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 .
Summary
Claims 1-17 are pending in this office action. Claims 16-17 are new. All pending claims are under examination in this application.
Priority
The current application was filed on December 21, 2023 is a 371 of PCT/EP2021/066751 filed June 21, 2021.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kohane et al. (US2013/0041311A1) in view of Zhao et al. (WO2010/093528A2), Villanueva et al. (WO2021/097224A1, published in May 2021), Mooney et al. (WO2016/161372A1), and Hunt et al. (US2020/0353292A1, published in November 2020).
[The Examiner is going to introduce each new reference and then combine them where appropriate to reject the instant claims.]
1. Kohane et al.
Kohane et al. is considered the closest prior art as it teaches methods, devices, and systems for on-demand ultrasound-triggered drug delivery (see title). Furthermore, Kohane et al. disclose injectable or implantable drug delivery systems providing on-demand ultrasound-triggered drug release and methods for controlling the release of drug in a patient are provided herein. The on-demand drug delivery systems contain a drug depot, and a drug encapsulated in an encapsulating material, where the encapsulating material is different from the depot. In the preferred embodiment, the depot also contains microbubbles that encapsulate one or more gases. The
microbubbles enhance the drug release when ultrasound is applied compared to the same system in the absence of microbubbles. In a preferred embodiment, the drug delivery system, contains an encapsulating material, preferably liposomes,
a drug to be delivered, microbubbles, and at least two hydrogel-forming precursor components. Following injection or implantation, the patient can control the time, location and dosage released by administering ultrasound (see abstract).
2. Zhao et al.
Zhao et al. teach on-demand and reversible drug release by external cue (see title). Also, Zhao et al. disclose that the invention provides a method to release drugs from a polymer matrix upon demand without degrading the matrix. By applying ultrasound to a self-healable polymer matrix in physiological environment, compounds of both low-molecular and high-molecular weights encapsulated in the matrix are delivered at controlled rates, while the integrity and stiffness of the matrix are unaffected (see abstract).
3. Villanueva et al.
Villanueva et al. teach cardioprotective microbubble-liposomal drug complexes (see title). In addition, Villanueva et al. disclose that the presently described drug-loaded liposomal conjugated to polymer microbubbles showed: i) increased tumor drug concentration; ii) reduced tumor growth; and ii) increased survival time in a mouse cancer model when exposed to concurrent high and low acoustic pressure ultrasonic pulses as compared to individual high or low acoustic pressure ultrasonic pulses. Notably, when unconjugated drug-loaded liposome were administered with free microbubbles and exposed to concurrent high and low acoustic pressure ultrasonic pulses, a superior tumor growth inhibition was also seen. Three weeks after treatments, DoxLPX+US group showed significantly better left ventricular function indices from echocardiography imaging than the free Dox group. Clinical methods using these liposomal conjugated microbubbles permit an increased therapeutic drug delivery and improved safety profile, respectively due to enhanced, preferential drug accumulation in target tumor tissue and simultaneously reduced drug delivery to non-target tissue (see abstract).
4. Mooney et al.
Mooney et al. teach immunoconjugates for programming or reprogramming of cells (see title). In addition, Mooney et al. disclose that the conjugate compositions and methods are useful to elicit/augment an immune response to a tumor or microbial infection or to reduce the severity of autoimmunity, chronic inflammation, allergy, asthma, periodontal disease, and transplant rejection (see abstract).
5. Hunt et al.
Hunt et al. teach automatically steering and focusing therapeutic ultrasound systems (see title). In addition, Hunt et al. disclose a system for therapeutic ultrasound includes one or more ultrasound transducer modules that are configured to generate ultrasound waves at a first power level and at a second power level, the first and second power levels being different and the second power level being sufficient to provide a therapeutic effect for a living subject, and an electronic controller in communication with the one or more ultrasound transducer modules, the electronic controller being programmed to cause the one or more ultrasound transducer modules to generate a first ultrasound wave at the first power level and detect a reflected ultrasound wave from the subject in response to the first ultrasound wave, determine a location of a target within the subject based on the detected reflected ultrasound wave, and, after determining the location of the target, generate a second ultrasound wave at the second power level focused at the target (see abstract).
