DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement (e.g., Y. L. Lo, C. Y. Hsu, H. R. Lin, pH- and thereto-sensitive pluronic/poly(acrylic acid) in situ hydrogels for sustained release of an anticancer drug, J Drug Target, 21 (2013) 54-66; US Patent Publication No. 20120100103; US Patent Publication No. 20140065226; US Patent Publication No. 20150366975A1 (¶[0004]-[0006])). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. 37 CFR 1.98(a)(1) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office.
Drawings
The drawings are not of sufficient quality to permit examination. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the text characters in the figures characters not sufficiently legible, due to font sizes and low resolution. Applicant may correct this defect by submitting higher-resolution drawings (minimum 300 DPI) with clear, machine-printed text, ensuring all text labels comply with 37 CFR § 1.84 (e.g., font size ≥ 0.32 cm (1/8 inch) for characters). Failure to correct the figure may result in expungement of non-compliant drawings. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings.
Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Claims Status
Claims 33-61 are pending and under current examination in this application.
Amendment to Claims, Specification, Drawings filed 24 January 2024, are acknowledged. Claims 1-32 have been canceled and new claims 33-61 have been added.
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 Applicant regards as his invention.
Claims 33-61 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, regards as the invention.
The term “nanocomposite gel” as referenced the second time in claim 33 is unclear, as it is not evident whether the gel itself is the nanocomposite, or whether nanoparticles are dispersed within a separate gel matrix. The Specification ¶[0021], seems to indicate combination with a gel matrix to form a nanocomposite gel after gelation as the final composition for administration, however that is not clear as the claim is currently written.
Dependent claims 34-61 are included in this rejection because they do not cure the defect noted above. Applicant is advised to rewrite the claim to avoid ambiguity to overcome this rejection and revise dependent claims to use consistent terminology associated with the revised independent claim to refer to the constituents thereafter (e.g., A pharmaceutical composition injectable nanocomposite gel comprising: one or more active ingredients, comprising at least one hydrophobic active ingredient; and a gel matrix formed by mixing amphiphilic alginate nanoparticles, a hyaluronic salt or derivative, an alginate salt or derivative, and an ionic crosslinker; wherein, the gel matrix comprising the amphiphilic alginate nanoparticles self-assembles into a nanoparticle encapsulating the at least hydrophobic active ingredient to form the injectable nanocomposite gel containing the active pharmaceutical composition).
Claims 41 and 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, regards as the invention.
Claims 41 and 52 are rendered indefinite for using the term “preferably” in the claim. The term "preferably" introduces ambiguity as to whether the claimed feature is optional or required. Claims must distinctly set forth the subject matter regarded as the invention, and terms like "preferably" make the scope unclear. See Ex parte Porter (1993), where the Board held that terms such as "preferably" create uncertainty about claim boundaries.
To overcome this rejection, Applicant should remove the term "preferably" and recite the feature as either mandatory or optional. Alternatively, Applicant may amend the claim to clearly define under what conditions the preferred feature applies.
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.
Claims 49, 54, 58-61 are 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.
Claims 49, 58-61 are rejected as being in improper multiple dependent form. Claim 49 depends from claim 48, which depends from claim 44, which further depends from claim 33. Claim 54 depends from claim 53, which depends from claim 44, which in turn depends from claim 33. Claim 58 and 61 depend from claim 57, which in turn depends from claim 55, which depends from claim 33. Likewise, claims 60 depends from claim 59, which depends from claim 58, and so forth as for claim 58. A multiple dependent claim cannot depend from any other multiple dependent claims (see MPEP § 608.01(n)).
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form (presenting its subject matter in a proper single dependent claim format), rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 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.
Claims 33-58 and 61 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Sun and Liu (WO2022006685A1; published 13 January 2022, hereinafter referred to as “Sun”).
