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 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 4, 10, 12, and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation "the catheter" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the catheter assembly of claim 10 which is an intermittent catheter which is a urinary catheter”. It is unclear how the catheter assembly “is” an intermittent/urinary catheter when the catheter assembly also comprises the external housing which surrounds a catheter. For the purpose of compact prosecution, this limitation is interpreted as “the catheter assembly of claim 10 which comprises an intermittent urinary catheter”.
Claim 17 recites the limitation "the catheter" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 18 is also rejected based on its dependency on Claim 17.
Claim 19 recites the limitation "catheter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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, 7-12, 14, 17, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Brien et al (US 2019/0126004).
Regarding Claim 1, O’Brien discloses a catheter assembly (Figs. 1-5) comprising:
an external housing (package 10, Figs. 1-5) comprising a main body (case 12, Figs. 1-5) and a cap (14, Figs. 1-5),
wherein the main body (12, Figs. 1-5) is elongate with an open end (end at rim 32, Figs. 1-5; ¶ [0033-0034]) and a closed end (22, Figs. 1-5; ¶ [0033-0034]); and,
wherein the cap (14, Figs. 1-5) and the closed end (22, Figs. 1-5) of the main body (12, Figs. 1-5) comprise corresponding mating surfaces (internal surface of cap and external surface of closed end, Figs. 1-5) such that the cap (14, Figs. 1-5) is mountable on the closed end (22, Figs. 1-5) of the main body (Figs. 1-5; ¶ [0009], Claims 5-6).
Regarding Claim 2, O’Brien discloses the main body (12, Figs. 1-5) and cap (14, Figs. 1-5) form a sterile cavity for housing a catheter (18, Figs. 1-5; ¶ [0009]).
Regarding Claim 3, O’Brien discloses the catheter (18, Figs. 1-5) is configured to be removed from the external housing (10, Figs. 1-5) in use (¶ [0009, 0037]).
Regarding Claim 4, O’Brien discloses the cap (14, Figs. 1-5) is configured to be mounted to the closed end (22, Figs. 1-5) of the main body (12, Figs. 1-5) during use of the catheter (18, Figs. 1-5; ¶ [0009]).
Regarding Claim 5, O’Brien discloses the mating surfaces engage with one another via an interference fit (¶ [0009] indicates the cap has a snap-fit connection to the bottom of the case; ¶ [0427] of Applicant’s published specification indicates that examples of interference fits are push-fit or click-fit, and therefore a snap-fit connection would be considered an interference fit).
Regarding Claim 7, O’Brien discloses the mating surface are respectively provided by an internal surface (46, Figs. 1-5) of the cap (14, Figs. 1-5), and an external surface (external surface of closed end 22, Figs. 1-5) of the main body (12, Figs. 1-5).
Regarding Claim 8, O’Brien discloses the internal surface (46, Figs. 1-5) of the cap (14, Figs. 1-5) comprises one or more ribs (threads 52, Figs. 1-5), the ribs (52, Figs. 1-5) comprising at least part of the mating surface (as seen in Figs. 1-5).
Regarding Claim 9, O’Brien discloses the external housing (10, Figs. 1-5) is for an intermittent catheter (¶ [0009, 0031]).
Regarding Claim 10, O’Brien discloses the catheter (18, Figs. 1-5; ¶ [0031]).
Regarding Claim 11, O’Brien discloses the catheter (18, Figs. 1-5) is a female catheter (¶ [0047]).
Regarding Claim 12, O’Brien discloses an intermittent urinary catheter (¶ [0031]).
Regarding Claim 14, O’Brien discloses the main body (12, Figs. 1-5) and/or cap (14, Figs. 1-5) are rigid (¶ [0006, 0007, 0009]).
Regarding Claim 17, O’Brien discloses the catheter (18, Figs. 1-5) has a length of between 90mm to 200 mm (¶ [0006]; the catheter tubing may be 91mm, the catheter tubing plus funnel may be 131 mm, both of which are within the claimed range).
Regarding Claim 18, O’Brien discloses the catheter (18, Figs. 1-5) has a length of between 130mm and 155mm (¶ [0006]; the catheter tubing plus funnel, which together can be considered the catheter, has a length of 131mm).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien et al (US 2019/0126004) in view of Maxwell (US 4106200).
Regarding Claim 6, O’Brien discloses the cap has a tapered mating surface (¶ [0035]) but does not disclose that the mating portion of the case has a corresponding tapered portion.
