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 Amendment
The amendment filed 08/10/26 has been entered. Claims 1, 8-9, and 11 have been amended. Claims 2-7 and 10 are in the original/ previously presented form. Thus, claims 1-11 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 03/13/26.
Specification
The disclosure is objected to because of the following informalities:
[0074] of the current Application’s PGPUB reads “filly threaded” and should likely read “[[filly]] fully threaded”
Appropriate correction is required.
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 1-3 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Lin (U.S. PGPUB No. 2020/0101276).
Regarding claim 1, Lin discloses a connection assist device (see FIG.3) for connecting (see FIG.11, [0033], and [0037]) a catheter connector (32) end to a patient line connector (42) end, the assist device comprising:
a patient line shield (16, see FIG.3) including a first patient line half (24, see ‘Modified Fig. 3’ below)
PNG
media_image1.png
539
865
media_image1.png
Greyscale
open (as shown in FIG. 3) and closeable relative to (see [0032]) a second patient line shield half (26), the patient line shield (16) including:
a first patient line shield portion (244) configured to house (see [0032] & [0035]) a portion of a patient line (40), and
a second patient line shield portion (27) configured to house (see [0032] & [0035]) the patient line connector end (461, see ‘Modified FIG. 3’ above and [0033], [0036], & FIG. 11: 461 exposed once cap 44 removed); and
a catheter shield (12) including a first catheter shield half (18) open (as seen in FIG. 3) and closeable relative to (see [0029]) a second catheter shield half (20), the catheter shield (12) including:
a first catheter shield portion (181) configured to house (see [0034]) a portion (32) of a patient catheter (32 houses catheter 30, see [0033]), and
a second catheter shield portion (21) configured to house (see [0034]) the catheter connector end (363, see [0033]: cap 34 covers connector end 363), the second catheter shield portion (21) additionally sized to receive (see FIG. 11 and [0037], spaces 21 and 27 overlap and thus are “sized to receive”) the second patient line portion (27) of the patient line shield (16) for connecting (see FIG.11 and [0037-0039]) the catheter connector end (363) to the patient line connector end (461),
wherein an outer diameter of the catheter shield (12) is less than (see FIG. 10 with 12 fitting inside 16 and see [0037]: 12 screwed into internal space of 16) an outer diameter of the patient line shield (16).
In the embodiment of FIG.3, Lin is silent to wherein an outer diameter of the catheter shield is “greater” than an outer diameter of the patient line shield.
However, in another embodiment, Lin teaches wherein an outer diameter of the catheter shield (12) is greater than an outer diameter of the patient line shield (16, see [0040]: “In another embodiment, the first connector bracket may also have a guiding space… Therefore, when docking and insertion are conducted, the second connector bracket is inserted into the guiding space of the first connector bracket”. The first connector bracket refers to the catheter shield 12 and the second connector bracket 16 refers to the patient line shield as in [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have modified the outer diameter of the catheter shield disclosed in Lin (FIG.3) to be greater than the outer diameter of the patient line shield as taught in Lin ([0040]).
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a catheter shield axially docked within a patient line shield to establish a sterile connection as in Lin FIG. 3 and [0037]) for another known element (a patient line shield axially docked within a catheter shield to establish a sterile connection as in Lin [0040]) in the art to obtain the predictable result of establishing a sterile connection via axial docking between a catheter shield and patient line shield (see MPEP § 2143.I.B), thus achieving wherein an outer diameter of the catheter shield is “greater” than an outer diameter of the patient line shield.
Lastly, moving the location of the catheter shield in Lin (FIG. 3) from being disposed within the patient line shield to being disposed around the patient line shield is a simple rearrangement of parts, which has been held to be unpatentable over the prior art because the rearrangement does not modify the operation of the device (see MPEP § 2144.04.VI.C).
Regarding claim 2, Lin discloses the connection assist device of claim 1, and Lin further discloses wherein the first catheter shield half (18, see FIG. 3) is connected hingedly (see [0029]) to the second catheter shield half (20).
Regarding claim 3, Lin discloses the connection assist device of claim 1, and Lin further discloses wherein the first patient line shield half (24) is connected hingedly to (see [0031]) the second patient line shield half (26).
