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 .
Notice of Amendment
In response to the amendment filed on 10/10/2024, cancelled claims 1-18 and new claims 19-22 are acknowledged. Claims 19-22 remain pending.
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 19-21 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,137,923 B2 in view of Kato et al. (US Patent No. 6,884,225 B2) (cited by Applicant).
Regarding claim 19, claim 1 of the reference patent discloses a guidewire, comprising:
an elongated core member having a proximal core section and a distal core section;
a distal tip attached to a distal end of the distal core section, the distal tip being formed from a metallic alloy or polymer and having a roughened outer surface for use in penetrating stenosed lesions in vessels; and
wherein the outer surface of some of the plurality of helical wire coils has the same roughened outer surface as the distal tip.
It is noted the reference patent does not specifically teach the distal tip having a stem, the stem of the distal tip is inserted into a plurality of helical wire coils having an outer surface. However, Kato et al. teaches the distal tip (5) having a stem (5a), the stem of the distal tip is inserted into a plurality of helical wire coils (4) having an outer surface (see Figures 2, 5-6, 12, and 14 and col. 4, lines 1-10 – “A front end of the helical spring 4 is firmly interfit to the stem portion 5a of the head plug 5 to have a leading end portion 6 superior in flexibility. In a front distal portion 10 including the head plug 5 and a part of the helical spring 4 extending from the head plug 5, two or three turns of the helical spring 4 is secured to the stem portion 5a of the head plug 5, a length L3 of a rigid portion 4A is 0.5 mm or less which extends from a top of the head plug 5 to a rear end of a portion in which the helical spring 4 is secured to the stem portion 5a”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of the reference patent to include the distal tip having a stem, the stem of the distal tip is inserted into a plurality of helical wire coils having an outer surface, as disclosed in Kato et al., so as to enable the manipulator to judge the manner of how the front distal tip contacts the lesion based on the feeling transmitted from the distal tip to the handle of the guidewire (see Kato et al.: col. 4, lines 59-67).
Regarding claim 20, claim 3 of the refence patent discloses the roughened outer surface includes any of micro bead blasting, laser roughening, sand paper, micro machining, and wire brush.
Regarding claim 21, it is noted the reference patent does not specifically teach the distal tip has a structural configuration including any of frusto-conical-shaped, mushroom-shaped, and angularly-shaped. However, Kato et al. teaches the distal tip has a structural configuration including any of frusto-conical-shaped, mushroom-shaped, and angularly-shaped (see Figures 2, 5-6, 12, and 14).
Claims 22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,137,923 B2 in view of Kato et al. and Lupton et al. (US Publication No. 2016/0331943 A1).
Regarding claim 22, it is noted neither the reference patent nor Kato et al. specifically teach the angularly-shaped distal tip has an edge for holding the distal tip in place when engaging hard plaque. However, Lupton et al. teaches the angularly-shaped distal tip (7) has an edge (8) for holding the distal tip in place when engaging hard plaque (see Figures 1-5 and 13-15 and [0116] – “The terminal member 7 tapers to a distal leading edge portion, which in this embodiment of the invention is a transversely extending elongated leading edge portion 8 in the form of a chisel edge for engaging and penetrating the occlusion or partial occlusion in a vessel of the vascular system as the guide wire 1 is urged through the vascular system”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the guidewire of the reference patent to include the angularly-shaped distal tip has an edge for holding the distal tip in place when engaging hard plaque, as disclosed in Lupton et al., so as to engage and penetrate the occlusion in the vessel of the vascular system as the guidewire is urged through the vascular system (see Lupton et al.: [0116]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571) 272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEVIN B HENSON/ Primary Examiner, Art Unit 3791
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