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
Newly submitted claim(s) 20 and 25 is/are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (Clm. 1-16, 18, 21, 23, 26, and 27) and II (Clm. 20, 25) are related as mutually exclusive inventions in an intermediate-final product relationship. Distinctness is proven for claims in this relationship if the intermediate product is useful to make other than the final product, and the species are patentably distinct (MPEP § 806.05(j)). In the instant case, the intermediate product is deemed to be useful without removing the outer layer to form a multi-layer tubing construction and the inventions are deemed patentably distinct because there is nothing of record to show them to be obvious variants.
Alternatively, inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination does not particularly require a heat shrinkability to the tubing. While shrinkability is required through reference to a “shrink ratio”, such a “shrink ratio” is not explicitly a “heat shrink” ratio and the instant claim does not specify whether the tubing article is considered at either the initial expanded inner diameter OR the recovered inner diameter, whereas the article of the subcombination is explicitly in a recovered configuration given the “heat shrink” product-by-process step and the step of removal of the outer layer. The subcombination has separate utility such as serving as a multi-layer tubular construct without any removal of the outer layer.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction between the two inventions is proper and reasonable for at least the following reasons:
(a) the inventions have acquired a separate status in the art in view of their different classification, whereby the tubing of the combination/intermediary product is a multi-layer construct (A61M25/0045) whereas the tubing of the subcombination/final product is a single layer construct principally concerned with the method by which the tubing is manufactured including heat shrinking steps and removal of an outer layer (A61M25/0009);(b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter, whereby the apparatus of Invention I is a multi-layer tubing device which, as claimed, could be useful for other operations than forming the tubing of Invention II, which requires Invention I only as an intermediary, whereby the article produced and claimed in Invention II explicitly lacks an outer layer;(c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries);(d) the prior art applicable to one invention would not likely be applicable to another invention.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 20 and 25 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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.
Claim(s) 1-5, 7-13, 15, 16, 18, 21, 23, 26, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0094392 (“Nguyen”) in view of U.S. Patent No. 10,898,616 (“Chen”).
Regarding Claims 1, 2, 13, 21, and 26 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”);
Nguyen discloses the invention substantially as claimed except that for disclosing the explicitly shrink ratio of an expanded inner diameter of the tube (prior to construction) to the recovered inner diameter of the tube. Specifically, while Nguyen does disclose that the tube is shrunk in order to compress and thermally bond the layers of the tube (Par. 25, 121, 126, 129) – i.e. the inner diameter of the tube exhibits a shrink ratio of some magnitude between a an inner diameter of the tube and a recovered diameter of the tube it is unclear what this shrink ratio might comprise.
Firstly, it is noted that the instant claims are directed toward an article of manufacture, not the method of its manufacture. As such, the “shrink ratio”, as claimed, merely denotes a capability of the tubing and cannot effectively control that the tubing is actually shrunk from an expanded inner diameter to a recovered inner diameter. Furthermore, it is noted that the claim is ambiguous as to whether the instantly claimed invention is to be considered in the expanded configuration or recovered configuration and therefore the claim is sufficiently broad as to read upon either arrangement.
Here, in Nguyen the final inner diameter of the article is a result of the mandrel incident to the operation of the shrink step, whereby due to the shrinking of the device the layers are compressed from an initial inner diameter to the diameter of the mandrel wherein the “mandrel’s diameter can be predetermined, based on the desired size of the resulting sheath” (Par. 122) - i.e. the ratio between an expanded inner diameter of the tube (i.e. the diameter of the intermediary tubing BEFORE shrink application) to the recovered inner diameter (i.e. the diameter of the final article) is explicitly variable.
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. Specifically, the disclosure of Chen denotes a range of known, acceptable, and useful heat shrink ratios between an intermediary product and the final product, whereby providing a heat shrink ratio of at least 1.2:1 to cause a heat shrink about a mandrel of sufficient diameter to affect a specific tubing dimension is obvious, offering only expected and predictable results of affecting the method of Nguyen to create a tubing system of sufficiently small size. It has been held that mere changes in size/proportion are obvious when they affect only such predictable and expected results, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976).
