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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 01 Jun 2026 has been entered.
Response to Amendment
Status of the Claims
Claims filed 02/28/2025 are under examination.
Claims 1, 3, 5, 7-10, 15-17, 19, 20, 23, 24 and 33-36 remain pending in the application.
Claims 2, 4, 6, 11-14, 18, 21, 22 and 25-32 are cancelled.
Claims 23, 33 and 34 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim 23 is withdrawn as it is directed to a species of peptide as the active agent, whereas the elected active agent was a protein.
Claims 1, 3, 5, 7-10, 15-17, 19, 20, 24, 35 and 36 are under consideration to the extent of the elected species, i.e., that the polymer is poly(hydroxy acids), the anionic surfactant is laureate and the active agent is a protein. Note that laureate is understood as an alternative spelling to “laurate” which is consistent with how it is used in the provisional application 62/787,186 (see claim 17).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: in the prior-filed application, Application No. 62/714,454, the applicant failed to provide adequate written description support for claims 1, 3, 5, 7-10, 15-17, 19, 20, 24, 35 and 36. Accordingly, priority cannot be granted at this time, thus claims 1, 3, 5, 7-10, 15-17, 19, 20, 24, 35 and 36 are granted the filing date of application 62/787,186 (31 December 2018).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/714,454 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application ‘454 fails to provide support for the zeta potential of the particles. Accordingly, claims 1, 3, 5, 7-10, 15-17, 19, 20, 24, 35 and 36 are not entitled to the benefit of the prior application.
Rejections Maintained
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, 7-10, 12, 15-17, 20, 24, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hanes et al. (US 2010/0215580, published 26 Aug 2010) as evidenced by the instant specification.
Hanes teaches a particle that comprises a pharmaceutically acceptable polymer core, a bioactive agent (e.g., a drug or medicament) encapsulated in the core and a surface-altering agent that is embedded or enmeshed in the particles surface, or disposed on the surface of the particle and that alters the surface of the particle to make it able to diffuse rapidly through mucus ([0021]). Hanes teaches that the particles comprising a surface-altering agent may have a zeta potential between -100 mV and 10 mV ([0014]), rendering obvious the zeta potential of claim 1. Hanes teaches that the zeta potential is determined by diluting samples in double distilled water ([0241]), which renders obvious the measurement method for the zeta potential, as in claim 1. Hanes teaches that the particles may have a variety of diameters such as greater than 100 nm, 2000 nm or 5000 nm or a diameter intermediate between these values ([0006]), rendering obvious the diameter of claims 1 and 16. While Hanes does teach the inclusion of polyethylene glycol ([0026]), Hanes does not teach that polyethylene glycol is a necessary part of the invention, thus rendering obvious the “polymeric particles do not contain chemically bound poly(ethylene glycol) on their surface” as in claim 1. Hanes teaches that various polymers that may be employed to make the polymeric particles of the invention, such as poly(lactic acid), poly(hydroxy acids), poly(glycolic acid) and poly(lactic acid-co-glycolic acid) ([0147]). Hanes teaches that copolymers of two or more polymers as described may be employed to make the polymeric particles of the invention ([0148]), rendering obvious the inclusion of polylactic acid (which is a poly(hydroxy acid)) and additional polymers in the polymeric matrix as recited in claims 1, 3, 10, 35 and 36. Regarding the bioadhesion force of about 500 mN/cm2 or greater as recited in claim 15, PLA or polylactic acid has a bioadhesion force of approximately 1800 mN/cm2, as evidenced by the instant specification in Figure 2A. Hanes teaches that the polymeric formulations biodegrade within a period that is acceptable in the desired application such as 4-8 hours on exposure to a physiological solution with a pH between 6 and 8 at a temperature between 25 and 37°C ([0080]), thus rendering obvious the limitation of “the polymer does not dissolve in water within one hour at a pH between 6 and 7, inclusive, at room temperature” as recited in claim 5.
