DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 34-38 and 44-51 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim 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.
Claim 34 recites the limitations “PBMCs”, “a subject”, and “an immune system influencing event” while clause (a) of parent claim 33 recites “PBMCs”, “a subject”, and “an immune system influencing event”. It is unclear whether the PBMCs, subject, and immune system influencing event of claim 34 is intended to be the same as that of claim 33.
Claim 35 recites the limitations “PBMCs”, “a subject”, and “an endocrine system influencing event” while clause (a) of parent claim 33 recites “PBMCs”, “a subject”, and “an endocrine system influencing event”. It is unclear whether the PBMCs, subject, and endocrine system influencing event of claim 35 is intended to be the same as that of claim 33.
Claim 36 recites the limitations “PBMCs” and “a subject” while parent claim 33 recites “PBMCs” and “a subject”. It is unclear whether the PBMCs and subject of claim 36 are intended to be the same as that of claim 33.
Claim 37 recites “a subject” while parent claim 33” recites “a subject”. It is unclear whether the subject is intended to be the same.
Claim 38 recites “a culture medium” and “human chorionic gonadotrophin or an HCG equivalent” while parent claim 33 recites “a culture medium and “human chorionic gonadotrophin or an HCG equivalent”. It is unclear whether applicant intends to reference the same culture medium and HCG or its equivalent in the claims.
Claim 44 recites “the patient” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 46 recites “a patient” while parent claim 45 recites “a patient”. It is unclear whether applicant intends to reference the same patient.
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 33, 35, 36, 37, 40, 42, and 44-51 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Yoshioka et al. “Intrauterine administration of autologous peripheral blood mononuclear cells promotes implantation rates in patients with repeated failure of IVF-embryo transfer.” Human Reproduction, vol. 21, no. 12, 2006, p. 3290-3294.
Regarding claim 33, Yoshioka teaches a method of producing a peripheral blood mononuclear cell ("PBMC") composition suitable for repairing or engineering a tissue (abstract) comprising:
(a) obtaining PBMCs from the blood of a patient at least two months after an immune-system influencing event or at least two months after an endocrine system influencing event (four or more failures of IVF-embryo transfer, “subjects”, pg. 3291; “preparation and intrauterine administration of PBMC”, p. 3291),
(b) culturing the PBMCs in a culture medium, which contains human chorionic gonadotrophin or an HCG equivalent, for a time sufficient to produce PMBCs that enhance growth when contacted with a tissue in need of repair or engineering in comparison to PBMCs not obtained or cultured according to (a) and (b) (abstract; hCG, “preparation and intrauterine administration of PBMC”, p. 3291; “clinical outcome” Table II; “results”, pg. 3291).
Regarding claim 35, Yoshioka et al. teaches the immune-system-influencing event or the endocrine-system-influencing event comprises hormonal treatment, controlled ovary stimulation, or oocyte retrieval during a cycle of in vitro fertilization (IVF) treatment (four or more failures of IVF-embryo transfer, “subjects”, pg. 3291).
Regarding claim 36, Yoshioka et al. teaches (a) comprises obtaining PBMCs from the blood of a subject at least two months after a dysfunction of the female reproductive tract (four or more failures of IVF-embryo transfer, “subjects”, pg. 3291).
Regarding claim 37, Yoshioka et al. teaches the PBMCs are obtained from the blood of a subject in need of tissue repair (abstract; hCG, “preparation and intrauterine administration of PBMC”, p. 3291; “clinical outcome” Table II; “results”, pg. 3291).
Regarding claim 40, Yoshioka teaches the HCG or HCG equivalent is present in the medium at a concentration of not less than 5 IU/mL (“preparation and intrauterine administration of PBMC”, p. 3291).
Regarding claim 42, Yoshioka et al. teaches said culturing is performed for a period of time in the range of 46 to 72 hours (48 h, “preparation and intrauterine administration of PBMC”, p. 3291).
