DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claim 16 is amended (6/28/2023). Claims 21-27 are new (6/28/2023). Claims 1-15 are cancelled (6/28/2023). No new matter was added. Thus, claims 16-27 are under examination.
Priority
Claims 16-27 are given a priority date of 4/19/2006, the filing date of US 11407882.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Information Disclosure Statements from 6/28/2023 and 8/30/2023 are considered.
Specification
The disclosure is objected to because of the following informalities (see MPEP § 608.01):
The use of the terms, “Corning” (p. 2), “Schott North America” (p.2) and “Telechem International” (p. 2), “Porex” (p. 6, 26, 28), “Small Parts, Inc” (p. 6), “R&H Filter Co.” (p. 6), “Advanced Glass and Ceramics” (p. 6), “Gelest” (p. 11), “United Chemical Technologies” (p. 11, 31), “Dow-Corning” (p. 11), “GE Advanced Materials” (p. 11), “Axon Instruments” (p. 11, 19), “Perkin-Elmer” (p. 11), “Tra-Con, Inc.” (p. 14), “3M Corporation” (p. 14), “Porous Materials” (p. 18), “Mott Metallurgical” (p. 18), “GE Osmonics” (p. 27-28), “Tar-Con” (p. 30), “McMaster-Carr” (p. 30), “Corning” (p. 32-34), “Pall Corp” (p. 32), and “Ultragaps” (p. 34) are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
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 16-27 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 16 is rejected. Claim 16 recites the limitation "the average fibril distance” at line 5. There is insufficient antecedent basis for this limitation in the claim.
Claims 17-27 are included in this rejection due to their dependency on claim 16.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 16-27 are rejected under 35 U.S.C. 103 as being unpatentable over Zamora et al. (US PGPUB 2006/0024347 A1; published 2/2/2006) in view of Plath et al. (“Current trends in biomaterial surface functionalization—nitrogen-containing plasma assisted processes with enhanced selectivity”, Vacuum, published 2003) and in further view of Shea et al. (“Bridged Polysilsesquioxanes. Molecular-Engineered Hybrid Organic-Inorganic Materials”, Chem. Matter, published 2001).
Regarding claim 16, Zamora et al. teach medical devices with expanded polytetrafluoroethylene surfaces (Paragraph 0101) with linkers that would noncovalently bind HBGF analog to the surface (Paragraph 0101), wherein the linkers would function as an interlayer, and the HBGF analogs would function as a functional layer for binding to biomolecules such as HBGFR (Paragraph 0099). Specifically, Zamora teaches that the present invention relates to methods for coating and coatings for medical devices comprising synthetic peptides and analogs of heparin-binding growth factors, particularly analogs further having a heparin-binding region and hydrophobic linker, and further comprising heparin or a heparin analog (Paragraph 0001). Further, Zamora teaches that the coating of the device of surface can be polyvinyl alcohol (Paragraph 0019), where the coating of a coated medical device may further be characterized in that it binds a cell surface receptor, supports cell attachment, or is vasoocclusive (Paragraph 0020).
Although Zamora et al. do not specify that the functional layer has functional sites at a density of at least 50 nanomoles/cm2, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranged involves only routine skill in the art. In re Aller, 105 USPQ 233. Therefore, it would have been obvious to one of ordinary skill in the art for the functional layer of Zamora et al. to have functional sites at a density of at least 50 nanomoles/cm2, through normal optimization procedures known in the art at the time of the invention, in order to minimize the size of the device, and maximize the detection signal.
Regarding claims 17-20, although Zamora et al. do not specify that the functional layer has functional sites at a density of at least 100, 500, 1000, 2500-150,000 nanomoles/cm2, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranged involves only routine skill in the art. In re Aller, 105 USPQ 233. Therefore, it would have been obvious to one of ordinary skill in the art for the functional layer of Zamora et al. to have functional sites at a density of at least 100, 250, 500, 1000, 2500-150,000 nanomoles/cm2, through normal optimization procedures known in the art at the time of the invention, in order to minimize the size of the device and maximize the detection signal.
