DETAILED ACTION
Notice of 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 .
Status of Claims
Claims 1-32, 38, 41, 46, and 47 are cancelled. Claims 33-37, 39-40, 42-45, and 48-52 are pending and under examination.
Priority
This application is a national stage entry of PCT/CA2021/050955 filed on 7/12/2021, which claims priority from provisional application 63/050,396 filed on 7/10/2020.
Objections/Rejections Withdrawn
The objection over claims 40 and 49 for missing “and” is withdrawn per applicant’s addition of “and” in these groups.
The objection over claims 39 and 48 for spelling of doxorubicin is withdrawn per applicant’s correction.
The objection over claim 43 for a missing period is withdrawn per applicant’s correction.
The objection over claim 44 is withdraw as applicant change the recitation to “mixing with”.
The rejection under USC 112(a) for “derivatives” is withdrawn per applicant’s deletion of “derivatives” from the claims.
The rejection under USC 112(b) for “derivatives” is withdrawn per applicant’s deletion of “derivatives” from the claims.
Tentatively, the rejection under USC 112(b) over molecular weight is withdrawn as applicant added that they are “average molecular weights”. However, applicant should note the new matter rejection incorporated below as there was no written support for “average molecular weight” in the originally filed disclosure.
The rejection under USC 112(b) for “preferably” in claims 33 and 42 and claims 34-41 and 43-52 is withdrawn per applicant’s amendment.
The rejection under USC 112(b) for the parenthetical “(on gel weight base)” is withdrawn per applicant’s amendments to the claims.
The rejection under USC 112(b) for “ratio ranging from” is withdrawn per applicant’s amendments to the claims.
The rejection under USC 112(b) for the use of the parenthetical (by weight) is withdrawn per applicant’s amendments to the claims.
The rejection under USC 112(b) for recitations of “biosimilar” or “protein-like” or “solid-like” is withdrawn per applicant’s amendments to the claims.
The rejection under USC 112(b) for lack of clarity in introduced steps of claim 44 is withdrawn per applicant’s amendments.
The rejection under USC 112(b) over claim 47 is withdrawn per applicant’s cancellation of claim 47.
The rejection under USC 112(b) for lack of antecedent basis for “the biosimilar or the antibody drug” and "the antibody or the biosimilar drug" is withdrawn per applicant’s amendments.
The rejection under USC 112(b) for lack of antecedent basis for “the combination thereof" is withdrawn per applicant’s amendments.
The rejection under USC 112(b) for lack of antecedent basis for the limitation "the fatty acid-conjugated alginate" is withdrawn per applicant’s amendment.
Rejections under USC 112(b) for being dependent on an indefinite claim where the rejections have been withdrawn are withdrawn as no longer applicable. However, they are maintained or warranted for dependent claims on claims rejected under USC 112(b).
The rejections under USC 103 are withdrawn per applicant’s amendments to claim 33.
The rejection under non-statutory double patenting over copending Application No. 18/409,244 is withdrawn per applicant’s filing of a terminal disclaimer which has been accepted.
As these rejections are withdrawn, applicant’s arguments to the withdrawn rejections are now moot.
New Rejections – As Necessitated by Amendments
Claim Rejections - 35 USC § 112(a) – New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33-37, 39-40, 42-45, and 48-52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant amended the claims to add “weight average molecular weight”/”Mw”, however, the originally filed disclosure does not particularly provide for “weight average molecular weight” or a method of calculation that would be specific to weight average molecular weight. Therefore, this amendment constitutes new matter to the claims and application. If applicant feels that the specification and/or the prior art provides that the items of the claim would use an interpretation of “average molecular weight” for molecular weights in the claims, applicant may not have to add new matter by introducing “weight average” to molecular weight, but present evidence from the prior art for the regular use of average MW for these polymers and/or an expert declaration to this point. Note applicant’s arguments cannot take the place of evidence where evidence is needed.
Claims 34-35, 39, 44-45, 48, and 51 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicant amended the claims to include the genus of water-soluble monoclonal antibody. Although the specification provides nine antibodies that would fit into this genus of water soluble monoclonal antibody, this does not provide for a sufficient number of such antibodies that would give ownership for this entire sub-genus. The originally filed specification does not call out monoclonal antibodies as a sub-genus, but it does more broadly indicate “antibodies”, which is the larger genus. Thus, applicant does have support for the particular species of these antibodies it provides in the claims and specification, but does not provide ownership of water soluble monoclonal antibodies.
