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
RCE Final Rejection
Claim Status
Claims 1, 11-12, 16, 20, 23, 26-27, 29, 33, 36-37, 41-42, 49-51, 54-55 were studied.
Upon amendment entrance, Claims 1, 11, 23, 27, 41, 42, and 54 are amended.
Upon amendment entrance, Claims 12 and 55* are canceled; Claims 2-10 remain cancelled.
Claims 1, 11, 16, 20, 23, 26-27, 29, 33, 36-37, 41-42, 49-51, and 54 are pending examination.
Note to Applicant: Remarks of 01/29/2026 listed Claim 54 as amended and cancelled. In checking with the submitted Claim set, Examiner acknowledges it is Claim 55 that is cancelled.
Priority Status
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Examiner acknowledged EFD as 01/11/2019.
Examiner Responses to Arguments/Amendments
The issues raised in the prior Office Action are addressed below:
I. Claim Amendments –
Upon amendment entrance, independent Claims 1 was modified to recite the following:
“A composition, comprising:
lopinavir, ritonavir, and tenofovir, and
one or more compatibilizers comprising a lipid excipient, a lipid conjugate excipient, or a combination thereof,
wherein the composition is a solid powder having a powder X-ray diffraction pattern comprising at least one peak at a first scattering angle having a signal to noise ratio of greater than 3, wherein the first scattering angle of the at least one peak is not attributable to any peak of a powder X-ray diffraction pattern for lopinavir, ritonavir, or tenofovir, or the one or more compatibilizers; and
wherein the solid powder comprises a unified repetitive multi-drug motif structure as measured by its powder X-ray diffraction pattern.”
Upon amendment entrance, independent Claims 27 was modified to recite the following:
“A method of making a composition, comprising:
dissolving lopinavir, ritonavir, tenofovir, and one or more compatibilizers comprising a lipid excipient, a lipid conjugate excipient, or a combination thereof in an alcoholic solvent to provide a solution,
spraying the solution from an inlet nozzle and evaporating the alcoholic solvent in a chamber to provide the composition comprising lopinavir, ritonavir, tenofovir, and the one or more compatibilizers,
wherein the composition is a solid powder having a solid powder X-ray diffraction pattern comprising at least one peak at a first scattering angle having a signal to noise ratio of greater than 3, wherein the first scattering angle of the at least one peak is not attributable to any peak of a powder X-ray diffraction pattern for lopinavir, ritonavir, tenofovir, or the one or more compatibilizers; and
wherein the solid powder comprises a unified repetitive multi-drug motif structure as measured by its powder X-ray diffraction pattern.”
II. Response to Claim Rejections - 35 USC § 112 –
With respect to Claims 1, 11, 16, 20, 23, 26-27, 29, 33, 36-37, 41-42, 49-51, and 54 rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement.
In view of Applicant’s amendment, the 35 U.S.C. § 112(a) rejection is maintained.
Applicant’s amended claims requiring three drugs with one or more compatibilizers, in a composition with specific X-ray diffraction properties. Within the structure-function aspect in the Instant Specification, there was not shown possession of a composition having the XRD functional read-outs for the combination of lopinavir, ritonavir, and tenofovir with specific compositions of one or more compatibilizers.
With respect to representative number of examples, Applicant has a small number of examples each having specific combinations of drugs and excipients. The representative example seen in Table 1, pg. 23 discloses “different drug compositions successful in producing
ordered multi-drug-combination structures using the composition and process described for LPV/RTV/TFV with two lipid and lipid conjugate excipients.” There are only two examples where the three (3) claimed compounds are present together, one also requiring Lamivudine. As such, the instant claims allow for additional elements due to the use of “comprising”, there is a limited number of examples where the MDM structures form.
