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 .
Information Disclosure Statement
The information disclosure statements filed 05/22/2023 and 12/05/2024 fail to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. All the Foreign Patent documents listed in both of the above mentioned information disclosure statements have not been considered since no copy of these documents have been provided. Additionally, US Patent documents 2008/071343A1 (in the IDS dated 12/05/2024) and 2002121472A1 (in the IDS dated 05/22/2024) also have not been considered since no US Patent documents exist with such numbers.
Claim Objections
Claims 6, 7 and 8 are objected to because of the following informalities: the claims set forth the limitation of a/the “fixing position” (emphasis added); however, this limitation is found to be grammatically incorrect since the term “position” is used to reference a location, while the above limitation seems to be referencing an actual structure, and not a location. Therefore, it is suggested the limitation (on lines 3 and 4 of claim 6, and line 5 of claims 7 and 8) be amended by replacing the word “position” with the word “portion”. 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 2-5 and 7 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.
Regarding claims 2, 3 and 4, which recite the limitation “the mounting position”, on line 7 of claim 2, lines 1, 4 and 7 of claim 3, and line 3 of claim 4, there is insufficient antecedent basis for this limitation in the claims. In order of overcome this rejection, it is suggested the above mentioned limitation be amended by deleting the word “position” and replacing it with the word “portion” (as first set forth on the 2nd to last line of independent claim 1, from which all the above mentioned claims depend).
Regarding claim 3 and 7, which set forth the term “via hole”, on line 7 of claim 3 and lines 5, 7 and 8 of claim 7, this term is found to be confusing since it is not clear what exact structure this term imparts/is referring to. Specifically, it is not clear if the word “via” imparts any structure to the term “via hole”, and if so, what exactly is said structure; and the originally filed disclosure does not aid in clarify the term “via hole”. Thus, one having ordinary skill in the art would not reasonable by apprised of the scope of the invention, thereby rendering the claims indefinite. For the purpose of examination, the term shall be interpreted broadly as a hole.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claims 1-3 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arbefeuille et al. (US PG Pub. 2019/0321207), hereinafter Arbefeuille.
Regarding claim 1, Arbefeuille discloses a delivery device comprising a sheath core (24); a TIP head (30), arranged at a distal end (28) of, and fixed relative to, the sheath core (24); and a fixing anchor (72), arranged on an outer wall of the sheath core (24) and close to a proximal end of the TIP head (30); the fixing anchor (72) is provided with a mounting portion (94), and a pull wire (100) is accommodated in the mounting portion (94), illustrated in Figures 1-3 and 9-11 ([0080], Lines 1-2; [0084], Lines 1-4; [0088], Lines 4-10 & [0091], Lines 12-15).
Regarding claim 2, Arbefeuille discloses the delivery device according to claim 1, wherein the fixing anchor (72) comprises a fixing portion (74/76), which is arranged on an outer side of the sheath core (24) and is fixed with the sheath core; an anchoring portion (AP), which is configured for anchoring a stent; and a basic portion (BP), wherein the fixing portion (74/76) is connected with the anchoring portion (AP) through the basic portion (BP), and the mounting portion (94) is arranged on the basic portion (BP), illustrated in Figures 1-3, 9-11 and modified figure 9, below ([0084], Lines 1-4).
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Regarding claim 3, Arbefeuille discloses the delivery device according to claim 2, wherein the mounting portion (94) comprises a via hole (94) formed in the basic portion (BP), and the via hole extends along a direction parallel to a radial direction of the sheath core (24) and extends through the basic portion (BP) along the direction, illustrated in Figures 1-3, 9-11 and modified figure 9, above.
Regarding claim 6, Arbefeuille discloses the delivery device according to claim 1, wherein the TIP head (30) comprises a cylindrical section (CS) which is provided with a fixing position (FP) arranged along a longitudinal direction of the cylindrical section; and the pull wire (100) is accommodated in the fixing position (FP), illustrated in Figures 1-3 and modified figure 3, below ([0088], Lines 8-10).
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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 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille.
Regarding claims 4 and 5, Arbefeuille discloses the delivery device according to claim 2, wherein the anchoring portion (AP) comprises a plurality of rod-shaped members arranged at a distal end of the basic portion (BP) and extend towards the distal end; the mounting portion (94) comprises punch holes (94) formed in the rod-shaped members of the anchoring portion (AP), the punch holes (94) extend along an axial direction of the sheath core, illustrated in Figures 2, 3, 9-11 and modified figure 9, above ([0088], Lines 4-6); and though it does not specifically disclose that there are two punch holes, each arranged on an adjacent one of the plurality of rod-shaped members, this parameter is deemed to be a mere matter of normal design choice, not involving a novel, inventive step. It would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate number of punch holes, including at least two arranged on adjacent rod-shaped members, since doing so amounts to a mere matter of duplication of the essential working parts which has been held to involve only routine skill in the art (see MPEP 2144.04). It is also to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of there being two punch holes, as opposed to any other number/amount.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille as applied to claim 6 above, and in view of Hopkins et al. (US PG Pub. 2013/0338788), hereinafter Hopkins.
