DETAILED ACTION
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 .
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.
Claim Status
Claims 1-17 are currently pending.
Priority
The instant application is a 371 of PCT/IB2021/053152 filed on 04/16/2021 and claims foreign priority to IN202041016518 filed on 04/16/2020 as reflected in the filing receipt dated on 04/26/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/14/2022 and 08/25/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant's election of Group I, claims 1-5 and 13-14 in the reply filed on 08/25/2025 is acknowledged. Because Applicant’s reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election is treated as an election without traverse. Claims 1-17 are pending in the application. Claims 6-12 and 15-17 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 1-5 and 13-14 are being examined on the merits herein.
Claim Objections
Claims 1-3 and 5 are objected to because of the following informalities:
In claim 1, the annotation “------ Formula-I” causes confusion as it appears that “Formula-I” is a separate compound appended to a chemical structure comprising sapogenin, linker, and polyethylene glycol, rather than a label for the compound comprising sapogenin, linker, and polyethylene glycol.
In claim 2, the terms “Sapogenin”, “Diosgenin”, “Solasodin”, “Tomatidine”, “11-Ketotigogenin”, “Hecogenin”, “Laxogenin”, “Smilagenin”, “Sarsasapogenin”, “Tigogenin”, “Epismilagenin”, and “Yamogenin” are inappropriately capitalized.
In claim 3, the terms “Succinate” and “Sebecate” are inappropriately capitalized.
In claim 3, a comma is missing between the terms “pimelate” and “malonate”.
In claim 5, the limitation “wherein the compound is selected from a group Diosgenin Polyethylene…” appears to be missing punctuation or a transitional phrase. The Examiner recommends adding a colon after the term “group”.
In claim 5, several terms within the Markush grouping “Diosgenin Polyethylene…Yamogenin Polyethylene Glycol Sebecate” are inappropriately capitalized.
In claim 5, line 20, there appears to be an extraneous space between the terms “Smilagenin Polyetheylene Glycol Malonate,” and “Sarsasapogenin Polyethylene glycol succinate”, which should be removed.
Appropriate correction is required.
Drawings
The drawings are objected to because 37 CFR 1.84(u)(1) (see MPEP 507(e)) states: View numbers must be preceded by the abbreviation “FIG.” Here, your drawings refer to “Figure 1” and “Figure 2”.
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 2-5 and 13-14 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.
Claims 2-5 and 13 recite the limitation “selected from a group…”. It is unclear whether the recited group is the only group from which the component can be selected from or whether there are other unrecited groups from which the component may be selected. Therefore, the metes and bounds of each claim are indefinite. The Examiner recommends amending the claims to recite “selected from the group…”.
Claims 2-4 and 13 recite the limitation “selected from a group comprising…”. The phrase “selected from” followed by a list indicates a Markush grouping, which by nature is closed claim language. Note: MPEP 2111.03 and 2173.05(h). However, the inclusion of the open claim language “comprising” makes the metes and bounds of what is in the group versus what is excluded from the group unclear. Therefore, the resulting claim is indefinite as it appears Applicant is attempting to set up a Markush group but the language is not consistent with what is utilized for signaling a Markush group. Proper Markush language is “selected from the group consisting of”. The Examiner suggests rewording the claim to include the Markush language.
Claim 14 recites the limitation “the active ingredient”. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from claim 1, which does not recite “an active ingredient”. Therefore, it is unclear to which active ingredient claim 14 refers. For the purpose of compact prosecution, the Examiner is interpreting the claim to depend from claim 13, which recites “active ingredient” and therefore provides sufficient antecedent basis for the claim.
Claim Interpretation
Claim 13 recites the limitation “optionally along with excipient”. The Examiner notes that excipient is not required by the claim.
Claim Rejections - 35 USC § 102
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 1-2 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (RSC Adv., 5, 74828–74834; published: 08/27/2015; PTO-892).
Regarding claims 1 and 2, Li teaches an amphiphilic polymer-drug conjugate poly(ethylene glycol) (PEG)-diosgenin, wherein the PEG and diosgenin segments are linked via an ester bond between a -COOH carboxylic acid linker (attached to PEG) and diosgenin (Li, Page 74828, R. Col. and Scheme 1A). Diosgenin reads on the sapogenin of instant claim 2, and together the polymer-drug conjugate reads on the compound of Formula-I as recited in instant claim 1.
