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 .
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:
“a securement feature” in claims 1, 15, and all dependent claims thereof;
“a delivery system” in claims 2 and all dependent claims thereof;
“a locator” in claims 12, 16, and all dependent claims 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
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is 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.
Regarding claim 15, the claim limitations “a capsule having a distal end and a proximal end, the proximal end of expandable member being coupled to the distal end of said capsule” in lines 3-4 are indefinite because it is unclear if these claim limitations of capsule having a distal end and a proximal end, the proximal end of expandable member being coupled to the distal end of said capsule is same as the claim limitations that are already recited in claim 13 or additional limitations.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 6-13 and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 2019/0388096; hereinafter Miller).
Regarding claim 1, Miller discloses a method and apparats for clamping tissue and occluding tubular anatomical structures. Miller shows a locator device (see abstract; fig. 23, 26, 35, 29-40) comprising: an expandable member (see par. [0011], [0059], fig. 1, 5, 23 and 25) having a distal end and a proximal end (see fig. 1, 5, 23 and 25) and shiftable between a delivery configuration and an expanded deployed configuration (see par. [0011], [0059], fig. 1, 5, 23 and 25); a capsule having a distal end and a proximal end (see 310 in fig. 23-25), the proximal end of said expandable member being coupled to the distal end of said capsule (see 310 in fig. 24); and a securement feature positioned to hold said expandable member in the expanded deployed configuration (see 320 in fig. 25); wherein said locator device is deliverable to a target site within a patient in the delivery configuration (see abstract; fig. 21-25, 40-41) and imageable from a different site within the patient when in the expanded deployed configuration (see par. [0010], [0090], [0100], [0104]).
Regarding claim 2, Mills shows wherein said locator device is deliverable to the target site with a delivery system (see 305 in fig. 18-20).
With regards to claim limitation “said expandable member and capsule are separable from the delivery system to be deployed, coupled together, at the target side" is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Miller is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 3, Miller shows further comprising an actuator (see fig. 73) extending proximally from the distal end of said expandable member and retractable proximally to shift said expandable member from the delivery configuration to the expanded deployed configuration (see fig. 73 and par. [0072]).
Regarding claim 6, Miller shows wherein said actuator includes one or more actuator elements each having a proximal end and a distal end and extending from the distal end of said actuator element at the distal end of said expandable member to the proximal end of said actuator element within said capsule (see fig. 30 and 73; par. [0072]).
Regarding claim 7, Millers shows wherein said securement feature is positioned to extend laterally away from said expandable member to engage laterally with said capsule to hold said expandable member with respect to said capsule to hold said expandable member in the expanded deployed configuration (see fig. 25, 26, 27 and 73).
Regarding claim 8, Miller shows wherein the proximal end of at least one of said one or more actuator elements is biased outwardly to secure said securement feature within a window defined in said capsule upon proximal retraction of said at least one of said one or more actuator elements to hold said expandable member to the expanded deployed configuration (see fig. 25, 26, 27 and 73).
Regarding claim 9, Miller shows wherein said securement feature is releasable (see fig. 25, 26, 27, 40 and abstract).
With regards to claim limitation “releasable from engagement within the window to allow said expandable member to return to the delivery configuration " is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Miller is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 10, Miller shows wherein said expandable member is formed of a shape memory material configured to return said expandable member to the delivery configuration (see par. [0059], [0076], [0078]).
Regarding claim 11, Millers wherein said expandable member is formed of a plurality of elongated elements formed of a shape memory material configured to bow outwardly into an expanded basket-type configuration upon application of force thereto (see par. [0059], [0076], [0078]; fig. 1), and configured to return said expandable member to the delivery configuration upon release of the force (see par. [0059], [0076], [0078]; fig. 1).
Regarding claim 12, Miller discloses a method and apparats for clamping tissue and occluding tubular anatomical structures. Miller shows a locator (see abstract; fig. 23, 26, 35, 29-40) comprising an expandable member having a proximal end and a distal end and shiftable between a delivery configuration and an expanded deployed configuration sized to engage an interior of an anatomical structure in which the locator is deployed (see abstract; fig. 23, 26, 35, 29-40); a capsule having a distal end and a proximal end (see 310 in fig. 23-25), the proximal end f said expandable member being coupled to the distal end of said capsule (see fig. 23-25), and a delivery system (see 305 in fig. 21-25) operatively associated with said locator (see abstract; fig. 21-25); wherein said locator is separable from said delivery system to be deployed at the target site in the expanded deployed configuration (see abstract; fig. 21-25, 40-41).
Regarding claim 13, further comprising an actuator (see fig. 73) operably coupled with said expandable member and retractable proximally to shift said expandable member from the delivery configuration to the expanded deployed configuration (see fig. 73 and par. [0072]).
