disclose a protocol comprising: obtaining a full placenta, placing the placenta with the side from which the umbilical cord protrudes face down in a basin, cutting radially from the edge of the placenta to cut out the umbilical cord stump (See Klen Pg. 289). The recovered material is understood to be a flat sheet of full thickness placenta (containing amnion, spongy layer/connective tissue layer, and chorion). Klen teach submerging the membranes into saline to wash away the majority of blood-clots, stretching the membranes onto strips of plastic net, covering the grafts by Tylexol, rolling up the grafts, inserting the rolled up grafts into vessels, plugging the vessels, filling the vessels with nitrogen, performing a primary freeze-drying (sublimation) step at -25o C, performing a secondary drying step by drying at a temperature of 39o C under vacuum, replacing vacuum with nitrogen, and sealing the bottles. The samples are storable at room temperature (See Klen, Pg. 290).
Klen also reference amnion, chorion and combined amnion-chorion grafts (See Klen, Pg. 289). Thus while the exemplified method of Klen is carried out on a full thickness placenta, Klen is also considered to disclose separation of amnion from chorion and separately processing each of these membranes in the same manner, individually. The embodiment of processing the individually, isolated chorion membrane of Klen is relied upon for the instant rejection:
Regarding claim 21: The method of Klen produces a dehydrated tissue graft. Applying the same processing methods to the chorion which has been separated from the amnion would yield a dehydrated chorion-only membrane. The method steps rendered obvious by Klen are comparable to the instant claims as follows:
The step of placing the chorion-only membrane on the strip of plastic net reads on a) placing a first chorion tissue layer on a drying fixture.
The step of subjecting the chorion-only membrane to the freeze-drying then drying under vacuum read on c) dehydrating the chorion[s] so as to produce a dehydrated tissue graft.
The steps of rolling up the grafts, and inserting the rolled up grafts into vessels reads on d) placing the dehydrated tissue graft in a package (the vessel reading on a package).
The step of plugging the vessels reads on e) sealing the package.
Klen differs from the method of the instant claims they do not add at least one additional chorion tissue layer onto the first chorion tissue layer.
However, Sulner et al, who is also directed to processing of placental membranes for formation of tissue grafting materials, teaches that multiple placental membrane (i.e. amnion and/or chorion) may be laminated together, and that lamination may provide greater stiffness and durability during the healing process (See Sulner et al, ¶0033).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art, at the time the invention was made to have layered multiple chorion-only grafts together on the plastic nets, covered the combination with Tylexol, and then dried the combination, thereby resulting in a dehydrated, multi-layered tissue graft comprising at least two layers of chorion tissue. The step of layering additional chorion-only membranes onto the first chorion membrane reads on b) adding at least one additional chorion tissue layer to the first chorion tissue layer. The motivation to do so is found in Sulner et al, who teaches that lamination provides greater stiffness and durability. One would have had a reasonable expectation of doing so because Klen teach how to produce chorion-only membranes, and layering multiple tissue layers over one another is well within the purview of the artisan of ordinary skill.
Regarding claim 22: Following the discussion of claim 21 above, in situations where at least three chorion membranes are provided together, provision of a third chorion tissue will read on b) adding at least two or more additional layers of chorion.
Regarding claim 25: Following the discussion of claim 21 above, the vessel can be considered to read on a pouch. The dictionary definition of “pouch” is “a bag of small or moderate size for storing or transporting goods” (See Merriam-Webster online dictionary “pouch”, IDS Ref #246). The broadest reasonable interpretation of this term will thus encompass any small or moderate size container (term “bag” is broadly interpreted as a container), it is not limited in terms of flexibility/rigidity or other structural features.
Claims 21-25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klen (International Congress on Research in Burns, 1970), in view of Sulner et al (US 2007/0038298), and further in view of Tseng (US Patent 6326019).
The teachings of Klen and Sulner are sets forth above. Klen, in view of Sulner et al, renders obvious claims 21, 22 and 25.