Combination of Kohane et al., Zhao et al., and Villanueva et al.
Regarding instant claim 1, Kohane et al., Zhao et al., and Villanueva et al. teach a composition comprising a matrix and a carrier encapsulating a therapeutic compound. The necessary citations of Kohane et al., Zhao et al., and Villanueva et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Kohane et al., Zhao et al., and Villanueva et al. Citations
A composition comprising a matrix and a carrier encapsulating a therapeutic compound,
Kohane et al. discloses a drug delivery system which is an injectable, multi-component system for providing on-demand, ultrasound-triggered drug release, containing an encapsulating material, preferably liposomes, microbubbles and a hydrogel (see title and abstract within Kohane et al).
In use, the liposomes carry the drugs and prevent their premature release. The hydrogel can be an alginate (see paragraph [0035] within Kohane et al). Alginate can be ionically cross-linked with divalent cations, in water, at room temperature, to form a hydrogel matrix (see paragraph [0038] within Kohane et al). The preferred cations for cross-linking of the polymers with acidic side groups to form a hydrogel are divalent and trivalent cations such as copper, calcium, aluminum, magnesium, strontium, barium (see paragraph [0044] within Kohane et al.). The overall charge for the liposome may be neutral, positive or negative. Preferably the overall charge for the liposome is neutral or the same as the charge of the drug to be encapsulated, if the drug has an overall charge (see paragraph [0069]) within Kohane et al.). A long list of drugs to be delivered is disclosed (see paragraphs [0120-0149] within Kohane et al). Liposomes were prepared according to the method (see paragraph [0180] within Kohane et al.) by modified thin lipid film hydration: DSPC:DSPG:cholesterol, negatively charged, DSPC:DODAB:cholesterol, positively charged, (molar ratio 3:1:2) and DSPC:cholesterol, neutral, (molar ratio 4:2). DextranCHO/CMC-ADH hydrogel was prepared according to the method disclosed (see paragraphs [0192-0197] within Kohane et al).
wherein the matrix is physically cross-linked and reversibly destabilizes without cavitation under an ultrasound stimulus to release the therapeutic compound without denaturation of the therapeutic compound
Kohane et al. disclose the microbubbles enhance the drug-release and the hydrogel maintains both the encapsulating materials and the microbubbles in close proximity to each other and in a relatively constrained location so that they can affect release when ultrasound is applied (see Figure 1; also see paragraph [0009] within Kohane et al). The encapsulating material will open up, thereby releasing the drug into the drug depot, which will erode and/or have pores with larger openings following ultrasound application. Then the drug depot will stop releasing drug when the ultrasound pulse is stopped (see paragraph [0167] within Kohane et al.).
Furthermore, Kohane et al. disclose the physical cross-linking of polyphosphazenes with cations such as Ca2+ or Al3+ (see paragraph [0040] within Kohane et al.). Also, see the physical cross-linking of alginate above within Kohane et al.
Kohane et al. does not disclose wherein the matrix is reversibly stabilized without cavitation.
However, Zhao et al. is also in the art of using ultrasound to release a therapeutic within a physically cross-linked matrix (see paragraphs [0029-0030] within Zhao et al.) where the matrix is reversibly stabilized. Zhao et al. disclose a method for releasing a bioactive agent on demand in response to an external cue (ultrasound), the method comprising providing a physiologically acceptable self-healing polymer matrix comprising the bioactive agent and inducing cavitation in the polymer matrix via ultrasound to release the drug (see paragraph [0009] within Zhao et al.).
