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 Arguments
Applicant's arguments filed 12/19/2025 have been fully considered but they are not persuasive.
Applicant argues that Chappa fails to disclose or suggest that the device of Chappa is “configured such that the occlusive element is positioned within a biological lumen of the canalicular anatomy. The occlusive element is positioned distal to the memory frame, with distal being more within the anatomy of the patient and the proximally positioned memory frame being closer to the exterior of the patient” as required in amended claim 1 (see page 2 of the remarks).
The examiner respectfully disagrees. In response to applicant's argument that the device of Chappa is not “configured such that the occlusive element is positioned within a biological lumen of the canalicular anatomy. The occlusive element is positioned distal to the memory frame, with distal being more within the anatomy of the patient and the proximally positioned memory frame being closer to the exterior of the patient”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
The examiner notes that the claimed invention is an apparatus, not a method. Therefore, the claims are examined in light of the structural components, not the functional components of the device. Structurally, the claim only requires a memory frame and an occlusive element in order to be “shaped to be delivered into and remain disposed within canicular anatomy” and “such that the memory frame is positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is positioned more internally within the canalicular anatomy” as required in the claim.
The examiner further notes that there are no dimensions in the claim to structurally define what it means to be “shaped to be delivered into and remain disposed within canicular anatomy”. In the PGPUB of the instant application US 20210298762, the canalicular occlusion device may have a diameter in the range of 0.1 mm to 10 mm in order to occlude canicular anatomy (para. 0006) and para. 0029 states “As the canaliculi measure 8-10 mm in length and 0.5-1.0 mm in diameter the ideal canalicular occlusion device design would fall within or just beyond these bounds, for example between 5-12 mm in length and 0.3 and 2.0 mm in width”. Chappa states in para. 0073 “The overall dimensions of the implantable device can be selected according to the particular application. For example, the length and/or width of the device can be selected to accommodate the particular implantation site”. Chappa further discloses that the total length of the device is between 1.1 cm to 0.6 cm or 6 mm to 11 mm in length (para. 0075) and the diameter of the memory frame may range between 0.25 mm to about 1 mm (para. 0074). Fig. 1 illustrates that the occlusive element 8 has a larger diameter than the memory frame and therefore the diameter would be larger than 1 mm. These dimensions fall under the diameter and length ranges to be “shaped to be delivered into and remain disposed within canicular anatomy”.
Since the device of Chappa is dimensioned to be positioned within the canalicular anatomy, a user is capable of implanting the device of Chappa in the canicular anatomy in a way where the “occlusive element is positioned distal to the memory frame…the memory frame is positioned proximal to the occlusive element such that the memory frame is positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is positioned more internally within the canalicular anatomy” as defined by the claim. Chappa further discloses the device may be used to treat a variety of ocular conditions (see para. 0197) and further states in para. 0062: “According to the present invention, a device has been developed that can be used to treat any implantation site within the body in which it is desirable to provide controlled release of one or more bioactive agents. In preferred embodiments, the device can be used to provide one or more bioactive agents to a treatment site that comprises a limited access region of the body, such as the eye, ear, brain, spine, and joints”. Therefore, since Chappa contemplates other intended uses of the device.
Applicant argues that there is no motivation to combine Chappa and Lyons since Chappa is directed to drug delivery, not occlusion of fluid flow. Applicant explains that occlusion of fluid flow requires additional engineering and problem solving to achieve and therefor one of ordinary skill would not contemplate combining Chappa and Lyons.
The examiner respectfully disagrees. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Chappa discusses the cap being used to either abut the incision/surgical cut above the incision (para. 0193: “the body member 2 is inserted into the eye by rotating or twisting the body member 2 into the eye until the cap 8 abuts the outer surface of the eye”) or when implanted into the incision (para. 0192: “a partial incision in the sclera can be made to create a scleral flap. Once the device has been implanted, and the cap 8 is placed so that it abuts the incision site, the scleral flap can be folded back over the device, thus providing a covering over the cap”). Therefore, the device of Chappa is an occlusion device because it occludes the incision/surgical cut that the device is placed therein. Therefore, both devices of Chappa and Lyons are occlusion devices used to treat and deliver drugs to an eye of a patient as shown and described in Fig. 5, para. 0106, 0112 of Chappa and Fig. 1, para. 0022, 0033 of Lyons.
