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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/11/2025 has been entered.
Election/Restrictions
Claims 3-5, 14, 16, 19, 21, 25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made with traverse (of Species F, Figs 40-46) in the reply filed on 10/20/2023.
Response to Arguments
Applicant’s amendments have overcome the previous rejections in view of Raymond.
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive. Alexander was reinterpreted in view of applicant’s amendments. However, Examiner notes that applicant argues that Alexander folds and therefore does not disclose that it radially expands. This is not persuasive the examiner makes it clear in the rejection that the “unexpanded position” is the position shown in Fig 1c, when it is already unfolded, and the expanded position is shown in Fig 1d. In other words, the “unexpanded position” is NOT the position shown in Fig 1a and that after “folding”, as shown in Fig 1c, can be considered the “unexpanded position.” Likewise applicant argues makes arguments against DiPoto but that argument is directed to the embodiment as shown in Figs 1-6 with slot 48 and pins 30, 44. However, the embodiment of Fig 193a-193b of DiPoto was relied upon. As such, the arguments against DiPoto is moot and the rejection of Alexander in view of DiPoto is deemed proper. New rejections for claims 15, 18, 26 were made in view of applicant’s amendments.
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: “actuator assembly” in claim 15.
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 (paragraph 146, which discuss object placed within the device to expand it) 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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6, 8, 10-13, 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Alexander US 2013/0190558 in view of Di Poto US 2005/0245942.
Regarding Claim 1, Alexander discloses a visualization device (#10, Figs 1a-1d) comprising:
an expandable retractor assembly (Figs 1a-d) having a visualization channel (#32), the retractor assembly comprising a first retractor member (#14 or #16) and a second retractor member (#12), and the retractor assembly configured to be coupled to an actuator assembly configured to actuate the retractor assembly (the examiner notes that the actuator assembly is functionally recited and not part of the claimed invention and that an actuator assembly such as a tool, like forceps or other type of the device can be used to actuate/move the retractor members),
wherein the retraction assembly transitions from an unexpanded position (position shown in Fig 1c) to an expanded position (position shown in Fig 1d),
wherein the retractor assembly expands uniformly radially outward along a full length of the assembly where expansion is taken along multiple radial directions (Fig 1c-1d, the entire length is uniformly radially expanded radially in multiple radial directions, as indicated by the dotted lines in the Fig below) such that a diameter of the assembly is greater in an expanded position (diameter as seen in Fig 1d, paragraph 60) than in an unexpanded position (diameter as seen in Fig 1c).
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Regarding Claim 6, Alexander discloses wherein the first retractor member is configured to move with respect to the second retractor member or the second retractor member is configured to move with respect to the first retractor member (as seen in Fig 1c-1d, paragraph 60-61).
Regarding Claim 8, Alexander discloses the first retractor member and the second retractor member are configured to move with respect to each other (as seen in Fig 1c-1d, paragraph 60-61).
Regarding Claim 10, Alexander discloses the first retractor member (#14 or #16) is positioned within the second retractor member (#12)(as seen in Figs 1c-1d).
Regarding Claim 11, Alexander discloses the device of claim 1, wherein the second retractor member (#12) is a sheath (Figs 1a-1d #12 is a “c” shaped sheath).
Regarding Claim 12-13, Alexander discloses the first retractor member forms the visualization channel (as seen in Fig 1c-1d)(paragraph 59), a surface (inner or interior surface of #14 or #16) of the first retractor member forms the visualization channel (Fig 1c-1d).
Alexander discloses the claimed invention as discussed above in claim 1 where an expandable joint (#8) includes “slider rails” (not shown) that is used to expand the device (paragraph 60, Fig 1c-1d, as indicated by the solid arrows) but does not disclose the first retractor member comprising a pin coupled thereto, the second retractor member defining a slot for receiving the pin, wherein when the retractor assembly transitions from an unexpanded state to an expanded state, the pin slides within the slot from a first position to a second position.
DiPoto discloses a similar visualization device (#9182, Figs 193a-193b) comprising:
an expandable retractor assembly (Fig 193a-193b) having a visualization channel (channel extending through #9182, Fig 193a-193b), the retractor assembly comprising a first retractor member (#9184) and a second retractor member (#9186),
a pin (#9190) and a slot (#9188),
wherein the pin is coupled to the first retractor member (Fig 193a-193b, paragraph 664) and the slot is defined in the second retractor member and configured to receive the pin (Fig 193a-193b, paragraph 664), such that when the retractor assembly transitions from an unexpanded state to an expanded state, the pin slides within the slot from a first position (as seen in Fig 193a) to a second position (as seen in Fig 193b, paragraph 664), where the pin and slot allows helps guide expansion of the visualization device (paragraph 664).
