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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference numeral “425” in Fig. 6A, reference numeral “455b” in Figs. 6A-6B, and reference numeral “434” in Fig. 9. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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(s) is/are: “a locking mechanism” in claims 1, 16 and 18; and “a hub feature” in claim 1.
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 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.
Regarding claims 16 (and thereby dependent claim 17), the phrase "the hub" in lines 3, 10 and 11 renders the claim(s) indefinite because claim 16 expressly includes references to each of “the dilator hub”, “the hub housing”, “the hub lumen”, and “the hub backloading element” thereby rendering the scope of the claim(s) unascertainable. It is unclear to which “hub” structure applicant specifically intended to refer back to from the broad list introduced “hub” structures. To move prosecution forward, the examiner assumed applicant intended to refer back to the “dilator hub” of line 2 (but consistent use of the selected full nomenclature for each limitation will cure any ambiguity/uncertainty). Appropriate correction is required.
Regarding claims 18 (and thereby dependent claims 19-20), the phrase "the hub" in lines 5, 13 and 14 renders the claim(s) indefinite because claim 18 expressly includes references to each of “the dilator hub”, “the hub housing”, “the hub lumen”, and “the hub backloading element” thereby rendering the scope of the claim(s) unascertainable. It is unclear to which “hub” structure applicant specifically intended to refer back to from the broad list introduced “hub” structures. To move prosecution forward, the examiner assumed applicant intended to refer back to the “dilator hub housing” of line 5 (but consistent use of the selected full nomenclature for each limitation will cure any ambiguity/uncertainty). Appropriate correction is required.
Claim 18 (and thereby dependent claims 19-20) recites the limitation "the target tissue" in line 24. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-4, 6 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bierman (US 2019/0269890).
Bierman discloses (see Figs. 1-11B and 27A-27B) a guidewire-locking dilator system comprising the following claim limitations:
(claim 1) A dilator hub (38) for use within a crossing device for facilitating access to a patient’s heart for coupling with one or more sheaths (see claim 1; [0002]; [0005]), the dilator hub (38) comprising: a dilator hub housing (70/72) defining a hub lumen (lumen shown in cross-sections of Figs. 3B and 4B) extending through the dilator hub housing (70/72), wherein the dilator hub housing (70/72) defines an outer diameter and the hub lumen defines an inner diameter (as shown in Figs. 3A-4C); a locking mechanism (30), disposed within the dilator hub housing (70/72), wherein the locking mechanism (30) engages with the hub lumen such that the locking mechanism (30) is configured to (i.e., capable of) secure a guidewire (28) to the hub lumen (as shown in Figs. 27A-27B); and a hub feature (78) disposed on an outer surface of the dilator hub housing (70/72) (as shown in Fig. 4B) wherein the hub feature (78) defines a feature diameter, wherein the feature diameter is larger than the outer diameter of the dilator hub housing (70/72) (as shown in Figs. 3A-4B and 6; [0083]; luer connection expressly provided on the exterior of the dilator hub housing);
(claim 2) wherein the locking mechanism (30) is configured within the hub housing (70/72) (as shown in Figs. 3B and 4B), and wherein the locking mechanism (30) is configured to (i.e., capable of) transition between a locked position and an unlocked position, wherein in the unlocked position the guidewire (28) is movable within the hub lumen (see exemplary Fig. 27A; [0102]), and wherein in the locked position the guidewire (28) is secured within the hub lumen (see Figs. 7A, 11A and 27B; [0070]-[0073]; [0093]; [0100]);
(claim 3) wherein in the unlocked position the hub housing (70/72) defines a variable outer diameter (as expressly shown in annotated Fig. 27A below);
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(claim 4) wherein in the locked position the hub housing (70/72) defines a uniform outer diameter (as expressly shown in annotated Fig. 27B below);
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(claim 6) wherein the locking mechanism (30) secures the guidewire (28) centrally within the hub lumen (as expressly shown in Figs. 6 and 27B); and
(claim 15) wherein the hub feature (78) is at least one ramp (at 78) disposed on the outer surface the dilator hub housing (70/72) (as shown in Figs. 3B-4B), wherein the at least one ramp (at 78) defines a proximal side and a distal side, and wherein the at least one ramp (at 78) increases in diameter from the proximal side to the distal side (as expressly shown in Figs. 4A-4B, tapering connector portion 78 increases in diameter from its proximal (to the patient) side to its distal (to the patient) side).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 and 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bierman as applied to claims 1-2 above, and further in view of Scopton et al. (US 2007/0293719).
Bierman, as applied above, discloses a guidewire-locking dilator system comprising all the limitations of the claim except for wherein the locking mechanism positions the guidewire against an inner surface of the hub lumen, and wherein the hub feature element defines an exoskeleton defining a collapsible frame, wherein the exoskeleton comprises nickel titanium.
However, regarding claim 5, Scopton teaches (see Figs. 16-17) a similar guidewire locking system comprising a locking mechanism (742) that positions the guidewire (22) against an inner surface of the hub lumen (as shown in Figs. 16-17). Accordingly, Scopton teaches that it is known that a unilateral locking arm and symmetrical bilateral locking arms are elements that are functional equivalents for securing the position of a guidewire relative to surgical instrumentation through which the guidewire passes ([0060]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the unilateral locking arm taught by Scopton for the symmetrical bilateral locking arms of Bierman because both elements were known equivalents for providing securing the position of a guidewire relative to surgical instrumentation through which the guidewire passes. The substitution would have resulted in the predictable results of providing a mechanism for securing the position of a guidewire to the device of Bierman.
