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 .
Response to Amendment
This office action is responsive to the amendment filed on 11/12/2025. As directed by the amendment: claims 1, 9, 17, 24, and 62 have been amended, claims 3, 16, 18, 20-21, 23, 25, 29-32, 34, 36, 38, 40, 45-48, 51-53, 55-60, and 63-69 have been cancelled, and claims 33, 37, and 39 have been withdrawn. Thus, claims 1-2, 4-15, 17, 19, 22, 24, 26-28, 33, 35, 37, 39, 41-44, 49-50, 54, 61-62, and 70 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 10, filed 11/12/2025, with respect to the claim objections have been fully considered and are persuasive. The applicant’s amendments to the claims overcome the minor informalities within the claims. The claim objections have been withdrawn.
Applicant’s arguments, see page 11, filed 11/12/2025, with respect to the USC 112(b) rejections have been fully considered and are persuasive. The applicant’s amendment to the claims overcome the issues of clarity within the claims. The USC 112(b) rejections of claims 9 and 22 have been withdrawn.
Applicant’s arguments, see pages 11-12, filed 11/12/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 as being unpatentable over Sananes et al (US 20190159784 A1), herein referenced to as “Sananes” in view of Baba et al (Characterization of a reversible thermally-actuated polymer-valve: A potential dynamic treatment for congenital diaphragmatic hernia) published in PLOS One on December 27, 2018, herein referenced to as “Baba” and Bhargava et al (Focused ultrasound actuation of shape memory polymers; acoustic-thermoelastic modeling and testing) published in RSC Advances on September 25, 2017, herein referenced to as “Bhargava” have been fully considered and are persuasive.
The applicant has amended claim 1 to further recite “wherein the focused-ultrasound activable actuator comprises a composite material comprising: one or more shape memory polymers; and a first additive comprising metal oxide particles, hollow glass microspheres, non-hollow glass microspheres, or any combination thereof”. The applicant asserts that the combination of references does not teach the new limitation.
The examiner agrees that the combination of references does not explicitly teach: and a first additive comprising metal oxide particles, hollow glass microspheres, non-hollow glass microspheres, or any combination thereof.
Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sananes in view of Baba, Bhargava, and Roberts et al (US 20200093498 A1).
Applicant's arguments, see pages 12-13, filed 11/12/2025, with respect to the rejection(s) of claim(s) 1 under 35 U.S.C. 103 as being unpatentable over Sananes in view of Baba and Bhargava, in regards to their combination have been fully considered but they are not persuasive.
The applicant argues that a person skilled in the art would not have a reasonable expectation of success in combining the cited references.
Specifically, they argue that there is no such reasonable expectation of success for substituting the material of Baba with that of Bhargava in the implantable device of Sanaes.
They argue that Baba describes only an in-vitro feasibility study of a thermo-responsive polymer valve while Bhargava describes focused-ultrasound activation of solid shape-memory-polymer filaments “submerged in water” for a “potential drug delivery system”. In essence, arguing that neither reference demonstrates operability of their systems in tissue or biological systems.
The examiner respectfully disagrees.
Firstly, the research is targeted to introduce these systems into tissue or biological systems as that is explicit goal of research for both Baba (see pages 2-3, Introduction paragraphs, begins with explanation of congenital diaphragmatic hernia (CDH), which is also what Sanaes seek to treat, and the field of art, and page 12, Conclusion paragraph, the polymer-valve units were tested to activate at temperatures slightly above physiological body temperature of 37 degrees Celsius, which are typical activation temperatures in the field of art for any devices that exhibit phase transition for deployment) and Bhargava (pages 45452-45453, Introduction, “Employing high-intensity FU has been researched for biomedical purposes for many years… Studies have been conducted reporting the use of ultrasound in acoustic energy transfer systems and for drug delivery…”). Hence, Baba and Bhargava are based on previous studies to be used in biological systems.
Secondly, in terms of biocompatibility, Baba explicitly teaches that the materials used in their studies are approved for human consumption and applications (page 4, Materials paragraph) and Bhargava teaches that their SMPs “comprise the biodegradability and biocompatibility of SMPs (page 45453, 2nd paragraph).
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.