The Examiner does acknowledge that cavitations are formed to release the bioactive agent, but the use of a self-healing matrix allows a skilled artisan (POSITA; person of ordinary skill in the art) to arrive at the same endpoint as disclosed within the instant application.
Additionally, the use of higher frequencies alongside low acoustic intensities would support ultrasound exposure without cavitation (see PTO-892 NPL U-W).
wherein the ultrasound stimulus comprises: (a) a range from about 0.5 MHz to about 15 MHz; (b) a peak-to-peak acoustic pressure between about 1 MPa and about 8 MPa; and (c) a duty cycle between about 1% and about 25%.
Kohane et al. disclose an ultrasound frequency of 20kHz (see paragraphs [0246-0247] within Kohane et al.).
Zhao et al. disclose an ultrasound frequency range of about 20KHz to about 1MHz (see claim 10 within Zhao et al.).
Neither Kohane et al. nor Zhao et al. disclose the peak-to-peak acoustic pressure and a duty cycle instant claim 1 limitations.
However, Villanueva et al. is also in the field of using ultrasound to release an active agent and meets the instant application ultrasound parameters:
peak-to-peak acoustic pressure of about 1 MPa (see page 20, line 10 within Villanueva et al.).
a duty cycle between about 1% and about 25% (see page 37, line 10 within Villanueva et al.).
Regarding instant claims 3-4 and 10, Kohane et al., Zhao et al., and Villanueva et al. teach wherein the matrix comprises an alginate hydrogel comprising the therapeutic compound, the alginate hydrogel being configured to release the therapeutic compound under an ultrasound stimulus. Please see the discussion and citation within instant claim 1 (ultrasound parameters). This would apply directly to a method for activating the drug release of the composition described within Table I. By exposing the composition (wound dressing) to ultrasound stimulus the therapeutic agent is released.
Regarding instant claims 5 and 17, Kohane et al., Zhao et al., and Villanueva et al. teach wherein the alginate hydrogel is selected from the group comprising calcium alginate, magnesium alginate, strontium alginate and barium alginate hydrogel. Kohane et al. disclose polysaccharides can also be cross-linked to form a water-insoluble network. For many polysaccharides, this can be accomplished by reaction with calcium salts or multivalent cations which cross-link the main polymer chains. Pectin, alginate, dextran, amylase and guar gum are subject to crosslinking in the presence of multivalent cations. Complexes between oppositely charged polysaccharides can also be formed; pectin and chitosan, for example, can be complexed via electrostatic interactions (see paragraph [0085] within Kohane et al.). Therefore, a skilled artisan (POSITA; person having ordinary skill in the art) would use this disclosure and purchase the commercially available calcium alginate.
Regarding instant claim 6, Kohane et al., Zhao et al., and Villanueva et al. teach wherein the therapeutic compound is a neutrally charged compound. Kohane et al. disclose one or more drugs, i .e. pharmaceutically active agents, are encapsulated in the encapsulating material. Suitable classes of active agents include, but are not limited to, antibiotic agents, antimicrobial agents, anti-acne agents, antibacterial agents, antifungal agents, antiviral agents, steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, anesthetic agents, antipruriginous agents, antiprotozoal agents, anti-oxidants, antihistamines, vitamins, and hormones (see paragraph [0121] within Kohane et al.). A skilled artisan (POSITA) would select a neutrally charged compound from this extensive list of drugs.
Regarding instant claims 7 and 11, Kohane et al., Zhao et al., and Villanueva et al. teach wherein the ultrasound stimulus is ranging from about 1 MHz to about 3.5 MHz. Villanueva et al. disclose the combined ultrasound wave has a frequency selected from the group consisting of 0.5 MHz to 1.0 MHZ, 0.75 MHz to 1.25 MHz, 0.9 MHz to 1.1 MHz, 1.0 MHz to 10.0 MHz, and 1.0 MHz (see pages 2 and 3, lines (2) 30-31 (3) 1 within Villanueva et al.).
