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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the drape (first recited in claim 1) and the instrument (first recited in claim 12) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-18 are objected to because of the following informalities:
Each of claims 2-18 recite “[t]he assembly” in at least their respective line 1. This should be changed to “[t]he drape adapter assembly” to establish proper antecedent basis with the “drape adapter assembly” recited in claim 1.
Claim 13 recites “the instrument alignment tabs”. This should be “the one or more instrument alignment tabs”, to establish proper antecedent basis with “one or more instrument alignment tabs” recited in parent claim 12. The Examiner notes that “the instrument alignment tabs” has been interpreted to be “the one or more instrument alignment tabs”.
Claim 15 recites “the one or more axial alignment features”. This should be “the one or more axial instrument alignment features” to establish proper antecedent basis with “one or more axial instrument alignment features” recited in parent claim 14.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-10 and 12-14 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Flatt (US2020/0170724).
Flatt discloses:
Re claim 1. A drape adapter assembly for securing a drape to a portion of a robotic medical system (mounting system 20 for securing a drape 50 to end effector EE, Fig. 2-3, para. [0061][0062]), comprising:
an outer housing (sterile barrier assembly 22, Fig. 14A, para. [0051]) configured to connect to the robotic medical system (coupled to first mounting portion 24, Fig. 14A-B, para. [0053]; mounting portion 24 for connection to robotic arm R, para. [0057]) such that the drape is positioned between the outer housing and the portion of the robotic medical system (drape 50 positioned between barrier assembly 22 and end effector EE, Fig. 1-3; see drape 50 attached to outer surface of interface plate 54, para. [0061]);
an inner housing (inner housing defined by mounting portions 24, 26, Fig. 2, 15B) disposed at least partially within the outer housing (mounting portions 24, 26 disposed partially within assembly 22, Fig. 14A-15B) and configured to carry one or more moveable actuation elements therein (configured to carry kinematic couplers 32 within receptacles 34, Fig. 5, SA, 15B, para. [0057]), the inner housing comprising:
a first inner housing portion (first mounting portion 24, Fig. 14A, para. [0057]; connector Cl disposed within connector C3, Fig. 14B); and
a second inner housing portion (second mounting portion 26, Fig. 15A, para. [0055]) fastened to the first inner housing portion (fastened to first mounting portion 24 via ste1ile barrier assembly 22, Fig. 15B, para. [0069]) such that the first inner housing portion and the second inner housing portion are axially retained to the outer housing (Fig. 15B).
Re claim 2. The assembly of claim 1, wherein the outer housing includes an inner wall (inner wall defined by interface plates 52, 54, Fig. 14A, para. [0061]) and one or more tabs extending from the inner wall (indexing fingers 64, Fig. 14A, para. [0064]; coupling 30 extending from interface plates 52, 54, Fig. 14A), wherein the one or more tabs are configured to be disposed between the first inner housing portion and the second inner housing portion to axially retain the inner housing (indexing fingers 64 associated with indexing recess 66 of the first and second mounting portions 24, 26 for connecting the mounting portions 24, 26 to the sterile barrier 22, Fig. 14A-15B, para. [0064]; coupling 30 to releasably secure first and second mounting portions 24, 26, Fig. 14A-15B, para. [0053]).
Re claim 3. The assembly of claim 2, wherein the first inner housing portion is configured to be inserted into the outer housing through a first outer housing opening (connector Cl of first mounting portion 24 configured to be inserted into proximal connector C3 of barrier assembly 22 through an opening in connector C3, Fig. 14A-B) and the second inner housing portion is configured to be inserted into the outer housing through a second outer housing opening (connector C1 of second mounting portion 26 configured to be inserted into distal connector C3 of barrier assembly 22 through an opening in connector C3, Fig. 15A-B) such that the one or more tabs of the outer housing are trapped between the first inner housing portion and the second inner housing portion (Fig. 14A-15B).
Re claim 4. The assembly of claim 3, wherein the inner housing defines a trough (trough defined by first indexing recess 66 of the mounting portion 24, Fig. 14A, para. [0064]), wherein the one or more tabs of the outer housing radially extend (the tabs extend radially and axially into the trough) into the trough (Fig. 14A-B).
Re claim 5. The assembly of claim 4, wherein the inner housing is configured to rotate relative to the outer housing (mounting portions 24, 26 can rotate relative to the barrier assembly 22 when the mounting portions 24,26 are detached from the assembly 22, Fig. 14A-15B) between an instrument-retained position (connected position, Fig. 15B) and instrument-unrestrained position (disconnected position, Fig. 14A).
