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 .
Response to Arguments
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive.
Applicant argues that Miller fails to disclose or suggest “the proximal end being operatively associated with a control on the handle for moving the proximal occluder toward and away from the distal occluder” as required in amended claim 1. Applicant explains that Miller fails to disclose or suggest a connection between the pushing member (push rod 320/proximal implant delivery tube 330E) and the proximal occluder by which the proximal occluder could be moved or retracted in a proximal direction, away from the distal occluder. Applicant states that the pushing members can only push in a distal direction.
The examiner respectfully disagrees. The examiner notes that the claim does not require direct connection between the proximal end of the proximal control shaft and the proximal occluder not the handle, but just to be “operatively associated”. The examiner further notes that “the proximal end being operatively associated with a control on the handle for moving the proximal occluder toward and away from the distal occluder” is functional language. Therefore, the device needs only to be capable of moving the proximal occluder toward and away from the distal occluder. Miller discloses a proximal control shaft (interpreted as proximal implant delivery tube 330E) having proximal 440 and distal ends 435 (Fig. 17, para. 0068, 0077), the distal end 435 being connected to the proximal occluder (see Figs. 32-35, para. 0070), the proximal end being operatively associated with a control on the handle for moving the proximal occluder toward the distal occluder (para. 0077 discloses that the proximal implant deliver tube 330E may move the proximal occluder toward the distal occluder via. second trigger 337E of the handle) and away from the distal occluder (para. 0077 further discloses that the proximal implant deliver tube is capable of being withdrawn via. a control of the handle and is thereby capable of moving the proximal occluder away from the distal occluder before the occluders lock together). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant argues that there is no basis to assume that the overtube is capable of being moveable between the positions as defined in amended claim 1 and therefore fails to disclose a disabling member selectively moveable between a first position in which it prevents engagement between the locking elements and a second position that enables engagement of the locking elements with each other to selectively prevent or permit engagement of the locking elements with each other.
The examiner respectfully disagrees. Para. 0072 of Miller discloses that the overtube “telescopically projects over distal implant delivery tube 310E and distal implant locking tube 220E of distal implant 205E”. Since the overtube is meant to project over the distal implant locking tube 220E of distal implant 205E, the overtube must project over recesses 265E, thereby preventing engagement between the recesses 265E and tangs 300E (para. 0072, 0074 of Miller) in a first position. This is further supported by the method of use which discloses that the distal implant 205E is deployed first while maintaining a connection with the retention tube and the locking tube extends proximally through the blood vessel, thereby indicating a second position where the locking tube 220E is not covered by the over tube to enable engagement of the locking elements Miller further discloses that enables engagement of the locking elements with each other to selectively prevent or permit engagement of the locking elements with each other (Figs. 73-77, para. 0075-0077 of Miller). The examiner further notes that the limitation is still functional. Therefore, the overtube needs only to be capable of performing the claimed function in order for the limitation to be met.
Drawings
The drawings are objected to because throughout the figures 1-15, the lines, numbers and letters are not uniformly thick and well defined (for example, see Figs. 1-2, 7, 9-10 and 14); and numbers and reference characters are not plain and legible for all figures (for example, see Figs, 1-2). This applies to shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color. The use of shading in the drawings fail to aid in understanding of the invention and it reduces legibility. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. See 37 CFR 1.84 (m) and (I). Furthermore, the use of photographs, as such in Fig. 14, are not ordinarily permitted in utility applications unless they are the only practicable medium for illustrating the claimed invention. See 37 CFR 1.84 (b) and MPEP 608.02 V.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
Claims 1-3, 7-9, 12, 14, and 15 are objected to because of the following informalities:
Claims 1 (lines 8 and 14), claim 2 (line 2), claim 14 (lines 3 and 5): “the legs” should recite “the plurality of legs” for consistency purposes.
Claim 1, line 8: “the legs” should recite “the plurality of legs of the distal occluder”.
Throughout claims 1-2, 7-9, and 14-15, “the occluders” are recited therein. However, the claims should recite “the distal and proximal occluders” or “the distal occluder and the proximal occluder” for consistency purposes.