Claim(s) 1-2, 4-15, 17, 19, 22, 26-28, 35, 41-44, 49-50, 54, 61, 62, and 70 are rejected under 35 U.S.C. 103 as being unpatentable over Sananes et al (US 20190159784 A1), herein referenced to as “Sananes” in view of Baba et al (Characterization of a reversible thermally-actuated polymer-valve: A potential dynamic treatment for congenital diaphragmatic hernia) published in PLOS One on December 27, 2018, herein referenced to as “Baba”, Bhargava et al (Focused ultrasound actuation of shape memory polymers; acoustic-thermoelastic modeling and testing) published in RSC Advances on September 25, 2017, herein referenced to as “Bhargava”, and Roberts et al (US 20200093498 A1), herein referenced to as “Roberts”.
Claim 1
Sananes discloses: An implantable, detachable, and removable medical device 12 (see Figs. 1-8, [0063], implantable in a body, deployable, [0125], expelled from the fetus by the release of pulmonary fluid under pressure) comprising: a therapeutic balloon 12 (see Figs. 1-8, [0063]) configured to perform a therapeutic activity (see [0007] tracheal occlusion and [0015] implant in a body cavity, particularly the trachea of a fetus) inside a living subject; and an activatable actuator 62 (see Figs. 1-8, [0086], an element that occludes the draining orifice 32, which is part of 12) operably connected to the therapeutic balloon 12; wherein the actuator 62 is capable of being activated between a closed state (see Fig. 7) and an open state (see Fig. 8, [0055]) remotely (see [0126]-[0127]); wherein the device 12 is configured to be in an implantation state (see Figs. 1, and 5, [0074]) to facilitate implantation of the device in the living subject (see Figs. 3-5, [0053]), in a therapeutic state (see Figs. 6 and 7, [0054] and [0074]) to facilitate performance of the therapeutic activity (see [0015]), and subsequently in an expulsion state (see Fig. 8, [0055], [0075], and [0099]) to facilitate expulsion of the medical device 12 from the living subject (see [0125]); and wherein the implantation state (see Figs. 1 and 5), therapeutic state (see Fig. 7), and expulsion state (see Fig. 8) are different from each other.
Sananes does not explicitly disclose: a focused-ultrasound activatable actuator; wherein the actuator is capable of being activated capable remotely via a focused ultrasound beam; wherein the focused-ultrasound activatable actuator comprises a composite material comprising: one or more shape memory polymers; and a first additive comprising metal oxide particles, hollow glass microspheres, non-hollow glass microspheres, or any combination thereof.
However, Baba in a similar field of invention teaches an implantable medical device balloon (see Fig. 1, see pages 2-3, 5th and 1st paragraphs, “the primary device utilized, the GVB16 Goldvalve detachable balloon”) with an activatable actuator polymer valve (see Fig. 1, in the open state, the polymer valve is heated to shrink, and when closed it is expanded, see pages 3-5, 5th paragraph, 1st and 4th-6th paragraphs, and 1st paragraph respectively for each page, the valve is a cylinder as it is formed around a cylinder core and then removed to be inserted into the lumen of a balloon implant). Baba further teaches: that the activatable actuator is a thermo-responsive polymer actuator (see page 5, 2nd paragraph).
The substitution for one known element (the activatable actuator as shown in Sananes) for another (thermo-responsive polymer actuator as shown in Baba) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of thermo-responsive polymer actuator shown in Baba would have yielded predictable results, namely, allowing for control of a valve of a balloon with localized temperature change rather than requiring to subject the patient to MRI, thus allowing for a more cost-effective procedure. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82, USPQ2d 1385 (2007).
The combination of Sananes and Baba does not explicitly teach: a focused-ultrasound activatable actuator; wherein the actuator is capable of being activated capable remotely via a focused ultrasound beam; wherein the focused-ultrasound activatable actuator comprises a composite material comprising: one or more shape memory polymers; and a first additive comprising metal oxide particles, hollow glass microspheres, non-hollow glass microspheres, or any combination thereof.
