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 Arguments
Applicant's arguments filed 12/11/25 have been fully considered but they are not persuasive. Applicant first argues that Hall did not disclose the feature of “at least one metallic structure formed by a single segment of wire arranged in a peak-valley configuration and in a helical arrangement” but only selects a portion of the clause to dispute. The examiner notes the broad language of “at least one” which is open ended and encompasses many metallic structures if giving the broadest reasonable interpretation. Hall clearly illustrates a plurality but more importantly each winding can be seen with peaks and valleys that as one moves about the circumference an adjacent peak of a ring segment is at a different location and not on the same plane to thus establish a helical arrangement. Thus it meets the scope of the claim.
It is noted that Applicant alleged the 112 rejections were overcome per the amendment to claim 1, however whether intentional or unintentional there is another ambiguous use of the clause “self-lubricating polymer” in claim 1 and thus the rejection is maintained. Applicant made no comments as to the clause or what was done to the claim, therefore it needs to be addressed as the disclosure provides no clarification what the phrase means.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance Hall teaches the claimed invention of having the metallic stent covered by two sets of laminate coatings of which clearly are polymers which can be considered both self-lubricating in giving the broadest reasonable interpretation or understanding of what applicant meant, such as possibly PTFE known to have lubricity. Second the other polymer used in the inner layers or laminates can be of polymers heat melted or alternatively sintered, see paragraphs 60,61 as it can be understood a protective layer can be a lubricating polymer and laminating layer can be a hot-meltable polymer. Applicant just recites functional polymers and fails to argue the prior art did not disclose the same polymers or prove otherwise. Because the Patent & Trademark Office does not have the testing facilities to provide factual evidence needed to establish that the claimed invention or subject matter is unobvious, the examiner properly shifts the burden to Applicants to show that unobvious differences exist, Ex parte Phillips, 28 USPQ 1302 (Bd Pat App & Inter, 4/27/93). Further Marrocco was just used for the connecting strip between laminate layers as stated in the abstract. Thus a prima facie case of obviousness has been established.
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 1,2 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 limitation “self-lubricating polymer” in line 9 of claim 1 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is not clear what is being accomplished, meaning is some "lubricating means" being released as the claim recites a "self-lubricating polymer" that implies it can do something itself. Thus, is some lubricating material provided in the polymer? Is the intended scope meaning that the surface is smooth and non-roughened? While the specification provides antecedent basis for the clause, it invokes an issue of ambiguity and clarity. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Claim 2 depends on claim 1 and is indefinite for such a reason.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (2016/0250048) in view of Marrocco et al. (10010403). Figure 5 illustrates a constructive arrangement introduced in endoprosthesis, consisting of at least one metallic (paragraph 83) structure 202,204,206 formed by a single segment of wire arranged in a peak-valley configuration and in a helical arrangement. With respect to the imitation of "hot-meltable polymer" it is considered to be a product-by-process limitation and even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself, The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, (In re Thorpe, 227 USPQ 964,966). Once the Examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product, In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 293 (Fed. Cir. 1983), MPEP 2113 II.). Figs. 3B,C show an outer coating layer made up of an outer laminate and an inner laminate, said outer laminate being made of a lubricating polymer 150 and said inner laminate being made of a hot-meltable (paragraphs 60,61) polymer 140 as it is capable of being melted when heated to melting temperature; and an inner coating layer made up of an outer laminate and an inner laminate, said outer laminate being made of a self-lubricating polymer 120 and said inner laminate being made of a hot-meltable polymer 110 as it is capable of being melted when heated to melting temperature; the constructive arrangement introduced in endoprosthesis comprises: at least a part of said metallic structure is arranged between the result of the hot-melting between the inner laminate of the outer coating layer and the inner laminate of the inner coating layer. However, Hall et al. did not disclose the constructive arrangement introduced in endoprosthesis further consists of at least one capillary structure axially arranged along an axial segment of the endoprosthesis; and said capillary structure is axially arranged between the result of the hot-melting between the inner laminate of the outer coating layer and the inner laminate of the inner coating layer. Marrocco et al. teach (abstract) a stent having laminated layers thereon with a capillary structure axially arranged along an axial segment of the endoprosthesis and arranged between the result of the hot-melting between the inner laminate of the outer coating layer and the inner laminate of the inner coating layer. It would have been obvious to one of ordinary skill in the art to utilize a capillary structure arranged along an axial segment of the endoprosthesis and said capillary structure is axially arranged between the result of the hot-melting between the inner laminate of the outer coating layer and the inner laminate of the inner coating layer as taught by Marrocco et al. in the stent of Hall et al. such that it limits the stent from foreshortening.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (2016/0250048) in view of Marrocco et al. (10010403) as applied to claim 1 above, and further in view of Hogan (6569191). Hall et al. in view of Marrocco et al. is explained supra. However, Hall et al. as modified by Marrocco et al. did not disclose three capillary structures equidistantly spaced, in a radial direction along an axial segment of
the endoprosthesis. Hogan teaches (Fig. 4) an endoprosthesis with three capillary structures 40 equidistantly spaced, in a radial direction along an axial segment of the endoprosthesis. It would have been obvious to one of ordinary skill in the art to utilize three capillary structures as taught by Hogan with the stent construction of Hall et al. in view of Marrocco et al. in order to increase the effect of the capillary structure, see Hogan, col. 7, lines 6-10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Krause et al. (2009/0264982) disclose a stent with inner and outer coating layers. Krause also discloses there can be connecting structure on the stent body.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Barrett can be reached at 571-272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799