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 1-11,13,15-17 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. In claim 1, the recitation of “an interlaced substrate” is not clear if it defines the “interlaced structure” recited earlier in the claim or the preamble. Did applicant use the term “substrate” as the intended target for the coating because the recitation of “interlaced structure” meant as a coated substrate? Additionally what is not clear is claim 1 also uses alternative language “and/or” which suggests only one of the first or second surfaces could be coated by a precursor chemical passing through the fluid-permeable substrate holder that has the second surface of the interlaced substrate on the holder, but how does it get to the first surface? Additionally it is not clear if there are layers because claim 1 recites “in a number of deposition cycles, forming a first coating on the first surface and/or forming a second coating on the second surface” but since the alternative language of “and/or” is used it is not evident if the cycles produces the two surfaces being coated with the use of and interpreted as an option. The second interpretation is that only one surface is required by the use of the OR in the claim but makes it unclear if multiple layers were established.
Any dependent claim not addressed below is rejected for depending on an indefinite independent claim and inherits the issue of its vagueness.
With respect to claim 3, the recited deposition requiring “at least two predetermined precursor chemicals into the reaction space” is ambiguous because the claim further recites “a deposition layer is produced across the first surface of the substrate and/or across the second surface of said substrate” that makes it unclear if a composite material defines the deposited layer on a surface or one of the first on the first and one on the second.
Regarding claim 5, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Further claim 5 is ambiguous because claim 1 does not necessarily require multiple chemicals, thus is there different chemicals being administered?
Claim 6 recites the limitation "any one of the precursor chemicals" in line 2 of the claim. Claim 1 at a minimum only requires one chemical. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the deposition layers" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 13, the phrase " such as a stent or a catheter or configured to form a part of such device" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. The claim is essentially limitless in scope as to being potentially any implantable tubular interlaced structure. See MPEP § 2173.05(d).
In claim 15 the recitation of “a first coating on a first surface and/or a second coating on a second surface, ..” is ambiguous as to whether two different coatings are even required due to the use of “or” in the claim since alternative language does not require two different coatings. Thus is there two surfaces?
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) 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chandrasekaran (2003/0153971). Fig. 2 shows an interlaced structure 22 configured as a stent 20. Fig. 5b shows that there are first and second surfaces that can be said to define exterior and interior surfaces respectively with first 66 and second 64 coatings respectively thereon. Chandrasekaran also disclose (paragraph 40) that the coatings can be different materials or compositions since they have different rates of biodegradation. Chandrasekaran also disclose the coated structures can be for a stent.
Claim(s) 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alt et al. (5788979). Fig. 3 shows an interlaced structure configured as a stent 25. Alt et al. disclose (col. 10, lines 4-10) that there are first and second surfaces that can be said to define exterior and interior surfaces respectively with first and second coatings respectively thereon. Alt also discloses (col. 10, lines 4-10) that the coatings can be different materials or compositions since they have different body effecting reactions. With respect to claim 17, Alt also disclose (Col. 8, lines 57,58,6263) the coated structures can be for a stent or catheter.
Claim(s) 1-7,9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shannon et al. (WO 98/0090) or, in the alternative, under 35 U.S.C. 103 as obvious over Zukowski (9579187). Fig. 4a shows a coated device 14. Shannon et al. disclose (page 1, lines 27-31) interlaced structures are known as seen in Fig. 4c. Thus, Shannon discloses (page 8, lines 27-33) a coating is formed on a first surface and/or forming a coating on a second surface of the substrate. Shannon et al. further disclose (page 17, lines 13-20) a liquid coating can be applied on the substrate surface(s).
With respect to the limitations found in claim 1 of “coating formed by a method of… obtaining a chemical deposition reactor with a reaction space formed by a reaction chamber and configured to receive, at least in part, a substrate holder made of a fluid-permeable material, onto which…. in a number of deposition cycles, forming a first coating on the first surface and/or forming a second coating on the second surface, wherein, each deposition cycle comprises delivering, with a flow of fluid, a precursor chemical into the reaction space such, that delivery of at least one precursor chemical into the reaction space occurs via said fluid-permeable material” is considered to be product-by- process limitations 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 different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, B02, 218 USPO 289, 292 (Fed. Cir, 1953}, MPEP 2113). Thus, the first and/or second surface of the substrate in the article/stent of Shannon is capable of being “coated” as recited in the claim. It is noted that Shannon discloses (Fig. 4a) a chemical deposition chamber 30. Shannon further show (Fig. 4c) a substrate holder or mandrel 50 for an article to be coated. However, Shannon et al. did not disclose the substrate holder made of a fluid-permeable material. Zukowski teaches (Figs. 20-23) a fluid-permeable material (col. 9, lines 23-25) as a substrate holder 72. Therefore in the alternative it would have been obvious to one of ordinary skill in the art to use a mandrel or substrate holder made of a fluid-permeable material as taught by Zukowski with the coated device of Shannon et al. such that the formation of the coating along the length is applied as desired, but provides a controlled flow of pressure in a chamber to apply a coating. Regarding claim 2, Zukowski teaches (Figs. 20-23) that the mandrel or substrate holder 72 is hollow. Please note claim is a product-by-process and thus the coating fluid is fully capable of being drawn through the permeable substrate holder. Regarding claim 3, it is noted that Shannon discloses (page 20, lines 13-18) additional coating material can be added together to provide an adhesive