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 .
Applicant’s response (amendments, arguments) is acknowledged.
The amendments have overcome the indefiniteness rejection.
Claims 1, 4-7, and 9-19 remain pending and examined on the merits.
As previously noted and maintained:
*The test results in Example 4, Tables 8A-8C have been under review relevant to advancing prosecution on the merits; however, the claimed invention/scope of the newly claimed “biologically active component (BAC)” still not is not deemed to have been claimed commensurate in scope with that tested.
The examiner invites applicant’s representative to schedule an interview to advance prosecution on the merits.
Election/Restrictions – Withdrawn, Based on 6/2/20 Amendments
Cancelling Elected Subject Matter, Previously Noted
Applicant’s election without traverse of Group II, as drawn to all the claims 1-18 (per the examiner’s rejoinder) telephonically with David Crichton, Applicant’s Representative, on 6/20/19, overriding the reply filed on 3/11/19 is acknowledged. Elected Invention: Group II, Claim 3 - A composition (intended use: sealant) requiring the combination of four (4) elements: fibrinogen, a divalent cation, factor Xia, and fibronectin; further requiring wherein the ratio of relative concentration ratio of fibronectin:fibrinogen is 0.1 to 0.2. Applicant had modified the written election of Group I, claim 1 to Group II and the elements of now cancelled claim 3 later by telephonic election, based on the Plantier reference cited via Third Party (Prior Art) Submission Under 37 CFR 1.290, citing Plantier, which was asserted by the third party to teach (including inherently) and/or render obvious all instant claims but for e.g. instant claim 3, as recited below directly from the third party analysis supplied and/or supplemented by the examiner as needed. Update: The elements of cancelled claim 3 which were incorporated into claim 1 have also now been cancelled. Thus, the election has been rendered moot.
Claim Rejections - 35 USC § 103 – Maintained
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 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 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.
Note 1: Previously Modified Only to Add New Claim 19 To Rejection,
Which Was Former Claim 3 Already Discussed Below;
Note 2: Previously the elements of cancelled Claim 3 were incorporated into Claim 1, but such was then cancelled and the phrase “biologically active component (BAC)” added.
Claims 1-2, 4-7, and 9-19 remain rejected under 35 U.S.C. 103 as being unpatentable over:
Plantier et al. (WO 2016128516) in view of Seelich et al. (US Patent No. 7241603), alone,
and/or further in view of:
Nur et al. (6,121,232) (cited instant specification para [0063], as also teaching tissue sealant compositions comprising fibrinogen as the “biologically active component (BAC)”; see also discussion immediately below).
Claimed Invention, Modified - A composition (intended use: sealant) requiring the combination of four (4) elements: fibrinogen, a divalent cation, factor XIa, and fibronectin; and the phrase “biologically active component (BAC)” which itself can be fibrinogen based on the specification description/definition. The instant specification defines that BAC can simply be fibrinogen itself (see instant specification para [0060]), and since the previous prior art combination of record comprised fibrinogen, without something more, the claimed invention as modified remains deemed to render prima facie obvious by the previous prior art of record.
Alternatively, other paragraphs indicate BAC can comprise other elements (e.g. BAC is a biologically active component that contains tranexamic acid, as an antifibrinolytic agent, and potential other components; see instant specification para’s [0061-0063]. However, since these are not instantly claimed, such does not are also equally rendered prima facie obvious over the prior art of record. Prior Art Reference Made of Record but Not (Yet) Needed to be Relied Upon As To “Other” Elements the BAC May Comprise (Based on the Current Amendments): Nur et al. (6,121,232), cited above and at instant specification para [0063], teach tissue sealant compositions comprising BAC that comprise elements “beyond” just fibrinogen, e.g. tranexamic acid, as an antifibrinolytic agent, and potential other components. Were specific BAC elements such as tranexamic acid claimed, Nur would be relied upon as teaching the skilled artisan’s knowledge of such as open for use within compositions such as that claimed based on the state of the art.