Sun discloses an injectable nanocomposite gel pharmaceutical composition formed by mixing amphiphilic alginate nanoparticle, a hyaluronic salt or derivative, an alginate salt or derivative, and an ionic crosslinker (claim 1 and 15) and an active ingredient (claim 2) selected from the group consisting of an antibody drug, a biosimilar drug, a protein-like drug, a chemo-drug, and the combination thereof (claim 3), further selected from the group consisting of trastuzumab, bevacizumab, gemtuzumab, inotuzumab, polatuzumab, sacituzumab, adalimumab, infliximab, rituximab, and the combinations thereof (claim 7), wherein the active ingredient is hydrophobic (i.e., gemtuzumab, inotuzumab, polatuzumab, sacituzumab or claim 9 compounds; claim 7-9), encapsulating the active ingredient to form a solid-like injectable drug-carrying gel (claim 17). “According to the invention, the amphiphilic alginate is able to self-assemble into a nano-sized spherical nanoparticle in an aqueous environment which can be applicable to encapsulate…” (¶[0019]), thus disclosing the limitations of instant claims 33-35.
Instant claims 36-43 directly recite the limitations disclosed by Sun as claims 6, and 8-14, respectively. The limitations of instant claim 44 and 45 are encompassed by Sun’s claims 15-17. Instant claims 46-54 also directly recite the limitation disclosed by Sun as instant claims 18, 21, 23-29, respectively.
Regarding instant claim 55-57, Sun teaches the use of trastuzumab (HER2 target, overexpressed in come breast cancers), bevacizumab (VEGF-A target, reducing new blood vessel growth to reduce blood supply to cancerous tumors), gemtuzumab (CD33 target, a protein found on the surface of most acute myeloid leukemia cells), inotuzumab (CD22 target, a protein expressed on the surface of most B-cell precursor acute lymphoblastic leukemia cells), polatuzumab (CD79b target, a protein expressed on the surface of B-cells in various types of non-Hodgkin lymphoma), sacituzumab (Trop-2 target, a protein overexpressed in many types of solid cancerous tumors), or rituximab (CD20 target, a protein found on the surface of B-cells) and the combinations thereof (claim 30), wherein combinations thereof claimed by Sun would necessarily provide “dual-function”. Thus, the limitations of instant claims 55-57 are taught by Sun.
Regarding instant claim 58, Sun teaches wherein, “Therefore, the present invention provides an antibody (or interchangably, biosmilar as disclosed in this invention) drug-containing injectable gel, which includes a water-soluble active ingredient selected from the group comprising of trastuzumab, bevacizumab, gemtuzumab, inotuzumab, polatuzumab, sacituzumab, adalimumab, infliximab, and rituximab, a pharmaceutically acceptable biosimilar or interchangeably antibody drug derivative, either alone or in combination with a second water-insoluble active ingredient, comprising paclitaxel, docetaxel, doxorubicin, and curcumin, encaspsulated in said amphiphilic alginate nanoparticle.” (¶[0043]), teaching co-administration of trastuzumab and paclitaxel as an appropriate embodiment of the invention wherein further, “the antibody drug-containing injectable nanocomposite gel may use alone or further include an additional pharmaceutically active ingredient that is carried by the amphiphilic alginate nanoparticle. Examples of the additional active ingredient if pharmaceutically required, which is also water-insoluble includes, but are not limited to, Vitamin A and its derivatives, Vitamin E and its derivatives, anti-cancer drugs such as paclitaxel, docetaxol, camptothecin, doxorubicine, etc.” (¶[0043]), teaching the co-administration may further include curcumin. In addition, co-delivery of paclitaxel and trastuzumab (T-mAb) gel solution is explicitly taught by Sun (¶[0035]-[0037], Figures 8-10; ¶[0079]-[0088]).
Regarding instant claim 61, Sun discloses wherein the injectable gel composition is administered via subcutaneous injection (claim 32), directly teaching the limitation of instant claim 61.
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 33, 55, and 57-60 are rejected under 35 U.S.C. § 103 as being unpatentable over Sun and Liu (WO2022006685A1; published 13 January 2022, hereinafter referred to as “Sun”) in view of Einbond and Redenti (US20130315983A1; published 28 November 2013, hereinafter referred to as “Einbond”), Banerjee and Krishnaswami (US20130224229A1; published 29 August 2013, hereinafter referred to as “Banerjee”) and Sun and Liu (WO2021174330A1; published 10 September 2021, hereinafter referred to as “Liu”).
Sun teaches the limitations of instant claims 33, 55, 57, 58, from which instant claims 59 and 60 depend, as described above, however does not explicitly teach the specific limitations of instant claims 59 and 60.
