DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group IV, claims 24-52, 73 and 74, in the reply filed on 8/25/2025 is acknowledged. Claims 1-23 and 54-72 are canceled.
Claim Objections
Claims 40, 51 and 74 are objected to because of the following informalities:
In claim 40, lines 1 and 2: “tum” should instead recite - - turn - -.
In claim 51, lines 1 and 2: “tum” should instead recite - - turn - -.
In claim 74, line 2: “tum” should instead recite - - turn - -.
Appropriate correction is required.
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 24-53, 74 and 74 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.
Claim 24 recites “the device comprising proximal and distal ends”. It is unclear if the device comprises 1) a proximal end and a distal end; or 2) a plurality of proximal ends and a plurality of distal ends. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 24 and interpretation 1). Claim 24 recites “a deployed state having an axis of symmetry”. An axis of symmetry as is known in the art is defined as an imaginary line that divides a shape into two identical halves, where one half is a mirror image of the other. However, no such symmetry exists in the disclosed invention. It is unclear how the disclosed helical filament can have an axis of symmetry as the device would necessarily not be symmetrical due to the continuous winding or turns of the helix. In the annotated figure below of Fig. 2B of from the instant invention, if the axis of symmetry is interpreted as the vertical axis running through the center of the device, it can be seen there is no symmetry between the left and right side. For example, when looking along the plane denoted by the horizontal dashed line, the left side is not a mirror image of the right side. There appears to be no axis that could be drawn through the device that would result in two halves being mirror images of one another. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the “axis of symmetry” as a central axis and the device not necessarily required to be symmetrical.
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Claim 26 recites “further comprising a filament”. It is unclear if: 1) the filament is the same structure that comprises the proximal end and the distal end, having the substantially linear deployed state and deployed state of claim 24; or 2) the device comprises the filament, wherein the filament is the element comprising the proximal end and the distal end and having the substantially linear deployed state and deployed state of claim 24. The indefiniteness arises from the use of “further” comprising in claim 26, which implies the filament is in addition to the elements of claim 24. However, as disclosed in the original disclosure, the filament is the element making up the claimed limitations of claim 24. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 26 as - - The device of Claim 24, separate and in addition to the elements of claim 24.
Claim 32 recites the limitation "the lumen of a tube or a needle" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 33 recites “wherein the undeployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter”. It is unclear how the shape is a helix in the undeployed state as claim 24 requires a substantially linear undeployed state. Further, the figures and specification show the helix in the deployed state. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the limitation as - - where in the deployed state - -. The term “much larger” in claim 33 is a relative term which renders the claim indefinite. The term “much” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 33 recites the limitation "the diameter " in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear which diameter the claim is referring to (of which element, segment, portion, etc.).
Claims 34 and 35 recite the limitation "the plurality of windings" in their respective line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 27 had previously introduced “windings or turns”. It is unclear if the turns are being used interchangeably. Applicant is advised to keep the language consistent throughout the claim. For example, the turns may be deleted from claim 27, or claims 34 and 35 may recite - - wherein the windings or turns vary in diameter (as per claim 34) - - and - - wherein the windings or turns approximately trace the shape of a spherical shell (as per claim 35) - -.
Claim 36 recites the limitation "the length" in line 1 and “the diameter” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 38 recites the limitation "the diameter" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 39 recites the limitation "the proximal most and distal most segments” in line 1 and “the line segment” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 40 recites “each of said turns”. It is unclear if this is referring to each of the most proximal turn and the most distal turn, or if it is also referring to each of the turns in the limitation of “windings or turns” in claim 27, from which claim 40 is dependent upon. Claim 40 further recites “resides in a potentially different plane”. The term “potentially” renders the claim indefinite because it is unclear if the limitations following the term are necessarily required. Claim 40 further recites the limitation "the line segment” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 41 recites the limitation "the radius of curvature” in line 1, “the diameter” in line 2, and “the material” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claims 43 and 44 recites the limitation "the distance" in their respective line 1. There is insufficient antecedent basis for this limitation in the claim. Claims 43 and 44 also recite “consecutive windings”. However, claim 27 from which claim 43 and 44 depend from, introduced the windings as “windings or turns”. Applicant is advised to keep the terminology consistent and for claims 43 and 44 to instead recite - - consecutive windings or consecutive turns - -.