Re claim 6. The assembly of claim 5, wherein the one or more tabs include one or more interaction tabs (second indexing finger 64, Fig. 14A, para. [0064]; coupling 30, Fig. 14A), wherein the inner housing includes one or more interaction components configured to interact with the one or more interaction tabs (second recess 66 of the mounting portion 24, Fig. 14A, para. [0064]; balls 75, 77 to interact with coupling 30, Fig. 14A-15B, para. [0073]), wherein the one or more interaction tabs and the one or more interaction components are configured to retain the inner housing in the instrument-unrestrained position and the instrument-retained position, and/or are configured to provide tactile feedback when the inner housing is rotated to the instrument-retained position or instrument-unrestrained position (intended use, fingers 64 can provide tactile feedback when the mounting portions 24, 26 are rotated to the connected position, Fig. 15B; see indexing fingers 64 being configured to promote proper alignment, para. [0065]).
Re claim 7. The assembly of claim 6, wherein the one or more interaction tabs include a first radial detent and a second radial detent (first and second ball detents 78, 80, Fig. 14A, para. 0070]), and wherein the one or more interaction components include a biased interaction member biased radially toward the one or more interaction tabs to radially engage the biased interaction member to the one or more interaction tabs and to cause the biased interaction member to enter the first radial detent or the second radial detent when rotationally aligned therewith (balls 75, 77 biased tow radially engage the ball detents 78, 80 when aligned, Fig. 14A-15B, para. [0073]).
Re claim 8. The assembly of claim 7, wherein the biased interaction member and the plurality of detents are configured to allow the biased interaction member to be urged out of the plurality of detents with a relative rotation of the outer housing relative to the inner housing (balls 77 can be pulled out of the detent pocket, para. [0098]).
Re claim 9. The assembly of claim 6, wherein the one or more tabs include one or more limit tabs (third indexing finger 64, Fig. 14A, para. [0064]), and wherein the inner housing includes one or more limit features (third recess 66 of the mounting portion 24, Fig. 14A, para. [0064]) configured to interact with the one or more limit tabs to limit a range of rotational motion of the inner housing relative to the outer housing (when mounting portion 24 if coupled to barrier assembly 22, the recess 66 implicitly limits rotational motion of the mounting portion 24, Fig. 14B, 15B).
Re claim 10. The assembly of claim 9, wherein the one or more limit tabs (third indexing finger 64, Fig. 14A, para. [0064]) or the one or more limit features (third recess 66 of the mounting portion 24, Fig. 14A, para. [0064]) include a limit pin (64) extending axially therefrom, and the other of the one or more limit tabs and the one or more limit features include an axial slot (recess 66) configured to receive the limit pin, wherein a dimension of the axial slot defines the range of rotation motion of the inner housing relative to the outer housing (See Fig. 4).
Re claim 12. The assembly of claim 3, wherein the outer housing (22) includes one or more instrument alignment tabs (another one of the indexing fingers 64. One indexing finger 64 corresponds to the one or more tabs recited in parent claim 2, another of the indexing fingers 64 corresponds to the one or more instrument alignment tabs recited in this claim 12.) distal of the one or more tabs (one of the indexing fingers 64) of the outer housing, wherein the one or more instrument alignment tabs are configured to align an instrument (instrument is end effector EE which is connected to 26. See paragraphs [0051] & [0064]) for insertion in the instrument-unrestrained position, and to retain an instrument (end effector EE) to the assembly in the instrument-retained position.
Re claim 13. The assembly of claim 12, wherein the first inner housing portion (24) includes one or more alignment slots (66) defined in an outer surface thereof configured to align with the instrument alignment tabs (64) to allow axial advancement of the first inner housing portion (24) into the outer housing (22) from the first outer housing opening (connector Cl of first mounting portion 24 configured to be inserted into proximal connector C3 of barrier assembly 22 through an opening in connector C3, Fig. 14A-B).
Re claim 14. The assembly of claim 13, wherein the first inner housing portion (24) includes one or more axial instrument alignment features (34) configured to force rotational alignment of the instrument (EE) and the inner housing (inner housing defined by mounting portions 24, 26, Fig. 2, 15B) when the instrument is inserted in the instrument-unrestrained position.
Claim(s) 1-2, 11, and 16-18 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Duval (US2011/0282359).
Duval discloses:
Re claim 1. A drape adapter assembly for securing a drape (1000 or 2000; para. [0015]) to a portion of a robotic medical system, comprising:
an outer housing (542h; para. [0111]) configured to connect to the robotic medical system such that the drape is positioned between the outer housing and the portion of the robotic medical system (See Fig. 10- drape 1000/2000 between 542 and 960);
an inner housing (542i) disposed at least partially within the outer housing and configured to carry one or more moveable actuation elements (542b - 542e; para. [0116],[0113]) therein, the inner housing comprising:
a first inner housing portion (one of 542i or 542a); and
a second inner housing portion (the other of 542i or 542a) fastened to the first inner housing portion such that the first inner housing portion and the second inner housing portion are axially retained to the outer housing.