It would have been obvious to modify to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the expandable joint (#8) of Alexander to have the pin and slot, where the pin is coupled to the first retractor member and the slot is defined in the second retractor member in view of DiPoto above because where the pin and slot allows helps guide expansion of the visualization device, where the pin and slot provide a rail type structure that aids in expansion. Examiner notes that one of ordinary skill recognizes that the slot would be extend generally linear such that the retractor members of Alexander is able to slide relative to each other to affect a uniform radial expansion (as seen in Fig 1c-1d of Alexander) along its full length.
Regarding Claim 38, Alexander as modified discloses the slot is linear (as discussed above in the modification in view of DiPoto, Fig 193a-193b in DiPito).
Regarding Claim 37, Alexander as modified discloses the claimed invention as discussed above where the pin and slot would be located along the length of the retractor assembly (see rejection for claim 1 above) but does not disclose the pin and slot are located centrally along the length of the retractor assembly.
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to place the pin and slot centrally along the length of the retractor assembly since it has been held that rearranging parts of an invention involves only routine skill in the art and being placed centrally is one of a finite number of locations (located proximally, centrally or distally) to place the pin and slot. In re Japikse, 86 USPQ 70. See MPEP 2144.04 (VI)(B). The examiner notes that current specification does not provide a criticality for the placement of the pin and slot.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Alexander US 2013/0190558 and Di Poto US 2005/0245942, as applied to claim 1 above, and in further view of Druma US 2015/0366583.
Alexander discloses the claimed invention as discussed above where the device can be used in the pelvic area and the spine, such as the sacrum (paragraph 8) but does not disclose wherein the visualization device is configured for insertion into a surgical site and the surgical site is in the cervical spine.
Druma discloses an expandable visualization device (as seen in Figs 1-3)(paragraph 54) that can be used in the pelvic region, sacrum region or other spinal areas such as the cervical spine such that the device can be used for visualization of different anatomies to treat different conditions (paragraph 56).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the device of Alexander as modified to be sized such that it can be configured for insertion into a surgical site and the surgical site is in the cervical spine because it is known in the art to use a visualization device on other anatomies such as the cervical spine to treat other conditions. In other words, with the modification, the device of Alexander as modified has increased utility as it can be used to provide visualization and treatment to other parts of the body, such as the cervical spine.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Alexander US 2013/0190558 and Di Poto US 2005/0245942
Regarding Claim 15, Alexander discloses a system comprising:
a visualization device (#10, Figs 1a-1d) comprising an expandable retractor assembly (Fig 1c-1d) having a visualization channel (#32), the retractor assembly comprising a first retractor member (#14 or #16) and a second retractor member (#12),
wherein when the retractor assembly transitions from an unexpanded position (position shown in Fig 1c) to an expanded position (position shown in Fig 1d),
the retractor assembly is configured to expand uniformly radially outward along a full length of the assembly where expansion is taken along multiple radial directions (Fig 1c-1d, the entire length is uniformly radially expanded radially in multiple radial directions, as indicated by the dotted lines in the Fig below) such that a diameter of the assembly is greater in an expanded position (diameter as seen in Fig 1d, paragraph 60) than in an unexpanded position (diameter as seen in Fig 1c).
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Alexander discloses the claimed invention as discussed above in claim 1 where an expandable joint (#8) includes “slider rails” (not shown) that is used to expand the device (paragraph 60, Fig 1c-1d, as indicated by the solid arrows) but does not disclose the first retractor member comprising a pin coupled thereto and a second retractor member defining a slot for receiving the pin; and an actuator assembly, wherein the actuator assembly is configured to be rotated with respect to the retractor assembly, wherein when the retractor assembly transitions from an unexpanded position to an expanded position, the pin slides within the slot from a first position to a second position, and wherein the retractor assembly couples to the actuator assembly to actuate the retractor assembly to expand uniformly radially outward along a full length of the assembly where expansion is taken along multiple radial directions such that a diameter of the assembly is greater in the expanded position than in the unexpanded position.
DiPoto discloses a similar visualization device (#9182, Figs 193a-193b) comprising:
an expandable retractor assembly (Fig 193a-193b) having a visualization channel (channel extending through #9182, Fig 193a-193b), the retractor assembly comprising a first retractor member (#9184) and a second retractor member (#9186),
a pin (#9190) and a slot (#9188),
wherein the pin is coupled to the first retractor member (Fig 193a-193b, paragraph 664) and the slot is defined in the second retractor member and configured to receive the pin (Fig 193a-193b, paragraph 664), such that when the retractor assembly transitions from an unexpanded state to an expanded state, the pin slides within the slot from a first position (as seen in Fig 193a) to a second position (as seen in Fig 193b, paragraph 664), where the pin and slot allows helps guide expansion of the visualization device (paragraph 664).
