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.
Claim(s) 2, 18, 19, 24, and dependents is/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 2 contains the trademark/trade name PEBAX, a registered trademark of ARKEMA SA. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. Here the tradename appears to be used in a genericized manner to describe ANY poly-ether-block-amide thermoplastic material irrespective of whether it was sourced from ARKEMA SA and particularly identified under the trademark PEBAX. As such, the claim is indefinite.
Regarding Claim 18, Applicant recites the limitation “A medical device manufactured using the tube of claim 1”. However, this limitation creates confusion as it is unclear what specific structure, if any, is actually required by the claim. It is unclear if Claim 18 positively requires the entire workpiece or Claim 1, any part of the workpiece of Claim 1, or none of the workpiece of Claim 1. For the sake of prosecution it will be presumed that the “medical device” which is manufactured “using” the tube of Claim 1 is the tube of Claim 1, per se.
Regarding Claim 19, Applicant recites the limitation “wherein the outer layer is removed”. However, this limitation creates confusion as to what precise structure is claimed. Specifically, it is unclear if the removed “outer layer” is positively required as part of the workpiece, i.e. the outer layer is removed, but retained, or if removal of the outer layer causes the outer layer to cease being part of the claimed workpiece and is discarded.
Regarding Claim 24, Applicant recites the limitation “wherein the outer layer of the tube is removed during assembly of the medical device”. Here the limitations of the claim are unclear as to what structure is positively required by the claim and whether the instant limitation is a process limitation or a functional limitation. Specifically, it is unclear if “is removed” is recited as an intended use, functional limitation indicating a future intended removal of the outer layer, but still positively requiring the outer layer to be physically present - OR – if the claim is reciting a finalized article AFTER an outer layer has been removed (although this would run afoul of 35 USC 112(d)) – OR – the claim is reciting a process limitation as part of a device claim, whereby such a limitation is indefinite on its face, see MPEP 2173.05(p)(II).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim(s) 18, 19, 22, and 24 is/are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 18, as discussed above, it is unclear if such omnibus recitation toward “using the tube of claim 1” actually requires the tube of Claim 1 to be part of the actually claimed workpiece. As such, it would appear that Applicant is seeking to obtain protection for inventions which do not include each and every limitation of parent Claim 1.
Regarding Claim 19 requires the outer layer to be “removed”. However, Claim 1 positively requires the “outer layer” to be part of the claimed tubing, whereby removal of the outer layer would cause it to no longer be part of the claimed tubing and therefore remove an element which was previously required by the parent claim in violation of 35 USC 112(d). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding Claim 22, Applicant recites the limitation “A medical device comprising at least the inner layer of the tube of claim 1”. However, this limitation fails to comply with 35 USC 112(d) as it infers that the outer layer is no longer a required part of the claimed workpiece and therefore Claim 22 fails to include all the limitations of the independent claim which it references.
Regarding Claim 24, as discussed above, it is unclear if the outer layer is actually positively required by Claim 24, which is dependent upon Claim 1.
Claim Rejections - 35 USC § 102
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, 2, 7-9, 12-13, 15, 16, 18-24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Publication No. 2010/0094392 (“Nguyen”) .
Regarding Claims 1, 2, 13, 18, 20, 21, 22, and 23 Nguyen discloses a catheter tube (66) comprising:
An inner layer (68) comprising thermoplastic material (Par. 10 – re: “polyamide”), wherein the thermoplastic is loaded with a radiopaque material (Par. 27); and
An outer layer (70 or 50 or Par. 126) comprising a fluoropolymeric material (Par. 72 or 91 or Par. 126 – re: PTFE or “fluoropolymers” or “FEP”).
Regarding Claim 7, Nguyen discloses the outer layer (50) is peelable (Par. 13, 87).
Regarding Claim 8, Nguyen discloses the radiopaque material comprises barium sulfate (Par. 15).
Regarding Claim 9, Nguyen discloses the radiopaque material comprises one or more of bismuth oxychloride, bismuth subcarbonate and tungsten metal powder (Par. 15).
Regarding Claim 12, Nguyen discloses the fluoropolymeric material of the outer layer comprises fluorinated ethylene propylene (FEP) (Par. 126).