Lyons explicitly teaches that it is beneficial for an occlusion device positioned in the eye to be formed of shape memory material (see para. 0031 which states that the device including the memory frame and the occlusive element is formed of SMP) such that it can transition from a constrained to an expanded form, as structurally required by the limitation, in order to “allow an implantable SMP ophthalmological device to be easily/simply inserted, deploy significant features for reliable retention after insertion, and maintain a flexibility/softness to ensure patient comfort both internally and externally. In one implementation, an SMP punctal plug can enter the narrow ocular punctum opening and expand with features both above and below the ostium to provide good mechanical capture and retention” (para. 0008 of Lyons). These specific features would be beneficial for the device of Chappa since the cap is designed to provide an anchoring feature to the device (para. 0109 of Chappa) and Chappa emphasizes the need to minimize irritation and increase comfort after insertion (para. 0192 of Chappa). Therefore, the rejection of Chappa in view of Lyons is maintained.
As previously stated, the claims are for an apparatus, not a method. Therefore, the limitation “for occlusion of fluid flow” is not structural language but functional language that describes the intended use of the device. The device of Chappa discloses the structure, as defined by the claim, to be defined as an occlusion device (i.e. the cap 8 as the occlusive element and the body member 2 as the memory frame) in order to meet the functional language for an intended use of “substantially preventing fluid from flowing through portions of a canalicular space of subject” as stated in the rejection and provides the intention of the device to be used for occlusion specifically within the eye as stated above. Therefore, the device of Chappa is capable of performing that intended function. Furthermore, since Chappa’s main intention is to treat the eye (para. 0063: “To facilitate discussion of the invention, use of the invention to treat an eye will be addressed. Eyes are selected as a result of the particular difficulties encountered when treating medical conditions of the eye, as described above... However, it is understood that the device and methods disclosed are applicable to any treatment needs”). Therefore, the device of Chappa could be used to occlude the canicular anatomy. Chappa further states in para. 0062: “According to the present invention, a device has been developed that can be used to treat any implantation site within the body in which it is desirable to provide controlled release of one or more bioactive agents. In preferred embodiments, the device can be used to provide one or more bioactive agents to a treatment site that comprises a limited access region of the body, such as the eye, ear, brain, spine, and joints”. In light of the maintained combination above, the modification to Chappa to allow the occlusive element 8 of Chappa to transition from the constrained to the expanded form is the structural requirement to meet the intended use “for occlusion of fluid flow”. Therefore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“fixation element” in claim 8: The limitation describing the fixation element in claim 8 fails to include sufficient structure to perform the recited function of "fixation". In the specifications, the fixation element is used to prevent migration of the occlusive device and described as T arms, S arms, loops, helix, coil, Y shape, golf tee, and sphere shaped structures (see page 12, lines 6-13 of the instant application). Therefore, the limitation will be interpreted as T arms, S arms, loops, helix, coil, Y shape, golf tee, and sphere shaped structures or any fixation structural equivalent thereof.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “more internally” in claim 1, line 14, is a relative term which renders the claim indefinite. The term “more internally” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Furthermore, as shown in Fig. 3 of the instant application, the occlusion device appears to be located at the same depth relative to the canalicular anatomy. Therefore, it is unclear to the examiner how the memory frame is more internal than the occlusive element without defining a structural component to base the relativity to.
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.
Claims 1-14 are rejected under 35 U.S.C. 101 because
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.
Claims 1-14 are 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 1 recites “such that the memory frame is positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is positioned more internally within the canalicular anatomy, as compared to the memory frame.”. As written, the language describing the structural components of the canalicular occlusion device (i.e. the memory frame and the occlusive element) are required and therefore positively claiming the body (specifically the canalicular anatomy) to meet the limitation. For examination purposes, the limitation is interpreted and should be written as “such that the memory frame is configured to be positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is configured to be positioned more internally within the canalicular anatomy, as compared to the memory frame.”.
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.
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, 4-7, 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Chappa (US 20050196424) in view of Lyons et al. (US 20120116504) [hereinafter Lyons].