Claim 3 (line 2 and lines 6-7): “the proximal end” should recite “a proximal end”.
Claim 3 (line 10), claim 7 (line 3): “the telescoping portion” should recite “the telescopically connectible portion”.
Claim 7, line 5: “the tubular body” should recite “the tubular proximal body”.
Claim 9 (line 9): “locking post” should recite “the locking post”.
Claim 9 (lines 7-9): “whereby locked occluders can be unlocked by advancing the distal occluder and locking post proximally to cause the distal portion of locking post may engage and urge the at least one tang outwardly to its stressed position, disengaged from the detent notch” should recite “whereby the proximal and distal occluders are configured to be unlocked by advancing the distal occluder and the locking post proximally to urge the at least one tang outwardly to the stressed position, disengaged from the detent notch” for grammatical purposes.
Claim 12 (line 3): “said separation” should recite “separation”.
Claim 4 was cancelled, however, claim 12 still depends from claim 4. Claim 12 should depend from claim 3.
Claim 15 (lines 2-3): “the walls of the blood vessel” should recite “walls of the blood vessel”.
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(s) is/are:
“a locking element engageable with a locking element of the other occluder” in claim 1. The limitation describing the locking elements of the proximal and distal occluders fail to include sufficient structure to perform the recited function of "locking ". The specification describes the locking elements of the proximal and distal occluders as one or more tangs of the proximal occluder engageable with a notch or detent groove of the distal occluder (para. 0025 of the instant application). Therefore, the locking elements are interpreted as one or more tangs engageable with a notch/detent groove or any structural equivalent thereof that is engageable with one another to lock the proximal and distal occluders together.
“a portion that is telescopically connectible with a portion of the other occluder” in claim 1. The limitation describing the telescoping portions of the proximal and distal occluders fail to include sufficient structure to perform the recited function of "telescoping ". The specification describes the telescoping portions of the proximal and distal occluders as a tubular body of the proximal occluder telescopically connectible with a locking post of the distal occluder (para. 0025 of the instant application). Therefore, the telescoping portions are interpreted as a tubular body engageable telescopically connectible with a locking post or any structural equivalent thereof of the proximal and distal occluders that telescopically connectible with each other.
“disabling member” in claims 1, 12, and 13. The limitation describing the disabling member (selectively moveable between a first position in which it prevents engagement between the locking elements and a second position that enables engagement of the locking elements with each other to selectively prevent or permit engagement of the locking elements with each other; functional language) fails to include sufficient structure to perform the recited function of "disabling ". The specification describes the disabling member as a shaft or tube (para. 0026 of the instant application). Therefore, the disabling member is interpreted as a shaft, tube, or any structural equivalent thereof that is selectively moveable between a first position in which it prevents engagement between the locking elements and a second position that enables engagement of the locking elements with each other to selectively prevent or permit engagement of the locking elements with each other.
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 1-3, 5-10, and 12-15 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 the limitation "the proximal legs" in line 12. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation is interpreted as “the plurality of legs of the proximal occluder”.
Claim 1 recites the limitation “the handle” in line 18. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation is interpreted as “a handle”.
Claim 3 recites the limitation “a handle” in line 2. It is unclear to the examiner if the handle introduced in claim 1 is the same or different than the handle discussed in claim 1, line 18. For examination purposes, the limitation is interpreted as “the handle”.
Claim 7 recites the limitation “the tang” in line 9. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the limitation is interpreted as “the at least one tang”.
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) 1-3, 5-10, and 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 20180021044) [hereinafter Miller].
