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 with traverse of Species A2 and Species B1 in the reply filed on 06/03/26 is acknowledged. The traversal is on the ground(s) that the current Application is not a national stage application and therefore the species restriction does not apply. The examiner thanks Applicant for pointing to the proper priority of the application being to U.S. practice. However, this argument is not found persuasive because the species restriction still applies under U.S. Practice:
The species are independent or distinct because species A requires a distinct and specific coupling position of the coupling hub (see page 3 of the restriction requirement mailed 04/10/26) and species B requires distinct and specific structural components at the distal tip of the cannula (see page 4 of the restriction requirement mailed 04/10/26).
In addition, these species are not obvious variants of each other based on the current record. There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claims 80, 89, and 91-95 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/03/26.
Status of Claims
The status of the claims is as follows:
Claims 81 and 84 are amended.
Claims 69-79, 82-83, 85-88, 90, and 96-97 are in the previously presented/ original form.
Claims 80, 89, and 91-95 are withdrawn.
Claims 1-68 are cancelled.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 03/29/24, 06/02/25, and 06/03/26 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
“tapered region” such as in at least claim 69. [0101] of the current Application’s PGPUB describes the tapered region but does not contain a numeral for the structure, nor is a numeral shown on the drawings. Applicant could remedy this drawing objection by amending the specification to include a numeral for the tapered region in [0101] and placing the numeral on FIG. 2 (see example by examiner in ‘Modified FIG.2’ below).
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“a first height” of the proximal portion as in at least claim 77. A height 564A is shown in FIG. 5c but according to [0122] appears to show a distal end height, not the “first height of the proximal portion”
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
The drawings are objected to because the axes labels in FIG. 5B appear to be mislabeled as planes—relevant to at least claim 71 (see MPEP § 608.02.V(n): graphical symbols may be used for conventional elements). The current drawing makes the interpretation of the “XZ” plane as recited in claim 71 a bit unclear because the individual axis of “z” and “x” are not illustrated. Applicant could remedy this drawing objection by removing a letter from each of the axis labels (see ‘Modified FIG. 5B’ below) to properly indicate a conventional axis element on a graph. If Applicant wishes to denote a plane, Applicant could include additional symbols for planes (i.e.: see “XZ” plane shown for example purposes only by examiner on ‘Modified FIG.5B below).
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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.
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: Numeral 242 as shown on FIG. 2 does not appear to be described in the specification. 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 Objections
Claims 86 and 90 are objected to because of the following informalities:
Claim 86 line 2: “Crosssectional” should likely read “Cross-sectional” for grammatical reasons
Claim 90 line 1 reads “wherein the distal tip” and should likely read “wherein [[the]] a distal tip of the cannula” to provide antecedent basis for distal tip
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 69-74, 76-79, 85-88, 90, and 86-97 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Badawi et al. (U.S. PGPUB No. 2016/0287438), hereinafter Badawi.
Regarding claim 69, Badawi discloses a device (see FIG. 2) for treating conditions of the eye (see [0001]), comprising:
a handle (202), the handle (202) comprising a housing (see [0085]) having a proximal portion (204, see ‘Modified FIG. 2’ below), and a distal portion (see ‘Modified FIG. 2’ below) comprising a grip portion (206, see ‘Modified FIG. 2’ below),
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the grip portion (206, see ‘Modified FIG. 2i’ below) comprising
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a first curved side (see ‘Modified FIG. 2i’ above), a second curved side (see ‘Modified FIG. 2i’ above) opposite the first curved side (see ‘Modified FIG. 2i’ above), and a tapered region (see ‘Modified FIG. 2i’ above) distal to the first and second curved sides (see ‘Modified FIG. 2i’ above), wherein the tapered region (see ‘Modified FIG. 2i’ above) is configured to receive fingers of the user (see [0085-0087]);
a cannula (212) coupled to a distal end (210, see [0085]) of the handle (202); and
an elongate member (see [0084] and [0101-0102]: elongate member coaxially disposed in cannula lumens of the embodiments. Specifically for ease of viewing, see [0097]: a slidable elongate member, not shown, advanceable through opening of cannula as shown in FIG. 20) slidably positioned in the cannula and configured to deliver one or more of a fluid and an implant to Schlemm's canal (see [0101-0103]).