Hanes teaches that the degradation rate of a biodegradable polymer depends in part on a variety of factors such as the molecular weight ([0078]). Hanes teaches that the greater the molecular weight, the higher the degree of crystallinity and/or the greater the biostability and the biodegradation is usually slower ([0078]). Hanes additionally teaches that the viscosity of the polymer can be adjusted by the molecular weight of the polymer and that the molecular weight of the polymer used in the composition of the invention can vary widely, depending on whether a rigid solid state (higher molecular weights) is desirable, or whether a fluid state (lower molecular weights) is desired ([0108]). Thus, in view of the teachings of Hanes, it is obvious that the molecular weight of the polymer is an art-recognized result effective variable such that determining that the molecular weight of the polylactic acid is between 2-10 kDa (claims 1, 7 and 8), that the second polymer has a higher molecular weight between 21-300 kDa (claim 8) and that the ratio of the low to high molecular weight polymer is between 30-90% (claim 9) would be a matter of optimization through routine experimentation. "[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). In the instant case, it is well established through the teachings of Hanes that the molecular weight of the polymer is related to the stability which affects the biodegradation of the polymer and it also known that adjusting the molecular weight adjusts the viscosity to a more rigid or fluid state. It is further obvious to use more than one polymer, as discussed supra, and the polymer would necessarily have a specified molecular weight and be in a ratio with the polylactic acid polymer. Determining the preferred molecular weight of each polymer and the ratio of each polymer to achieve the preferred biodegradation and viscosity of the polymeric particle would thus be a matter of mere routine experimentation for one of ordinary skill in the art.
Regarding the limitation of claim 1 that the polymeric particles show systemic uptake between 10-80%, this is understood as a property that would necessarily be present in the polymeric particles made obvious over the teachings of Hanes. As evidenced by the instant specification, the negative zeta potential coupled with an appreciable bioadhesivity work in concert to enhance systemic uptake and specifically the negative zeta potential predominates in providing the beneficial properties (page 18 last paragraph). As Hanes renders obvious a negative zeta potential and the use of polylactic acid which has a high bioadhesivity, as described supra, the particles of Hanes would thus have the recited system uptake percentages. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Regarding the moiety on the surface of the polymeric particles that imparts a negative zeta potential bonded to a polymer as recited in claim 1, Hanes teaches the inclusion of surface-altering agents used to decrease the mucoadhesion of a substance and increase its mobility in mucus ([0004]). The surface-altering agent may comprise one or more chemical entities or may be incorporated covalently into the polymer vehicle ([0005]) or disposed on the surface of the particle ([0018]). Hanes teaches a variety of suitable surface-altering agents such as an anionic protein such as serum albumin ([0026], [0125]), rendering obvious the imparts a negative zeta potential/charge of claim 1 and a protein is known to have carboxylic acid groups, rendering obvious the carboxylic acids of claim 1. Proteins are composed of many amino acids, and thus the anionic serum albumin as taught by Hanes renders obvious the “amino acids” of claim 17. Hanes further teaches that the mass of the surface-altering agent makes up at least 1/100 of the mass of the particle ([0012]), which is equivalent to 1% w/w, rendering obvious the 0.0001-5% wt/wt of claim 17.
Regarding claim 20, Hanes teaches that the bioactive agent may be a protein ([0025]). Regarding claim 24, Hanes teaches formulations comprising a pharmaceutically acceptable carrier ([0221], [0224]).
Hanes does not expressly teach polymeric particles with a protein active agent, zeta potential between -10 and -80 mV, a diameter between 100 nm and 5000 nm, the absence of chemically bound poly(ethylene glycol) and an uptake between 10% and 80% with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed a particle with a polymer core of poly(hydroxy acids) such as poly(lactic acid), poly(glycolic acid), poly(lactic acid-co-glycolic acid) or mixtures thereof, an anionic protein surface-altering agent and a protein bioactive agent where the zeta potential of the particle is between -100 mV and 10 mV and the particle size is between 100 and 5000 nm. One of ordinary skill in the art would have been motivated to do so as particles are taught by Hanes for diffusing through mucus and each of the components and parameters are taught as suitable for the particles. The limitation of the systemic uptake of the particles would necessarily be met by the negative zeta potential of the particles, as evidenced by the instant specification as described supra. One of ordinary skill in the art would have a reasonable expectation of successfully forming particles, as taught by Hanes, with the cited components and parameters for the particles since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions, namely forming particles for diffusion through mucus.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Hanes.
Response to Arguments
Applicant's arguments filed 26 Dec 2025 have been fully considered but they are not persuasive.
The applicant argues that the examiner does not meet the legal standard for inherency in an obviousness rejection.
The applicant argues that the specified property of systemic uptake possessed by particles encompassed by the instant claims is not an inherent property (page 12 of brief). Applicant argues that in vivo data for rats shown on pages 66 and 67 of the specification showed one rat out of five that had an uptake of zero and thus the specified systemic uptake is not necessarily present (page 13 of brief). The applicant argues that the examiner acknowledges that Hanes does not expressly describe all the claimed features and thus reliance on In re Best is flawed (page 14 of remarks). Applicant argues that the examiner fails to demonstrate identical or substantially identical compositions or processes that lead a person of ordinary skill in the art to identify the same scientific principles in Hanes and the instant claims and thus the examiner’s statements are merely conclusory or speculative (page 14 of brief).