Claim Rejections - 35 USC § 112(b)
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 33-37, 39-40, 42-45, and 48-52 are 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.
Maintained Rejections – Not Addressed by Applicant/Modified Due to Amendments
Claims 33, 40, 42 and 49 are indefinite for the recitations of “wherein the ionic crosslinkers contain one or more…”, “the gross concentration of the ionic crosslinker” and “the ionic crosslinker” after providing for a recitation of “a mixture of ionic crosslinkers” and then a recitation of “two or more ionic crosslinkers” before this “wherein” clause and concentration limitation. It is unclear if applicant is referring to ionic crosslinkers in the mixture or if applicant is referring to the “two or more ionic crosslinkers” to apply these limitations onto. If applicant is referring to the mixture, the applicant might consider recited “wherein the mixture of ionic crosslinkers contains…” and “wherein the gross concentration of the mixture of ionic crosslinkers…”.
Claims 34-37, 39, 43-45, 48 and 50-52 are rejected as being dependent on indefinite claims.
Further notes on this previous rejection -
Note that subsequent recitations of an item need to be in line with what was presented before for antecedent basis. For example, “the ionic crosslinkers” in claim 42 and “the ionic crosslinker” in claim 49 do not have antecedent basis from “a mixture of ionic crosslinkers” or “two or more ionic crosslinkers” as it would be unclear which of the crosslinkers in the mixture or the two or more are being referred back to. Applicant may refer back to “the two or more ionic crosslinkers contain one or more….” and “the two or more ionic crosslinkers are a chloride….” in claim 42 or “wherein an ionic crosslinker of the two or more ionic crosslinkers is selected…” in claim 49. Note similar changes needed for claims 33 and 40.
The term “highly porous structure” in claim 33 is a relative term which renders the claim indefinite. The term “highly porous structure” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the claim provides for a pore size, highly porous appears to relate more toward pore density. However, it is uncertain if this is what applicant means to be the case and what the numerical standard for being “highly porous” would be. Applicant might consider removing the recitation of “highly” from the claim.
Claims 34-37, 39, 43-45, 48 and 50-52 are rejected as being dependent on indefinite claims.
Further notes on this maintained rejection that now applies to claim 33 after import-
Although this limitation also refers to a pore size, it still does not provide clarity to what is considered “highly porous structure”. It is not clear if this is a certain number of pores present or a certain pore volume or a certain percentage of porosity. Additionally, “highly” does not provide a quantitative figure for what would be considered “highly” for prior art to read on the claim or not. It is suggested that applicant delete “highly” as one way to resolve this issue.
New Rejection – As Necessitated by Amendment
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 36 after amendment directs the group to “the amphiphilic alginate nanoparticle” which is defined in claim 33 to be “oleic acid conjugated”. Note that claim 36 is dependent on claim 33, and thus, this amendment broadens the scope of what the amphiphilic alginate nanoparticle can be. If applicant means to add an additional the amphiphilic alginate nanoparticle, then applicant might rename this group as “an additional amphiphilic alginate nanoparticle” and remove the oleic acid version in the group of claim 36 since it is already part of claim 33. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments/Advisory Notice
The examiner considers the arguments to the claimed formulation providing “self-healing” and “shear-thinning” properties while noting data from figure 2 (pages 8 and 9 of applicant’s arguments). This is convincing of a structural and functional property for this formulation of gels’ utility in light of applicant’s additional amendment to add there is porosity and pore size, which is a further structural feature of the nanocomposite gel formulation found to have these properties. The combined references used in the rejections under USC 103 did not provide such a claimed gel formulation with property to be expected.
In regard to the other argument of synergistic behavior of drugs, the synergy may be the result of particular drug combinations, however, in figure 10, the use of drugs with the gels does provided improved treatment via decreased tumor size compared to use of the free drugs. Note though, that the drugs are not part of independent claim 33 and additionally the data is toward a specific drug combination (paclitaxel and trastuzumab) with the gel rather than the full scope of antibodies and chemo-drugs.
The applicant should note that rejections under USC 112 above need to be addressed before consideration to allowance.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK V STEVENS/ Primary Examiner, Art Unit 1613
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