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 .
Detailed Action
This is in response to the non-provisional application filed 05/07/2024.
Claim Interpretation - 35 USC § 112(f)
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.
Allowable Subject Matter
Claims 6-9, are 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.
Claims 18-20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claims 6-8 recites wherein the primary engagement feature comprises: a body lumen having a body lumen diameter; and a channel operably coupled with the body lumen, the channel having a channel width less than the body lumen diameter. Claim 8 recites wherein the engagement feature further comprises one or more secondary engagement features disposed proximally of the primary engagement feature. Claim 18 recites wherein the primary engagement feature comprises: a body lumen having a body lumen diameter that is greater than the first diameter of the guidewire; and a channel operably coupled with the body lumen, the channel having a channel width that is less than the first diameter of the guidewire and greater than the second diameter of the guidewire.
The Office agrees the art of record fail to teach or suggest these features.
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 16-20 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 16 refers to “the body member” There is insufficient antecedent basis for this limitation. It appears from context the applicant might have intended to refer to the “working member”. If the applicant amends claim 16 to refer to the “working member” instead of the body member, the Office will withdraw the rejection.
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.
Claim(s) 1, 5, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 4,988,356 (Crittenden et al.)
Regarding claims 1, 5, 10 Crittenden et al. discloses as shown in Figures 7-10 a medical system, comprising: an introducer device including an elongate shaft (generally indicated as A) defining a shaft lumen therethrough, the elongate shaft including a proximal region, and a proximal hub (generally indicated as B) secured relative to the proximal region of the elongate shaft, the proximal hub including: a primary channel (generally indicated as C) extending through the proximal hub and fluidly coupled with the shaft lumen; a secondary channel (channel through which guide member 12 is slidably mounted through, see col. 4, lines 20-34) extending through the proximal hub and fluidly coupled with the shaft lumen; a guide catheter (guide member 12, see col. 4, lines 20-34) adapted to be advanced through the secondary channel and into the shaft lumen; a guidewire (guidewire 14, col. 4, lines 20-34) adapted to be advanced through the secondary channel; and a working catheter (catheter 10, see col. 4, lines 20-34) adapted to be advanced through the primary channel and into the shaft lumen when the guide catheter has been withdrawn proximally such that a distal end of the guide catheter is capable of remaining within the secondary channel, the working catheter including a catheter shaft including a distal region (region where catheter merges with guidewire is distal to the proximal end of the catheter and is thus considered a distal region, see col. 4, lines 54-68 and col. 6, lines 1-9), the distal region of the working catheter adapted to releasably engage the guidewire, wherein the distal region of the working catheter includes a distal body defining a primary engagement feature (opening through which guidewire 14 extends) adapted to releasably engage the guidewire, wherein the primary channel is curved (curved cross section) and the secondary channel is straight (extends in a straight direction) and intersects the primary channel. See annotated Figure 7 (provided below) and col. 4, lines 54-68 and col. 6, lines 1-9 and Figures 8-10 :
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Claim(s) 16, 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Number 6,231,543 (Hegde et al.)
Regarding claim 16, Hegde et al. discloses as shown in figure 3 a working catheter (catheter assembly, see col. 3, lines 16-18) capable of being be used in combination with an introducer device having a bifurcated hub, the bifurcated hub defining a first passageway adapted to accommodate the working catheter and a second passageway adapted to accommodate a guide catheter and a guidewire, the second passageway intersecting the first passageway, the guidewire having a first diameter outside of an engagement region and a second diameter less than the first diameter within the engagement region, the working catheter comprising: an elongate catheter shaft extending from a proximal region to a distal region; a working member secured within the distal region, the working member comprising: a primary engagement feature (seal 30, see col. 4, lines 14-43) that is adapted to releasably secure the body member to a guidewire; and one or more secondary engagement features (valve 40, see col. 4, lines 46-65) that are each adapted to releasably secure the body member to the guidewire, wherein the working member further comprises a working feature (surfaces of seal 30 and valve 40 which engage the guidewire).