Regarding claim 1, Chappa discloses an occlusion device used to treat the eye (Figs. 1, 5, para. 0062-0063, 0076, 0194-0195) comprising:
a memory frame 2 comprising a memory material (Fig. 1, para. 0081-0084); and
an occlusive element 8 positioned distal to the memory frame (see Fig. 1 of Chappa, the occlusive element is interpreted as being positioned distal the memory frame. The examiner notes that “distal” is a relative term and dependent on insertion of the device and therefore the intended use of the device. This is supported by the special definition of the instant application stating “the term "distal" refers to the portion of the device (such as occlusive element in the shape of a cap 302 shown in Fig. 2, as an example) that is intended to be inserted and deployed deep within the canalicular system” (see para. 0008 of PGPUB of the instant application US 20210298762)),
wherein the occlusive element is configured to substantially prevent fluid from flowing through portions of a canalicular space of subject (see note below in regards to intended use),
wherein the occlusive element 8 is attached to the memory frame 2 (para. 0111),
wherein the memory frame 2 extends into the occlusive element 8 (para. 0111 of Chappa discloses that the occlusive element (interpreted as the cap) “can be fabricated to include an aperture, into which the body member (which is the interpreted memory frame) is placed and thereafter soldered, welded, or otherwise attached”. Therefore, the memory frame does extend into the occlusive element),
wherein the occlusive element 8 is further shaped to be delivered into and remain disposed within canalicular anatomy (see note below regarding intended use), and
wherein the memory frame is positioned proximal to the occlusive element (see Fig. 1 of Chappa, the memory frame is interpreted as being positioned proximal of the occlusive element because the memory frame is the portion of the device near a fixation element (interpreted as the portion comprising tip 10 which is shaped like a helix, see Figs. 1-2, para. 0077; see 112f above). The examiner notes that the special definition in the instant application states “The term “proximal” refers anatomically from within the canalicular system towards the puncta and external to the patient. When referring to a device of the present invention it represents the portion of the delivery device near a fixation element in para. 0009 of PGPUB of the instant application US 20210298762)), such that the memory frame is positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is positioned more internally within the canalicular anatomy, as compared to the memory frame (see note below regarding intended use).
Chappa further discusses that the memory frame may deform from a linear shape for insertion in a constrained form and returns to its remembered shape in an unconstrained form once the memory frame is within the eye (para. 0193). However, Chappa fails to disclose wherein the occlusive element has a constrained form for insertion and an expanded form for occlusion of fluid flow and wherein the memory frame and the occlusive element are configured to cooperatively expand to hold the canalicular occlusion device in the canalicular anatomy.
Lyons in the same field of endeavor teaches a canalicular occlusion device 10 (Figs. 1-4, para. 0022, 0030) an occlusive element 30 configured to substantially prevent fluid from flowing through portions of a canalicular space of a subject (Fig. 3, para. 0040-0042 teaches that the flange 30 is larger in diameter a canalicular space of a subject. Therefore, the occlusive element of Lyons is capable of substantially preventing fluid from flowing through portions of the canalicular space of the subject), wherein the occlusive element 30 is attached to a memory frame 15 (Fig. 4, para. 0034), wherein the occlusive element 30 is formed of a shape memory material (para. 0031) such that the occlusive element has a constrained form for insertion (Figs. 1-2, para. 0034, 0044) and an expanded form for occlusion of fluid flow (Fig. 3, para. 0034, 0044), wherein the memory frame 15 and the occlusive element 30 are configured to cooperatively expand to hold the canalicular occlusion device in the canalicular anatomy (para. 0027-0028).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the occlusive element in Chappa to be formed of shape memory material such that the occlusive element transitions from the constrained to expanded form, as taught by, Lyons in order to provide easier insertion and deployment of the occlusive element without minimizing the retention characteristics of the occlusive element after insertion and provides a flexibility/softness to ensure patient comfort both internally and externally (para. 0008 of Lyons).
Note: “configured to substantially prevent fluid from flowing through portions of a canalicular space of subject” is interpreted as functional language which describes an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case, the occlusive element (interpreted as cap 8) of Chappa is used to occlude a target site in the eye (see Fig. 5, para. 0106, 0109). Therefore, the occlusive element of Chappa is capable of substantially preventing fluid from flowing through portions of the canaliculus. Since the device of Chappa includes all of the structure required in claim 1 to substantially prevent fluid from flowing through portions of the canaliculus, the device of Chappa meets the functional limitations of the claim.
Note: “wherein the occlusive element 8 is further shaped to be delivered into and remain disposed within canalicular anatomy” is interpreted as functional language which describes an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The examiner notes that the claimed invention is an apparatus, not a method. Therefore, the claims are examined in light of the structural components, not the functional components of the device. Structurally, the claim only requires a memory frame and an occlusive element in order to be “shaped to be delivered into and remain disposed within canicular anatomy”. The examiner further notes that there are no dimensions in the claim to structurally define what it means to be “shaped to be delivered into and remain disposed within canicular anatomy”. In the PGPUB of the instant application US 20210298762, the canalicular occlusion device may have a diameter in the range of 0.1 mm to 10 mm in order to occlude canicular anatomy (para. 0006) and para. 0029 states “As the canaliculi measure 8-10 mm in length and 0.5-1.0 mm in diameter the ideal canalicular occlusion device design would fall within or just beyond these bounds, for example between 5-12 mm in length and 0.3 and 2.0 mm in width”. Chappa states in para. 0073 “The overall dimensions of the implantable device can be selected according to the particular application. For example, the length and/or width of the device can be selected to accommodate the particular implantation site”. Chappa further discloses that the total length of the device is between 1.1 cm to 0.6 cm or 6 mm to 11 mm in length (para. 0075) and the diameter of the memory frame may range between 0.25 mm to about 1 mm (para. 0074). Fig. 1 illustrates that the occlusive element 8 has a larger diameter than the memory frame and therefore the diameter would be larger than 1 mm. These dimensions fall under the diameter and length ranges to be “shaped to be delivered into and remain disposed within canicular anatomy”.
Note: “such that the memory frame is positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is positioned more internally within the canalicular anatomy” is interpreted as functional language which describes an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The examiner notes that the claimed invention is an apparatus, not a method. Therefore, the claims are examined in light of the structural components, not the functional components of the device. Structurally, the claim only requires a memory frame and an occlusive element in order to meet the limitation such that the memory frame is configured to be positioned more closely to the external end of the canalicular anatomy, and such that the occlusive element is configured to be positioned more internally within the canalicular anatomy. As stated in the note above, the device of Chappa is dimensions to be positioned within the canalicular anatomy. Chappa further discloses the device may be used to treat a variety of ocular conditions (see para. 0197) and further states in para. 0062: “According to the present invention, a device has been developed that can be used to treat any implantation site within the body in which it is desirable to provide controlled release of one or more bioactive agents. In preferred embodiments, the device can be used to provide one or more bioactive agents to a treatment site that comprises a limited access region of the body, such as the eye, ear, brain, spine, and joints”. Therefore, since Chappa contemplates other intended uses of the device and the device of Chappa is shaped and sized to treat the canicular anatomy, a user is capable of implanting the device of Chappa in the canicular anatomy “such that the memory frame is positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is positioned more internally within the canalicular anatomy” as defined by the claim.
Regarding claim 2, modified Chappa discloses wherein the memory frame 2 is a length equal to or shorter than a distance from the subject's ocular punctum to an end of the subject's canalicular space (Note: page 4, lines 1-2 of the instant application discloses that the length of the memory frame has a length in the range of 0.1 mm to 10 mm. Para. 0075 of Chappa discloses that the memory frame (interpreted as body member 2) has a length of less than 1 cm, in the range of about 0.25 cm to about 1 cm (i.e. a length less than 10 mm, in the range of about 2.5to 10 mm). Since the length of the memory frame of Chappa meets the length requirement of the range in the instant application, the memory frame of Chappa also meets the limitation).
Regarding claim 4, modified Chappa discloses wherein the memory material is selected from the group consisting of polynomomene, polycaprol actone, polyenes, nylons, polycyclooctene (PCO), blends of PCO and styrene-butadiene rubber, polyvinylacetate/polyvinylidinefluoride(PVAc/PVDF), blends of PVAc/PVDF/polymethylmethacrylate(PMMA), polyurethanes, styrene-butadiene copolymers, polyethylene, trans-isoprene, blends of polycaprolactone and n-butylacrylate, and combinations thereof (para. 0081-0082 of Chappa).
Regarding claim 5, modified Chappa discloses wherein the memory material is a metal selected from the group consisting of stainless steel, cobolt, nickel, chromium, molybdenum, titanium, nitinol, tantalum, platinum-iridium alloy, gold, magnesium, and a combination thereof (para. 0081, 0084 of Chappa).
Regarding claim 6, modified Chappa discloses wherein at least a part of the memory frame 2 is completely covered by the occlusive element 8 (see Fig. 1 of Chappa which illustrates a proximal-most part of the frame is completely covered by the occlusive element, para. 0111 of Chappa discloses that the cap can be fabricated to include an aperture, into which the body member is placed and thereafter soldered, welded, or otherwise attached).
Regarding claim 7, modified Chappa discloses wherein the occlusive element 8 comprises a memory material selected from the group consisting of polytetrafluoroethylene, polyethylene terephthalate, polyethylene, silicone, acrylate polymer, urethane polymer, rayon, rubber, latex, polyurethane, thermoplastic polyurethane, polyvinylchloride and a combination thereof (para. 0081-0082, 0110, 0111 of Chappa).
Regarding claim 12, modified Chappa discloses all of the limitations set forth above in claim 1. Modified Chappa further discloses that the memory frame 2 may be made of a rigid material to provide improved implant/explant characteristics to the device (para. 0080 of Chappa). However, modified Chappa fails to disclose wherein the memory frame has a rigidity in a range of 1 kPa to l0 kPa.
There is no evidence of record that establishes that changing the rigidity of memory frame 2 would result in a difference in function of the modified Chappa device. Further, a person having ordinary skill in the art, being faced with modifying the memory frame of modified Chappa, would have a reasonable expectation of success in making such a modification and it appears the device would function as intended being given the claimed rigidity. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the rigidity “may” have a rigidity in the range of 1kPa to 10kPa (see page 4, lines 1-2 of the instant application) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the memory frame 2 of modified Chappa to have a rigidity in a range of 1 kPa to l0 kPa as an obvious matter of design choice within the skill of the art.
Regarding claim 13, modified Chappa discloses having a length in a range of 0.1mm to 10mm (para. 0075 of Chappa).
Regarding claim 14, modified Chappa discloses having a diameter in a range of 0.1mm to 10mm (para. 0074, 0190-0191 of Chappa).
Alternative rejection of claim 1
Claim(s) 1, 3, and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over a variant embodiment of Chappa (US 20050196424) in view of Lyons et al. (US 20120116504) [hereinafter Lyons].
Regarding claim 1, Chappa discloses an occlusion device used to treat the eye (Figs. 5, 7, para. 0062-0063, 0194-0195, 0201) comprising:
a memory frame (interpreted as portion of body member 52 comprising a helical shape; see annotated Fig. 7 below, para. 0201); and
an occlusive element 58 positioned distal to the memory frame (see Fig. 7 of Chappa, the occlusive element is interpreted as being positioned distal the memory frame. The examiner notes that “distal” is a relative term and dependent on insertion of the device and therefore the intended use of the device. This is supported by the special definition of the instant application stating “the term "distal" refers to the portion of the device (such as occlusive element in the shape of a cap 302 shown in Fig. 2, as an example) that is intended to be inserted and deployed deep within the canalicular system” (see para. 0008 of PGPUB of the instant application US 20210298762)),
wherein the occlusive element is configured to substantially prevent fluid from flowing through portions of a canalicular space of subject (see note above in the first rejection of claim 1 regarding intended use),
wherein the occlusive element 58 is attached to the memory frame 52 (Fig. 7, para. 0111, 0201),
wherein the memory frame 52 extends into the occlusive element 58 (para. 0111 of Chappa discloses that the occlusive element (interpreted as the cap) “can be fabricated to include an aperture, into which the body member (which is the interpreted memory frame) is placed and thereafter soldered, welded, or otherwise attached”. Therefore, the memory frame does extend into the occlusive element),
wherein the occlusive element 58 is further shaped to be delivered into and remain disposed within canalicular anatomy (see note above in the first rejection of claim 1 regarding intended use), and
wherein the memory frame is positioned proximal to the occlusive element (see Fig. 7 of Chappa, the memory frame is interpreted as being positioned proximal of the occlusive element because the memory frame is the portion of the device near a fixation element (interpreted as tapered portion 54 which is shaped like a golf tee which is also a tapered structure, Fig. 7, see 112f above). The examiner notes that the special definition in the instant application states “The term “proximal” refers anatomically from within the canalicular system towards the puncta and external to the patient. When referring to a device of the present invention it represents the portion of the delivery device near a fixation element in para. 0009 of PGPUB of the instant application US 20210298762)), such that the memory frame is positioned more closely to an external end of the canalicular anatomy, and such that the occlusive element is positioned more internally within the canalicular anatomy, as compared to the memory frame (see note above in the first rejection of claim 1 regarding intended use).
However, the embodiment of Fig. 7 does not expressly disclose that the memory frame comprises a memory material.
Chappa teaches another embodiment of the occlusive device shown in Fig. 1 comprising a memory frame 2 comprising a memory material (Fig. 1, para. 0081-0084).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the memory frame in the embodiment of Fig. 7 to include the memory material of the embodiment of Fig. 1 since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07).