Regarding claim 13, Scopton teaches (see Figs. 22-23) a similar guidewire locking system wherein the hub feature element defines an exoskeleton (1030) defining a collapsible frame (1038) (as shown between Figs. 22-23; [0065]-[0067]), wherein the exoskeleton (1030) comprises nickel titanium ([0066]) in order to beneficially provide a stent-like locking mechanism on the exterior of a shaft to allow for selectively collapsing and securing two system component together via radial compression ([0065]-[0067]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Bierman to have the hub feature element define an exoskeleton defining a collapsible frame, wherein the exoskeleton comprises nickel titanium in order to beneficially provide a stent-like locking mechanism on the exterior of a shaft to allow for selectively collapsing and securing two system component together via radial compression, as taught by Scopton.
Claim(s) 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Bierman as applied to claim 1 above, and further in view of Lindekugel et al. (US 2023/0129318).
Bierman, as applied above, discloses a guidewire-locking dilator system comprising a connection portion (78) that may include a luer type connection or any other type of connection wherein the male and female connectors can be reversed ([0083]; [0089]-[0090]). Bierman fails to expressly disclosed the hub feature comprising a cap configured to engage the outer surface of the dilator hub housing via protrusions and a cavity having a treaded frictional engagement or an elastic material that is deformable to receive a therapy sheath.
However, Lindekugel teaches a similar guidewire locking system comprising releasable connections between hubs and additional system components comprising either conventional luer lock connections ([0044]) having a cap (i.e., the rotatable luer lock cap) configured to engage the outer surface of the dilator hub housing via protrusions (i.e., threads) and a cavity (i.e., recess/cavity between adjacent threads) having a threaded frictional engagement (i.e., a conventional luer lock) or an elastic material that is deformable to receive a therapy sheath ([0044]; i.e., a conventional snap-fit connection expressly disclosed). Accordingly, Lindekugel teaches that it is known that conventional luer lock or snap-fit connections and luer slip connections are elements that are functional equivalents for releasably engaging a system hub with other system components ([0044]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted a conventional luer lock or snap-fit connection as taught by Lindekugel for the luer slip connection of Bierman because both elements were known equivalents for providing a releasable engagement between a system hub and other system components. The substitution would have resulted in the predictable results of providing a releasable engagement between a hub and other components to the device of Bierman.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bierman as applied to claim 1 above, and further in view of Almutawa (US 2024/0100301).
Bierman, as applied above, discloses a guidewire-locking dilator system comprising all the limitations of the claim except for the hub feature comprising an expanding collet defining a variable collet diameter, wherein the variable collet diameter is variable between a contracted diameter and an expanded diameter, wherein the contracted diameter is smaller than a therapy sheath inner diameter, and the expanded diameter is larger than the therapy sheath inner diameter.
Regarding claim 14, Almutawa teaches (see Fig. 7C) a similar guidewire locking system wherein the hub feature (760/772) comprising an expanding collet defining a variable collet diameter (i.e., variable diameter portion 772 internally contracts during insertion and externally expands when at rest and locked within recess 766; [0065]), wherein the variable collet diameter is variable between a contracted diameter (i.e., during insertion into sleeve 764, hinge 772 flexes/contracts radially inward) and an expanded diameter (as shown at rest in Fig. 7C and when tab 770 is locked within recess 766), wherein the contracted diameter is smaller than a therapy sheath inner diameter (i.e., during insertion into sleeve 764, hinge 772 with tab 770 flexes/contracts radially inward to fit within sheath/sleeve 764), and the expanded diameter is larger than the therapy sheath inner diameter (as shown at rest in Fig. 7C and when tab 770 is locked within recess 766) in order to beneficially provide a selectively removable connection between the hub and an adjacent system component, further preventing axial movement therebetween, and allowing for selective disconnection as desired by a user ([0065]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device of Bierman to have the hub feature comprising an expanding collet defining a variable collet diameter, wherein the variable collet diameter is variable between a contracted diameter and an expanded diameter, wherein the contracted diameter is smaller than a therapy sheath inner diameter, and the expanded diameter is larger than the therapy sheath inner diameter in order to beneficially provide a selectively removable connection between the hub and an adjacent system component, further preventing axial movement therebetween, and allowing for selective disconnection as desired by a user, as taught by Almutawa.
Allowable Subject Matter
Claims 16-20 are allowed. It is noted that claims 16-20 remain subject to 112 rejections that must be resolved before these claims can be in proper condition for allowance.
The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious an assembly for facilitating access to a patient’s heart or a method of providing therapy access within a patient’s body as claimed that includes, in combination with the claim(s) as a whole, a hub backloading element disposed about the hub housing wherein the hub backloading element defines an element diameter, wherein the element diameter is different than the outer diameter of the hub and the inner diameter of the hub. The closest prior art appears to be Bierman (US 2019/0269890) disclosing a similar guidewire-locking assembly, but failing to disclose or teach the dilator hub including a hub backloading element having a diameter different from the outer and inner diameters of the dilator hub.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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