Further, the Instant Specification discloses, on pg. 26, “Representative XRD pattern for this combination is presented in FIGURE 1H. Thus, the present Example describes methods for controlled solvent removal from a fully solubilized mixture of 3 API and 2 excipients by spray-drying, which lead to formation of novel multi-drug motifs in the powder form.” This yet again indicates ideas & concepts known in the art which would make distinction between the prior art and the Instant Application clearer and is not present.
This pattern the Applicant relies on, “constituents of the quintenary mixture show sharp diffraction peaks unique to their crystal lattices.” is true in a quaternary mixture (a blend of four distinct crystalline phases); each constituent produces its own unique diffraction pattern when analyzed by X-ray diffraction (XRD). This is diffraction pattern is essentially a “fingerprint” of the crystal’s lattice structure, determined by the arrangement of atoms and the spacing between planes”
Applicant further states, “the data indicated that the combination pharmaceutical composition powder had structural features similar to hydrated DSPC even in the presence of 3 API and pegylated DSPE. In contrast, multidrug combinations composed of hydrophobic ritonavir, etravirine and efavirenz were previously produced as amorphous solid dispersions. The data showed a physical transformation from the pure crystalline forms of the therapeutic agents, but not complete amorphous conversion.”
Applicant does not provide a means to determine this difference in comparison to another composition which would show unexpected results. In measuring lattice parameter shifts, and tracking crystallinity evolution those changes (on which the Applicant relies) are not discussed within the Instant Specification as being the inventive step/novel aspect (if it is those changes/ratios/combinations that affect the overall composition), and hence makes its results unexpected.
Thus, the above information about does not aid in establishing a single, well-delineated example. The example used within the Instant Specification, Applicant’s specific combination, ratio, and formulation to yield superior results is not established. The formulation has not shown synergistic properties, increased bioavailability, reduced toxicity, or unexpected stability that goes beyond merely the sum of its parts. What is already known in the art about these three (3) API’s, lipid excipients and methods within a composition compared to the Applicant’s Invention is not clear.
Therefore, a new rejection by amendment is necessitated.
III. Response Claim Rejections - 35 USC § 103 –
35 U.S.C.§ 103:
Claims 1, 11, 16, 20, 23, 26, 41-42, 49-51, and 54, rejected under 35 U.S.C. § 103 as being unpatentable over Hailiang Chen in US 2012/0046220 Al (hereinafter "Chen") in view of S. Perazzolo (hereinafter "Perazzolo") and further in view of RH Muller, et al. in "Solid lipid nanoparticles (SLN) for controlled drug delivery - a review of the state of the art" (hereinafter "Muller").
Claims 27, 29, 33, 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Chen, Perazzolo and Muller and further in view of J. Staniforth in WO 2008/075102 Al (hereinafter "Staniforth").
Claims 1, 11, 16, 20, 23, 26-27, 29, 33, 36-37, 41-42, 49-51, and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Hailiang Chen in US 2012/0046220 Al in view of S. Perazzolo and in view of J. Staniforth in WO 2008/075102 A1.
After reconsideration in view of Applicant amendment, arguments, and the additional limitations added to Independent Claim 1 and Claim 27, the 103 rejections of record are withdrawn. All arguments relating to that rejection are moot.
IV. Maintained Rejection –
Upon amendment entrance, Applicant modified the Claims which created new issues.
Hence, a new rejection was necessitated.
Claim Rejections - 35 USC § 112
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.
112(a) for Written Description -
Claims 1, 11, 16, 20, 23, 26-27, 29, 33, 36-37, 41-42, 49-51, and 54 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163.
While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Level of skill and knowledge:
The artisans using applicant’s method would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which specific mechanism of action, combination of inhibitors influence the desired pharmacological activity and which diseases would benefit from this activity.
