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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 23-25 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claims 23-25, there is no support in the original disclosure for a continuous lumen and thus it constitutes new matter. In particular, the original disclosure is silent regarding a lumen being continuous.
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, 5, 7, 10, 21-25 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2006/0278546 to State et al. (State).
Regarding claim 1, State discloses a package (10) for a medical device, the package comprising an elongate carrier tube (11) having a single lumen (12, 14, €0028) formed therein capable of having a medical device (40) disposed therein, wherein the carrier tube has a first end, wherein the carrier tube (11) includes an elastomeric material (¶0033), wherein the carrier tube includes a tube wall (17) and wherein a slit (32) is formed in the tube wall, the slit (32) configured to shift between a first width configuration and a temporarily widened width configuration that allows a medical device to be removed directly from lumen of the carrier tube through the slit since it has the structure as recited, the elastomeric material of the carrier tube biases the slit toward the first width configuration (€0033). In particular, since prior art has the structure as recited, then it would be capable of functioning with a medical device as recited.
Regarding claim 5, State further discloses slit (32) extends axially along the tube wall (Fig 1).
Regarding claim 7, State further discloses carrier tube (11) capable of being arranged in spiral configuration (Fig 2).
Regarding claim 10, State further discloses carrier tube (11) capable of being arranged in helical configuration since it has the structure as recited.
Regarding claim 21, State further discloses slit (32) in fluid communication with single lumen (12, 14).
Regarding claim 22, State further discloses exterior of the tube in fluid communication with single lumen through the slit (32) (Fig 1).
Regarding claim 23, State further discloses the lumen being continuous at the exterior.
Regarding claim 24, State discloses a package (10) for medical device, the package comprising a carrier tube (11) having a single continuous lumen (12, 14, €0028) formed therein, a medical device (40) disposed within the single continuous lumen, the carrier tube includes an elastomeric material (€0033), carrier tube includes a tube wall (17) and an axially extending slit (32) formed in tube wall, axially extending slit is configured to shift between a first width configuration and temporarily widen width configuration that allows the medical device to be removed laterally from the single continuous lumen of the carrier tube through the slit, the elastomeric material of the tube biases the slit toward the first width configuration (€0033). In particular, the slit is capable of functioning with the medical device as recited since it has the structure as recited.
Regarding claim 25, State discloses a package (10) for medical device, the package comprising a carrier tube (11) having a single continuous lumen (12, 14, €0028) formed therein, a medical device (40) disposed within the single continuous lumen, carrier tube includes a tube wall (17) and an axially extending slit (32) formed in tube wall, axially extending slit is configured to shift between a first width configuration and temporarily widen width configuration that allows the medical device to be removed laterally from the single continuous lumen of the carrier tube through the slit, the elastomeric material of the tube biases the slit toward the first width configuration (€0033). In particular, the slit is capable of functioning with the medical device as recited since it has the structure as recited.
Claim(s) 24-25 is/are rejected under 35 U.S.C. 102a1 as being anticipated by US 2019/0118213 to Keeney et al. (Keeney).
Regarding claim 24, Keeney discloses a package for medical device (109, Fig 1), the package comprising a carrier tube (130) having a single continuous lumen formed therein, a medical device (110) disposed within the single continuous lumen, the carrier tube includes an elastomeric material (€0031), carrier tube includes a tube wall and an axially extending slit (132) formed in tube wall, axially extending slit is configured to shift between a first width configuration and temporarily widen width configuration that allows the medical device to be removed laterally from the single continuous lumen of the carrier tube through the slit, the elastomeric material of the tube biases the slit toward the first width configuration (€0031).
Regarding claim 25, Keeney discloses a package for medical device, the package comprising a carrier tube (130) having a single continuous lumen formed therein, a medical device (110) disposed within the single continuous lumen, carrier tube includes a tube wall and an axially extending slit (132) formed in tube wall, axially extending slit is configured to shift between a first width configuration and temporarily widen width configuration that allows the medical device to be removed laterally from the single continuous lumen of the carrier tube through the slit, the elastomeric material of the tube biases the slit toward the first width configuration (€0031).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over State in view of US 2015/0246202 to Menamara.
Regarding claim 2, State teaches the package of claim 1 but does not teach the tube wall substantially transparent. However, Menamara discloses a tube packaging (Fig 7) and in particular discloses the tubing (20) being transparent (¶0084). One of ordinary skill in the art would have found it obvious to manufacture the State tubing out of transparent material as suggested by Menamara in order to view the item through the wall of the tubing (Menamara, ¶0084).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over State in view of US 2012/0037525 to Peck et al. (Peck).
Regarding claim 3, State teaches the package of claim 1 but does not teach the recited material. Peck discloses a package (Fig 6) for a medical device, the package comprising an elongate carrier tube (12) capable of having a medical device (10) disposed therein, wherein the carrier tube (12) includes an elastomeric material (¶0035), wherein the carrier tube includes a tube wall (23a) and wherein a slit (22’, Fig 4, ¶0034) is formed in the tube wall. Peck further discloses the elastomeric material includes silicone (¶0035). One of ordinary skill in the art would have found it obvious to change the elastomeric material of the State tube to be silicone as suggested by Peck in order to facilitate packaging since it has been held that selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding claim 4, State teaches the package of claim 1 but does not teach the recited material. Peck discloses a package (Fig 6) for a medical device, the package comprising an elongate carrier tube (12) capable of having a medical device (10) disposed therein, wherein the carrier tube (12) includes an elastomeric material (¶0035), wherein the carrier tube includes a tube wall (23a) and wherein a slit (22’, Fig 4, ¶0034) is formed in the tube wall. Peck further discloses elastomeric material includes PTFE (¶0035). One of ordinary skill in the art would have found it obvious to change the elastomeric material of the State tube to be PTFE as suggested by Peck in order to facilitate packaging since it has been held that selection of a known plastic to make a container of a type made of plastics prior to the invention was held to be obvious. In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over State in view of US 2004/0045999 to Babij, JR (Babij).
Regarding claim 6, State teaches the package of claim 1 except for the slit including undulations. However, Babij discloses a sleeve (Fig 7) wherein a slit (14a) including undulations extends along the sleeve. One of ordinary skill in the art would have found it obvious to change the shape of the State slit to include undulations as suggested by Babij in order to facilitate opening of the sleeve to access the medical device.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over State in view of US 2018/0214665 to Cicalis.
Regarding claims 8-9, State discloses the package of claim 7 but does not teach adjacent loops secured by discrete bonding members including adhesive. However, Cicalis discloses tubular packaging (Fig 1) and in particular discloses the carrier tube in spiral configuration (Fig 1) and a plurality of adjacent loops secured together by discrete bonding members including adhesive (22) (¶0030). One of ordinary skill in the art would have found it obvious to incorporate adhesive to the carrier tube of State as suggested by Cicalis in order to keep the loops secured to each other.
Response to Arguments
Applicant's arguments filed 4/27/2026 have been fully considered but they are not persuasive. Initially it is noted that applicant does not argue the rejection of the dependent claims. Applicant argues that the prior art does not teach medical device be removed directly from the carrier tube through the slit. This is not persuasive because a medical device has not been explicitly claimed and so long as prior art has the structure as recited, then it can be used in the manner as recited. Furthermore, the claims only require the slit to shift in different width configuration and the medical device can be moved within the lumen such that the closed wall is not in between the slit and the device in order for the device to be removed from the slit.
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 ROBERT POON whose telephone number is (571)270-7425. The examiner can normally be reached Monday thru Friday, 8:30 am to 6:00 pm.
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/ROBERT POON/Examiner, Art Unit 3735
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