Claim 50 recites the limitation "the proximal most segment" in line 1 and “the line segment” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 51 recites the limitation “the line segment” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 52 recites the limitation "the radius of curvature" in line 1, “the diameter” in line 2, and “the material” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim 73 recites the limitation "the length" in line 1 and “the diameter” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 74 recites the limitation "the diameter" in line 1. There is insufficient antecedent basis for these limitations in the claim.
Claim(s) 27-31, 37, 42, 45-49, 53 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 24-27, 32-34, 36, 48, 49, 73 and 74 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Batiste (US 2008/0183206).
Claim 24. A device (900) for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state ([0050]), and a deployed state having an axis of symmetry (interpreted as central axis due to the 35 U.S.C. 112 issue above; therefore interpreted as the horizontal axis in Fig. 14 for example, running through the center of device 900), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (claim 24 is directed to an apparatus claim and therefore cannot recite method steps or positive recitations to the human body. Therefore, the device only needs to be capable of having the axis be approximately perpendicular to the fluid flow. One of ordinary skill in the art could place the device of the prior perpendicular in a vessel large enough to accommodate the device if desired).
Claim 25. The device of claim 24, wherein the medical use is embolic protection ([0003], [0041]).
Claim 26. The device of claim 24, further comprising a filament (800) ([0049]).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape comprising windings or turns in the deployed state (Fig. 14; [0052], [0053]).
Claim 32. The device of claim 26, wherein the undeployed state is configured to fit within the lumen of a tube or a needle, wherein said lumen has a diameter in the range of about 0.05 mm and about 1.0 mm and a length in the range of about 10 mm and about 400 mm ([0051], the discussed dimensions of the filament would allow it to be in such a claimed lumen).
Claim 33. The device of claim 24, wherein the deployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter (Fig. 14; [0051], [0052]).
Claim 34. The device of claim 27, wherein the plurality of the windings vary in diameter (Fig. 14; [0052]).
Claim 36. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel (Fig. 14).
Claim 48. The device of claim 26, wherein the filament is made from a shape memory alloy or a super-elastic alloy ([0050]).
Claim 49. The device of claim 26, further comprising an end piece (1300) (Fig. 14; [0054]).
Claim 73. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel (Fig. 14).
Claim 74. The device of claim 36, wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel (Fig. 14; the device fits within the vessel and therefore the diameter must be less than the vessel to fit therein).
Claim(s) 24-28, 33, 34, 36, 48, 73 and 74 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Ellingwood (US 2008/004640).
Claim 24. A device (110) capable for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state ([0055]), and a deployed state (Fig. 4) having an axis of symmetry (interpreted as central axis due to the 35 U.S.C. 112 issue above and is therefore the vertical central axis in Fig. 4), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (claim 24 is directed to an apparatus claim and therefore cannot recite method steps or positive recitations to the human body. Therefore, the device only needs to be capable of having the axis be approximately perpendicular to the fluid flow. One of ordinary skill in the art could place the device of the prior perpendicular in a vessel large enough to accommodate the device if desired).
Claim 25. The device of claim 24, wherein the medical use can be embolic protection as the shape of the device can serve the purpose of embolic protection due to its coiling nature.
Claim 26. The device of claim 24, further comprising a filament (112).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape comprising windings or turns in the deployed state (Fig. 4; [0071]).
Claim 28. The device of claim 26, wherein the filament is configured with a circular cross section ([0032]).
Claim 33. The device of claim 24, wherein the deployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter (Fig. 4).