To be clear, claim 16 only recites a working catheter and not a guide catheter, guidewire, or an introducer device. Claim 16 only recites a working catheter capable of use with a guide catheter, guidewire, or an introducer device. The limitations relating to the guide catheter, guidewire, or an introducer device are interpreted as functional and the Office interprets Hegde et al. as disclosing them because a working catheter capable of use with guide catheter, guidewire, and an introducer device. See col. 3, lines 19-41.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 2, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,988,356 (Crittenden et al.) in view of U.S. Patent Publication Number 2023/0101242 (Steel et al.)
Regarding claim 2, Crittenden et al. fails to disclose a first hemostasis valve fluidly coupled with the primary channel; and a second hemostasis valve fluidly coupled with the secondary channel.
Steel et al., from the same field endeavor teaches a similar system as shown in Figure 1, where the system incudes a first hemostasis valve fluidly coupled with the primary channel; and a second hemostasis valve fluidly coupled with the secondary channel for the purpose of regulating the passage of fluid in each of the channels. See paragraph [0078].
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 medical system disclosed by Crittenden et al. to include a first hemostasis valve fluidly coupled with the primary channel; and a second hemostasis valve fluidly coupled with the secondary channel as suggested by Steel et al. in order to regulate the passage of fluid in each of the channels.
Regarding claim 3, Crittenden et al. in view of Steel et al. fail to disclose a third hemostasis valve disposed between the proximal hub and the elongate shaft, thereby providing a fluid tight volume within the primary channel and the secondary channel.
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 system disclosed by Crittenden et al. in view of Steel to include a third hemostasis valve because it would only require the duplication of parts without producing a new and unexpected result (would still regulate the passage of fluid through the device). See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
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 system disclosed by Crittenden et al. in view of Steel such that third hemostasis valve disposed between the proximal hub and the elongate shaft, thereby providing a fluid tight volume within the primary channel and the secondary channel because it would only require a rearrangement of parts without changing how the device operates (would still regulate the passage of fluid through the device). see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,988,356 (Crittenden et al.) in view of U.S. Patent Publication Number 2003/0171642 (Schock et al. et al.)
Regarding claim 4, Crittenden et al. fails to disclose wherein the guidewire has a first diameter over the guidewire outside of an engagement region, and a second diameter less than the first diameter within the engagement region.
Schock et al., from the same field of endeavor teaches a similar system with a guidewire with an engagement region as shown in Figure 4B where the guidewire has a first diameter over the guidewire outside of an engagement region, and a second diameter less than the first diameter within the engagement region. See paragraph [0046].
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 medical system disclosed by Crittenden by substituting the guidewire disclosed by Crittenden for the one taught by Schock et al. such that the guidewire has a first diameter over the guidewire outside of an engagement region, and a second diameter less than the first diameter within the engagement region because it would only require the simple substitution of one known alternative for another to produce nothing but predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
Claim(s) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Number 4,988,356 (Crittenden et al.) in view of U.S. Patent Publication Number 2023/0101242 (Steel et al.)