Villanueva et al. disclose the release of a therapeutic agent encapsulated by liposomes conjugated to polymer microbubbles and released by ultrasound (see page 11, lines 21-31 and page 12, lines 1-14 within Villanueva et al.).
Regarding instant claims 8 and 12, Kohane et al., Zhao et al., and Villanueva et al. teach wherein the peak-to-peak acoustic pressure of the ultrasound stimulus is comprised between about 2 and about 5 MPa. Villanueva et al. disclose the US (ultrasound) pulse is a high acoustic pressure US (ultrasound) pulse (~1 MPa) (see page 20, line 10 within Villanueva et al.). Villanueva et al. is outside the range of peak-to-peak acoustic pressure by ultrasound stimulus. The self-healing matrix within Zhao et al. disclosed within instant claim 1 would allow for higher acoustic pressures such as 4 MPa (see PTO-892 NPL W; page 193701-2, right column, paragraph 3).
Therefore, a skilled artisan (POSITA) would adjust the threshold of the peak-to-peak acoustic pressure of the ultrasound stimulus.
Regarding instant claim 13, Kohane et al., Zhao et al., and Villanueva et al. teach wherein the duty cycle of ultrasound is comprised between about 5% and about 20%. Villanueva et al. disclose that the overall duty cycle was 10% (see page 37, line 10 within Villanueva et al.).
Combination of Kohane et al., Zhao et al., Villanueva et al., and Mooney et al.
Regarding instant claim 2, Kohane et al., Zhao et al., Villanueva et al., and Mooney et al. teach wherein the matrix forms a net having a pore size comprised between about 1 nm to about 15 nm. Mooney et al. disclose the pore size is less than about 10 nm…(see page 92, paragraph 4 within Mooney et al.).
Mooney et al. disclose the use of an alginate hydrogel (see page 15, paragraph 2 within Mooney et al.). Furthermore, Mooney et al. disclose the timed pDNA release with ultrasound (see page 28, paragraph 1 within Mooney et al.).
Therefore, a skilled artisan (POSITA) would combine the teachings of Kohane et al. and Mooney et al. under routine experimental conditions due to the disclosed overlap in the two references.
Regarding instant claims 9 and 15, Kohane et al., Zhao et al., Villanueva et al., and Mooney et al. teach a wound dressing comprising a composition according to instant claim 1. Mooney et al. disclose that the compositions and methods are also useful in wound healing, e.g., to treat smoldering wounds (slow healing), thereby altering the immune system toward healing and resolution of the wound. [The Examiner is relying on the fact that smoldering wounds are a form of chronic wounds (see PTO-892 NPL U; NF)].
Regarding instant claim 16, Kohane et al., Zhao et al., Villanueva et al., and Mooney et al. teach a method of treating a chronic wound, the method comprising: applying to the chronic wound a wound dressing according to claim 9; and applying ultrasound stimulus. Please see the discussions and citations within instant claims 1 and 9 for the necessary rejection text.
Combination of Kohane et al., Zhao et al., Villanueva et al., and Hunt et al.
Regarding instant claim 14, Kohane et al., Zhao et al., Villanueva et al., and Hunt et al. wherein the ultrasound beam is an unfocused ultrasound beam. Hunt et al. disclose the use of an unfocused ultrasound beam.
Hunt et al. disclose the use of a therapeutic ultrasound machine (see claims 1-20 within Hunt et al.). The use of a focused and unfocused ultrasound beam would allow a skilled artisan (POSITA) to expand the ultrasound therapy available for a subject.
Analogous Art
The Kohane et al., Zhao et al., Villanueva et al., Mooney et al., and Hunt et al. references are directed to the same field of endeavor as the instant claims, that is, a composition comprising a matrix and a carrier encapsulating a therapeutic compound, wherein the matrix is configured to release the therapeutic compound under an ultrasound stimulus.
