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 with traverse of Group I, claims 1-8 and 15-17, in the reply filed on 24 July 2026 is acknowledged. The traversal is on the grounds that the cited references do not disclose the polyarylene ether ketone is covalently bound to a metallic support, and that none of the references disclose a metallic support that needs increased hydrophilicity, such that the present claims define a contribution over the prior art. This is not found persuasive for the following reasons.
In response to Applicant’s argument that the cited references do not disclose the polyarylene ether ketone is covalently bound to a metallic support, this is not found persuasive. As set forth in paragraph 20 of the action mailed 29 May 2026, given that Springate in view of Loyau and Averick discloses an endoprosthesis comprising a metal coated with polyarylene ether ketone (i.e., polyaryl) to which fucoidan is bonded through a diaminopropane identical to that of the present invention, it is clear the fucoidan would necessarily inherently attach to the metal through a terminal functional group identical to that presently claimed. The basis for inherency is not based on mere possibility or probability, but based on the fact that the prior art references explicitly meet all the claim limitations. It is the examiner’s position that a sound basis has been set forth for believing that the product of the prior art is the same as that claimed. The Office realizes that the claimed properties are not positively stated by the references. However, the references teach all of the claimed components. Therefore, the claimed properties would inherently necessarily be capable of being achieved by the prior art. If it is Applicant’s position that this would not be the case: (1) persuasive evidence would need to be provided to support this position; and (2) it would be the Office’s position that the application contains inadequate disclosure in that there is no teaching as to how to obtain the claimed properties with only the claimed components. Given that it is the examiner’s position that a sound basis has been provided in the rejections of record for believing that the products of the Applicant and the prior art are the same, one would expect the claimed properties to necessarily be present (i.e., naturally flow from the prior art), and thus, the burden is properly shifted back to Applicant to show that they are not. Applicant has provided no evidence (i.e., data) demonstrating the polyarylene ether ketone of Springate in view of Loyau and Averick would not covalently bond to a metallic support.
In response to Applicant’s argument that none of the references disclose the need for increased hydrophilicity of a metallic support, this is not found persuasive. Given that Springate and Averick are both drawn to implantable medical devices, the increased hydrophilicity disclosed by Averick would be relevant to Springate. It is further noted that “if a technique has been used to improve one device and the person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill”. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Given that Springate in view of Loyau and Averick disclose an endoprosthesis comprising metal coated with polyarylene ether ketone to which fucoidan is bonded through a diaminopropane identical to that of the present invention, it is clear the fucoidan would necessarily attach through a terminal functional group identical to that presently claimed.
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 24 July 2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 7-8, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Springate et al. (WO 2019/210414 A1, “Springate”) in view of Loyau et al. (US 2016/0279249 A1, “Loyau”) and Averick et al. (WO 2019/156949 A1, “Averick”).
With respect to claims 1-2, Springate discloses a fucan which is a fucoidan covalently bound to a secondary component such as metal ([0005], [00016]). The secondary component is bonded to the fucoidan through a functionality including a primary amine ([00034]). Springate further discloses a surgical device suitable for implantation in a patient (i.e., an endoprosthesis) that is coated with the composition ([00054]). That is, Springate discloses an endoprosthesis including those made from metal coated with fucoidan (i.e., a biologically active film) through a primary amine, where the fucoidan is covalently bound to the metal.
However, Springate does not disclose the primary amine includes that of formula (I) presently claimed, or that the film comprises one or more polyaryl chains.
Loyau teaches a fucoidan of the formula FUCO-C1-[NH]x-R1, where x is 0 (p0119-0121]) and R1 is a primary amine ([0124], [0127]). The fucoidan is aminated by a primary amine that includes diaminopropane ([0256-0258]). The aminated fucoidan provides improved treatment for acute vascular thrombotic diseases ([0024], [0062]). Loyau teaches reacting the fucoidan with diaminopropane identical to the reaction of the present invention (instant specification, page 8, lines 11-13).
Springate and Loyau are analogous inventions in the field of fucoidans containing amine functionalities.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fucoidan of Springate to react with a primary amine that is diaminopropane as taught by Loyau in order to provide improved treatment for acute vascular thrombotic diseases (Loyau, [0024], [0062]).
However, Springate in view of Loyau does not disclose the film comprises one or more polyaryl chains.
Averick teaches a hydrophilic polymer that is polyarylene ether ketone having a plurality of repeating units each comprising an aryl group (i.e., polyaryl) ([0006-0008]). The hydrophilic polymer is used on medical devices (claim 15) including implants to increase hydrophilicity ([0039]). The polyarylene ether ketone corresponds to the claimed Linker comprising a linear or branched polyaryl chain.
Springate in view of Loyau and Averick are analogous inventions in the field of implantable medical devices.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device of Springate in view of Loyau to be coated with polyarylene ether ketone as taught by Averick in order to increase the hydrophilicity of the device (Averick, [0029]).
Given Springate in view of Loyau and Averick discloses an endoprosthesis comprising metal coated with polyarylene ether ketone (i.e., polyaryl) to which fucoidan is bonded through a diaminopropane identical to that of the present invention, it is clear the fucoidan would necessarily attach to the metal through a terminal functional group identical to that presently claimed.
With respect to claim 7, Springate discloses the surgical device (i.e., endoprosthesis) includes a stent ([00054]); stents are known to have web-like structures and thus the endoprosthesis is a web.
With respect to claim 8, Springate discloses the metallic atom includes titanium alloys ([00016]).