Regarding claim 1, Miller discloses an apparatus (Fig. 42, 73, para. 0072, 0075) for temporarily controlling blood loss from a blood vessel 77 (para. 0069-0070) comprising:
a delivery tube 305E having a distal outlet (Figs. 8, 21, 73, para. 0075);
a distal occluder 205E contained in the delivery tube 305 (Figs. 21-23, para. 0069) and comprising a distal body 215E and a plurality of legs 235E extending from the distal body 215E (Fig. 42, para. 0072) and which may assume (i) a diametrically reduced delivery configuration in which it can be contained in the delivery tube 305 (Figs. 21-23, para. 0062, 0072) and (ii) a diametrically expanded deployed configuration in which the legs 235E are extended radially of the distal body 215E (Fig. 42, para. 0062, 0064, 0072);
a proximal occluder 210E contained in the delivery tube 305 proximally of and separate from the distal occluder 205E (Figs. 34-35, 43, para. 0062, 0069, 0072), the proximal occluder 210E comprising a proximal body 275E and a plurality of legs 295E extending from the proximal body 275E (Figs. 42-43, para. 0065, 0072), the proximal legs (interpreted as the legs 295E of the proximal occluder 210E, see 112(b) rejection above) being configured to assume (i) a diametrically reduced delivery configuration in which it can be contained in the delivery tube (Fig. 7, para. 0065, 0072) and (ii) a diametrically expanded deployed configuration in which the legs 295E of the proximal occluder 210E are extended radially of the proximal body 275E (Fig. 42-43, para. 0065, 0072);
a proximal control shaft 330E having proximal 440 and distal ends 435 (Fig. 17, para. 0068, 0077), the distal end 435 being connected to the proximal occluder (see Figs. 32-35, para. 0070), the proximal end being operatively associated with a control on the handle for moving the proximal occluder toward the distal occluder (para. 0077 discloses that the proximal implant deliver tube 330E may move the proximal occluder toward the distal occluder via. second trigger 337E of the handle) and away from the distal occluder (para. 0077 further discloses that the proximal implant deliver tube is capable of being withdrawn via. a control of the handle and is thereby capable of moving the proximal occluder away from the distal occluder before the occluders lock together);
the proximal and distal occluders 205E, 210E, when deployed, being adjustably movable toward and away from each other thereby controllably varying the degree to which a blood vessel disposed between the occluders can be occluded (Figs. 32-39, para. 0069-0070, 0072);
each occluder 205E, 210E, when deployed, having a portion that is connectible with a portion of the other occluder (para. 0072, 0074), each of the connectible portions having a locking element engageable with a locking element of the other occluder, thereby to lock the deployed occluders together (para. 0072, 0074, 0077); and
a disabling member (overtube, not shown) selectively moveable between a first position in which it prevents engagement between the locking elements and a second position that enables engagement of the locking elements with each other to selectively prevent or permit engagement of the locking elements with each other (para. 0072, 0075, 0077; see note below).
Note: The limitation “selectively moveable between a first position in which it prevents engagement between the locking elements and a second position that enables engagement of the locking elements with each other to selectively prevent or permit engagement of the locking elements with each other” is interpreted as functional language and intended use of the claimed invention. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Miller discloses an overtube, interpreted as the claimed disabling member, that telescopically projects over distal implant delivery tube 310E and distal implant locking tube 220E of distal implant/occluder 205E. Therefore, the overtube is positioned over the distal implant delivery tube 310E and the distal implant locking tube 220E (see para. 0072). Furthermore, para. 0075-0077 discloses that the proximal implant is slidably disposed about the distal implant retention tube 310E and when the proximal occluder 210E is distally being advanced, the distal implant retention tube 310E is held in place. Since the overtube is telescopically positioned over the distal implant locking tube 220E, the overtube must be capable of being selectively moveable between a first position in which it prevents engagement between the locking elements (para. 0072 discusses the first position in which the distal implant locking tube 220E is covered by the overtube) and a second position that enables engagement of the locking elements with each other of the occluders 205E, 210E (Fig. 73, para. 0075 discusses the second position in which the distal implant locking tube extends proximally though the blood vessel, thereby the overture must be moved proximally to expose the locking tube) to selectively prevent or permit engagement of the locking elements with each other such that the user may extend the overtube to be disposed over the distal implant locking tube 220E to prevent the locking elements from engaging with each other (para. 0072) or may retract the overtube to expose the distal implant locking tube 220E of the distal occluder 205E to connect and lock with the proximal occluder 210E, while still maintaining the connection between the distal implant delivery tube 310E and the distal implant locking tube 220E as shown in Figs. 74-77. Therefore, Miller discloses the structural component required i.e. the disabling member/overtube for the functional limitation. The examiner notes that a recitation of the intended use of the claimed invention and/or functionality of the claimed invention the must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, Miller discloses the legs 235E, 295E of the occluders 205E, 210E being interdigitated when the occluders 205E, 210E are locked together in the absence of tissue between the occluders 205E, 210E (Fig. 77, para. 0066, 0077).