Claim 34. The device of claim 27, wherein the plurality of the windings vary in diameter (Fig. 4; [0071]).
Claim 36. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel (Fig. 4; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 48. The device of claim 26, wherein the filament is made from a shape memory alloy or a super-elastic alloy ([0055]).
Claim 73. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel (Fig. 4; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 74. The device of claim 36, wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel (Fig. 4; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a diameter less than the diameter of the vessel).
Claim(s) 24-27, 29, 32-36, 38, 43, 46, 49, 73 and 74 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Dibie et al (US 5413586).
Claim 24. A device (100) for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state col. 9, ll. 53-61), and a deployed state (Figs. 1, 3) having an axis of symmetry (102) (interpreted as central axis due to the 35 U.S.C. 112 issue above), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (Fig. 15)
Claim 25. The device of claim 24, wherein the medical use is embolic protection (col. 1, ll. 6-7).
Claim 26. The device of claim 24, further comprising a filament (100).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape comprising windings or turns in the deployed state (Figs. 1, 3).
Claim 29. The device of claim 26, wherein the length of the filament is between about 7 and about 300 mm (col. 6, ll. 38-42).
Claim 32. The device of claim 26, wherein the undeployed state is configured to fit within the lumen of a tube or a needle, wherein said lumen has a diameter in the range of about 0.05 mm and about 1.0 mm and a length in the range of about 10 mm and about 400 mm (col. 6, ll. 26-30; the disclosed dimensions would allow the filament to fit within a lumen as claimed).
Claim 33. The device of claim 24, wherein the deployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter (Figs. 1, 3).
Claim 34. The device of claim 27, wherein the plurality of the windings vary in diameter (col. 3, ll. 32-39; Figs. 1, 3).
Claim 35. The device of claim 27, wherein the plurality of windings approximately trace the shape of a spherical shell (Fig. 3).
Claim 36. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel (the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 38. The device of claim 35, wherein the diameter of said spherical shell is less than or equal to the diameter of the vessel (the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a diameter lesser than the diameter of the vessel).
Claim 43. The device of claim 27, wherein the distance (P1) between consecutive windings exceeds about 0.7 mm (Fig. 3; col. 3, ll. 50-53).
Claim 46. The device of claim 24, further comprising a radiopaque marker (col. 4, ll. 11-17).
Claim 49. The device of claim 26, further comprising one or two end pieces (300, 400).
Claim 73. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel (the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 74. The device of claim 36, wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel (the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a diameter lesser than the diameter of the vessel).
Claim(s) 24-27, 29, 33, 36, 39, 40, 47, 50 and 51 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Rothman (WO 9107928).
Claim 24. A device (6) for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state (Fig. 2; p. 7, ll. 23-25), and a deployed state having an axis of symmetry (interpreted as central axis due to the 35 U.S.C. 112 issue above and is therefore the horizontal axis running across the center of the device in Fig. 4), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (claim 24 is directed to an apparatus claim and therefore cannot recite method steps or positive recitations to the human body. Therefore, the device only needs to be capable of having the axis be approximately perpendicular to the fluid flow. One of ordinary skill in the art could place the device of the prior perpendicular in a vessel large enough to accommodate the device if desired).
Claim 25. The device of claim 24, wherein the medical use can be embolic protection as the shape of the device can serve the purpose of embolic protection due to its coiling nature.
Claim 26. The device of claim 24, further comprising a filament (p. 7, ll. 19-21).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape comprising windings or turns in the deployed state (Fig. 4).
Claim 29. The device of claim 26, wherein the length of the filament is between about 7 and about 300 mm (p. 9, ll. 15-19; length is deployed state is within the claimed range).
Claim 33. The device of claim 24, wherein the deployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter (Fig. 4).
Claim 36. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel (Fig. 4).
