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 office action is in response to Applicant’s Amendment and Response to Restriction/Election Requirement filed on 2/9/2026, where claims 14, 20 and 21 are canceled, claims 1 and 2 are amended and claims 34-36 are newly added.
Claims 1-13, 15-19 and 22-36 are pending in the instant application.
Election/Restrictions
Applicants’ election, without traverse, for the invention of Group I drawn to drawn to a polymeric compound, or composition thereof, encompassing claims 1-13, 15-19, 22-25, 32 and 34-36, in the reply filed on 2/9/2026 is acknowledged. Applicants’ election, without traverse, for the species: the compound of Run #65: Formula (II): the poly(hydroxylic) alcohol of A is beta-cyclodextrin where w is 2, the poly(hydroxylic) alcohol of B is glycerol where x is 1-5, and the multifunctional carboxylic compound of D is citric acid where Z is an average of 1-5 per beta-cyclodextrin from the polymer distribution obtained, where the molar ratio of A:B:D is (w+x)/z = 3.0, encompassing claims 1, 2, 4-11, 13, 16-19, 22, 24, 25 and 34-36, in the reply filed on 2/9/2026 is acknowledged. However, the Office disagrees with the list of claims encompassed by the elected species. The claims encompassed by the elected species are 1, 2, 4-8, 10, 11, 13, 15-19, 22-25 and 35. Claim 9 is not encompassed because the election did not include derivatized cyclodextrin. Claims 34 and 36 are not encompassed by the elected species because the elected species requires w=2, whereas in claim 34, w=1 and in claims 36, w=3-6. Claims 15 and 23 are included in the encompassed elected species. Moreover, the description of the elected species is inconsistent with the description of run #65 in the specification. Run #65 on p. 43 of the specification lists A=citric acid, B=beta-cyclodextrin, C=absent and D=glycerin, with a ratio of A:B:C:D of 6:1:0:1, thus w=6, x=1, y=0 and z=1, giving (x+y+z)/w = 2/6=0.33. The above description of the elected species has A=beta-cyclodextrin, B=glycerol and D=citric acid, which does not match the specification. For search and consideration of the claims, it is the description in the specification which will bound the elected species.
The requirement is still deemed proper and is therefore made FINAL.
Claims 26-31 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention.
Claims 3, 9, 12, 32, 34 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species.
Claims 1, 2, 4-8, 10, 11, 13, 15-19, 22-25 and 35 will be examined on the merits herein.
In searching for Applicants’ elected species, the Examiner came across prior art which reads on the broader genus claimed. Solely in an effort to expedite prosecution, the Examiner has extended the search to include the disclosure of the prior art cited below.
Priority
The application is a continuation-in-part of PCT/US2021/037513 filed on 6/15/2021, which claims priority to provisional application 63/039108 filed on 6/15/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 1/6/2023, 2/4/2025 and 2/9/2026 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
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.
Claims 1, 2, 4-8, 10, 11, 13, 15-19, 22-25 and 35 are rejected for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 limits the polymer of formula (I) to be a “linear polymer, simple branched polymer, hyperbranched polymer or dendritic polymer”, then claim 1 adds the proviso that “provided that when x and y are both 0, then the polymer of formula (I) is not crosslinked polymer”. Since claim 1 does not include crosslinked polymer in the list of polymer types, the negative proviso results in claim 1, and its’ dependents, being indefinite due to the scope of polymer types encompassed being unclear.
Claim 15 is further indefinite for reciting "the polyester layers" and “the core”. There is insufficient antecedent basis for these limitations in the claim. Claim 15 also recites “the monomers” but never specifies which of monomers A, B, C or D is being referred to, which renders the scope of claim 15 unclear.
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.
Claims 2, 11 and 35 are rejected under 35 U.S.C. 112(d) 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 2 recites, “monomers A and B are a poly(hydroxylic) alcohol that can be the same or different, and monomer D is a multifunctional carboxylic compound, wherein the molar ratio of A:B:D is (w+x)/z = 0.05-4”. However, claim 1 requires that A is a multifunctional carboxylic compound. The only polymer elements allowed to be a poly(hydroxylic)alcohol, as per claim 1, are B, C and/or D. Similarly, claim 1 requires that D is a poly(hydroxylic)alcohol. The only polymer elements allowed to be a multifunctional carboxylic compound, as per claim 1, are A, B and/or C. Thus, claim 2 broadens the definition of A and D beyond the scope allowed by claim 1. 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.
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.
Claim 1, 2, 4-7, 13, 16-18, 22, 24 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adeli et al. (US 2011/0159113A1, PTO-892).
Adeli et al. discloses a hyperbranched polyester comprising glycerol and citric acid, where the mole ratios of citric acid:glycerol are in the range 5:1 to 12:1 (where using the instant labels of “A” for citric acid and “D” for glycerol, corresponds to a z/w range of 0.083 to 0.20). (Claims 5, 9; Figure 2 (below)) The polymer of Adeli meets the instant limitation where x=y=0. Adeli also discloses that the hyperbranched polyester may be used to encapsulate a drug, such as cisplatin, which meets the instant limitation of a “polymeric adduct”. (¶0026-0027)
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With respect to claims 16 and 17 and the recitation regarding the effect, or quantitative guest molecule solubility improvement, produced by the claimed polymer, because Adeli et al. discloses a product which is structurally identical to the instantly claimed structure the property claimed is necessarily present. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). (MPEP 2112.01(II))
Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 2, 4-8, 10, 13, 16-18, 22, 24 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Namazi et al. (Adv. Pharm. Bull., 2011, IDS).