Regarding claim 9, Lin discloses a method of removing (see [0036]) a minicap (34, see FIG. 3) from a catheter connector end (363) of a patient catheter (30) and connecting (see FIG. 11) the catheter connector end (363) to a patient line connector end (461), the method comprising:
Locating a minicap catcher (14) about the (see FIG. 8) catheter connector end (363, see [0036]: catcher 14 placed about catheter connector end to remove cap 34 disposed over end 363) to engage the minicap (34) protecting (see [0033]: cap 34 screwed onto 363 to cover the end) the catheter connector end (363);
engaging a catheter shield (12) about (12 engages about at least inner portion 22 of catcher 14, see FIG. 8 and [0036]) the minicap catcher (14), such that
a first catheter shield portion (181, see FIG. 3) engages a portion (32) of the patient catheter (32 houses catheter 30, see [0033]), and
a second catheter shield portion (211 of space 21, see Fig. 3 and [0029]) houses (see [0036]: space 21 houses at least internal portion of minicap catcher) the minicap catcher (14); and
rotating (see rotation arrow in FIG. 8 and [0036]) the minicap catcher (14) relative to the catheter shield (12) to remove (see [0036] and cap 34 shown removed in FIG. 9) the minicap (34) from the catheter connector end (363);
removing (see FIG. 9 and [0036]) the minicap catcher (14) from the catheter shield (12);
engaging (see FIG. 11) a patient line shield (16) about the patient line connector end (461), such that:
a first patient line portion (244) engages (see [0032] & [0035]) a portion of the patient line (40), and
a second patient line portion (27) engages the patient line connector end (461, see [0033], [0036], & FIG. 11: 461 exposed once cap 44 removed and engaged into space 27, better seen in FIG. 3); and
inserting (see FIG. 11 and [0037]: at least annular ring of 27 is inserted into space 21) the second patient line portion (27) into the second catheter shield portion (21) such that the patient line connector end (461) connects to the catheter connector end (363),
wherein an outer diameter of the catheter shield (12) is less than (see FIG. 10 with 12 fitting inside 16 and see [0037]: 12 screwed into internal space of 16) an outer diameter of the patient line shield (16).
In the embodiment of FIG.3, Lin is silent to wherein an outer diameter of the catheter shield is “greater” than an outer diameter of the patient line shield.
However, in another embodiment, Lin teaches wherein an outer diameter of the catheter shield (12) is greater than an outer diameter of the patient line shield (16, see [0040]: “In another embodiment, the first connector bracket may also have a guiding space… Therefore, when docking and insertion are conducted, the second connector bracket is inserted into the guiding space of the first connector bracket”. The first connector bracket refers to the catheter shield 12 and the second connector bracket 16 refers to the patient line shield as in [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have modified the outer diameter of the catheter shield disclosed in Lin (FIG.3) to be greater than the outer diameter of the patient line shield as taught in Lin ([0040]).
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a catheter shield axially docked within a patient line shield to establish a sterile connection as in Lin FIG. 3 and [0037]) for another known element (a patient line shield axially docked within a catheter shield to establish a sterile connection as in Lin [0040]) in the art to obtain the predictable result of establishing a sterile connection via axial docking between a catheter shield and patient line shield (see MPEP § 2143.I.B), thus achieving wherein an outer diameter of the catheter shield is “greater” than an outer diameter of the patient line shield.
Lastly, moving the location of the catheter shield in Lin (FIG. 3) from being disposed within the patient line shield to being disposed around the patient line shield is a simple rearrangement of parts, which has been held to be unpatentable over the prior art because the rearrangement does not modify the operation of the device (see MPEP § 2144.04.VI.C).
Regarding claim 10, Lin discloses the method of claim 9, and Lin further discloses wherein engaging the patient line shield (16) includes clamshelling (see open clamshells 24/26 in FIG. 6 and closed in FIG. 7, see [0031] for description of pivoting of the clamshells 24/26) the patient line shield (16) about the patient line connector end (461, see [0033], [0036], & FIG. 11: 461 exposed once cap 44 removed).
Regarding claim 11, Lin discloses the method of claim 9, and Lin further discloses wherein inserting (see FIG. 11 and [0037]: at least annular ring of 27 is inserted into space 21) the second patient line portion (27) into the second catheter shield portion (21) includes threadingly connecting (as seen in FIG. 11 and described in [0037]. See also [0033]: thread 363 on end 361) the patient line connector end (461) connects to the catheter connector end (363).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Lin as applied to claim 1 above, and further in view of Locati et al. (U.S. PGPUB No. 2019/0240396), hereinafter Locati.
Regarding claim 4, Lin discloses the connection assist device of claim 1, and Lin discloses further comprising a minicap catcher (14, see FIG.3), the minicap catcher including:
a first minicap catcher portion (22, see [0030]) sized to receive (see FIG. 9 and [0036]) a minicap (34) protecting the catheter connector end (363, see [0033]: cap 34 covers connector end 363), and
a second minicap catcher portion (outer surface of bushing 14) providing an extension surface (outer surface of bushing extends along longitudinal axis and therefore forms an “extension surface”), wherein the second catheter shield portion (21) is sized to receive the first minicap catcher portion (22, see [0036]: 22 accommodated within 21) of the minicap catcher (14).