Regarding claim 13, Li teaches nanoparticles comprising PEG-diosgenin conjugate loaded with anticancer drug HCPT (Li, Page 74829, Section 2.5), which reads on the instantly claimed composition comprising the compound of instant claim 1 and an active ingredient, wherein the active ingredient is an active pharmaceutical ingredient. The Examiner notes that the instant claim language does not require that the composition further include an excipient (see Claim Interpretation above). Thus, the drug-loaded nanoparticles of Li reads on all limitations of claim 13.
Regarding claim 14, Li teaches that the drug-loaded nanoparticles are prepared by dissolving 10 mg HCPT active ingredient and 20 mg of PEG-diosgenin conjugate compound in distilled water (Li, Page 74829, R. Col.), resulting in a 1:2 ratio of the active ingredient to the compound, which lies within and thus anticipates the instantly claimed range.
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 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 1-3, 5, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (RSC Adv., 5, 74828–74834; published: 08/27/2015; PTO-892), as applied to claims 1-2 and 13-14 above, and further in view of Gao (MOJ Bioequiv Availab., 5(3), 125‒128; published: 05/02/2018; PTO-892).
Li teaches the invention(s) of claims 1-2 and 13-14 as discussed in detail above and further incorporated herein.
Regarding claims 3 and 5, while Li teaches a carboxylic acid linker, Li does not teach wherein the carboxylic acid is succinate, adipate, glutarate, pimelate, malonate, or sebecate. Gao teaches that PEG polymers are routinely modified with anhydrides such as succinic anhydride, which provides a free -COOH group for bioconjugation and acts as a spacer between the polymer and drug in order to control the site and rate of drug release (Gao, Page 127, R. Col.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PEG of Li with alternative carboxylic acid linkers, such as the succinyl group of Gao, which reads on the succinate-derived linker of claim 3, in order to optimize the drug release kinetics of the PEG-diosgenin carrier as desired by Li (Li, Page 74829, L. Col.).
The PEG-diosgenin conjugate taught by the combination of Li and Gao reads on Applicant’s elected species of claimed compound, diosgenin polyethylene glycol succinate, as recited in claim 5.
One of ordinary skill in the art would reasonably expect success in modifying the PEG-diosgenin conjugate of Li with the teachings of Gao as proposed because the combined references teach that the proposed synthetic methods are well known in the art to be useful in developing new drug delivery systems with improved pharmacokinetic and pharmacodynamic profiles (Gao, Page 125, L. Col.).
Claims 1-2, 4, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (RSC Adv., 5, 74828–74834; published: 08/27/2015; PTO-892), as applied to claims 1-2 and 13-14 above, and further in view of Gursahani et al. (J. Pharm. Sci., 98(8), 2847-2856; published: 04/30/2009; PTO-892).
Li teaches the invention(s) of claims 1-2 and 13-14 as discussed in detail above and further incorporated herein.
Regarding claim 4, while Li teaches a PEG polymer, Li does not teach wherein the PEG is PEG 200, PEG 400, PEG 600, PEG 800, PEG 1000, or PEG 2000. Gursahani teaches that PEG size plays a dominant role in controlling the rate and mechanism of PEG-conjugate absorption and permeability across the pulmonary epithelium (Gursahani, Page 2848, L. Col.), noting that the permeability of the pulmonary epithelium to PEG is effectively linear for PEG sizes of 550, 1000, 2000, and 3400, whereas larger PEG sizes of 5000 and greater exhibited a significantly slower rate of elimination from the tissue (Gursahani, Page 2851, L. Col.). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PEG-diosgenin conjugate of Li by substituting the PEG, which has a molecular weight of 5000 (Li, Page 74829, L. Col.), with a lower molecular weight PEG, such as the PEG 1000 or PEG 2000 of Gursahani, which read on PEG species recited in claim 4, in order to improve the permeability and drug release rate of the PEG-diosgenin conjugate according to therapeutic need.
One of ordinary skill in the art would reasonably expect success in modifying the PEG-diosgenin conjugate of Li, which is implemented in the treatment of lung tumors (Li, Page 74832, R. Col.) with the teachings of Gursahani as proposed because the combined references teach that modulating the molecular weight of PEG in bioconjugates is useful strategy for altering the diffusion rate of the polymer-drug conjugate across the pulmonary epithelium (Gursahani, Page 2853, L. Col.).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X. Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616