Namazi et al. discloses a dendrimer comprising beta-cyclodextrin, poly(ethylene glycol) and citric acid, where the dendrimer acts as a host for a drug such as naltrexone. (Figure 5 (below)) Namazi discloses that the G2 dendrimer upon which the beta-cyclodextrin becomes bound, has a mole ratio of citric acid:PEG of 8:1. (Figure 2) Namazi further discloses that the number of beta-cyclodextrin bound was quantified by NMR as being 2 molecules for every one molecule of G2. (p. 42, Col. 2) Hence, the mole ratio of citric acid:PEG:beta-cyclodextrin disclosed by Namazi is 8:1:2 (where using the instant labels of “A” for citric acid, “B” for PEG and “D” for beta-cyclodextrin, corresponds to a x+z/w value of 0.38). Alternatively, using the instant labels of “A” for beta-cyclodextrin, “B” for PEG and “D” for PEG, gives a dendrimer where x=1, w=2 and z is 8 citric acids for every 2 beta-cyclodextrin or z=4. The dendrimer of Namazi meets the instant limitation where y=0.
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With respect to claims 16 and 17 and the recitation regarding the effect, or quantitative guest molecule solubility improvement, produced by the claimed polymer, because Namazi et al. discloses a product which is structurally identical to the instantly claimed structure the property claimed is necessarily present. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). (MPEP 2112.01(II))
Accordingly, the instant claims are anticipated by the prior art.
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 2, 4-8, 10, 11, 13, 15-18, 22, 24, 25 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Namazi et al. (Adv. Pharm. Bull., 2011, IDS), in view of Adeli et al. (US 2011/0159113A1, PTO-892).
The disclosure of Namazi and Adeli are referenced as discussed above. Neither prior art reference discloses a polymer comprising beta-cyclodextrin, glycerol and citric acid.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the G2 portion of Namazi could be substituted with the dendrimer of Adeli, to yield a glycerol/citric acid dendrimer with beta-cyclodextrin bound via the terminal carboxyl groups, thereby arriving at the instant invention. One would reasonably expect that the dendrimer of Adeli would be a suitable replacement for the G2 of Namazi because Namazi discloses that the synthetic approach to binding beta-cyclodextrin to the dendrimer uses formation of an ester bond between the cyclodextrin hydroxyls and the terminal carboxyl groups of citric acid, via dicyclohexylcarbodiimide (DCC) coupling. Therefore, the terminal citric acid carboxyls of Adeli would react the same with beta-cyclodextrin, as the G2 of Namazi. Moreover, Namazi teaches that the guest drug is encapsulated by the cyclodextrin cavity directly, as well as in the void spaces of the PEG/citric acid dendrimer. Adeli teaches that the guest drug is encapsulated by the void spaces of the glycerol/citric acid dendrimer. Hence, in modifying Namazi in the manner suggested one would expect to reap the aggregate benefits of encapsulation of a guest molecule in both the cyclodextrin cavity and the void spaces of the dendrimer. Indeed, one could readily envision the encapsulation of two different guest molecules by modifying Namazi in this manner, where the beta-cyclodextrin encapsulates one drug and the void spaces encapsulate another.
With respect to the claimed mole ratios of the components of the polymer, the mole ratios disclosed by Adeli and Namazi, render the claimed ranges obvious by either lying within or overlapping said ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 19 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Namazi et al. (Adv. Pharm. Bull., 2011, IDS), or in the alternative over Adeli et al. (US 2011/0159113A1, PTO-892), or in the alternative over the combination of Namzi/Adeli, in view of Braga et al. (US 2016/0168224, PTO-892).
The disclosure of Namazi and Adeli are referenced as discussed above. Neither prior art reference discloses a pharmaceutical composition comprising additives or a combination of a cyclodextrin-dendrimer adduct with a separate polymeric host compound.
Braga et al. discloses a pharmaceutical composition comprising a controlled release and delivery system such as cyclodextrin(s), polymer(s), mucoadhesive polymer(s), lipid vesicles, polymersomes, solid lipidic nanoparticles, polymeric micro- or: nanoparticles, micro- or nanocapsules, micro- or nanoemulsions, dendrimers, micelles, polymeric micelles, inorganic nanoparticles, carbon nanoparticles, transdermal patches, implantable polymeric matrix, or an association of these systems, wherein the pharmaceutical composition may be formulated for topical, oral, nasal, pulmonary, intravenous, transdermal, or subcutaneous administration, together with a pharmaceutically acceptable carrier or excipient. (Claims 8 and 17)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the drug delivery compounds of Namazi, Adeli or Namazi/Adeli could be formulated as pharmaceutical compositions together with excipients or carriers, for topical, oral, nasal, pulmonary, intravenous, transdermal, or subcutaneous administration, thereby arriving at the instant invention. Brage provides guidance that formulation of drug delivery compounds, such as dendrimer and cyclodextrins, in this manner is routine in the art. In addition, it would be obvious that the cyclodextrin-dendrimers of Namazi or Adeli could be combined with a separate polymeric host compound, because Braga teaches that “an association of these systems” may be employed, which is reasonably interpreted as any combination of one or more of the listed drug delivery means.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DALE R MILLER/Primary Examiner, Art Unit 1693
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