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 .
Specification
The disclosure is objected to because, in para. [0001] of the specification as filed, U.S. Pat. No. 11,426,175 is not cited as being issued from U.S. Pat. App. No. 16/032,688, and U.S. Pat. No. 12,121,238 is not cited as being issued from U.S. Pat. App. No. 17/822,090.
Appropriate correction is required.
Claim Interpretation - 35 USC § 112
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
With respect to claim 21, “expansile means for occluding a vascular condition” is presumed to correspond to hydrogel or POLYBLEND as mentioned in the specification.
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.
Claims 2-21 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “bulb” in claims 2-5, 7, 11-14,17-19, and 21 is used by the claims to mean (from the specification as filed): an “expansile member,” a “retention sleeve, which physical sits over expansile member,” “a retention sleeve…[that] acts like a cage for the expansile member,” “expanded gel,” “caged gel,” a “sleeve [that] functions as a hollow shell,” or one of “proximal and distal bulged ends;” while the accepted meanings are (from the Merriam-Webster [online] Dictionary):
“1:
a: a resting stage of a plant (such as the lily, onion, hyacinth, or tulip) that is usually formed underground and consists of a short stem base bearing one or more buds enclosed in overlapping membranous or fleshy leaves
b: a fleshy structure (such as a tuber or corm) resembling a bulb in appearance
c: a plant having or developing from a bulb
2: a bulb-shaped part, specifically: a glass envelope enclosing the light source of an electric lamp or such an envelope together with the light source it encloses
3: a rounded or swollen anatomical structure
4: a camera setting that indicates that the shutter can be opened by pressing on the release and closed by ending the pressure.”
The term is indefinite because the specification does not clearly redefine the term.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruiz (5,976,174). Ruiz discloses, in at least in figures 1A-2 and col. 3, line 29 to col. 4 line 52 and col. 5, lines 57-65; an occlusive device, comprising: a first bulb (15) comprising a first plurality of cells (within the mesh of 12); a second bulb (16) comprising a second plurality of cells (within the mesh of 12); and a middle portion (17) connecting the first bulb and the second bulb, wherein the middle portion has a cross-sectional dimension smaller than a corresponding cross- sectional dimension of the first bulb and the second bulb; wherein the first bulb comprises a hollow shell (a portion of 12).
Claims 2-5, 7-9, 11-15 and 17-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chavatte et al. (9,114,019). Chavatte et al. discloses, at least in figures 1A-2B and col. 4, line 27 to col. 5, line 39 and col. 9 line 61 to col. 11, line 19; an occlusive device, comprising: a first bulb (22, as shown in fig. 2A and 2B) comprising a first plurality of cells (pores of containment device 20); a second bulb (24) comprising a second plurality of cells (pores); and a middle portion (26) connecting the first bulb and the second bulb, wherein the middle portion has a cross-sectional dimension smaller than a corresponding cross- sectional dimension of the first bulb and the second bulb; wherein the first bulb comprises a hollow shell; wherein the occlusive device further comprises an expansile material within an interior of the first bulb, wherein: in a first configuration, the expansile material (50) is unexpanded and positioned entirely within the interior of the bulb, and in a second configuration, the expansile material at least partially expands out (i.e., secretes out--according to col. 4, line 60 to col. 5, line 32) of the plurality of cells (pores) of the bulb; wherein the first bulb remains substantially static in both the first and second configurations, such that in the second configuration, an overall shape of the first bulb is substantially the same as its shape in the first configuration; wherein the occlusive device further comprises a core (an inner containment device, according to col. 10, lines 43-57) positioned within the interior of the first bulb, wherein the expansile material surrounds the core (when the expansile material secretes out of the core); wherein an amount of the expansile material within the interior of the first bulb is determined based on a thickness of the core; wherein the core comprises a polymeric material (i.e., polymeric materials for containment devices, according to col. 9, line 62 to col. 10, line 5); wherein in the first configuration, the expansile material sits immediately under an inner surface of the first bulb (before secretion out of the first bulb; and wherein in the first configuration, the expansile material fills an entire space underneath an inner space of the first bulb (before secretion out of the first bulb).
Chavatte et al. also disclose an occlusive device, comprising: a substantially static bulb comprising a narrow portion (26) and at least one wide portion (at 22 or 24), wherein the bulb comprises a plurality of cells (pores) between an interior of the bulb and an exterior surface of the bulb; and an expansile material (50) within the interior of the bulb, wherein: in a first configuration, the expansile material is unexpanded and positioned entirely within the interior of the bulb and bonded to a surface within the bulb, and in a second configuration, the expansile material at least partially expands out (i.e., secretes out) of the plurality of cells of the bulb; wherein the at least one wide portion of the bulb comprises a first wide portion (22) and a second wide portion (24); wherein the first wide portion is positioned on a first side of the narrow portion, and wherein the second wide portion is positioned on a second side of the narrow portion, different from the first side; wherein the bulb comprises a hollow shell (20); wherein the expansile material completely fills the interior of the bulb when in the second configuration; wherein the occlusive device further comprises a core (an inner containment device, according to col. 10, lines 43-57) positioned within the interior of the bulb, wherein the expansile material surrounds the core (when the expansile material secretes out of the core); and wherein the core is composed of a polymeric material (i.e., polymeric materials for containment devices, according to col. 9, line 62 to col. 10, line 5).
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.
Claims 6, 10,16, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Chavatte et al. (9,114,019) in view of Karmon (7,749,267). Chavatte et al. disclose the invention substantially as claimed. Chavatte et al. disclose, at least in figures 1A-2B and col. 4, line 27 to col. 5, line 39 and col. 9 line 61 to col. 11, line 19; an occlusive device comprising: a substantially static bulb comprising a narrow portion (26) and at least one wide portion (at 22 or 24), wherein the bulb comprises a plurality of cells (pores) between an interior of the bulb and an exterior surface of the bulb; and an expansile material (50), wherein: in a first configuration, the expansile material is unexpanded and positioned entirely within the bulb and bonded to a surface within the bulb (before secretion out of the bulb); and in a second configuration, the expansile means at least partially expands out (i.e., secretes out) of the plurality of cells of the bulb.
However, Chavatte et al. do not explicitly disclose that the expansile material is composed of a hydrogel, is expandable on contact with blood, or is an expansile means for occluding a vascular condition. Nevertheless, Chavatte et al. disclose, in col. 4, lines 53-55; that the expansile material (50) may be “any other filling material now or hereafter known in the art.” Karmon teaches, in col. 16, lines 34-39 and col. 18, lines 43-47; a filling material for an occlusive device and for bone and other tissues, organs, and vessels (according to col. 15, lines 23-33), wherein the material comprises hydrogel, which is expandable on contact with blood or is an expansile means capable of occluding a vascular condition. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Karmon, to modify the expansile material of Chavatte et al., so that it includes hydrogel, is expandable on contact with blood, or is an expansile means for occluding a vascular condition. Such a modification would make for a biocompatible filling material that is easily inserted into a bulb and/or bone.
Conclusion
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/JULIAN W WOO/Primary Examiner, Art Unit 3771