Regarding claims 23-24: Klen teaches rinsing a full thickness placenta in saline to remove the majority of blood clots. Klen further teaches that the tissue can be rehydrated in antibiotic solution at the point of use (See Klen, Pg. 290). Klen does not teach contacting the layered chorion tissues with at least one antibiotic prior to dehydration.
Tseng et al teach use of antibiotics in rinse solutions for rinsing blood clots off placental membranes. Specifically, Tseng et al teach use of antibiotic solutions comprising penicillin, streptomycin, neomycin, and amphotericin B. (See Tseng et al, col. 4, ln 60-col. 5, ln 1)
Given that the placental material of Klen is intended for use in humans and thus safety and reduction in bacterial load/contamination is always a priority, it would have been prima facie obvious as a matter of routine optimization to further have included antibiotics in the rinse solution used by Klen in preparation of the chorion-only membranes, in addition to the rehydration solution. The rationale for this conclusion of obviousness is that Tseng et al teach use of antibiotics in rinse solutions in preparation of placental membranes, and one would be motivated to optimize decontamination in order to ensure sterility of any products intended for surgical human use. By including an antibiotic solution in the rinse solution in the method of Klen the chorion layers would be contacted with at least one antibiotic, the antibiotic including streptomycin, prior to placing the chorion layers on the drying fixture, which is prior to step c).
Claims 21-22 and 25-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Klen (International Congress on Research in Burns, 1970), in view of Sulner et al (US 2007/0038298), and further in view of Schankereli (US Patent 5782914).
The teachings of Klen and Sulner are sets forth above. Klen, in view of Sulner et al, renders obvious claims 21, 22 and 25.
Regarding claims 25-27: Klen teach storing the dehydrated placental tissue in vessels (bottles). Under the broadest reasonable interpretation of the claim, the bottle can read on ‘an inner pouch’. However, substitution of alternative packaging known in the art to be suitable for containing tissue grafts would have been prima facie obvious.
Schankereli is cited for disclosure of moisture-proof sterilizing pouches which actually contain an inner and outer pouch, said inner pouch being nested within the outer pouch. The nested format facilitates sterile handling in an operating room (See Schankereli, col. 4, ln 33-41). Schankereli’s pouches are specifically designed for use with dehydrated transplantable tissue . The pouches are evacuated of oxygen (replaced with argon or nitrogen) to limit free radical formation (oxidation) of the tissue during sterilization process, thus inhibiting chemical and physical changes to the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22).
Given that both Klen and Schankereli teach deoxygenated containers for storage of dehydrated tissue grafts at room temperature, it would have been prima facie obvious to have substituted the double pouch of Schankereli for the bottles of Klen. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395. The double pouch of Schankereli reads on wherein the package is a pouch, wherein the pouch is an inner pouch, and then following sealing the dehydrated tissue in the inner pouch, the sealed pouch is placed in an outer pouch, which is subsequently sealed.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 8357403, in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows:
The patented claims are directed to a method of producing a multilayer placental tissue graft. The patented claims cover embodiments where the tissue graft comprises a first layer of modified amnion, and one or more additional layers, wherein the additional layers can be chorion (See patented claim 3 and 4). No limit is placed on the number of additional layers, thus provision of multiple chorion is included in the patent claim scope. Therefore the patented method covers embodiments wherein the multilayer laminate tissue graft comprises at least two (including at least three) layers of chorion.
Regarding claims 21-22 and 25-27: The patented method comprises providing the first and one or more additional layers together, mounting on a drying fixture, then dehydrating (see claim 9). Thus steps a)-c) are considered taught by the patented claims.
The patented claims do not specify placing the dehydrated graft in a package. However, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41).
