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 .
Claim Rejections - 35 USC § 112
Claims 8, 9, 13, 14, 22 and 23 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.
In re claim 8, there is insufficient antecedent basis for the limitations “the protrusions” and “the indentations”. For examination purposes, as best understood, the limitation “the protrusions” and “the indentations” will be interpreted as “the one or more protrusions” and “the one or more indentations” respectively.
In re claim 9, see above (In re claim 8).
In re claim 13, the limitation “wherein one or more of the slits are close-ended slits, each of which does not have an open end” raises a clarity concern when viewed in combination with its parent claim (claim 10). Examiner notes that claim 10 requires the “one or more slits” be “open-ended slits” while claim 13, which depends from claim 10, requires the “one or more slits” be “close-ended slits”. It is unclear how the “one or more slits” could be both “open-ended” and “close-ended”. Examiner believes Applicant intended for claim 13 to depend from claim 1, instead of claim 10. Therefore, for examination purposes, claim 13 will be interpreted as depending from claim. Examiner notes that dependent claim 14 inherits the same deficiencies.
In re claim 22, see above (In re claim 8).
In re claim 23, see above (In re claim 8).
Allowable Subject Matter
The following is an Examiners statement of reasons for the indication of allowable subject matter:
The closest prior art is Keenan et al. (US 9,872,947), Spanier et al. (US 2023/0063196) and MacDonald (US 2016/0258248).
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In re claim 1, Keenan discloses an apparatus (abstract), comprising:
a blood pump (abstract, Examiner FIG. 1), comprising:
an axial shaft (A) configured for insertion into, and rotation within, a body of a subject (FIG. 3; col. 13, lines 50-52);
a coupling element (C), comprising:
a first portion (C1), which is disposed around the axial shaft (Examiner FIG. 1) and:
a second portion (C2); and
an impeller (408), comprising:
a bushing (B) coupled to the second portion of the coupling element (Examiner FIG. 1: bushing coupled to second portion via 424); and
one or more blades (blades of 408) coupled to the bushing (Examiner FIG. 1: blades coupled to bushing via 424) such that, as the axial shaft rotates, the blades rotate, thereby pumping blood of the subject (col. 13, lines 50-52).
Keenan does not disclose wherein the first portion:
is made out of a shape-memory material,
is shaped to define one or more slits that facilitate a is shaped to define one or more slits that facilitate a radial expansion of the first portion such that the first portion is placeable around the axial shaft, and
is shape-set to have an inner diameter that is smaller than an outer diameter of the axial shaft such that, following a placement of the first portion around the axial shaft, the first portion becomes radially contracted around, and thus locked in place with respect to, the axial shaft;
In re claim 1, Spanier discloses an apparatus (abstract), comprising:
a blood pump (abstract: “intravascular blood pump”; FIG. 1), comprising:
an axial shaft (12) configured for insertion into, and rotation within, a body of a subject (FIG. 1; [0057]);
a coupling element (FIG. 4A: combination of 30 and 33), comprising:
a first portion (33, shown in greater detail in FIG. 4B), which is disposed around the axial shaft (FIGS. 4A-4B) and:
is shaped to define one or more slits (36)
a second portion (13); and
an impeller (10), comprising:
a bushing (32) coupled to the second portion (FIGS. 4A-4B) of the coupling element; and
one or more blades (blades of 10) coupled to the bushing (FIGS. 4A-4B; coupled via shaft 12) such that, as the axial shaft rotates, the blades rotate, thereby pumping blood of the subject [0057].
Spanier does not disclose wherein the first portion:
is made of a shape-memory material,
is shaped to define one or more slits that facilitate a radial expansion of the first portion such that the first portion is placeable around the axial shaft, and
is shape-set to have an inner diameter that is smaller than an outer diameter of the axial shaft such that, following a placement of the first portion around the axial shaft, the first portion becomes radially contracted around, and thus locked in place with respect to, the axial shaft; and
As discussed above, neither Keenan or Spanier disclose a first portion that is a) made out of shape memory material, b) shaped to facilitate radial expansion such that the first portion is placeable around the axial shaft and c) shape-set to have an inner diameter that is smaller than an outer diameter of the axial shaft such that, following a placement of the first portion around the axial shaft, the first portion becomes radially contracted around, and thus locked in place with respect to, the axial shaft.
Macdonald discloses a fastener (FIG. 4: 206) made of a shape memory material (abstract). As shown in FIG. 4, the faster includes an array of fingers (302) with enlarged ends (304) used to interlock with a receiving component (FIG. 2: 208). As discussed in Macdonald, the fastener can be shape-set such that cooling of the fastener causes the enlarged ends to interlock with the receiving component [0013]. Examiner notes that the fastener of Macdonald is a part of a well system component, however as discussed in Macdonald, use of the fastener is not limited to well systems [0015].
Although Macdonald discloses the fastener being used outside of well systems, none of the potential applications described by Macdonald are directed to medical devices, or more specifically blood pumps. Examiner asserts that it would not have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling element of Keenan or Spanier to be: a shape memory material, shaped to define one or more slits that facilitate a radial expansion and shape-set, as taught by Macdonald. Examiner can think of no reason one of ordinary skill in the art would have been motivated to make such a modification other than hindsight. Examiner notes that the same analysis (see paragraphs 10-17) applies to independent claim 15.
Regarding claims 2-7, 10-12, and 21 these claims depend from claim 1 (or 15) and therefore also include eligible subject matter.
Examiner notes that claims 8, 9, 13, 14, 22 and 23 also include eligible subject matter but are rejected under 35 U.S.C. § 112 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 (see above section Claim Rejections 35 U.S.C. § 112).
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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