DETAILED ACTION
Claims 1-5, 44-46 and 52-57 are currently pending and under examination.
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 .
Withdrawn Rejections
The prior rejection of claims 54-57 are rejected under 35 U.S.C. 112(b) is withdrawn in light of Applicant’s argument that derivatives maintains the core structure of the parent compound tenofovir and the instant specification provides examples of tenofovir derivatives at least examples of tenofovir alafenamide, tenofovir disoproxil, tenofovir alafenamide fumarate and tenofovir disoproxil fumarate ([0005], [0022], [0124], which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 02/13/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 02/13/2026, it is noted that no claims have been amended.
Maintained Rejections:
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 and 52-55 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0246174 (previously applied) in view of US 2018/235900 (previously applied) and WO 2018/178721 (previously applied).
Regarding claims 1-2, the limitation of a method for loading a solid material into a drug delivery implant, wherein the drug delivery implant comprises a housing that defined an internal cavity, wherein the internal cavity is separated into a reservoir chamber and a filtrate chamber by a porous filter membrane, wherein the reservoir chamber comprises an inlet port and wherein the filtrate chamber comprises an outlet port, the method comprising injecting a mixture into the reservoir chamber via the inlet port and wherein the porous filter membrane is permeable to the solvent by essentially impermeable to the solid material and removing the solvent from the filtrate chamber via the outlet port such that the solid material is retained within the drug deliver implant is met by the ‘174 publication teaching a capsule configured for in vivo refilling of a therapeutic agent (abstract). Figure 32a demonstrates two ports with separate reservoir chamber and chamber near the outlet port (Figure 32a). Refill capability comprises a collapsible bladder located within a capsule having a first end and a second end. The collapsible bladder can be constructed of elastic material and can be filled with therapeutic agent ([00194]-[00195]). The septum comprises self-sealing material and is configured to receive an injection of a therapeutic agent [0016]. The capsule comprises one or more of the following including titanium [0020]. The first port is taught to extend through the bladder, the second port is taught to extend through the capsule but not through the bladder [0037]. Refilling of a therapeutic agent containing in an capsule, the method comprising implanting in vivo a capsule comprising a first port and a second port and an internal bladder, wherein the first port extends through the capsule and the internal bladder and the second port extends through the capsule but not the bladder, inserting a first needle into a first port, inserting a second needle into the second port, injecting therapeutic agent into the first port and withdrawing fluid from the second port [0040]. The first syringe contains the therapeutic agent and the second syringe is empty and can be used to withdraw fluid from the inner volume [0202]. Antiretroviral active agents are taught [0206] and include tenofovir [0206]. The active agent is taught to have a particle size [0207].
The ’174 publication does not specifically teach a suspension of the solid material in a solvent (claim 1) wherein the active agent having at least one phophonamidate ester group (claims 52-53), is a tenofovir derivative (claimed 54-55).
The ‘900 publication teaches medical devices filled reservoirs such as cylinder comprised of a polymer film which contains a reservoir of active agent. The medical devices are useful or long-term disease prevention such as prevention of HIV infection (abstract). N active agent is deposited into a portion of the first porous membrane that is received in the cavity [0008]. The composition is taught to include tenofovir alafenamide fumarate and be released through subcutaneous implantation [0020].
The ‘721 publication teaches liquid compositions of stabilized active species to form a suspension (abstract). Tenofovir is taught as a composition containing stabilized particles of at least one species (page 4, lines 1-10). Suspension of the active species is stable with a fine suspension of the tenofovir prodrug, tenofovir disoproxil fumerate (page 6, lines 5-10).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use tenofovir derivatives as taught by the ‘721 publication in the device taught by the ‘174 publication because the ‘174 publication teaches the device used to treat HIV and may include tenofovir. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use a suspension of tenofovir derivatives in the injection solution taught by the ‘174 publication as the ‘721 publication teaches stable suspensions of tenofovir was known to be used at the time of the invention and the ‘900 publication teaches the use of Tenofovir in implants was known to treat HIV wherein the ‘174 publication teaches an implant wherein the active agent is known to be in particle form and wherein the implant treats HIV.
Claim(s) 3-5 and 44-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0246174 in view of US 2018/235900 and WO 2018/178721 as applied to claims 1-2 and 52-55 above, and further in view of US 2005/0119737 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-2 and 52-55 are taught by the combination of the ‘174 publication, the ‘900 publication and the ‘721 publication.
The combination of references does not specifically teach wherein the porous filter membrane has a porosity of 0.2 um to 10 um (claim 3, 44) is formed of metal or metal alloy (claim 4, 45) specifically titanium (claim 5, 46).
