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
Applicant’s election without traverse of Group I, claims 1-10, 12-20, and 22-24 in the reply filed on 02/05/2026 is acknowledged.
Claim Objections
Claim 24 is objected to because of the following informalities: “double bond” should read “double bonds”. Appropriate correction is required.
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 10, 13, 15-17, 22 and 24 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 10 recites the limitation "the polymerizable groups" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
NOTE: For the prior art purposes, the examiner will interpret the claim depends from claim 3 which requires polymerizable groups on the saccharide.
Claims 22 and 24 are included in the rejection as they dependent from claim 10.
Claim 13 recites the limitation "the bond of the adhesion promoter to the medical product" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 12 does not require the carrier layer is bonded to the medial product directly.
Claim 15 recites the limitation "the polymerizable group" in line 3. There is insufficient antecedent basis for this limitation in the claim.
NOTE: For the prior art purposes, the examiner will interpret the claim depends from claim 3 which requires polymerizable groups on the saccharide.
As to claims 16 and 17, the claims use open-ended Markush language (i.e., “selected from the group comprising,” instead of the standard “selected form the group consisting of” language. The claims are indefinite because it is unclear whether alternatives other than those listed are intended to be encompassed.
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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dickerson et al. (US 5677276).
As to claims 1 and 2, Dickerson et al. discloses a conjugate comprising hyaluronate (saccharide) and a peptide containing the sequence Arg-Gly-Asp (RGD - integrin-binding motif) material (functional layer – promotes tissue regeneration and wound healing- see abstract) coated on implantable materials such as a biodegradable mesh (see abstract, col. 3, lines 50-55).
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) 1-6, 8-10, 12-14, 16-20, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schedler et al. (WO 2018/210989) in view of Dickerson (US 5677276).
As to claim 1, Schedler et al. discloses a medical device comprising a substate and at least one functional layer that has biomimetic and/or bio-repulsive properties (see 0008 of the translation). The functional layer comprises sugar alcohols (saccharide) (see 0026 of the translation).
Schedler et al. fails to teach the functional layer contains peptide sequences with integrin-binding motifs as required by claim 1.
Dickerson discloses conjugating saccharide polymers with peptides containing the integrin-binding motif Arg-Gly-Asp (RGD) for use as a coating a medical product to promote cell adhesion to biomaterial matrices (see abstract, col. 3, lines 50-55, and col. 6, lines 3-10).
It would have been obvious to one having ordinary skill int eh art before the effective filing date of the claimed invention to incorporate the integrin-binding peptides such as RGD of Dickerson into the functional coating of Schedler et al. One would have been motivated to do so since both are directed to coating medical devices with saccharide based functional coatings and Dickerson further teaches that RGD peptides promote integrin-mediated cell attachment which would improve biological interaction of implant surfaces and conjugating such materials with saccharides.
As to claim 2, the peptide sequence used is RGD (see Schedler- abstract).
As to claim 3, Schedler states the saccharide are chemically functionalized for polymerization/coating formation. Schedler states the monosaccharide is functionalized via at least one reactive group that is suitable for polymerization (see 0037 of translation). Dickerson teaches that integrin-binding peptides can be chemically coupled to saccharide matrices through reactive functional groups on the peptides such as amines or other nucleophilic groups. It would have been obvious to one having ordinary skill in the art to incorporate the peptides taught by Dickerson into the polymerizable saccharide coating chemistry of Schedler. One would have been motivated to do so since Schedler teaches functionalized saccharides capable of participating in coating forming reactions and Dickerson teaches reactive peptide molecules capable of reacting with saccharide chemistry.
As to claim 5, Dickerson teaches coupling integrin-binding peptides to saccharide matrices through chemical reactions (see abstract, Figs. 1-3, cols. 3-6). It would have been obvious to one having ordinary skill in the art to first create the saccharide coating layer and subsequently react integrin-biding peptides with the saccharide matrix to form the functional layer.
As to claim 4, Schedler and Dickerson fail to teach copolymerization as claimed. Schedler teaches polymerizable saccharide monomers used to form the coating it would have been obvious to modify the peptides of Dickerson with polymerizable or reactive functional groups, so the peptides could participate in the same polymerization reaction as the saccharide components. Such modification would allow copolymerization thereby creating the polymerized coating layer.