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 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 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).
Regarding Claim 12, Nguyen discloses the fluoropolymeric material of the outer layer comprises fluorinated ethylene propylene (FEP) (Par. 126).
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 Claim 18 and 23, Nguyen discloses that the tube is a catheter intermediate (Abstract), i.e. a “sheath” being a type of catheter.
Regarding Claim 27, Nguyen discloses that the tube may consist of only an inner layer and an outer layer (see e.g. Fig. 24 – see particularly at step 106, Fig. 30 before the heat shrink layer has been provided or step 114, Fig. 30 after the heat shrink layer has been removed).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0094392 (“Nguyen”) and U.S. Patent No. 10,898,616 (“Chen”) as applied above, and further in view of U.S. Patent No. 5,300,048 (“Drewes”).
Regarding Claim 6, Nguyen, as modified by Chen, 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”) and U.S. Patent No. 10,898,616 (“Chen”) 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).
Response to Arguments
Applicant's arguments filed with respect to the claims have been fully considered but they are not persuasive.
Applicant argues (Pg. 8) that “there must be some suggestion or motivation, either in the references themselves of in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings”. In the instant case, Nguyen makes it clear that the multi-layer tubing exhibits a shrink ratio between an initial expanded configuration and a recovered configuration (Par. 25), whereby the recovered diameter in the final form of the tubing is a resultant of the absolute shrinkability of the tubing and the diameter of the mandrel over which the tubing is shrunk (Par. 122) and wherein different mandrel diameter sizes can be employed (creating smaller or larger shrink ratios) depending on the desired dimensions of the resulting tubing (Par. 122). Chen is relied upon to demonstrate known heat shrink ratios for catheter tubing which are known to be useful in the art, thereby establishing a range of potential shrink ratios that might be applied in the Nguyen invention to permit the tubing to be shrunk to a suitably smaller mandrel to affect suitably small tubing. The motivation here is clear, with Chen establishing a reasonable expectation of success that such shrink ratios could be achieved to cause the tubing of Nguyen to be shrunk to a sufficiently small size and whereby changes in size/proportion are understood to be obvious when they affect only expected and predictable results, see Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), and In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976). The prior art, in combination, teaches all of the instant limitations – i.e. a multi-layered shrinkable tubing when can be shrunk to different ratios dependent upon the mandrel over which the article is applied and heat shrink ratios known to be achievable.
Finally, Examiner notes that the instant claim is directed toward an article of manufacture, not the method by which the article is constructed, and the instant claim does not specify whether or not the tubing is being claimed in the recovered configuration or the initial expanded configuration. Consideration as to the tubing of Nguyen can be made with consideration as to the state of the tubing in an initial expanded configuration, wherein the shrink ratio must be considered as only the potential capability for the tubing to be shrunk to such dimensions OR as to the state of the tubing in a recovered configuration after the tubing has been heat shrunk upon a specific mandrel having a specific diameter. Consideration of Nguyen, in view of Cheng, establishes a clear obvious motivation to providing tubing which can be heat shrunk in ratios greater than 1.2:1 in order to affect Nguyen’s desired compression of the layers about a specific mandrel selected for the purposes of affecting the “desired size of the resulting sheath” (see Nguyen at Par. 122).
Applicant argues (Pg. 10) “Nguyen’s construction requires three layers”. However, this is not persuasive. Specifically, there are arrangements in Nguyen wherein the tubing consists of two layers (e.g. 66, Fig. 24), with such tubing being present without an additional heat shrink layer at various times during manufacture (see e.g. 106 – before the heat shrink tubing is applied OR 114 – after the heat shrink tubing has been removed).
Conclusion
THIS ACTION IS MADE FINAL. 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 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).
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, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 06/18/2026
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