coating. Thus the coated item of Shannon is fully capable of having a deposition layer resulting from at least two precursor chemicals delivered into the reaction space to coat the item first surface and/or second surface of the substrate. With respect to claim 4, Shannon et al. further disclose (page 18, lines 28-37) a second liquid could also be applied on the substrate stent. Again Applicant is reminded this is a product claim and the delivery of chemicals to coat are process steps not necessarily required in a product claim. However, in the alternative as already mentioned Zukowski teaches a permeable substrate holder which is capable of having a liquid dispersed therethrough and Shannon discloses multiple means of applying coatings on the stent substrate along with use of a chamber, thus multiple delivery ways for applying the chemical to coat is obvious in view of the combined teachings. With respect to claim 5, the claim is a product claim and thus the coated item of Shannon is fully capable of having precursor chemicals delivered into the reaction space by separated pulses to coat the item. Claims are directed to the coated item, not how the delivery of chemical to the reaction space to coat the item is accomplished. With respect to claim 6, the claim is a product claim and thus the coated item of Shannon is fully capable of having reverse flow opposite to precursor chemicals delivered into the reaction space to coat the item. Claims are directed to the coated item, not what the chamber to coat is designed as. Regarding claim 7, Shannon discloses (page 6, lines 19,20, page 7, lines 9-14,33-37, Fig. 4a) the coating can be provided such that any one of the first coating and the second coating are formed by the at least one deposition layer deposited across the first surface of the substrate and/or across the second surface of said substrate. With respect to claim 9, the claim is a product claim and thus the coated item of Shannon is fully capable of having adjusting pressure of fluid into the reaction space to coat the substrate. Claims are directed to the coated item, not what the chamber to coat is designed as. Regarding claim 10, Zukowski teaches (col. 9, line 23) the substrate holder is made of a fluid-permeable material to be selected as a porous metal. With respect to claim 11, Shannon shows (Fig. 4c) a tubular substrate holder 50 in addition the teaching of Zukowski shows substrate holder 72 cross-section as tubular. Regarding claims 12,13, Shannon disclose the device to be coated is a stent 14 shown in Fig. 4c as a mesh.
Claim(s) 1,7,8,12,13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alt et al. (5788979) or, in the alternative, under 35 U.S.C. 103 as obvious over Zukowski (9579187). Fig. 3 shows a coated device 25. Alt et al. disclose (col. 10, lines 4-6) interlaced structures are known as seen in Fig. 3. Alt et al. disclose (col. 10, lines 4-10) a coating is formed on a first surface and/or forming a coating on a second surface of the substrate. Alt et al. further disclose (col. 10, lines 12,13) a liquid coating can be applied on the substrate surface(s). With respect to the limitations found in claim 1 of “coating formed by a method of… obtaining a chemical deposition reactor with a reaction space formed by a reaction chamber and configured to receive, at least in part, a substrate holder made of a fluid-permeable material, onto which…. in a number of deposition cycles, forming a first coating on the first surface and/or forming a second coating on the second surface, wherein, each deposition cycle comprises delivering, with a flow of fluid, a precursor chemical into the reaction space such, that delivery of at least one precursor chemical into the reaction space occurs via said fluid-permeable material” is considered to be product-by- process limitations 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 different between the claimed product and the prior art product (In re Marosi, 710 F.2d 798, B02, 218 USPO 289, 292 (Fed. Cir, 1953}, MPEP 2113). Thus, the first and/or second surface of the substrate in the article/stent of Alt et al. is capable of being “coated” as recited in the claim. It is noted that Alt discloses (col. 10, lines 12,13) a chemical deposition chamber is used since dipping is a process to coat the stent. However, Alt et al. did not disclose a substrate holder made of a fluid-permeable material used to coat the device. Zukowski teaches (Figs. 20-23) a fluid-permeable material (col. 9, lines 23-25) as a substrate holder 72. Therefore in the alternative it would have been obvious to one of ordinary skill in the art to use a mandrel or substrate holder made of a fluid-permeable material as taught by Zukowski with the coated device of Alt et al. such that the formation of the coating along the length is applied as desired, but provides a controlled flow of pressure in a chamber to apply a coating. Regarding claim 7, Alt et al. disclose (col. 4, lines 5-9, col. 5, lines 58-65) the coating formed on the stent substrate can be deposited by layers forming across the first surface of the substrate and/or across the second surface of the substrate.
Regarding claim 8, Alt et al. disclose (col. 10, lines 5-10) the coating formed by the method, wherein the deposition layers forming the first coating differ from the deposition layers forming the second coating by virtue of at least composition thereof.
With respect to claim 12, Fig. 3 shows an essentially tubular interlaced structure formed as a mesh 25 to be coated.
Regarding claim 13, Alt et al. disclose (col. 8, lines 57,58,62,63) the device to be coated is a stent or catheter.
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) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shannon et al. (WO 98/0090) or, in the alternative, under 35 U.S.C. 103 as obvious over Zukowski (9579187) as applied to claim 1 above, and further in view of Dubrow et al. (2006/0204738). Please note the claim is a product claim and not a method of making or coating. Thus, since Shannon disclose a coated stent or item, it is fully capable of being coated by an atomic layer deposition process. Further Shannon discloses (Fig. 5) that deposition processes are capable of being used on the stent but did not state it was ALD. Dubrow et al. teach that coatings can be used on stents and onto the exterior and/or interior surfaces, see paragraphs 14,114. Dubrow et al. further teach (paragraph 171) that ALD is an advantageous coating process. It would have been obvious to one of ordinary skill in the art to alternatively select ALD as a coating process as taught by Dubrow et al. to produce the coating on the item of Shannon and alternatively modified by Zukowski due to its ability to apply thin, conformal coatings, see Dubrow paragraph 171.
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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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799