The examiner is not persuaded by these arguments. The examiner maintains that structure of the instant claims is obvious from the teachings of Hanes. Specifically, it is obvious to form a particle with a polymer core of poly(hydroxy acids) such as poly(lactic acid), poly(glycolic acid), poly(lactic acid-co-glycolic acid) or mixtures thereof, an anionic protein surface-altering agent and a protein bioactive agent where the zeta potential of the particle is between -100 mV and 10 mV and the particle size is between 100 and 5000 nm. It is known from the instant specification that the uptake depends on the negative zeta potential and bioadhesivity (page 18) and as the same structure of the instant claims is obvious from Hanes, namely particles constructed with negative zeta potential and the highly bioadhesive polylactic acid, the particles will necessarily have the same functional property of system uptake between 10-80%. Even the optional limitation of the molecular weight between 2-10kDa for polylactic acid is obvious as a matter of routine experimentation as detailed in the non-final office action (page 7). Thus, in contrast to the applicant’s assertion that each of the claimed features is not described by Hanes, the examiner maintains that each of the structural features of the claimed particles are obvious from the teachings of Hanes and the limitation of the uptake describes a functional process present in the particles rendered obvious. The examiner notes that mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). "It is not invention to perceive that the product which others had discovered had qualities they failed to detect."); In re Wiseman, 596 F.2d 1019, 1023 [201 USPQ 658] (CCPA 1979) (rejecting the notion that "a structure suggested by the prior art, and, hence, potentially in the possession of the public, is patentable ... because it also possesses an inherent, but hitherto unknown, function which [patentees] claim to have discovered. This is not the law. A patent on such a structure would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art."
Regarding the applicants assertion that the data at pages 66-67 of the specification indicate that the uptake property is not necessarily present, the examiner does not find this persuasive as the data is not clear as to what is presented. The applicant looks to table 7 which provides uptake data for PLA particles in five different rats and notes that one of the rats had an uptake of 0.0% which is outside the claimed range and thus indicates that the property is not necessarily present. The data presented, however, is not clear and is inconclusive in this regard. As a first matter, other than the particles having polylactic acid (PLA) it is not clear what the parameters of the particles were (e.g. particle diameter, zeta potential, molecular weight of the PLA, active used) and how they compare with the instant claims. Second, the presentation of the data in the tables is unclear as to why certain numbers are used and others are not. For instance, part of the uptake calculation presented uses data values from three FTIR peaks at a zero hour control and a 5 hour sample, as shown in Tables 5 and 6 for rat #1. However, these data points are not consistent with the data in tables 3 and 4 where the values for rats 1-5 are presented. For example, the zero time point for rat 1 in table 3 is 0.08871 whereas in table 5 the zero time point is listed as 0.08119. The reason for the discrepancy is not provided and the use of the different values would generate different calculation results. Example calculations are not provided for rats 2-5 but the examiner notes that the peak values for rat 3 (i.e. the rat identified as having 0.0% uptake) were greater after 5 hours (table 4) than at zero hour (table 3), thus indicating uptake present in the rat. Based on these inconsistencies in the data, there is sufficient reason to discount the result in table 7 as evidence against the uptake property being necessarily present. A final reason to not see the data as persuasive is that the functional limitation of the claim is broader than what was tested. The limitation is “the polymeric particles show systemic uptake between 10% and 80% in a mammal” which has no limitation on the time at which the uptake must occur. The examiner notes that the specification on page 62 indicates that “blood samples were also tested at 1 hour, 2 hours, 3 hours, and 4 hours, in addition to the 5 hour time points presented below. However, only the 5 hour time points are presented due to the fact that only at these time points was the polymer detected, while at all other time points nothing was detected.” Thus, the limitation of systemic uptake is not a static feature of the particles that is met upon immediate administration but is instead a property that varies with time. The claims do not require that the uptake is 10-80% after 5 hours but merely that the uptake is 10-80%, which is broad and includes uptake occurring at any point after at administration. The applicant indicates that there is a delay to the uptake, as noted above, where polymer was not detected for the first four hours and there is nothing to suggest that uptake would not continue after 5 hours. Based on this information, instead of assuming that no uptake ever occurs and the uptake truly is 0.0% for rat 3, the more likely conclusion is that the uptake was delayed in this rat but would still exhibit results at further time points commensurate to the other rats tested. Thus the measurement for rat 3 at the 5 hour time point is not persuasive that the functional property of uptake across the broad range of 10-80% is not a necessary consequence of administering the particles rendered obvious over Hanes.