Regarding claim 70, Badawi teaches the device of claim 69, and Badawi further discloses wherein the first curved side and the second curved side are convex (see outward curving surface of first and second curved sides in ‘Modified FIG. 2i’ above, similar to “convex”/ outwardly curved surface shown by Applicant in FIG. 5B and described in [0116]).
Regarding claim 71, Badawi teaches the device of claim 70, and Badawi further discloses wherein the first curved side and second curved side are symmetric across an XZ plane (see ‘Modified FIG. 2ii’ below: first and second curved sides could be reflected across XZ plane as shown and overlap and therefore are symmetric across the plane).
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Regarding claim 72, Badawi teaches the device of claim 69, and Badawi further discloses wherein the grip portion (206, see ‘Modified FIG. 2’ above) comprises an actuator (214, see [0085]: 214 is “drive assembly”) configured to move the elongate member (elongate member not shown but disposed in lumen of cannula, see [0101-0103]. See [0109]: “drive assembly”, such as 214, for moving elongate member).
Regarding claim 73, Badawi teaches the device of claim 72, and Badawi further discloses wherein the grip portion (206) further comprises a planar surface (see ‘Modified FIG. 2iii’ below—rectangular flat surface of top of handle located proximal to actuator on grip portion) proximal of the actuator (214), the planar surface continuous with an actuator border around the actuator (see ‘Modified FIG. 2iii’ below).
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Regarding claim 74, Badawi teaches the device of claim 73, and Badawi further discloses wherein the planar surface is a first planar surface (see ‘Modified FIG. 2iv’ below), and the grip portion (206) further comprises a second planar surface (same as first planar surface, only on bottom face of handle), wherein the first planar surface is on a top of the handle and the second planar surface on a bottom of the handle (second planar surface on bottom face of handle where device rests, see ‘Modified FIG. 2iv’ below).
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Regarding claim 76, Badawi teaches the device of claim 72, and Badawi further discloses wherein the grip portion (206) further comprises a neck (see ‘Modified FIG. 2v’ below) proximal of the actuator (214).
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Regarding claim 77, Badawi teaches the device of claim 76, and Badawi further discloses wherein the proximal portion has a first height at a distal end thereof (see ‘Modified FIG. 2vi’ below),
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the neck has a second height (see ‘Modified FIG. 2vi’ above), and the distal portion has a maximum height (see ‘Modified FIG. 2vi’ above) aligned with at least a portion of the actuator (gear portion of 214 as shown in see ‘Modified FIG. 2vi’ above), and wherein the first height and the maximum height are greater than the second height (as seen in see ‘Modified FIG. 2vi’ above).
Regarding claim 78, Badawi teaches the device of claim 77, and Badawi further discloses wherein the handle comprises a continuous curve between the maximum height and the second height (see outline traceable without any breaks/interruptions from max to second height as shown in ‘Modified FIG. 2vi’ above).
Regarding claim 79, Badawi teaches the device of claim 69, and Badawi further discloses wherein the handle comprises a fluid reservoir at least partially contained therein (see [0032]: handle comprises a fluid reservoir and [0084]: “When a fluid composition is to be delivered into Schlemm's canal, the system may also be configured to include a fluid assembly in the handle.”).
Regarding claim 85, Badawi teaches the device of claim 69, and Badawi further discloses wherein the grip portion includes a textured surface having raised elements, indented elements, or a combination thereof (see [0087]: The grip portion may be raised, depressed, or grooved in certain areas, or textured to improve hold of the handle by the user or to improve comfort of the user.).
Regarding claim 86, Badawi teaches the device of claim 69, and Badawi further discloses wherein the grip portion comprises two or more crosssectional shapes along a longitudinal axis of the handle (for visualization purposes only, see cross-sections along longitudinal axis of handle as shown in FIG. 10B and FIG. 22D).