Regarding claims 21-24, Zamora et al. teach that the functional layer may comprise hydroxyl groups (Paragraph 0100). Specifically, Zamora teaches that the coating of the device of surface can be polyvinyl alcohol (Paragraph 0019), where the coating of a coated medical device may further be characterized in that it binds a cell surface receptor, supports cell attachment, or is vasoocclusive (Paragraph 0020). Further, Zamora teaches sequential application of multiple coatings to a substrate (i.e., silyl-heparin followed by a second coating), thereby suggesting layered coating architectures (Figure 7A; Paragraphs 19, 45, 126, 154). Zamora also teaches compounds having functional groups including amine and hydroxyl groups capable of interacting with and binding to polymeric and medical device surfaces (Paragraphs 51-60; 100).
Regarding claim 25, although Zamora et al. do not specify that the substrate has a thickness of 5 to 125 micrometers, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranged involves only routine skill in the art. In re Aller, 105 USPQ 233. Therefore, it would have been obvious to one of ordinary skill in the art for the functional layer of Zamora et al. to have a with a thickness of 5 to 125 micrometers, through normal optimization procedures known in the art, in order to minimize the size of the device and maximize the detection signal.
Regarding claim 26, although Zamora et al. do not specify that the polytetrafluorethylene has a fibril distance between nodes of between 0.5 and 2 micrometers, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranged involves only routine skill in the art. In re Aller, 105 USPQ 233. Therefore, it would have been obvious to one of ordinary skill in the art for the functional layer of Zamora et al.to have polytetrafluorethylene with a fibril distance length between 0.5 and 2 micrometers.
Regarding claim 27, Zamora et al. teach in the synthetic HBGF analogs, the Y region of the foregoing formulas is a linker that is sufficiently hydrophobic to non-covalently bind the HBGF analog to a medical device surface, including a polymeric or metal medical device surface where such surfaces are typically hydrophobic surfaces (i.e., polytetrafluoroethylene, expanded polytetrafluoroethylene, and metals including stainless steel, titanium, platinum, and nitinol), where preferably, the binding of the HBGF analogs to the hydrophobic surface is of sufficient quantity to be detected by an analytical method such as an enzyme-linked immunoassay or a biological assay (Paragraph 101).
Zamora et al. do not teach or suggest that the functional layer comprising amine and hydroxyl groups define surface functional sites of a functional layer characterized by a specified site density. Further Zamora et al. do not teach or suggest that the interlayer comprises sol-gel nor the functional layer organosilane.
Plath teaches that in biomaterial surface functionalization, the density and selectivity of functional groups (i.e. amino groups) on polymer surfaces are critical parameters controlling biomolecule immobilization and surface performance (Abstract). Plath further teaches that surface functionalization processes (i.e. plasma treatment) are used to generate and control the density of functional groups, including amino groups, on polymer surfaces (Section 1.3). Additionally, Plath teaches that amino, hydroxyl, carboxyl and epoxy groups are commonly introduced onto polymer surfaces and are effective for covalent or non-covalent attachment of biomolecules (Section 1.2). Specifically, Plath teaches that the efficiency of surface functionalization is characterized in terms of functional group density, such as amino group density, and such density is a measurable and tunable property (Section 2.3).