The applicant argues that the examiner fails to explain why a person of ordinary skill in the art would ignore the teachings in the art that polymeric particles with features specified by the claims would have poor systemic uptake.
The applicant notes that Hanes teaches zeta-potentials between -100 mV – 10 mV and that in Fig 8 Hanes tests particles less than -10 mV and greater than -10 mV with and without PEG on their surface (page 16 of brief). The applicant notes that in this example that the particles with zeta potentials less than -10 mV and without PEG on their surface had lower diffusivity than the particles with zeta potentials greater than 10 mV and with PEG and the applicant argues from this that Hanes demonstrates that the most promising polymeric particles have a near neutral surface charge with PEG on their surface and that one or ordinary skill would not then develop the claimed particles based on this example from Hanes (page 16 of brief).
The examiner does not find this persuasive and notes that the rejection with Hanes was made under 35 U.S.C. 103 which requires that “a patent for a claimed invention may not be obtained… if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been prima facie 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.” “A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” KSR, 550 U.S. at ___, 82 USPQ2d at 1397. “[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” Id. Office personnel may also take into account “the inferences and creative steps that a person of ordinary skill in the art would employ.” Id. At, 82 USPQ2d at 1396. While Hanes may not provide a specific embodiment of the instantly claimed invention, the examiner maintains that the invention as claimed is nonetheless made obvious over Hanes et al. The rejection is not based on the modification of a specific embodiment within Hanes and it is not necessary for Hanes to embody the particles in an example in order to render obvious the claimed particles. The claimed features are obvious from the teachings of Hanes as a whole and following the line of reasoning presented by the applicant would require unnecessarily discounting the majority of Hanes’s teachings. Hanes does not draw the same conclusions as the applicant based on the results of Fig 8 and it would not be proper to force their interpretation into the teachings of Hanes. For instance, Hanes does not teach particles with zeta potentials less than -10 mV as unsuitable but rather teaches zeta potentials for the particles may range from -100 mV to 10 mV ([0014]). Additionally, while Hanes does teach PEG as a possible substituent for the particles, Hanes teaches other possible substituents instead of PEG and does not require a substituent such as PEG at all ([0037]). Similarly, Hanes teaches a variety of diffusivities for the particles ([0011]) and particles without PEG and with negative zeta potentials shown in Fig 8 have the desired diffusivity of Hanes (e.g. size 200 nm COOH particles of Fig 8). Again, the examiner does not find the applicants argument persuasive as Hanes does not present the data of Fig 8 as limiting to the teachings and the applicants interpretation would require ignoring all the other features such as zeta potential ([0014]), particle size ([0006]), and polymers ([0147]) that are clearly taught by Hanes as suitable for the invention.
The applicant argues that the examiner disregards guidance provided by the MPEP and legal standards.
The applicant argues that a the MPEP indicates that a preferred species or subgenus different from the claimed species or subgenus may weigh against selecting the claimed species or subgenus and notes that Hanes teaches particles with PEG as a preferred embodiment (pages 17-18 of brief).
The examiner does not find this persuasive. As noted above and in the office action, Hanes teaches each of the claimed features as suitable for the particles and a particular embodiment, even a preferred embodiment, is not to be interpreted as overriding all other teachings encompassed by the art. Merely reciting a preferred embodiment alternative to the instantly claimed compound does teach not away from using the other forms as additionally taught. Furthermore, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). Furthermore, the examiner notes that the claimed features are not undisclosed in Hanes and merely pulled from a genus to reach a conclusion of obviousness, but instead the features are clearly identified. For example, Hanes does not merely teach a broad genus of negative zeta potentials but clearly identifies a suitable range of zeta potentials from -100 mV to 10 mV ([0014]). Other features such as the particle size and polymer are clearly identified within the teachings of Hanes (e.g. [0006], [0147]) and render obvious the instantly claimed features.
The applicant argues that the examiner fails to credibly explain why a skilled artisan would have a reasonable expectation of success in developing the polymeric particles specified by the instant claims.
The applicant looks to ([0039]) which states “substances in need of increased diffusivity may, for example, be hydrophobic, have many hydrogen bond donors or acceptors, or be highly charged” and to Figure 8 with polystyrene-PEG particles having less charge and more diffusivity than polystyrene-COOH particles as evidence that one or ordinary skill would not reasonably expect particles with negative charge and without PEG as being suitable for delivery of an active agent (pages 19-20 of brief).
