DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-3, 6, 8-9, 11-13, 15-18, 28, 34-36, 38, and 40-41 are pending and under examination in the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 6, 8-9, 11-13, 15-18, 28, and 34 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Regarding claims 1 and 17, they recite “a culture media comprising endothelial feeder cells, or parts thereof” and “a culture media that has been preconditioned with a feeder cell line of endothelial cells, or parts thereof”, respectively. The recitation of “parts thereof” creates ambiguity and renders the claim indefinite because it is unclear which parts of the endothelial cells are meant. Therefore, the metes and bounds of the claim cannot be determined. Claims 2-3, 6, 8-9, 11-13, 15-16, and 34 that directly or indirectly depend from claim 1 and claims 18 and 28 that depend from claim 17 are similarly rejected.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, 8-9, 12-13, 17, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (Lee et al., “Cryopreservation of porcine spermatogonial stem cells by slow-freezing testis tissue in trehalose”. J Anim Sci. 2014 Mar;92(3):984-95).
Regarding claims 1 and 17, Lee et al. teaches a method of enriching spermatogonial stem cells (SSCs) from a population of testis-derived cells containing at least one SSC, wherein the population of cells is derived from the testis of a livestock animal, the method comprising: contacting said population of testis-derived cells to a culture media comprising endothelial feeder cells, or parts thereof, and maintaining culture conditions suitable for SSC cell maintenance and enrichment (Proliferation Capacity, page 986, right column, last paragraph to page 987, left column, first paragraph).
Regarding claims 3: Following discussion of claim 1 above, Lee et al. further teaches that the feeder cells are yolk sac-derived endothelial cells (Proliferation Capacity, page 986, right column, last paragraph, line 4).
Regarding claims 8: Following discussion of claim 1 above, Lee et al. further teaches that the feeder cells are pre- treated with a mitosis inactivating agent, such as Mitomycin-C (Proliferation Capacity, page 986, right column, last paragraph, last line to page 987, left column, first paragraph, first line).
Regarding claim 9: Following discussion of claim 1 above, Lee et al. further teaches that the culture media further comprises glial cell-derived neurotrophic factor (GDNF) and human basic fibroblast growth factor (hbFGF) (Proliferation Capacity, page 986, right column, last paragraph).
Regarding claims 12: Following discussion of claim 1 above, Lee et al. further teaches isolating enriched SSCs from the culture media (Proliferation Capacity, page 987, left column, first paragraph).
Regarding claims 13: Following discussion of claim 1 above, Lee et al. further teaches that the SSCs are porcine SSC (page 984, Abstract, right column).
Regarding claim 34: Following discussion of claim 1 above, Lee et al. further teaches a population of enriched SSC produced by contacting a population of testis-derived cells to a culture media comprising endothelial feeder cells (Proliferation Capacity, page 986, right column, last paragraph to page 987, left column, first paragraph).
It is noted that claim 34 recites “a population of enriched SSC produced by the method of claim 1”. This is a product-by-process limitation that claims cells made by the method of claim 1 by contacting the population of testis-derived cells to a culture media comprising endothelial feeder cells. MPEP 2113 states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Claim(s) 1 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Lee et al. (Lee et al., “Cryopreservation of porcine spermatogonial stem cells by slow-freezing testis tissue in trehalose”. J Anim Sci. 2014 Mar;92(3):984-95) as evidenced by Haigh et al. (Haigh et al., “The fps/fes tyrosine kinase is expressed in myeloid, vascular endothelial, epithelial, and neuronal cells and is localized in the trans-golgi network”. Cell Growth Differ. 1996 Jul;7(7):931-44.).
Regarding claim 1, the teachings of Lee et al. are set forth in detail above.
Regarding claim 6, Lee et al. does not specifically teach that the feeder cells are characterized by expression of cytoplasmic tyrosine kinase encoded by a fes (fps/fes) oncogene. However, Haigh et al. provides evidence that the fps/fes tyrosine kinase is expressed in endothelial cells (Title and abstract). Therefore, expressing
cytoplasmic tyrosine kinase encoded by a fes (fps/fes) oncogene by the endothelial feeder cells is inherently and necessarily present in Lee et al. Accordingly, the mere recitation of its presence in the instant claims is not sufficient to distinguish the instant claims from prior art. “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent.” See MPEP 2112.01 or In re Best, 195 USPQ 430, 433 (CCPA 1997).