It would therefore have been prima facie obvious to have packaged the dehydrated placental tissue grafts of the patented claims in the packaging of Schankereli for the purpose of protecting the dehydrated placental tissue grafts against oxidation and contamination during storage and/or transport to the facilities where the grafts will ultimately be used. The rationale for the conclusion of obviousness is that the sealed, deoxygenated pouch of Schankereli provides protection of the dehydrated tissue against oxidation, which would result in physical and/or chemical change to the tissue. This disclosed benefit provides a motivation to utilize the specific sealed, deoxygenated double pouch package of Schankereli. The double pouch package of Schankereli meets the limitations of claims 25-27.
Regarding claim 23: Patented claims 2-3 teaches contacting the amnion layer with antibiotic before dehydration. Though the patented claim doesn’t specify treating the chorion layers with antibiotic, it is considered to have been prima facie obvious to have performed the same treatment on each of the tissue layers provided in the graft.
Regarding claim 24: Official notice is taken that gentamycin and streptomycin are well-known antibiotics that would have been prima facie obvious choices for the antibiotic to use in the patented method.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9272003, in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows: The patented claims are directed to a method of producing a multilayer laminate placental tissue graft. The patented claims cover embodiments where the laminate comprises a first layer of chorion and one or more additional layers, wherein the additional layers can also be chorion (See patented claim 3 and 4). Therefore the patented method covers embodiments wherein the multilayer laminate tissue graft comprises at least two (including at least three) layers of chorion.
Regarding claims 21-22 and 25-27: The patented method comprises providing the first and one or more additional layers together, then dehydrating. Though the patented claims do not specify placing on a drying rack, this is considered to be prima facie obvious as the tissue layers require support. Thus steps a)-c) are considered taught by the patented claims.
The patented claims do not specify placing the dehydrated graft in a package. However, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41).
It would therefore have been prima facie obvious to have packaged the dehydrated placental tissue grafts of the patented claims in the packaging of Schankereli for the purpose of protecting the dehydrated placental tissue grafts against oxidation and contamination during storage and/or transport to the facilities where the grafts will ultimately be used. The rationale for the conclusion of obviousness is that the sealed, deoxygenated pouch of Schankereli provides protection of the dehydrated tissue against oxidation, which would result in physical and/or chemical change to the tissue. This disclosed benefit provides a motivation to utilize the specific sealed, deoxygenated double pouch package of Schankereli. The double pouch package of Schankereli meets the limitations of claims 25-27.
Regarding claim 23: Patented claim 2 teaches contacting the amnion layer with antibiotic before dehydration. Though the patented claim doesn’t specify treating the chorion layers with antibiotic, it is considered to have been prima facie obvious to have performed the same treatment on each of the tissue layers provided in the graft.
Regarding claim 24: Official notice is taken that gentamycin and streptomycin are well-known antibiotics that would have been prima facie obvious choices for the antibiotic to use in the patented method.
Claims 21, 22, and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9533011, in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows: The patented claims are directed to a method of producing a multilayer laminate placental tissue graft. The patented claims cover embodiments where the laminate comprises a first layer of modified amnion, a second layer of chorion, and one or more additional layers, wherein the additional layers can also be chorion (See patented claim 7). Therefore the patented method covers embodiments wherein the multilayer laminate tissue graft comprises at least two (including at least three) layers of chorion.
Regarding claims 21-22 and 25-27: The patented method comprises providing the first, second and additional layers together, then dehydrating. Though the patented claims do not specify placing on a drying rack, this is considered to be prima facie obvious as the tissue layers require support. Thus steps a)-c) are considered taught by the patented claims.
The patented claims do not specify placing the dehydrated graft in a package, nor specifically a package having the features of claims 25-27. However, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41).
It would therefore have been prima facie obvious to have packaged the dehydrated placental tissue grafts of the patented claims in the packaging of Schankereli for the purpose of protecting the dehydrated placental tissue grafts against oxidation and contamination during storage and/or transport to the facilities where the grafts will ultimately be used. The rationale for the conclusion of obviousness is that the sealed, deoxygenated pouch of Schankereli provides protection of the dehydrated tissue against oxidation, which would result in physical and/or chemical change to the tissue. This disclosed benefit provides a motivation to utilize the specific sealed, deoxygenated double pouch package of Schankereli. The double pouch package of Schankereli meets the limitations of claims 25-27.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 9533011, in view of Schankereli (US Patent 5782914), and further in view of Tseng (US Patent 6326019).