The examiner does not find this persuasive. The applicant has taken a statement from Hanes with hypothetical scenarios and a single example in Figure 8 and drawn conclusions not taught by Hanes and that would seek to override the clear teachings of Hanes. The examiner notes that the teaching of ([0039]) pointed to by the applicant, speaks generically of substances that may need increased diffusivity but does not provide any direct teachings as to how the particles of Hanes should be formed. Hanes clearly identifies the features that would be suitable for the invention (e.g. ([0006], [0014], [0147]), thereby providing the reasonable expectation of success to one of ordinary skill. Similarly, the single example of Fig 8 using polystyrene particles would not be understood by one of ordinary skill in the art as limiting the teachings of Hanes and the only particle form that would have a reasonable expectation of success. To interpret the teachings of Hanes in this way would require one to disregard all the other teachings of Hanes in favor of a single embodiment, even though Hanes does not present the teaching in this way. While polystyrene-PEG particles may be suitable for the invention, as taught by Hanes, this is not to the exclusion of other particles which are obvious from Hanes, such as having a zeta potential from -100 mV to 10 mV ([0014]) and polymers such as polylactic acid ([0147]). Hypothetical scenarios without clear reduction to practice, as pointed to by the applicant, would not be understood by one of ordinary skill in the art as limiting the features clearly taught by Hanes as suitable for particles of the invention.
The applicant argues that the examiner makes self-contradictory statements on Hanes.
The applicant points to statements by the examiner regarding particles diffusing rapidly through mucus and the use of polylactic acid having a high bioadhesivity as being contradictory (page 21 of brief). The examiner is not persuaded by this as the bioadhesivity of polylactic acid is a feature of the polymer the examiner pointed to, as evidenced by the instant specification, to indicate that the particles would necessarily have the required uptake percentage of the instant claims. Hanes does not present the polylactic acid as having a bioadhesivity incompatible with the particles of the invention but instead clearly teaches polylactic acid as a polymer suitable for the invention (e.g. [0147]). The applicants argument requires turning general statements from Hanes regarding diffusivity into teaching that limits the choice of polymer and zeta potential, in contrast to what is clearly identified and taught by Hanes as suitable for the invention. In other words, Hanes clearly identifies zeta potentials from -100 mV to 10 mV and polymers such as polylactic acid as suitable for the invention and at no point discourages these features in the particles. One of ordinary skill in the art would have a reasonable expectation of success in implementing these features as their inclusion is presented positively in Hanes and they are only ever identified as compatible, not incompatible, for the particles.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Hanes et al. (US 2010/0215580, published 26 Aug 2010) as evidenced by the instant specification as applied to claims 1, 3, 5, 7-10, 12, 15-17, 20, 24, 35 and 36 above and further in view of Lindmark et al. (The Journal of Pharmacology and Experimental Therapeutics, Vol. 275, No. 2, published 25 July 1995).
The teachings of Hanes are described supra. Regarding the surface-altering agent of Hanes, Hanes further teaches that the surface-altering agent may alter the charge or increase the hydrophilicity of the particle, or otherwise promote motility through mucus and may enhance the average rate at which the particles move in or through mucus and Hanes teaches a variety of suitable agents such as anionic proteins and surfactants but does not limit the possible agents to the recited examples ([0026]).
Hanes does not teach the anionic surfactant laureate. This deficiency is made up for in the teachings of Lindmark.
Lindmark teaches that sodium salts of medium chain fatty acids, such as laurate, enhance the absorption of hydrophilic drugs across the intestinal mucosa (see entire document, specifically the abstract).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used sodium laurate as a surface-altering agent in the particles of Hanes. Laurate is known to promote drug absorption across the intestinal mucosa, as taught by Lindmark, and suitable surface-altering agents for the particles are those that promote motility through mucus and enhance the average rate at which the particles move in or through mucus, as taught by Hanes. Thus, one would have a reasonable expectation of success in using laurate as a surface-altering agent as it is known to enhance the absorption of hydrophilic drugs across the intestinal mucosa.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Hanes in view of Lindmark.
Citation of Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The examiner notes Shea et al. (US 2015/0209293) is not relied upon in the above rejection but is pertinent to the applicants current claims as Shea described surface functionalized polymeric particles with negative zeta potentials.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/EDWIN COLEMAN MITCHELL/Examiner, Art Unit 1619
Prosecution Insights