Regarding claim 16, Miller discloses a method and apparats for clamping tissue and occluding tubular anatomical structures. Miller shows a method of locating a target site at a first anatomical location from a site at a second anatomical location (see par. [0010], [0090], [0100], [0104]), said method comprising: delivering a locator to the target site (see abstract; fig. 23, 26, 35, 29-40), the locator being configured to shift between a delivery configuration and an expanded deployed configuration (see par. [0011], [0059], fig. 1, 5, 23 and 25); shifting the locator to an expanded deployed configuration (see par. [0011], [0059], fig. 1, 5, 23 and 25); and imaging the locator from the second anatomical location when the locator is in the expanded deployed configuration (see par. [0010], [0090], [0100], [0104]).
Regarding claim 17, Miller shows wherein the locator comprises an expandable member formed of a material imageable from the second anatomical location (see par. [0010], [0090], [0100], [0104]).
Regarding claim 18, Miller shows further comprising expanding an anatomical wall at the first anatomical location to facilitate imaging of the expanded locator and the first anatomical location from the second anatomical location ((see par. [0010], [0090], [0100], [0104]).
Regarding claim 19, Miller shows further comprising securing the locator in the expanded deployed configuration and separating the locator from the delivery system used to deliver the locator to the target site to deploy the locator at the target site (see abstract; fig. 24-25 and 40-41).
Regarding claim 20, Miller shows Miller shows further comprising returning the locator to the delivery configuration and removing the locator from the target site (see fig. 40-41).
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 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Miller et al. (US 2019/0388096; hereinafter Miller), in view of Noonan et al. (US 2017/0119412; hereinafter Noonan).
Regarding claim 4, Miller discloses the invention substantially as described in the 102 rejection above, but fails to explicitly state that the actuator includes a pull wire extending proximally to a proximal end of said pull wire controllable by a medical professional to shift said expandable member between the delivery configuration and the expanded deployed configuration.
Noonan discloses an object capture with a basket. Noonan teaches actuator having a pull wire extending proximally to a proximal end of pull wire controllable by a medical professional to shift said expandable member between the delivery configuration and the expanded deployed configuration (see par. [0083]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of a pull wire extending proximally to a proximal end of pull wire controllable by a medical professional to shift said expandable member between the delivery configuration and the expanded deployed configuration in the invention of Miller, as taught by Noonan, to be able to provide better control of the expandable member by providing pull wires to individually control different portion of the expandable member.
Regarding claim 5, Miller and Noonan disclose the invention substantially as described in the 103 rejection above, furthermore, Noonan teaches said pull wire has a proximal section extending to the proximal end pull wire, and a distal section extending from said proximal section to the distal end of said expandable member (see par. [0083]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of pull wire has a proximal section extending to the proximal end thereof, and a distal section extending from said proximal section to the distal end of said expandable member in the invention of Miller, as taught by Noonan, to be able to provide better control of the expandable member by providing pull wires to individually control different portion of the expandable member.
Regarding claim limitation “said proximal pull wire section is separable from said distal pull wire section to deploy said locator device at the target site" is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Miller and Noonan is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 14, Miller discloses the invention substantially as described in the 102 rejection above, but fails to explicitly state that the actuator includes a pull wire extending proximally to a handle at a proximal end of said delivery system controllable by a medical professional to shift said expandable member between the delivery configuration and the expanded deployed configuration; and said pull wire is separable from said expandable member to allow separation of said locator from said delivery system.
Noonan discloses an object capture with a basket. Noonan teaches actuator includes a pull wire extending proximally to a handle at a proximal end of said delivery system controllable by a medical professional to shift said expandable member between the delivery configuration and the expanded deployed configuration (see par. [0083]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of actuator includes a pull wire extending proximally to a handle at a proximal end of said delivery system controllable by a medical professional to shift said expandable member between the delivery configuration and the expanded deployed configuration in the invention of Miller, as taught by Noonan, to be able to provide better control of the expandable member by providing pull wires to individually control different portion of the expandable member.
Regarding claim limitation “said pull wire is separable from said expandable member to allow separation of said locator from said delivery system " is directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Miller and Noonan is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
Regarding claim 15, Miller shows wherein said locator device further comprises: a capsule having a distal end and a proximal end (see 310 in fig. 23-25), the proximal end of said expandable member being coupled to the distal end of said capsule (see fig. 23-25); and a securement feature positioned to hold said expandable member in the expanded deployed configuration (see 320 in fig. 25, 31 and 35).
Response to Arguments
Upon further consideration, the examiner has withdrawn the previous claim interpretation under 35 USC 112 (f) for claim elements “expandable member” in claims 1, 12 and 17, and “delivery system” in claim 12.