Claim(s) 1, 9, 11, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Lee et al. (Lee et al., “Cryopreservation of porcine spermatogonial stem cells by slow-freezing testis tissue in trehalose”. J Anim Sci. 2014 Mar;92(3):984-95) as evidenced by Ackermann et al. (Ackermann et al., “Pathologic Basis of Veterinary Disease” (Sixth Edition), Chapter 3. 2017. Inflammation and Healing. Endothelial Cell Growth Factors. Pages 1-2).
Regarding claims 1 and 9, the teachings of Lee et al. are set forth in detail above.
Regarding claims 11 and 16, Lee et al. teaches that the endothelial feeder cells comprise murine C166 cells (Proliferation Capacity, page 986, right column). Although Lee et al. does not specifically teach that the feeder cells express growth factors, such as DGF, NGF, and TGF-beta Ackermann et al. provides evidence that endothelial cells express growth factors, such as DGF, NGF, and TGF-beta (Abstract). Therefore, the culture media of Lee et al. comprising the endothelial feeder cells inherently and necessarily comprises growth factors such as DGF, NGF, and TGF. Accordingly, the mere recitation of its presence in the instant claims is not sufficient to distinguish the instant claims from prior art. “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent.” See MPEP 2112.01 or In re Best, 195 USPQ 430, 433 (CCPA 1997).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 8-9, 12-13, 15, 17-18, 28, 34-36, 38, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Lee et al., “Cryopreservation of porcine spermatogonial stem cells by slow-freezing testis tissue in trehalose”. J Anim Sci. 2014 Mar;92(3):984-95), in view of Oatley et al. (WO2013122864A1, filed on 02/11/2013).
Regarding claims 1, 3, 8-9, 12-13, 17, and 34, the teachings of Lee et al. are set forth in detail above.
Regarding claims 2 and 18: Following discussion of claim 1 above, Lee et al. fails to teach that the endothelial feeder cells are maintained in a layer in or on a gelatin coated culture surface.
However, Oatley et al. teaches a method of enriching spermatogonial stem cells (SSCs) from a population of testis-derived cells containing at least one SSC, said method comprising providing a media that has been preconditioned with a feeder cell line and contacting said population of testis-derived cells with said preconditioned media under conditions suitable for SSC cell maintenance and enrichment wherein the feeder cells are maintained in a layer in or on a gelatin coated culture surface (claim 1 of Oatley et al. and page 29, Creation of Bovine Somatic Cell (BSC) feeders). Oatley et al. further teaches that without such coating the cells do not attach to the plastic well and cannot be maintained long-term in culture (page 6, paragraph 1).
Therefore, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have maintained the endothelial feeder cells of Lee et al. in a layer on a gelatin coated culture surface with a reasonable expectation of success. One would have been motivated to have done so in order to improve cells adhesion to the cell culture surface and maintain them long-term in culture as taught by Oatley et al.
Regarding claim 15, Lee et al. further teaches that the SSCs are porcine SSC (page 984, Abstract, right column). Oatley et al. teaches that the culture media further comprises GDNF, FGF2, SDF-la, and CSF-1 (page 4, lines 22-26).
Regarding claim 28: Following discussion of claim 17 above, Lee et al. fails to teach removing the endothelial feeder cells from the preconditioned culture media prior to contacting preconditioned culture media to the population of testis-derived cells.
However, Oatley et al. teaches removing the feeder cells from the preconditioned culture media prior to contacting preconditioned culture media (claims 4 and 19 of Oatley et al.). Oatley et al. further teaches that the feeder free culture method allows for generation of a population of SSC cells that is free from contamination by feeder cells for use in in vitro fertilization and other aspects of commercial bovine production (page 16, lines 17-23).