However, Bhargava in a similar field of invention teaches a thermos-responsive polymer actuator (see Fig. 1) for a medical device (see page 45452, 1st paragraph, in the field of medicine, delivery of drugs in a controlled manner). Bhargava further teaches: a focused-ultrasound activatable actuator (see page 45452, abstract, “focused ultrasound (FU)-induced thermal actuation of shape memory polymers (SMPs); wherein the actuator (see page 45452, abstract, “focused ultrasound (FU)-induced thermal actuation of shape memory polymers (SMPs)) is capable of being activated capable remotely via a focused ultrasound beam FU transducer (see page 45452, abstract, “SMP filament submerged in water coupled with the acoustic waves generated by a FU transducer”, see also Fig. 2, FU source is remotely activating the SMP actuator) wherein the focused-ultrasound activatable actuator focused ultrasound (FU)-induced thermal actuation of shape memory polymers (SMPs) comprises a composite material comprising: one or more shape memory polymers (see page 45452, abstract, “focused ultrasound (FU)-induced thermal actuation of shape memory polymers (SMPs))
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sananes and Baba and the substituted thermo-responsive polymer actuator of Baba to incorporate the teachings of Bhargava and have a medical device with the thermo-responsive polymer actuator and have the thermo-responsive polymer that is a focused-ultrasound activatable thermos-responsive polymer. This is due to focused ultrasound (FU)-induced thermal actuated polymer are common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thermo-responsive polymer actuator of Baba as substituted into Sananes to incorporate the teachings of Bhargava and teach the thermo-responsive polymer actuator is a focused-ultrasound activatable actuator; wherein the actuator is capable of being activated capable remotely via a focused ultrasound beam. Motivation for such can be found in Bhargava as focused ultrasound is a more flexible stimuli compared to fixed body heat temperature, does not require magnetic or florescent particle that can compromise the biocompatibility of SMPs, and is a safer and effective trigger to achieve remotely controlled shape recovery in a controlled and selective manner (see page 45453, 2nd paragraph).
The combination of Sananes, Baba, and Bhargava does not explicitly teach: the composite material comprising: and a first additive comprising metal oxide particles, hollow glass microspheres, non-hollow glass microspheres, or any combination thereof.
However, Roberts in a similar field of invention teaches an implantable medical device 2 (see Figs. 1-2, tamponade balloon catheter assembly) with a composite material 19 (see Fig. 2, [0028], polymeric material which 23 is embedded into). Roberts further teaches: and a first additive comprising metal oxide particles (will not be examined here due to being an optional claim limitation), hollow glass microspheres (will not be examined here due to being an optional claim limitation), non-hollow glass microspheres 23 (see Figs. 2-3, [0028], glass beads, which are non-hollow microspheres, as beads are not hollow, are inserted into the polymer material of 19 which is a balloon microcatheter tip, hence “micro”, and Figs. 2-3, they are shown to be spherical), or any combination thereof.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sananes, Baba, and Bhargava to incorporate the teachings of Roberts and teach a composite material of the focused-ultrasound activatable actuator with non-hollow glass microspheres. Motivation for such can be found in Roberts as glass microspheres are echogenic, having echogenic properties, meaning they can better attenuate/intensify ultrasound reflection (see [0028]-[0030]).
Claim 2
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. The combination of Baba and Bhargava teaches: wherein the actuator (cylinder actuator of Baba modified to be a focused-ultrasound activatable actuator) is capable of being activated remotely via a focused ultrasound beam (Bhargava, see page 45452, abstract).
Claim 4
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Fig. 7) comprises the actuator 62 being in the closed state (see Fig. 7, 62 is a closed state, as it is closing the outlet valve) and the expulsion state (see Fig. 8) comprises the actuator 62 being in the open state (see Fig. 8, the valve is opened, hence an open state).
Claim 5
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the implantation state (see Figs. 1 and 5) and therapeutic state (see Fig. 7) are characterized by the actuator 62 being in its closed state (see Figs. 1, 5, and 7, 62 is a closed state, as it is closing the outlet valve); and wherein activation (see [0126]-[0127]) of the actuator 62 from its closed state (see Fig. 7) to its open state (see Fig. 8) activates the expulsion state (see Fig. 8) of the device 12.
Claim 6
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the device is in the implantation state (see Fig. 5, then inflated to Fig. 6/7) when being implanted in the living subject, subsequently in the therapeutic state (Figs. 6-7, after being inflated from Fig. 5) when performing the therapeutic activity in the living subject, and further subsequently in the expulsion state (see Fig. 8, [0054]-[0055], after deployment, the valve is opened to drain the balloon) when being expelled (see [0124]-[0125]) from the living subject.
Claim 7
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Figs. 6-7) is characterized by the therapeutic balloon 12 having a larger volume and/or cross- sectional size (see Fig. 7, [0078], inflated) than the same of the expulsion state (see Fig. 8, [0075], deflated) of the device 12.