Regarding claims 11-13 Crittenden et al. discloses as shown in Figures 7-10 a medical system, comprising: an introducer device including an elongate shaft (generally indicated as A) defining a shaft lumen therethrough, the elongate shaft including a proximal region, and a proximal hub (generally indicated as B) secured relative to the proximal region of the elongate shaft, the proximal hub including: a primary channel (generally indicated as C) extending through the proximal hub and fluidly coupled with the shaft lumen; a secondary channel (channel through which guide member 12 is slidably mounted through, see col. 4, lines 20-34) extending through the proximal hub and fluidly coupled with the shaft lumen; a guide catheter (guide member 12, see col. 4, lines 20-34) adapted to be advanced through the secondary channel and into the shaft lumen; a guidewire (guidewire 14, col. 4, lines 20-34) adapted to be advanced through the secondary channel; and a working catheter (catheter 10, see col. 4, lines 20-34) adapted to be advanced through the primary channel and into the shaft lumen when the guide catheter has been withdrawn proximally such that a distal end of the guide catheter is capable of remaining within the secondary channel, the working catheter including a catheter shaft including a distal region (region where catheter merges with guidewire is distal to the proximal end of the catheter and is thus considered a distal region, see col. 4, lines 54-68 and col. 6, lines 1-9), the distal region of the working catheter adapted to releasably engage the guidewire, wherein the distal region of the working catheter includes a distal body defining a primary engagement feature (opening through which guidewire 14 extends) adapted to releasably engage the guidewire, wherein the primary channel is curved (curved cross section) and the secondary channel is straight (extends in a straight direction) and intersects the primary channel. See annotated Figure 7 (provided below) and col. 4, lines 54-68 and col. 6, lines 1-9 and Figures 8-10 :
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Crittenden et al. fails to disclose the hub including: a first hemostasis valve disposed at a proximal end of the hub; a second hemostasis valve disposed at the proximal end of the hub, the second hemostasis valve parallel with but spaced from the first hemostasis valve.
Steel et al., from the same field endeavor teaches a similar system as shown in Figure 1, where the system incudes a hub with a hemostasis valve for the purpose of regulating the passage of fluid in each of the channels. See paragraph [0078].
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 medical system disclosed by Crittenden et al. to include a first hemostasis valve disposed at a proximal end of the hub as suggested by Steel et al. in order to regulate the passage of fluid through a proximal end of the hub.
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 system disclosed by Crittenden et al. in view of Steel to include a second hemostasis disposed at the proximal end of the hub, the second hemostasis valve parallel with but spaced from the first hemostasis valve because it would only require the duplication of parts without producing a new and unexpected result (would still regulate the passage of fluid through the device). See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Regarding claim 13, So modified, the Office interprets Crittenden et al. in view of Steel et al. as disclosing wherein the secondary channel extends linearly through the hub from the second hemostasis valve to an intersection between the primary channel and the secondary channel. See Figure 7 and rejection of claim 11.
Regarding claim 14, Crittenden et al. in view of Steel et al. fail to disclose a diameter of the secondary channel narrows from proximal to distal.
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 system disclosed by Crittenden et al. in view of Steel et al. such that a diameter of the secondary channel narrows from proximal to distal as a matter of engineering design choice. Applicant has not disclosed narrowing of the channel’s diameter provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0048].
One of ordinary skill in the art, furthermore, would have expected Crittenden’s channel, and applicant’s invention, to perform equally well with either the diameter taught by Crittenden or the claimed narrowing diameter because both spacing dimensions would perform the same function of providing a space to advance a guidewire or catheter equally well considering the relative dimensions disclosed.
Regarding claim 15, Crittenden et al. in view of Steel et al. fail to disclose a third hemostasis valve fluidly coupled between the primary channel and the shaft lumen, thereby providing a fluid-tight volume between the first hemostasis valve, the second hemostasis valve and the third hemostasis valve.
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 system disclosed by Crittenden et al. in view of Steel to include a third hemostasis valve because it would only require the duplication of parts without producing a new and unexpected result (would still regulate the passage of fluid through the device). See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
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 system disclosed by Crittenden et al. in view of Steel such that a third hemostasis valve fluidly coupled between the primary channel and the shaft lumen, thereby providing a fluid-tight volume between the first hemostasis valve, the second hemostasis valve and the third hemostasis valve because it would only require a rearrangement of parts without changing how the device operates (would still regulate the passage of fluid through the device). see In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G LOUIS whose telephone number is 571-270-1965. The examiner can normally be reached on Monday – Friday, 9:30 – 6:00 pm.
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/RICHARD G LOUIS/ Primary Examiner, Art Unit 3771