Lin is silent to the minicap catcher “including a first minicap catcher half open and closeable relative to a second minicap catcher half”.
However, Locati teaches a minicap catcher (10E, see FIG. 16 and [0167]: device 10 for removing cap, such as needle shield 8 shown in FIG. 1 and FIG. 11, or other rigid tubular cap, see [0138], such as a minicap) including a first minicap catcher half (70A) open and closeable (via hinge 182) relative to (see [0175]) a second minicap catcher half (70B).
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 minicap catcher disclosed in Lin to be formed as a first minicap catcher half open and closeable relative to a second minicap catcher half as taught by Locati for the purpose of visualizing the internal minicap catcher compartment formed between the two halves to facilitate selection of an appropriately sized minicap catcher (see [0163-0165]), thus achieving the minicap catcher “including a first minicap catcher half open and closeable relative to a second minicap catcher half”.
Regarding claim 5, the modified system of Lin teaches the connection assist device of claim 4, and Lin further discloses wherein an inner wall (walls of 22, see FIG. 1 and [0030]) of the first minicap catcher portion (22) defines a cavity (221, see FIG. 1 and [0030]) configured to engage (as seen in FIG. 9 and described in [0036]) the minicap (34).
Regarding claim 6, the modified system of Lin teaches the connection assist device of claim 4, and Lin further discloses wherein at least one of the patient line shield (16, see FIG. 1 and [0031]), the catheter shield (12, see [0029]) or the minicap catcher (14) is at least partially cylindrical (see cylindrical shapes in FIG.1).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lin in view of Locati as applied to claim 4 above, and further in view of Denzer et al. (U.S. PGPUB No. 2015/0045729), hereinafter Denzer.
Regarding claim 7, the modified system of Lin teaches the connection assist device of claim 4, and Lin further discloses wherein the second minicap catcher portion (outer surface of bushing 14, see FIG. 8) extends from the catheter shield (12) when the second minicap catcher portion (outer surface of bushing 14) engages (as seen in FIG. 8, surface 14 surrounds portion 21 during cap removal) the second catheter shield portion (21).
Modified Lin is silent to the second minicap catcher portion “is inserted into” the second catheter shield portion.
However, Denzer teaches a minicap catcher (240, see FIG. 4F and [0089]) and a tubular shield (210) comprising a second tubular shield portion (see ‘Modified FIG. 4F’ below)
PNG
media_image2.png
421
585
media_image2.png
Greyscale
configured to house a catheter connector end (210 houses drug delivery end and thus is “configured to” house a catheter connector end), the minicap catcher (240) including a first minicap catcher portion (246T, see FIG.4C and [0093]) for receiving a minicap (266) protecting a drug delivery end (syringe 260 with needle 265, see [0051]), and a second minicap catcher portion providing an extension surface (longitudinally extending surfaces 241, see ‘Modified FIG. 4F above or FIG. 4C), wherein the second minicap catcher portion (second minicap catcher portion includes extension surface as seen in ‘Modified FIG. 4F’ above) is inserted into (see FIG. 4F and [0082]) the second tubular shield portion 9210).
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 second catheter shield portion disclosed by Lin to have a diameter larger than the second minicap catcher portion such that the second minicap catcher portion is inserted into the second catheter shield portion (currently, Lin discloses the second minicap catcher portion/ outer extension surface disposed “about” the second catheter shield portion) as taught by Denzer for the purpose of housing the cap catcher within the device such that the cap and drug delivery end are protected until the device cap is to be removed (see [0082]), or forming internal locking/friction mechanisms for ensuring that the minicap catcher cannot be accidentally withdrawn (see [0089]), thus achieving the second minicap catcher portion “is inserted into” the second catheter shield portion.
Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a second minicap catcher portion surrounding a second catheter shield portion) for another known element (a second minicap catcher portion inserted into a second catheter shield portion) in the art to obtain the predictable result of removing a protective cap form the end of a drug delivery device (see MPEP § 2143.I.B).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lin (U.S. PGPUB No. 2020/0101276) in view of Locati (U.S. PGPUB No. 2019/0240396).