The previous claim rejection under 35 USC 112 (b) of claims 4-10 and 12-20 has been withdrawn in view of Applicant’s amendments to claim 4-7, 12, 13, 15, 16, 18 and 19.
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments on pages 7-8, with respect to claim interpretation under 35 USC 112 (f), the examiner respectfully disagrees. The examiner maintains that claim elements “a securement feature” in claims 1, 15; “a delivery system” in claims 2, 12; “a locator” in claims 12, 16 do invoke 35 USC 112 (f) because the claim limitations use a term used as a substitute for “means” that is a generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. For claim element “securement feature”, the examiner notes that securement feature is not a proper structure and is a generic placeholder not modified by sufficient structure for performing the claim function (“...hold said expandable member in the expanded deployed configuration”).
For claim element “delivery system”, the examiner notes that a delivery system is not a proper structure and is a generic placeholder not modified by sufficient structure for performing the claim function (said locator device is deliverable to the target site with a delivery system in claim 2). MPEP 2181 lists claim elements that would invoke 35 USC 112 (f) (“mechanism for,” “module for,” “device for,” “unit for,” “component for,” “element for,” “member for,” “apparatus for,” “machine for,” or “system for”). The Applicant argues that a delivery system is well understood to one of ordinary skill in the art as a physical/structural components, however, the examiner notes that a delivery system is not well known structure such as catheter, introducers, sheaths, guidewires, or other known deployment mechanism to transport device to a target site. As stated above, MPEP 2181 clearly stats that claim recites “system for” would invoke 35 USC 112 (f).
For claim element “locator”, the examiner notes that locator is not a proper structure and is a generic placeholder not modified by sufficient structure for performing the claim function (“...engage an interior of an anatomical structure” in claim 12 and “...shift between a delivery configuration and an expanded deployed configuration” in claim 16). The examiner notes that the claim element “locator” is not well known in art to be used as a beacon which is clearly understandable to anyone of ordinary skill in the art as a structure.
In response to Applicant’s arguments on pages 9-12, with respect to prior art rejection of 1, 2, 3, 7, 12 and 13, the examiner respectfully disagrees.
With respect to claim 1, the applicant argues that prior art Miller does not disclose all the claim limitations set forth in claim 1, particularly the claim limitations of the proximal end of said expandable member being coupled to the distal end of said capsule; and the securement feature positioned to hold said expandable member in the expanded deployed configuration, the examiner respectfully disagrees. Claim 1 does not limit that the proximal end of said expandable member is attached or directed attached to the distal end of the capsule, or that the proximal end of said expandable member is directly coupled to the distal end of the capsule. The examiner has interpreted the term “couple” as linked or come together between two parts. The examiner maintains that prior art Miller does show a capsule having a distal end and a proximal end (see 310 in fig. 23-25), the proximal end of said expandable member being coupled to the distal end of said capsule (figs. 23-25 shows that the proximal end of the expandable member 205 is indirectly coupled to the distal end of capsule 310). Furthermore, the examiner notes that claim 1 merely limits that the securement feature is positioned to hold the expandable member in the expanded deployed configured, but claim 1 does not limit how the expandable member is expanded in the deployed configuration. Therefore, the examiner maintains that Miller does show a securement feature positioned to hold said expandable member in the expanded deployed configuration (fig. 25 clearly shows that the securement features 320 is positioned to hold the expandable member 205 in the expanded deployed configuration).
In response to Applicant’s argument on page 10, with respect to claim 2, the examiner respectfully disagrees. The examiner maintains Miller shows wherein said locator device is deliverable to the target site with a delivery system (see 305 in fig. 18-20). In fig. 8-9, Miller shows that the capsule 310 and delivery system are separable, and fig. 24 shows that expandable member 205 and capsule 310 are separable from the delivery system to be deployed, coupled together, at the target site. The examiner notes that claim 2 does not limit that the expandable member and the whole capsule are totally separable from the delivery system. Therefore, the claim limitations “said expandable member and capsule are separable from the delivery system to be deployed, coupled together, at the target side" are directed to the intended use of the invention. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Therefore, as taught, the combined invention disclosed by Miller is capable of performing the functions as set forth by applicant. Also, see MPEP 2114.
In response to Applicant’s argument on page 10, with respect to claim 3, the examiner respectfully disagrees. The Applicant argues that since Miller states that the expandable member naturally expands into an expanded configuration, there is no reason why one of ordinary skill in the art modify Miller to include an actuator to shift the distal implant body 215, however, the examiner for claim 3 did not propose any modification to Miller to include the actuator. Furthermore, claim 3 merely limits an actuator to shift the expandable member from delivery configuration to the expanded deployed configuration, but the claim 3 does not limit that the actuator is performing the expanding of the expandable member. Miller shows further comprising an actuator (see fig. 73) extending proximally from the distal end of said expandable member and retractable proximally to shift said expandable member from the delivery configuration to the expanded deployed configuration (see fig. 73 and par. [0072]).