It would have been obvious to modify to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the expandable joint (#8) of Alexander to have the pin and slot, where the pin is coupled to the first retractor member and the slot is defined in the second retractor member in view of DiPoto above because where the pin and slot allows helps guide expansion of the visualization device, where the pin and slot provide a rail type structure that aids in expansion. Examiner notes that one of ordinary skill recognizes that the slot would be extend generally linear such that the retractor members of Alexander is able to slide relative to each other to effect a uniform radial expansion (as seen in Fig 1c-1d of Alexander) along its full length.
DiPoto also discloses the use of an actuator assembly (#200, Fig 16-17), wherein the actuator assembly is configured to be rotated with respect to a retractor assembly (#24, Fig 4-6 having a pin #44 and slot #48, paragraph 320) to expand the retractor assembly radially (paragraph 338, Figs 18-19, where the actuator assembly pushes the retractor assembly apart and expands radially and guided by the pin and slot arrangement).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Alexander as modified to include an actuator assembly in view of additional teachings of DiPoto because this provides a known type of device to expand a visualization device. With the modification, the examiner notes that when the actuator assembly is deployed, the outward force would cause the retractor members to move apart and because of the pin and slot arrangement, the expansion would continue to expand uniformly, radially outward in multiple radial directions (as discussed above).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Alexander US 2013/0190558 and Di Poto US 2005/0245942
Regarding Claim 26, Alexander discloses a method of using a visualization device in a surgical site comprising:
inserting at least a portion of an expandable retractor assembly (#10, Fig 1a-1c) into an incision and positioning adjacent the surgical site (paragraph 61), the retractor assembly comprising a first retractor member (#14 or #16) and a second retractor member (#12);
expanding the retractor assembly uniformly radially outward along its full length where expansion is taken along multiple radial directions (after unfolding as seen in Fig 1c, the retractor assembly is expanded, paragraph 60-61, the entire length is uniformly radially expanded radially in multiple radial directions, as indicated by the dotted lines in the Fig below)’ and
expanding a visualization channel of the retractor assembly extending from a proximal end to a distal end of the retractor assembly (Fig 1c-1d, paragraph 60-61).
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Alexander discloses the claimed invention as discussed above in claim 1 where an expandable joint (#8) includes “slider rails” (not shown) that is used to expand the device (paragraph 60, Fig 1c-1d, as indicated by the solid arrows) but does not disclose the retractor assembly comprising a first retractor member comprising a pin coupled thereto and a second retractor member defining a slot for receiving the pin; engaging an actuator assembly with the expandable retractor assembly; wherein when the retractor assembly transitions from an unexpanded position to an expanded position, the pin slides within the slot from a first position to a second position.
DiPoto discloses a similar visualization device (#9182, Figs 193a-193b) comprising:
an expandable retractor assembly (Fig 193a-193b) having a visualization channel (channel extending through #9182, Fig 193a-193b), the retractor assembly comprising a first retractor member (#9184) and a second retractor member (#9186),
a pin (#9190) and a slot (#9188),
wherein the pin is coupled to the first retractor member (Fig 193a-193b, paragraph 664) and the slot is defined in the second retractor member and configured to receive the pin (Fig 193a-193b, paragraph 664), such that when the retractor assembly transitions from an unexpanded state to an expanded state, the pin slides within the slot from a first position (as seen in Fig 193a) to a second position (as seen in Fig 193b, paragraph 664), where the pin and slot allows helps guide expansion of the visualization device (paragraph 664).
It would have been obvious to modify to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the expandable joint (#8) of Alexander to have the pin and slot, where the pin is coupled to the first retractor member and the slot is defined in the second retractor member in view of DiPoto above because where the pin and slot allows helps guide expansion of the visualization device, where the pin and slot provide a rail type structure that aids in expansion. Examiner notes that one of ordinary skill recognizes that the slot would be extend generally linear such that the retractor members of Alexander is able to slide relative to each other to affect a uniform radial expansion (as seen in Fig 1c-1d of Alexander) along its full length.
DiPoto also discloses the use of an actuator assembly (#200, Fig 16-17), wherein the actuator assembly is configured to be rotated with respect to a retractor assembly (#24, Fig 4-6 having a pin #44 and slot #48, paragraph 320) to expand the retractor assembly radially (paragraph 338, Figs 18-19, where the actuator assembly pushes the retractor assembly apart and expands radially and guided by the pin and slot arrangement).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Alexander as modified to include an actuator assembly in view of additional teachings of DiPoto because this provides a known type of device to expand a visualization device. With the modification, the examiner notes that when the actuator assembly is deployed, the outward force would cause the retractor members to move apart and because of the pin and slot arrangement, the expansion would continue to expand uniformly, radially outward in multiple radial directions (as discussed above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAN CHRISTOPHER L MERENE/Primary Examiner, Art Unit 3773