Re claim 2. The assembly of claim 1, wherein the outer housing (542h) includes an inner wall and one or more tabs (para. [0111] - “As shown, the manipulator includes an inner frame 542i movably coupled to an outer shell 542h, for example by sliding joints, rails, or the like.” The portion of 542 to which the sliding joints or rails are connected are an inner wall, and the sliding joints or rails form tabs. extending from the inner wall, wherein the one or more tabs are configured to be disposed between the first inner housing portion and the second inner housing portion to axially retain the inner housing (542i; para. [0111]).
Re claim 11. The assembly of claim 1, wherein the inner housing(542i) defines one or more axial channels (See Fig. 10; para. [0124], [0116] - “Outputs 542b, 542c, 542d, and 542e distally protrude from the distal face 542a of instrument manipulator 542, as shown for example in FIG. 5C-4”) configured to receive and allow axial movement of the actuation elements (542b - 542e).
Re claim 16. The assembly of claim 1, wherein the inner housing (542i, 542a) is entirely contained within the outer housing(542h) (See Fig. 5A-1).
Re claim 17. The assembly of claim 1, wherein the outer housing is generally cylindrical and has proximal portion having a bell shape (See annotated Fig. 5A-1 below).
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Re claim 18. The assembly of claim 17, wherein the outer housing comprises one or more alignment lands extending from an inner wall of the proximal portion for alignment with an instrument controller (para. [0121]; Fig. 10; 962b-962e are actuated by actuating elements 542a-542e to control the robotic medical system, and aligned parallel with the alignment land(s)) of the robotic medical system.
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Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art to claim 15 is Flatt (US2020/0170724).
In regards to claim 15, while Flatt discloses one or more axial alignment features (34) (on the first inner housing portion (24) as required by parent claim 14), Flatt does not disclose one or more axial pins extending distally from the first inner housing portion (24) and configured to insert into an alignment aperture on a proximal side of the instrument. Rather in Flatt the axial pins (34) are inserted around balls (32) on the outer housing (22). There is no teaching, suggestion, or motivation in the prior art to modify the prior art to have all of the missing claim limitations, in combination with all other claim limitations, without the use of impermissible hindsight.
Response to Arguments
Applicant's arguments filed 4/02/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “single inner housing”, that two components being “axially retained” to each other precludes any axial movement between those two components) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The Applicant argues that Flatt does not disclose “a second inner housing portion fastened to the first inner housing portion” because in Flatt the components are releasably attached through the sterile barrier assembly. The Examiner notes that the BRI of the term fastened encompasses indirect connections and connections made using other components, including encompassing being releasably attached through another component such as a sterile barrier assembly. Indeed, as pointed out by the Applicant, the specification of the instant application includes such fastening methods such as “screwed on, glued, magnetically attached, otherwise attached”. The Examiner notes that the term “screwed on” encompasses using intermediate components, e.g. screw(s), bolt(s), etc.. Likewise, the term “glued” implies another material, i.e. an adhesive, between the first inner housing and the second inner housing.
The Applicant argues that in Duval the outer shell (542h) and the inner frame (542i)/distal face (542a) of inner frame of Duval are not components of a drape adapter assembly but part of an instrument manipulator 542. The Examiner notes that the term “drape adapter assembly” is recited in the preamble of the claims of the instant application, and the body of the claims fully and intrinsically set forth all of the limitations of the claimed invention. Therefore, the components in question in Duval are part of a drape adapter assembly because Duval anticipates the limitations of the claims. See MPEP § 2111.02. Furthermore, the Examiner notes that a component can be part of a drape adapter assembly that in turn is part of an instrument manipulator; being part of an instrument manipulator does not preclude being part of a drape adapter assembly that is part of an instrument manipulator.
The Applicant argues that Duval does not disclose the claimed “second inner housing portion fastened to the first inner housing portion such that the first inner housing portion and the second inner housing portion are axially retained to the outer housing” because, allegedly, axial movement between the first inner housing portion and the outer housing or between the second inner housing portion and the outer housing means that the first or second inner housing portions cannot be not axially retained in the outer housing. The Examiner notes that the BRI of the term “axially retained” does not preclude axial movement between the component being axially retained in another component. Furthermore, the axial movement in Duval occurs during assembly prior to a latching process being completed. Likewise, in the instant application, the components in question appear to be movable relative to each other during assembly, and appear capable of being moved axially relative to each other if the components are unfastened from each other. Claim 1 does not claim a device that can never be disassembled such that axial movement between the components in question is never possible.
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 GREGORY T PRATHER whose telephone number is (571)270-5412. The examiner can normally be reached Monday-Thursday 9 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Minnah Seoh can be reached at 571-270-7778. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GREGORY T PRATHER/
Examiner, Art Unit 3618
/MINNAH L SEOH/ Supervisory Patent Examiner, Art Unit 3618