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 .
Election/Restrictions
Applicant’s election without traverse of Species B (Fig. 4) in the reply filed on 9/18/2025 is acknowledged. Claims 1-17 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
“deflection-filter 142” in [0030]-[0034];
“connection mechanism 144” in [0034];
“connector 146” in [0034]; and
“screw 471” in [0045].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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 Objections
Claim 5 is objected to because of the following informalities: the extra comma after “device” in line 2 should be deleted to be grammatically correct. 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 1-17 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 1 recites “for locking a guidewire” in line 3. However, a guidewire is already recited in line 2 of claim 1. It is unclear if the locking is referring to the same guidewire introduced in line 2 or a new/additional guidewire. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret will interpret line 3 as - - for locking the guidewire - -.
Regarding claim 5, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 5 as - - wherein said embolic protection device comprises a filter or a deflector unit
Claim 6 recites the limitation "the tube" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "said tube" in line 2. There is insufficient antecedent basis for this limitation in the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “a dampening function”, and the claim also recites “preferably comprising one or more springs and/or one or more spring mechanisms” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 11 as having the term “preferably” deleted.
Claim 14 recites the limitation "the first state" in line 2 and “a third predetermined force level” in lines 4-5. There is insufficient antecedent basis for these limitations in the claim. The recitation of “a third predetermined force level” would imply there is a first and second predetermined force level. However, no such predetermined levels have been introduced into the claim language and therefore it is unclear in claim 14 how many predetermined force levels are required. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 14 as requiring just one predetermined force level.
Claim 16 recites the limitation "the first state" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation "a second predetermined force level" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. The recitation of “a second predetermined force level” would imply there is a first predetermined force level. However, no such predetermined level has been introduced into the claim language and therefore it is unclear in claim 17 how many predetermined force levels are required. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret claim 17 as requiring just one predetermined force level.
Claim(s) 2-4, 8, 10, 12, 13, 15 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
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 claim 1 because the term “mechanism” (generic placeholder) is coupled to the functional language of “for locking a guidewire relative to said handle” without further structural modifiers either preceding or following the generic placeholder. For the purpose of examination, the term will be read as a clamping box and screw (which is the disclosed corresponding structure, as described in paragraph [0044] of the published application) or an equivalent structure, which is any structure that performs the identical function of the generic placeholder(s) specified in the claim in substantially the same way.
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 § 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) 1-3. 5-10 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lepak et al (US 6214026).
Lepak et al disclose the following limitations:
Claim 1. An introducer assembly (50) for minimally invasive deployment of a medical device in a vessel (col. 1, ll. 11-17), the introducer assembly comprising: a guidewire (22); a handle (60) with a locking mechanism (61, 54) for locking the guidewire relative to said handle (col. 6, ll. 22-36)1;
a medical device (20) (col. 4, ll. 16-17); and
a delivery system (40) (col. 5, ll. 15-25; Figs. 5A, 5B).
Claim 2. The introducer assembly according to claim 1, wherein said medical device is an embolic protection device (20) (col. 4, ll. 16-17).
Claim 3. The introducer assembly according to claim 1, comprising a tube (64) with a lumen (65) for receiving said guidewire (col. 6, ll. 37-38).
Claim 5. The introducer assembly according to claim 2, wherein said embolic protection device comprises a filter (20) (col. 4, ll. 16-17).
Claim 6. The introducer assembly according to claim 5, wherein the tube (64) is indirectly attached to the embolic protection device (20) (Figs. 5A, 5B; col. 6, ll. 22-36; all elements of the assembly 50 as shown in Figs. 5A, 5B are considered attached to one another, indirectly, when the guidewire (22), which contains the embolic protection device (20), is clamped (attached) onto the handle (60).
Claim 7. The introducer assembly according to claim 2, wherein in use in said vessel a pressure on embolic protection device (20) by said tube (64) is controllable by a position of said guidewire relative said handle to control a position of said embolic protection device in said vessel (Figs. 5A, 5B; col. 6, ll. 22-36; all elements of the assembly 50 as shown in Figs. 5A, 5B are attached to one another, indirectly, when the guidewire (22), which contains the embolic protection device (20), is clamped onto the handle (60). Therefore, moving the position of one element would cause movement and change in position of another element since the assembly is all connected. Therefore, moving the guidewire relative to the handle when the guidewire is unlocked, then re-locking the guidewire onto the handle in its new position, and moving the tube, can cause the embolic protection device to apply a certain pressure onto the vessel.
