DETAILED ACTION
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
Claim 4 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/13/2026.
Applicant’s election without traverse of Species A in the reply filed on 02/13/2026 is acknowledged.
Claims 1-3, 5-8 are pending and examined below.
Claim Interpretation
Regarding claim 1, the claim recites an external guide cannula, but does not positively claim an internal sampling cannula. Rather, the internal sampling cannula is only described with respect to the positively claimed external sampling cannula. As such any limitations in regards to the internal sampling cannula does not hold any patentable weight and are thus not considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 5, the claim recites the limitation “wherein the internal sampling cannula is sealed at a distal head end thereof”. However, claim 1, does not positively claim the internal sampling cannula, the claim is not further limiting.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120136277 A1 (hereinafter referred to as “Landrigan”).
Regarding claim 1, Landrigan, a bone marrow needle, teaches a device for collection of biological material (abstract), comprising:
an external guide cannula (18; paragraph [0058]; Figures 1-3) for an internal sampling cannula (as shown in Figures 1-3),
wherein:
the external cannula has a first mantle wall (the walls of 18; as shown in Figure 1-3) which defines an inner lumen (as shown in Figures 1-3) and a distal terminal (60; paragraph [0067]; Figure 2);
the first mantle wall has a first plurality of openings (66; paragraph [0069]; as shown in Figure 2) which are distributed axially and circumferentially along a first side wall in different longitudinal and/or angular positions with reference to an axis of the first mantle wall (as shown in Figure 2);
the external guide cannula has a proximal end external to a grafting site (as shown in Figures 1-3), the proximal end comprising a grasping terminal (16; paragraph [0059]; as shown in Figure 3) and an inlet opening in the inner lumen bounded by the first mantle wall (28; paragraph [0059]; as shown in Figure 3);
the internal sampling cannula has a second mantle wall which defines an internal lumen, the internal sampling cannula being configured to be coaxially inserted inside the external guide cannula so that the external guide cannula and the internal sampling cannula are mobile with respect to each other by axial translation and/or an angular displacement;
the second mantle wall of the internal sampling cannula has a second plurality of openings which are distributed axially and circumferentially along the second mantle wall in different longitudinal and/or angular positions with reference to an axis of the second mantle wall;
the openings in the second plurality of openings passing through a distal part of the internal sampling cannula and the openings in the first plurality of openings defined in a distal part of the external guide cannula are distributed according to two interrelated orders so that the axial translation and/or angular displacement of the internal sampling cannula with respect to the external guide cannula leads some of the openings of the inner sampling cannula to be in a coincident position with some of the openings of the external guide cannula, which have different axial and/or angular positions along an axial and/or angular extension of the first mantle wall and are communicating with the lumen of the internal sampling cannula depending on a relative axial and/or angular position of the internal sampling cannula with respect to the external guide cannula;
the biological material can be extracted through some of the openings in the internal sampling cannula from different sites along the external guide cannula, the remaining openings in the external guide cannula coinciding with closed portions of the second mantle wall and failing to communicate with the inner lumen of the internal sampling cannula; and
the internal sampling cannula has a proximal end that is equipped with a terminal configured to protrude outwards from the lumen of the external guide cannula and enable a relative positioning of the internal sampling cannula relative to the external guide cannula in predefined relative axial and/or angular positions in which the openings of the internal sampling cannula and the openings of the external guide cannula coincide with some of the openings of the outer external guide cannula with at least some of the openings of the internal sampling cannula.
Note: as discussed in the claim interpretation section, the italicized text relate to the internal sampling cannula which has not been positively claimed and thus does not hold any patentable weight.
Regarding claim 2, Landrigan teaches wherein distributions of the openings on the external guide cannula and on the internal sampling cannula are arranged to provide three or more relative positions in which holes of the external guide cannula and of the internal sampling cannula, which align to put in communication the lumen of the internal sampling cannula with the holes of the external guide cannula, coincide with as many different sampling sites along an axial and/or angular extension of the external cannula in a distal terminal portion of the external guide cannula ((“The inner cannula is longitudinally and axially movable relative to the outer cannula to simultaneously selectively align at least one first opening with at least one second opening to permit aspiration of bone marrow therethrough and to misalign at least one first opening and at least one second opening to restrict aspiration of bone marrow therethrough”; paragraph [0007]; paragraph [0082], [0114]; as shown in Figures 1-3), and wherein relative positioning means (129; paragraph [0089]; Figure 8) between the distal terminal portion of the external guide cannula and a distal terminal portion of the internal guide cannula is designed to provide relative stopping positions corresponding to the three or more positions with translation steps between the external guide cannula and the internal sampling cannula of predetermined amounts. or in a progressive and continuous manner (paragraph [0089]; Figure 8).
Regarding claim 3, Landrigan teaches wherein the relative positioning means consist of a series of spacer elements interposed between the distal terminal of the external guide cannula and the distal terminal of the internal sampling cannula, wherein each of the spacer elements has a predetermined thickness corresponding to an axial distance between two successive conditions of coincidence of the holes of the external guide cannula with the holes of the internal sampling cannula, and wherein each of the spacer elements is movable in a progressive sequence from an interposition position to a staggered position with respect to the interposition position, progressively reducing a distance between the distal terminals of the external guide cannula and internal sampling cannula (paragraph [0089]; Figure 8).
Regarding claim 5, Landrigan teaches wherein the internal sampling cannula is sealed at a distal head end thereof (124; paragraph [0082]; Figure 2).
Regarding claim 6, Landrigan teaches wherein the external guide cannula is open at a distal head end thereof, wherein a perforation tip can be axially engaged inside the external guide cannula and removed therefrom, wherein the perforation tip has a distal end configured as a perforation cutting edge and a proximal end configured to protrude out of the external guide cannula with a grasping end, and wherein the perforation tip is equipped with removable coupling means to the external cannula and has such a length, so that in a position coupled to the external cannula, the distal end with the perforation cutting edge of the perforation tip escapes from the distal end of the external guide cannula (64; paragraph [0068], [0092]; Figure 7A, 12-13).
Regarding claim 7, Landrigan teaches wherein passage lights of the openings along the first and/or the second mantle walls are variable with reference to an axial position of the openings with respect to the distal ends of the external guide cannula and/or of the internal sampling cannula, so as to compensate for variations in aspiration depression generated at different openings as a function of an axial position of the openings along the external guide cannula and the internal sampling cannula which would arise if the openings all had passing lights of identical dimensions (129/80; paragraph [0089]; Figure 8B).
Regarding claim 8, Landrigan teaches wherein a proximal grasping terminal of the external guide cannula and a proximal terminal of the internal sampling cannula are equipped with cooperative end-of-stroke stops that delimit a displacement of the internal sampling cannula with respect to the external guide cannula between two extreme positions of maximum introduction of the internal sampling cannula into the external guide cannula and maximum extraction of the internal sampling cannula with respect to the external guide cannula (as shown in Figure 3).
Conclusion
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/ABID A MUSTANSIR/ Examiner, Art Unit 3791