Regarding claim 7, Arbefeuille discloses the delivery device according to claim 6, wherein the fixing position (FP) comprises a via hole which is arranged along a longitudinal direction of the cylindrical section (CS) and axially extends through the cylindrical section, wherein the via hole has a distal port (PD) at a distal end of the via hole and a proximal port (PP) at a proximal end of the via hole, illustrated in Figure 3 and modified figure 3, above ([0080], Lines 1-4 & [0088], Lines 8-10 – to clarify, the longitudinal via hole, in the cylindrical section of TIP head 30, has a proximal port PP at an opening at its proximal end where pull wire 100 is inserted and tucked in, and has a distal port PD at an opening at its distal end, i.e. the luminal channel, to allow a guidewire through); but does not specifically disclose the TIP head comprising a first tapered section coaxially arranged at a distal end of the cylindrical section and a second tapered section coaxially arranged at a proximal end of the cylindrical section.
However, Hopkins teaches a delivery device, in the same field of endeavor, comprising
a TIP head (35) having a first tapered section (36) coaxially arranged at a distal end of a central cylindrical section (38) and a second tapered section (37) coaxially arranged at a proximal end of the central cylindrical section (38) and connected with a sheath core (31), illustrated in Figures 1, 4 and 5 ([0046], Lines 5-13).
In view of the teachings of Hopkins, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the TIP head, of the delivery device of Arbefeuille, to have a shape such that it comprises a first tapered section coaxially arranged at a distal end of the cylindrical section and a second tapered section coaxially arranged at a proximal end of the cylindrical section and connected with a sheath core, as taught by Hopkins, such that the distal port is located at a junction between the first tapered section and the cylindrical section and the proximal port is located at a junction between the second tapered section and the cylindrical section; since doing so amounts to a mere change in shape/form of a component/TIP head, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04). It is also to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the TIP head have a shape/from with first and second tapered sections coaxially arranged at the distal and proximal ends, respectively, of the cylindrical section, as opposed to having any other shape/form.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Arbefeuille as applied to claim 6 above, and in view of Hopkins and Jiang (CN 109700565A – English translation provided).
Regarding claim 8, Arbefeuille discloses the delivery device according to claim 6, but does not specifically disclose the TIP head comprising a first tapered section coaxially arranged at a distal end of the cylindrical section and a second tapered section coaxially arranged at a proximal end of the cylindrical section, and the fixing position comprising a groove located on an outer surface, and arranged along a longitudinal direction, of the cylindrical section, wherein a distal end of the groove is located at a junction between the first tapered section and the cylindrical section and a proximal end of the groove is located at a junction between the second tapered section and the cylindrical section.
However, Hopkins teaches a delivery device, in the same field of endeavor, comprising
a TIP head (35) having a first tapered section (36) coaxially arranged at a distal end of a central cylindrical section (38) and a second tapered section (37) coaxially arranged at a proximal end of the central cylindrical section (38) and connected with a sheath core (31), illustrated in Figures 1, 4 and 5 ([0046], Lines 5-13). Additionally, Jiang teaches a delivery device, in the same field of endeavor, comprising a TIP head (32) having a fixing position comprising a groove (321) located on an outer surface, and arranged along a longitudinal direction, of the TIP head; wherein a pull wire (15) is accommodated in the fixing position/groove (321), illustrated in Figures 4 and 6 (English translation, pg. 6, 2nd to last Line – pg. 7, Line 3).
In view of the teachings of Hopkins and Jiang, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the TIP head, of the delivery device of Arbefeuille, to have a shape such that it comprises a first tapered section coaxially arranged at a distal end of the cylindrical section and a second tapered section coaxially arranged at a proximal end of the cylindrical section and connected with a sheath core, as taught by Hopkins, since doing so amounts to a mere change in shape/form of a component/TIP head, which is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04 - It is also to be noted that neither the claim, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the TIP head have a shape/from with first and second tapered sections coaxially arranged at the distal and proximal ends, respectively, of the cylindrical section, as opposed to having any other shape/form). It further would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the fixing position, of the delivery device of Arbefeuille, such that it comprises a groove located on an outer surface, and arranged along a longitudinal direction, of the cylindrical section, as taught by Jiang, such that a distal end of the groove is located at a junction between the first tapered section and the cylindrical section and a proximal end of the groove is located at a junction between the second tapered section and the cylindrical section; since both references teach art equivalent means for securing a device, to be delivered, to the TIP head via the pull wire.
Regarding claim 9, Arbefeuille in view of Hopkins and Jiang disclose the delivery device according to claim 8, wherein Jiang further teaches the delivery device further comprises a fixing member/walls of the groove (321), which surround a proximal end portion of the groove to fix a pull wire (15), illustrated in Figure 6 (English translation of Jiang, pg. 6, 2nd to last Line – pg. 7, Line 3 – to clarify, the walls of the groove surround the groove and enable fixing of pull wire 15 via an interference fit, as disclosed by Jiang).
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/DINAH BARIA/Primary Examiner, Art Unit 3774