Claim 8. The introducer assembly according to claim 1, including further comprising:
a tube (64) attached to the handle (60),
wherein the assembly is configured for the guidewire (22) to be drawn through the tube (Figs. 5A, 5B),
wherein the locking mechanism, is configured in the assembly such that the guidewire drawn through the tube is also drawn through the locking mechanism,
wherein the locking mechanism is in a first state configured to positionally lock the guidewire that is drawn through the locking mechanism and in a second state the locking mechanism is configured to allow the guidewire to positionally move col. 6, ll. 22-36).
Claim 9. The introducer assembly according to claim 1, wherein the locking mechanism comprises a lock unit (61, 54) and wherein the guidewire is positionally locked in relation to the lock unit (Figs. 5A, 5B; col. 6, ll. 22-36).
Claim 10. The introducer assembly according to claim 9, wherein the lock unit is configured to clamp the guidewire in a first state (Figs. 5A, 5B; col. 6, ll. 22-36).
Claim 17. The introducer assembly according to claim 8, wherein the locking mechanism is further configured in the first state to change to the second state if the guidewire is subjected to a force in relation to the locking mechanism that is above a second predetermined force level (Figs. 5A, 5B; col. 6, ll. 22-36; if the cap 52 is not securely fastened all the way to the handle (not tightening the threads all the way) and loosely locks the guidewire, the guidewire can be moved with enough force).
Claim(s) 1, 4, 9-11 and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Look et al (US 20200121356).
Look et al discloses the following limitations:
Claim 1. An introducer assembly (Figs. 18-20, 36) for minimally invasive deployment of a medical device in a vessel, the introducer assembly comprising: a guidewire (4102 in Fig. 36 showing the distal end of the assembly); a handle (190 in Figs. 18-20 showing the proximal end of the assembly) with a locking mechanism (192, 200) for locking the guidewire relative to said handle ([0062], [0063])2;
a medical device (4168) ([0103]; Fig. 36); and
a delivery system (4000) ([0103]; Fig. 36).
Claim 4. The introducer assembly according to claim 1, wherein said locking mechanism includes at least one spring (204) arranged to provide limited relative movement of the guidewire relative the handle while in a locked state of the locking mechanism (Fig. 19; spring 204 distally biases outer tubing 198, thereby keeping the assembly in a locked state and limiting the relative movement of the guidewire relative to the handle).
Claim 9. The introducer assembly according to claim 1, wherein the locking mechanism comprises a lock unit (198, 200) and wherein the guidewire is positionally locked in relation to the lock unit (Fig. 19; [0062], [0063]).
Claim 10. The introducer assembly according to claim 9, wherein the lock unit is configured to clamp the guidewire in a first state (Fig. 19; [0062], [0063]).
Claim 11. The introducer assembly according to claim 9, wherein the locking mechanism further comprises a dampening function that comprises a spring (204), wherein the spring is linear or progressive ([0062], [0063], the spring provides a dampening function between Figs. 19 and 20 when the trigger 196 is pressed, dampening rearward movement of outer tubing 198. The spring can only be linear or progressive and therefore encompasses the claim language as Applicant has claimed it in the alternative).
Claim 13. The introducer assembly according to claim 11, wherein the dampening function is asymmetrical in relation to the lock unit (Figs. 19, 20; the spring is only on the proximal side of the locking mechanism and is therefore asymmetrical).
Allowable Subject Matter
Claim 12 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 and rewritten to obviate the 35 U.S.C. 112 rejections as interpreted by the Examiner above.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Look et al, discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed introducer assembly comprising, inter alia, the dampening function is symmetrical in relation to the lock unit. Instead, the dampening function (via spring 204) of Look et al is asymmetrical and only placed on the proximal side of the locking mechanism to bias the outer tubing 198 distally to keep the locking mechanism in a locked state in the spring’s resting configuration. It would not have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the spring of Look et al to thereby make the dampening function symmetrical (both on the proximal and distal sides of the locking mechanism) as that would render the spring 204 inoperable for its intended purpose of providing distal bias to maintain the guidewire in its locked state. Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
1The male screw thread 61 and female screw thread 54 of cap 52 in the device Lepak et al clamps onto the guidewire to thereby lock the guidewire and is therefore considered an equivalent of Applicant’s locking mechanism in light of the 35 U.S.C. 112(f) claim interpretation.
2 The outer tubing 198 and the wedge tube 200 of Look et al clamps onto the guidewire to thereby lock the guidewire and is therefore considered an equivalent of Applicant’s locking mechanism in light of the 35 U.S.C. 112(f) claim interpretation.