Regarding claim 8, Lin discloses a connection assist device (see FIG.3) for connecting (see FIG.11, [0033], and [0037]) a catheter connector end (363) to a patient line connector end (461), the assist device comprising:
a minicap catcher (14), the minicap catcher including:
a first minicap catcher portion (22, see [0030]) sized to receive (see FIG. 9 and [0036]) a minicap (34) on the catheter connector end (363, see [0033]: cap 34 covers connector end 363); and
a second minicap catcher portion (outer surface of bushing 14) providing a user gripping surface (see [0036]: user grips outside surface of 14 to rotate cap bushing and remove cap 34);
a patient line shield (16, see FIG.3) including a first patient line half (24) open (as shown in FIG. 3) and closeable relative to (see [0032]) a second patient line half (26), the patient line shield (16) including:
a first patient line portion (244) configured to house (see [0032] & [0035]) a portion of a patient line (40), and
a second patient line portion (27) configured to house (see [0032] & [0035]) the patient line connector end (461, see ‘Modified FIG. 3’ above and [0033], [0036], & FIG. 11: 461 exposed once cap 44 removed); and
a catheter shield (12) including a first catheter shield half (18) open (as seen in FIG. 3) and closeable relative to (see [0029]) a second catheter shield half (20), the catheter shield (12) including:
a first catheter shield portion (181) configured to house (see [0032] & [0034])) a portion (32) of a patient catheter (32 houses catheter 30, see [0033]), and
a second catheter shield portion (21) configured to house (see [0034]) the catheter connector end (363, see [0033]: cap 34 covers connector end 363), the second catheter shield portion (21) additionally sized to receive the first minicap catcher portion (22, see [0036]: 22 accommodated within 21) of the minicap catcher (14) and the second patient line portion (27, see FIG. 11 and [0037]: spaces 21 and 27 overlap and thus 21 is “sized to receive” 27) of the patient line shield (16),
wherein an outer diameter of the catheter shield (12) is less than (see FIG. 10 with 12 fitting inside 16 and see [0037]: 12 screwed into internal space of 16) an outer diameter of the patient line shield (16).
In the embodiment of FIG.3, Lin is silent to wherein an outer diameter of the catheter shield is “greater” than an outer diameter of the patient line shield and the minicap catcher “including a first minicap catcher half open and closeable relative to a second minicap catcher half”.
However, in another embodiment, Lin teaches wherein an outer diameter of the catheter shield (12) is greater than an outer diameter of the patient line shield (16, see [0040]: “In another embodiment, the first connector bracket may also have a guiding space… Therefore, when docking and insertion are conducted, the second connector bracket is inserted into the guiding space of the first connector bracket”. The first connector bracket refers to the catheter shield 12 and the second connector bracket 16 refers to the patient line shield as in [0037]).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to have modified the outer diameter of the catheter shield disclosed in Lin (FIG.3) to be greater than the outer diameter of the patient line shield as taught in Lin ([0040]).
A person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (a catheter shield axially docked within a patient line shield to establish a sterile connection as in Lin FIG. 3 and [0037]) for another known element (a patient line shield axially docked within a catheter shield to establish a sterile connection as in Lin [0040]) in the art to obtain the predictable result of establishing a sterile connection via axial docking between a catheter shield and patient line shield (see MPEP § 2143.I.B), thus achieving wherein an outer diameter of the catheter shield is “greater” than an outer diameter of the patient line shield.
Lastly, moving the location of the catheter shield in Lin (FIG. 3) from being disposed within the patient line shield to being disposed around the patient line shield is a simple rearrangement of parts, which has been held to be unpatentable over the prior art because the rearrangement does not modify the operation of the device (see MPEP § 2144.04.VI.C).
Lin (all embodiments) remains silent to the minicap catcher “including a first minicap catcher half open and closeable relative to a second minicap catcher half”.
However, Locati teaches a minicap catcher (10E, see FIG. 16 and [0167]: device 10 for removing cap, such as needle shield 8 shown in FIG. 1 and FIG. 11, or other rigid tubular cap, see [0138], such as a minicap) including a first minicap catcher half (70A) open and closeable (via hinge 182) relative to (see [0175]) a second minicap catcher half (70B).
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 minicap catcher disclosed in Lin to be formed as a first minicap catcher half open and closeable relative to a second minicap catcher half as taught by Locati for the purpose of visualizing the internal minicap catcher compartment formed between the two halves to facilitate selection of an appropriately sized minicap catcher (see [0163-0165]), thus achieving the minicap catcher “including a first minicap catcher half open and closeable relative to a second minicap catcher half”.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 8, and 9 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
A new 35 U.S.C. § 103 claim rejection under Lin (FIG. 3 in view of the embodiment taught in [0040]) has been used to address the newly amended claim limitations of 1, 8, and 9, rendering the argument against the 35 U.S.C. § 102 claim rejection under Lin (FIG. 3) moot.
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 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