As set forth in the previous rejection:
A Third Party (Prior Art) Submission Under 37 CFR 1.290, citing Plantier, was asserted by the third party to teach (including inherently) and/or render obvious all instant claims but for e.g. instant claim 3 (now cancelled). The teachings cited by the third party analysis supplied to the Office were recited below and/or supplemented by the examiner as needed.
Plantier teach all the elements of the claimed invention including fibrinogen (e.g. as the “biologically active component (BAC)” (see Tables below), but for fibronectin.
While Plantier does not teach the addition of fibronectin, Plantier is open to the addition of other elements by use of the transition phrase “comprising” alone in claim 1.
However, Seelich teach the addition of fibronectin, as previously set forth below (regarding elected claim 3, now cancelled and the subject matter of which also cancelled from claim 1 where it had been incorporated, rendering the restriction moot):
At issue is whether there would have been motivation within the art to add fibronectin as an element to the fibrinogen composition, and the ratios (now cancelled) of the latter to the former as claimed (e.g. 0.1 to 0.2). The answer is deemed yes based on secondary reference Seelich which expressly teach this fibronectin:fibrinogen ratio (col. 7, lines 47-54); for adhesive/sealant use (col. 2, line 21) and further citing fibrin sealant prior art, evidencing that the state of the art knew that fibrin/fibrinogen compositions were known by those of ordinary skill specifically for use as sealants (cover page, right column, 7th reference):
[Col. 7, lines 47-54]
The protein composition according to the invention advantageously comprises fibronectin and fibrinogen at a ratio of from 0.02 to 0.5, preferably from 0.02 to 0.25, also preferred from 0.02 to 0.2, more preferred from 0.04 to 0.16, most preferred around 0.1 (0.05 to 0.15), i.e., in contrast to highly pure fibrinogen preparations (WO 94/20524), it still contains substantial portions of fibronectin.
Further, Seelich expressly states that fibrinogen is a critical element for adhesive/sealant compositions such as that of Plantier also, as it is of crucial importance for growing in of cells in wound healing and that an optimum composition comprising fibrinogen for fibrin clot formation (such an adhesive/sealant composition would be directed towards) should also comprise fibronectin
[Col. 1, lines 48-55]
Although the complicated procedures of wound healing so far by no means have become completely clear, it is considered to be certain that the presence of fibronectin in the clot is of crucial importance for the growing in of cells and thus for wound healing.
A fibrin clot of optimum composition therefore should also comprise a content of fibronectin in addition to its main component, fibrinogen.
Thus, as to the elected invention of Group II, as represented by claim 3, it would have been prima facie obvious to add the fibrinectin to a fibrinogen (adhesive/sealant) composition such as Plantier for the advantageous reasons set forth above in Sealant and to then employ a fibronectin:fibrinogen [ratio of e.g. 0.1 to 0.2] as taught in Seelich in a fibrinogen (adhesive/sealant) composition of Plantier.
As for all the remaining claims, such are all taught by Plantier as discussed below and as already set forth of record via Third Party (Prior Art) Submission Under 37 CFR 1.290 and not disputed per se during the recent interview with applicant’s representative (interview summary attached):
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Claim 3 (NEW CLAIM 19, ADDED BACK IN, AMENDMENTS FILED 10/23/20), the elected composition, was not asserted to be taught by Plantier by the Third Party Submission, but is rendered prima facie obvious over Plantier in view of Seelich as discussed above.
Claim 4 is inherently taught by Plantier as the clottable proteins of Plantier are not taught to be above 79.8% of the total amount of proteins (where the total amount excludes factor XIa) in one or more formulations of Plantier, as Plantier does not per se require any other clottable proteins if factor XIa were selected as the clottable protein, as discussed/cited above in Plantier:
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Claim 12 is inherently taught by Plantier, as Plantier does not require any Vitamin K dependent clotting zymogens (based on search of Plantier reference for such).
