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 .
DETAILED ACTION
This action is in response to papers filed July 16, 2025. Applicant’s reply to the restriction/election requirement of January 17, 2025 has been entered. Claims 1-24 have been amended; and no claims have been canceled or newly added. Claims 1-24 are pending in the application.
Priority
Applicant’s claim for the benefit of prior-filed WIPO International Application No. PCT/US2021/012015, filed January 3, 2021 under 35 U.S.C. 365(c), which claims the benefit of prior-filed U.S. Provisional Patent Application No. 62/956,795, filed January 3, 2020 under 35 U.S.C. 119(e), is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10 and 21-24, is acknowledged. Applicant’s elections of i) “HPMC” as the species of further constituent, ii) “cisplatin” as the species of therapeutic agent, iii) “head and neck” as the species of organ being treated, and iv) “tumor” as the species of condition being treated are all also acknowledged. The Examiner has determined that claims 1, 2, 4, 5, 9, and 10 read on the elected subject matter.
Accordingly, claims 3, 6-8, and 11-24 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on July 16, 2025. Claims 1, 2, 4, 5, 9, and 10 are currently under examination.
Drawings
The drawings are objected to because of the following:
1. Figure 2 lacks a proper label for each of the y-axis and the x-axis disclosing the parameter shown and the units.
2. Figure 5 lacks a proper legend for the three different line plots shown.
3. Figure 6 appears to be improperly labeled as a partial view, i.e. Fig. 6C. Applicant is advised to delete the “C)”.
4. Figure 8 appears to be unintelligible. The y-axis is generically labeled “drug concentration” rather than reciting the actual drug employed. The various bar plots shown are not meaningfully labeled, and one of ordinary skill in the art does not understand the spectrum from “injection site” on the left to “deep tissue” on the right with respect to what is being depicted by each of the individual bar plots.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1, 2, 4, 5, 9, and 10 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.
Claim 1 is indefinite for the following reasons:
1. Claim 1 is directed to a “therapeutic composition” that contains a “therapeutic agent”, the release of which is “controlled” by a coating containing chitosan. Claim 1, however, never discloses what, in fact, is actually being treated. Since claim 1 never discloses what in fact is necessarily being treated, such that what is being treated is an unknown variable “x”, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “a therapeutic agent” that treats the unknown “x”. Moreover, the “therapeutic agent” is also even further limited by the claim to only those agents whose release is “controlled” by a coating containing chitosan. The “therapeutic agent” that falls within the scope of this additional limitation would, of course, depend not simply on what is being treated, but would depend on the composition and characteristics of the coating, including the nature and amount of the chitosan. Since the claim provides very little to no information about the composition and characteristics of the coating, including the nature and amount of the chitosan, one of ordinary skill in the art cannot definitively ascertain which “therapeutic agents” thus further fall within the purview of “therapeutic agents” whose release is “controlled” by the coating containing chitosan. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “therapeutic agent” and thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
2. Claim 1 stipulates that the composition is “for delivery to a targeted population of cells”. The “targeted” population of cells is arbitrary and subjective, and is not defined by the claim. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of which cells are the “targeted” cells and which cells are not “targeted”.
3. Claim 1 stipulates that the composition comprises “an aqueous solution” that includes “a chitosan gel” and also includes “a plurality of particles embedded in the gel”. An aqueous solution and a chitosan gel are two completely different forms. Hence, an aqueous solution said to include a chitosan gel is incongruous. Further, one of ordinary skill in the art would not understand an aqueous solution that contains a plurality of particles embedded in anything. This sound more like a suspension than a solution. One of ordinary skill in the art thus cannot make heads or tails out of an aqueous solution that includes a chitosan gel and a plurality of particles. Moreover, one of ordinary skill in the art cannot definitively ascertain whether the actual composition being claimed in necessarily in the form of a solution, or rather is necessarily in the form of a liquid suspension, or rather is necessarily in the form of a solid or semi-solid gel or hydrogel.