Regarding claim 87, Badawi teaches the device of claim 69, and Badawi further discloses wherein a center section (middle of grip portion 206) of the grip portion comprises an oval cross-sectional shape with a major axis and a minor axis (see ‘Modified FIG. 2vii’ below),
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the center section of the grip portion including the top surface, the bottom surface, and the one or more actuators (oval cross-section as shown continues through top surface, the actuator, and bottom surface).
Regarding claim 88, Badawi teaches the device of claim 87, and Badawi further discloses wherein the grip portion (206) comprises a circular cross-sectional shape with a first diameter (see ‘Modified FIG.2viii’ below)
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proximal (toward handle) of the center section (aligned with actuator as seen in ‘Modified FIG. 2vii’ above in the rejection of claim 87) and a circular cross-sectional shape with a second diameter (see ‘Modified FIG.2viii’ above) distal (toward cannula) of the center section, wherein the first diameter is greater than the second diameter (see ‘Modified FIG.2viii’ above).
Regarding claim 90, Badawi teaches the device of claim 87, and Badawi further discloses wherein the distal tip (see FIG. 3) further comprises a distal edge having a straight portion (312, see also [0095]), a proximal edge having a curved portion (322), and a lumen opening (see [0084] & [0090]).
Regarding claim 96, Badawi teaches the device of claim 71, and Badawi further discloses wherein the first curved side and second curved side (see modified figure provided with rejection of claim 71 above) are configured to facilitate user rotation of the handle around a longitudinal axis of the handle (see [0010] & [0087]: handle configured for both left and right handed use to be flipped==rotated in clockwise/counter clockwise fashion).
Regarding claim 97, Badawi teaches the device of claim 96, and Badawi further discloses wherein the first curved side and the second curved side (see modified figure provided with rejection of claim 71 above) are configured to facilitate rotation of the handle about 10 degrees to about 180 degrees around the longitudinal axis of the handle (see [0010] & [0087]: handle configured for both left and right handed use to be flipped==rotated in clockwise/counter clockwise fashion 180degrees).
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.
Claims 75, 81-82, and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Badawi (U.S. PGPUB No. 2016/0287438).
Regarding claim 75, Badawi discloses the device of claim 74, but, in the embodiment of FIG.2, Badawi is silent to “further comprising a second actuator, wherein the first actuator is on the top of the handle, the second actuator is on the bottom of the handle and the second planar surface is proximal of the second actuator.”
However, in a different embodiment (See FIG. 4A), Badawi teaches a device for treating condition of the eye comprising a handle (414) and a first actuator (406, see [0115]), the device further comprising a second actuator (406), wherein the first actuator (406) is on the top of the handle (see “top” in ‘Modified FIG. 4A’ below and [0115]),
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the second actuator (406) is on the bottom of the handle (bottom is opposite “top”) and the second planar surface (see ‘Modified FIG. 4A’ below) is proximal of the second actuator (406).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator assembly disclosed in Badawi (FIG.2) to be formed of a first and second actuator with the second planar surface proximal of the second actuator as taught by Badawi (FIG.4A) for the purpose of allowing the delivery system to be used in multiple orientations, with either the left or right hand, and on either of the patient’s eyes (see [0115]), thus achieving “further comprising a second actuator, wherein the first actuator is on the top of the handle, the second actuator is on the bottom of the handle and the second planar surface is proximal of the second actuator.”
Regarding claim 81, Badawi teaches the device of claim 79, and Badawi further discloses wherein the handle includes a proximal portion comprising a proximal cavity (see [0032] and [0083-0084]: fluid reservoir provided in handle and therefore there must be a proximal cavity for holding such a fluid reservoir).
Badawi (FIG. 2) is silent to wherein the handle includes a proximal portion comprising a proximal cavity “having a proximal opening, the proximal cavity having a coupling hub therein, the coupling hub including a coupling portion, and wherein the handle further comprises a connector configured to receive an external fluid device to transfer fluid into the fluid reservoir and to be released from the handle with the external fluid device coupled thereto.”