The teachings of US Patent 9533011 and Schankereli are set forth above and render obvious claims 21, 22, and 25-27.
Regarding claims 23-24: The claims of US Patent 9533011 do not further teach contacting the placental tissue layers, including the at least two chorions, with an antibiotic prior to dehydrating.
Tseng et al teach use of antibiotics in rinse solutions for rinsing blood clots off placental membranes. Specifically, Tseng et al teach use of antibiotic solutions comprising penicillin, streptomycin, neomycin, and amphotericin B. (See Tseng et al, col. 4, ln 60-col. 5, ln 1)
However, given that the patented method is producing a tissue graft intended for use with humans, safety and reduction in bacterial load/contamination is always a priority, it would have been prima facie obvious as a matter of routine optimization to further have contacting the placental layers, including the two chorion, with antibiotics during preparation. The rationale for this conclusion of obviousness is that Tseng et al teach use of antibiotics, including streptomycin, in rinse solutions in preparation of placental membranes, and one would be motivated to optimize decontamination in order to ensure sterility of any products intended for surgical human use.
Claims 21, 22, and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9186382, in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows:
The patented claims are directed to a method of producing a multilayered placental tissue graft. The patented claims cover embodiments where the graft comprises at least two layers of chorion. Therefore the patented method covers embodiments wherein the multilayer tissue graft comprises at least two (including at least three) layers of chorion.
Regarding claims 21-22 and 25-27: The patented method comprises providing the multiple layers of chorion, then dehydrating and freeze-drying to produce the tissue graft. Though the patented claims do not specify placing on a drying rack, this is considered to be prima facie obvious as the tissue layers require support. Thus steps a)-c) are considered taught by the patented claims.
The patented claims do not specify placing the dehydrated graft in a package, nor specifically a package having the features of claims 25-27. However, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41).
It would therefore have been prima facie obvious to have packaged the dehydrated placental tissue grafts of the patented claims in the packaging of Schankereli for the purpose of protecting the dehydrated placental tissue grafts against oxidation and contamination during storage and/or transport to the facilities where the grafts will ultimately be used. The rationale for the conclusion of obviousness is that the sealed, deoxygenated pouch of Schankereli provides protection of the dehydrated tissue against oxidation, which would result in physical and/or chemical change to the tissue. This disclosed benefit provides a motivation to utilize the specific sealed, deoxygenated double pouch package of Schankereli. The double pouch package of Schankereli meets the limitations of claims 25-27.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9186382, in view of Schankereli (US Patent 5782914), and further in view of Tseng (US Patent 6326019).
The teachings of US Patent 9186382 and Schankereli are set forth above and render obvious claims 21, 22, and 25-27.
Regarding claims 23-24: The claims of US Patent 9186382 do not further teach contacting the placental tissue layers, including the at least two chorions, with an antibiotic prior to dehydrating.
Tseng et al teach use of antibiotics in rinse solutions for rinsing blood clots off placental membranes. Specifically, Tseng et al teach use of antibiotic solutions comprising penicillin, streptomycin, neomycin, and amphotericin B. (See Tseng et al, col. 4, ln 60-col. 5, ln 1)
However, given that the patented method is producing a tissue graft intended for use with humans, safety and reduction in bacterial load/contamination is always a priority, it would have been prima facie obvious as a matter of routine optimization to further have contacting the placental layers, including the two chorion, with antibiotics during preparation. The rationale for this conclusion of obviousness is that Tseng et al teach use of antibiotics, including streptomycin, in rinse solutions in preparation of placental membranes, and one would be motivated to optimize decontamination in order to ensure sterility of any products intended for surgical human use.
