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 .
Preliminary Amendment
As directed by the amendment filed on 17 July 1, 2024: claim(s) 1-20 have been added. Thus, claims 1-20 are presently pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6, 13-14, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nassutt et al. (US 20160278790 A1) in view of Begg (US 20180250029 A1).
Regarding Claim 1, Nassutt discloses a method of collecting bone and/or cellular material during a bone harvesting procedure ("method of collecting bone and/or cellular material during a surgical procedure" [0006]), the method comprising:
(a) operating a reaming, milling, or drilling tool so that the tool reams, mills, or drills into a canal of a bone to generate bone and/or cellular material ("operating a reamer extending through the first and second seals so that a reaming portion of the reamer drills into a bone of the patient and creates bone and/or cellular material" [0006]);
(b) inserting a bone harvesting tool into the bone canal ("direct reaming end/portion 62 within the intramedullary canal of a patient's long bone" [0026]),
(c) generating negative pressure within an internal cavity of the bone harvesting tool, the negative pressure causing the bone and/or cellular material to flow from the patient and into the internal cavity of the bone harvesting tool ("generating negative pressure within an internal cavity of the bone harvesting tool, the negative pressure causing the bone and/or cellular to flow from the patient and into the internal cavity" [0006]); and
(d) collecting the bone and/or cellular material in a storage container fluidly connected to the internal cavity of the bone harvesting tool ("collecting the bone and/or cellular material in a storage container removably and fluidly connected to the internal cavity of the bone harvesting tool" [0006]).
Nassutt fails to disclose the bone harvesting tool comprising an inner tube at least partially disposed within an outer tube such that a ventilation channel is formed between the inner and outer tubes, and the bone and/or cellular material flow through the inner tube. However, Begg teaches a tissue resecting instrument (Abstract) wherein the bone harvesting tool comprising an inner tube ("outer tube 650" [0044]; FIG. 3C) at least partially disposed within an outer tube ("outer sheath 620" [0045]; FIG. 3C) such that a ventilation channel is formed between the inner and outer tubes ("annular channel 622 defined between outer sheath 620 and fixed outer tube 650" [0045]; FIG. 3C), and the bone and/or cellular material flow through the inner tube ("outflow fluid is suctioned, along with tissue and other debris, through openings 652, 642 of outer tube 650 and cutting member 640, respectively, as indicated by arrows “B.”" [0045]; FIG. 3C). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Nassutt to incorporate the teachings of Begg to safely perform tissue resection ([0003-0004]).
Regarding Claim 2, Nassutt discloses identifying a set of patients undergoing an existing surgical operation in which bone and/or cellular material is to be removed from the patient ("identifying a set of patients undergoing an existing surgical operation in which bone and/or cellular material is to be removed from the patient" [0007]); screening the set of patients using criteria to ascertain a subset of patients who qualify to donate bone and/or cellular material ("screening the set of patients using certain criteria to ascertain a subset of patients who qualify to donate bone and/or cellular material" [0007), wherein a first aspect of the criteria requires the subset of patients to be undergoing an existing operation in an ordinary course of events, which is not a surgery dedicated predominantly to extracting the bone and/or cellular material ("a first aspect of the criteria requires the subset of patients to be undergoing an existing operation in the ordinary course of events, which is not a surgery dedicated predominantly to extracting the bone and/or cellular material" [0007]); and selecting the patient from the subset of patients and performing steps (a) through (d) ("selecting the patient from the subset of patients and performing steps (a) through (d)" [0007]).
Regarding Claim 3, Nassutt discloses the surgical operation is an orthopedic operation involving reaming, milling or drilling of a medullary canal of the bone ("surgical operation may be an orthopedic operation involving reaming of a bone of the patient, in particular a medullary canal of the bone" [0007]).