Claim 8
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 7, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Figs. 6-7) is characterized by the therapeutic balloon 12 being expanded or inflated (see [0078], inflated) and the expulsion state (see Fig. 8) is characterized by the therapeutic balloon 12 being contracted or deflated (see [0075], deflated).
Claim 9
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the implantation state (see Figs. 1 and 5) is characterized by the medical device 12 comprising an implant-accessory 70 + 72 (see Fig. 5, [0100]) that is operably and detachably connected to the therapeutic balloon 12; wherein the implant-accessory 70 + 72 is capable of providing a fluid (see [0100] and [0103], injection of fluid) into a lumen 32 (see Fig. 1, [0066]) of the therapeutic balloon 12; and wherein the implant accessory 70 + 72 is detachable and removable (see Figs. 5-6, after inflation, 70 + 72 is removed from 12 without deflating it, [0114]-[0118]) without deflating the therapeutic balloon 12 upon detachment and removal of the implant accessory (see [0114]-[0118]).
Claim 10
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 9, see 103 rejection above. Sananes further discloses: wherein the expulsion state (see Fig. 8) is characterized by the medical device 12 being free of and not operably connected to the implant-accessory 70 + 72 (see Fig. 8, 12 is not attached to 70 + 72, [0116] and [0121]-[0126]).
Claim 11
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 9, see 103 rejection above. Sananes further discloses: wherein the implant-accessory facilitates 70 + 72 providing the medical device 12 to a desired region (see [0111]-[0114]) of the living subject and the implant-accessory facilitates converting (see [0111]-[0114]) the device 12 from the implantation state (see Figs. 1 and 5) to the therapeutic state (see Figs. 6-7).
Claim 12
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 11, see 103 rejection above. Sananes further discloses: being configured to be disconnected from the implant-accessory 70 + 72 after the therapeutic state (see Fig. 6) of the device 12 is activated (see [0111]-[0116]).
Claim 13
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 8, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Fig. 6) comprises the therapeutic balloon 12 being inflated with a biologically-benign fluid (see [0081] and [0114], physiological liquid); and wherein the expulsion state (see Fig. 8) comprises the therapeutic balloon 12 being deflated as a result of being mostly free of the biologically-benign fluid (see [0124]-[0125]) or as a result of containing less of the biologically-benign fluid (see [0124]-[0125]) than in the therapeutic state (see Fig. 5).
Claim 14
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 13, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Figs. 6 and 7) comprises the therapeutic balloon 12 remaining inflated substantially only by a fluid pressure of the biologically-benign fluid (see [0114], the fluid inflates by the fluid, [0117]-[0118]) inside the therapeutic balloon 12.
Claim 15
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 13, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Fig. 6) comprises the therapeutic balloon 12 being fluidically sealed (see [0114]-[0118], the actuator keeps the balloon from leaking).
Claim 17
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Bhargava further teaches: wherein the actuator (see page 45452, abstract, “focused ultrasound (FU)-induced thermal actuation of shape memory polymers (SMPs)”) comprises a polymer component shape memory polymers (see page 45452, abstract) capable of absorbing focused ultrasound focused ultrasound (FU) (see page 45452, abstract); wherein one or more characteristics of the polymer component (see 45452, abstract, returning to their permanent or original shape) change as a result of it absorbing the focused ultrasound (see page 45452, abstract); wherein the actuator is activated as a result of the change of the one or more characteristics of the polymer component (see 45452, abstract, temperature and shape changes, see also page 45460, Table 1, changes the modulus of the material based on the phase, see also page 45461 Fig. 7, temperature is raised to Tg which is 350 kelvin/76 Celsius); and wherein the polymer component shape memory polymers comprises a shape change polymer capable of absorbing focused ultrasound (see page 45452, abstract, “focused ultrasound (FU)-induced thermal actuation of shape memory polymers (SMPs)”); wherein the shape change polymer is at least partially heated by absorbing the focused ultrasound as a result of which the polymer component undergoes an ultrasound-induced shape change (see 45452, abstract, “focused ultrasound (FU)-induced thermal actuation of shape memory polymers (SMPs)” and temperature and shape changes, see also page 45460, changes the modulus of the material based on the phase see also page 45461 Fig. 7, temperature is raised to Tg which is 350 kelvin/76 Celsius).
