DETAILED ACTION
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)1 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080045965 A1 to Miller et al. (hereinafter, Miller) in view of “Adequacy of Powered vs Manual Bone Marrow Biopsy Specimens: A Retrospective Review of Sequential Marrow Aspirates and Biopsies in 68 Patients” to Lynch et al. (hereinafter, Lynch).
Regarding Claim 1, Miller discloses a method (Abstract “…methods are provided to remove biopsy specimens from a bone and/or associated bone marrow using a powered drive… and/or… with manual drivers.”) comprising inter alia:
coupling a cutting cannula to a powered driver, the cutting cannula comprising a cutting tip (Miller discloses a powered driver 200 coupled to a biopsy needle set 100b (cutting cannula) via a coupler assembly 250 and a cutting tip 101, paras. [0092], [0145]);
actuating the powered driver to rotate the cutting cannula and cut through a cortical layer of a bone via the cutting tip of the cutting cannula (Miller discloses actuating the driver to rotate the needle and penetrate the cortex (cortical layer of a bone), para. [0124]);
decoupling the powered driver from the cutting cannula while the cutting cannula extends through the cortical layer of the bone (Miller discloses separating the driver while the needle remains seated in the patient bone, para. [0125] and para. [0074] “Coupler assemblies… allow easy separation of an associated powered driver from an IO device such that the IO device may remain in place in a patient to allow bone marrow aspiration or removal of bone and/or bone marrow biopsy specimens.”);
coupling an extraction assembly to the cutting cannula (Miller discloses a manual driver 98 (extracting assembly) that couples to the same needle hub 150 utilized by the powered driver. The manual driver 98 is distinct from the powered driver and serves as the assembly for manual manipulation, para. [0239]); and
manually rotating at least a portion of the extraction assembly to achieve rotation of the cutting cannula and coring of a sample of marrow from the bone via the cutting tip of the cutting cannula (Miller discloses using the manual driver 98 to manually rotate the needle to core a sample of bone marrow, para. [0005]).
Miller discloses the claimed invention as set forth and cited above except for expressly reciting that the extraction assembly is coupled to the cutting cannula while the cutting cannula extends through the cortical layer of the bone.
However, Miller does an intermediate step where the interpreted cutting cannula remains in place in the patient, which teaches that the needle is sitting in the patient, through the cortex, with the powered drive is removed (para. [0074]). Miller further teaches that the manual driver fits the same connection point that the power driver is removed from (para. [0239]). Miller warns at para. [0007] that manual bone penetration leads to fatigue which to a skilled artisan suggests that intended cut through the cortical layer of bone would be best done, and obviously done, using the powered driver – then the powered driver is removed to allow bone marrow aspiration or removal of bone and bone marrow specimens (para. [0074]).
While Miller does not explicitly disclose the specific sequence of switching from powered to manual mode while the cutting cannula extends through the cortical layer of bone, Miller explicitly teaches a kit containing both a powered driver 200 and a manual driver 98 that are interchangeably coupled to the same needle hub 150. Miller explicitly teaches that the IO device may remain is place to allow bone marrow aspiration or removal of bone and/or bone marrow specimens (para. [0074]) and explicitly teaches where bone and bone marrow can be removed/aspirated by the manual rotation of an extraction assembly couplable to the cutting cannula and adapted for rotation (para. [0005]). Therefore, it appears notoriously obvious, when viewing Miller, that the intended first step is using the powered driver to penetrate bone, and then bone marrow may easily removed using their rotation method – the powered driver would not be removed, just to be replaced again.
Furthermore, as additional motivation, Lynch is a reference in the analogous art of bone marrow retrieval using automatic or manual means (Abstract, Objectives). Lynch teaches under results that core biopsy specimens obtained by a manual method are superior.
Therefore, it would have been obvious to one having an ordinary skill in the art at the time the application was filed to utilize the powered drive of Miller for the initial penetration of the hard cortical bone to avoid operator fatigue, decouple the driver as taught, and then attach the manual driver to perform the final coring step. This hybrid method approach predictably uses each tool for its primary intended purpose, a motor driven initial coring step, removal of the powered drive, and in view of Lynch, it would have been obvious to coupling the manual extraction assembly for manual rotation to provide a superior core biopsy sample.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791