Regarding Claim 4, Nassutt discloses resecting a cortical portion of the bone to open the bone and generate loose bone and/or cellular material ("drills into a bone of the patient and creates bone and/or cellular material" [0006]); generating negative pressure within the internal cavity of the bone harvesting tool ("generating negative pressure within an internal cavity of the bone harvesting tool" [0006]), the negative pressure causing the loose bone and/or cellular material to flow from the patient, into the internal cavity of the bone harvesting tool ("negative pressure causing the bone and/or cellular to flow from the patient and into the internal cavity" [0006]); and collecting the loose bone and/or cellular material prior to performing step (b) ("during the reaming process, bone and/or cellular material may be extracted" [0026]).
Nassutt fails to specify the loose bone and/or cellular material to flow from the patient through the inner tube. However, Begg teaches the negative pressure causing the loose bone and/or cellular material to flow from the patient through the inner tube ("outflow fluid is suctioned, along with tissue and other debris, through openings 652, 642 of outer tube 650 and cutting member 640, respectively, as indicated by arrows “B.”" [0045]; FIG. 3C). Therefore, it would have been obvious to modify Nassutt to safely perform tissue resection ([0003-0004]).
Regarding Claim 5, Nassutt discloses collecting residual bone and/or cellular material from the reaming, milling or drilling tool after performing step (b) ("collecting the bone and/or cellular material in a storage container removably and fluidly connected to the internal cavity of the bone harvesting tool" [0006]).
Regarding Claim 6, Nassutt discloses combining the residual bone and/or cellular material from the reaming, milling or drilling tool with the bone and/or cellular material collected in the storage container ("allow bone and/or cellular material to pass over shaft 64, into sleeve 42, and subsequently through internal cavity 21 of chamber 20 and into handle 41" [0022]).
Regarding Claim 13, Nassutt discloses a method of collecting bone and/or cellular material during a bone harvesting procedure ("method of collecting bone and/or cellular material during a surgical procedure" [0006]), the method comprising:
(a) resecting a cortical portion of a bone to open the bone and generate loose bone and/or cellular material ("operating a reamer extending through the first and second seals so that a reaming portion of the reamer drills into a bone of the patient and creates bone and/or cellular material" [0006]);
(b) collecting the loose bone and/or cellular material generated in step (a) ("collecting the bone and/or cellular material in a storage container removably and fluidly connected to the internal cavity of the bone harvesting tool" [0006]);
(c) operating a reaming, milling or drilling tool so that the tool reams, mills or drills into a medullary canal of the bone to generate bone and/or cellular material ("direct reaming end/portion 62 within the intramedullary canal of a patient's long bone" [0026]);
(d) inserting at least a portion of a bone harvesting tool into the medullary canal of the bone ("direct reaming end/portion 62 within the intramedullary canal of a patient's long bone" [0026]), the bone harvesting tool comprising an internal cavity, a storage container in fluid communication with the internal cavity ("a storage container removably and fluidly connected to the internal cavity of the bone harvesting tool" [0006]),
(e) generating negative pressure within the internal cavity of the bone harvesting tool, the negative pressure causing the bone and/or cellular material generated in step (c) to flow from the patient through the inner tube and into the internal cavity of the bone harvesting tool ("generating negative pressure within an internal cavity of the bone harvesting tool, the negative pressure causing the bone and/or cellular to flow from the patient and into the internal cavity" [0006]);
(f) collecting the bone and/or cellular material generated in step (c) in the storage container ("collecting the bone and/or cellular material in a storage container removably and fluidly connected to the internal cavity of the bone harvesting tool" [0006]); and
(g) collecting residual bone and/or cellular material from the reaming, milling or drilling tool ("collecting the bone and/or cellular material in a storage container removably and fluidly connected to the internal cavity of the bone harvesting tool" [0006]).
Nassutt fails to specify an outer tube and an inner tube, the inner tube being at least partially disposed within the outer tube such that a ventilation channel is formed between the inner and outer tubes. However, Begg teaches an outer tube and an inner tube ("outer tube 650" & "outer sheath 620" [0044-0045]; FIG. 3C), the inner tube being at least partially disposed within the outer tube such that a ventilation channel is formed between the inner and outer tubes ("annular channel 622 defined between outer sheath 620 and fixed outer tube 650" [0045]; FIG. 3C). Therefore, it would have been obvious to modify Nassutt to safely perform tissue resection ([0003-0004]).