Claim 39. The device of claim 26, wherein the proximal most and distal most segments (6a) of said filament in the deployed state are substantially collinear with the line segment connecting the proximal and distal ends (Fig. 4).
Claim 40. The device of claim 27, further comprising a most proximal turn and a most distal turn, wherein each of said turns resides in a potentially different plane roughly parallel to the line segment connecting the proximal and the distal ends (Fig. 4).
Claim 47. The device of claim 24, further comprising an echogenic marker (p. 7, ll. 19-21; the tantalum material serves as the echogenic marker as Applicant has disclosed in the instant specification tantalum is echogenic).
Claim 50. The device of claim 26, wherein the proximal most segment of said filament in the deployed state is substantially collinear with the line segment connecting the proximal and distal ends.
Claim 51. The device of claim 27, further comprising a most proximal turn, wherein said turn resides in a plane roughly parallel to the line segment connecting the proximal and the distal ends (Fig. 4).
Claim(s) 24-27, 29-31, 33, 36, 46, 48, 73 and 74 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wallace et al (US 2002/0019647).
Claim 24. A device (100) for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state ([0014]), and a deployed state having an axis of symmetry (interpreted as central axis due to the 35 U.S.C. 112 issue above and is therefore the horizontal axis running across the center of the device in Fig. 1), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (claim 24 is directed to an apparatus claim and therefore cannot recite method steps or positive recitations to the human body. Therefore, the device only needs to be capable of having the axis be approximately perpendicular to the fluid flow. One of ordinary skill in the art could place the device of the prior perpendicular in a vessel large enough to accommodate the device if desired).
Claim 25. The device of claim 24, wherein the medical use is embolic protection ([0013]).
Claim 26. The device of claim 24, further comprising a filament ([0048]).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape comprising windings or turns in the deployed state (Fig. 1).
Claim 29. The device of claim 26, wherein the length of the filament is between about 7 and about 300 mm ([0049]).
Claim 30. The device of claim 26, wherein the diameter of the filament is less than about 0.2 mm ([0048]).
Claim 31. The device of claim 26, wherein the diameter of the filament is less than about 0.15 mm ([0048])
Claim 33. The device of claim 24, wherein the deployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter (Fig. 1).
Claim 36. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel (Fig. 1; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 46. The device of claim 24, further comprising a radiopaque marker ([0047]).
Claim 48. The device of claim 26, wherein the filament is made from a shape memory alloy or a super-elastic alloy ([0044]).
Claim 73. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel (Fig. 1; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 74. The device of claim 36, wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel (Fig. 1; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a diameter less than the diameter of the vessel).
Claim(s) 24-27, 29-34, 36, 37, 48, 73 and 74 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Wensel et al (US 5895398).
Claim 24. A device (18) for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state (Fig. 1b), and a deployed state having an axis of symmetry (interpreted as central axis due to the 35 U.S.C. 112 issue above and is therefore the axis running across the central shaft 16 in Fig. 1a which extends along the central axis of device 18), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (claim 24 is directed to an apparatus claim and therefore cannot recite method steps or positive recitations to the human body. Therefore, the device only needs to be capable of having the axis be approximately perpendicular to the fluid flow. One of ordinary skill in the art could place the device of the prior perpendicular in a vessel large enough to accommodate the device if desired).
Claim 25. The device of claim 24, wherein the medical use is embolic protection (col. 2, ll. 31-39).
Claim 26. The device of claim 24, further comprising a filament (col. 4, ll. 22-49).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape comprising windings or turns in the deployed state (Fig. 1c).
Claim 29. The device of claim 26, wherein the length of the filament is between about 7 and about 300 mm (col. 4, ll. 22-49).
Claim 30. The device of claim 26, wherein the diameter of the filament is less than about 0.2 mm (col. 4, ll. 22-49).
Claim 31. The device of claim 26, wherein the diameter of the filament is less than about 0.15 mm (col. 4, ll. 22-49).