State of the art & predictability or unpredictability of the art:
Pruvost A, Negredo E, Théodoro F, et al. Antimicrob Agents Chemother, 2009, 53(5): 1937-1943. Pilot pharmacokinetic study of Human Immunodeficiency Virus-infected patients receiving tenofovir disoproxil fumarate (TDF): Investigation of systemic and intracellular interactions between TDF and abacavir, lamivudine, or lopinavir-ritonavir (hereinafter “Pruvost”)
Kearney BP, Mathias A, Mittan A, et al. J Acquir Immune Defic Syndr, 2006, 43: 278-283. Pharmacokinetics and safety of tenofovir disoproxil fumarate on coadministration with lopinavir/ritonavir (hereinafter “Kearney”).
U.S. Food and Drug Administration (FDA) - VIREAD (tenofovir disoproxil fumarate) (hereinafter “FDA”).
Caira, M.R. in Current Applications of Powder X-Ray Diffraction in Drug Discovery and Development (pub’d 02/17/2005; hereianfter “Caira”).
In representation of the art, Kearney discloses the pharmacokinetic interaction between tenofovir (300 mg once daily) and lopinavir (400/100 mg twice daily) as determined in 27 HIV-negative subjects. Co-administration of lopinavir/ritonavir increase tenofovir AUC (32%), Cmax (15%) and Cmin (51%).
Lopinavir and ritonavir pharmacokinetics were unaffected by tenofovir (n=24). Clinical estimates of renal function were unaffected by administration of tenofovir alone or with lopinavir/ritonavir. The increase in tenofovir exposure is not believed to be clinically relevant based on the safety and efficacy of this combination in HIV-infected patients in long-term controlled clinical trials.
Pruvost discloses pharmacokinetic studies of tenofovir (TFV) disoproxil fumarate (TDF; the prodrug of tenofovir) showing plasma concentrations of tenofovir (300 mg once daily) with lopinavir/ritonavir (400/100 mg twice daily, n=14) or nevirapine (400 mg once daily, n=13) were determined in HIV positive patients. Tenofovir AUC, Cmax and Ctrough were 50%, 33% and 72% higher, respectively, in the presence of lopinavir/ritonavir when compared to nevirapine. The authors suggest that observed increase in tenofovir exposure may involve intestinal P-glycoprotein inhibition by lopinavir and/or ritonavir. Ritonavir acts as a pharmacokinetic booster that inhibits certain drug transporters in the gut and kidneys. This leads to increased absorption and delayed elimination of tenofovir.
According to the U.S. Food and Drug Administration (FDA) accessdata.fda.gov, September 2016 Summary of Product Characteristics from Gilead Sciences, Viread (tenofovir disoproxil fumarate) is a nucleotide reverse transcriptase inhibitor indicated for treating HIV-1 infection and chronic hepatitis B in adults and certain pediatric populations. The tenofovir disoproxil fumarate was evaluated in healthy volunteers in combination with other antiretroviral and potential concomitant drugs.
When tenofovir disoproxil fumarate (300 mg once daily) was administered with lopinavir/ritonavir (400/100 mg twice daily), there was no significant effect on lopinavir/ritonavir PK parameters. Tenofovir AUC increased by 32%, Cmin increased by 51%, and there was no change in Cmax. No dose adjustment is recommended.
The increased exposure of tenofovir could potentiate tenofovir-associated adverse events, including renal disorders. A higher risk of renal impairment has been reported in patients receiving tenofovir disoproxil fumarate in combination with a ritonavir or cobicistat boosted protease inhibitor. A close monitoring of renal function is required in these patients. In patients with renal risk factors, the co-administration of tenofovir disoproxil fumarate with a boosted protease inhibitor should be carefully evaluated. FDA - Table 13 (pg. 28, coadministration of tenofovir with lopinavir/ritonavir) and Table 14 (pg. 30, Changes in Pharmacokinetic Parameters for Co-administered Drug in the Presence of VIREAD® (tenofovir disoproxil fumarate)) summarizes pharmacokinetic effects of the co-administered drug on tenofovir pharmacokinetics and its effects on the pharmacokinetics of co-administered drug.