Claim 19
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 17, see 103 rejection above. Bhargava further teaches: wherein the polymer component shape memory polymers is characterized by a component transition temperature (Tcm,trans) Tg (see page 45460, Table 1); wherein the polymer component shape memory polymers or one or more portions thereof undergo the shape change from a temporary shape (see page 45461, Fig. 7, temporary shape) to a permanent shape (see Fig. 7, shape recovery/permanent shape) when the polymer component or said one or more portions thereof are heated to within 35 °C of Tcm,trans (see Fig. 7, temperatures of 350 – 316 kelvin are within 35 degrees Celsius of 72 degrees Celsius) or a temperature approximately equal to or greater than Tcm,trans (see Fig. 7, temperatures of 350-391 are greater than Tg); wherein Tcm,trans Tg is selected from the range of 40 °C to 100 °C (see Table 1, Tg is 72 degrees Celsius, hence between 40-100).
Claim 22
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 17, see 103 rejection above. Bhargava further teaches: wherein the ultrasound- induced shape change (see Fig. 7) occurs as a result of exposure of the composite material or the one or more portions thereof to ultrasound (see abstract) characterized by frequencies selected from the range of approximately 300 kHz to approximately 3 MHz 0.5 MHz (see Fig. 9, page 45462, 5th paragraph) and 1.5 MHz (see Fig. 14, page 45463, 1st paragraph); and wherein the polymer component is an ultrasound- absorbing material characterized by an ultrasound attenuation coefficient selected from the range of 0.05 dB/mm to 10 dB/mm (see Table 2, 82.5 (dB MHz-1 m-1 is the ᾱ; α = ᾱfb; α is the ultrasound attenuation coefficient, f is the frequency so when calculated and converted to db/mm, it is 0.0825 db/mm, which is between 0.05 db/mm to 10 dB/mm).
The combination of Sananes, Baba, and Bhargava does not explicitly teach: and an energy intensity selected from the range of approximately 1 W/cm2 to approximately 3 W/cm2;
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Sananes, Baba, Bhargava, and Roberts to have and an energy intensity selected from the range of approximately 1 W/cm2 to approximately 3 W/cm2 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Sananes, Baba, and Bhargava would not operate differently with and an energy intensity selected from the range of approximately 1 W/cm2 to approximately 3 W/cm2. Further, applicant places no criticality on the range claimed, as larger ranges for an energy intensity are recited of 0.1 W/cm2 to 100 W/ cm2. As such, the smaller range is not critical as energy intensity levels outside of the range allow the device to function.
Claim 26
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 17, see 103 rejection above. Baba further teaches: wherein the actuator polymer valve is a valve polymer valve (see Fig. 1, in the open state, the polymer valve is heated to shrink, and when closed it is expanded, see pages 3-5, 5th paragraph, 1st and 4th-6th paragraphs, and 1st paragraph respectively for each page, the valve is a cylinder as it is formed around a cylinder core and then removed to be inserted into the lumen of a balloon implant) for retaining a biologically-benign fluid caprine amniotic fluid (see page 1, 1st paragraph under methods) in the therapeutic balloon balloon or for releasing a biologically-benign fluid from the therapeutic balloon (see page 1, 1st paragraph under methods).
Claim 27
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 26, see 103 rejection above. Baba further teaches: wherein the open state (see Fig. 1, open state fluid flows) of the actuator polymer valve is configured to allow the biologically-benign fluid caprine amniotic fluid to pass therethrough and the closed state (see Fig. 1, closed) of the actuator polymer valve is configured to block passage (see Fig. 1) of the biologically- benign fluid caprine amniotic fluid therethrough.
Claim 28
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 26, see 103 rejection above. Baba further teaches: wherein the actuator polymer valve comprises a fluid-escape conduit balloon lumen in which the polymer valve is inserted (see pages 3-4, 5th paragraph and 1st paragraph respectively) and the polymer component is a plug (see Fig. 1, in the open state, the polymer valve is heated to shrink, and when closed it is expanded, see pages 3-5, 5th paragraph, 1st and 4th-6th paragraphs, and 1st paragraph respectively for each page, the valve is a cylinder as it is formed around a cylinder core and then removed to be inserted into the lumen of a balloon implant); wherein the closed state (see Fig. 1, see pages 3-4, 5th paragraph and 1st paragraph respectively) of the actuator polymer valve is characterized by the plug the cylinder of the polymer valve blocking fluid flow through the fluid-escape conduit (see pages 3-4, 5th paragraph and 1st paragraph respectively), thereby retaining the biologically-benign fluid in the therapeutic balloon (see Fig. 1).
