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 of the following informalities: Paragraph 25 should be amended to read “…and the sharpened edge 12a is sufficient ...”
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation is: “a cutting member” in claims 21, 35; “a separator member” in claims 27 and 36; and “a cutting means” in claim 40.
Of note, claims 29, 37 positively recites “a separator tube” which would then not invoke the “means plus function” interpretation for “a separator member”.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 34 is objected to because of the following informalities: Lines 1-2 recites “the slit sheath”. Claim 34 is dependent off of claim 21 which claims “”…slit a sheath”. For clarity purposes to avoid any antecedent issues, the “slit sheath” of claim 34 should be “the . 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 22-24 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 22 recites the limitation "a mating piece removably connected to and mated with the body member”. Claim 22 is dependent off of claim 21 which already claims “a removable mating piece” in line 3. It is unclear if the “a mating piece” of claim 22 would be the same or different “removable mating piece” of claim 21. For examination purposes, the “a mating piece” of claim 22 will be interpreted to be referring to the “removable mating piece” of claim 21.
Claim 23 recites the limitation "the first passage is comprised of a recessed area of the body member and a recessed area in the mating piece”. Claim 23 is ultimately dependent off of claim 21 which already claims “a body member including a first recessed area…a removable mating piece including a second recessed area, wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage”” in lines 2-5. It is unclear if the recessed areas of claim 23 would be the same or different recessed areas of claim 21 and if claim 23 would then further limit claim 21/22. For examination purposes, the recessed areas of claim 23 will be interpreted to be referring to the “first and second recessed areas” of claim 21.
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 21-25, 34, 35, 40, are rejected under 35 U.S.C. 102(a)(1) as anticipated by U.S. Patent Publication 2006/0167417 to Kratz.
As to claim 21, Kratz discloses a torque device comprising: a body member (20, figure 1, 8) including a first recessed area (40a,b figure 8); removable mating piece (30a, figure 16, paragraph 2, the hub can be removable mated to at least section 30b as well as interact with device 20 to house the sheath 28) including a second recessed area (inside of the distal portion of 30a as seen in figure 10), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (figure 12, where sheath 28 extends within the hub 30a, and groove sections 40a,b), a cutting member (38, paragraph 39, the cutting can be a hard metal knife blade, as supported by the specification in paragraph 23 to read on the “cutting member”) removably located within the first passage (figure 11-13, the first passage is defined by the recessed areas of the body and the removable mating piece, the device 20 moves the cutting member as seen in figure 11-13 along the sheath 28 past the hub 30a, the cutting member is located in the first passage as seen in figure 13 since the first passage is defined by the inside of hub 30a), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (figure 12) to slit a sheath (28) through the first passage (figure 11-13, paragraph 44-45).
As to claim 22, Kratz discloses a mating piece removably connected to and mated with the body member (paragraph 36, figure 10,11, the retainer portion 36 allows the mating piece 30a to mate with the device 20).
As to claim 23, Kratz discloses the first passage is comprised of a recessed area of the body member and a recessed area in the mating piece that align with each other (figure 8, 10, 11).
As to claim 24, Kratz discloses a second passage (the proximal most area of where the sheath 28 extends between hub 30a and device 20) connected to the first passage, the second passage having a third recessed area of the body member (40c) and a fourth recessed area (the inside proximal area of 30a) in the matting piece that mate with each other (figure 10, 11).
As to claim 25, Kratz discloses a clamp mechanism (30b) which selectively pressed against an elongated implant wire (22) of a medical implant. The hub member 30b connects with 30a which can then apply a pressure to the 22. The clamp mechanism 30b can be selectively pressed since it can also be removed from 30a.
As to claim 34, Kratz discloses the torque device directs the slit sheath out of the first passage while leaving a medical implant in place (figure 13, paragraph 40).
As to claim 35, Kratz discloses an implant delivery device for delivering a medical implant operatively connected to an elongated wire (paragraph 27, figure 1) comprising: a torque device comprising: a body member (20, figure 1, 8) including a first recessed area (40, figure 8); removable mating piece (30a, figure 16, paragraph 2, the hub can be removable mated to at least section 30b as well as interact with device 20 to house the sheath 28) including a second recessed area (inside of 30a as seen in figure 10), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (figure 12, where sheath 28 extends within the hub 30a, and groove sections 40a,b), a cutting member (38, paragraph 39, the cutting can be a hard metal knife blade, as supported by the specification in paragraph 23 to read on the “cutting member”) removably located within the first passage (figure 11-13, the first passage is defined by the recessed areas of the body and the removable mating piece, the device 20 moves the cutting member as seen in figure 11-13 along the sheath 28 past the hub 30a, the cutting member is located in the first passage as seen in figure 13 since the first passage is defined by the inside of hub 30a), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (figure 12) to slit a sheath (28) through the first passage (figure 11-13, paragraph 44-45).
As to claim 40, Kratz discloses a torque device comprising: a body member (20, figure 1, 8) including a first recessed area (40 figure 8); a removable mating means (30a, figure 16, paragraph 2, the hub can be removable mated to at least section 30b as well as interact with device 20 to house the sheath 28) for forming a first passage (figure 12, where sheath 28 extends within the hub 30a, and groove sections 40a,b) through the body member, wherein the removable mating means including a second recessed area (inside of 30a as seen in figure 10), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form the first passage extending through the body member (figure 12), a cutting means (38, paragraph 39, the cutting can be a hard metal knife blade, as supported by the specification in paragraph 23 to read on the “cutting member”) for splitting a sheath passing through the first passage removably located within the first passage (figure 11-13, paragraph 44-45), and wherein the cutting means is positioned in the first passage in between the body and the removable mating means (figure 12).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 21-25, 27-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,492,938. Although the claims at issue are not identical, they are not patentably distinct from each other because, with respect to claim 21, the reference patent claims a torque device comprising: a body member (claim 1) including a first recessed area (claim 1); removable mating piece (claim 1) including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (claim 1), a cutting member (claim 1) removably located within the first passage (claim 1), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (claim 1) to slit a sheath (claim 1) through the first passage (claim 1).