However in an alternate embodiment (see FIG. 23E and [0125]), Badawi teaches a device for treating conditions of the eye comprising a handle (2334) comprising a fluid reservoir (2302), wherein the handle (2334) includes a proximal portion (such as the portion shown in FIG. 23E) comprising a proximal cavity (cavity within 2334 housing fluid assembly 2316) having a proximal opening (2328, see [0126]), the proximal cavity having a coupling hub (see ‘Modified FIG. 23E’ below and [0125-0129]: coupling hub as shown has structures allowing for coupling to 2326) therein,
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the coupling hub (see ‘Modified FIG. 23E’ above) including a coupling portion (ball bearing 2324 for opening the seal, see [0126]), and wherein the handle (2334) further comprises a connector (2326) configured to receive an external fluid device to transfer fluid into the fluid reservoir and to be released from the handle (see [0126]) with the external fluid device coupled thereto (“configured to” is functional language. Therefore the connector structure need only be capable of being released from the handle “with the external fluid device coupled thereto”. The nozzle could be integrally formed with the external fluid reservoir and therefore meets the claim limitation—for example a nozzle of a prefilled syringe).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal cavity of the handle disclosed in Badawi (FIG.2) to include a proximal opening and a coupling hub therein, the coupling hub including a coupling portion, and wherein the handle further comprises a connector configured to receive an external fluid device to transfer fluid into the fluid reservoir and to be released from the handle with the external fluid device coupled thereto as taught by Badawi (FIG.23E) for the purpose of allowing the fluid reservoir of the handle to be controllably filled by way of a sealed proximal hub mechanism (see [0126-0128]), thus achieving “having a proximal opening, the proximal cavity having a coupling hub therein, the coupling hub including a coupling portion, and wherein the handle further comprises a connector configured to receive an external fluid device to transfer fluid into the fluid reservoir and to be released from the handle with the external fluid device coupled thereto”.
Regarding claim 82, the modified system of Badawi teaches the device of claim 81, but Badawi (FIG.2) is silent to “wherein the connector engages the coupling portion of the coupling hub.”
However, in an alternate embodiment (see FIG. 23E and [0125]), Badawi teaches a device for treating conditions of the eye comprising a handle (2334) comprising a fluid reservoir (2302), wherein the handle (2334) includes a proximal portion (such as the portion shown in FIG. 23E) comprising a proximal cavity (cavity within 2334 housing fluid assembly 2316) having a proximal opening (2328, see [0126]), the proximal cavity having a coupling hub (see ‘Modified FIG. 23E’ below and [0125-0129]: coupling hub as shown has structures allowing for coupling to 2326) therein,
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the coupling hub (see ‘Modified FIG. 23E’ above) including a coupling portion (ball bearing 2324 for opening the seal, see [0126]), and wherein the handle (2334) further comprises a connector (2326), wherein the connector (2326) engages (see [0126]) the coupling portion (ball bearing 2324) of the coupling hub (see ‘Modified FIG. 23E’ above).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal cavity of the handle disclosed in Badawi (FIG.2) to include a proximal opening and a coupling hub therein, the coupling hub including a coupling portion, the handle comprising a connector, wherein the connector engages the coupling portion of the coupling hub as taught by Badawi (FIG.23E) for the purpose of allowing the fluid reservoir of the handle to be controllably filled by way of a sealed proximal hub mechanism (see [0126-0128]), thus achieving “wherein the connector engages the coupling portion of the coupling hub.”
Regarding claim 84, the modified system of Badawi teaches the device of claim 81, but Badawi (FIG.2) is silent to “wherein the connector comprises a connector body including one or more extensions configured to engage one or more abutments within the proximal cavity of the handle when the connector is coupled to the coupling hub.”