The combination of Sananes, Baba, and Bhargava teaches: and wherein the therapeutic state comprises the actuator being in the closed state (Sananes and Baba, the actuator is modified to be the polymer valve, and it remains closed in the therapeutic state while being inflated to occlude the trachea); and wherein the ultrasound-induced shape change of the polymer component activates the open state of the actuator (Sananes, Baba, and Bhargava, the actuator is modified to be made of a ultrasound thermoplastic polymer and the use of ultrasound heats the polymer component to activate it into the open state as shown in Baba).
Claim 35
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 28, see 103 rejection above. The combination of Baba and Bhargava further teaches: wherein the ultrasound- induced shape change (Bhargava modifies Baba to be ultrasound actuatable, retaining Baba’s shape which is a cylinder that decreases in the cross-section dimension/diameter, see Fig. 1) is a decrease (see Fig. 1, the cylinder decreases in a cross-sectional dimension) in cross-sectional dimension of the plug the cylinder that comprises the polymer valve within the balloon lumen from at least equal to or greater than a diameter of the fluid-escape conduit the balloon lumen (see Fig. 1) to less than the diameter of the fluid-escape conduit (see Fig. 1).
Claim 41
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 27, see 103 rejection above. The combination of Sananes and Baba teaches: wherein the actuator and the polymer component thereof are configured to remain physically connected to or a part of the medical device in the implantation state, in the therapeutic state, and in the expulsion state (Sananes in Figs. 1, 5, 6, and 8, the three states, that the actuator remains physically connected to/within/is a part of the medical device, which Baba changes the expulsion state to remain physically connected, the actuator shrinks to let fluid out rather than removed from the channel and further into the device).
Claim 42
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Fig. 6) and expulsion state (see Fig. 8) are characterized by the device 12 being free of and physically disconnected from any component that is at least partially external to the living subject (see Figs. 6 and 8, [0115], the physician detaches the balloon and leaves it in the patient, and removes any external extending device).
Claim 43
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: being configured to remain implanted in the living subject in the therapeutic state for at least 12 hours.
The language, " being configured to remain implanted in the living subject in the therapeutic state for at least 12 hours," merely recites an intended use of the apparatus. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Sananes meets the structural limitations of the claim, and is capable of remaining in the therapeutic state for at least 12 hours within the living subject as the balloon remains inflated as long as the outlet valve isn’t opened (see [0117]).
Claim 44
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the therapeutic state (see Figs. 6-7) is characterized by the therapeutic balloon 12 having an inflated diameter maximum transverse extension Et (see Fig. 7, [0078]) selected from the range of 6 mm to 12 mm (see [0078], between 5 mm and 9 mm, a extension of 7 mm for example is between 6 mm and 12 mm); wherein the therapeutic state (see Figs. 6-7) is characterized by the therapeutic balloon 12 having a length the length (see [0079]) selected from the range of 10 mm to 30 mm (see [0079], between 15 mm and 25 mm); and wherein the expulsion state (see Fig. 8) is characterized by the therapeutic balloon 12 having a deflated diameter (see [0075]) selected from the range of 0.5 mm to 2 mm (see [0075], between 1 and 1.5 mm).
Claim 49
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the device 2 is configured to be self-expelled via a natural bodily process of the living subject and does not require an invasive removal procedure (see [0125], the balloon 12 is then capable of being expelled from the fetus by the release of pulmonary fluid under pressure).
Claim 50
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: wherein the device 12 is an occlusion device 12 (see [0118], occluded) and the therapeutic activity is an occlusion (see [0118]).
Claim 54
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 50, see 103 rejection above. Sananes further discloses: wherein the living subject is an infant or a fetus (see [0118], fetus, [0125], few days after birth, hence then an infant)
Claim 61
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Sananes further discloses: being free of electronics, a sensor, a battery, electrical wires, or any combination thereof (see Figs. 1-8, the device does not have electronics, a sensor, a battery, or electrical wires).