The ‘737 publication teaches an ocular implant device that is insertable for the introduction of medication (abstract). The filters can comprise ceramic, stainless steel, titanium, PHEMA and any number of polymers [0039]. The filter can be constructed of titanium [0040]. The filter can be constructed as a flow restrictor which includes multiple through holes that are used to effectively control flow between the distant and proximal ends of the opening [0042]. The drugs delivery device is taught include drugs in the porous filter or body material which dissolve over time and are released into the eye [0077]. A sinter titanium flow restricting filter is preferred [0087]. The filter is taught to have desired pore size [0090]. The pore size can be 0.2 micron ([0066], [0068]).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use titanium porous filter taught by the ‘737 publication for the membrane taught by the ‘174 publication because the ‘174 publication teaches the membrane member to enclose the therapeutic compristion and allow for solvent to flow through wherein the ‘737 publication teaches the desired pore size in a titanium filter used in implantable medical devices wherein therapeutic agent does not exit the filter until the active agent is dissolved. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘174 publication teaches the medical device may comprise titanium and the ‘737 publication specifically teaches the use of titanium filters in drug releasing medical devices.
Claim(s) 56-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2015/0246174 in view of US 2018/235900 and WO 2018/178721 as applied to claims 1-2 and 52-55 above, and further in view of US 2014/0094475 (previously applied) and WO 2004/045592 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-2 and 52-55 are taught by the combination of the ‘174 publication, the ‘900 publication and the ‘721 publication.
The combination of references does not specifically teach urocanic acid (claims 56-57).
The ‘475 publication teaches solid forms of antiretroviral compounds and antioxidative acids (abstract). Active agents are taught to include tenofovir ([0006], [0019]). Anti-oxidative acid compound sufficient to produce solid forms of antiretroviral compounds is taught [0022]. The anti-oxidative acid is taught [0056].
The ‘592 publication teaches antioxidants are taught to include amino acids such as urocanic acid (page 25, lines 25-35).
It would have been prima facie obvious to one of ordinary skill in the art to use urocanic acid in the composition taught by the combination of references as the ‘475 publication teaches that it known to use antioxidant acids in combination with an implant tenofovir and the ‘174 publication teaches implantable tenofovir. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use urocanic acid as the ‘174 publication teaches the composition may include amino acids and the ‘592 publication teaches urocanic acid is an amino acid antioxidant. Thus one of ordinary skill in the art before the filing date of the claimed invention would be motivated to use known amino acid antioxidants in the composition taught by the ‘174 publication as the use of antioxidant with tenofovir composition is known and the use of amino acids implants is known in medical devices which include tenofovir.
Response to Arguments:
Applicant’s arguments have been fully considered but are not deemed to be persuasive.
103: the ‘174 publication (Ferrari), the ‘900 publication (Swarner) and the ‘721 publication (Rannard)
Applicant argues the ‘174 publication does not teach or suggest loading a solid material through a porous filter membrane. The ‘174 publication discloses a collapsible internal bladder and two septum ports for refill/evacuation. It does not disclose or suggest a method in which a suspension of a solid material is injected into a reservoir chamber and solvent is selectively removed through the porous filter membrane as required by claims 1 and 2. Neither the ‘900 publication of the ‘721 publication remedy this deficiency. The cited documents do not teach a POSITA to redesign the device that requires a two chamber implant separated by a porous filter membrane and further having a filtrate side outlet configured for solvent only removal.
In response, the ‘174 publication teaches an implantable in vivo capsule comprising a first port and a second part and an internal bladder, wherein the first port extends through the capsule and the internal bladder and the second port extends through the capsule but does not extend through the bladder, inserting a first needles into the first part and a second needle into the second port, injecting the therapeutic agent not the first port and withdrawing fluid from the second port [0040] wherein therapeutic agent is taught as injected in the first port and withdrawing fluid from the second port (claim 10), thus teaching adding solvent/therapeutic agent to the bladder and withdrawing the solvent from the second port teaching fluid communication and thus porous.
Applicant argues hindsight reasoning.
As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
Applicant argues the cited documents do not recognize the problem of using filtration based solvent removal approach.
In response, the ‘174 publication teaches an implantable in vivo capsule comprising a first port and a second port and an internal bladder, wherein the first port extends through the capsule and the internal bladder and the second port extends through the capsule but does not extend through the bladder, inserting a first needles into the first part and a second needle into the second port, injecting the therapeutic agent not the first port and withdrawing fluid from the second port [0040] wherein therapeutic agent is taught as injected in the first port and withdrawing fluid from the second port (claim 10), thus teaching adding solvent/therapeutic agent to the bladder and withdrawing the solvent from the second port teaching fluid communication and thus porous. Thus the solvent removal was taught by the ‘174 publication.
103: the ‘174 publication (Ferrari), the ‘900 publication (Swarner) and the ‘721 publication (Rannard) in further view of the ‘737 publication (Bene)
Applicant argues the ‘737 publication fails to cure the deficiencies of the ‘174 publication, the ‘900 publication, the ‘721 publication.
In response, Applicant’s arguments regarding the ‘174 publication, the ‘900 publication and the ‘721 publication are addressed above as first presented.
Applicant argues the ‘737 publication is directed to different structures and different problems than those addressed by the claimed methods. The porous element functions as a flow restrictor and/or microbial barrier within a lumen.
In response, the ‘737 publication teaches the filters can comprise ceramic, stainless steel, titanium, PHEMA and any number of polymers [0039]. The filter can be constructed of titanium [0040]. The filter can be constructed as a flow restrictor which includes multiple through holes that are used to effectively control flow between the distant and proximal ends of the opening [0042]. The drugs delivery device is taught include drugs in the porous filter or body material which dissolve over time and are released into the eye [0077]. A sinter titanium flow restricting filter is preferred [0087]. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use titanium porous filter taught by the ‘737 publication for the membrane taught by the ‘174 publication because the ‘174 publication teaches the membrane member to enclose the therapeutic compristion and allow for solvent to flow through wherein the ‘737 publication teaches the desired pore size in a titanium filter used in implantable medical devices wherein therapeutic agent does not exit the filter until the active agent is dissolved. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘174 publication teaches the medical device may comprise titanium and the ‘737 publication specifically teaches the use of titanium filters in drug releasing medical devices.
Applicant argues hindsight.
As for the assertion that the rejection is based on hindsight, as noted in MPEP 2145, any obviousness rejection is in a sense necessarily a reconstruction based on hindsight reasoning and is not improper if it takes into account only knowledge within the level of ordinary skill in the art at the time the claimed invention was made. Applicants have provided no evidence that the rejection is not based on knowledge available to those of ordinary skill in the art.
103: the ‘174 publication (Ferrari), the ‘900 publication (Swarner) and the ‘721 publication (Rannard) in further view of the ‘475 publication (Indukuri), the ‘592 publication (Bertilsson)
Applicant argues the ‘475 publication does not disclose urocanic acid. The context is solid oral/co-crystal loading/refilling. There is not teaching or disclosure to use any disclosed solid form, acid or anti-retroviral compound in the specific implant loading and refiling context reacted in claims 1-2. The office action does not explain why a POSITA would have been motivated to identify the implant system already clacking by importing teachings form the ‘475 publication that is directed to solid state pharmaceutical forms and not implant loading.
In response, the ‘475 publication teaches solid forms of antiretroviral compounds and antioxidative acids (abstract). Active agents are taught to include tenofovir ([0006], [0019]). Anti-oxidative acid compound sufficient to produce solid forms of antiretroviral compounds is taught [0022]. The anti-oxidative acid is taught [0056]. It would have been prima facie obvious to one of ordinary skill in the art to use urocanic acid in the composition taught by the combination of references as the ‘475 publication teaches that it known to use antioxidant acids in combination with an implant tenofovir and the ‘174 publication teaches implantable tenofovir.
Applicant argues the ‘592 publication (Bertilsson) is non-analogous art. It contains a generic list of antioxidants but provides not teaching or motivation to select urocanic acid specifically to stabilize a phosphonamidite ester. It is directed to methods of promoting neurogenesis and neurological treatment mechanisms, not drug delivery implant design or loading methods.
In response, the ‘475 publication teaches solid forms of antiretroviral compounds and antioxidative acids (abstract). Active agents are taught to include tenofovir ([0006], [0019]). Anti-oxidative acid compound sufficient to produce solid forms of antiretroviral compounds is taught [0022]. The anti-oxidative acid is taught [0056]. The ‘592 publication teaches antioxidants are taught to include amino acids such as urocanic acid (page 25, lines 25-35). One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use urocanic acid as the ‘174 publication teaches the composition may include amino acids and the ‘592 publication teaches urocanic acid is an amino acid antioxidant. Thus, one of ordinary skill in the art before the filing date of the claimed invention would be motivated to use known amino acid antioxidants in the composition taught by the ‘174 publication as the use of antioxidant with tenofovir composition is known and the use of amino acids implants is known in medical devices which include tenofovir.
Applicant argues to arrive at claims 56-57 a POSITA would heed to reconstruct Applicant’s two chamber implant with a porous filter membrane and solvent removal along process which is not taught and then selectively importing teachings of the ‘475 publication and the ‘592 publication, directed to different fields and different problems. Absent hindsight knowledge gleaned from the instant Application, the cited documents provide no teaching, suggestion or motivation to arrive at the claimed combination in the manner required.
In response, Applicant’s arguments regarding the ‘174 publication and the structure of the device and porous filter are addressed as first presented. The ‘475 publication teaches solid forms of antiretroviral compounds and antioxidative acids (abstract). Active agents are taught to include tenofovir ([0006], [0019]). Anti-oxidative acid compound sufficient to produce solid forms of antiretroviral compounds is taught [0022]. The anti-oxidative acid is taught [0056]. It would have been prima facie obvious to one of ordinary skill in the art to use urocanic acid in the composition taught by the combination of references as the ‘475 publication teaches that it known to use antioxidant acids in combination with an implant tenofovir and the ‘174 publication teaches implantable tenofovir. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use urocanic acid as the ‘174 publication teaches the composition may include amino acids and the ‘592 publication teaches urocanic acid is an amino acid antioxidant. Thus, one of ordinary skill in the art before the filing date of the claimed invention would be motivated to use known amino acid antioxidants in the composition taught by the ‘174 publication as the use of antioxidant with tenofovir composition is known and the use of amino acids implants is known in medical devices which include tenofovir.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. 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.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
Prosecution Insights