As to claims 22-25, 27-32, 34 see reference patent claim 1.
As to claim 33, see reference patent claim 4.
As to claim 35, the reference patent claims an implant delivery device for delivering a medical implant operatively connected to an elongated wire (claim 1) comprising: a torque device (claim 1) comprising: a body member (claim 1) including a first recessed area (claim 1); removable mating piece (claim 1) including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (claim 1), a cutting member (claim 1) removably located within the first passage (claim 1), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (claim 1) to slit a sheath through the first passage (claim 1).
As to claims 36-39, see reference claim 1.
As to claim 40, the reference patent claims a torque device comprising: a body member (claim 1) including a first recessed area (claim 1); a removable mating means (claim 1) for forming a first passage (claim 1) through the body member, wherein the removable mating means including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form the first passage extending through the body member (claim 1), a cutting means (claim 1) for splitting a sheath passing through the first passage removably located within the first passage (claim 1), and wherein the cutting means is positioned in the first passage in between the body and the removable mating means (claim 1).
Claim 26 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,492,938 in view of U.S. Patent 5,261,887 to Walker.
As the claim 26, the reference patent claims the device above but is silent about the clamp mechanism comprises a collet and a screw member that is selectively contactable with the collet, so as to increase or decrease a diameter of the collet.
Walker teaches a similar device (catheter splitter) comprising a clamp mechanism (24, 26, 28, figure 1, col. 6 ll. 20-25,) comprises a collet (28) and a screw member (24) that is selectively contactable with the collet, so as to increase or decrease a diameter of the collet (col. 6 ll. 20-25) for the purpose of controlling the device tightening down on a wire. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the clamp mechanism of the reference patent comprise a collet and screw member that is selectively contactable with the collet, so as to increase or decrease a diameter of the collet in order to control the device tightening down on a wire.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,406,520. Although the claims at issue are not identical, they are not patentably distinct from each other because, with respect to claim 21, the reference patent claims a torque device comprising: a body member (claim 1) including a first recessed area (claim 1); removable mating piece (claim 1) including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (claim 1), a cutting member (claim 1) removably located within the first passage (claim 1), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (claim 1) to slit a sheath (claim 1) through the first passage (claim 1).
As to claims 22-25, 27-32, 34 see reference patent claim 1.
As to claim 26, see reference patent claim 2.
As to claim 33, see reference patent claim 7.
As to claim 35, the reference patent is directed an implant delivery device for delivering a medical implant operatively connected to an elongated wire (claim 1) comprising: a torque device (claim 1) comprising: a body member (claim 1) including a first recessed area (claim 1); removable mating piece (claim 1) including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (claim 1), a cutting member (claim 1) removably located within the first passage (claim 1), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (claim 1) to slit a sheath through the first passage (claim 1).
As to claims 36-39, see reference claim 1.
As to claim 40, the reference patent is directed a torque device comprising: a body member (claim 1) including a first recessed area (claim 1); a removable mating means (claim 1) for forming a first passage (claim 1) through the body member, wherein the removable mating means including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form the first passage extending through the body member (claim 1), a cutting means (claim 1) for splitting a sheath passing through the first passage removably located within the first passage (claim 1), and wherein the cutting means is positioned in the first passage in between the body and the removable mating means (claim 1).
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,076,261. Although the claims at issue are not identical, they are not patentably distinct from each other because, with respect to claim 21, the reference patent claims a torque device comprising: a body member (claim 1) including a first recessed area (claim 1); removable mating piece (claim 1) including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (claim 1), a cutting member (claim 1) removably located within the first passage (claim 1), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (claim 1) to slit a sheath (claim 1) through the first passage (claim 1).
As to claims 22, 23, 25, 27-32, 34 see reference patent claim 1.
As to claim 24, see reference patent claim 2.
As to claim 26, see reference patent claim 3.
As to claim 33, see reference patent claim 5.
As to claim 35, the reference patent is directed an implant delivery device for delivering a medical implant operatively connected to an elongated wire (claim 1) comprising: a torque device (claim 1) comprising: a body member (claim 1) including a first recessed area (claim 1); removable mating piece (claim 1) including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form a first passage extending through the body member (claim 1), a cutting member (claim 1) removably located within the first passage (claim 1), wherein the cutting member is positioned in the first passage in between the body ember and the removable mating piece (claim 1) to slit a sheath through the first passage (claim 1).
As to claims 36-39, see reference claim 1.
As to claim 40, the reference patent is directed a torque device comprising: a body member (claim 1) including a first recessed area (claim 1); a removable mating means (claim 1) for forming a first passage (claim 1) through the body member, wherein the removable mating means including a second recessed area (claim 1), wherein the first recessed area of the body member is aligned with the second recessed area of the removable mating piece to form the first passage extending through the body member (claim 1), a cutting means (claim 1) for splitting a sheath passing through the first passage removably located within the first passage (claim 1), and wherein the cutting means is positioned in the first passage in between the body and the removable mating means (claim 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 5,687,72 to Kraus (as cited reference A15 in the IDS filed 07/31/2024), U.S. Patent 6,497,681 to Brenner (as cited reference A4 in the IDS filed 07/31/2025), U.S. Patent Publication 2009/0049698 to Drake (as cited reference A41 in the IDS filed 07/31/2025), and U.S. Patent Publication 2014/0121753 to Dorn (as cited reference A25 in the IDS filed 07/31/2025) all disclose similar devices pertinent to the scope of the claims.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771