As to claim 6, Dickerson teaches coupling integrin-binding peptides to saccharide matrices through chemical reactions (see abstract, Figs. 1-3, cols. 3-6). Dickerson fails to teach successive reactions of peptides functionalized with reactive groups with saccharides functionalized with polymerizable groups as claimed. Reversing the order of sequential functionalization steps would have been an obvious variation of surface modification technique. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
As to claim 8, the saccharides are monosaccharides (see 0031 of Schedler).
As to claim 9, Schedler states the saccharides in their non-functional form is a sugar alcohol (see 0034).
As to claims 10, 22, and 24, the saccharide has polymerizable groups that comprise reactive multiple bonds such as vinyl and allyl groups (See 0037).
As to claims 12, 13, and 23 the coating comprises a carrier layer located on the substrate (see 0032 of Scheler – translation) where the carrier layer has an adhesion promoter (see 0032). The functional layer is bonded to the carrier layer (see 0032). The adhesion promoter is a silane compound (see 0032).
As to claim 14, Schedler et al. states the bonds between the carrier and the substrate is a covalent bond (see 0032).
As to claim 16, the medical product can be formed of a metal such as nickel, titanium, platinum, iridium, gold, cobalt, etc. (See 0017 of translation – Schedler).
As to claim 17, the medical product can be formed of a plastic material such as polyamides, PTFE, ePTFE, polyolefins, etc. (See 0018).
As to claim 18, Schedler teaches the device can be a permanent implant (see 0002).
As to claims 19-20, the medical product can be an endovascular, neurovascular or cardiovascular device (see 0060 of Schedler).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schedler et al. (WO 2018/210989) in view of Dickerson (US 5677276) as applied to claim 1 above, and further in view of Willis et al. (US 2009/0317443).
The teachings of Schedler et al. and Dickerson as applied to claim 1 are as stated above.
Schedler et al. and Dickerson fail to teach layer is created by polymerization of polymerizable molecules carrying a saccharide unit and a peptide unit as required by claim 7.
Schedler et al. teaches saccharide based coatings having polymerizable saccharide chemistry where the coating is formed via polymerization. Dickerson teaches saccharide-peptide conjugates where the peptide has integrin binding motifs.
Willis et al. discloses a coated implant coated with a primer and a biocompatible polymer that forms a covalent bond with the primer layer (see abstract). Willis et al. teaches the coating is obtained by polymerizing monomers that include functional pendant groups (see 0026) such as reactive double bonds (acrylates, methacrylates).
It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the saccharide-peptide molecules of Schedler modified by Dickerson et al. to include polymerizable functionality as taught by Willis et al. One would have been motivated to do so since in order to obtain a stable bioactive saccharide based functional layer having integrin-binding activity.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schedler et al. (WO 2018/210989) in view of Dickerson (US 5677276) as applied to claim 1 above, and further in view of Joner et al. (US 2009/0053280).
The teachings of Schedler et al. and Dickerson are as applied to claim 1 above.
Schedler et al. and Dickerson fail to teach the spacer between the polymerizable groups and the peptide as required by claim 15.
Joner et al. discloses a medical device (stent- see abstract), that has a coating where the coating has chemical entity having the formula P-S-A where P represents integrin selective peptide; S is a spacer (organic spacer); and A represents an anchor (see 0052-55). The coating prevents restenosis (see 0005- functional layer). Joner et al. states the spacer is positioned between the peptide and the anchor and is any molecule that allows the integrin selective peptide to bond to integrin (see 0072). The anchor is any component that is capable of binding to the surface of a base metal stent (see 0083). Joner teaches molecules having polymerizable groups such as acrylates, attachment of bioactive ligands to the polymerizable groups and polymerization of the molecules to form functional coating layers.
It would have been obvious to one having ordinary skill in the art to modify Schedler et al. and Dickerson to incorporate the space taught by Joner et al. One would have been motivated to do so since both are directed to coating medical devices with coatings having peptide sequences with integrin-binding motifs, where Joner et al. further teaches the uses of spacers between the anchor material (bound to the medical product) and the peptide in order to improve ligand accessibility (see 0072).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Colen et al. (US 2005/0192657) discloses a medical device (stent) that comprises a layer of sugar, sugar derivative, or an inorganic salt (see 0009). The coating can comprise a polysaccharide, polypeptide, surfactant, or a combination thereof (see 0026).
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/CACHET I. PROCTOR/
Examiner
Art Unit 1712
/CACHET I PROCTOR/Primary Examiner, Art Unit 1712