In response to Applicant’s argument on pages 10-11, with respect to claim 7, the examiner respectfully disagrees. The examiner maintains that Millers does show wherein said securement feature is positioned to extend laterally away from said expandable member to engage laterally with said capsule to hold said expandable member with respect to said capsule to hold said expandable member in the expanded deployed configuration (fig. 25, 26, 27 and 73 shows that the securement features 320 is positioned to extend laterally away from expandable member 205 to engage laterally with said capsule 310 to hold the expandable member 205 with respect to said capsule 310 to hold said expandable member 205 in the expanded deployed configuration).
In response to Applicant’s argument on page 11, with respect to claim 12, the examiner respectfully disagrees. The applicant argues that prior art Miller does not disclose all the claim limitations set forth in claim 1, particularly the claim limitations of the proximal end of said expandable member being coupled to the distal end of said capsule; and that the locator shiftable between a delivery configuration and an expanded deployed configuration sized to engage an interior of an anatomical structure. Claim 12 does not limit that the proximal end of said expandable member is attached or directed attached to the distal end of the capsule, or that the proximal end of said expandable member is directly coupled to the distal end of the capsule. The examiner has interpreted the term “couple” as linked or come together between two parts. The examiner maintains that prior art Miller does show a capsule having a distal end and a proximal end (see 310 in fig. 23-25), the proximal end of said expandable member being coupled to the distal end of said capsule (figs. 23-25 shows that the proximal end of the expandable member 205 is indirectly coupled to the distal end of capsule 310). Furthermore, the examiner notes that claim 12 merely limits that the locator in expanded deployed configuration sized to engage an interior of an anatomical structure, but claim 12 does not limit how the location engages with the interior of an anatomical structure or if the location directly engages with the interior of the anatomical structure. Therefore, the examiner maintains that Miller does show a locator comprising an expandable member having a proximal end and a distal end and shiftable between a delivery configuration and an expanded deployed configuration sized to engage an interior of an anatomical structure in which the locator is deployed (see abstract; fig. 23, 26, 35, 29-40 shows that the locator in inserted through blood vessel 450; which reads on the claim limitation of “engage an interior of an anatomical structure”).
In response to Applicant’s argument on pages 11-12, with respect to claim 13, the examiner respectfully disagrees. The Applicant argues that since Miller states that the expandable member naturally expands into an expanded configuration, there is no reason why one of ordinary skill in the art modify Miller to include an actuator to shift the distal implant body 215, however, the examiner for claim 13 did not propose any modification to Miller to include the actuator. Furthermore, claim 13 merely limits an actuator to shift the expandable member from delivery configuration to the expanded deployed configuration, but the claim 13 does not limit that the actuator is performing the expanding of the expandable member. Miller shows further comprising an actuator (see fig. 73) extending proximally from the distal end of said expandable member and retractable proximally to shift said expandable member from the delivery configuration to the expanded deployed configuration (see fig. 73 and par. [0072]).
In response to Applicant’s arguments on pages 12-13, with respect to claims 4-5 and 14-15, the examiner respectfully disagrees. The Applicant argues that since Miller discloses that the expandable member naturally expands into an expanded configuration, it would not have been obvious to provide pull wire in Miller. The examiner notes that Miller disclosing that the expandable member comprising elastic material that can expand naturally does not teach away to adding pull wires to shift said expandable member between delivery configuration and the expanded deployed configuration. In par. [0072], Miller states an actuator can be used to expose the distal implant and allow the legs (expandable members) to expand radially. Therefore, the examiner maintains that one of ordinary skill in the art would have found it obvious to have utilized the teaching of a pull wire extending proximally to a proximal end of pull wire controllable by a medical professional to shift said expandable member between the delivery configuration and the expanded deployed configuration in the invention of Miller, as taught by Noonan, to be able to provide better control of the expandable member by providing pull wires to individually control different portion of the expandable member.
With regards to claim 15, the examiner notes that claim 15 merely limits that the securement feature is positioned to hold the expandable member in the expanded deployed configured, but claim 13 does not limit how the expandable member is expanded in the deployed configuration. Therefore, the examiner maintains that Miller does show a securement feature positioned to hold said expandable member in the expanded deployed configuration (fig. 25 clearly shows that the securement features 320 is positioned to hold the expandable member 205 in the expanded deployed configuration).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sharma et al. (US 2021/0361342) discloses a medical delivery system and teaches a capsule (see fig. 5 and 6) and a a securement feature (see fig. 5 and 6).
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 SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 5pm.
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, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797
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