Maxwell teaches a marker compass, thus directed to the same problem solving endeavor of securely attaching a cap to the opposite, non-functional end of a device during use, where the cap and the exterior portion of the case have mating surfaces with corresponding tapered portions (Col. 3 lines 10-26) which allows the cap, when removed from the writing end, to be securely attached to the non-writing end of the marker so that the device can be utilized as a compass.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the mating portion of the case to have a corresponding tapered portion to the tapered mating surface of the cap, as taught by Maxwell, to ensure the cap and the case are securely attached together during use, as taught by Maxwell (Col. 3 lines 10-26).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien et al (US 2019/0126004) in view of Hagel (US 2014/0262860).
Regarding Claim 15, O’Brien is silent whether the main body and/or cap are comprised of polypropylene.
Hagel teaches a urinary catheter, thus being in the same field of endeavor, where the main body and or cap are comprised of polypropylene (¶ [0014]).
Therefore, it would have been obvious to modify the main body and cap of O’Brien to be made of polypropylene, as taught by Hagel (¶ [0014]). Hagel indicates that polypropylene is known within the art to be suitable for the use for urinary catheter packaging, and it has been held that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination (See MPEP § 2144.07).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien et al (US 2019/0126004) in view of Schembri et al (US 6575906).
Regarding Claim 16, O’Brien is silent whether one or both of the mating surfaces comprise an overmolded element.
Schembri teaches a medical container, thus being in the same field of endeavor, with a cap with an overmolded thread ring (Col. 3 lines 17-20). Schembri indicates the threads of the cap can either be incorporated into the metal casing or overmolded onto the metal cap (Col. 3 lines 17-20).
Therefore, it would have been obvious to modify the cap of O’Brien to have the threads of O’Brien be overmolded onto the cap, as taught by Schembri, as Schembri indicates that both incorporation into the cap and overmolding onto the cap are suitable means of providing a cap with threads to improve connection to a container (as motivated by Schembri Col. 3 lines 17-20).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Brien et al (US 2019/0126004) in view of Palmer (US 10912918).
Regarding Claim 19, O’Brien is silent whether the assembly has a length of between 2 mm and 10mm longer than the length of the catheter.
Palmer teaches a urinary catheter package, thus being in the same field of endeavor, where the assembly has a length of 10mm-20mm longer than the catheter (Col. 7 lines 53-67). This allows the packaging to closely surround the catheter and make the packaging highly portable (Col. 5 lines 15-18 and 37-40).
Therefore, it would have been obvious to modify the assembly of O’Brien to have a length of between 10mm and 20mm longer than the length of the catheter, as taught by Palmer, to allow the packaging to closely surround the catheter and make the packaging highly portable (as motivated by Palmer Col. 5 lines 15-18 and 37-40).
O’Brien/Palmer does not explicitly disclose the assembly has a length of 2mm-10mm longer than the length of the catheter.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the catheter assembly of O’Brien/Palmer to be from 10mm-20mm longer than the length of the catheter to be between 2mm-10mm longer than the length of the catheter as applicant appears to have placed no criticality on the claimed range (see ¶ [0025] of the published application indicating the length of the assembly “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding Claim 20, O’Brien is silent whether the catheter assembly has a length of 10-25cm.
Palmer teaches a urinary catheter package having a length of 10-25 cm (Col. 7 lines 53-67; the catheter may have a length of 10-15cm, and the container is preferably no more than 1-2cm longer than the catheter, making the length of the catheter assembly in the range of 11-17cm, which is fully within the range of 10-25cm). This allows the catheter to be suited to a female patient and compactly stored (Col. 7 lines 53-67).
Therefore, it would have been obvious to modify the length of the catheter assembly of O’Brien to be between 10-25cm, as taught by Palmer, to allow the catheter to be suited to a female patient and compactly stored (as motivated by Palmer Col. 7 lines 53-67).
Regarding Claim 21, O’Brien is silent whether the catheter assembly has a length of between 140mm and 165mm.
Palmer teaches a urinary catheter package having a length of 100-250 mm (Col. 7 lines 53-67; the catheter may have a length of 10-15cm, and the container is preferably no more than 1-2cm longer than the catheter, making the length of the catheter assembly in the range of 11-17cm; a 13cm catheter would have a packaging 14-15cm long, which is fully within the range of 140mm-165mm). This allows the catheter to be suited to a female patient and compactly stored (Col. 7 lines 53-67).
Therefore, it would have been obvious to modify the length of the catheter assembly of O’Brien to be between 140mm and 165mm, as taught by Palmer, to allow the catheter to be suited to a female patient and compactly stored (as motivated by Palmer Col. 7 lines 53-67).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
WO 2019/123004 to Donnelly et al
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781