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 .
Election/Restrictions
Applicant’s election of Group II, claims 34-44 in the reply filed on 12/23/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 44 is 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 44 depends from claim 43 and recites the limitation “the cannula is a first cannula and the distal end of the first cannula is closed by inserting a second cannula coaxially through the first cannula after the stylet is removed, a distal end of the second cannula closing the distal end of the first cannula”, which renders the claim indefinite because it appears to contradict the limitation “the distal end of the cannula being closed” recited in claim 43. It is unclear how both limitations can be satisfied at the same time.
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.
Claim(s) 34-36, 38, and 40-42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Allee et al. (US Patent No. 7,850,651 B2) (cited by Applicant).
Regarding claim 34, Allee et al. discloses a method of aspirating bone marrow, the method comprising:
placing a needle assembly into bone of a patient, the needle assembly comprising a cannula (114) attached to a handle (127) and a stylet (148) assembled into the cannula through a luer connector (126) at the handle (see col. 6, lines 61-67 – “The stylet 148 generally includes a rigid needle portion 150 having an end cap 152 at one end and a needle tip 154 at an opposite end. The end cap 152 includes a Luer lock having threads 156 for connecting the stylet 148 to external threads 129 of the Luer lock 126 of the inner needle 114, as illustrated in FIGS. 8A and 8B”), the cannula having at least one side aperture (134), the cannula passing through a mechanism that is attached to and distal to the handle, the mechanism including a threaded tube (116) and a lead screw (128) receivable in the threaded tube (see Figures 8A-C and col. 6, lines 56-60 – “The cannulated inner needle 114 includes a handle portion 127, a Luer lock connector 126, a threaded portion 128, a needle portion 130, an open tip 132, and a plurality of ports 134 (FIG. 8C) around its outer diameter proximate to the open tip 132”);
removing the stylet after the needle assembly is placed into the bone (see col. 7, lines 12-16 – “ After the assembly 110 is inserted into the bone cortex, the stylet 148 is removed from cooperation with the inner needle 114 and a suitable device, such as a syringe, is attached to the Luer lock 126 of the inner needle 114 to aspirate bone marrow”);
aspirating bone marrow through the at least one side aperture (see col. 7, lines 12-16 – “ After the assembly 110 is inserted into the bone cortex, the stylet 148 is removed from cooperation with the inner needle 114 and a suitable device, such as a syringe, is attached to the Luer lock 126 of the inner needle 114 to aspirate bone marrow”); and
retrieving the cannula from the bone by rotating the lead screw relative to the threaded tube (see col. 6, lines 6-33 – “To aspirate additional bone marrow, the inner aspiration needle 14 is threaded further into the threaded collar 16 a predetermined number of degrees, such as about 90.degree., so that the inner aspiration needle 14 protrudes from the outer needle 12 to a second length L2 (FIG. 7B), which is greater than the first length L1. Rotating the inner aspiration needle 14 in this manner, while keeping the outer needle 12 stationary, advances the tip 32 of the needle 30 deeper into the bone and rotates the tip 32 such that the ports 34 are perpendicular to their previous position. Thus, the outer needle 12 serves as a guide for the inner aspiration needle 14 to direct the inner aspiration needle 14 to the bone. This process is performed as many times as needed to obtain a desired amount of bone marrow. Withdrawing bone marrow using the assembly 10 provides numerous advantages. For example, rotating the inner aspiration needle 14 so that its position in the bone changes permits withdrawal of bone marrow from different areas of the bone to prevent the aspirated marrow from possibly being diluted with peripheral blood”).
Regarding claim 35, Allee et al. discloses the stylet extends through the cannula and past the at least one side aperture (see Figures 8A-C).
Regarding claim 36, Allee et al. discloses the lead screw is attached to the handle, and wherein rotating the threaded lead screw relative to the threaded tube includes turning the handle (see Figures 7B and 8A and col. 6, lines 6-11 – ““To aspirate additional bone marrow, the inner aspiration needle 14 is threaded further into the threaded collar 16 a predetermined number of degrees, such as about 90.degree., so that the inner aspiration needle 14 protrudes from the outer needle 12 to a second length L2 (FIG. 7B), which is greater than the first length L1”).
Regarding claim 38, Allee et al. discloses adjusting a length of the cannula that extends beyond a distal end of the threaded tube by advancing the lead screw into the threaded tube or reversing the lead screw out of the threaded tube (see Figures 7B and 8A and col. 6, lines 6-11 – ““To aspirate additional bone marrow, the inner aspiration needle 14 is threaded further into the threaded collar 16 a predetermined number of degrees, such as about 90.degree., so that the inner aspiration needle 14 protrudes from the outer needle 12 to a second length L2 (FIG. 7B), which is greater than the first length L1”).
Regarding claim 40, Allee et al. discloses the lead screw is hollow and the cannula extends through the hollow lead screw (see Figure 8A).
Regarding claim 41, Allee et al. discloses the at least one side aperture includes plural side apertures arranged along a length of the cannula near a distal end of the cannula (see Figure 8C).