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II. Regarding the alternative prior art combination with newly cited Nur:
Nur teach tissue glue/sealant composititions comprising fibrinogen as the BAC (entire document, see especially, col. 2, last para through col. 3, end of first para), where the amount of fibrinogen can be calibrated depending on the desired effects: “The degrees of activity of fibrinogen can be balanced by providing a higher amount of fibrinogen in the solution so that the proper use of the fibrinogen containing solution ( BAC) is not hampered.” Nur also teach where the BAC may comprise elements beyond fibrinogen, such as tranexamic acid and arginine to further stabilize the composition (col. 3, lines 45-50).
Thus, even if the instantly claimed invention were to comprise further elements as part of the BAC (e.g. tranexamic acid, arginine, etc.), beyond just fibrinogen as taught by Plantier and Seelich, such would have been prima facie in view of Nur.
Response to Amendments & Arguments - Filed 1/22/24
Regarding the amendments and arguments filed 1/22/24, such have been fully considered but are not yet found persuasive. The new claims amendments remain deemed not fully commensurate in scope with that tested and the arguments thereto in the most recent response – and the examiner invites applicant to schedule an interview to explore claim scope language that may overcome the rejection and aimed at aligning the claim scope with the ‘unexpected results’ asserted.* At this writing, the disposition remains that the prior art combination teachings and suggestions over the scope of that claimed renders such obvious. *The test results in Example 4, Tables 8A-8C have been under review relevant to advancing prosecution on the merits; however, the claimed invention/scope of the newly claimed “biologically active component (BAC)”.
The rejection is maintained that while applicant has now amended the claims to more specific elements and ratios of those elements, such has not overcome the barriers noted. These elements (even if not called BAC2 per se) are present in the prior art of record which equally teach routinely optimizable amounts thereof.
In response to applicant's argument against the references, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Thus, the rejection over the prior art combination applied is maintained. Asserted unexpected results cannot be ascertained yet, as noted previously because: There remains uncertainty based on the original disclosure as to what each and every element was actually present in the assertedly tested composition, which the amendment and response here re: page 9 and 11 filed 7/29/22 do not remedy, re: that the amendments included “further specif[ied] elements actually present in the BAC2 product tested according to the invention.” The original disclosure leaves this still in question and the prior art combination is deemed to teach and/or render obvious such still for the reasons of record below.
The amendments, after full consideration, fall for the same previous reasons: they simply claim the standard elements of what may be in BAC2, but without specificity as to what was actually present in the asserted BAC2 product described instantly. Applicant again argues that based on the new amendments, such is distinguishable from the prior art combination. However, the rationale previously applied is maintained for the reasons of record: Nur requires transexamic acid. Notwithstanding, Nur is relied upon for its other teachings; however, primary reference Plantier in view of Seelich do not. Thus, for the reasons of record, the combination applied is still deemed to render prima facie obvious the instantly claimed invention.
As previously stated and still relied upon relevant to the asserted unexpected results: The arguments assert that the experimental data filed in the affidavit demonstrate the superiority of the claimed invention, and assert such yields unexpected beneficial performance properties using BAC2 versus fibrinogen alone (response page 6, 8). This may be so; however, such is a moot exercise until the invention is claimed to reflect the specific scope of that product tested, as the claims remain drawn to a label “BAC2” without claiming the elements themselves comprised within that label. Thus, until such, the prior art combination is deemed to render prima facie obvious the claimed invention absent amendment of the scope of the invention to elements within BAC2, at which time such may be weighed against the elements taught within the prior art compositions applied. Further, as previously stated, regarding the previously added phrase that the composition comprises a “biologically active component (BAC)”, the examiner noted the instant specification describes/defines can be fibrinogen itself (para [0059]), notwithstanding that applicant is now adding “additional plasma proteins” are present in BAC2 (e.g. referring to fibrinogen?).
Thus, the prior art combination of record is still deemed to render the claimed invention prima facie obvious for the reasons of record. (See also previous Response to Arguments, earlier Office actions in line with the above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654