DETAILED ACTION
Claims 1-20 are currently pending and have been examined.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12,171,441 in view of Li (US 20100253190). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and claims 1-13 of US 12,171,441 are directed to a method of harvesting and processing bone and cellular material including steps of receiving bone and cellular material, storing the material, and instructing to send the material to a facility to store the material. Claims 1-13 of US 12,171,441 do not expressly teach storing the cancellous bone, cortical bone chips, and bone marrow in at least one of a first container, second container, and third container, wherein the first container is configured for typification of a patient, the second container is configured for safety and quality examination, and the third container configured to receive harvested cancellous bone, cortical bone chips, and bone marrow material of a patient for a subsequent use.
Li, however, teaches to a storage tank containing cartridges storing stem cells that are connected via a compartment unit (Fig. 9B; para. 61). The cartridges can be removed separately via a telescoping arm (Fig. 9B; para. 61). The Examiner further asserts that the usage of the containers has been interpreted as intended use. A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see MPEP 2114 and Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The Examiner notes the recited prior art has the capability to perform the limitations indicated as intended use.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Li based on the motivation of providing a storage apparatus in which independent storage-access operation, lowering cost and raising storage-access accuracy can be achieved (Li – para. 2).
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 15-18 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 15 recites “instructing the cancellous bone, cortical bone chips, and bone marrow to be sent to a facility”. However, it is unclear how bone material can be given instructions to be sent to a facility. Appropriate clarification and correction is required. Dependent claims 16-18 are also rejected due to their dependency from Claim 15.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Marom (US20130052169) in view of Li (US 20100253190).
As per claim 15, Marom teaches a method for storing harvested bone and cellular material, comprising:
receiving cancellous bone, cortical bone chips, and bone marrow (para. 91-92: material collected from patient including bone and bone marrow materials);
storing the cancellous bone, cortical bone chips, and bone marrow in at least one of a first container (para. 143: stem cells harvested from bone and bone material are stored in various tanks for later use); and
instructing the cancellous bone, cortical bone chips, and bone marrow to be sent to a facility configured to store cancellous bone, cortical bone chips, and bone marrow (para. 143-145, 166: after stem cell collection and storage the material is then sent to a bank for storage).
Marom does not expressly teach storing the cancellous bone, cortical bone chips, and bone marrow in at least one of a first container, second container, and third container, wherein the first container is configured for typification of a patient, the second container is configured for safety and quality examination, and the third container configured to receive harvested cancellous bone, cortical bone chips, and bone marrow material of a patient for a subsequent use.
Li, however, teaches to a storage tank containing cartridges storing stem cells that are connected via a compartment unit (Fig. 9B; para. 61). The cartridges can be removed separately via a telescoping arm (Fig. 9B; para. 61). The Examiner further asserts that the usage of the containers has been interpreted as intended use. A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform, see MPEP 2114 and Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The Examiner notes the recited prior art has the capability to perform the limitations indicated as intended use.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to combine the aforementioned features in Li with Marom based on the motivation of providing a storage apparatus in which independent storage-access operation, lowering cost and raising storage-access accuracy can be achieved (Li – para. 2).
As per claim 16, Marom and Li teach the method according to claim 15. Marom teaches wherein the subsequent use is for the patient whose cancellous bone, cortical bone chips, and bone marrow has been harvested (para. 8: stem cell transplants can be either autologous or allogenic).
As per claim 17, Marom and Li teach the method according to claim 15. Marom teaches wherein the subsequent use is for another patient that is not the patient whose cancellous bone, cortical bone chips, and bone marrow has been harvested (para. 8: stem cell transplants can be either autologous or allogenic).
As per claim 18, Marom and Li teach the method according to claim 15. Marom does not expressly teach wherein the containers are detachably connected to each other.
Li, however, teaches to a storage tank containing cartridges storing stem cells that are connected via a compartment unit (Fig. 9B; para. 61). The cartridges can be removed separately via a telescoping arm (Fig. 9B; para. 61).
The motivations to combine the above mentioned references are discussed in the rejection of claim 15, and incorporated herein.
Prior Art Rejection
All of the cited references fail to expressly teach or suggest, either alone or in combination, the features found within claims 1-14 & 19-20. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: obtaining identification data collected from identifying a set of patients undergoing an existing surgical procedure in which a bone of the patient is to be reamed or resected and cancellous bone, cortical bone chips, and bone marrow material removed; obtaining screening data collected from screening the patients using a set of criteria to ascertain a subset of patients who qualify to donate cancellous bone, cortical bone chips, and bone marrow; reaming bone from the subset of patients with a tool to extract cancellous bone, cortical bone chips, and bone marrow material during an orthopedic procedure; and instructing that the extracted material be sent to a facility.
The most relevant prior art of record includes:
Woods et al. (US Patent Publication 20120052049) teaches a method for treating preselected diseases comprising the steps of providing a therapeutic dose of a mesenchymal stem cell composition, the mesenchymal stem cell composition comprising mesenchymal stem cells harvested from at least one tissue selected from the group consisting of placental tissue, bone marrow, dental tissue, testicle tissue, and dermal tissue; and systemically administering the mesenchymal stem cell composition to the patient suffering from a preselected disease or diseased state through an intravenous injection. Porter et al. ("Osteogenic Potential of Reamer Irrigator Aspirator (RIA) Aspirate Collected from Patients Undergoing Hip Arthroplasty") teaches using RIA aspirate to develop improved, clinically expeditious, cost-effective technologies for accelerating the healing of bone and other musculoskeletal tissues. Brevnova et al. (US Patent Publication 20080215364) teaches to collection, extraction, preservation, containment, packaging, delivery and storage of the stem cells in a storage medium that can be cost-effectively maintained by the donor, parent or guardian at home or in a custodial location.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Meridew (US 9445907 B2) teaches to preparing a femoral neck for receiving a neck implant includes resecting a femoral head from a femoral neck of a patient according to a pre-operative patient-specific plan. The method also includes removing only cancellous bone from the femoral neck and proximal femoral bone of the patient using a patient-specific broach.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan K Ng whose telephone number is (571)270-7941. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-7949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jonathan Ng/Primary Examiner, Art Unit 3619
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