Claim 62
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of any of one of the preceding claims (see 103 rejections above). Sananes further discloses: a method for treating a condition in a living subject (see Figs. 1-8, [0118]), the method comprising: implanting the medical device with the aid of an implant-accessory 16 + 70 + 72 (see Fig. 5, [0100]); filling the therapeutic balloon 12 with a biologically-benign fluid (see [0081] and [0114], physiological liquid) via the implant- accessory 16 + 70 + 72; and detaching (see Figs. 5-6, [0115])) the implant-accessory 16 + 70 + 72 from the medical device 12.
Claim 70
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 1, see 103 rejection above. Baba further teaches: wherein the actuator comprises [a plug that is ejected from the valve (will not be examined due to being directed to a non-elected species, see restriction above)], a cylinder polymer valve is a cylinder that contracts to open the valve (see Fig. 1, in the open state, the polymer valve is heated to shrink, and when closed it is expanded, see pages 3-5, 5th paragraph, 1st and 4th-6th paragraphs, and 1st paragraph respectively for each page, the valve is a cylinder as it is formed around a cylinder core and then removed to be inserted into the lumen of a balloon implant) that contracts to open the valve polymer valve + balloon lumen, [a ring that compresses to form a flat membrane (will not be examined due to being directed to a non-elected species, see restriction above)], [or a flat member that folds (will not be examined due to being directed to a non-elected species, see restriction above)].
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sananes in view of Baba, Bhargava, and Roberts as applied to claim 17 above, and further in view of Mazurek-Budzyńska et al (Shape Memory Polymers, 15, found in Functional Polymers, online June 8th, 2019), herein referenced to as “Mazurek-Budzyńska”.
Claim 24
The combination of Sananes, Baba, Bhargava, and Roberts teaches: The medical device of claim 17, see 103 rejection above. The combination of Sananes, Baba, and Bhargava does not explicitly teach: wherein shape memory polymer comprises polycyclooctene (PCOE), polycaprolactone (PCL), poly(lactic acid)(PLA), poly(lactic-co-glycolic acid)(PLGA), polyethylene (PE), polypropylene (PP), and thermoplastic polyurethane (TPU), or any combination thereof; andwherein the shape memory polymer comprises a crosslinking moiety derived from a crosslinking precursor selected from the group consisting of: a di(4-cyclooctenol) succinate, dicumyl peroxide (DCP), dibenzoyl peroxide (DBzP), di(tert-butyl) peroxide, and any combination thereof.
However, Mazurek-Budzyńska in a similar field of invention teaches shape memory polymers (see pages 605-654) for use in medical devices (see page 606, biomedical applications). Mazurek-Budzyńska further teaches: wherein shape memory polymer shape memory polymers (see pages 605-654) comprises polycyclooctene (PCOE) (will not be examined due to being an optional claim limitation), polycaprolactone (PCL) PCL (see page 607), poly(lactic acid)(PLA) PLA (see page 607), poly(lactic-co-glycolic acid)(PLGA) (will not be examined due to being an optional claim limitation), polyethylene (PE) polyethylene (see page 640, paragraph under 5.2.1), polypropylene (PP) (will not be examined due to being an optional claim limitation), and thermoplastic polyurethane (TPU) thermoset polyurethane (see page 644, 1st paragraph), or any combination thereof; and wherein the shape memory polymer shape memory polymer comprises a crosslinking moiety crosslinked (see page 628) derived from a crosslinking precursor crosslinked with (see page 628) selected from the group consisting of: a di(4-cyclooctenol) succinate (will not be examined due to being an optional claim limitation), dicumyl peroxide (DCP) (see page 628, dicumylperoxide), dibenzoyl peroxide (DBzP) (will not be examined due to being an optional claim limitation), di(tert-butyl) peroxide (will not be examined due to being an optional claim limitation), and any combination thereof.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Sananes, Baba, Bhargava, and Roberts to incorporate the teachings of Mazurek-Budzyńska and have the shape memory polymer with a polycaprolactone (PCL), poly(lactic acid)(PLA), polyethylene (PE), or thermoplastic polyurethane (TPU) and comprises a crosslinking moiety derived from a crosslinking precursor consisting of dicumyl peroxide (DCP). This is due to polycaprolactone (PCL), poly(lactic acid)(PLA), polyethylene (PE), or thermoplastic polyurethane (TPU) and dicumyl peroxide (DCP) are common in the art, thus it would be obvious to combine. See in re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960) (2100).
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771