Claim 32. The device of claim 26, wherein the undeployed state is configured to fit within the lumen of a tube or a needle, wherein said lumen has a diameter in the range of about 0.05 mm and about 1.0 mm and a length in the range of about 10 mm and about 400 mm (col. 4, ll. 22-49; the disclosed dimensions of the filament allow it to fit within a lumen a claimed).
Claim 33. The device of claim 24, wherein the deployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter (Fig. 1c).
Claim 34. The device of claim 27, wherein the plurality of the windings vary in diameter (Fig. 1c).
Claim 36. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel (Fig. 1c)
Claim 37. The device of claim 36, wherein the length is in the range of about 7 mm and about 20 mm (col. 4, ll. 22-49).
Claim 48. The device of claim 26, wherein the filament is made from a shape memory alloy or a super-elastic alloy (col. 4, ll. 22-49).
Claim 73. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel (Fic. 1c)
Claim 74. The device of claim 36, wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel (Fic. 1c; the device fits within the vessel and therefore the diameter must be less than the vessel to fit therein).
Claim(s) 24-28, 33, 34, 36, 48, 73 and 74 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Jayaraman.
Claim 24. A device (22) for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state ([0084]), and a deployed state having an axis of symmetry (interpreted as central axis due to the 35 U.S.C. 112 issue above and is therefore interpreted as the vertical central axis running across the device in Figs. 8-14), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (claim 24 is directed to an apparatus claim and therefore cannot recite method steps or positive recitations to the human body. Therefore, the device only needs to be capable of having the axis be approximately perpendicular to the fluid flow. One of ordinary skill in the art could place the device of the prior perpendicular in a vessel large enough to accommodate the device if desired).
Claim 25. The device of claim 24, wherein the medical use is embolic protection as the shape of the device can serve the purpose of embolic protection due to its coiling nature.
Claim 26. The device of claim 24, further comprising a filament (Figs. 8-14).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape comprising windings or turns in the deployed state (Figs. 8-14; [0062]).
Claim 28. The device of claim 26, wherein the filament is configured with a circular cross section ([0095]; the diameter of the filament is discussed which would indicate the cross section is circular).
Claim 33. The device of claim 24, wherein the deployed state is configured in the shape of a helix wherein the pitch is much larger than the diameter (Figs. 8-14).
Claim 34. The device of claim 27, wherein the plurality of the windings vary in diameter (Figs. 8-14).
Claim 36. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than the diameter of the vessel (Figs. 8-14; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 48. The device of claim 26, wherein the filament is made from a shape memory alloy or a super-elastic alloy ([0021]).
Claim 73. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel (Figs. 8-14; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 74. The device of claim 36, wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel (Figs. 8-14; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a diameter less than the diameter of the vessel).
Claim(s) 24-27, 40, 45, 51, 73 and 74 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kupiecki et al (US 5669931).
Claim 24. A device (20) for medical use in a patient's vessel containing a fluid flow, the device comprising proximal (end closest to user) and distal ends (end furthest from user), a substantially linear undeployed state (Fig. 2A), and a deployed state (Fig. 2B) having an axis of symmetry (interpreted as central axis due to the 35 U.S.C. 112 issue above and is therefore interpreted as the horizontal central axis extending across segment 27 in Fig. 2B), wherein in the deployed state, the axis of symmetry can be approximately perpendicular to the fluid flow (claim 24 is directed to an apparatus claim and therefore cannot recite method steps or positive recitations to the human body. Therefore, the device only needs to be capable of having the axis be approximately perpendicular to the fluid flow. One of ordinary skill in the art could place the device of the prior perpendicular in a vessel large enough to accommodate the device if desired).
Claim 25. The device of claim 24, wherein the medical use is embolic protection as the shape of the device can serve the purpose of embolic protection due to its coiling nature.
Claim 26. The device of claim 24, further comprising a filament (the filament is interpreted as the coiled element in Fig. 2A in its linear state).