Claims 21, 22, and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9433647, in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows:
The patented claims are directed to a method of producing a multilayered placental tissue graft. The patented claims cover embodiments where the graft comprises at least two layers of chorion (see patented claim 5). Therefore the patented method covers embodiments wherein the multilayer tissue graft comprises at least two (including at least three) layers of chorion.
Regarding claims 21-22 and 25-27: The patented method comprises providing the multiple layers of placental tissue graft, which can be chorion, placing the layers of placental tissue graft onto a drying fixture, then drying the graft.
The patented claims do not specify placing the dehydrated graft in a package, nor specifically a package having the features of claims 25-27. However, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41).
It would therefore have been prima facie obvious to have packaged the dehydrated placental tissue grafts of the patented claims in the packaging of Schankereli for the purpose of protecting the dehydrated placental tissue grafts against oxidation and contamination during storage and/or transport to the facilities where the grafts will ultimately be used. The rationale for the conclusion of obviousness is that the sealed, deoxygenated pouch of Schankereli provides protection of the dehydrated tissue against oxidation, which would result in physical and/or chemical change to the tissue. This disclosed benefit provides a motivation to utilize the specific sealed, deoxygenated double pouch package of Schankereli. The double pouch package of Schankereli meets the limitations of claims 25-27.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 9433647, in view of Schankereli (US Patent 5782914), and further in view of Tseng (US Patent 6326019).
The teachings of US Patent 9433647 and Schankereli are set forth above and render obvious claims 21, 22, and 25-27.
Regarding claims 23-24: The claims of US Patent 9433647 do not further teach contacting the placental tissue layers, including the at least two chorions, with an antibiotic prior to dehydrating.
Tseng et al teach use of antibiotics in rinse solutions for rinsing blood clots off placental membranes. Specifically, Tseng et al teach use of antibiotic solutions comprising penicillin, streptomycin, neomycin, and amphotericin B. (See Tseng et al, col. 4, ln 60-col. 5, ln 1)
However, given that the patented method is producing a tissue graft intended for use with humans, safety and reduction in bacterial load/contamination is always a priority, it would have been prima facie obvious as a matter of routine optimization to further have contacting the placental layers, including the two chorion, with antibiotics during preparation. The rationale for this conclusion of obviousness is that Tseng et al teach use of antibiotics, including streptomycin, in rinse solutions in preparation of placental membranes, and one would be motivated to optimize decontamination in order to ensure sterility of any products intended for surgical human use.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9463207, in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows:
The patented claims are directed to a method of producing a multilayered placental tissue graft. The patented claims cover embodiments where the graft comprises at least two layers of chorion. Therefore the patented method covers embodiments wherein the multilayer tissue graft comprises at least two (including at least three) layers of chorion.
Regarding claims 21-22 and 25-27: The patented method comprises providing the multiple layers of placental tissue graft, which can be chorion, placing the layers of placental tissue graft onto a drying fixture, then drying the graft.
The patented claims do not specify placing the dehydrated graft in a package, nor specifically a package having the features of claims 25-27. However, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41).
It would therefore have been prima facie obvious to have packaged the dehydrated placental tissue grafts of the patented claims in the packaging of Schankereli for the purpose of protecting the dehydrated placental tissue grafts against oxidation and contamination during storage and/or transport to the facilities where the grafts will ultimately be used. The rationale for the conclusion of obviousness is that the sealed, deoxygenated pouch of Schankereli provides protection of the dehydrated tissue against oxidation, which would result in physical and/or chemical change to the tissue. This disclosed benefit provides a motivation to utilize the specific sealed, deoxygenated double pouch package of Schankereli. The double pouch package of Schankereli meets the limitations of claims 25-27.
Regarding claim 23: Patented claim 2 teaches contacting the amnion layer with antibiotic before dehydration. Though the patented claim doesn’t specify treating the chorion layers with antibiotic, it is considered to have been prima facie obvious to have performed the same treatment on each of the tissue layers provided in the graft.
Regarding claim 24: Official notice is taken that gentamycin and streptomycin are well-known antibiotics that would have been prima facie obvious choices for the antibiotic to use in the patented method.