Shea teaches that bridged polysilsesquioxanes are hybrid organic-inorganic materials formed by sol-gel polymerization of organosilane precursors, which produce crosslinked network coatings and surface modifiers having tunable chemical functionality (Abstract; Introduction, Paragraphs 1-2). Further, Shea teaches that these materials are widely used for surface modification and coatings, and that incorporation of functional organic groups into the siloxane network enables control over surface properties and functionality (Introduction, Paragraphs 1-2). Additionally, Shea teaches that such sol-gel-derived networks can include a variety of functional groups (i.e. amines, ethers, amides, ureas) within the structure, thereby providing chemically functionalized surfaces (Introduction: Paragraph 2).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the coating of Zamora to include or optimize amine and/or hydroxyl functional groups using known surface functionalization approaches, as taught by Plath and Shea, in order to improve biomolecule binding, surface interaction, and coating performance. The combination merely involves the application of known surface functionalization techniques to a known coating system to achieve predictable improvements in functionality, which is considered obvious. See MPEP 2143 (combination of familiar elements according to known methods to yield predictable results); KSR v. Teleflex, Inc., 550 US 398 (2007)). Further, one of ordinary skill in the art would have had a reasonable expectation of success in making such a modification, as both Plath and Shea demonstrate that functional group incorporation (including amine-containing groups) into polymeric or hybrid coating surfaces is routine and reliably produces surfaces capable of interacting with biomolecules, thereby predictably enhancing the functionality of Zamora’s coatings.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Patent No. US 7923054 B2
(From Parent Application No. 11/407,882)
Claims 16-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 10-14 and 43 of Patent No. 7923054 B2 (from initial parent application No. 11/407,882), which has been allowed and issued. Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons that follow. This is a nonstatutory double patenting rejection because the patentably indistinct claims have in fact been patented and issued.
Parent claim 1 recites “An article comprising a support layer adjacent to a polytetrafluoroethylene substrate comprising a porous microstructure having a fibril sizelength between 0.5 and 5 microns and a thickness of about 125 microns or less, an interlayer over at least a portion of said microstructure and a functional layer attached to said interlayer, said functional layer having functional sites with a density of at least 50 nanomoles/cm².”
Parent claims 7-9 recite an article defined from claim 38 with functional site densities of at least 100-250 nanomoles/cm².
Parent claims 10-14 recite “An article as defined in claim 38 wherein said functional sites comprise hydroxyl, carboxyl, aldehyde, and epoxide groups.”
Parent claim 43 recites “An article comprising a support layer adjacent to a polytetrafluoroethylene substrate comprising a porous microstructure having a fibril sizelength between 0.5 and 5 microns and a thickness of about 250 microns or less, an interlayer over at least a portion of said microstructure and a functional layer attached to said interlayer, said functional layer having functional sites with a density of at least 50 nanomoles/cm², and a biomolecule attached to said functional sites.”
Instant independent claim of current application 18/118,844 recites a method of creating a functionalized article comprising providing a porous polytetrafluorethylene substrate having a fibrillar microstructure, depositing an interlayer (including a sol-gel coating or polymer such as polyvinyl alcohol), and attaching a functional layer to achieve a specified functional site density. Dependent claims 17-27 of current application 18/118,844 further define functional site density ranges, interlayer composition, functional group selection, substrate thickness, fibril spacing, and material selection. Overall, the method steps of independent claim 16 of current application 18/118,844 merely recite conventional steps for forming the same functionalized article structure as recited in parent claims 1 and 43. It would have been obvious to one of ordinary skill in the art at the time of the invention to employ routine fabrication steps, including deposition of an interlayer (sol gel or polymer coatings) and subsequent functionalization, to produce the known article of the parent claims, as such steps are inherent in or necessary to form the claimed structure.
To the extent the instant claims of current application 18/118,844 differ, such differences are directed to process parameters (pressure, thickness, fibril spacing), interlayer material selection, and functional group selection, which constitute result-effective variable and routine optimization of known fabrication techniques used to achieve predictable variations in functional site density and surface functionality.
Thus, the subject matter of claims 16-27 of the current application 18/118,844 would be obvious to one of ordinary skill in the art in view of the disclosure of claims 1, 7-9, 10-14 and 43 of Patent No. 7923054 B2 (from initial parent application No. 11/407,882).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ROSE LAFAVE whose telephone number is (703)756-4747. The examiner can normally be reached Compressed Bi-Week: M-F 7:30-4:30.
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/ELIZABETH ROSE LAFAVE/Examiner, Art Unit 1684
/HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684