Claim 27. The device of claim 26, wherein the filament is configured with a helical shape (segment 27) comprising windings or turns (30) in the deployed state (Fig. 2B).
Claim 40. The device of claim 27, further comprising a most proximal turn and a most distal turn, wherein each of said turns resides in a potentially different plane roughly parallel to the line segment connecting the proximal and the distal ends (Fig. 2B).
Claim 45. The device of claim 26, wherein the filament includes a hollow lumen (lumen formed by windings 22, better seen in Fig. 2C).
Claim 51. The device of claim 27, further comprising a most proximal turn, wherein said turn resides in a plane roughly parallel to the line segment connecting the proximal and the distal ends (Fig. 2B).
Claim 73. The device of claim 27, wherein the length of a line segment connecting the proximal and the distal ends in the deployed state is larger than or equal to the diameter of the vessel (Figs. 7, 8; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a line segment larger than the diameter of the vessel).
Claim 74. The device of claim 36, wherein the diameter of every turn or winding is less than or equal to the diameter of the vessel (Figs. 7, 8; the device can be placed in a vessel such that the central axis runs along the length of the vessel and can therefore have a diameter less than the diameter of the vessel).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 41, 42, 52, 53 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rothman.
Claims 41 and 52. Rothman discloses the invention substantially as claimed above, but fails to disclose the radius of curvature at any point along the filament exceeds a critical value equal to the diameter of the filament divided by twice the critical strain of the material from which the filament is made. Applicant has disclosed the criticality in the claimed value of the radius of curvature is such that the strain suffered at any point of the device is less than or equal to the critical strain required to bring about an elastic-to-plastic transformation upon transition from the deployed to the undeployed state. In this way, the device can transfer between its shapes without substantial differences between the initial and final deployed shape. It would have been obvious to one of ordinary skill in the art at the time the invention was made that the device of Rothman possesses the same quality and characteristics because Rothman discloses the properties of the filament relies on its built-in shape memory and its ability to return from its collapsed constrained configuration to its relatively unstressed expanded configuration (p. 11, ll. 10-18). Such deformation would be known in the art to occur without plastic deformation.
Claims 42 and 53. Rothman discloses the invention substantially as claimed above, but fails to disclose the critical value is greater than about 0.6 mm. However, Rothman discloses varying the size of the device (p. 9, ll. 4-6). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have the dimensions and critical strain result in a critical value greater than about 0.6 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, Applicant has not provided evidence of the criticality of the claimed critical in the instant specification. In paragraph [0059] of the published instant specification, Applicant discloses exemplary dimensions and critical value of the device in order to return it to its original configuration. However, Applicant has not provided evidence, such as how the claimed “greater than about 0.6 mm” have unexpected results and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Claim 44 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jayaraman.
Claim 44. Jayaraman discloses the invention substantially as claimed above, including the helix comprises a plurality of turns (Figs. 8-14) but fails to disclose the distance between consecutive turns is less than about 1.5 mm. However, Jayaraman discloses various dimensional properties of the device are result effective variables, including the pitch and spacing between the turns ([0065], [0066], [0090]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the distance between the consecutive turns to the claimed values based upon the defect to be treated, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 24-53, 73, 74 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 9220588.
Claims 24-53, 73, 74 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10226321
Claims 24-53, 73, 74 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11207170.
Although the claims at issue are not identical, they are not patentsably distinct from each other because the elements of the claims of the instant application are to be found in the claims of the patents. Thus the difference between the claims of the instant application and the claims of the patents lies in the fact that the patents claims include many more elements and is thus much more specific. Thus, the invention of the claims of the patents is in effect a “species” of the “generic” invention of the claims of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims are anticipated by the claims of the patents, it is not patentsably distinct from the claims of the patents.
Conclusion
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/KATHERINE SHI/Primary Examiner, Art Unit 3771