With respect to claims 15 and 17, Averick teaches the aryl groups are phenyl groups ([0033]) (i.e., comprise one aromatic ring and are unsubstituted).
With respect to claim 16, given that aryl groups broadly fall within the categories of “condensed” or “non-condensed”, the aryl groups of Springate in view of Loyau and Averick would inherently be one of the two categories, and thus the claim is considered met by the prior art.
Allowable Subject Matter
Claims 3-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for indicating allowable subject matter. Claims 3-6 contain allowable subject matter over the “closest” prior art Springate et al. (WO 2019/210414 A1, “Springate”), Loyau et al. (US 2016/0279249 A1, “Loyau”), and Averick et al. (WO 2019/156949 A1, “Averick”).
Springate discloses a fucan which is a fucoidan covalently bound to a secondary component such as metal ([0005], [00016]). The secondary component is bonded to the fucoidan through a functionality including a primary amine ([00034]). Springate further discloses a surgical device suitable for implantation in a patient (i.e., an endoprosthesis) that is coated with the composition ([00054]). That is, Springate discloses an endoprosthesis including those made from metal coated with fucoidan (i.e., a biologically active film) through a primary amine, where the fucoidan is covalently bound to the metal.
However, Springate does not disclose the primary amine includes that of formula (I) presently claimed, or that the film comprises one or more polyaryl chains. Further, Springate does not disclose wherein the Linker is represented by Formula (III) as presently claimed, nor wherein the aryl group is an optionally substituted 4-nitrophenyl of Formula (IV) as presently claimed, nor wherein the Fucoidan is a compound comprising the repetition of one or more units of Formula (V) as presently claimed. Additionally, Springate does not disclose where the Fucoidan is a mixture of weight average molar weight between 5 and 30,000 g/mol.
Loyau discloses a fucoidan of the formula FUCO-C1-[NH]x-R1, where x is 0 (p0119-0121]) and R1 is a primary amine ([0124], [0127]). The fucoidan is aminated by a primary amine that includes diaminopropane ([0256-0258]). The aminated fucoidan provides improved treatment for acute vascular thrombotic diseases ([0024], [0062]). Loyau teaches reacting the fucoidan with diaminopropane identical to the reaction of the present invention (instant specification, page 8, lines 11-13).
However, Loyau does not disclose wherein the Linker is represented by Formula (III) as presently claimed, nor wherein the aryl group is an optionally substituted 4-nitrophenyl of Formula (IV) as presently claimed, nor wherein the Fucoidan is a compound comprising the repetition of one or more units of Formula (V) as presently claimed. Further, while Loyau discloses the fucoidan moiety has an average molecular weight of 2,000-100,000 Da ([0044]), Loyau does not provide any motivation for selecting an average molecular weight within that range and therefore does not provide and teaching, suggestion, or motivation to set the Fucoidan weight average molar weight to be between 5 and 30,000 g/mol.
Averick discloses a hydrophilic polymer that is polyarylene ether ketone having a plurality of repeating units each comprising an aryl group (i.e., polyaryl) ([0006-0008]). The hydrophilic polymer is used on medical devices (claim 15) including implants to increase hydrophilicity ([0039]). The polyarylene ether ketone corresponds to the claimed Linker comprising a linear or branched polyaryl chain.
However, Averick does not disclose where the Fucoidan is a mixture of weight average molar weight between 5 and 30,000 g/mol, nor does Averick does not disclose wherein the Linker is represented by Formula (III) as presently claimed, nor wherein the aryl group is an optionally substituted 4-nitrophenyl of Formula (IV) as presently claimed, nor wherein the Fucoidan is a compound comprising the repetition of one or more units of Formula (V) as presently claimed. Instead, Averick teaches the hydrophilic polymer is represented by Formula I below, where Ar1, Ar2, Ar3, and Ar4 are optionally substituted aryl; each of X1 and X2 is independently selected from O or the structures shown below, wherein Y is a C1-10 alkyl, wherein one or more carbons in the C1-10 alkyl is optionally replaced with a heteroatom, a carbonyl, or NR1R2, Ra is selected from the group consisting of OR1, NR1R2, C1-5 alkyl, a primary, secondary, tertiary, or quaternary ammonium salt moiety, a pyridinium salt moiety, a guanidino or guanidinium salt moiety, a peptide, an amino acid, or a zwitterionic species, where R1 and R2 are independent H or a C1-5 alkyl, and provided that at least one of the X1s and all the X2s in each of the one or more units is not O, m and n are each an integer of 1, 2, or 3, and o and p are each an integer of 0, 1, or 2 ([0024]). None of X1 or X2 and the structures represented by them correspond to the claimed Linker of claim 3. Further, Averick discloses that Ar1, Ar2, Ar3, and Ar4 are phenyl groups ([0033]), but does not disclose the use of an optionally substituted 4-nitrophenyl of Formula (IV) presently claimed.
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Formula I
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X1 or X2 alternate structures
Thus, none of the references, either alone or in combination, disclose the inventions of claims 3-6, and thus claims 3-6 contain allowable subject matter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Steven A Rice whose telephone number is (571)272-4450. The examiner can normally be reached Monday/Wednesday 07:30-12:30 and 20:30-22:30; Tuesday/Thursday/Friday 07:30-16:30 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Callie E Shosho can be reached at (571) 272-1123. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A RICE/Examiner, Art Unit 1787
/CALLIE E SHOSHO/Supervisory Patent Examiner, Art Unit 1787