Regarding claim 3, Miller discloses a handle 332E at the proximal end of the apparatus (Fig. 73, para. 0075), the delivery tube 305E being mounted to the handle for movement in a proximal direction from a distal position (Fig. 73, para. 0075),
the distal occluder 205E having an integral, proximally extending locking post 220E (Figs. 42, 73, para. 0072);
a distal retention shaft 310E fixed to the handle (Figs. 48-50, 73-74, para. 0072, 0075; The examiner notes that since the distal retention shaft 310 is not disclosed to detach from the handle, it is interpreted as being fixed to the handle), and detachably connected to the proximal end of the locking post 220E (Figs. 48-50, 77, para. 0072, 0077), thereby to maintain a relative position of the distal occluder 205E during retraction of the delivery tube 305E from its distal position (Figs. 73-74, para. 0075-0077);
the locking post 220E comprising the portion of the distal occluder 205E that is connectible to the proximal occluder 210E (Figs. 42-45, para. 0074).
Regarding claim 5, Miller discloses wherein the connection between the proximal control shaft 330E and the proximal occluder 210E is separable by manipulation from the handle (Figs. 73-77, para. 0077).
Regarding claim 6, Miller discloses wherein the locking element of the distal occluder 205E comprises a detent notch 265E formed on the locking post (Fig. 46, para. 0072).
Regarding claim 7, Miller discloses further comprises: the proximal body of the proximal occluder 210E is tubular and comprises the connectible portion of the proximal occluder 210E and is receptive to the locking post 220E (Fig. 46, para. 0072, 0074);
at least one tang 300E formed from the tubular proximal body (Fig. 46, para. 0074), the at least one tang 300E having an unstressed configuration that projects radially inwardly of the tubular proximal body (Figs. 46-47, para. 0074), the at least one tang 300E having sufficient resilience to be urged radially outwardly to a stressed position from its unstressed position (interpreted as the position when the at least one tang is not within the grooves/recesses 245E of distal occluder 205, para. 0077), when in its unstressed configuration, being engageable with the detent notch 245E of the locking post, thereby locking the occluders together (Figs. 46-47, para. 0074, 0077).
Regarding claim 8, Miller discloses wherein the disabling member (overtube, not shown but described in para. 0072) comprises:
a disabling tube (interpreted as the tubular body of the overtube) disposed between the locking post 220E and proximal body of the proximal occluder 210E (para. 0072 discloses the overtube is positioned over the distal implant delivery tube 310E and distal locking tube 220E which comprises the locking element of the distal occluder 205E (para. 0072). Since, the overtube is meant to be positioned over and thereby covering the distal locking tube 220E which comprises the locking element of the distal occluder 205E and is movable to allow separation of the distal implant delivery and distal locking tube, the overtube must be retracted to be disposed between the locking post 220E and proximal body of the proximal occluder 210E in order to allow the proximal occluder to lock with the distal occluder and to allow separation between the distal implant delivery and distal locking tube (para. 0076-0077)), and being movable between a distal position in which it blocks engagement of the locking elements of the proximal and distal occluders and a retracted position in which the engagement of the locking elements of the occluders is enabled (see note below).