Obviousness
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 modify the ultrasound-triggered drug delivery system disclosed by Kohane et al. using the teachings of Zhao et al., Villanueva et al., Mooney et al., and Hunt et al. to incorporate the necessary claim limitations.
The Kohane et al., Zhao et al., Villanueva et al., Mooney et al., and Hunt et al. references all have considerable overlap with the use of ultrasound to coordinate the release of a therapeutic agent. Therefore, a skilled artisan (POSITA) would be motivated to consult these citations.
Starting with Kohane et al., the skilled person only had to try the necessary claim limitations disclosed by Zhao et al., Villanueva et al., Mooney et al., and Hunt et al. The combination of Kohane et al., Zhao et al., Villanueva et al., Mooney et al., and Hunt et al. would allow one to arrive at the present application without employing inventive skill. This combination of the ultrasound-triggered drug delivery system taught by Kohane et al. along with the use of the necessary claim limitations taught by Zhao et al., Villanueva et al., Mooney et al., and Hunt et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
It would have only required routine experimentation to modify the ultrasound-triggered drug delivery system disclosed by Kohane et al. with the use of the necessary claim limitations taught by Zhao et al., Villanueva et al., Mooney et al., and Hunt et al. This combined modification would have led to an enhanced ultrasound-triggered drug delivery system that would be beneficial for patients.
In the context of instant method claims 10-16 the desired purpose defines an effect that arises from and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition according to the prior art, and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Response to Arguments
Applicant's arguments filed April 16, 2026 have been fully considered but they are not persuasive.
The instant claim amendments were sufficient to address the claim objections, 35 U.S.C. §112(b) rejections, the 35 U.S.C. §101 rejection, and the 35 U.S.C. §102 rejection. Furthermore, the objections to the drawings have been addressed by replacements. Therefore, they are all withdrawn from the non-final office action dated December 17, 2025.
The amendments did necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that a prima facie case for obviousness has not been established by the Examiner.
Examiner’s Rebuttal: The Examiner has successfully mapped all of the instant claim limitations to the prior art. All references are analogous art.
In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. The examiner must determine whether a reference is analogous art to the claimed invention when analyzing the obviousness of the subject matter under examination. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023) [see M.P.E.P. 2141.01(a)].
Below is an alternative obviousness analysis for the present application:
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the ultrasound-triggered drug delivery disclosed by Kohane et al., using the teachings of Zhao et al., Villanueva et al., Mooney et al. and Hunt et al. in order to arrive at the subject matter of the instant claims.
The Kohane et al., Zhao et al., Villanueva et al., Mooney et al. and Hunt et al. references all have considerable overlap in the ultrasound stimulus arts. In this instance, Kohane et al. and Zhao et al. supply the template for the ultrasound-triggered drug delivery from a physically cross-linked matrix, Villanueva et al. supplies the required ultrasound parameters, Mooney et al. supplies the claim-specific pore size and wound healing application, both within ultrasound therapy, while Hunt et al. supplies the support for use of the unfocused ultrasound beam. All references are directed to the ultrasound stimulus arts and therefore constitute analogous art under MPEP §2141.01(a). A POSITA would have reasonably consulted the five references when seeking to develop an enhanced ultrasound-triggered drug delivery from a physically cross-linked matrix.
Given these teachings, a POSITA would have been motivated to combine the ultrasound-triggered drug delivery from a physically cross-linked matrix as disclosed within Kohane et al. and Zhao et al., the required ultrasound parameters taught by Villanueva et al., the claim-specific pore size and wound healing application within ultrasound therapy disclosed by Mooney et al., and the support for the unfocused ultrasound beam disclosed by Hunt et al.
The modification constitutes a simple substitution of one known element for another to obtain a predictable result [MPEP §2143(I)(B)].
The combination represents the use of a known technique to improve a similar device in the same way [MPEP §2143(I)(C)].