However, Chappa fails to disclose wherein the occlusive element has a constrained form for insertion and an expanded form for occlusion of fluid flow and wherein the memory frame and the occlusive element are configured to cooperatively expand to hold the canalicular occlusion device in the canalicular anatomy.
Lyons in the same field of endeavor teaches a canalicular occlusion device 10 (Figs. 1-4, para. 0022, 0030) an occlusive element 30 configured to substantially prevent fluid from flowing through portions of a canalicular space of a subject (Fig. 3, para. 0040-0042 teaches that the flange 30 is larger in diameter a canalicular space of a subject. Therefore, the occlusive element of Lyons is capable of substantially preventing fluid from flowing through portions of the canalicular space of the subject), wherein the occlusive element 30 is attached to a memory frame 15 (Fig. 4, para. 0034), wherein the occlusive element 30 is formed of a shape memory material (para. 0031) such that the occlusive element has a constrained form for insertion (Figs. 1-2, para. 0034, 0044) and an expanded form for occlusion of fluid flow (Fig. 3, para. 0034, 0044), wherein the memory frame 15 and the occlusive element 30 are configured to cooperatively expand to hold the canalicular occlusion device in the canalicular anatomy (para. 0027-0028).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the occlusive element in Chappa to be formed of shape memory material such that the occlusive element transitions from the constrained to expanded form, as taught by, Lyons in order to provide easier insertion and deployment of the occlusive element without minimizing the retention characteristics of the occlusive element after insertion and provides a flexibility/softness to ensure patient comfort both internally and externally (para. 0008 of Lyons).
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Annotated Fig. 7 of Chappa
Regarding claim 3, modified Chappa discloses further comprising a linear frame (see annotated Fig. 7 above).
Regarding claim 8, modified Chappa discloses further comprising a fixation element (interpreted as tapered portion 54 which is shaped like a golf tee which is also a tapered structure, see 112f above), wherein the linear frame is located between the occlusive element and the fixation element (see annotated Fig. 7 of Chappa above).
Regarding claim 9, modified Chappa discloses all of the limitations set forth above in claim 8. However, modified Chappa does not expressly disclose that the memory frame, the fixation element, and the occlusive element comprise the same material.
Chappa teaches another embodiment of the occlusive device shown in Fig. 2 comprising a memory frame 2, a fixation element (interpreted as distal end 6 of memory frame 2 which includes a sharp/pointed end), and an occlusive element 8, wherein the memory frame, the fixation element, and the occlusive element comprise the same material (Fig. 2, para. 0082, 0086, 0110-0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the memory frame, the fixation element, and the occlusive element in the embodiment of Fig. 7 to be formed of the same material, as taught by of the embodiment of Fig. 2 since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07).
Regarding claim 10, modified Chappa discloses all of the limitations set forth above in claim 8. However, modified Chappa does not expressly disclose wherein the memory frame, the fixation element, and the occlusive element comprise different materials.
Modified Chappa discloses that the embodiment of the occlusive device shown in Fig. 2 comprises a memory frame 2, a fixation element (interpreted as distal end 6 of memory frame 2 which includes a sharp/pointed end), and a occlusive element 8, wherein the memory frame, the fixation element, and the occlusive element comprise the different material (Fig. 2, para. 0082, 0086 discloses that fixation element may be formed of polyamide, 0110-0112 disclose that the occlusive element and the memory frame may comprise different materials and coated with different polymeric coatings).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the memory frame, the fixation element, and the occlusive element in the embodiment of Fig. 7 to be formed of different materials, as taught by of the embodiment of Fig. 2 since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07).
Regarding claim 11, modified Chappa discloses all of the limitations set forth above in claim 8. However, modified Chappa does not expressly disclose wherein the memory frame comprises nitinol and the fixation element comprises a polymer.
Modified Chappa discloses that the embodiment of the occlusive device shown in Fig. 2 comprises a memory frame 2 and a fixation element (interpreted as distal end 6 of memory frame 2 which includes a sharp/pointed end), wherein the memory frame comprises nitinol (para. 0081, 0084) and the fixation element comprises a polymer (para. 0086).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the memory frame and the fixation element in the embodiment of Fig. 7 to be formed of nitinol and polymer, respectively, as taught by of the embodiment of Fig. 2 since it is well within the general skill of one skilled in the art to select a known material based on its suitability for its intended use. (In re Leshin 125 USPQ 416; MPEP 2144.07).
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 LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771