DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 23 September 2026, in the matter of Application N° 18/282,974. Said documents have been entered on the record. The Examiner further acknowledges the following:
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Claims 1-4 and 6-14 are pending, where claims 1-3 and 6-14 remain withdrawn from consideration. No claims have been added or canceled.
Claim 4 has been amended adding the product-by-process limitation reciting that the polyoxyethylene structure of the previously claimed composition “is derived from polyethylene glycol or branched polyethylene glycol.”
No new matter has been added.
Thus, claim 4 continues to represent all claims currently under consideration.
Information Disclosure Statement
One Information Disclosure Statement (IDS) filed 10 July 2026 is acknowledged and has been considered.
Withdrawn Rejections
Rejection under 35 USC 102
Applicants’ remarks directed at the teachings of Kikuta are adequate in overcoming the previously raised anticipation rejection over the claim. Said rejection is withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 25 June 2026 since the art that was previously cited continues to read on the amended and previously recited 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.
Claim 4 is 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 claim 4 are previously discussed. The amendment to the claim and its interpretation are discussed above.
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’ grounds of traversal do not appear to have changed with the exception of adding the remark that the claim has been amended to recite the PEO component having been derived from polyethylene glycol or branched polyethylene glycol.
The remarks maintain 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 thus remain unpersuasive. Said rejection is therefore maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