Note: The limitation “being movable between a distal position in which it blocks engagement of the locking elements of the proximal and distal occluders and a retracted position in which the engagement of the locking elements of the occluders is enabled” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Miller discloses the structural component i.e. the disabling member (overtube, para. 0072) to necessitate the functional language of claim 8. Miller discloses that internal locking rod 436E (Figs. 48-50, para. 0072) may be replaced by the overtube. The overtube is positioned over the distal implant delivery tube 310E and distal locking tube 220E which comprises the locking element of the distal occluder 205E (para. 0072). Para. 0072 discloses that “the rod must be removed or withdrawn before separation of the interlock components” and thereby the overtube must be movable as well to allow separation of the interlock components. Since, the overtube is meant to be positioned over and thereby covering the distal locking tube 220E which comprises the locking element of the distal occluder 205E, and must be retracted in order to allow separation of the distal implant delivery distal locking tube, the overtube is capable of performing the function of being movable between a distal position in which it blocks engagement of the locking elements and a retracted position in which the engagement of the locking elements is enabled.
Regarding claim 9, Miller further comprising:
the locking post 220E having a proximal portion (interpreted as portion comprising interlock 266E) proximally of the detent notch 265E and a distal portion distal of the detent notch (interpreted as portion positioned within proximal occluder 210E, see Figs. 43-44, para. 0072), the proximal portion being of a diameter receivable by the tubular proximal body and the disabling tube (Figs. 44-45, para. 0072, 0074), the distal portion having an outer diameter greater than the proximal portion (see annotated Fig. 46 of Miller below) and substantially the same (see note below in regards to the interpretation of “substantially”) as the disabling tube (para. 0072 discloses that the overtube telescopically projects over distal implant delivery tube 310E and distal implant locking tube 220E of distal implant 205E. Since the overtube can telescopically fit over the locking tube 220E, it meets the limitation); whereby locked occluders can be unlocked by advancing the distal occluder and locking post proximally to cause the distal portion of locking post may engage and urge the at least one tang 300E outwardly to its stressed position, disengaged from the notch (see note below).
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Annotated Fig. 46 of Miller
Note: The examiner notes that under broadest reasonable interpretation, “substantially” is defined as “being largely but not wholly that which is specified” (see attached Merriam-Webster dictionary definition of “substantial”). In the specification of the instant application discloses that the distal portion of the locking post has an outer diameter “substantially the same” as the disabling tube so that it can closely slide within the tubular body of the proximal occluder (para. 0028). Miller discloses that the overtube/disabling tube can telescopically fit over the locking post 220E in para. 0072 such that the outer diameter of the locking post is “largely but not wholly” the same to allow the disabling tube and the locking post to slide relative to one another.
Note: “whereby locked occluders can be unlocked by advancing the distal occluder and locking post proximally to cause the distal portion of locking post may engage and urge the tang outwardly to its stressed position, disengaged from the notch” is interpreted as functional language which describes an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the device of Miller includes all of the structure required in claim 9 i.e. proximal and distal portion of the locking post, proximal occluder comprising at least one tang and the distal occluder comprising the detent notch to perform the function of unlocking the locked occluders by advancing the distal occluder and locking post proximally to cause the distal portion of locking post may engage and urge the tang outwardly to its stressed position, disengaged from the notch. Since the device of Miller includes all of the structure required in claim 9, the device of Miller meets the functional limitations of the claim.
Regarding claim 10, Miller discloses wherein the delivery tube 305E comprises a needle having a sharp, tissue piercing tip (Fig. 73, para. 0075).
Regarding claim 12, Miller discloses wherein the disabling member overlies a mechanical interlock the locking post 220E and retention shaft (interpreted as the distal retention shaft 310E introduced in claim 3, see 112(b) rejection above) to prevent said separation (para. 0072).
Regarding claim 13, Miller discloses wherein the disabling member is retractable to a non-overlying position to enable separation of the mechanical interlock (Figs. 76-77, para. 0076-0077).
Regarding claim 14, Miller discloses further comprising: the legs 295E of the proximal occluder 210E being out of registry with the legs 235E of the distal occluder 205E so that when the blood vessel is clamped by the occluder, the legs will apply oppositely directed forces to the blood vessel at circumferentially spaced locations about an axis of the occluder (Figs. 76-77, para. 0092).
Regarding claim 15, Miller discloses wherein the occluders have sufficient stiffness to constrain the walls of the blood vessel in a serpentine configuration (para. 0077-0078, 0116).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771