Regarding instant claims 59 and 60, Sun teaches co-administration of paclitaxel and trastuzumab and indicates further addition of curcumin as an acceptable embodiment of the invention, as discussed above. Sun also teaches that the active ingredient can be selected from paclitaxel and curcumin (claim 24), however, Sun does not explicitly disclose wherein the active ingredient is a mixture of trastuzumab, paclitaxel and curcumin.
Einbond teaches the co-administration of curcumin and paclitaxel (claims 6-8) and Banerjee teaches the co-administration of an improved solubility curcumin derivative (claim 16) with at least one additional anti-cancer chemotherapeutic agent selected from the group consisting of herceptin [trastuzumab] and paclitaxel (claim 32). Liu teaches the use of an amphiphilic alginate-oleic acid nanoparticle with anti-cancer activity, used as a delivery system for a drug or biological material (claims 1, 2 and 8).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add co-administration of curcumin to the invention of Sun, given it is indicated to be an appropriate embodiment of the invention by Sun. Further, Einbond teaches co-administration of curcumin with paclitaxel, Banerjee teaches co-administration of curcumin derivatives with trastuzumab and paclitaxel, and Liu teaches use of the amphiphilic alginate-oleic acid nanoparticle with anti-cancer activity which can be used as a delivery system for a drug or biological material, thus adding curcumin to the active ingredients disclosed in the invention by Sun would be motivated by similar combinations including curcumin or curcumin derivatives known in the art for the same purpose of treating cancer. One would have a reasonable expectation of success to make a change, since like combinations have been previously used and indicate enhanced treatment efficacy (see Einbond and Banerjee disclosures).
Claim Rejections – Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. § 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. § 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. § 101.
Claims 33-58 and 61 are provisionally rejected under 35 U.S.C. § 101 as claiming the same invention as that of the claims of co-pending Application No. 18/015,495 (US20230248642A1; published 10 August 2023, hereinafter referred to as “’495”). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
‘495 discloses an injectable nanocomposite gel pharmaceutical composition formed by mixing amphiphilic alginate nanoparticle, a hyaluronic salt or derivative, an alginate salt or derivative, and an ionic crosslinker (claim 33) and an active ingredient (claim 34) selected from the group consisting of an antibody drug, a biosimilar drug, a protein-like drug, a chemo-drug, and the combination thereof (claim 35), further selected from the group consisting of trastuzumab, bevacizumab, gemtuzumab, inotuzumab, polatuzumab, sacituzumab, adalimumab, infliximab, rituximab, and the combinations thereof (claim 37), wherein the active ingredient is hydrophobic (i.e., gemtuzumab, inotuzumab, polatuzumab, sacituzumab or claim 39 compounds; claim 37-39), encapsulating the active ingredient to form a solid-like injectable drug-carrying gel (claim 44). “According to the invention, the amphiphilic alginate is able to self-assemble into a nano-sized spherical nanoparticle in an aqueous environment which can be applicable to encapsulate…” (¶[0019]), thus disclosing the limitations of instant claims 33-35.
Instant claim 36 is encompassed within claim 36 of ‘495. Instant claim 37 and 38 directly correlate with ‘495 claims 38 and 39. Instant claims 39-41 and 43 limitations are encompassed within ‘495 claim 33. Instant claim 42 is encompassed with ‘495 claims 33 and 40. Instant claims 44, 45, ad 47 are encompassed within ‘495 claims 42-44. Instant claims 46, 48, and 49 correspond with ‘495 claim 45, 47, and 48, respectively.
Instant claims 50-52 and 54 are encompassed within ‘495 claim 42. Instant claim 53 is taught by ‘495 claim 49.
Regarding instant claim 55-57, ‘495 teaches the use of trastuzumab (HER2 target, overexpressed in come breast cancers), bevacizumab (VEGF-A target, reducing new blood vessel growth to reduce blood supply to cancerous tumors), gemtuzumab (CD33 target, a protein found on the surface of most acute myeloid leukemia cells), inotuzumab (CD22 target, a protein expressed on the surface of most B-cell precursor acute lymphoblastic leukemia cells), polatuzumab (CD79b target, a protein expressed on the surface of B-cells in various types of non-Hodgkin lymphoma), sacituzumab (Trop-2 target, a protein overexpressed in many types of solid cancerous tumors), or rituximab (CD20 target, a protein found on the surface of B-cells) and the combinations thereof (claim 50), wherein combinations thereof claimed by Sun would necessarily provide “dual-function”. Thus, the limitations of instant claims 55-57 are taught by ‘495.