Regarding claim 44, Yoshioka et al. teaches obtaining fresh PBMCs from the blood of a patient in need of tissue repair or engineering and mixing them with the cultured PBMCs of (b) to produce a composition comprising fresh and cultured PBMCs (“preparation and intrauterine administration of PBMC”, p. 3291).
Regarding claim 45, Yoshioka teaches a composition produced by the method of claim 33 which comprises cultured PBMCs obtained from, or suitable for treatment of, a patient in need of tissue repair or engineering (see discussion for claim 33; abstract; hCG, “preparation and intrauterine administration of PBMC”, p. 3291; “clinical outcome” Table II; “results”, pg. 3291).
Regarding claim 46, Yoshioka teaches fresh PBMCs from the blood of a patient in need of tissue repair or engineering thereby providing a composition comprising cultured and fresh PBMCs (“preparation and intrauterine administration of PBMC”, p. 3291).
Regarding claim 47, Yoshioka teaches a method for repairing, regenerating, or engineering a tissue comprising contacting the tissue in need of repair, regeneration, or engineering with the composition of claim 45 (see discussion for claim 45; abstract; “preparation and intrauterine administration of PBMC”, p. 3291; “clinical outcome”, Table II; “results”, pg. 3291).
Regarding claim 48, Yoshioka teaches the tissue in need of repair, regeneration, or engineering comprises uterine tissue (“cell suspension gently administered to the uterine cavity”, see “preparation and intrauterine administration of PBMC”, p. 3291; “PBMC administration can elicit functional changes in endometrial surface epithelial cells”, see “discussion”, p. 3922).
Regarding claim 49-51, Yoshioka teaches the tissue in need of repair, regeneration, or engineering comprises non-uterine tissue, vascular, endothelial, fat, bone, cartilage, cardiac muscle, skeletal muscle, or neurons (PBMC composition improves embryo implantation and clinical pregnancy rates, which encompasses vascular tissue growth: abstract; “results”, pg. 3291; Table II; col. 1, pg. 3293; “PBMC administration can elicit functional changes in endometrial surface epithelial cells”, see “discussion”, p. 3922).
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.
Claim 34 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yoshioka et al. “Intrauterine administration of autologous peripheral blood mononuclear cells promotes implantation rates in patients with repeated failure of IVF-embryo transfer.” Human Reproduction, vol. 21, no. 12, 2006, p. 3290-3294 (IDS; copy submitted in parent application) in view of U.S. Patent Application Publication No. 2005/0250088 (Boldt).
Regarding claim 34, Yoshioka teaches all the limitations of claim 33. Yoshioka does not teach (a) comprises obtaining PBMCs from the blood of a subject at least two months after an immune-system-influencing event or the endocrine-system-influencing event comprises chemotherapy, radiation treatment, or a treatment that induces autoimmunity.
However, Boldt teaches “long term storage of oocytes…is desirable for women undergoing chemo- or radio-therapy for the treatment of cancers…or other procedures that have the potential to leave the individual sterile” ([0023]). Boldt further discloses oocyte retrieval is desirably performed prior to chemotherapy or radiotherapy, which is then followed by IVF and implantation of the “fertilized oocyte” to restore fertility ([0023]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Yoshioka such that the immune-system-influencing event or the endocrine-system-influencing event comprises chemotherapy or radiation treatment prior to IVF as taught by Boldt, because Boldt teaches performing oocyte retrieval prior to chemotherapy or radiation treatment, and following the treatment with IVF and embryo transfer is a desirable means to attempt to restore a patient’s fertility following such treatment ([0023]).
Claims 38 and 41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yoshioka et al. “Intrauterine administration of autologous peripheral blood mononuclear cells promotes implantation rates in patients with repeated failure of IVF-embryo transfer.” Human Reproduction, vol. 21, no. 12, 2006, p. 3290-3294 in view of U.S. Patent Application Publication No. 2009/0053182 (Ichim et al.).