The art provides a finite number of identified, predictable solutions, and the POSITA would have pursued the claimed configuration with a reasonable expectation of success [MPEP §2143(I)(E); KSR].
The combination of the ultrasound-triggered drug delivery taught by Kohane et al. along with the use of the necessary claim limitations taught by Zhao et al., Villanueva et al., Mooney et al. and Hunt et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
Furthermore, the additional claim limitations taught by Zhao et al., Villanueva et al., Mooney et al. and Hunt et al. would have been viewed by a POSITA as routine design optimizations or known modifications for ultrasound-triggered drug delivery from a physically cross-linked matrix. The motivation for doing so would have been to develop an enhanced drug delivery system triggered by ultrasound stimulus. Implementing these features in Kohane et al.’s ultrasound-triggered drug delivery would not require more than ordinary skill or routine experimentation.
Accordingly, the combination of Kohane et al., Zhao et al., Villanueva et al., Mooney et al. and Hunt et al. provides all the elements of the claimed invention. The resulting enhanced ultrasound-triggered drug delivery from a physically cross-linked matrix, constitutes no more than the predictable outcome of combining familiar prior art components, and therefore the claimed subject matter would have been obvious to a POSITA prior to the effective filing date of the invention.
Applicant Argument: The Applicant argues that the Examiner used impermissible hindsight reasoning to construct the 35 U.S.C. §103 rejection.
Examiner’s Rebuttal: The Examiner respectfully disagrees. However, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight [or piece-meal reasoning.] But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).]
Applicant Argument: The Applicant argues that the surprisingly result of the claimed characteristics that the ultrasound stimulus allow the release of the cargo without putting the patient at risk of harm or destroying the matrix puts makes the instant application unique over the prior art.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (Claims directed to a method of effecting analgesia without producing physical dependence by administering the levo isomer of a compound having a certain chemical structure were rejected as obvious over the prior art. Evidence that the compound was unexpectedly nonaddictive was sufficient to overcome the obviousness rejection. Although the compound also had the expected result of potent analgesia, there was evidence of record showing that the goal of research in this area was to produce an analgesic compound which was nonaddictive, enhancing the evidentiary value of the showing of nonaddictiveness as an indicium of nonobviousness.). [see M.P.E.P. 716.02(c)]. In this instance, the prior art of record is stronger than the unexpected results.
Applicant Argument: The Applicant argues that the secondary references do not teach every aspect of the claimed invention.
Examiner’s Rebuttal: The Examiner is relying on the combination of all the 35 U.S.C §103 to teach each and every instant claim limitation. The secondary references are not required to teach every instant claim limitation.
Applicant Argument: The Applicant argues the instant claim limitation where the matrix undergoes a non-destructive, reversible, destabilization is not taught by the art of record.
Examiner’s Rebuttal: The Examiner has found the Zhao et al. reference to address this instant claim limitation.
Zhao et al. is also in the art of using ultrasound to release a therapeutic within a physically cross-linked matrix (see paragraphs [0029-0030] within Zhao et al.) where the matrix is reversibly stabilized. Zhao et al. disclose a method for releasing a bioactive agent on demand in response to an external cue (ultrasound), the method comprising providing a physiologically acceptable self-healing polymer matrix comprising the bioactive agent and inducing cavitation in the polymer matrix via ultrasound to release the drug (see paragraph [0009] within Zhao et al.).
The Examiner does acknowledge that cavitations are formed to release the bioactive agent, but the use of a self-healing matrix allows a skilled artisan (POSITA; person of ordinary skill in the art) to arrive at the same endpoint as disclosed within the instant application.
Additionally, the use of higher frequencies alongside low acoustic intensities would support ultrasound exposure without cavitation (see PTO-892 NPL U-W).
Thus, the 35 U.S.C. §103 rejection for instant claims 1-17 is maintained.
Conclusion
No claims are allowed.
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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