Regarding Claim 13, Nguyen discloses the fluoropolymeric material of the outer layer comprises polytetrafluoroethylene (PTFE) (Par. 72 or 91).
Regarding Claim 15, Nguyen discloses the outer layer (e.g. PTFE) has a higher melt point than the inner layer (e.g. polyamide).
Regarding Claim 16, Nguyen discloses that the sheath may be expandable and therefore provided in expanded form in use (Par. 101) and that the sheath may be heat shrinkable such that prior to processing it is provided in an expanded/unprocessed form (Par. 126).
Regarding Claims 19 and 24, Nguyen discloses the outer layer is removable (Par. 87 or 126)
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.
Claim(s) 3-5 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0094392 (“Nguyen”).
Regarding Claim(s) 3-5, Nguyen discloses the invention substantially as claimed except for disclosing the %wt ratio of the radiopaque material in the inner layer. Nguyen does however disclose that the outer layer may carry radiopaque filler in a ratio of 5-45% by weight (Par. 79) and does correlate the impregnation of radiopaque material in the outer layer with that of the inner layer (Par. 27). As such, the ordinary artisan would have found it obvious to impregnate the inner layer of the sheath of Nguyen with 30-40% radiopaque filler material using the same range direction provided with respect to the outer layer described by Nguyen, in order to ensure that the material is sufficiently radiopaque under fluoroscopic visualization without compromising the structure of the layer. It has been held that discovering the optimal or workable range for a result effective variable requires only routine and customary skill in the art and is obvious, see In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and it has been held that the recitation of a range in which the claimed range overlaps with or lies within constitutes a prima facie case of obviousness, see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding Claims 10-11, Nguyen discloses the inner layer may have a wall thickness which can be varied depending upon the particular application of the sheath/catheter/tubing and that the wall thickness may lie within the range of about 0.005” to about 0.010”. As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the inner layer of Nguyen to have a wall thickness of about 0.010”, a value which lies within the range suggested by Nguyen, see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0094392 (“Nguyen”) as applied above, and further in view of U.S. Patent No. 5,300,048 (“Drewes”).
Regarding Claim 6, Nguyen discloses the invention substantially as claimed except that that the radiopaque material is dispersed substantially uniformly throughout the inner layer. Although, of relevance, Nguyen likewise fails to suggest that dispersal of the radiopaque material might be non-uniform. In the instant case Examiner notes that there presents only two possible options for impregnating the inner layer of Nguyen with radiopaque material and that it must be either uniform or non-uniform and that it has been held that selecting one specific solution from a finite number of possible solutions is obvious, see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Specifically, Drewes resolves that polymeric layers of a catheter tube may be impregnated with a radiopaque agent which is “homogenous and evenly dispersed” (Abstract). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the inner layer of Nguyen to have uniform/even dispersal of the radiopaque material, as disclosed by Drewes, in order to ensure that all sections of the catheter are evenly visible under fluoroscopy.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0094392 (“Nguyen”) as applied above, and further in view of U.S. Patent No. 9,937,319 (“Leeflang”)
Regarding Claim 14, Nguyen discloses the invention substantially as claimed except that fluoropolymeric material of the outer layer comprises perfluoroalkoxy alkanes (PFA). However, Leeflang discloses that as an alternative to PTFE or FEP an outer layer of catheter tubing may be formed of PFA (see Detailed Summary – Par. 28). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the outer layer of the catheter tubing of Nguyen to comprise PFA, as disclosed by Leeflang, whereby Leeflang clearly establishes it to comprise a suitable alternative to PTFE or FEP and it has been held that selecting an art recognized material based upon its suitability for an intended purpose is obvious, requiring only routine and customary skill in the art, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0094392 (“Nguyen”) as applied above, and further in view of U.S. Patent No. 10,898,616 (“Chen”)
Regarding Claim 17, Nguyen discloses the invention substantially as claimed except for explicitly disclosing the shrink ratio of an expanded inner diameter of the tube to a recovered inner diameter of the tube. However, Chen discloses that in such catheters produced via heat shrinking the reduction ratio of the heat-shrink tubing may have a ratio between 1.30:1 and 1.84:1 (see Clm. 8). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize a heat shrink greater than 1.2:1, as disclosed by Chen, in order to ensure that the catheter can be reduced to a sufficiently small size while permitting ease of manufacture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
01/21/2026