Claims 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-18 of U.S. Patent No. 10874697, in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows:
The patented claims are directed to a method of producing a multilayered placental tissue graft. The patented claims cover embodiments where the graft comprises at least one layer of modified amnion and at least one additional layer. The at least one additional layer can be chorion (see claim 17). Therefore the patented method covers embodiments wherein the multilayer tissue graft comprises at least two (including at least three) layers of chorion in addition to the modified amnion layer.
Regarding claims 21-22 and 25-27: The patented method comprises providing the multiple layers of placental tissue graft, which can be chorion, placing the layers of placental tissue graft onto a drying fixture, then drying the graft.
The patented claims do not specify placing the dehydrated graft in a package, nor specifically a package having the features of claims 25-27. However, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41).
It would therefore have been prima facie obvious to have packaged the dehydrated placental tissue grafts of the patented claims in the packaging of Schankereli for the purpose of protecting the dehydrated placental tissue grafts against oxidation and contamination during storage and/or transport to the facilities where the grafts will ultimately be used. The rationale for the conclusion of obviousness is that the sealed, deoxygenated pouch of Schankereli provides protection of the dehydrated tissue against oxidation, which would result in physical and/or chemical change to the tissue. This disclosed benefit provides a motivation to utilize the specific sealed, deoxygenated double pouch package of Schankereli. The double pouch package of Schankereli meets the limitations of claims 25-27.
Regarding claim 23: Patented claim 14 teaches contacting the amnion layer with antibiotic before dehydration. Though the patented claim doesn’t specify treating the chorion layers with antibiotic, it is considered to have been prima facie obvious to have performed the same treatment on each of the tissue layers provided in the graft.
Regarding claim 24: Official notice is taken that gentamycin and streptomycin are well-known antibiotics that would have been prima facie obvious choices for the antibiotic to use in the patented method.
Claims 21, 22, and 25-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 7-8 of U.S. Patent No. 9265800;
claims 7-8 of U.S. Patent No. 9272005;
claims 1-11 of U.S. Patent No 11504449;
claims 9-11 of U.S. Patent No 8642092;
each optionally in view of Schankereli (US Patent 5782914).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims render obvious the instant claims as follows:
The patented claims are to a dehydrated, multilayered placental tissue graft, wherein the placental tissue graft comprises at least two layers of chorion membrane, and wherein the dehydrated placental tissue graft is sealed in a package. The patented claims are effectively related to the current claims as product and methods of making said product.
Regarding claims 21, 22 and 25: The claimed steps (placing the first, and then second or subsequent chorion layers upon one another on a drying rack, then dehydrating, then placing in a package and sealing) would be prima facie obvious, if not inherent steps required to produce the claimed grafts. In all patents, the sealed package reads on a pouch.
Regarding claims 25-27: US Patent 11504449 teaches the packaging to have the same construction as required by the instant claims. For the remaining patents, Schankereli disclose moisture-proof sterilizing packaging for dehydrated tissue grafts, said packaging comprising an inner and out pouch, wherein the inner pouch is evacuated of oxygen (replaced with argon or nitrogen) to limit oxidation of the tissue which thus inhibits chemical and physical change of the tissue (See Schankereli, col. 3, ln 57-col. 4, ln 22 & col. 4, ln 33-41). It would have been prima facie obvious to have substituted the double pouch of Schankereli for the bottles of Klen. Substitution of one element for another known in the field is considered to be obvious, absent a showing that the result of the substitution yields more than predictable results. See KSR International Co. v Teleflex Inc 82 USPQ2d 1385 (US 2007) at page 1395. The double pouch of Schankereli reads on wherein the package is a pouch, wherein the pouch is an inner pouch, and then following sealing the dehydrated tissue in the inner pouch, the sealed pouch is placed in an outer pouch, which is subsequently sealed.
Conclusion
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/ALLISON M FOX/ Primary Examiner, Art Unit 1633