In the Instant Case, the claims are drawn to:
a combination of lopinavir, ritonavir, or tenofovir, assembled with excipients under specific conditions, forming a homogeneous pharmaceutical powder with a unified repetitive multi-drug motif (MDM) structure; and
a method of administering the combination pharmaceutical composition, which includes mixing the combination pharmaceutical composition with an aqueous solvent to provide an aqueous dispersion. The combination pharmaceutical composition can be parenterally administered as an aqueous dispersion to a subject in need.
The functional language seen in Claims 1 and 27, “…wherein the composition is a solid powder having a powder X-ray diffraction pattern comprising at least one peak at a first scattering angle having a signal to noise ratio of greater than 3, wherein the first scattering angle of the at least one peak is not attributable to any peak of a powder X-ray diffraction pattern for lopinavir, ritonavir, or tenofovir, or the one or more compatibilizers; and wherein the solid powder comprises a unified repetitive multi-drug motif structure as measured by its powder X-ray diffraction pattern” has no definition provided.
Notably, the embodiment of “a solid powder having a powder X-ray diffraction pattern comprising at least one peak at a first scattering angle having a signal to noise ratio of greater than 3, wherein the first scattering angle of the at least one peak is not attributable to any peak of a powder X-ray diffraction pattern for lopinavir, ritonavir, or tenofovir, or the one or more compatibilizers; and wherein the solid powder comprises a unified repetitive multi-drug motif structure as measured by its powder X-ray diffraction pattern” disclosed in the Instant specification (pg. 10, lns. 21-33 to pg. 11, lns. 1-10) does not include defining features of what constitutes the data from an X-ray diffraction pattern of scattered X-ray intensity versus the diffraction angle, or 2θ. Specifically, the applicant failed to disclose the primary 2θ peak positions, corresponding d-spacings, or relative intensity values required to definitively identify and characterize the claimed crystalline form of the composition.
The prior art of Caira guides a skilled artisan through specific understanding, “…Since each crystalline phase presents a unique PXRD pattern, a physical mixture of two or more crystalline phases is the sum of the individual patterns, their respective intensity profile contributions being weighted by the mass fraction of each phase present. This is the basis of traditional quantitative analysis of mixtures of crystalline phases, one of the best-known applications of the PXRD technique. In particular, the PXRD patterns of two or more polymorphic forms of a given drug will generally differ significantly and their mixtures can thus be quantified. This is of major importance in the control of polymorphic purity when an API occurs in different crystal forms having different physical properties (e.g. dissolution rates).
Caira continues on pgs. 4-5 with illustrative studies relating to Figure 2 as to how “multi-component compounds and increasingly in the context of the characterization of new pharmaceutically relevant phases might display advantageous properties, such as enhanced solubility of the active pharmaceutical ingredient (API).” The rate of absorption of the compound then depends upon its rate of dissolution that, in turn, may depend upon crystal size and crystalline form.
An issue of concern is in having distinctly different PXRD patterns with changes occuring to its solubility. The combination of different compounds with excipients can cause probable formation of a binary compound, a salt or a co-crystal being the most likely products. Caira, on pg. 5-6, demonstrates this through the example of cyclodextrin inclusion complexes of drugs. Caira demonstrates non-covalent interactions can cause changes in drugs and excipients which lead to changes in functional properties.
Inclusion complexes are used with oral combination antiretroviral treatments, or Highly Active Antiretroviral Therapy (HAART), to improve drug delivery and performance (which is in the scope of the Instant Application). To act as a compatibilizer, they are typically modified and encapsulate the drug and increase its solubility. By increasing the solubility of poorly soluble antiretroviral drugs, cyclodextrins enhance their absorption in the gastrointestinal tract, leading to improved oral bioavailability.
The Instant Specification fails to establish a structure-function correlation as to how the combinations of drugs with excipients would or would not have functional properties unexpectedly different than to what is already disclosed in the field of art. Applicant failed to discuss how the pharmaceutical composition combination of lopinavir, ritonavir, and tenofovir in its relevant phases might display advantageous properties.