However, in an alternate embodiment (see FIG. 23E and [0125]), Badawi teaches a device for treating conditions of the eye comprising a handle (2334) comprising a fluid reservoir (2302), wherein the handle (2334) includes a proximal portion (such as the portion shown in FIG. 23E) comprising a proximal cavity (cavity within 2334 housing fluid assembly 2316), the proximal cavity having a coupling hub (see ‘Modified FIG. 23E’ below and [0125-0129]: coupling hub as shown has structures allowing for coupling to 2326) therein,
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wherein the handle (2334) further comprises a connector (2326), and wherein the connector (2326) comprises a connector body (see ‘Modified FIG. 23Ei’ below) including one or more extensions (see ‘Modified FIG. 23Ei’ above)
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configured to engage one or more abutments (abutment surfaces of ball bearing 2324 and 2330, see engagement as described in at least [0126]) within the proximal cavity of the handle (2334) when the connector (2326) is coupled to the coupling hub (as shown in FIG. 23E and described in [0126]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal cavity of the handle disclosed in Badawi (FIG.2) to include a proximal opening and a coupling hub therein, the coupling hub including a coupling portion, the handle comprising a connector, wherein the connector comprises a connector body including one or more extensions configured to engage one or more abutments within the proximal cavity of the handle when the connector is coupled to the coupling hub as taught by Badawi (FIG.23E) for the purpose of allowing the fluid reservoir of the handle to be controllably filled by way of a sealed proximal hub mechanism (see [0126-0128]), thus achieving “wherein the connector comprises a connector body including one or more extensions configured to engage one or more abutments within the proximal cavity of the handle when the connector is coupled to the coupling hub.”
Claim 83 is rejected under 35 U.S.C. 103 as being unpatentable over Badawi as applied to claim 81 above, and further in view of Balan et al. (U.S. PGPUB No. 2020/0108207), hereinafter Balan.
Regarding claim 83, the modified system of Badawi teaches the device of claim 81, but Modified Badawi (FIG. 2 in view of FIG. 23E) is silent to “wherein the coupling portion includes threads configured to engage a distal luminal wall of the connector.”
However, Balan teaches a device for treating conditions of the eye (see FIG. 1A and [0039-0040]) comprising a handle (104 & 108) comprising a fluid reservoir (300 coupled to syringe 124, see FIG. 5A, [0042]: FIG.1A can be connected directly to syringe or to pre-fill component 300 as in FIG. 5A, and [0066]), wherein the handle (104&108) includes a proximal portion (108) comprising a proximal cavity (cavity shown containing syringe 124 in FIG. 1A), the proximal cavity having a coupling hub (see coupling hub in FIG. 5A containing luer connector 128. See also [0042] & [0066-0067]) therein, the coupling hub (see FIG. 5A) including a coupling portion (luer connector 128 as shown in FIG. 1B and described in [0042-0043]: removable coupling at luer connector by twisting using conventional luer), and wherein the handle (see [0066]: connector 300 connected to handle) further comprises a connector (300, see FIG. 5A and [0067]), wherein the coupling portion (luer connector 128) includes threads (see threads on luer connector 128 as shown in FIG. 1B and described in [0042-0043]: removable coupling at luer connector by twisting using conventional luer) configured to engage a distal luminal wall of the connector (see [0066]: 300 coupled to luer in same manner syringe would be as described in [0042-0043]. Further, “configured to” is functional language and therefore threads and alignment of connector/coupling portion structures would allow for a distal luminal wall of the connector to be engaged at the threads of coupling portion).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the coupling portion of the coupling hub disclosed in Modified Badawi to include threads configured to engage a distal luminal wall of the connector as taught by Balan for the purpose of attaching the connector and coupling portion of the coupling hub by way of standard connection mechanisms known in the art (see [0043]) or to allow the external fluid device to be decoupled separately from the connector (see [0077-0080]), thus achieving “wherein the coupling portion includes threads configured to engage a distal luminal wall of the connector”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Consider rotated embodiments of Badawi such as FIG. 24 seeming to show the handle/ neck heights and orientation claimed by the current Application
Germann et al. (U.S. PGPUB No. 2017/0245984) teaches a similar handle structure to that of the current invention (see at least Fig. 1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights