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 .
Election/Restrictions
Applicant's election with traverse of Group I1: Claims 1-11 and Species A in the reply filed on 9/9/2025 is acknowledged. The traversal is on the following grounds:
Regarding the restriction between Group I and Group II, applicant argues that there would not be a serious burden if groups I and II were examined together. The examiner disagrees because groups I and II are drawn to fundamentally different devices. As noted in the restriction requirement, the searches for a glaucoma shunt and a drug delivery device are substantially distinct due to their different classifications.
Regarding the requirement for election of species, applicant argues that the examiner has not demonstrated that there would be serious search burden if all species of the pump actuator were to be examined. This argument has not been found persuasive because the instant application discloses and claims five distinct pump/actuator arrangements, each arrangement having completely different structure that would require different search strategy. If examined, there would be a serious search and examination burden because each of these distinct configurations would have to be considered separately.
Applicant also argues that the species are improperly identified by claims rather than the different embodiments of the invention (middle of Page 7).
The examiner is well aware that claims themselves are not species, and it is noted that the Restriction Requirement does in fact indicate the different embodiments of the invention that correspond to each species (i.e. a ferromagnet, an implanted electromagnet and an external ferromagnet, a piezoelectric material, a thermal actuator, and an electromagnet configured to produce a phase change). The claims that are exemplified by these species were included by the examiner merely for Applicant’s convenience.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-10 and 12-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/9/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 4 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 4 requires that “no power source for activating the pump is implanted into the person,” and therefore claims the human body.
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tu et al. (US 2005/0049578) in view of Dos Santos (US 9,528,633; hereinafter referred to as “Dos Santos ‘633)
With respect to Claim 1, Tu teaches an implantable assembly (Figure 9) for managing an eye disease (glaucoma; see Abstract and paragraph [0002]), the assembly comprising:
a passive flow structure (stent 52 comprising inlet portion 33 and outlet portion 34; Figure 9) to be implanted into a patient to drain aqueous humor from the eye (see Abstract, paragraphs [0019-0022] and [0097]); and
a pump (the pumping region as defined in the annotated figure below) to be implanted into the person and coupled to the passive flow structure (33, 34, 52) and into an outflow site (the anterior chamber 20; see Abstract, paragraph [0096], and Figure 9). The pump is configured to be activated (via actuator 64) to accelerate drainage of aqueous humor through the passive flow structure, only when power is supplied from a power source (paragraphs [0091-0097]).
Tu does not explicitly teach that power is supplied to the pump by a wireless power transfer source that is external to the eye and that is brought into proximity with the eye.
Dos Santos ‘633 teaches a MEMS device for pumping fluids in ophthalmic treatments including glaucoma (Figures 2-7; Column 1, Lines 14-27; Column 4, Line 57 through Column 5, Line 4); the assembly comprising a passive flow structure 104 and a pump 160, wherein the pump is configured to selectively control the flow rate of aqueous humor that drains from the anterior chamber in response to a sensed pressure (Column 5, Lines 50-59). Dos Santos ‘633 further teaches that the pump may be powered by an external power source, such that the power source communicates wirelessly from outside the eye via inductive coupling when a wireless power transfer source is brought into proximity to the eye (Column 5, Lines 23-30). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to modify Tu’s implantable glaucoma management shunt and pump to be powered by a wireless power transfer source that is external to the eye and that is brought into proximity with the eye, as suggested by Dos Santos ‘633, in order to provide a well-known, alternate means for powering the pump that prevents the need for implanting the power source within the eye.
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Annotated Figure 9 of Tu
With respect to Claims 2 and 3, Tu teaches that the pump, when activated, forces aqueous humor through the passive flow structure at a fluid flow rate that equals the patient’s aqueous production rate. Specifically, Tu teaches that a desirable flow rate is 2.4 microliters/minute, which falls within the claimed ranges of 1-10 microliters per minute (Claim 2) and 0.1-100 microliters per minute (claim 3). See paragraph [0080].
With respect to Claim 5, Tu teaches that the pump comprises a flexible membrane 38, an actuator 64 attached to the flexible membrane, an inlet check valve 35A, and an outlet check valve, wherein the inlet and outlet check valves communicate with a variable volume (the interior of the tubular structure defined by membrane 38) that is defined in part by flexible membrane 38 (Figure 9; paragraph [0097]). The actuator is configured to, when energized, displace the flexible membrane to increase and/or decrease the volume of the space between the check valves, thereby drawing aqueous humor into the volume through the inlet check valve and force the aqueous humor out of the volume through the outlet check valve (paragraph [0097]).
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Tu et al. (US 2005/0049578) and Dos Santos (US 9,528,633) as applied to claim1 above, and further in view of Dos Santos US 2013/0150771; hereafter referred to as “Dos Santos 2013”).
With respect to Claim 4, Tu and Dos Santos ‘633 reasonably suggest the assembly of Claim 1, wherein the power source is disposed as an external power source (i.e. outside of the eye; see Dos Santos ‘633: Column 5, Lines 26-30). The assembly suggested by Tu and Dos Santos ‘633 therefore does not have a power source that is implanted into the person.
However, in the event that this interpretation is not clearly envisaged by applicant, Dos Santos 2013 teaches a system for powering ocular implants, the implant being a pump [0022] that is configured to use in treating glaucoma in a patient (see entire disclosure, especially Figures 1 and 3 and paragraphs [0001-0006] and [0020]). Specifically, wireless power is provided by an external battery 244 and wireless power transfer source 242 that are housed on a pair of eyeglasses 204 or other external support structure adjacent the patient’s eye (Figure 2; paragraph [0029]), thereby enabling the power transfer source 242 to emit an electromagnetic field in that supplies a sufficient amount of energy to power the implant (paragraphs [0020] and [0029-0032]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the glaucoma shunt and pumping assembly of Tu and Dos Santos ‘633 to have the external power source and wireless power transfer source disposed on a pair of eyeglasses or other support structure held in close proximity to the eye, as suggested by Dos Santos 2013, in order to provide a well-known means for securing the power source and power transfer source to the patient adjacent the eye.
With respect to Claim 11, Tu and Dos Santos ‘633 reasonably suggest the assembly of Claim 1, wherein the power source is disposed as an external power source (i.e. outside of the eye; see Dos Santos ‘633: Column 5, Lines 26-30). Tu and Dos Santos ‘633, however, do not specifically teach that the the wireless power transfer source is attached to eyeglasses.
Dos Santos 2013 teaches a system for powering ocular implants, the implant being a pump [0022] that is configured to use in treating glaucoma in a patient (see entire disclosure, especially Figures 1 and 3 and paragraphs [0001-0006] and [0020]). Specifically, wireless power is provided by an external battery 244 and wireless power transfer source 242 that are housed on a pair of eyeglasses 204 or other external support structure adjacent the patient’s eye (Figure 2; paragraph [0029]), thereby enabling the power transfer source 242 to emit an electromagnetic field in that supplies a sufficient amount of energy to power the implant (paragraphs [0020] and [0029-0032]). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the glaucoma shunt and pumping assembly of Tu and Dos Santos ‘633 to have the external power source and wireless power transfer source disposed on a pair of eyeglasses or other support structure held in close proximity to the eye, as suggested by Dos Santos 2013, in order to provide a well-known means for securing the power source and power transfer source to the patient adjacent the eye.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tu and Dos Santos ‘633 as applied to claims 1 and 5 above, and further in view of Olsen (US 2002/0173773).
With respect to Claim 6, Tu and Dos Santos ‘633 reasonably suggest the assembly of Claims 1 and 5, wherein the pump is activated by a magnetic field interaction between the implanted actuator and the wireless power transfer source only when power is being applied by the wireless power transfer source (see Tu: paragraphs [0091-0097] and Dos Santos ‘633: Column 5, Lines 26-30) (see the rejection of Claims 1 and 5 above). Tu and Dos Santos ‘633, however, do not specifically teach that the actuator comprises an implanted ferromagnet.
Olsen teaches a permanent magnet solenoid pump for use in an implantable substance delivery device (see Title, Abstract) comprising at least one permanent magnet 66 made of a ferromagnetic material [0041]). The pump further comprises a coil 68 that is configured to produce an electromagnetic axial force that activates and moves the permanent magnet 66, thereby imparting motion to the pump only when the power source is energized [0041]. Olsen teaches that this configuration is small, energy efficient, and accurate (see Abstract and paragraph [0009]), such that it is suitable as an implantable medical pump. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the instant application to further modify the assembly of Tu and Dos Santos ‘633 such that the actuator comprises an implanted ferromagnet that interacts with a magnetic field produced by the power transfer source, as suggested by Olsen, in order to provide a well-known, alternate implantable pump configuration that is small, energy efficient, and accurate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Adelberg (US 6,077,299) teaches a magnetically-adjustable pump for draining aqueous humor in glaucoma.
Samakar (US 2020/0297536) teaches a peristaltic micropump and external wireless transmission device for treating glaucoma .
Pang (US 2009/0306594) teaches an implantable pump for delivering drugs to a patient’s eye, the pump comprising a wireless power source (paragraphs [0010], [0080]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Philip R Wiest whose telephone number is (571)272-3235. The examiner can normally be reached M-F 9-6 EST.
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, Nicholas Weiss can be reached at (571) 270-1775. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP R WIEST/Primary Examiner, Art Unit 3781