Specifically, the specification lacks sufficient data and reasoning to establish that combining these active pharmaceutical ingredients (APIs) results in unexpected or enhanced physicochemical characteristics, such as increased solubility of the API. The Applicant hasn’t shown how, through comparative data, superior drug efficacy, faster therapeutic action, and/or optimized processing efficiency. Without comparative evidence demonstrating that the combination yields synergistic or non-obvious enhancements over the individual compounds or known formulations of similar combinations in the art, the claimed benefits remain unsupported.
Existence of working examples/Specification:
In the Instant Application, the therapeutic approach used is called oral combination antiretroviral treatment (cART) or highly active antiretroviral treatment (HAART). On pg. 18, lns. 9-21 of the Instant Specification discloses “combination multiple-drug particles were generated, having a stable drug-combination motif in a powder form. These particles were then made into a nanosuspension dosage form. The powders were not amorphous.”
With respect to working examples in the Instant Specification, there is a lack of accurate representatives. On pg. 24 of the Instant Specification, Table 1 notes the combinations with Table 2 indicating the combinations producing MDM’s. The working example has the combination as listed in the claims, all of which all three drugs but with the inclusion of a 4th drug, Lamivudine.
Also, since Applicant provides a limited data sample (or speculative clinical results) that fails to discuss how relevant phases or dosing ratios of the combination produced the asserted pharmaceutical effect. Because the applicant hasn't demonstrated the mechanism or pharmacological relevance of combining all three agents, they have not described or enabled the full scope of their claims.
The Instant Claims allows for combinations with different structures with unlimited excipients, the Instant Specification lists examples of a subset of all possible combinations is such that one would not know whether a combination would or would not have the functional property claims.
Overall Conclusion:
Kearney, Pruvost, FDA, and Caira report the status of the art for the scope discussed in the Instant Claims. In the combination of the prior art that is available in the field, the functional property of the antiviral agents of the Instant Specification are known. The combinations of tenofovir, lopinavir and ritonavir as an antiretroviral therapy teaches, before the effective filing date, that ritonavir is included primarily to boost drug levels rather than for its own antiviral properties. It inhibits the liver enzyme CYP3A, which slows the metabolism of lopinavir, keeping lopinavir concentrations high enough to effectively block the virus. Tenofovir is a nucleoside reverse transcriptase inhibitor (NRTI) that prevents the virus from converting its RNA into DNA. Lopinavir acts later in the viral lifecycle, functioning as a protease inhibitor (PI) to stop the virus from assembling into mature, infectious particles. Combining these classes limits the virus at multiple stages and this is demonstrated in the art.
Kearney, Pruvost, FDA, and Caira as prior art demonstrates as to how the combination of excipients and API drugs can cause changes in the functional properties of the combinational drug. This was disclosed in the clinical studies the references contained. In the explanation above, the Instant Application fails to establish a structure-function correlation as to how the combinations of drugs and excipients (to which they are claiming) would have different results than what is already known in the art.
Kearney, Pruvost, FDA and Caira teach representative samples which addresses the pharmaceutical advantage of combining these API’s; this is difficult to determine from the Instant Application four (4) samples. The lack of representative examples within the Instant Specification indicates the Applicant was not in possession of the invention, nor are there enough working examples to thoroughly demonstrate the invention.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
In this case, given the status of the prior art established by the references, the lack of structure/function correlation relating to the functional limitations, and the lack of a representative number of examples, the independent claims are rejected for lack of written description.
Dependent claims 11, 16, 20, 23, 26, 29, 33, 36-37, 41-42, 49-51, and 54 do not resolve these issues, since these claims do not further limit or provide further structure towards a resolution. Accordingly, these claims are also rejected.
Conclusions
Claims 1, 11, 16, 20, 23, 26, 27, 29, 33, 36-37, 41, 42, 49-51 and 54 are rejected.
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.
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/JOSMALEN M. RAMOS-LEWIS, Ph.D./Patent Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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