4. Claim 1 stipulates that the “gel” has a viscosity rendering it suitable for administration by injection. The “gel”, presumably the chitosan gel specifically, appears to be but one constituent of the composition as a whole, since the aqueous solution “includes” the “gel” and the plurality of particles are embedded in the “gel”. Hence, the gel appears to be a separate entity from the aqueous solution and the plurality of particles. The “gel”, in fact, could be a minor component of the composition as a whole, which in fact could be mostly water. Even if the “gel” was a pure solid with a very high viscosity, the “gel” as a minor component of the aqueous solution could still be injected as part of the aqueous solution, which the claim states is what the “gel” is, i.e. a component included in the aqueous solution. In other words, there seems to be no real correlation between the viscosity of the “gel” and whether or not the “gel” can be injected as part of the composition as a whole. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed viscosity, and thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 2 contains the acronym “HPMC”, which is not defined by the claim. Claims must stand alone to define the invention, and should not reply on the specification, drawings, or extraneous materials to give them meaning. Applicant is advised to first define the term by its formal chemical name or structure, and then the acronym can be employed.
Claim 10, which depends from claim 1, stipulates in a wherein clause that “the particles are in direct physical contact with the chitosan gel”. Claim 1 already provides that the particles are “embedded in” the chitosan gel. One of ordinary skill in the art would generally understand particles that are embedded within a gel are thus in direct physical contact with the gel. One of ordinary skill in the art thus cannot definitively ascertain how claim 10 is supposed to further limit claim 1.
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 10 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 10, which depends from claim 1, stipulates in a wherein clause that “the particles are in direct physical contact with the chitosan gel”. Claim 1 already provides that the particles are “embedded in” the chitosan gel. One of ordinary skill in the art would generally understand particles that are embedded within a gel are thus in direct physical contact with the gel. Claim 10 thus does not appear to further limit claim 1 from which it depends.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 2, 4, 5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Maki et al. (U.S. Patent Application Pub. No. 2017/0136127), in view of Dash et al. (U.S. Patent Application Pub. No. 2009/0275526).
Applicant Claims
Applicant’s elected subject matter is directed to a hydrogel composition for treating head and neck tumors and suitable for injection, comprising chitosan and hydroxypropylmethylcellulose (HPMC), and further comprising microparticles 500-2000 nm (i.e. 0.5-2 microns) in size, embedded within the hydrogel, comprising a chemotherapeutic agent (e.g. cisplatin) and a chitosan coating.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Maki et al. disclose a hydrogel composition for e.g. treating cancer (e.g. head and neck cancer) and suitable for injection, comprising e.g. chitosan and hydroxypropyl methylcellulose (HPMC) in an aqueous medium, and further comprising particles, embedded within the hydrogel composition, comprising e.g. cisplatin (i.e. a chemotherapeutic agent) (abstract; paragraphs 0002, 0006, 0007, 0013, 0015, 0018, 0019, 0036, 0039, 0043, 0052, 0056, 0058, 0070, 0076, 0077, 0127, 0183).
Dash et al. disclose a composition for treating cancer, and suitable for injection to a target localized site, comprising particles e.g. 400-700 nm in size comprising e.g. cisplatin (i.e. a chemotherapeutic agent), and a chitosan coating; wherein the chitosan coating provides mucoadhesive properties to adhere the nanoparticles to cancer cells and provide sustained release of the chemotherapeutic agent (e.g. cisplatin) to thus increase the selectivity and effect of the therapeutic agent on the cancer cells (abstract; paragraphs 0004, 0008, 0018, 0022, 0027, 0028, 0036, 0037, 0040, 0044, 0048, 0049).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Maki et al. do not explicitly disclose that the particles comprising cisplatin further include a chitosan coating, and are 500-2000 nm in size. These deficiencies are cured by the teachings of Dash et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Maki et al. and Dash et al., outlined supra, to devise Applicant’s presently claimed composition.
Maki et al. disclose a hydrogel composition for e.g. treating cancer and suitable for injection, comprising e.g. chitosan and hydroxypropyl methylcellulose (HPMC) in an aqueous medium, and further comprising particles containing e.g. cisplatin. Since Dash et al. disclose that particles e.g. 400-700 nm in size comprising cisplatin and a chitosan coating, which particles are in an aqueous medium, can be readily injected directly into a local tumor site, wherein the chitosan coating provides mucoadhesive properties to adhere the nanoparticles to cancer cells and provide sustained release of the chemotherapeutic agent (e.g. cisplatin) to thus increase the selectivity and effect of the therapeutic agent on the cancer cells; one of ordinary skill in the art would thus be motivated to include a chitosan coating on the particles containing cisplatin in the Maki et al. composition, and to employ particles about e.g. 400-700 nm in size, with the reasonable expectation that the resulting composition, when injected directly into a local tumor site, will exhibit increased selectivity and a more potent effect on the cancer cells, in part, through adhesion of the particles to cancer cells and sustained release of the chemotherapeutic agent.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617