DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Request for Continued Examination (RCE), Amendments and Remarks, filed 7 May 2026, in the matter of Application N° 18/282,974. Said documents have been entered on the record. The Examiner further acknowledges the following:
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7 May 2026 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-4 and 6-14 are pending, where claims 1-3 and 6-14 remain withdrawn from consideration.
Claim 5 has been canceled. No claims have been added.
Claim 4 has been amended with the limitations of canceled claim 5 reciting that “the urethane resin having a polyoxyethylene structure in a main chain and/or a side chain”. Claim 4 has been additionally amended to remove the term “derived”. The Examiner notes that this amendment does not change the overall interpretation of the sourcing of the claimed components. Lastly, the claim has been amended to further limit the polycarbonate polyol to having a structural unit from an aliphatic polyol. Support for the final amendment is taken from the originally-filed disclosure (see e.g., Examples 1-3).
No new matter has been added.
Thus, claim 4 now represents all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statement(s) (IDS) have been filed for consideration.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 13 February 2026 since the art that was previously cited continues to read on the amended limitations.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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 4 and 5 are rejected under 35 U.S.C. 103 as obvious over Xu et al. (Polymer; 2013; ISR reference) in view of Haruyuki (JP H07-53764(A); machine translation attached).
The limitations of claims 4 and 5 are previously discussed.
Xu discloses the production of polyethylene glycol-modified polyurethanes using PEG diglycidyl ether and PEG bis(amine) and that such attachments are accomplished through the reduction of H-bonded urea groups (see e.g., Abstract). Figure 1 discloses the reaction between polyhexamethylene carbonate diol (PCD) and 4,4’diphenylmethane diisocyanate (MDI) to produce an isocyanate-terminated prepolymer to which PEG is then grafted to the prepolymer.
The Examiner notes that the limitation directed to the claimed isocyanate is that it is “derived from an aliphatic isocyanate.” The broadest reasonable interpretation of this limitation is that while the isocyanate of the claimed invention is “derived from” an aliphatic isocyanate, that the final derived form of the isocyanate may not necessarily be aliphatic.
Based on this interpretation, the Examiner submits that Xu anticipates the claimed invention.
To the extent that the instantly claimed subject matter is not anticipated by the descriptive matter of the reference, it would be so recognized by persons of ordinary skill in the chemical arts. Of particular note, Haruyuki discloses producing polyurethane urea through the addition of diisocyanate groups to either end of the compound (R1). See e.g., ¶[0006]-¶[0008]. The reference further defines such diisocyanates as including hexamethylene diisocyanate (HMDI). See e.g., Reference Example 2 at ¶[0022].
Thus, one would have more than a reasonable expectation of successfully creating the instantly claimed composition, particularly since the compositions taught in the reference, at the very least, represent obvious variations which very closely read on those compositions which are instantly claimed. That is, both 4,4’-diphenylmethane diisocyanate and hexamethylene diisocyanate are considered to be obvious variants of one another in view of their both possessing isocyanate groups on either end of their respective structures:
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MPEP §2144.06(II) states that “[i]n order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on Applicants’ disclosure or the mere fact that the components at issue are functional or mechanical equivalents.”
In the instant case, both references disclose reacting a polycarbonate polyol compound with an isocyanate in order to produce a polyurethane urea compound. The overlapping disclosure leading to the reasonable expectation of success is that both isocyanate compounds are diisocyanates wherein the isocyanate groups flank the remainder of the structure.
Therefore, the invention as a whole would also have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claim 4 under 35 USC 103(a) as being unpatentable over the combined teachings of Xu et al. and Haruyuki et al. have been fully considered but they are not persuasive.
Applicants traverse the rejection on the grounds that the instantly claimed compositions are shown to possess excellent mechanical strength and that they are inhibited from platelet adsorption and adsorption of various proteins. It is further asserted that the Office has not demonstrated that the prior art recognizes MDI and HMDI as equivalents for the specific purpose of producing medical compositions with the claimed properties.
Lastly, in support of the aforementioned effects, Applicants cite Examples 1-13 as defined and presented in Tables 1 and 2 (see Spec., pg. 38-39) and Tables 6 and 7 for the depiction of the alleged critical properties. For the purposes of discussion, Tables 1 and 2 are noted as presenting Examples 1-10 and 11-17, respectively.
Regarding their evidentiary showings, Applicants state that each of Examples 1-13 use both a polycarbonate polyol derived from (or “from”, as amended) an aliphatic polyol (PCD from 1,6-hexanediol) and an aliphatic isocyanate (HMDI).
Examples 14-17 are presented and highlighted as being comparative examples. Examples 14 and 15 use HMDI, but not PCD, while Examples 16 and 17 use PCD, but not HMDI. In each of the four comparative examples alternate isocyanates and isocyanate compounds are used.
Results for the properties of each of Examples 1-17 are presented in Tables 16 and 17. Of particular note is that Examples 14 and 15 depict a combination of HMDI and PEG and that the platelet adhesion values measured for these two Examples yield the lowest results of all the Examples.
Addressing Applicants’ assertion that the references fail to disclose this property, the Examiner submits that Haruyuki, for instance, discloses in ¶[0001] and ¶[0003] that the polyurethane urea compositions of the practiced invention act as a filter that has good separation efficiency and low adhesion of blood cells, and have excellent antithrombotic properties and have use as a medical material. Paragraph [0006] defining the suitable isocyanate compounds as including MDI as disclosed by both references, and HMDI as disclosed by Haruyuki.
Applicants’ remarks appear to be more focused on a combination of PCD and HMDI, as exemplified in the instant specification and the properties that result from such combinations.
However, the Examiner, in response, respectfully submits that the composition as amended, continues to be read on by the art of record as the scope of the recited polycarbonate polyol is still inclusive of polyethylene glycol and/or polyethylene oxide, both of which are recognized by the state-of-the-art as species of polycarbonate polyols.
Applicants’ arguments are additionally not considered to be commensurate in scope with the purported evidence, and are thus, unpersuasive. Said rejection is therefore maintained.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kikuta et al. (JP 2019189768 (A); of record).
As amended, claim 4 recites a medical composition comprising a urethane resin, the urethane resin having a structural unit derived from a polycarbonate polyol and a structural unit derived from an aliphatic isocyanate and containing said aliphatic group and said isocyanate group in said urethane resin, and having at least one urea bond, the polycarbonate polyol having a structural unit from an aliphatic polyol, and the urethane resin having a polyoxyethylene structure in a main chain and/or a side chain.
Kikuta discloses a polyurethane resin comprising a structural unit derived from polyol (A) and a structural unit derived from polyisocyanate (B) (see e.g., Abstract, claim 1). Polyol (A) comprises a structure represented by following general formula (1), and the polyisocyanate contains an aliphatic polyisocyanate (b-1) or an alicyclic polyisocyanate (b-2).
General formula (1) defined as:
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General formula (3) is a species thereof and is defined as being embodied by the following polyol:
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Thus, the limitations of the instantly amended invention are considered to be expressly met.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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