Regarding claim 38, Yoshioka teaches all the limitations of claim 33. Yoshioka is silent on the presence of carbon dioxide in the culture of the PBMCs.
However, Ichim teaches a method of culturing cells, such as PBMCs (abstract; [0013]), comprising: propagating a portion of BMCs in the presence of 5% carbon dioxide ([0157]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Yoshioka such that the PBMCs are cultured in 5% carbon dioxide as taught by Ichim, because providing such a condition is optimal for cell culture and incubation to maintain cell viability.
Regarding claim 41, Yoshioka in view of Ichim teaches all the limitations of claim 33. Yoshioka is silent on the temperature at which the PBMCs are cultured.
However, Ichim further teaches cells are cultured at a temperature of 37°C in a culture medium ([0157]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Yoshioka and Ichim such that the PBMCs are cultured at a temperature of 37°C as taught by Ichim, because 37°C is an optimal temperature for cell culture and incubation to maintain cell viability.
Claim 39 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yoshioka et al. “Intrauterine administration of autologous peripheral blood mononuclear cells promotes implantation rates in patients with repeated failure of IVF-embryo transfer.” Human Reproduction, vol. 21, no. 12, 2006, p. 3290-3294 in view of U.S. Patent Application Publication No. 2003/0124720 (Schoonjans et al.).
Regarding claim 39, Yoshioka teaches all the limitations of claim 33. Yoshioka teaches the culture medium comprises RPMI 1640 medium (“preparation and intrauterine administration of PBMC”, p. 3291). Yoshioka does not teach the culture medium includes L-glutamine and albumin.
However, Schoonjans teaches a method for culturing mammalian cells, comprising a culture medium including RPMI 1640, L-lgutamine, and albumin ([0019]; [0021]). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the culture medium of Yoshioka to include L-glutamine and albumin as taught by Schoonjans as such components are beneficial for mammalian cell culture ([0019]; [0021]).
Claim 43 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yoshioka et al. “Intrauterine administration of autologous peripheral blood mononuclear cells promotes implantation rates in patients with repeated failure of IVF-embryo transfer.” Human Reproduction, vol. 21, no. 12, 2006, p. 3290-3294 in view of JP 2004275145 (Kuwana et al.; IDS, see translation copy provided in parent application).
Regarding claim 43, Yoshioka teaches all the limitations of claim 33. Yoshioka teaches the PBMCs are cultured in vitro (“preparation and intrauterine administration of PBMC”, p. 3291), but do not specify the cells are cultured on fibronectin.
However, Kuwana teaches a method of culturing PBMCs, wherein the cells are cultured in a culture medium on a fibronectin coated plate (abstract). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Yoshioka such that the PBMCs are cultured on fibronectin as taught by Kuwana, because fibronectin provides a substance for attachment of the PBMCs for proliferation.
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 33, 35, 37, 38, 42, and 44-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,185,348. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 33 of the instant application is merely broader in scope than all that is recited in claim 1 of the ‘348 patent. That is, claim 33 is anticipated by claim 1 of the ‘348 patent. Once applicant has received a patent for a species or a more specific embodiment, applicant is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)). Claims 35, 37, 38, 42, and 44-48 of the instant application are anticipated by claims 1 and 2 of the ‘348 patent, by the same reasoning.
Claims 33-47 and 49-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8, 9, 20-25, 27, and 28 of U.S. Patent No. 11,957,384. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 33 of the instant application is merely broader in scope than all that is recited in claim 1 of the ‘384 patent. That is, claim 33 is anticipated by claim 1 of the ‘384 patent. Once applicant has received a patent for a species or a more specific embodiment, applicant is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)). Claims 34-47 and 49-51 of the instant application are anticipated by claims 1-3, 8, 9, 20-25, 27, and 28 of the ‘384 patent, by the same reasoning.
Conclusion
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/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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