Regarding instant claim 58, ‘495 teaches “Therefore, the present invention provides an antibody (or interchangably, biosmilar as disclosed in this invention) drug-containing injectable gel, which includes a water-soluble active ingredient selected from the group comprising of trastuzumab, bevacizumab, gemtuzumab, inotuzumab, polatuzumab, sacituzumab, adalimumab, infliximab, and rituximab, a pharmaceutically acceptable biosimilar or interchangeably antibody drug derivative, either alone or in combination with a second water-insoluble active ingredient, comprising paclitaxel, docetaxel, doxorubicin, and curcumin, encaspsulated in said amphiphilic alginate nanoparticle.” (¶[0046]), teaching co-administration of trastuzumab and paclitaxel as an appropriate embodiment of the invention wherein further, “the antibody drug-containing injectable nanocomposite gel may use alone or further include an additional pharmaceutically active ingredient that is carried by the amphiphilic alginate nanoparticle. Examples of the additional active ingredient if pharmaceutically required, which is also water-insoluble includes, but are not limited to, Vitamin A and its derivatives, Vitamin E and its derivatives, anti-cancer drugs such as paclitaxel, docetaxol, camptothecin, doxorubicine, etc.” (¶[0049]), teaching the co-administration may further include curcumin. In addition, co-delivery of paclitaxel and trastuzumab (T-mAb) gel solution is explicitly taught by Sun (¶[0038]-[0040], Figures 8-10; ¶[0081]-[0096]).
The limitation of instant claim 61 is directly taught by ‘495 claim 52.
Claim Rejections – Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
Claims 33, 55, and 57-60 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of co-pending Application No. 18/015,495 (US20230248642A1; published 10 August 2023, hereinafter referred to as “’495”) in view of Einbond and Redenti (US20130315983A1; published 28 November 2013, hereinafter referred to as “Einbond”), Banerjee and Krishnaswami (US20130224229A1; published 29 August 2013, hereinafter referred to as “Banerjee”) and Sun and Liu (WO2021174330A1; published 10 September 2021, hereinafter referred to as “Liu”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
’495 teaches the limitations of instant claims 33, 55, 57, 58, from which instant claims 59 and 60 depend, as described above, however does not explicitly teach the specific limitations of instant claims 59 and 60.
Regarding instant claims 59 and 60, ’495 teaches co-administration of paclitaxel and trastuzumab and indicates further addition of curcumin as an acceptable embodiment of the invention, as discussed above. ’495 also teaches that the active ingredient can be selected from paclitaxel and curcumin (claim 48), however, ’495 does not explicitly disclose wherein the active ingredient is a mixture of trastuzumab, paclitaxel and curcumin.
Einbond teaches the co-administration of curcumin and paclitaxel (claims 6-8) and Banerjee teaches the co-administration of an improved solubility curcumin derivative (claim 16) with at least one additional anti-cancer chemotherapeutic agent selected from the group consisting of herceptin [trastuzumab] and paclitaxel (claim 32). Liu teaches the use of an amphiphilic alginate-oleic acid nanoparticle with anti-cancer activity, used as a delivery system for a drug or biological material (claims 1, 2 and 8).
It would have been prima facie obvious to one of ordinary skill in the art prior to the instant effective filing date to add co-administration of curcumin to the invention of ’495, given it is indicated to be an appropriate embodiment of the invention by ’495. Further, Einbond teaches co-administration of curcumin with paclitaxel, Banerjee teaches co-administration of curcumin derivatives with trastuzumab and paclitaxel, and Liu teaches use of the amphiphilic alginate-oleic acid nanoparticle with anti-cancer activity which can be used as a delivery system for a drug or biological material, thus adding curcumin to the active ingredients disclosed in the invention by ’495 would be motivated by similar combinations including curcumin or curcumin derivatives known in the art for the same purpose of treating cancer. One would have a reasonable expectation of success to make a change, since like combinations have been previously used and indicate enhanced treatment efficacy (see Einbond and Banerjee disclosures).