Regarding Claim 14, Nassutt discloses the step of combining at least two of the bone and/or cellular material collected in steps (b), (f) and (g) into a cumulative harvest ("allow bone and/or cellular material to pass over shaft 64, into sleeve 42, and subsequently through internal cavity 21 of chamber 20 and into handle 41" [0022]).
Regarding Claim 18, Nassutt discloses identifying a set of patients undergoing an existing surgical operation in which bone and/or cellular material is to be removed from the patient ("identifying a set of patients undergoing an existing surgical operation in which bone and/or cellular material is to be removed from the patient" [0007]); screening the set of patients using criteria to ascertain a subset of patients who qualify to donate bone and/or cellular material ("screening the set of patients using certain criteria to ascertain a subset of patients who qualify to donate bone and/or cellular material" [0007), wherein a first aspect of the criteria requires the subset of patients to be undergoing an existing operation in an ordinary course of events, which is not a surgery dedicated predominantly to extracting the bone and/or cellular material ("a first aspect of the criteria requires the subset of patients to be undergoing an existing operation in the ordinary course of events, which is not a surgery dedicated predominantly to extracting the bone and/or cellular material" [0007]); and selecting the patient from the subset of patients and performing steps (a) through (d) ("selecting the patient from the subset of patients and performing steps (a) through (g)" [0007]).
Regarding Claim 20, Nassutt discloses combining the residual bone and/or cellular material from the reaming, milling or drilling tool with the bone and/or cellular material collected in the storage container ("allow bone and/or cellular material to pass over shaft 64, into sleeve 42, and subsequently through internal cavity 21 of chamber 20 and into handle 41" [0022]).
Claim(s) 7-9, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nassutt et al. in view of Begg, and further in view of Lynch et al. (US 20170071610 A1).
Regarding Claims 7-9 and 19, Nassutt/Begg fails to specify the bone is one of a femur or a tibia bone; the reaming, milling or drilling tool is a device separate from the bone harvesting tool; and steps (a), (b), (c) and (d) are performed without irrigating water or a saline solution. However, Lynch teaches an intramedullary autograft harvesting instrument (see Abstract) wherein the bone is one of a femur or a tibia bone ("femur and tibia" [0005]); the reaming, milling or drilling tool ("cutting rod 10" [0034]) is a device separate from the bone harvesting tool ("harvesting member 20" [0034]); and steps (a), (b), (c) and (d) are performed without irrigating water or a saline solution (“method may be performed without the use of saline solution” [0019]). Therefore, it would have been obvious to modify Nassutt/Begg to help shape/compact the harvested tissue and simplify the procedure while preserving cell viability ([0004]).
Claim(s) 10 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nassutt et al. in view of Begg, and further in view of Buchel (US 5024615 A).
Regarding Claims 10 & 15, Nassutt/Begg fails to specify during the collecting step, ambient air flows through the ventilation channel in a proximal-distal direction. However, Buchel teaches a surgical aspiration device (col. 1 ln. 65-69) wherein during the collecting step, ambient air flows through the ventilation channel in a proximal-distal direction ("outer tube is imperforate throughout its extent except for the inlet opening so that ambient air can enter it only through the inlet opening" col. 3 ln. 26-28; FIGs. 1 & 3). Therefore, it would have been obvious to modify Nassutt/Begg to ensure a continuous flow of air during aspiration (col. 2 ln. 46-47).
Allowable Subject Matter
Claims 11-12 & 16-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None the cited references specify a hollow adapter housing including a first inwardly projecting ledge and a second inwardly projecting ledge distal to the first inwardly projecting ledge, the ventilation channel disposed between the first and second ledges; wherein the inner tube forms a first seal with the first ledge and the outer tube forms a second seal with the second ledge.
It would not have been obvious to modify the references to arrive at the invention due to the addition of the ledges, thus increasing complication and cost.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. The references provided on the attached PTO-892 form are considered relevant to applicant’s disclosure and are cited to further show the general state of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
Prosecution Insights