Therefore, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have removed the endothelial feeder cells of Lee et al. from the preconditioned culture media prior to contacting preconditioned culture media with a reasonable expectation of success. One would have been motivated to have done so to allow for generation of a population of SSC cells that is free from contamination by feeder cells for use in in vitro fertilization and other aspects of commercial bovine production as taught by Oatley et al.
Regarding claim 35: Following discussion of claim 34 above, Oatley et al. teaches a method of generating at least one livestock animal progeny comprising administering a population of the enriched SSCs to a testis of a recipient male livestock animal, allowing said enriched SSCs to generate a colony of spermatogonia in said recipient male livestock animal, and mating said recipient male livestock animal with a female livestock animal of the same species as said recipient male livestock animal (claim 27 of Oatley et al. and page 4, lines 3-4).
Therefore, it would have been prima facie obvious to one of the ordinary skills in the art before the effective filing date of the claimed invention to have modified the method of enriching spermatogonial stem cells (SSCs) of Lee et al. and further administered the resulted enriched population of SSCs to a testis of a recipient male livestock animal, such as porcine, allowed said population to generate a colony of spermatogonia, and mated the male animal with a female livestock mammal of the same species as said recipient male livestock animal with a reasonable expectation of success. One would have been motivated to have done so in order to generate the desired livestock animal progeny as taught by Oatley et al.
Regarding claim 36: Following discussion of claim 35 above, Oatley et al. teaches that the population of enriched SSCs is administered to the lumen of a seminiferous tubule of said recipient male livestock animal (page 14, lines 30-32).
Regarding claim 38: Following discussion of claim 35 above, Lee et al. further teaches that the SSCs are porcine SSC (page 984, Abstract, right column). Also, Oatley et al. teaches that the SSCs are porcine cells and the recipient livestock animal and the female livestock animal are porcine animals (page 4, lines 3-4).
Regarding claim 41, Oatley et al. teaches a kit for maintaining spermatogonial stem cells (SSCs) in a feeder system comprises a culture system comprising a plurality of feeder cells and a medium suitable for SSC cell growth, an applicator, and instructional material, wherein said instructional material comprises instructions for the use of said kit to maintain the SSCs in the culture system (claim 32 of Oatley et al.).
Claim(s) 1, 34-35, and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (Lee et al., “Cryopreservation of porcine spermatogonial stem cells by slow-freezing testis tissue in trehalose”. J Anim Sci. 2014 Mar;92(3):984-95), in view of Oatley et al. (WO2013122864A1, filed on 02/11/2013), as evidenced by Sada et al. (Sada et al., “The RNA-binding protein NANOS2 is required to maintain murine spermatogonial stem cells. Science. 2009 Sep 11;325(5946):1394-8).
Regarding claims 1, and 34-35, the teachings of Lee et al. and Oatley et al. are set forth in detail above.
Regarding claim 40: Following discussion of claim 35 above, Oatley et al. teaches using certain or transgenically generated ("genetically") male-sterile bovines as recipients for donor sperm stem cells with which the animals also are immuno-compatible. Spermatogenesis in these animals is severely disrupted (page 15, lines 21-24).
Although Oatley et al. does not specifically teach that recipient male livestock animal is genetically modified to reduce or eliminate NANOS2 function, Sada et al. provides evidence that NANOS2 is a key stem cell regulator that is expressed in self-renewing spermatogonial stem cells and maintains the stem cell state during spermatogenesis (Abstract). Therefore, disrupting spermatogenesis in the transgenically generated ("genetically") male-sterile recipients, inherently and necessarily results into reducing or eliminating NANOS2 function. Accordingly, the mere recitation of its presence in the instant claims is not sufficient to distinguish the instant claims from prior art. “When the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent.” See MPEP 2112.01 or In re Best, 195 USPQ 430, 433 (CCPA 1997).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HANAN ISAM ABUZEINEH whose telephone number is (571)272-9596. The examiner can normally be reached Mon- Fri 8:30-5:00.
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Hanan Isam Abuzeineh
/H.I.A./Examiner, Art Unit 1633
/CHRISTOPHER M BABIC/Supervisory Patent Examiner, Art Unit 1633