Claims 33-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of co-pending Application No. 17/909,709 (US20230122200A1; published 20 April 2023, hereinafter referred to as “’709”). Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons outlined below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
’709 teaches discloses gel compositions comprising amphiphilic alginate-oleic acid nanoparticles with anti-cancer activity as a delivery system for active agent drugs or biological agents (claims 1-12; including proteins, peptide, and antibodies) encapsulating two or more active agents (claims 15 and 16). Alginate manufacture is described to be manufactured by conventional measures including production based on algae sources, wherein alginates in intracellular matrix nature brown algae as gel contain sodium calcium, magnesium, strontium and barium ions, such that the counterion compositions are decided by the ion-exchange equilibrium with seawater (¶[0040]), teaching the use of ionic crosslinkers. The amphiphilic alginate self-assembles into a nanoparticle (¶[0097] and [0098]; FIG.3 and 4), with zeta potentials (mV) and size (nm) listed in Table 3 (¶[0099]) indicating moderately stable nano gels as well as by the mention of colloidal stability (claim 9).
‘790 teaches the use of resulting amphiphilic sodium alginate having molecular weights of 5000-50,000 g/mol and 10,000- 60,000 g/mol with 24-48 hours of hydrolysis and 100,000- >600,000 g/mol with 0-6 hours hydrolysis (¶[0086] and [0087]; Table 1).
‘790 also teaches hydrophobic active ingredient encapsulation, “The as-prepared oleic acid-modified sodium alginate (AGO macromolecule), a form of amphiphilic macromolecule was employed to encapsulate hydrophobic drug is disclosed. A highly hydrophobic drug (water-insoluble), curcumin, was prepared…”, resulting in nanoparticles with gel nanocomposite features (¶[0111]-[0113]; Table 4). Further, the use of oleic acid-modified sodium alginate amphiphilic macromolecule to encapsulate the highly hydrophobic drugs curcumin and paclitaxel is disclosed resulting in composite nanoparticles carrying the encapsulated drug with colloidal stability (¶[0114] and [0115]). Administration was by injection in vivo experiments (¶[0108] and [0109]).
Thus, the limitations of instant claims 33, 34, 36-42, 46-53, 55, 57-61 are taught by ‘790. ‘790 does not explicitly teach the use of trastuzumab, bevacizumab, gemtuzumab, inotuzumab, polatuzumab, sacituzumab, adalimumab, infliximab, rituximab, and the combinations thereof as active ingredients. However, ‘790 teaches the active ingredient as an antibody (claim 12), in which all of the compounds of instant claims 35 and 56 are encompassed within. In addition, ‘790 teaches, “Furthermore, the oleic acid-modified sodium alginate (AGO) disclosed in this invention ensures its great drug encapsulation capability toward single or multiple drugs of water-insoluble property. Experimental observations also substantiated it's beneficial to (1) reduce cytotoxicity possibly exerted from those highly-potent pharmaceutic ingredients for anti-cancer, anti-proliferation, and anti-inflammation, etc. purposes. (2) enhance water solubility of those highly-water-insoluble drugs to enhance their bioavailability upon therapy, (3) synergize therapeutic performance while dual-drug co-administration was carried out to treat difficult-to-cure diseases such as metastasized solid tumors, etc. (4) form stable colloidal dosage over short-to-long term storage period for clinical uses as demanded, and (5) give potential versatility for a subsequent novel dosage form for specific delivery. While this specification contains many specifics, these should not be construed as limitations on the scope of the invention or of what may be claimed, but rather as descriptions of features specific to particular embodiments or examples of the invention. Certain features that are described in this specification in the context of separate embodiments or examples can also be implemented in combination in a single embodiment.” (¶[0118] and [0119]). Thus, the addition of trastuzumab, a known cancer therapeutic antibody, would be an obvious variation of the ‘790 invention.
The concentration ratio limitations of instant claims 43-45 and 54 would be obvious as a matter of routine experimental optimization.
To overcome double patenting rejections, the Applicant may file a terminal disclaimer pursuant to 37 C.F.R. § 1.321, which disclaims any portion of the term of the present application that would extend beyond the expiration of the cited patents/applications. Alternatively, the Applicant may amend the claims to recite limitations not disclosed or suggested in the cited references to establish patentable distinction.
Conclusion
No claims are allowed. Double patenting rejections are provisional because the patentably indistinct claims of the co-pending applications have not in fact been issued patents.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L. SCOTLAND whose telephone number is (571) 272-2979. The examiner can normally be reached M-F 9:00 am to 5:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (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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/RL Scotland/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615