Regarding claim 42, Allee et al. discloses the bone marrow is aspirated during retrieval of the cannula from the bone (see col. 6, lines 6-33 – “To aspirate additional bone marrow, the inner aspiration needle 14 is threaded further into the threaded collar 16 a predetermined number of degrees, such as about 90.degree., so that the inner aspiration needle 14 protrudes from the outer needle 12 to a second length L2 (FIG. 7B), which is greater than the first length L1. Rotating the inner aspiration needle 14 in this manner, while keeping the outer needle 12 stationary, advances the tip 32 of the needle 30 deeper into the bone and rotates the tip 32 such that the ports 34 are perpendicular to their previous position. Thus, the outer needle 12 serves as a guide for the inner aspiration needle 14 to direct the inner aspiration needle 14 to the bone. This process is performed as many times as needed to obtain a desired amount of bone marrow. Withdrawing bone marrow using the assembly 10 provides numerous advantages. For example, rotating the inner aspiration needle 14 so that its position in the bone changes permits withdrawal of bone marrow from different areas of the bone to prevent the aspirated marrow from possibly being diluted with peripheral blood”).
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.
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) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allee et al., further in view of Chu et al. (US Publication No. 2011/0071430 A1).
Regarding claim 37, it is noted Allee et al. does not specifically teach rotating the lead screw relative to the threaded tube includes turning the threaded tube. However, Chu et al. teaches rotating the lead screw relative to the threaded tube includes turning the threaded tube (see [0042] – “Step 4: using a sleeve of the acquiring element to move relative to the stylet through helical motion of screw threads thereof; the screw threads allow the stylet to move a fixed distance after turning the sleeve one round; hence, it is affirmative to accurately confirm the position of the drill in collaboration with the image guidance”; see also [0044]-[0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Allee et al. to include rotating the lead screw relative to the threaded tube includes turning the threaded tube, as disclosed in Chu et al., so as to accurately position the needle assembly into a target area by convenient calculation with a fixed distance corresponding to the specific pitch of the screw threads and number of turns of the sleeve (see Chu et al.: [0044]-[0045]).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allee et al., further in view of Haddock et al. (US Publication No. 2007/0260255 A1).
Regarding claim 39, it is noted Allee et al. does not specifically teach the length of the cannula that extends beyond the distal end of the threaded tube is adjustable between about 1 inch and about 8 inches. However, Haddock et al. teaches the length of the cannula that extends beyond the distal end of the threaded tube is adjustable between about 1 inch and about 8 inches (see [0059] – “When outer sleeve 100, middle sleeve 200, and trocar 300 are assembled together, shaft 302 will preferably extend 2 to 4 cm beyond the distal end of middle sleeve 200. Shaft 202 of middle sleeve 200 will preferably extend 2 to 4 cm beyond the distal end of outer sleeve 100. The length of shaft 102 of outer sleeve 100 is preferably in the range of one-fourth to three-quarters the length of shaft 302 of trocar 300, more preferably in the range of one-third to one-half the length of shaft 302”; see also [0056]-[0058]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Allee et al. to include the length of the cannula that extends beyond the distal end of the threaded tube is adjustable between about 1 inch and about 8 inches, as disclosed in Haddock et al., so as to form an opening in bone for sequential dilation of tissue (see Haddock et al.: Abstract).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allee et al., further in view of Goldenberg (US Publication No. 2007/0219460 A1).
Regarding claim 43, Allee et al. teaches the at least one side aperture is near a distal end of the cannula (see Figure 8C) but does not specifically teach the distal end of the cannula being closed. However, Goldenberg teaches the distal end of the cannula being closed (see Figure 6 and [0063] – “In this embodiment, an aspiration needle 200 is provided and while similar to the needle 100, the needle 200 has a number of differences, including that it is a closed tip needle in that a distal end 214 of a cannula 210 is not open as in the needle 100 but instead, the distal end 214 is closed. In order to facilitate the advancement of the distal end 214, the closed end preferably includes a solid pointed distal tip as opposed to the tapered distal end (frustoconical shape) of the needle 100 that terminates in the main opening into the interior of the needle 100”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Allee et al. to include the distal end of the cannula being closed, as disclosed in Goldenberg, so as to facilitate placement at a specimen site to collect and permit aspiration of the specimen from the specimen site (see Goldenberg: [0015]).
Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Allee et al. and Goldenberg, further in view of Miller (US Publication No. 2007/0016100 A1) (cited by Applicant).
Regarding claim 44 as best understood, it is noted neither Allee et al. nor Goldenberg specifically teach the cannula is a first cannula and the distal end of the first cannula is closed by inserting a second cannula coaxially through the first cannula after the stylet is removed, a distal end of the second cannula closing the distal end of the first cannula but leaving open the at least one side aperture of the first cannula. However, Miller teaches the cannula is a first cannula (80) and the distal end of the first cannula is closed by inserting a second cannula (62e) coaxially through the first cannula after the stylet is removed, a distal end (64) of the second cannula closing the distal end of the first cannula but leaving open the at least one side aperture (88a, 88b, 88c) of the first cannula (see Figures 8A-C and [0090] – “Various techniques and procedures may be satisfactorily used to selectively align sampling port 68 with respective sampling ports 88a, 88b and 88c. When sampling port 68 of inner penetrator 62a is respectively aligned with sampling port 88a, 88b or 88c of outer penetrator 80e, respective portions of bone marrow may be suctioned from adjacent target areas”; see also [0087], [0089], and [0092]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Allee et al. and Goldenberg to include the cannula is a first cannula and the distal end of the first cannula is closed by inserting a second cannula coaxially through the first cannula after the stylet is removed, a distal end of the second cannula closing the distal end of the first cannula but leaving open the at least one side aperture of the first cannula, as disclosed in Miller, so as to allow sampling from multiple target areas while at the same time installing or inserting the device into only a single penetration site (see Miller: [0087]).
Conclusion
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791